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I'll believe it when I see it.
After any required approval of the transaction by the various regulatory authorities, the Company intends to issue a dividend of the sales proceeds to ENZC shareholders on the date of record of the declared and approved dividend.
Although it sounds like the whole 250 million to the shareholders, they weren't specific saying it will be all of it.
Hope so.
One would think that Virogentics needs to be an active company in order o be sold to another entity.
If anyone is in contact with ENZC please forward to them.
Last time I tried to contact them my email was returned.
Virogentics, Inc.
Company Number
0803848455
Status
Forfeited Existence
Incorporation Date
1 December 2020 (over 2 years ago)
Dissolution Date
10 March 2023
Company Type
Domestic For-Profit Corporation
Jurisdiction
Texas (US)
Registered Address
1999 BRYAN ST STE 900
DALLAS
75201-3140
TX
USA
Alternative Names
Virogentics, Inc. (trading name, 2020-12-01 - 2023-03-10)
Inactive Directors / Officers
Diana Zhabilov, director
Vcorp Services, LLC, agent
Registry Page
https://mycpa.cpa.state.tx.us/coa/
https://opencorporates.com/companies/us_tx/0803848455
Biogenysis, Inc.
Company Number
0803848463
Status
In Existence
Incorporation Date
1 December 2020 (over 2 years ago)
Company Type
Domestic For-Profit Corporation
Jurisdiction
Texas (US)
Registered Address
1999 BRYAN ST STE 900
DALLAS
75201-3140
TX
USA
Alternative Names
Biogenysis, Inc. (trading name, 2020-12-01 - )
Agent Name
Vcorp Services, LLC
Agent Address
1999 Bryan St., Ste. 900, Dallas, TX, 75201-3136, USA
Directors / Officers
CHARLES COTROPIA, president
CHARLES COTROPIA, director
Vcorp Services, LLC, agent
Registry Page
https://mycpa.cpa.state.tx.us/coa/
https://opencorporates.com/companies/us_tx/0803848463
Really
You asked:
It doesn't cure HIV./AIDS
It lessens the threat of HIV expanding,
It keeps it in check to some extent.
It helps strengthens the immune system.
About ITV-1 - ImmunH
Most importantly, we have successfully completed Phase III for ITV-1 – ImmunH, which is comprised of a clinical trial (see Final Report https://www.immunh.com/finalreporten) conducted in Specialized Hospital for Active Treatment of Infectious and Parasitic Deceases “Professor Ivan Kirov”, Sofia on 31 patients suffering from AIDS in the advanced stages of the disease. The results of the clinical trial can be summarized as follows:
improvement in the immune indices in the absolute number of Ly, CD3 T, CD4 T, CD8 T, B Ly, NK and in the percentage of CD3 T, CD4 T, CD8 T, B Ly, NK, and of the index CD4/CD8,
decrease in the viral load,
a good treatment effect on opportunistic infections,
very good compatibility with all of the other modern antiretroviral drugs,
very good tolerance in all patients and complete absence of side effects
We are currently working on completing the final Phase IV and receiving a Permit for Mass Use on the territory of Bulgaria and complete the registration process of ITV-1 – ImmunH and bring the medicine to the market. After we have registered the medicine in Bulgaria, we will be able to register ITV-1 - ImmunH in different countries across the globe with a shortened registering process due to the Mutual Recognition Agreement (MRA) for medicinal products,
OTHER DISEASES
We have tested ITV-1 – ImmunH on volunteers suffering from other diseases such as Cancer, Chronic Hepatitis B and C, Diabetes A and B, Rheumatoid Arthritis, and other severe illnesses with tremendous healing results, as the medicine stimulates the immune answer and strengthens the immune system of the human being.
https://www.immunh.com/itv-1en
Inactivated Pepsin Fragment (IPF) Technology
One Company technology, invented by Harry Zhabilov, the CSO of the Company, includes a patented antiviral peptide that has been tested in clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria. This therapeutic, known as ITV-1, is a suspension of Inactivated Pepsin Fragment (IPF), a purified extract of porcine pepsin. ITV-1 has been shown to strengthen the immune system and may be used to facilitate a broad range of applications. ITV-1 has been tested in HIV patients in a clinical trial conducted under the strict guidelines of the European Union. HIV patients tested in these trials showed the following beneficial outcomes:
Improvement in the immune indices in the absolute number of Ly, CD3 T, CD4 T, CD8 T, B Ly, NK and in the percentage of CD3 T, CD4 T, CD8 T, B Ly, NK, and of the index CD4/CD8.
Decrease in the viral load.
Demonstrated beneficial effect on opportunistic infections.
Demonstrated very good compatibility with all of the other modern antiretroviral drugs.
Demonstrated very good tolerance in all patients and complete absence of side effects.
This Enzolytics anti-HIV treatment is now being advanced through the certification stage, after which it will be available for patient therapy. ITV-1 has also demonstrated a positive effect on different kinds of cancer due to its ability to stimulate the immune system.
https://enzolytics.com/proprietary-therapeutics/
Here is the report from ITV-1 first clinical trials:
https://www.immunh.com/finalreporten
I believe this is just the tip of the iceberg and we are not on the Titanic I repeat we are not on the Titanic.
There are a lot of unknowns that will come out once the deal closes.
This deal had to be in the works for months
Somebody wants ENZC technology and I believe ENZC management will be involved in the new company.
Where is ENZC headed?
To the Beach?
To Disneyland?
To the Moon?
Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, and Sagaliam Acquisition Corp. (NASDAQ: SAGA) ("Sagaliam"), a special purpose acquisition company ("SPAC"), announced today, April 17, 2023, they have executed a non-binding term sheet for the sale of Biogenysis, Inc. ("BGEN") and Virogentics, Inc. ("VIRO"), operating subsidiaries of Enzolytics. The value of the transaction is $250,000,000 The definitive agreement is being finalized with an expected closing date of May 19, 2023.
Under the terms of the agreement, BGEN and VIRO will become wholly owned subsidiaries of Sagaliam, currently trading on NASDAQ, and will adopt SAGA Scientific Holdings Corp. as the corporate name.
The transaction, once completed, will provide BGEN and VIRO with significant additional capital to continue their development and expansion of existing and future technology platforms. In addition, Sagaliam expects to raise additional capital through a private investment in public equities ("PIPE"). The anticipated capital raise from the PIPE is expected to be primarily used by BGEN and VIRO to pay transaction-related expenses and fund the clinical trials of ITV-1, marketing of IPF Immune™, production of fully human monoclonal antibodies (mAbs) and continued advancement in its proprietary technology involving the application of Artificial Intelligence (AI) in therapeutic discoveries and production.
The Chief Scientific Officer of VIRO, Harry Zhabilov, offered the following update on the production of ITV-1 vials for the Africa initiative and European Medicines Agency ("EMA") permitting progress, "Production of the necessary anti-HIV immunotherapy treatments for use in the hospitals located in Central and Eastern regions of Africa was successfully completed on April 12, 2023, and will be delivered to the hospitals in the coming weeks." With the preliminary results of Toxicology studies of the Company's ITV-1 anti-HIV therapeutic confirming that the therapy is non-toxic and demonstrating the safety of administration of this patented proprietary immunotherapy, VIRO has negotiating a contract with a German company to perform the pharmacokinetics methodology the EMA has required as part of the EMA permitting process. VIRO wishes to recognize the contribution that Dr. Lachezar Ivanov has made in this endeavor."
The CEO of BGEN, Dr. Gaurav Chandra, emphasized the progress being made by the Company using its Artificial Intelligence (AI) platform. "We continue to utilize our disruptive AI platform to identify conserved immutable epitopes on viruses and then produce species-specific monoclonal antibodies targeting those sites. We are advancing in production of multiple monoclonal antibodies against HIV, SARS-CoV-2, and the Feline Leukemia virus. Our AI platform drives the Company's drug discovery and development and executes our strategy to produce multiple therapeutics protected by International Patents. We take pride in strengthening our IP portfolio and protecting the anti-virus therapeutics, their production method, use in diagnostics and prognostics. Our application of Artificial Intelligence to drug formulation and creation is a move ahead of big pharma's monoclonal antibody discovery and development. We recognize that large pharmaceutical companies are now focused more than ever on the significant advantage provided by AI in creating highly successful therapeutics. We continue to engage with large pharma and discuss potential partnerships involving our AI platform."
Enzolytics CEO Charles Cotropia stated, "Enzolytics is focused on accelerating the growth of our clinical products, technology platforms and multiple programs now in progress. This agreement with Sagaliam will allow us to accelerate progress in each of these areas."
https://www.stocktitan.net/news/ENZC/enzolytics-inc-announces-execution-of-non-binding-term-sheet-with-nan3wyeoq2jm.html
So SAGA gets Biogenysis, Inc. and Virogentics, Inc. for $250,000,000.
What exactly do they get?
Well what ever is owned by Biogenysis, Inc. and Virogentics, Inc.
ENZOLYTICS, INC.
SUPPLEMENTAL REPORT
SUBSEQUENT EVENTS
December 2, 2020
Business Combination Agreement with Bioclonetics Immunotherapeutics, Inc. Resulting in Change of Control
On November 30, 2020, Enzolytics, Inc. (the “Company”) entered into a Business Combination Agreement with Bioclonetics Immunotherapeutics, Inc., (“Bioclonetics”) a Texas Corporationcontrolled by Charles S. Cotropia, the Company’s current Chief Executive Officer.
As consideration for the Business Combination, and in exchange for 100% of the issued and outstanding stock of BioClonetics, the Company has agreed to issue a total of 204,430,000 newly issued shares of Series B Preferred Stock to Charles S. Cotropia, and others Bioclonetics Designees
and 90,570,000 shares of newly issued Series B Preferred Stock to Harry Zhabilov, the Company’s
current Chief Financial Officer.
Control Block Transfer Agreement
In addition, on November 30, 2020, the Zhabilov Trust, the Company’s Controlling Shareholder,entered into a Control Block Transfer Agreement, under which the Zhabilov Trust has agreed totransfer 35,100,000 shares of Series A Preferred Stock and 231,000,000 shares of Common Stock
(together the “Control Block”) to Charles S. Cotropia and other Bioclonetics Designees.
Once such share issuances and transfers are completed, Charles S. Cotropia will be the Company’s new Control Block holder and majority shareholder, in addition to his role as Chief Executive Officer of Enzolytics, Inc., resulting in a Change of Control.
Formation of Two New Wholly-Owned Subsidiaries
Pursuant to the terms of the Business Combination Agreement, on November 24, 2020, the Company formed two new Texas corporations as wholly-owned subsidiaries for the purpose of licensing certain patented technologies: Biogenysis, Inc. and Virogentics, Inc.
Two Patent License Agreements
On November 30, 2020, Biogenysis, Inc., a wholly-owned subsidiary of Enzolytics, Inc., entered into a Patent License Agreement with Bioclonetics in order to license the U.S. Provisional Patent Application No. 63/078,482, filed September 15, 2020, entitled NOVEL HIV-BINDINGPEPTIDES for treating, preventing and reducing the risks of HIV, including all patents issuing therefrom and any foreign counterparts thereof.
Also on November 30, 2020, Virogentics, Inc., a wholly-owned subsidiary of Enzolytics, Inc., entered into a Patent License Agreement with the Zhabilov Trust in order to license the U.S. Patent No. 7,479538, entitled Irreversibly - Inactivated pepsinogen fragment and Pharmaceutical composition the same for detecting preventing and treating HIV; U.S. Patent No. 8,066982, Irreversibly - Inactivated pepsinogen fragment and Pharmaceutical composition compressing the same for detecting preventing and treating HIV, including all patents issuing therefrom and any foreign counterparts thereof.
https://www.otcmarkets.com/otcapi/company/financial-report/265788/content
The press release speaks of mAbs and AI that wasn't in the original patent license agreements.
Who is going to run SAGA Scientific Holdings Corp?
Probably the same people running point now.
It is quite possible to include stock as SAGA value is way under 250 million.
However SAGA is expected to raise additional capital through a private investment in public equities ("PIPE").
From today's PR:
The transaction, once completed, will provide BGEN and VIRO with significant additional capital to continue their development and expansion of existing and future technology platforms. In addition, Sagaliam expects to raise additional capital through a private investment in public equities ("PIPE"). The anticipated capital raise from the PIPE is expected to be primarily used by BGEN and VIRO to pay transaction-related expenses and fund the clinical trials of ITV-1, marketing of IPF Immune™, production of fully human monoclonal antibodies (mAbs) and continued advancement in its proprietary technology involving the application of Artificial Intelligence (AI) in therapeutic discoveries and production.
Going to be interesting how this is ironed out.
The ability of ENZC to get a definitive agreement speaks volume of the power of the technology they possess.
This isn't a high risk high reward deal, this is a show me the DATA, we like the DATA, let's do a deal.
Someone has been shown something we haven't seen and knows something we don't know.
Timely, Interesting, Accurate
What is a PIPE raise?
Private investment in public equity deals (PIPE) is when a private investor, like a mutual fund or large institution, buys a chunk of shares at a below-market price. PIPE deals are a way for companies to raise a large amount of money quickly.
KEY TAKEAWAYS
Private investment in public equity deals (PIPE) is when a private investor, like a mutual fund or large institution, buys a chunk of shares at a below-market price.
PIPE deals are a way for companies to raise a large amount of money quickly.
They can be unpopular with existing shareholders because they dilute the existing pool of shares and reduce its value.
PIPE deals have similarities to some of the massive government bailouts seen in recent years, but they typically involve smaller, less systemically important companies.
https://www.investopedia.com/terms/p/pipe-deal.asp#:~:text=Private%20investment%20in%20public%20equity,stock%20at%20a%20preferred%20price.
All companies Pfizer included. It doesn't matter who they have on their staff.
How the speed of the Covid vaccine breakthrough is changing the way Pfizer thinks about the future
KEY POINTS
Pfizer’s chief business innovation officer Aamir Malik says the pace of the Covid vaccine development has led the pharmaceutical giant to rethink how long it should take to bring new drugs to market.
From AI to redesign of clinical trials, the pharma company sees the potential to cut years off the traditional timeline for bringing new medicines to market, Malik said at the recent CNBC Work Summit.
The mRNA technology underlying Covid vaccines was being perfected in the lab for decades ahead of its biggest real-world test during the pandemic, but the actual breakneck pace at which Covid vaccines and antiviral drugs like Paxlovid came through clinical trials and to the market was unprecedented. That’s an experience and speed of discovery that Pfizer
hopes to replicate as it looks to the future of vaccine and drug development.
Aamir Malik, who joined Pfizer in August 2021 as chief business innovation officer, said far from any letdown after the huge success of the Covid vaccine, he came into a company where “there was almost an even renewed energy” within the organization after the vaccine success. “Let’s do that again, and let’s figure out what are all the other problems that we can bring this kind of mindset, our resources, our capabilities, to try and solve,” Malik said at the recent CNBC Work Summit.
Tapping into that energy, Malik said, means understanding and learning from the “importance of speed” in the Covid vaccine success story.
“It was very evident in the pandemic because it needed to be solved with urgency, and we’ve taken this concept of speed now and applied it to everything we do,” he told CNBC’s Bertha Coombs. “If we can find a way to take three years out of the timeline of developing a drug which can last orders of magnitude longer, that’s three years faster we can bring a medicine to a patient. And in order to make a change like that requires tremendous ingenuity, but there’s a belief it can be done.”
The same set of factors do not exist for all human disease conditions, Malik said, “but we know it’s possible, so we’re very focused on that in terms of how we make decisions, how do we accelerate the clinical trial process.”
While this may put pressure on employees, it’s pressure to come up with ideas. “It’s not just a matter of ‘lets all of us work harder to get to that same outcome,’” Malik said. “I think what it creates environment for is how do we create very different ways of thinking.”
The traditional model of recruiting patients for clinical trials, for example, has been in place for decades, and has been criticized for a variety of reasons, from general lack of access to representative populations to specific inequities in trial design related to age, gender, race and ethnicity. “Now we are asking ourselves what if we turned that on its head?” Malik said. “What if we were to create partnerships with larger cities, what if we were to take AI and machine learning technology and apply it to this problem. ... The pressure is to solve a problem. The pressure isn’t simply to do what we were doing before and work much harder to achieve the same goal in the same way,” he added.
https://www.cnbc.com/2022/11/15/how-pfizer-is-taking-the-speed-of-covid-vaccine-success-into-future.html
How long does it take to get a drug approved?
Here are some key takeaways from the new report:
On average, it takes 10.5 years for a Phase I program to progress to regulatory approval.
From 2011–2020, a drug in a Phase 1 clinical trial had a 7.9% likelihood of approval (LOA)
.
Of the 14 major disease areas, hematology therapies had the highest LOA from Phase I (23.9%). This is seven times greater than the least-successful group, urology (3.6%).
Rare disease therapies were also notably successful with an overall LOA of 17.0%.
Immuno-oncology therapies provide a rare pocket of success in oncology R&D with an overall LOA of 12.4%, compared to 5.3% for all oncology approaches.
Development programs with trials employing patient preselection biomarkers are twice as likely to be approved (15.9%). Nearly one in two that reach Phase II are successful.
https://www.bio.org/blogs/how-long-does-it-take-get-drug-approved
It is up to the company to decide when they will uplist and it has nothing to do with it being a Biotech however you knew that.
Why they haven't yet is a mystery to all except the company.
It takes time for ANY Biotech to bring products to the market.
ENZC has been operating on a shoestring budget and have been able to push through with some accomplishments.
They have a long way to go and will need significant funding to reach major accomplishments.
ENZC is a Biotech company so everything is late.
High Risk
High Reward
When ENZC delivers certain goods HIGH REWARDS will be in PLAY!
Time is not of essence, delivery of goods are.
Giddy Up ENZC Giddy Up
Will Enzolytics continue to deliver on their goods?
IPF immune @ Amazon - delivered
IPF immune @ Walmart - delivered
ITV-1 therapeutic @ Africa in progress
On-going patents, plans, research and products:
A.I. is a significant driver for advancing healthcare, and understanding the Human Microbiome will be pivotal to that transformation, to unlock the potential of the Human Microbiome by utilizing Artificial Intelligence.
Enzolytics is building on the consortium to utilize A.I. to assess the effects of nutrition, genetics, and the human microbiome on diseases. This is a part of the Company's long-term strategy to enter the personalized medicine market and build a strong I.P. portfolio.
Build prediction models for infectious diseases (preferably COVID), mental health disorders, and chronic medical diseases.
Identify biomarkers for infectious diseases and chronic medical diseases.
Identify novel targets and clear intervention strategies for infectious diseases and chronic medical diseases.
In submissions under the Patent Cooperation Treaty (PCT), Enzolytics, Inc. has pending international patent applications covering the use of any of its discovered numerous conserved Coronavirus epitopes or conserved HIV epitopes in the production of monoclonal antibodies, the production of vaccines or use in diagnostic tests for detecting the viruses in patients.
In its PCT Patent Applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, (2) producing a vaccine against HIV or the CoronaVirus, or (3) for use in any diagnostics to identify whether a person has HIV or the CoronaVirus.
The Company considers these filings significant because:
For a monoclonal antibody to be effective (that is to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, a virus mutation will render the therapeutic ineffective.
The Company has analyzed over 2 Million Coronavirus isolates and over 100,000 HIV isolates and have identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 9 conserved sites on the HIV virus.
The Company's patent claims cover these findings in a number of ways, claiming the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:
For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
For producing a vaccine against HIV or the CoronaVirus.
For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
For use in any diagnostic test to identify whether a person has HIV or the CoronaVirus.
The Company fully expects that the patent claims sought in these applications will be issued in the U.S. and the foreign countries in which they are filed. And the Company intends to prosecute the applications in all major countries around the world. The life for any patent issued is 20 years from the effective priority date. In the case of the Company's applications, the priority dates are early in the pandemic time frame, as the Company was alert to the need for and significance of making the discoveries found. Use of any of the 19 Coronavirus epitopes or any of the 9 HIV epitopes in the production of a therapeutic, vaccine or diagnostic will be covered by the issued patents.
SARS-CoV-2 THERAPEUTICS
Addressing the COVID-19 pandemic, the Company is producing monoclonal antibodies targeting conserved sites on the SARS-CoV-2 virus identified using Artificial Intelligence. The conserved targeted conserved sites are found in all variants of concern - including the COVID-19 Omicron variant. Thus, the monoclonal antibodies being produced by the Company, due to the conserved nature of the targeted epitopes, are expected to be effective against current and future variants of the COVID-19 virus.
The Company is using multiple processes to accelerate the production of these monoclonal antibodies. As acknowledged by experts in the field, numerous monoclonal antibodies are needed for effective therapy. By using accelerated technology systems in collaboration with Abveris, a division of Twist Bioscience Corporation, desired antibodies may be produced in shorter time frames. Abveris applies advanced immunization methods combined with B cell screening and hybridoma-based antibody discovery technologies to provide comprehensive gene-to-antibody discovery services. In addition, the Company has a strong working relationship with Samsung Biologics, which provides end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for produced antibodies.
Will the muzzle come off?
Will get to look under the hood?
ENZC has been saying for "years" to defeat a virus:
It is just the FACTS nothing more nothing less...
Some people can't handle the truth!!!
Did ENZC license their Patent or did REGN some how or some way have a discovery very very similar to ENZC
Don't know however REGN14287 looks like, feels like, sounds like, seems like something out of a laboratory from Texas A&M Institute for Preclinical Studies (TIPS).
Licensing Your Patent: Steps and Strategies
Obtaining a patent ought not be the last step in commercializing your invention. Unless you plan to hold on to your patent as a means of deterring industry competitors, you may choose one of several paths available to commercialize your patented invention or monetize your patent. The three most common methods available to patent owners are:
to manufacture and market the patented invention independently;
to sell the patent to another entity; or
to license the patent to one or multiple entities.
This article deals with licensing. As an initial point to clarify terminology, when should you use licence vs. license? In the United States, license is both a noun and a verb while in Canada and other English-speaking countries, licence is used as the noun and license as the verb.
Is licensing a good option for me?
The licensing approach is often taken by those who do not have access to enough capital to independently manufacture and market their patented invention or simply have no interest in doing so themselves. Licensees pay licensors for the rights to manufacture and market the invention themselves, however, the rights still ultimately belong to the licensor. This is what distinguishes licensing from a sale. Royalties received in exchange for a licence are negotiable but are likely going to result in a return on the patent that is lower than that which would result from manufacturing and marketing the patent invention independently. Licensing, thus, is an avenue for monetization which mitigates risk but may simultaneously limit return.
In considering whether to license your invention, you should be thinking about whether you have the capital, know-how and/or desire to bring your invention to market, and whether retaining the rights in the patent is important to you. Licensing provides a means of bringing your invention to market despite a lack of business know-how and capital. While the ultimate return is lower than that which might be attained by making and selling the product independently, the trade-off is that both your financial investment and the demand on your time and energy are substantially reduced. If retaining rights in the patent is not especially important to you, you may wish to consider selling your patent rights outright to see an immediate lump sum return and dispense with any ongoing obligations with respect to the product and patent.
Another essential question to ask yourself is what commercial role your patented invention fulfills. For example, is it an invention that improves products already available on the market, or is it entirely novel? The answer to this question may help identify profitable licensing opportunities and business partnerships. For example, if your product improves and is intended to be used with an existing product, the manufacturer of that product may be a perfect partner. It is also important to ask yourself whether you are willing to work with multiple partners (non-exclusive licensing) or not (exclusive licensing or rights transfer), and which approach would best suit your vision for your invention.
Exclusive licensing means licensing rights in the invention to a single licensee to the exclusion of everyone else including you. Licensees like exclusive licensing because they obtain a monopoly in respect of the invention and can therefore, in the absence of competition, demand a higher price. The flipside of this is that you too can demand a higher price in exchange for the licence as you are taking a risk on a single licensee and giving up, at least temporarily, a valuable asset.
There is, however, also a place for non-exclusive licensing. This type of licensing is more common with products which don’t entail as high an investment to begin production and sale, or which can be profitably marketed and sold by multiple licensees simultaneously. An advantage of non-exclusive licensing is that your return doesn’t depend solely on the successful marketing of the product by a single licensee.
Licensing can give your invention a competitive advantage. Sales of your product may be considerably higher when marketed by a dominant player in the market than they would be were you to bring the product to market yourself as a small and/or new company. Some licensing agreements include provisions that allow the licensor to terminate the agreement if licensees are not meeting certain targets set out therein. These provisions can help ensure that a licensor sees a certain degree of return on the licence. To ensure a profitable and equitable licensing agreement, consider speaking with a member of our team.
Determining the feasibility of getting a licence
The next step in the licensing process is to determine whether your patented invention would be desirable to potential licensees. There are several criteria that should be considered to establish feasibility of licensing, with the most significant being patentability, marketability and profitability.
The first consideration to be assessed is patentability. Owning a patent or pending patent application is usually a condition for licensing. Without legal ownership rights to an invention, you do not have the right to stop others from making, using or selling the invention, and therefore do not have a valuable asset for which others are likely to want to pay. You will likely find it difficult to persuade a potential licensee to pay you for a product which can be legally copied by any number of competitors as soon as it’s made public. Ideally, you have a patent and therefore exclusive right to make, use and sell your invention. Although a patent application, prior to issuing to a patent, does not come with any exclusive rights to the product, it can be a valuable card to play because it shows a potential licensee that you are serious about your invention, have invested in its protection, and may one day have exclusive rights to licence.
In order to obtain a patent for your invention, the invention must constitute patentable subject matter and be novel, non-obvious and useful. Not all subject matter is patentable, for example, subsection 27(8) of the Patent Act states that no patent can issue for any “mere scientific principle or abstract theorem”. Methods of medical treatment are also not patentable in Canada. An invention must also be new, meaning the same thing has not previously been publicly disclosed anywhere in the world, and non-obvious, meaning that even if the same thing does not exist, the invention cannot be an obvious improvement to something that does exist. Finally, the requirement that an invention be useful is almost always met and requires only that the invention work. Fulfilling these requirements is also important for creating a commercially feasible product. Further requirements include having kept your invention confidential or, in certain countries, applying for a patent within twelve months of the date of your earliest public disclosure of the invention.
Secondly, the marketability of your invention needs to be evaluated. Ideally, your product will have unique features that will appeal to consumers and be directed at a demographic that would be willing and able to purchase it. Inventions that are not marketable risk being unappealing to consumers, which would result in low sales and thus low profits, making them a bad investment for potential licensees.
It is key for your invention to be in some way different from similar offerings on the market to incentivize consumers to switch to or begin purchasing your product. Even if your invention is novel, there are likely substitutes available on the market that perform the function that it is intended to fulfil. Your invention, thus, must have a distinct feature, a better cost to benefit ratio, or another way of positively differentiating itself from market alternatives.
Finally, the invention needs to be commercially feasible. In essence, revenue made from selling the patented invention must exceed the licensee's costs of producing and selling it, which includes royalties that are paid to you as the patent owner. If there is no profit for the licensee in selling your patented invention, it is unlikely that you will be able to find a licensee. The profit margin is also likely to be a key factor in the royalty rate you can negotiate.
There are other factors that play a less significant role in deciding whether your invention is licensable. Among such factors is the composition of the industry market of your invention (i.e., how much market share companies hold on average, and whether there are dominant players that want to retain their advantage or smaller players that want to expand their market share) and the current demand for the need that your product fulfills. However, assessing whether your invention is patentable, marketable and profitable will largely enable you to determine whether there is potential for licensing.
Seeking out potential licensees
After you have determined whether your invention has licensing potential, you must seek licensees who are willing to purchase a licence and manufacture and market the invention. To find licensees for your invention, consider doing the following:
Assess the current market and the stakeholders within it, and ask yourself the following questions: Who is currently manufacturing competitive products or market alternatives? Are there any large entities looking for an avenue to enter this market? Are there existing players that want to strengthen their foothold?
Assess currently available market alternatives by reviewing publications of trade associations or trade shows, library databases, business directories, and patent databases.
Advertise your patent for sale or licensing.
It may be helpful to create a prospective list with 40-50 potential targets to ensure that, despite some rejection, you will be able to secure a licensee or licensees. Triage your list of potential targets in order of likelihood of investment. Helpful criteria to rank your list may include geographical location, size of the company, company policy on entering into new licence agreements, whether the company is already producing similar products, and whether it is possible to contact the company's decision-makers.
Approaching licensees
As the patent application process is lengthy, it is beneficial to begin seeking a licence after your patent application has been filed rather than waiting until a patent issues. Before disclosing still confidential details of your invention at this stage, however, you may want to consider requiring that potential licensees sign a non-disclosure agreement. Although your disclosure won’t affect the patentability of your invention since you’ve filed a patent application, public disclosure of your invention may prompt others to produce your invention while your patent application is pending, or innovate such that your invention is no longer the newest and most desirable product on the market.
When approaching potential licensees, it is crucial to have a presentation strategy that will demonstrate to potential licensees how your invention will help improve their market standing. Your pitch should include the following:
The issues with currently available products and the methods by which your invention fixes those issues. This strategy, often referred to as addressing the "pain points" of a business or product, will immediately help investors visualize what function your invention can play in their operations.
How your invention differs from currently available products, and what unique and marketable features it possesses.
The cost vs. benefit analysis of your product that details the additional benefits of your invention, and an approximate cost matrix of production and distribution.
The legal status of your invention, such as whether you have a patent pending or an issued patent.
Information about yourself: who you are, why you think your values and future goals for the invention will be a good fit for the company, and why you have decided to contact this specific company for producing your invention.
Once a licensee has agreed to purchase a licence to your invention, the payment scheme will need to be determined. In many cases, licensees pay the licensor an advance payment before the manufacturing and distribution of the product begins. The amount of royalties paid must also be determined. The typical range of royalties is between 2-5% although some industries, such as the pharmaceutical industry, often pay royalties of 1%. Finally, the type of licence, whether exclusive or non-exclusive, must also be discussed. Licensees will be willing to pay a higher licensing fee to obtain the exclusive rights to sell the patented invention.
Presenting a clear and accurate conception of the benefits of your invention and its contribution to the current market will aid you in attracting a licensee. Equally important is having an accurate estimate of the value of your patent to both rely on in the course of negotiation and to obtain the most suitable payment scheme for your needs.
After licensing
After a licensing agreement has been secured, it is important to ensure that your patent is maintained in force by paying any required maintenance fees as they come due. Failure to maintain your patent could result in termination of your licensing agreement. It may also be necessary to monitor whether your patent is being infringed, as enforcing the patent against infringers may continue to be your responsibility as a condition of the licence. Ensuring that your patent is not being infringed protects the value of your patent rights to your licensees and ensures that the licensing relationship continues to result in ongoing profits for both sides.
https://www.heerlaw.com/patent-licensing-steps-strategies
Is there a connection between Regeneron and Enzolytics?
Regeneron previous antibody had limitations due to the way it attacked the virus:
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and
Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-new-us-government-agreement-purchase
Regeneron’s lastest antibody is different as it binds outside the RBD and NTD regions:
Differentiated vs. prior antibody approaches:
• Binding site outside of immunodominant, highly variable RBD and NTD regions, lowering risk of losing activity against future variants
• Targeted epitope highly conserved, with over 99.9% conservation since beginning of the pandemic
• Demonstrated high neutralization potency against all known SARS-CoV-2 variants and lineages to date
https://investor.regeneron.com/static-files/5f682777-4984-400b-bacb-3041044bb4b6
Somehow in a short period of time when the FDA shut down their previous antibody, Regeneron introduces a new and improved antibody that is totally different from their previous antibodies and uses a different procedure from the one they spent decades creating VelocImmune and related VelociSuite technologies.
Regeneron, which early on in the pandemic developed a monoclonal antibody cocktail to address a treatment paradigm for COVID, is pivoting to what CEO Len Schleifer called “the jackpot antibody.”
In response to the original antibodies losing their efficacy, the company has developed a new one. The drug, dubbed REGN-14287, “has demonstrated potency against all known SARS variants and lineages to date,” reported Regeneron chief scientific officer George Yancopoulos, adding that the biotech expects the drug to enter clinical development later this year.
https://www.mmm-online.com/home/channel/jpm23-week-storm-prep-top-of-mind-for-biopharma-ceos/
What changed their focus?
Why the sudden change in direction?
Are other companies involved?
Could Enzolytics be involved?
Monoclonal Antibodies Are Now Being Recognized as a Significant Therapeutic for Treating COVID-19.
A new wave of recognition is now emerging in the healthcare and political arenas regarding the significance of monoclonal antibodies. The U.S. government has spent $2.65 Billion on the Regeneron monoclonal antibodies and on August 20, 2021, the UK approved the Regeneron/Roche antibodies cocktail for COVID-19. There is now widespread recognition of the potential effectiveness and role that monoclonal antibodies can play in current and future pandemics.
The Enzolytics process differs from the process used by Regeneron. Regeneron antibodies are produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system. Enzolytics’ process does not use mice with a genetically modified human immune system. The Enzolytics’ proprietary methodology for creating hybridomas produces a specific monoclonal antibody secreted by human immune B cells—obtained from convalescent donor patients—followed by isolating a single cell that produces a monoclonal antibody that targets an identified conserved epitope on the virus.
A primary distinction of the Enzolytics process for creating fully human monoclonals is the starting point is from human “immune-B cells” from humans who have survived successfully from a "natural" CoronaVirus infection. These antibodies will retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They are expected to provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, and, in the recombinant form, will have accessibility to the virus epitopes (binding sites) not accessible with a whole antibody.
https://enzolytics.com/company-news/
There are currently no monoclonal antibody treatments authorized for use in the United States. Because the virus that causes COVID-19 continues to change, previously available monoclonal antibody treatments do not protect against the currently circulating variants and subvariants.Dec 7, 2022
https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/treatment-recovery/monoclonal-antibodies
https://www.cms.gov/monoclonal
5 REASONS WHY ENZOLYTICS IS A COMPELLING CHOICE!
https://www.aviseanalytics.com/5-reasons-why-enzolytics-inc-is-a-compelling-choice/
!
5 REASONS WHY ENZOLYTICS IS A COMPELLING CHOICE!
Posted at 10:02h in Biotechnology by admin 0 Comments
Enzolytics Inc. (OTCPK: ENZC) is leveraging over 40 years of drug development experience to develop proprietary antiviral peptides and monoclonal antibodies for the treatment of Infectious Diseases. The Company is using a combination of patented-HIV therapeutics and an exclusive methodology, for creating fully human IgG1 monoclonal antibodies, which can target and neutralize HIV Virus to treat infectious diseases with non-toxic passive immunotherapy.
Enzolytics is committed to the development of proteins and monoclonal antibodies, which can combat a wide array of infectious diseases such as Hepatitis (A, B, C), rabies, influenza A and B, tetanus and diphtheria, besides Rheumatoid Arthritis and some forms of cancer. The Company is extending its proprietary technology to create anti-SARS-CoV-2 (Coronavirus) monoclonal antibodies, intended for the treatment of COVID-19.
Enzolytics Inc. (OTCPK: ENZC)
Market Cap: $ 676.73M; Current Share Price: 0.278 USDChart
Data by YCharts
An Industry with Large Unmet Needs
Human Immunodeficiency Virus (HIV) compromises the body’s immunity by attacking CD4 cells (a type of T cell), exposing it to a host of infections and diseases and ultimately leading to the development of AIDS. According to data provided by Centres for Disease Control and Prevention, an estimated 1.1 million people in the U.S are afflicted with this disease and 1 in 7 or 15% of those affected are unaware of their condition. In 2017, over 38,739 people were diagnosed with HIV and 6 dependent areas and nearly 15,807 deaths were registered among people diagnosed with HIV.
Advances in treatment and care, such as development of antiretroviral therapy (ART), have increased the life expectancy of people diagnosed with HIV and helped arrest the disease from progressing to AIDS, with an estimated 20.9 million people on ART as of 2017. There is no cure for the disease as yet, with existing therapeutic options seeking to stop the progression of the disease and alleviating symptoms.
Antiretroviral Therapy can be categorised as highly active antiretroviral therapy (HAART) or combination antiretroviral therapy (cART), however they can cause adverse reactions, severe toxicity and exacerbate existing co-morbidities. Scientific advancements have led to the discovery and development of Protease Inhibitors, Integrase Inhibitors, Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitors (NNRTIs), Chemokine co-receptor antagonists and Entry inhibitors that seek to overcome the limitations of the existing treatment options.
According to a report by GlobalData, the global HIV market will reach $22.5 billion by 2025 growing at a CAGR of 3% from $16.3 billion in 2015.
Image Source: Company
A Key Collaboration with Intel Corporation
In May 2021, the Company published a white paper through a thought leadership collaboration with Intel Corporation (NASDAQ: INTC) titled “Optimizing Empathetic A.I. to Cure Deadly Diseases”. The paper highlights the Company’s use of Artificial Intelligence, which is a novel approach to assessing virus sequences so that the segments essential for a virus survival are promptly identified. Intel’s Empathetic A.I helps outsource healthcare related decisions to machines, thereby enabling healthcare practitioners to spend more time in developing relationships with patients. Furthermore, Intel’s Programmable Integrated Unified Memory Architecture (PIUMA) will speed up drug discoveries and predict virus mutations with great speed and accuracy.
Speaking on the collaboration with Intel, Charles Cotropia, CEO of Enzolytics, stated,
“We are honored and privileged to work with the preeminent international corporation Intel in a collaborative manner focused on the optimum way to advance healthcare using science and technology together. Combining science with technology will guarantee success.”
A Promising Therapeutic Candidate for HIV
The Company’s lead candidate is an anti-HIV therapeutic known as ITV-1, which is a suspension of Inactivated Pepsin Fragment (IPF) that has demonstrated the potential to strengthen the immune system and neutralize the HIV virus, in clinical studies conducted in the European Union. Enzolytics proprietary technology enables the creation of human cell lines that are capable of producing fully human monoclonal antibodies. CLONE 3, one of these antibodies has the potential to completely neutralize 95 percent of HIV-1 strains and viral subtypes.
Enzolytic’s portfolio of therapeutics may not only be used as immunotherapeutic treatment for HIV/AIDS but also serve as a prophylactic and therapeutic vaccine against HIV. The treatment offers significant improvement over existing therapies such as ARV, by demonstrating a better efficacy and non-toxicity, besides being for a shorter duration and cost effective.
Merger with BioClonetics Immunotherapeutics, Inc brings in a Synergistic Platform
In December 2020, the Company announced the completion of the merger with BioClonetics Immunotherapeutics, Inc. The Companies are now pursuing two diverse but complementary therapy platforms, namely antiviral peptide and fully human anti-monoclonal antibodies.
Speaking on the synergy of these two technologies Harry Zhabilov, CSO of Enzolytics, commented,
“The technologies of the combined entities will afford the Company the opportunity to unlock the potential of our HIV-AIDS treatments at a time when the seriousness of the disease is still a major concern given that the current form of treatment for HIV patients is antiretroviral treatment and where such treatment is only accessible to 40% of the 36 million peoples in the world infected by HIV – leaving 60% of the 36 million infected HIV patients with no treatment.”
The Company’s anti-HIV mAb in PBMC neutralization assays are in the final testing phase and will be followed by animal trials at the California National Primate Research Center, UC Davis (Davis, CA). In addition, Enzolytics is developing anti-SARS-Cov-2 (CoronaVirus) monoclonal antibodies, based on its research that there is a significant correlative structure between the HIV virus and the SARS-CoV-2 virus. The antibodies are intended to act as a therapeutic and produce a phage display anti-SARS-CoV-2 (CoronaVirus) vaccine.
Extensive Intellectual Property Rights Portfolio
Enzolytics has built a strong intellectual property rights portfolio with patents covering its technology related to peptide which cover Pepsin Fragment (IPF) identified and characterized by the amino acid sequence GDEPLENYLDTEYF and the Clone 3 cell line, fully human monoclonal antibodies (mAbs) that specifically target and neutralize the HIV-1 virus. The Company also has multiple patents pending covering the recombinant of the Clone 3 antibody and coverage of small molecules (mini-peptides) among others.
Key Takeaways
On June 7, the Company announced a protocol to produce therapeutics for HIV as well as existing and future pandemics, an outcome of its collaboration with Intel Corporation, which seeks to leverage Artificial Intelligence to aid discoveries and development in healthcare. The coloration extends to investigating the relationship and interaction between monoclonal antibodies with viruses in 3-dimensional matrices.
The Company has built multiple strategic research and development collaborations and partnerships and has currently set milestones, which are necessary to land partnerships with other biopharmaceutical companies, which have expressed interest in the Company’s technology and pipeline. Some of these milestones include Testing of anti-HIV Monoclonal Antibodies at University of Montana, Broad-based neutralization testing of existing anti-HIV Monoclonal Antibodies at University of Strasbourg, France, Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California, Using Artificial Intelligence, identification of additional conserved immutable target sites (epitopes) on the HIV-1 virus and Production of additional Monoclonal Antibodies targeting identified sites (epitopes) on the HIV virus as per a Company
Clinical Trials are fraught with risk and uncertainty. The Company is looking at developing a diverse pipeline of candidates which will help mitigate the risk in case of adverse results or the failure to meet endpoints in any of its ongoing trials of a particular candidate. The success of its clinical trials will help the Company advance its pipeline but it should also be prepared to face any setbacks, in case its trials fail to meet their endpoints.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Click here to please visit our detailed disclosure
References
https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
https://enzolytics.com/
https://www.globaldata.com/hiv-market-will-see-modest-growth-to-22-5-billion-by-2025-says-globaldata/
https://www.biospace.com/article/releases/enzolytics-inc-completes-merger-with-bioclonetics-immunotherapeutics-inc-/
https://finance.yahoo.com/news/enzolytics-inc-intel-corporation-co-110000244.html
https://stockdaymedia.com/enzolytics-reports-progress-on-its-multiple-therapeutics-platforms-and-initiatives-enzc/
Yep,
We are all aware that you are all NONSENSE.
Thanks for confirming.
Yep Charles Cotropia dotted the I and crossing the T has brought this company a long way.
It has nothing to do with investors connecting DOTS.
You don't know JACK.
Nobody but the company does.
Will the company deliver the goods?
What will the results be?
We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon achievement of defined milestones.
https://www.biospace.com/article/releases/enzolytics-reports-progress-on-its-multiple-therapeutics-platforms-and-initiatives/
Have those milestones be met?
"In the year ahead, Enzolytics will share additional plans regarding our technologies, planned partnerships, and projects, as well as achievements in each of our therapeutics platforms. We have full faith in our long-term vision and mission and are confident in our team's ability to achieve set goals."
https://www.theglobeandmail.com/investing/markets/stocks/ENZC/pressreleases/12620871/enzolytics-inc-announces-the-completion-of-the-2020-and-2021-audited-financials/
To accelerate and fully execute in the successful production of the multiple monoclonal antibodies the subject of the Company's intellectual property (specifically the numerous monoclonal antibodies (mAbs) targeting both human and animal viruses), the Company continuously engages with numerous entities to accomplish the successful goal of production, testing and delivery of successful therapeutics. Entities with whom the Company is working includes companies having:
Expertise in providing specialized peptides having precise amino acid sequences corresponding to the precise target sites on both the Coronavirus and HIV viruses which are then used in the Company's Texas lab against which mAbs are being produced. This strategy accelerates the production of the mAbs for further development.
Specialized cell soring technology that is complementary to the process used in the Company's lab to accelerate production of mAbs for advancing production.
Expertise in hybridoma production techniques for production of mAbs using hybridoma methodologies that are complementary to the process used in the Company's lab.
Animal trials centers, both in the U.S. and abroad, for preparation of animal trials.
Promotional entities with specialized expertise in targeting large funding sources for the purpose of raising the substantial funds needed for the production of the recombinant mAbs necessary for future trials and for conducting animal trials.
As to each of these entities, and those with whom the Company currently works on an ongoing basis, the Company has entered into NDA's (Nondisclosure Agreements) necessary to preserve and protect the intellectual property being discussed and exchanged between the parties. These contractual restrictions are critical for the Company and its partners. Maintenance of strict confidentiality is absolutely essential to preserving intellectual property rights (patent rights) which are now being sought and which will be sought in the future. Premature disclose of technical information may and generally does bar the right to successfully seek patent protection at a later date. The Company is not able to share specific information regarding arrangements regarding these NDA's
https://www.yahoo.com/now/enzolytics-announces-international-patent-office-103000840.html
Are we there yet?
Circa 2019
It probably was the 7th when you looked at it.
WIPO is located in Switzerland so there time is ahead of our time.
You can't guarantee a reverse split here unless you are an insider releasing privilege information.
Are you trying to scare people to sell their shares.
What is the purpose of your outlandish predictions.
ENZC does not release PRs with the expectation of a stock price rise, they release PRs to share information with their shareholders.
PRESS RELEASES do not rise up stock prices certain RESULTS does.
What did ENZC envision in April 2022?
Enzolytics' primary U.S. lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious disease?s?, including SARS-CoV-2 and HIV-1. The lab uses the Company's proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, thereby avoiding ineffectiveness due to virus mutation.
Enzolytics's Dallas laboratory is managed by Harry Zhabilov, the Company's CSO. From the Dallas laboratory, Mr. Zhabilov coordinates the development and the production of two of the Company's primary therapeutics, ITV-1 and IPF Immune. Both therapeutics are produced under patents invented by Mr. Zhabilov, U.S. Patent Nos. 8,066,982, 7,479,538, and 8,309,072.
Upon completion of scheduled toxicology studies, the ITV-1 therapeutic will be made available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya and South Africa. Dr. Chandra is coordinating the introduction of ITV-1 for individuals in Africa. This is significant, recognizing that out of the 34 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. In addition, 91% of the world's HIV-positive children live in Africa.
Prior successful Clinical Trials were completed earlier under the Bulgarian Drug Agency requirements. The Company plans to complete further clinical trials to fulfill EMA requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America.
The Company has engaged Scendea (https://www.biospace.com/article/enzolytics-reports-its-engagement-of-scendea-usa-inc-a-leading-international-product-development-and-regulatory-consulting-group-to-guide-the-progress-toward-clinical-trials-and-market-approval-for-its-itv-1-anti-hiv-therapeutic/) to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA.Scendea (https://www.scendea.com) is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Scendea's service will focus on reducing time-to-market and minimizing development costs. Scendea's team offers strategic and operational support in quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory, guiding the Company's ITV-1 therapy efficiently to market approval.
In the approval process, Scendea's critical role is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.
Thereafter, CMC and GMP Requirements for FDA and EMA will be completed under the direction of Eurofin, followed by production of ITV-1 as per EMA and FDA requirements and Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements
https://www.centralcharts.com/en/1224249-enzolytics-inc/news/3675740-correction-enzolytics-inc-reports-progress-and-future-plans
IPF Immune is in the marketplace
ITV-1 therapeutic is next to hit the marketplace
What will follow next?
Charles and company may have miss projected deadlines however they have delivered the goods and will continue to do so.
Certainly there are many unknowns at the present time and much will be revealed at some point.
This little bitty biotech company is heading towards some humongous accomplishments that should allow to dance with Big Pharma.
It is March Madness
Go Huskies
Go ENZC
When will the full story of Enzolytics, Regeneron and probably other unnamed suitors come to light.
Regeneron previous antibody had limitations due to the way it attacked the virus:
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and
Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-new-us-government-agreement-purchase
Regeneron’s lastest antibody is different as it binds outside the RBD and NTD regions:
Differentiated vs. prior antibody approaches:
• Binding site outside of immunodominant, highly variable RBD and NTD regions, lowering risk of losing activity against future variants
• Targeted epitope highly conserved, with over 99.9% conservation since beginning of the pandemic
• Demonstrated high neutralization potency against all known SARS-CoV-2 variants and lineages to date
https://investor.regeneron.com/static-files/5f682777-4984-400b-bacb-3041044bb4b6
Somehow in a short period of time when the FDA shut down their previous antibody, Regeneron introduces a new and improved antibody that is totally different from their previous antibodies and uses a different procedure from the one they spent decades creating VelocImmune and related VelociSuite technologies.
Regeneron, which early on in the pandemic developed a monoclonal antibody cocktail to address a treatment paradigm for COVID, is pivoting to what CEO Len Schleifer called “the jackpot antibody.”
In response to the original antibodies losing their efficacy, the company has developed a new one. The drug, dubbed REGN-14287, “has demonstrated potency against all known SARS variants and lineages to date,” reported Regeneron chief scientific officer George Yancopoulos, adding that the biotech expects the drug to enter clinical development later this year.
https://www.mmm-online.com/home/channel/jpm23-week-storm-prep-top-of-mind-for-biopharma-ceos/
What changed their focus?
Why the sudden change in direction?
Are other companies involved?
Could Enzolytics be involved?
Monoclonal Antibodies Are Now Being Recognized as a Significant Therapeutic for Treating COVID-19.
A new wave of recognition is now emerging in the healthcare and political arenas regarding the significance of monoclonal antibodies. The U.S. government has spent $2.65 Billion on the Regeneron monoclonal antibodies and on August 20, 2021, the UK approved the Regeneron/Roche antibodies cocktail for COVID-19. There is now widespread recognition of the potential effectiveness and role that monoclonal antibodies can play in current and future pandemics.
The Enzolytics process differs from the process used by Regeneron. Regeneron antibodies are produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system. Enzolytics’ process does not use mice with a genetically modified human immune system. The Enzolytics’ proprietary methodology for creating hybridomas produces a specific monoclonal antibody secreted by human immune B cells—obtained from convalescent donor patients—followed by isolating a single cell that produces a monoclonal antibody that targets an identified conserved epitope on the virus.
A primary distinction of the Enzolytics process for creating fully human monoclonals is the starting point is from human “immune-B cells” from humans who have survived successfully from a "natural" CoronaVirus infection. These antibodies will retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They are expected to provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, and, in the recombinant form, will have accessibility to the virus epitopes (binding sites) not accessible with a whole antibody.
https://enzolytics.com/company-news/
There are currently no monoclonal antibody treatments authorized for use in the United States. Because the virus that causes COVID-19 continues to change, previously available monoclonal antibody treatments do not protect against the currently circulating variants and subvariants.Dec 7, 2022
https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/treatment-recovery/monoclonal-antibodies
Texas has size and is long however they are going to have their hands full with Xavier.
Yep ENZC to the 4s soon and also later.
$.40 10K
$$4 Africa
$$$40 Partnerships/Licenses
Gonzaga has Timme who seems like he has been playing there for a decade.
UCONN was operating on all cylinders and the Hogs couldn't keep up.
The UCLA had Gonzaga against the ropes however Gonzaga kept punching back and finally got the hook, line and sinker in to come out on top.
It is March Madness!
Hopefully we see some GOOD Madness from ENZC.
UCONN is in great shape. Gonzaga will be a tough out however UCONN has the defense to push through all the way to the National Championship.
Go Huskies
Go ENZC
There will be no hostile takeover.
In connection with the Holding Company Reorganization, all outstanding shares of common stock
and preferred stock of the Predecessor were automatically converted into identical shares of
common stock or preferred stock, as applicable, of the Holding Company on a one-for-one basis,
and the Predecessor’s existing stockholders and other holders of equity instruments, became
stockholders and holders of equity instruments, as applicable, of the Holding Company in the same
amounts and percentages as they were in the Predecessor prior to the Holding Company
Reorganization.
The Holding Company adopted a certificate of incorporation (the “Certificate”) and bylaws (the
“Bylaws”) that are, in all material respects, identical to the certificate of incorporation and bylaws
of the Predecessor immediately prior to the Holding Company Reorganization, with the possible
exception of certain amendments that are permissible under Section 251(g)(4) of the DGCL.
As part of the business combination of Bioclonetics, Inc. and Enzolytics, Inc., the controlling
shareholder of Enzolytics agreed to transfer 35,100,000 shares of its Series A Preferred Stock and
231,000,000 shares of its common stock, which represented Enzolytics control block, to three
individuals of BioClonetics, who became officers of the Company. As a result, the three
individuals obtained a majority voting interest in Enzolytics, resulting in change in the majority
ownership control in Enzolytics. The business combination was accounted for as a business
combination pursuant to Financial Accounting Standards Board (“FASB”) Accounting Standards
Codification (“ASC”) Topic 805, Business Combinations. The Company has elected not to apply
pushdown accounting for the change in control. As a result, Enzolytics capital structure will
continue to be reported as it was prior to November 30, 2020.
Following the business combination, the Company issued 204,430,000 shares of its Series B
Convertible Preferred Stock to officers of BioClonetics who owned the intellectual property rights
to the U.S. Provisional Patent Application No. 63/078,482, filed September 15, 2020, relating to
NOVEL HIV-BINDING PEPTIDES for treating, preventing and reducing the risks of HIV,
including all patents issuing therefrom and any foreign counterparts thereof.
In addition, the Company issued 90,750,000 shares of its Series B Convertible Preferred Stock to
the controlling stockholder of Enzolytics who owned the intellectual property rights to U.S. Patent
No. 7,479538, entitled Irreversibly- Inactivated pepsinogen fragment and Pharmaceutical
composition the same for detecting preventing and treating HIV and U.S. Patent No. 8,066982,
Irreversibly - Inactivated pepsinogen fragment and Pharmaceutical composition compressing the
same for detecting preventing and treating HIV, including all patents issuing therefrom and any
foreign counterparts thereof.
https://docs.publicnow.com/viewDoc?hash_primary=0C75DCBD88C21937F3BDA188AD1D069F2E7F0F8B
Thanks
I know a few years back ENZC mentioned that their solution to HIV will be a "faction" of the cost to what is currently available.
The info below is from a PR dated March 14, 2022:
While the healthcare focus for the last 2 years has been on the COVID-19
pandemic, the HIV pandemic has continued unabated. Over 16 million people are
infected with HIV, with approximately 10% being children. There are 1.7
Million new cases each year and approximately 1 Million deaths. Over 50% of
the worldwide patients with HIV/AIDS are located in Africa.
The only therapy for treating infected patients is antirational (ARV) drugs,
but these drugs are not available to 27% of those infected. The ARV therapies
which are available cause substantial side effects and are expensive. The ARV
therapy Biktarvy produced by Gilead costs $42,635 per year. The global HIV
market is estimated to be over $30 billion this year and is expected to grow
to over $36 billion globally by 2027.
The info below is from a PR dated April 25, 2022:
The statistics for HIV are alarming.
* Of the 34 Million individuals living with the HIV virus today, only 66%
had access to antiretroviral treatment - leaving 34% with no treatment.
* 1.7 million people become newly infected with HIV each year.
* 1 Million people die yearly from AIDS-related illnesses. 2,700 die each
day - over 300 are children (almost twice the number who die from cancer).
* 32.7 million people have died from AIDS-related illnesses since the start
of the pandemic.
Antiretroviral drugs have significant drawbacks.
* They do not cure a patient and must be taken for life.
* They are extremely expensive.
* The cost of Biktarvy by Gilead is $42,635 per year.
* The cost of Dovato by ViiV Healthcare/GSK is $27,540 per year.
* The cost of Dolutegravir/tenofovir is $48,000 per year.
* It is well recognized (even by the producers of these drugs - as is
publicly revealed in advertisements for the drugs) that these
antiretroviral drugs cause serious damage over time to the heart and
the kidneys, they decrease bone density, and they contribute to
Vitamin D deficiency. These are only some of the potential negative
side effects attributed to the therapies.
* HIV infections are most treatable during their earlier stages, and
patients cannot take antiretrovirals during earlier stages since drug
resistance often develops.
* Limited or no treatment options exist when viral load and CD4 cell counts
are at their worst, i.e., AIDS.
The reason these ARV drugs do not cure is because they do not act on the virus
in the same way that our ITV-1 therapeutics or our a monoclonal antibody can.
In the case of using monoclonal antibodies, our technology is to produce
monoclonal antibodies that target immutable, conserved epitopes on the virus
so that a therapeutic cure may be achieved.
I have not heard anything from the company on the pricing of ITV-1.
Do you have a link to the post?
ENZC
Enzolytics, Inc. Announces the Completion of the 2020 and 2021 Audited Financials
ACCESSWIRE - Mon Dec 19, 2022
COLLEGE STATION, TX / ACCESSWIRE / December 19, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).
Enzolytics, Inc. announces the completion of the 12/31/2020 and 12/31/2021 audited financials. The Company has refiled the 12/31/2021 Disclosure Statement reflecting the completion of the audit covering 2020 and 2021. These filings provide investors with detailed audited information about the Company's operations, business strategies, and financials. The reports will assist the Company's investors in understanding the Company's operations and its focus. In conjunction with the completion of the audits, and as part of the Company's ongoing commitment to transparency and accountability, Enzolytics is planning to become a fully reporting 34 Act Filer with the SEC.
No specific date given as to when ENZC will become a fully reporting 34 Act Filer with the SEC.
The Company CEO, Charles Cotropia, said, "Enzolytics is focused on accelerating the growth of our clinical products, technology platforms, and multiple applications now in progress. The Company is making substantial advancement in its three synergistic therapeutic platforms generating multiple clinical products for human and veterinary use. Over the last two years, we have focused on advancing our research and development and strengthening our Intellectual Property portfolio covering our technologies. As a result, we have made significant strides and substantive progress on multiple fronts. Our completion of a two-year audit is just one of the many objectives we have set and achieved.
What are these three synergistic therapeutic platforms?
IPF Immune
ITV-1 anti-HIV therapeutic
fully feline Monoclonal Antibodie
"In the year ahead, Enzolytics will share additional plans regarding our technologies, planned partnerships, and projects, as well as achievements in each of our therapeutics platforms. We have full faith in our long-term vision and mission and are confident in our team's ability to achieve set goals."
What are the plans regarding our technologies?
Who are these planned partnerships?
ENZC already have a relationship/collaboration with 2 billion dollar companies:
As of March 2023 Samsung Biologics has a market cap of $45.33 Billion. This makes Samsung Biologics the world's 380th most valuable company by market cap according to our data. The market capitalization, commonly called market cap, is the total market value of a publicly traded company's outstanding shares and is commonly used to measure how much a company is worth.
Twist Bioscience Enterprise Value is comparatively stable at the moment as compared to the past year. Twist Bioscience reported Enterprise Value of 1.94 Billion in 2022. Tangible Asset Value is likely to gain to about 1 B in 2023, whereas Free Cash Flow is likely to drop (209 M) in 2023.
Abveris (Twist Boston) whom ENZC `is working with was acquired by Twist in November 2021 for 190 million dollars.
What projects?
The Company COO, Dr. Gaurav Chandra, noted, "At Enzolytics, innovation is driven through our ecosystems with a collective mission to accelerate innovation. Our A.I. platform drives the Company's drug discovery and development and represents an overall strategy to produce therapeutics covered by an all-encompassing Intellectual Property portfolio. We take pride in strengthening our I.P. portfolio covering the anti-virus therapeutics, their method of production, diagnostics and prognostics. Our application of Artificial Intelligent to drug formulation and creation has made possible our move beyond big pharma's monoclonal antibody discovery and development. Enzolytics continues to forge ahead with the immediate strategy to identify novel biomarkers and therapeutic targets, design innovative diagnostic and prognostic tests, and expand the Company's Patent portfolio.
"In addition, Enzolytics' long-term plan is to be a serious contender in the personalized medicine market. The Company acknowledges the importance of an all-encompassing One Health approach recognizing the link between the health of people, animals, and the environment. As part of that approach, we identified conserved sites for Monkey Pox (https://www.nasdaq.com/press-release/enzolytics-announces-the-discovery-of-conserved-target-sites-on-the-monkeypox-virus) 2 weeks before WHO declared it a Global Public Health Emergency. Enzolytics continues to partner and engage with technology, genetics, veterinary centers, diagnostic and regulatory companies applying that strategy in each of these areas."
There is a lot going on with ENZC and although we all want information now, the company has shared as much as they can and are probably under constraint due to the NDAs.
EZNC usually put on a press release at least once a month or more often if information needs to be shared.
There are a lot of unknowns to us shareholders at the moment however when the veil is lifted I'm hopeful ENZC will "shock the world" just like UCONN Huskies did back 1999.
It is "March Madness" time and we may get some very much anticipated madness from ENZC
Go UCONN
Go ENZC
SHOCK the WORLD!!!
Why Is Biopharma Paying 75% Of The FDA’s Drug Division Budget?
https://www.forbes.com/sites/johnlamattina/2022/09/22/why-is-biopharma-paying-75-of-the-fdas-drug-division-budget/?sh=387407b87480
It’s an issue that surfaces every five years when Congress debates renewal of the Prescription Drug User Fee Act (PDUFA). The first incarnation of PDUFA occurred in 1992, at a time when drugs were getting approved far more quickly in Europe than in the U.S. by as many as 3 -4 years. Americans were outraged by this. Why should Europeans get access to important new medicines especially when many originated in the U.S.? In response, Congress held hearings to understand the problem. The FDA testified that they were grossly understaffed and needed more money to hire additional experts to evaluate the benefits and risks of potential new medicines. So, how did Congress come up with these needed funds? It decreed that drug companies must pay a “user fee” each time they filed a New Drug Application (NDA). These funds would then be used to support the FDA’s drug division. User fees, which were $200,000 in 1992, have now risen to as high as $3.1 million.
This is an interesting situation. To market a drug, a company needs FDA approval, and now said company has to pay for the privilege of an FDA review – which can result in an outright rejection. But user fees had the desired impact. By hiring 600 new reviewers, the backlog of NDAs awaiting approval in 1992 was addressed. As a result, the biggest year of NDA approvals to that point occurred in 1996 with 56 drug approvals. As a concession to agreeing to user fees, the pharmaceutical industry was promised that the FDA would reduce review times for NDAs to 12 months for those that were considered “standard” applications and to six months for priority applications that involved significant advances over existing treatments. This was a welcome change for the industry but also for patients who were awaiting access to new medicines.
Since then, the PDUFA Act has been renewed every five years and the latest iteration, PDUFA VII, is now being debated by Congress. However, drug industry critics are far from enamored by this act as evidenced by a recent article in the N.Y. Times. One issue is that user fees make up 75% of the FDA’s Drug Division and it is claimed that this makes the FDA beholden to drug companies. Another concern voiced by critics is that as a result of PDUFA, the FDA is “decreasing regulatory standards, shortening approval times and increasing industry involvement in FDA decision making” and that these practices are harming patients.
First of all, despite user fees, the FDA not only continues to reject NDAs, it also will send them back to sponsors when it feels that more studies are needed for approval. Most biopharma executives will tell you that the FDA isn’t beholden to anyone. But more important has been the value brought to patients that the interactions between the FDA and the industry bring. This was never more critical than when Covid-19 hit. FDA/industry cooperation was crucial in bringing vaccines, antibodies, antivirals and other therapeutants to Americans in record time. These actions saved millions of lives and prevented millions of hospitalizations. These interactions need to be encouraged, not challenged.
Critics argue that by rushing to approval on the basis of less clinical evidence being required increases the chances that “you’re going to miss something” - something that could harm patients. However, the counter argument to this is that if you or a loved one have a severe disease, one that could be treated or cured by a medicine in late stage development, you want access to that drug as soon as possible. Patient advocacy groups often criticize the FDA for being too slow to approve life-saving medications. This dilemma has nothing to do with user fees. Instead, it demonstrates the challenge the FDA faces in trying to protect Americans both in curing diseases and approving safe medications in a timely manner.
Well if there is an agreement in place no money has changed hands as it would had to show up in the financials or have been reported (8K) as a significant event.
ENZC probably would license and not sell the technology as it is too valuable.
ENZC had this technology many years before Regeneron, which early on in the pandemic developed a monoclonal antibody cocktail to address a treatment paradigm for COVID, is pivoting to what CEO Len Schleifer called “the jackpot antibody.”
In the video below (1:50) the CEO also said
Something must be up besides the stock price.
Yes it sounds limited to the sexual contact.
It sound beneficial for prevention.
ENZC is developing a treatment for now to help millions that are infected and hopefully a vaccine one day.
How is HIV passed from one person to another?
Most people get HIV through anal or vaginal sex, or sharing needles, syringes, or other drug injection equipment (for example, cookers).
Why can't ENZC get grant money?
It is not that we don't request it.
There are going to be a lot of stories about our little bity company when the Veil comes off.
Texas Biomed HIV vaccine candidate aims to block virus before it takes root
https://www.txbiomed.org/news-press/news/hiv-vaccine-ro1/
SAN ANTONIO (February 13, 2023) — The National Institutes of Health has awarded $3.8 million to Texas Biomedical Research Institute to further develop a promising HIV vaccine candidate that stops the virus upon entry, before it begins rapidly spreading throughout the body.
Professor Marie-Claire Gauduin, PhD
Texas Biomed Professor Marie-Claire Gauduin, PhD, has been developing this novel vaccine approach for more than 10 years with the support of NIH grants, including one for out-of-the-box, yet feasible ideas. The new four-year grant will enable Dr. Gauduin and her team to build on promising results in nonhuman primates and delve deeper into how the vaccine works on molecular and genetic levels. She will also gather more robust data about safety, efficacy and different delivery methods.
“I am excited to move forward, and hope to get to the preclinical stage for human trials,” Dr. Gauduin says.
The idea
An effective HIV vaccine has eluded the biomedical community for decades. Part of the challenge is that the virus spreads throughout the body within days of initial infection, reaching peak viral levels within two weeks.
Dr. Gauduin thought, then, why not try to stop HIV where it enters, before it infects individual cells and gains a foothold in the rest of the body?
“I had this idea as a postdoc,” Dr. Gauduin says. “I thought it had to be naïve because nobody was talking about it. It was so obvious and simple to me; I thought someone would have already done it.”
The innovation
Dr. Gauduin’s vaccine specifically targets the interior lining of the vagina and rectum, called the mucosal epithelium, which is where the virus is most likely to enter the body. The vaccine stimulates the production of antibodies specifically in these areas. Much like a bouncer checking for fake IDs just inside the door, or sentries along a castle wall, the antibodies are well positioned to quickly respond and block the virus from proceeding any further.
The vaccine is designed to specifically enter basal, or base, cells in the mucosal epithelium. As those basal cells differentiate to build up the epithelial tissue, the vaccine is passed on to all newly made cells (represented in green).
The vaccine does not target just any cell in the epithelium, but is designed to enter the basal cells that make up the base layer of the lining. These basal cells are “mother” cells, generating replacement cells as needed in the vagina and rectum. For females, the epithelial lining builds up and is sloughed off in each menses cycle; while the rectum lining remains more constant and new cells are generated as old ones die.
“The idea is that as long as the vaccine is in the mother cells, it will be passed on and be present in all new epithelial cells in these regions,” Dr. Gauduin says. “I did not think it would work so well, but it did!”
Preventing unwanted mutations
The vaccine, which has been patented, is a live attenuated vaccine, meaning it is based on the full genetic code of HIV, but has certain parts cut or removed so it is not harmful. Live attenuated vaccines are used for several diseases, such as smallpox and yellow fever, but have failed with HIV in the past because the virus mutated enough over decades to regain its potency.
To prevent this from happening in her vaccine, Dr. Gauduin is putting multiple safeguards in place. She cuts the genetic code in key places related to viral function. Notably, she removed the vaccine virus’s ability to replicate and spread. The so-called “single-cycle” vaccine virus can enter cells, but then becomes trapped, unable to leave. The cells signal that they contain the vaccine virus to the immune system, which then makes antibodies. The antibodies do not attack the cells with the vaccine, likely because the immune system recognizes those cells are native.
Promising results
A microscopy image of vaginal tissue from a female macaque vaccinated with a version of the vaccine. The white line is the basal or base layer of the mucosal epithelium, which is the interior tissue lining; cells stained in blue have built up along the lining through the menses cycle; and cells glowing green contain the vaccine, forming the top layer of the lining, which pathogens would encounter first.
In her previous studies, Dr. Gauduin found that vaccinated nonhuman primates took much longer to become infected with SIV, the monkey equivalent of HIV, than the unvaccinated group. While they eventually became infected after repeat exposures, the vaccinated animals completely controlled the infection – there were no signs or symptoms of disease and no detectable levels of SIV in the blood, which is the gold standard for measuring infection. One animal continued to control infection for more than three years with no side effects.
“So potentially we have developed a therapeutic vaccine that can control HIV with one dose, no boosting required, compared to daily antiretroviral pills,” Dr. Gauduin says.
The next round of studies will involve a larger group of animals, which is required to prove safety and efficacy before the vaccine can move forward to human clinical trials. Dr. Gauduin will gather more data about where the vaccine goes in the body and how it controls infection.
Currently, the vaccine is delivered directly to the mucosal lining by liquid drops. Dr. Gauduin will explore other delivery methods that may prove more efficient, which will be critical for making it practical for mass immunization in developing countries.
Funding and Patent information:
R01 NIH AI172539
Previous grants: R56 NIH/NIAID AI084171; R01 NIH/NIAID AI090705
U.S. Patents: 9730996, 2017; 10751406, 2020
source of information provided in previous message:
https://www.heerlaw.com/patent-licensing-steps-strategies
Did ENZC license their Patent?
Don't know however REGN14287 looks like, feels like, sounds like, seems like something out of a laboratory from Texas A&M Institute for Preclinical Studies (TIPS).
Licensing Your Patent: Steps and Strategies
Obtaining a patent ought not be the last step in commercializing your invention. Unless you plan to hold on to your patent as a means of deterring industry competitors, you may choose one of several paths available to commercialize your patented invention or monetize your patent. The three most common methods available to patent owners are:
to manufacture and market the patented invention independently;
to sell the patent to another entity; or
to license the patent to one or multiple entities.
This article deals with licensing. As an initial point to clarify terminology, when should you use licence vs. license? In the United States, license is both a noun and a verb while in Canada and other English-speaking countries, licence is used as the noun and license as the verb.
Is licensing a good option for me?
The licensing approach is often taken by those who do not have access to enough capital to independently manufacture and market their patented invention or simply have no interest in doing so themselves. Licensees pay licensors for the rights to manufacture and market the invention themselves, however, the rights still ultimately belong to the licensor. This is what distinguishes licensing from a sale. Royalties received in exchange for a licence are negotiable but are likely going to result in a return on the patent that is lower than that which would result from manufacturing and marketing the patent invention independently. Licensing, thus, is an avenue for monetization which mitigates risk but may simultaneously limit return.
In considering whether to license your invention, you should be thinking about whether you have the capital, know-how and/or desire to bring your invention to market, and whether retaining the rights in the patent is important to you. Licensing provides a means of bringing your invention to market despite a lack of business know-how and capital. While the ultimate return is lower than that which might be attained by making and selling the product independently, the trade-off is that both your financial investment and the demand on your time and energy are substantially reduced. If retaining rights in the patent is not especially important to you, you may wish to consider selling your patent rights outright to see an immediate lump sum return and dispense with any ongoing obligations with respect to the product and patent.
Another essential question to ask yourself is what commercial role your patented invention fulfills. For example, is it an invention that improves products already available on the market, or is it entirely novel? The answer to this question may help identify profitable licensing opportunities and business partnerships. For example, if your product improves and is intended to be used with an existing product, the manufacturer of that product may be a perfect partner. It is also important to ask yourself whether you are willing to work with multiple partners (non-exclusive licensing) or not (exclusive licensing or rights transfer), and which approach would best suit your vision for your invention.
Exclusive licensing means licensing rights in the invention to a single licensee to the exclusion of everyone else including you. Licensees like exclusive licensing because they obtain a monopoly in respect of the invention and can therefore, in the absence of competition, demand a higher price. The flipside of this is that you too can demand a higher price in exchange for the licence as you are taking a risk on a single licensee and giving up, at least temporarily, a valuable asset.
There is, however, also a place for non-exclusive licensing. This type of licensing is more common with products which don’t entail as high an investment to begin production and sale, or which can be profitably marketed and sold by multiple licensees simultaneously. An advantage of non-exclusive licensing is that your return doesn’t depend solely on the successful marketing of the product by a single licensee.
Licensing can give your invention a competitive advantage. Sales of your product may be considerably higher when marketed by a dominant player in the market than they would be were you to bring the product to market yourself as a small and/or new company. Some licensing agreements include provisions that allow the licensor to terminate the agreement if licensees are not meeting certain targets set out therein. These provisions can help ensure that a licensor sees a certain degree of return on the licence. To ensure a profitable and equitable licensing agreement, consider speaking with a member of our team.
Determining the feasibility of getting a licence
The next step in the licensing process is to determine whether your patented invention would be desirable to potential licensees. There are several criteria that should be considered to establish feasibility of licensing, with the most significant being patentability, marketability and profitability.
The first consideration to be assessed is patentability. Owning a patent or pending patent application is usually a condition for licensing. Without legal ownership rights to an invention, you do not have the right to stop others from making, using or selling the invention, and therefore do not have a valuable asset for which others are likely to want to pay. You will likely find it difficult to persuade a potential licensee to pay you for a product which can be legally copied by any number of competitors as soon as it’s made public. Ideally, you have a patent and therefore exclusive right to make, use and sell your invention. Although a patent application, prior to issuing to a patent, does not come with any exclusive rights to the product, it can be a valuable card to play because it shows a potential licensee that you are serious about your invention, have invested in its protection, and may one day have exclusive rights to licence.
In order to obtain a patent for your invention, the invention must constitute patentable subject matter and be novel, non-obvious and useful. Not all subject matter is patentable, for example, subsection 27(8) of the Patent Act states that no patent can issue for any “mere scientific principle or abstract theorem”. Methods of medical treatment are also not patentable in Canada. An invention must also be new, meaning the same thing has not previously been publicly disclosed anywhere in the world, and non-obvious, meaning that even if the same thing does not exist, the invention cannot be an obvious improvement to something that does exist. Finally, the requirement that an invention be useful is almost always met and requires only that the invention work. Fulfilling these requirements is also important for creating a commercially feasible product. Further requirements include having kept your invention confidential or, in certain countries, applying for a patent within twelve months of the date of your earliest public disclosure of the invention.
Secondly, the marketability of your invention needs to be evaluated. Ideally, your product will have unique features that will appeal to consumers and be directed at a demographic that would be willing and able to purchase it. Inventions that are not marketable risk being unappealing to consumers, which would result in low sales and thus low profits, making them a bad investment for potential licensees.
It is key for your invention to be in some way different from similar offerings on the market to incentivize consumers to switch to or begin purchasing your product. Even if your invention is novel, there are likely substitutes available on the market that perform the function that it is intended to fulfil. Your invention, thus, must have a distinct feature, a better cost to benefit ratio, or another way of positively differentiating itself from market alternatives.
Finally, the invention needs to be commercially feasible. In essence, revenue made from selling the patented invention must exceed the licensee's costs of producing and selling it, which includes royalties that are paid to you as the patent owner. If there is no profit for the licensee in selling your patented invention, it is unlikely that you will be able to find a licensee. The profit margin is also likely to be a key factor in the royalty rate you can negotiate.
There are other factors that play a less significant role in deciding whether your invention is licensable. Among such factors is the composition of the industry market of your invention (i.e., how much market share companies hold on average, and whether there are dominant players that want to retain their advantage or smaller players that want to expand their market share) and the current demand for the need that your product fulfills. However, assessing whether your invention is patentable, marketable and profitable will largely enable you to determine whether there is potential for licensing.
Seeking out potential licensees
After you have determined whether your invention has licensing potential, you must seek licensees who are willing to purchase a licence and manufacture and market the invention. To find licensees for your invention, consider doing the following:
Assess the current market and the stakeholders within it, and ask yourself the following questions: Who is currently manufacturing competitive products or market alternatives? Are there any large entities looking for an avenue to enter this market? Are there existing players that want to strengthen their foothold?
Assess currently available market alternatives by reviewing publications of trade associations or trade shows, library databases, business directories, and patent databases.
Advertise your patent for sale or licensing.
It may be helpful to create a prospective list with 40-50 potential targets to ensure that, despite some rejection, you will be able to secure a licensee or licensees. Triage your list of potential targets in order of likelihood of investment. Helpful criteria to rank your list may include geographical location, size of the company, company policy on entering into new licence agreements, whether the company is already producing similar products, and whether it is possible to contact the company's decision-makers.
Approaching licensees
As the patent application process is lengthy, it is beneficial to begin seeking a licence after your patent application has been filed rather than waiting until a patent issues. Before disclosing still confidential details of your invention at this stage, however, you may want to consider requiring that potential licensees sign a non-disclosure agreement. Although your disclosure won’t affect the patentability of your invention since you’ve filed a patent application, public disclosure of your invention may prompt others to produce your invention while your patent application is pending, or innovate such that your invention is no longer the newest and most desirable product on the market.
When approaching potential licensees, it is crucial to have a presentation strategy that will demonstrate to potential licensees how your invention will help improve their market standing. Your pitch should include the following:
The issues with currently available products and the methods by which your invention fixes those issues. This strategy, often referred to as addressing the "pain points" of a business or product, will immediately help investors visualize what function your invention can play in their operations.
How your invention differs from currently available products, and what unique and marketable features it possesses.
The cost vs. benefit analysis of your product that details the additional benefits of your invention, and an approximate cost matrix of production and distribution.
The legal status of your invention, such as whether you have a patent pending or an issued patent.
Information about yourself: who you are, why you think your values and future goals for the invention will be a good fit for the company, and why you have decided to contact this specific company for producing your invention.
Once a licensee has agreed to purchase a licence to your invention, the payment scheme will need to be determined. In many cases, licensees pay the licensor an advance payment before the manufacturing and distribution of the product begins. The amount of royalties paid must also be determined. The typical range of royalties is between 2-5% although some industries, such as the pharmaceutical industry, often pay royalties of 1%. Finally, the type of licence, whether exclusive or non-exclusive, must also be discussed. Licensees will be willing to pay a higher licensing fee to obtain the exclusive rights to sell the patented invention.
Presenting a clear and accurate conception of the benefits of your invention and its contribution to the current market will aid you in attracting a licensee. Equally important is having an accurate estimate of the value of your patent to both rely on in the course of negotiation and to obtain the most suitable payment scheme for your needs.
After licensing
After a licensing agreement has been secured, it is important to ensure that your patent is maintained in force by paying any required maintenance fees as they come due. Failure to maintain your patent could result in termination of your licensing agreement. It may also be necessary to monitor whether your patent is being infringed, as enforcing the patent against infringers may continue to be your responsibility as a condition of the licence. Ensuring that your patent is not being infringed protects the value of your patent rights to your licensees and ensures that the licensing relationship continues to result in ongoing profits for both sides.