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Some of what SRNE will be acquiring...
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ANP Technologies Licenses Technology to Celgene
January 10, 2020 Press Release
Newark, DE (Jan. 10, 2020 ) – ANP Technologies Inc. (ANP) and Fulgent Pharma LLC through their partner Moffitt Cancer Center have successfully licensed the rights to develop a novel targeted therapy in the area of leukemia to Celgene (CELG), now Bristol Myers Squibb (BMY), a landmark deal that leverages ANP’s nanotherapeutic platform technology. The partners will work together to develop a new cancer therapy for Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). The potential new therapy will target a novel pathway receptor.
The Moffitt research team recently discovered that a specific pathway receptor is up-regulated in MDS and AML malignant cells, and in particular the malignant stem cells, thus offering a potentially favorable disease-specific target for therapies. By utilizing a ligand specific for this pathway receptor along with a covalently linked nanoparticle developed by ANP and licensed to Fulgent Pharma, the team was able to show potential for treating this type of leukemia at the stem cell level.
We are taking it to the next level, partnering with ANP/Fulgent Pharma to help accelerate translating this discovery from the laboratory to patients in need said Jarett Rieger, Senior Director, Innovation & Industry Alliances, Moffitt
“Moffitt takes a team approach when it comes to cancer care and research. Our immunology and hematology teams worked together on this novel therapy. We are taking it to the next level, partnering with ANP/Fulgent Pharma to help accelerate translating this discovery from the laboratory to patients in need,” said Jarett Rieger, Sr. Director, Innovation & Industry Alliances of Moffitt.
“With our proprietary nano-delivery and nanotherapeutic technology platform, ANP has successfully developed multiple therapies including nanoencapsulated pactlitaxel, which is currently in clinical and licensed to Fulgent Pharma, as well as a nanoencapsulated antibody cocktail of drugs for the treatment of Ebola infection, which was funded for nonhuman primate testing by the US Department of Defense,” says Dr. Ray Yin, President and CEO of ANP. “The Moffitt collaboration expands our nanotechnology platform and spectrum of drug development, enabling ANP and Fulgent Pharma to develop new targeted therapies to benefit cancer patients.”
The Moffitt collaboration expands our nanotechnology platform and spectrum of drug development, enabling ANP and Fulgent Pharma to develop new targeted therapies to benefit cancer patientsRay Yin, President and CEO, ANP Technologies
About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 6,500 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube.
About ANP Technologies, Inc.
ANP Technologies, Inc. is a world leader in developing innovative nano-therapeutics. In addition to the novel targeted therapy, ANP has also developed nanoencapsulated chemotherapeutics, antibody therapies, immune-oncology and mRNA-based vaccines. Visit ANPTINC.com for more information.
About Fulgent Pharma
Fulgent Pharma is a clinical-stage specialty pharmaceutical company developing oncology therapies that leverage a
proprietary nano-drug delivery technology. Fulgent Pharma’s pipeline features three unique drug platforms: nanoencapsulated chemotherapy drugs being developed via the 505(b)(2) pathway, novel targeted therapies, and small molecule based immuno-oncology drugs. The Company’s lead asset, FID-007, is a nanoencapsulated paclitaxel with improved drug solubility and efficacy, as well as decreased toxicity, and is currently tested in clinical trials. Fulgent Pharma was founded in 2015 and is headquartered in Temple City, California. Fulgent Pharma was spun off from Fulgent Genetics, Inc., (NASDAQ:FLGT) a comprehensive genetic testing company, in 2016.
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For further reading, please visit https://delawarebio.org/member-news/anp-technologies-in-partnership-with-fulgent-pharma-teams-with-moffitt-cancer-center-to-develop-a-new-class-of-leukemia-therapies/
Interesting material posted on twits.
https://stocktwits.com/Gianlucamm3/message/296865486
A THOUGHT EXPERIMENT. What would happen when....
1. The open label phase 1 Covi-MSC results are announced indicating that 90+% of the first 20 ARDS patients recovered and went home after 5 days.
2. The Abivirtinib phase 2 results are that 80-90% of the first 60 patients never develop ARDS and an EUA is granted.
3. Covi-Stix and Covi-Trace are both granted EUA's.
4. Warpspeed or DARPA grants are awarded.
5. Partnerships with upfront, milestone and high royalties are signed with big companies for worldwide distribution and sales.
6.Could this begin next week? Or in early March? AND WHEN IT DOES, WHAT WILL SORRENTO'S SHARE PRICE BE?
Some evidence Stix has approval in Europe! And I expect news on Abivirtinib and Covi-MSC any day now...along with one or two test approvals!
Sorrento has eight (8) potential Covid Emergency Use Authorization candidates...all Blockbusters! Here's a partial overview.
1. Covi-Stix rapid accurate virus test
2. Covi-Track rapid accurate antibody test
3. Covi-push 2020 injection
4. Covi-Drops 2020 nose drops
5. Covi-Vax 2020 lipid DNA injection($34 million DARPA funding!)
6. Abivirtinib ARDS prevention
7. Covi-MSC Stem Cell ARDS treatment
8. Covi-Shield antibody cocktail
Each of these EUA's could be accompanied by Operation Warp Speed or DARPA grants and multi-billion dollar international sales. Additionally there could multi-billion dollar worldwide marketing partnerships. Dr.Ji says there is "humungous" interest from Mexico, Brazil and Europe.
Timing? Some could come in DAYS. Some in WEEKS. Others in several MONTHS.
2 good and able men who have faithfully served their country now on board!
About John Brennan
Mr. Brennan served for 25 years in a variety of roles at the CIA, rising from analyst to station chief, and finally being appointed as the agency’s Director by President Barack Obama. He also served as Deputy National Security Advisor for Homeland Security and Counterterrorism. Brennan earned a Bachelor of Arts degree from Fordham University, and is a Distinguished Fellow at the Fordham University Law School. He earned a Master of Arts from the University of Texas at Austin, where he currently serves as a Distinguished Non-Resident Scholar and a senior advisor to the University’s Intelligence Studies Projects.
About Wesley Clark
General Clark served for 34 years in the U.S. Army, rising through the ranks to earn his fourth star as a full general in 1996. He served as the Supreme Allied Commander Europe of NATO where he commanded Operation Allied Force in the Kosovo War. Highly decorated throughout his career, Gen. Clark was awarded the U.S. Presidential Medal of Freedom by President Bill Clinton. He is a graduate of the U.S. Military Academy at West Point, where he was class valedictorian. After graduating from West Point, General Clark was awarded a Rhodes Scholarship to the University of Oxford where he earned degrees in Philosophy, Politics and Economics. He earned a master’s degree in military science from the Command and General Staff College. General runs Wesley K. Clark and Associates consulting firm and is Chairman and CEO of Enverra, a boutique investment bank.
Covi-Stix approved in Europe? On the Riley interview Dr. Ji said, "So the demand is humungous internationally...we have people from Europe, Mexico, Brazil. They all want the product....a big revenue generator ." It is produced by Fortune Bio. On slide 8 of the January 2021 Corporate Presentation it says Sorrento has an "option to acquire up to 51%." of Fortune Bio.
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And for more see
Sadly Covid will be around for many years. Vaccines aren't 100% protective. There are anti-maskers and anti-vaccers in large numbers. Covid variants will continue to arise. And it will be another year or so for the poorer countries to be vaccinated. Sorrento's Covid pipeline will be needed. I expect worldwide marketing partnerships.
I agree that March and April will see important advances in at least 6 Covid programs.
1. STIX-expected EUA approval
2. MSC (P2) application for EUA in March/April. The magic number of patients is 40 with good data.
3.Abivertinib (covid) Sorrento has enrolled over 60+ patients and has 5 locations, but the magic number again with good data is 40. Expect EUA application in late March.
4.Covi-GeneMab approved for P1
5. Covi-Drops approved for P1b/P2 (it’s just at matter of figuring out the right dosage level).
6. COVI-AMG-The FDA is expediting the approval process even more for covid drugs of late. EUA in March/April. Testing is currently being done in US, Brazil, and Mexico.
Of course OWS and government contracts and grants should be expected along the way. There is a good chance most of these will be advanced. Covid is a worldwide pandemic and likely will need to be dealt with for many years around the world.
And we shouldn't forget that both the DAR-T and second generation Oncolytic Virus should enter the clinic. And the NK and Celularity investments values should continue to increase. I expect they'll be worth a billion ...as will the PSS lawsuit settlement ! And the steadily increasing institutional ownership accumulation will bring us to the point where they're ready to move the share price dramatically !
Another Sorrento patent...this is for fully human TIM3. Emerging data from human clinical trials shows that TIM3 acts as a ‘checkpoint’ receptor and that inhibition of TIM3 enhances the antitumour effect of PD1 blockade.
https://uspto.report/patent/grant/10,927,171?fbclid=IwAR0EkX9qUMUZ_u5Sbesj7dS3L25yVuxCtLrcB5L6n8xoughi_xdJ76h5qJs
For those who are following Sorrento investments ...their NK investment(through ImmunityBio) value reached $370 million today! And what will their 25% interest in Celularity bring them when the IPO hits the market very soon? And the PSS lawsuit settlement ? And I expect some very attractive partnerships with both the Covid and cancer portfolios full of blockbusters! Upfront payments, milestones and royalties should be sweet!
It will be a big deal if Sorrento has a partnership with UPS/Marken on COVI-STIX(and other Sorrento tests?). Here is part of a Marken news release from last summer(Marken is an UPS subsidiary)...
"As one of the leading biological kit producers for clinical trials, Marken has expanded its operations in Miami with a new, larger and healthcare-dedicated kit production facility. This new facility will allow Marken to expand its current kit production capacity to support ongoing clinical trials and also accommodate the rapidly growing demand to produce COVID-19 test kits for its clients in the U.S.
Since the beginning of the COVID-19 pandemic, Marken’s service portfolio, which includes Direct to Patient (DTP) and Home Healthcare (HHC) services, has allowed the company to support ongoing clinical trials by delivering to patients remotely in 80 countries worldwide. Kits produced at Marken’s four global facilities can now be shipped to clinical sites and COVID-19 test sites anywhere in the United States by utilizing the UPS global network.
Marken also plans to expand its existing kit production facilities in Germany, Singapore and China and intends to be a leading provider to the industry."
There could be 8 EUA's this year! Covi-Stix will be the first.
1. Covi-Stix rapid accurate virus test
2. Covi-Track rapid accurate antibody test
3. Covi-push 2020 injection
4. Covi-Drops 2020 nose drops
5. Covi-Vax 2020 lipid DNA injection
6. Abivirtinib ARDS prevention
7. Covi-MSC Stem Cell ARDS treatment
8. Covi-Shield antibody cocktail
Each of these EUA's could be accompanied by Operation Warp Speed grants and multi-billion dollar international sales. Additionally there could multi-billion dollar worldwide marketing partnerships. Dr.Ji says there is "humungous" interest from Mexico, Brazil and Europe.
And we can expect a dozen or more cancer IND's this year. Those ready to go will be chosen from...
* 20 ADC's(Antibody Drug Conjugates)targets
* 12 ADNAB (Mayo Clinic Albumin Bound platform)targets
* 12 DAR-T targets with the first entering the clinic soon. These will go after hard to treat indications (MM,lymphoma,glioma,liver and pancreatic)
* a second generation oncolytic virus
Funding? EUA grants and sales. Huge profits from Celularity and ImmunityBio investments. PSS lawsuit settlement. Partnership up-front, milestone and royalty payments. The company has an embarrassment of valuable resources!
This analysis makes sense to me. The last takeover offer was a laughable $7! Sorrento now has big time potential in Covid, cancer and pain! Any new offers are in triple digits IMO!
More than rumours !
"Sorrento Therapeutics applied Dec. 22 to the FDA to receive emergency use authorization for Covi-Stix. The company said the test uses a shallow nasal swab that can provide results in 15 minutes and that its technology is 100 times more sensitive than conventional rapid antigen tests, which have shown limited reliability.
The Covi-Stix testing program is voluntary for UPS crews and is only available to individuals who have tested negative prior to departure with an Abbott Labs ID Now COVID-19 test, with questions still remaining about its false negativity rate.
“The test should be conducted approximately one hour prior to top of descent,” the internal email said. “A ‘presumptive positive’ test at the top of descent is intended to allow UPS to coordinate turning the affected crew member (and any contact-traced crew member in the aircraft) directly back to ANC (Anchorage) on the next outbound flight without processing through Hong Kong and being subject to quarantine.”
Data from the self-administered test is being collected to help secure FDA certification and prove the viability of the testing methodology."
Prior to the antigen test, the process was for pilots to get a rapid test in Anchorage so they could fly in with a negative test. In Hong Kong, officials would conduct a more aggressive nasal test, which takes several hours to return results. Anyone who tests positive on their tests is taken to quarantine at the convention center until their body starts to produce enough antibodies to be considered no longer susceptible to contracting COVID.
Why do I now believe SORRENTO COULD BE WORTH $200+ per share in 12 months? Someone did this rather extensive but still ongoing DD concerning SRNE. It was done over the last couple of weeks taking into account multiple sources publicly available (including some rumours). I hope it’s of value to all considering an investment in this company.
- New COVI-MSC trial starting. Phase 1b tests 100% patients recovered from mechanical ventilation and leaving hospital after a week. Phase II trials starting to enroll 80 or more patients.
- Abivertinib - Treats Covid at late stages by reducing immune overload (cytokine storm). Stage 2 trials in progress in US and Brazil nearing completion. Trials increased to 5 hospitals (2/11/2021 - 75% enrolled, results due by March 11). Further take into account NDA in China for Abivertinib for NSCLC.
- Covi-Stix you probably saw the video. SRNE is mass producing a lateral flow Covid test that gives results at home within 15 mins like a pregnancy test. There are rumors that UPS Air crew is testing the product and CVS Pharmacy to have ordered 75 million tests. Multiple other tests pending approval- Antibody 15 min test, 30 min spit test and a multi virus test package.
- RESPI-STIX patent applied for Jan 16 to create combination test for antibody and current viruses including Covid, Flu A and B – manufacturing at Zhengzhou Fortune Bioscience Co.
- Testing Lab approved in California for Covid (will speed up in house testing and provide source of revenue).Also UPS field testing.
- Covi-GUARD STI-1499 antibody which kills 100% of Covid. Rumored this has been licensed or sold to a big player for $2bn. Phase 2 trials pulled by SRNE and focusing on STI-2020 which is a refined version of 1499 with increased potency and requires smaller dosage. DARPA is funding with at least $34m to bring STI-2020 (COVI-AMG) to the end of P2 trials and beyond. It also looks like STI-2020 preserves binding against UK and SA Covid mutations. COVI-AMG trials in US, Brazil and Mexico.
- Covi-Drops STI-2099 (Refined version of 1499) nasal antibody spray kills all Covid in early stages and can be administered in doctors office, or maybe at pharmacy or at home.
- Covid programs in progress with strong potential vaccines removed from pipeline to focus on test and therapies. However, T-VIVIA-19 could come back to beat mutations if others fail.
- SP-102 Ph3 trial results-potentially the first FDA approved epidural steroid product for the treatment of sciatica (massive market) likely due by the end of March 2021.
- Rheumatoid Arthritis pain relief using Sofusa DoseConnect started Ph1b trial Jan 2021. Drug already approved(Enbrel) – this is all about the delivery. Expect rapid results and a massive market. Sofusa is also in trials for lymphatic centered cancer and Covid vaccine.
- Subsidiary Company - ADNAB, Inc. - to develop and commercialize ADNAB Platform Products for Haematological Malignancies and Solid Tumours Based on an Exclusive Technology License from the Mayo Clinic- Multiple IND’s in 2021(up to 10).
- Lee’s Pharmaceutical announces its Anti-PD-L1 Antibody Socazolimab, licensed from SRNE, receives breakthrough therapy designation in China for the treatment of recurrent or metastatic cervical cancer.
- Concortis subsidiary has 20 different ADC options ready.
- MabPharm subsidiary has the North American, European and Japanese rights to 4 biobetters now in phase 3 trials in China.
- The first DAR-T trial will enter clinic any day. There could be a dozen targets. Dr. Ji says it is 10 to 100 times as effective as CAR-T.
- Sure, SRNE right now only has one drug approved (ZTildo), but sales here are growing massively.
- Significant recruitment in manufacturing roles in Q4 2020 and Q1 2021(over 90 new positions to be filled).
- Acquiring multiple companies over the last years. I.e. SRNE owns 25% of Celularity who are listing for approx. $2bn due to merger with GX Acquisition Corp. ACEA acquisition due for completion and announcement is imminent.
- It also looks like SRNE has won a court case with PSS for Cynviloq cancer drug he bought from us. We now have the drug back in our pipeline and expecting $1bn compensation to follow.
- SRNE owns 10 million shares of Immunity Bio. They are merging with NK in June. PSS is chairman making it more likely SRNE’s Cynviloq case will be settled before then, $$ NK SP surging.
- Multiple cancer and pain relief plays which triggered lowball BO offer of $7 a year ago before SRNE started developing for Covid. BlackRock has increased their stake in SRNE massively and now holds 6.7% of all shares.
- Four analysts have SRNE at $20-35 which seems very conservative when taking into account the pipeline.
- CEO gets share options if he maintains SP above $17-130 for six consecutive months.
- Last but not least, with more than 60m shares short SRNE remains poised for a massive short squeeze.
DNA and cellular products brings to mind 2020 plasmid DNA and COVI-MSC. And how many new Smartpharm technologies!
Jess...Sorrento has a about 90 job openings! I'd say they're expanding nicely and obviously are well financed!
Here are someone's thoughts on the big picture...
"Quick observations. PM vol is low, very low. Short interest has been reduced tremendously. Numbers are from approx. 40% down to 14%. Few, if any, news releases or PR's. Remindful of quiet period companies will exhibit prior to major moves upward. On a scale of 10x to 100x their share price. Institutional ownership moving steadily higher and higher. Increased noise from opposition (shorts) in face of no noise or very little noise from supporters (longs). This is simply a distraction to what is meaningful and movement behind the public curtain. Goals and objectives already stated as challenge, market cap between 100 Billion and 200 Billion, equals approx. $400 to $800/share over 3-5 years. Lucrative revenue streams increasing almost weekly equals doubt being erased as to importance of SRNE's products and methods. Increased and diversified holdings and partnerships. And these partnerships are with upper echelon companies. No resistance from these new partnerships to owning SRNE stock. A lot of money out there with no home. And many others.
My take; we are close to seeking a new level share price indicative of new paradigm. Perhaps even a buyout by big pharma or partnership with another biotech. End result is we see large price increases imminently."
Very dissappointing article! Mentions cash situation and does not even mention very profitable investment in Celularity and ImmunoBio or the rapidly approaching PSS settlement. Nor does it mention the pain portfolio with blockbuster SP-102 and RTX advancing nicely. And how doe it ignore the ADNAB portfolio, Abivertinib, DAR-T,CAR-T and SmartPharm technology?
You may have noticed that the ClinicalTrials entries are sometimes not up to date. Here's some information that hasn't been posted yet! It's from a recent interview .
"The Phase II trial has also been amended to eliminate the 40mg dose group, so the estimated sample size is 375 patients, said Ji. Currently, the ClinicalTrials.gov entry includes a 500-participant target meant to evaluate 40mg, 100mg and 200mg doses of COVI-AMG.
Sorrento is also planning similar trials in Mexico and Brazil with COVI-AMG, said Ji. While the single-arm, open-label trial in Mexico will largely be a safety study, a Phase II, double-blind, placebo-controlled trial is planned in Brazil, he said. As such, more than 1,000 patients will be enrolled in the different COVI-AMG studies, explained Ji. COVI-AMG is designed to be delivered through an intravenous (IV) push administration over 2–5 minutes at 100mg or 200mg doses. Ji emphasised that these doses are significantly lower than those of its competitors. Eli Lilly’s bamlanivab is authorised at a 700mg dose, while Regeneron Pharmaceuticals’ mAb cocktail of casirivimab and imdevimab is dosed at 1,200mg each....
In addition to the mAbs delivered via IV push, Sorrento is awaiting FDA clearance to start a Phase I study with the intranasal formulation of STI-2099 (COVI-DROPS), said Ji. This would further reduce the quantity of mAb required for efficacy to 1–2 log less than the IV formulation, said Ji. Sorrento is studying both the IV and intranasal formulations individually, but is exploring a potential future combination, said SVP of Antiviral and Immunology Robert Allen."
The SOFUSA drug delivery system is often overlooked. It has blockbuster potential. It has applications in Arthritis,
cancer and Covid.
"The Sofusa® Lymphatic Delivery System (SLDS) is a new method of treatment designed to deliver
injectable medicines directly into lymphatic and systemic capillaries just beneath the epidermis via a
proprietary microneedle and microfluidics system. In 2015, the Sofusa team partnered with a design
firm to translate insights gained from real patients into an elegant and functional wearable armband
design for the delivery system. This breakthrough design has now been realized by combining
microfabrication techniques (associated with silicon chip manufacturing) with precision molding
and traditional drug delivery manufacturing capabilities.
How is the SLDS different from other microneedle systems? Nanostructured polymer patterns layered
on top of our microneedles have been shown to activate cellular pathways (Kam et al., 2013) and
dramatically enhance absorption of large molecules up to 150kDa (10-fold, Walsh et al., 2015) through
the epidermis. This results in Sofusa’s unique biodistribution profile - higher lymphatic concentrations
and lower systemic concentrations - relative to intravenous (IV) infusions, subcutaneous (SC) injections,
and intradermal (ID) injections. In addition, our proprietary microfluidics system enables precise and
customizable flow profiles to optimize and tune drug levels over time.
What is the problem with current treatment methods? Many therapeutic targets are located
peripherally or in systemic organs, and drug delivery via the systemic (blood) circulation provides
adequate exposure in these targets. However, it is more difficult to achieve adequate drug exposure to
targets that reside primarily in the immune system (lymph nodes or lymphatic capillaries),
or in a microtumor environment. Many formulation approaches (e.g. lipid conjugates, nanoparticles, intradermal
injections) have been attempted to improve the relative lymphatic/systemic biodistribution ratio, but
with limited success. Historically, the primary option to improve target exposure was to deliver higher
systemic doses and/or prolonged the half-life. This often results in trade-offs between maximum
efficacy/response and toxicity or tolerability. In addition, traditional injections or infusions deliver a
bolus of drug, which results can result in a high Cmax or “burst” that can result in adverse events.
How do we solve these problems? The Sofusa (“soft transdermal infusion”) system enables maximal
drug exposure to immune system targets by delivering higher concentrations of directly via lymphatic
capillaries to lymph nodes. The significance of intra-lymphatic targeting has now been validated in
preclinical studies with an improved clinical response in both RA and oncology models. We have also
demonstrated in solid tumor models that access to lymphatic capillaries resulted in increased tumor
penetration and an improved response with a significantly lower dose vs intravenous infusion. By
accessing lymphatic capillaries and increasing the exposure of immune targets to the drug, Sofusa has
potential to improve clinical response, to lower AE’s/dosing, or both. In addition, with precise and
tunable flow profiles, we may reduce burst-associated adverse events AND improve the overall patient
experience by avoiding the pain and anxiety associated with traditional injections.
The Sofusa Lymphatic Delivery System is a strategic asset for Sorrento with broad potential application,
and we are open to partnering opportunities to accelerate development and use of this exciting
platform technology."
EUA's can be expected on Covid phase 2 trial results( Abivertinib trials are all phase 2; COVI-MSC enters phase 2 in a few weeks). And cancer trials can receive Breakthrough designation before the end of phase 2.
"A drug that receives Breakthrough Therapy designation is eligible for the following:
*All Fast Track designation features
*Intensive guidance on an efficient drug development program, beginning as early as Phase 1
*Organizational commitment involving senior managers
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation.
Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request."
My opinion is that both would be complementary. I could see Abivirtinib being used earlier to prevent ARDS and COVI-MSC being used later for more severe cases. And then there is the possibility that they could be used together.
Both technologies should work against any ARDS case no matter what the cause....Covid, pneumonia , sepsis, burns or any coronavirus variant. Let's hope both succeed!
Your entire argument will collapse when COVI-STIX is approved!
The ABIVERTINIB Covid trials are proceeding rapidly and we should get interim results in about a month. The COVI-MSC trial was scheduled by PSC for next August. Sorrento licenced it and the trial was not only advanced by 8 months but has had very encouraging results!
In a few months the excellent investments in Celularity and ImmunoBio will produce hundreds of millions in profit!
Meanwhile the 2020 Mab trials are expanding in the US, Brazil and Mexico with great potential.
And there has been nothing but good news about the excellent ADNAB technology licenced from the Mayo Clinic!
And in the pain program SP-102 and RTX have enormous potential and trials should conclude this year!
COVI-STIX uses the latest technology to be affordable at the same time it is both rapid and 98-99% accurate. Dr. Ji said that there is "humungus" interest in Mexico, Brazil and Europe as well as the US.
I don't know of a better small biotech investment with so many shots on goal! I will hold for triple digits.
I have held Sorrento less than a year and am up almost 700%. And there is a lot of Covid news to come. I like our chances with COVI-MSC. And Abivertinib looks interesting against cytokine storm. But trials take time. That's the way it is with all biotechs! We should hear soon about the Covid tests. I don't agree that Covid is going away. And I like everything I hear about the three forms(injection, DROPS and plasmid DNA) of the 2020 Mab.
Meanwhile the cancer portfolio is advancing. It alone is worth the current share price! Abivertinib has outstanding potential in 3 or 4 indications. The Mayo Clinic ADNAB technology is going after 10 indications and was an amazing aquisition. The Smartpharm technology is equally exciting. And the Dar-T trial should be announced any day. And there are a couple more Chinese and Korean partnerships advancing nicely...milestone and royalty payments are not far off.
The pain portfolio is also worth more than the current share price!SP-102 has a huge potential market and so does RTX! These are both blockbusters IMO.
The Sorrento share price is not inflated. It has been held down by organized shorting. That too will end. The Sorrento Covid, cancer and pain portfolios are great. And investments in Celularity and ImmunoBio are about to pay off. And the PSS lawsuit will soon be settled . Each one of these could net Sorrento over a billion $. I remain long and strong!
I can't find another small biotech with better triple digit potential!
This stock deserves a board. Very interesting technology.
China Oncology Focus says socazolimab wins NMPA's breakthrough therapy status
Feb. 09, 2021 9:22 AM ETSorrento Therapeutics, Inc. (SRNE)By: Aakash Babu, SA News Editor19 Comments
China Oncology Focus Limited (NYSE:COF) announces that anti-PD-L1 antibody, socazolimab, licensed from Sorrento Therapeutics (NASDAQ:SRNE) for the greater China territory, has been granted breakthrough therapy designation (BTD) by the China National Medical Products Administration (NMPA) to treat recurrent or metastatic cervical cancer.Products with BTD from the NMPA may be considered for conditional approval and priority review when submitting a new drug application.Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform.China Oncology's affiliate Lee’s Pharma plans to file new drug application in China in Q2 2021 for the drug, the company said.
Sorrento has 10 million shares of ImmunityBio which will translate into 8.2 million shares of the merged company.
These T cells will kill the virus not mask it's receptors.
Oral Vaccine stable at room temperature being tested
3.71 (14.1%) Upgrade to Real-Time
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ImmunityBio & NantKwest Announce FDA Authorization to Study hAd5 T-Cell COVID-19 Vaccine for Combination of Subcutaneous, Ora...
February 11 2021 - 06:13PM
Business Wire
FDA authorized the expansion of the active Phase 1 COVID-19 vaccine trial and a second trial to test a novel combination of T-cell-based hAd5 subcutaneous prime vaccine with a room-temperature oral or sublingual boost, to induce comprehensive immune protection through CD4+ and CD8+ T cells to both Spike (S) and Nucleocapsid (N) antigens, as well as generate systemic and mucosal antibodies
The first COVID-19 trials conducted to deliver both S and N proteins via multiple routes (skin, gut, or under the tongue) to activate the entire immune system and drive T-cell and B-cell memory, which are required for long-term immune protection
Oral, room-temperature boost that stimulates immunity to both S and N proteins could potentially serve as a universal boost to other S-based vaccines while also targeting escape mutants
Testing of novel combination of oral boost to subcutaneous prime is based on positive NIH/BARDA-sponsored non-human primate data showing potent T-cell and antibody response to hAd5 after oral boost, with rapid inhibition of virus replication to undetectable levels following SARS-CoV-2 challenge
ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced they have received FDA authorization to expand Phase I testing of a bivalent hAd5 T-cell COVID-19 vaccine. The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts. The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration. As a result, the companies will enroll another 105 participants in the U.S. trials of their vaccine candidate, which is unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus.
The expectations of inducing protective immune responses in healthy volunteers – with this novel combination of an oral boost with a subcutaneous prime – are based on the positive findings reported in the NIH/BARDA-sponsored Non-Human Primate (NHP) study. This recent data showed that when administered with an oral boost, the bivalent vaccine resulted in potent stimulation of S- and N-specific T cells with potent antibody release from memory B cells following viral challenge. Additionally, activation of the full immune system by S and N proteins resulted in complete viral clearance of SARS-CoV-2 in lung and nasal passages following the challenge. On the basis of these findings, ImmunityBio has expanded the current Phase 1 study of subcutaneous prime with oral or sublingual boost to explore the potential of this second-generation vaccine to reduce disease and transmission of the virus.
The oral trial is a new study (NCT04732468) and the sublingual trial is the cohort C expansion to the Phase 1 subcutaneous trial (NCT04591717), which was initiated last Fall. Both oral and sublingual trials are anticipated to begin this month and will be conducted at two sites in California. Based on the findings of these trials involving over 100 participants, the optimal combination of route of administration and dose will be determined and entered into the Phase 2 / 3 design.
“The NHP study findings reinforce our hypothesis that a T-cell-based vaccine could be protective, not only in preventing mild, moderate, and severe disease, but also in potentially limiting transmission of the virus,” said Patrick Soon-Shiong, MD, Chairman and CEO of ImmunityBio. “We believe that the key to creating long-term immunity to the SARS-CoV-2 virus and overcoming the variants that are rapidly developing around the world is to create a vaccine that activates not only antibodies but also memory B and T cells to multiple antigens. Furthermore, room-temperature stable formulations for oral delivery have the potential to solve the cold-chain challenges of distribution and the ability to generate mucosal IgA antibody barriers to the virus in the upper respiratory tract where it first enters the body.”
One Vaccine, Two Trials, Three Routes of Immune Protection
The first two cohorts of the Phase Ib, open label, dose-ranging study (NCT04591717) of the vaccine received two different dose levels (.5 and 1ml). Participants received two subcutaneous injections 21 days apart. No grade three or four AEs and no SAEs were observed at either dose level and, in the intermediate (1ml) dose group, immunogenicity was observed as early as 14 days after the prime. An additional group of 40 subjects will be enrolled to evaluate safety, reactogenicity, and immunogenicity of the combination of hAd5 in four different cohorts receiving sublingual and subcutaneous formulations to select an optimal combination dose for future studies.
The second Phase 1b trial (NCT04732468) is designed to assess the safety, reactogenicity, and immunogenicity of the combination of hAd5 in oral capsule and subcutaneous formulations; and to select an optimal combination dose for future studies. Up to 65 subjects will be enrolled in the four-cohort study, which is anticipated to begin in Q1.
About the T-Cell-Based Vaccine Candidate
Developed by ImmunityBio and manufactured by NantKwest, this second generation hAd5 vectored vaccine is unique in targeting both spike (S) and nucleocapsid (N) SARS-CoV-2 proteins to generate B and T cell memory to these antigens and long-term immunity to the virus. Most of the COVID-19 vaccines approved by the FDA or in late-stage clinical trials deliver only the spike protein, which has already mutated several times. Another unique characteristic of the hAd5 design is its use of a second-generation hAd5 platform that was developed to elicit anti-SARS-CoV-2 immune responses even in Ad-immune individuals, meaning subjects can receive the vaccine multiple times, if necessary. The stimulation of anti-hAd5 immune responses is attenuated with the second-generation platform in comparison with the first-generation platforms, due to additional genetic deletions. The hAd5 room temperature-stable oral capsules were developed in partnership with UK-based biotechnology company iosBio.
Phase I trials have been initiated in the U.S. and recruitment is set to begin in February in Cape Town, South Africa for a trial (NCT04710303) of subcutaneous administration to be followed by additional trials using sublingual delivery and room temperature-stable oral capsules.
NantKwest Transaction
As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest (NASDAQ: NK). The combination, which is expected to close in the first half of 2021, will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.
About ImmunityBio
ImmunityBio, Inc. is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T-cell) immune systems to create long-term “immunological memory.” This novel approach is designed to eliminate the need for high-dose chemotherapy, improve upon the outcomes of current CAR T-cell therapies, and extend beyond checkpoint inhibitors.
ImmunityBio’s platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). The company is also in Phase 2 or 3 trials for indications such as first- and second-line lung cancer, triple-negative breast cancer, metastatic pancreatic cancer, recurrent glioblastoma, and soft tissue sarcoma in combination with the company’s synthetic immune modulator (Aldoxorubicin).
ImmunityBio is also developing therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2 with its second-generation human adenovirus (hAd5) vaccine technologies.
About NantKwest
NantKwest (NASDAQ: NK) is an innovative, clinical-stage, immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cells—as well as their activity against a broad range of cancers—has been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwest’s goal is to transform medicine by bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit www.nantkwest.com.
Forward-Looking Statements
The latest I have seen was this...
"In addition to the mAbs delivered via IV push, Sorrento is awaiting FDA clearance to start a Phase I study with the intranasal formulation of STI-2099 (COVI-DROPS), said Ji. This would further reduce the quantity of mAb required for efficacy to 1–2 log less than the IV formulation, said Ji. Sorrento is studying both the IV and intranasal formulations individually, but is exploring a potential future combination, said SVP of Antiviral and Immunology Robert Allen."
It makes sense to me that the first will be 2020 injected followed by COVI-DROPS. Next might be the combination Allen referenced. The Vaccibody would follow in my opinion. As it has both Covid and cancer applications they will want to be sure they get it right!
Thanks for the kind words...but just feel free to repost anything you find of interest. Sorrento is an amazing stock IMO.
ImmunityBio has a vaccine pill!(Sorrento has 10 million shares)
Covid vaccine pill enters clinical trials
By Mico Tatalovic
US and South Africa trials test oral vaccine whose capsule technology was developed in UK
A US-based company, ImmunityBio, has acquired worldwide rights to technology developed in the UK to deliver Covid-19 vaccines in a pill or tablet form, and has now started clinical trials.
ImmunityBio’s human adenovirus (hAd5) Covid-19 vaccine candidate is being tested in people in South Africa as well as in the US, following successful tests in non-human primates.
The vaccine is designed to activate the immune system through virus-specific T-cells and to generate memory B-cells with neutralising antibodies, which ImmunityBio says could protect against emerging coronavirus mutations.
The trials involve different formulations of the vaccine, including oral capsules that are stable at room temperature and were first developed by Stabilitech, a company now known as iosBio and headquartered in Burgess Hill in the UK.
Wayne Channon, chair of iosBio, says the company started work on the technology, called OraPro, in 2015 and was backed by two Innovate UK grants worth in total over £2.2 million to explore its use in delivering a vaccine for the Zika virus. But when coronavirus struck early last year, Innovate UK allowed the company to repurpose the remaining grant money to develop a Covid-19 vaccine candidate.
The firm eventually partnered with ImmunityBio, which Channon says understood the potential of the technology and had the funding and capacity to usher it through clinical trials and scale up production quickly. They are now working together on trials and if all goes well, Channon expects to have the vaccine ready for rollout later this year.
The vaccine candidate targets both the mutation-prone outer spike protein of the coronavirus and the more stable inner nucleocapsid protein, activating antibodies, memory B-cells and T-cells with the goal of creating longer-term protection. The hope is that it will serve as “a universal T-cell boost to current vaccines or address mutations where other vaccines might fail”, according to ImmunityBio.
“Unlike antibody-based vaccines, T-cell-based vaccines kill the infected cell, preventing virus replication, and could provide long-term immune memory to recipients,” said Patrick Soon-Shiong, chair and chief executive of ImmunityBio. “Pursuing a vaccine that does not rely solely on targeting the S protein where the mutations are occurring is of critical importance as multiple variants of the Sars-Cov-2 virus have appeared globally, with concentrated outbreaks beginning in South Africa.”
Soon-Shiong said that trials of the oral vaccine in South Africa were spurred on by “exciting results” that showed “complete protection to a viral challenge in our non-human primate data”.
A pill form allows the vaccine to be delivered to the gut, where most of the immune cells are, says Channon, and also has the added benefit of being easily transported. Similarly, in its tablet form, the vaccine can be given by placing it under the tongue—which is also being tested in the South African trial.
The oral vaccine delivery platform technology “has the potential to transform the way people take vaccines and addresses the challenges of storage and global distribution of vaccines”, Soon-Shiong added. “Given the need for global distribution in both developing and developed countries, the enormous challenge of cold-chain requirements could be mitigated by a room temperature stable formulation of hAd5 that can be administered without the need for needles,” he said.
Here is the merged pipelines link for NK/ImmunityBio. The shares Sorrento will hold in the merged company previously was estimated at $150M equity. That estimation was back in mid January. Expect more in a strong biotech IPO market, and as the multi P 2&3 trials progress.
https://nantkwest.com/transaction/
ImmunityBio and NantKwest news.(Sorrento has 10 million ImmunityBio shares)NK hit $30 on this news.
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced they have received FDA authorization to expand Phase I testing of a bivalent hAd5 T-cell COVID-19 vaccine. The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts. The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration. As a result, the companies will enroll another 105 participants in the U.S. trials of their vaccine candidate, which is unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus.
The expectations of inducing protective immune responses in healthy volunteers – with this novel combination of an oral boost with a subcutaneous prime – are based on the positive findings reported in the NIH/BARDA-sponsored Non-Human Primate (NHP) study. This recent data showed that when administered with an oral boost, the bivalent vaccine resulted in potent stimulation of S- and N-specific T cells with potent antibody release from memory B cells following viral challenge. Additionally, activation of the full immune system by S and N proteins resulted in complete viral clearance of SARS-CoV-2 in lung and nasal passages following the challenge. On the basis of these findings, ImmunityBio has expanded the current Phase 1 study of subcutaneous prime with oral or sublingual boost to explore the potential of this second-generation vaccine to reduce disease and transmission of the virus.
The oral trial is a new study (NCT04732468) and the sublingual trial is the cohort C expansion to the Phase 1 subcutaneous trial (NCT04591717), which was initiated last Fall. Both oral and sublingual trials are anticipated to begin this month and will be conducted at two sites in California. Based on the findings of these trials involving over 100 participants, the optimal combination of route of administration and dose will be determined and entered into the Phase 2 / 3 design.
“The NHP study findings reinforce our hypothesis that a T-cell-based vaccine could be protective, not only in preventing mild, moderate, and severe disease, but also in potentially limiting transmission of the virus,” said Patrick Soon-Shiong, MD, Chairman and CEO of ImmunityBio. “We believe that the key to creating long-term immunity to the SARS-CoV-2 virus and overcoming the variants that are rapidly developing around the world is to create a vaccine that activates not only antibodies but also memory B and T cells to multiple antigens. Furthermore, room-temperature stable formulations for oral delivery have the potential to solve the cold-chain challenges of distribution and the ability to generate mucosal IgA antibody barriers to the virus in the upper respiratory tract where it first enters the body.”
One Vaccine, Two Trials, Three Routes of Immune Protection
The first two cohorts of the Phase Ib, open label, dose-ranging study (NCT04591717) of the vaccine received two different dose levels (.5 and 1ml). Participants received two subcutaneous injections 21 days apart. No grade three or four AEs and no SAEs were observed at either dose level and, in the intermediate (1ml) dose group, immunogenicity was observed as early as 14 days after the prime. An additional group of 40 subjects will be enrolled to evaluate safety, reactogenicity, and immunogenicity of the combination of hAd5 in four different cohorts receiving sublingual and subcutaneous formulations to select an optimal combination dose for future studies.
The second Phase 1b trial (NCT04732468) is designed to assess the safety, reactogenicity, and immunogenicity of the combination of hAd5 in oral capsule and subcutaneous formulations; and to select an optimal combination dose for future studies. Up to 65 subjects will be enrolled in the four-cohort study, which is anticipated to begin in Q1.
About the T-Cell-Based Vaccine Candidate
Developed by ImmunityBio and manufactured by NantKwest, this second generation hAd5 vectored vaccine is unique in targeting both spike (S) and nucleocapsid (N) SARS-CoV-2 proteins to generate B and T cell memory to these antigens and long-term immunity to the virus. Most of the COVID-19 vaccines approved by the FDA or in late-stage clinical trials deliver only the spike protein, which has already mutated several times. Another unique characteristic of the hAd5 design is its use of a second-generation hAd5 platform that was developed to elicit anti-SARS-CoV-2 immune responses even in Ad-immune individuals, meaning subjects can receive the vaccine multiple times, if necessary. The stimulation of anti-hAd5 immune responses is attenuated with the second-generation platform in comparison with the first-generation platforms, due to additional genetic deletions. The hAd5 room temperature-stable oral capsules were developed in partnership with UK-based biotechnology company iosBio.
Phase I trials have been initiated in the U.S. and recruitment is set to begin in February in Cape Town, South Africa for a trial (NCT04710303) of subcutaneous administration to be followed by additional trials using sublingual delivery and room temperature-stable oral capsules.
NantKwest Transaction
As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest (NASDAQ: NK). The combination, which is expected to close in the first half of 2021, will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.
ANOTHER Sorrento partnership (35%) ImmuneOncia advancing 2 Mabs!
IMC-001 (anti-PD-L1 mAb)
PD-L1 is a clinically validated immune-checkpoint target which is over-expressed on tumor cells and tumor-infiltrating immune cells in multiple tumor types. PD-L1 inhibits the natural anti-tumor immune response in the following ways. It prevents recruitments of new T cells to the tumor by preventing priming and activation of new T cells in the lymph nodes. Also, it deactivates cytotoxic T cells in the tumor microenvironment. Antibodies blocking PD-L1 can reactivate T-cell activity and proliferation, which leads to enhanced anti-tumor immunity.
IMC-001 is a fully human anti-PD-L1 IgG1 type monoclonal antibody which has shown promising results in terms of safety and efficacy in the dose-escalation first-in-human study despite the patients were heavily pretreated. IgG1 type antibody targeting PD-L1 on tumor enables unique combinations, such as with a NK cell-based therapy, which is unique in its property among other PD-1/PD-L1 targeting agents. We have received an approval for a multi-regional PHASE II STUDY of IMC-001 in Korea, and clinical trial application (CTA) in China is planned in 2Q 2020.
IMC-002 (anti-CD47 mAb)
CD47 is a transmembrane protein broadly expressed on cell’s surface and often overexpressed on cancer cells. CD47 on cancer cells interacts with a myeloid inhibitory immunoreceptor SIRPa on macrophages to deliver a “don’t-eat me” signal inhibiting phagocytic activity (cancer cell killing). Blocking CD47-SIRPa interaction restores phagocytic activity of macrophages. Blocking the interaction shows a clear clinical benefit especially when combined with other agents for enhancing the pro-phagocytic signal. However, because CD47 is also expressed on normal cells such as red blood cells (RBCs), first-generation clinical-stage CD47 blockers which shows binding to RBCs were found to cause significant adverse events such as anemia.
IMC-002 is a fully human IgG4 type monoclonal antibody that was engineered to maximize efficacy (tumor phagocytosis) without causing hemagglutination. IMC-002 is highly differentiated as it does not bind to RBCs even at the high concentration of micro-molar range, which is much higher than the clinically effective level. Lack of RBC binding may improve the safety profile and the PK profile by bypassing the ‘antigen sink’ effect. FDA had recently cleared IND application and PHASE I STUDY of IMC-002 is being initiated in the U.S. for solid tumors and lymphomas.
Combinational blockade of PD-L1 and CD47 has been shown to enhance anti-tumor effects in vivo. It represents an interesting opportunity to combine IMC-001 and IMC-002 in the clinic. ImmuneOncia is also currently developing additional antibodies targeting novel immune-checkpoints.
One BTD granted already. "“China NMPA granted socazolimab breakthrough therapy designation in recognition of both significant unmet medical need and positive and promising clinical results of socazolimab treatment for patients with recurrent or metastatic cervical cancer,” said Dr. Benjamin Li Xiaoyi, Chief Executive Officer of Lee’s Pharma. “Cervical cancer is the fourth most lethal cancer in women worldwide and the third cause of cancer-related death in developing countries. There is currently no recommended standard of care treatment for this disease in China. Socazolimab has the potential to be the leading anti-PD-L1 antibody in the treatment of this indication. Socazolimab has demonstrated outstanding efficacy and safety profile in the clinical trials so far in treating cervical cancer patients."
9 ADNAB cancer drugs now: 1 auto-immune drug coming: 2 of the cancer drugs applying for breakthrough designation: ADNAB potential as a spin-off
"The ADNAB platform will make use of Sorrento’s G-MAB library of fully humanized monoclonal antibodies, which makes it well-placed to deliver an extensive collection of product candidates to combat liquid and solid tumors.
Sorrento, however, believes the platform has potential to be effective in areas other than oncology and work has already begun on developing it for auto-immune diseases.
Later this year, the company intends to file several Investigational New Drug (IND) applications and will also apply for Breakthrough Therapy designation in both ovarian and endometrial cancers.
H.C. Wainwright analyst Ram Selvaraju thinks the new entity is good news for investors.
“In our view, ADNAB's formation merely underscores Sorrento's expertise and commitment to developing next-generation antibody-based drugs using a variety of disruptive, cutting-edge technology platforms,” the 5-star analyst said. “We also note that entities like ADNAB could, if successful, be spun out of Sorrento into an independent listed company, thus unlocking further shareholder value.”
Here's some background on the anti-PD-L1 deal with Lee's Pharmaceutical in 2014.
NEWS PROVIDED BY
Sorrento Therapeutics, Inc.
Oct 03, 2014, 02:41 ET
SAN DIEGO, Oct. 3, 2014 /PRNewswire/ -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a late-stage clinical oncology company developing new treatments for cancer and its associated pain, today announced that China Oncology Focus Limited, an Affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma), a public biopharmaceutical company listed on the main board of Hong Kong Stock Exchange (0950) with over 20 years of operation in China's pharmaceutical industry, has licensed Sorrento's fully human immune-oncology anti-PD-L1 monoclonal antibody (mAb) STI-A1014.
Under the terms of the agreement, Lee's Pharma received exclusive rights to develop and commercialize the antibody for the greater Chinese market, including Mainland China, Hong Kong, Macau, and Taiwan. In turn, Sorrento will receive an up-front payment, potential future milestone payments and high single digit to double digit royalties on future net sales. In total, Sorrento has the potential to receive more than $46 million upon the successful attainment of key milestones. Additionally, Lee's Pharma will invest $3.6 million by purchasing common stock in Sorrento at a substantial premium to the current market price.
Sorrento's proprietary G-MAB® library platform was used to identify and generate STI-A1014. The theoretical diversity of the library has been calculated to be more than one quadrillion unique antibodies, making it one of the largest fully human antibody libraries available to pharmaceutical and biotechnology companies for drug discovery and development partnerships.
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Additional antibodies and additional indications in the huge Chinese market! More great news!