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WHAT IS HAPPENING IN BRAZIL? The news release said (highlites added)...
"The current partnership with Synova Health leverages high quality clinical trial sites IN ADDITION TO a dozen centers already enrolling COVID-19 patients for another Sorrento Phase 2 clinical trial (Abivertinib). ADDITIONAL STUDIES are also being discussed for early clearance in parallel or immediately following this study. PRIORITY ACCESS to multiple trials is being given to Brazilian patients following the rapid and openly collaborative interactions Sorrento has been able to establish with ANVISA regulators.
“We are very satisfied with the progress made in Brazil so far, and we have developed strong local relationships in support of multiple studies,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “By focusing on the geographies most impacted by COVID-19, we are able to implement synergistic programs to answer safety and efficacy questions related to our product candidates while helping patients where the disease has been spreading the most. We expect this next Phase 2 Pivotal study to confirm the clinical benefits initially observed in our recently completed open label Phase 1b study. If confirmed, we are ready to establish a plan for development and MANUFACTURING COMMITMENTS that are required by ANVISA to take the product candidate from clinical trials to emergency use authorization (EUA) approval, including generating the data needed to support making the drug accessible prior to any full registration.”
I see at least three important implications.
1. They are adding new high quality sites IN ADDITION TO the DOZEN sites already enrolling for the Abivirtinib trials (results soon).
2. ADDITIONAL STUDIES are being discussed. Could this include COVI-AMG, COVIDROPS and Gene-Mab? Or some combinations of the top 5 Covid candidates? Sorrento is being given PRIORITY ACCESS "to multiple trials".
3. Sorrento has made MANUFACTURING COMMITMENTS. Clearly that means establishing manufacturing arrangements in Brazil. Sorrento could then have manufacturing capacity in the US, China and Brazil! All part of becoming a worldwide Pharma!
How important is Brazil for Sorrento's future? Keeping in mind that Abivirtinib, COVI-MSC, COVI-AMG and diagnostics will all soon seek Brazilian approvals.
2020 U.S. population 330 million
2020 Brazil population 213 million (66% of US)
2020 S.America population 431 million (30% larger than US)
Brazilian trials will be faster and cheaper than US trials.
Brazilian approvals are usually more rapid than US approvals.
And D......added this interesting insight...
"Excellent description of the Sofusa technology. Also keep in mind that metastasis of cancers mostly happens through the lymphatic system. Sofusa injections may be able to target the lymphatic ganglia with cytotoxic molecules or combination to prevent spreading of cancers. As an example (although futuristic) kidney cancer usually leads to organ removal for surgery may lead to spreading of cancerous cells. If the lymphatic system could be targeted with cytotoxic before the surgery, it may make it possible to remove the cancer from the kidney without removing the entire organ.
Just to put some perspective of the great potential all these technologies have. Let the stock players keep at it and but whenever you can, in the long term we (the positive supporters) will be happy financially and happy to belong to a company providing so much relief to human suffering (and animal suffering in the pet market)"
The Sofusa news is extremely important. K...... did a good job explaining how Sofusa works.
"So just how big is today's news about the initial success of the Sofusa technology?
1st, this is a technology that aims at lymphatic delivery.
What does this mean? Well, when trying to fight a disease, it's difficult to target the lymphatic system. Because of how it works and the fact that it is spread throughout our body.
So there are MANY, MANY drugs out there that treat several conditions through the lymphatic system. But, because of what we just explained, those drugs sometimes don't work. They are not properly "delivered". They don't get to where they need to get to make the necessary interaction and solve the problem.
Sorrento has developed a technology that can deliver drugs to where they actually need to go in the lymphatic system. So this is definitely breakthrough technology. Other companies are aiming to find similar solutions. But we are definitely talking about very advanced bio-tech.
In this case, we have a patient suffering from rheumatoid arthritis. This is a condition that worsens with time. It's very painful and limits the patient's movement. It's not very common, so we are talking about 1.5 million people in the USA and about 30 million worldwide.
But remember, the technology Sorrento is developing will be able to deliver drugs treating many other diseases related to the lymphatic system. So the market for Sofusa is very, very large.
The press release tells us Sofusa was tested on "First Enbrel-Non-Responding" patients. What does this mean?
Patients who need the drug Enbrel and, even though they have not been taking the drug for long (it's a "first" for them) they are not responding to it. It isn't helping them.
Now, Sofusa comes into play. It's job is to deliver Enbrel to the patient effectively. To "take" Enbrel to where it needs to go in the lymphatic system..
The 1st obvious advantage is that the drug wasn't helping and now helps. But there are other important advantages.
Since the drug is being carried to its targeted "destination" the dosage needed, diminishes. Because less is "lost along the way". This is important because many diseases related to the lymphatic system, such as rheumatoid arthritis, are chronic, lifelong conditions. Being able to administer less drugs really helps the patient. Now you have a drug that actually works, more potently, which reduces its dosage. All this thanks to Sorrento.
The press release points out an important factor: This is a trial on ONE type of drug/treatment. Other such trials testing the effectiveness of Sofusa are already taking place. Again, this is proof of the potentially huge market for this delivery system.
Just to get an idea, the release mentions anti-PD1 and anti-CTLA4 antibodies. These are a type of drugs that inhibit the activity of certain proteins (they inhibit PD1 and CTLA4, which are types of proteins. By stopping their activity, they help in stopping the growth of cancer tumors). There are several drugs that fall under these categories and treat a wide variety of cancers. Sofusa can potentially play a vital role in all these treatments.
This is like several companies developing apps while Sorrento is developing a new smartphone technology. Each app has its rightful use and market. But once the new smartphone is up and working, all apps will need it. So this technology has huge revenue implications. The fact we are hearing good news about it is HUGE.
As for the results themselves: The DAS28 test measures rheumatoid activity in 28 joints in the patient's body. The joints might be swollen or tender (hurting).
This patient had a DAS28 score of 4.6, with 18 out of 28 joints compromised. That is considered moderate to high disease activity. There are 4 levels of DAS 28 scores going from remission (the best) to high (the worst). So this patient was not in the worst shape going in, but pretty bad.
Using Sofusa to deliver the Enbrel drug, in just 4 weeks (this is a very short time for this type of disease!!) the results went from 4.6 to 3.0. The total amount of compromised joints, from 18 to 11. That is a dramatic change. The patient went from being somewhere between level 3 and 4, to being in the lower level 2, called "low disease activity", which indicates it's moving towards remission (the lowest level). For someone suffering from this condition, it's a real life changer. For the company selling Enbrel, it's a real market changer. And if it can equally help people with tumors, Sofusa becomes a major therapeutic factor.
I hope investors understand this. It's another major development in an already extremely promising pipeline which is currently badly undervalued. If the price doesn't spike today by 10-15%, as it should, just from this news, it would be disappointing.
But if you are long, today's price change isn't what matters the most. It’s the understanding that Sorrento / SRNE has ANOTHER ace in its hand!"
This is great news. The lymphatic system is a very important part of the immune system . I like this..."In pre-clinical biodistribution studies, these proprietary microneedles and microfluidics system have consistently demonstrated the ability to deliver over 40-fold increases in drug concentration to targeted lymph nodes (with lower drug concentration in systemic organs) when compared to traditional intravenous (“IV”) and subcutaneous (“SC”) injections. After a 1-hour administration with Sofusa, elevated lymph node concentrations have been measured beyond 72 hours."
40 fold!
Sorrento Reports Positive Initial Result in Dosing of First Enbrel-Non-Responding Rheumatoid Arthritis Patient With the Sofusa® Lymphatic Drug Delivery Device
May 19, 2021 at 9:30 PM EDT
Sofusa is a drug delivery platform technology which delivers biologic therapies through the skin directly into the lymphatic system with potential to improve efficacy and safety and reduce the required dosing (as compared to traditional systemic or subcutaneous injections or infusions).
This is the first in-human Sofusa lymphatic delivery of a large molecule biologic for treatment. Additional immune-oncology trials with checkpoint inhibitors such as anti-PD1 and anti-CTLA4 antibodies are in place for solid tumors.
The first patient, who was a non-responder to Enbrel subcutaneous injections treatment, had a DAS28 score equal to 4.6, with a swollen joint count of 7 and tender joints of 11. After 4 weekly doses of Sofusa-delivered Enbrel, the patient’s DAS28 score dropped by 33%, total swollen joint count by 29%, and tender joint count by 45%, without any serious adverse events or skin reactions observed.
SAN DIEGO, May 19, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the first patient has been treated in a Phase 1b proof-of-concept, open-label study to assess the safety and pilot efficacy of Enbrel administered by the Sofusa Lymphatic Delivery System for the treatment of Rheumatoid Arthritis.
Abnormal immune system function is implicated in many conditions such as cancer and autoimmune diseases (e.g., Rheumatoid Arthritis, Multiple Sclerosis and Psoriasis). Sofusa’s nanotopography draped microneedles have been shown to reversibly open tight junctions in the skin and facilitate paracellular and transcellular transport across the epidermis directly into the lymphatic system. In pre-clinical biodistribution studies, these proprietary microneedles and microfluidics system have consistently demonstrated the ability to deliver over 40-fold increases in drug concentration to targeted lymph nodes (with lower drug concentration in systemic organs) when compared to traditional intravenous (“IV”) and subcutaneous (“SC”) injections. After a 1-hour administration with Sofusa, elevated lymph node concentrations have been measured beyond 72 hours.
Clinical study STI-SOFUSA-1003 is focused on patients with moderate to severe Rheumatoid Arthritis. Patients eligible for this study are those who failed to develop an adequate response to Enbrel delivered through SC injections. “While biologic therapy helps many patients with autoimmune conditions, there are many who do not achieve an adequate response. Enbrel is an approved and well-characterized drug for Rheumatoid Arthritis, and by switching non-responding patients to Sofusa-delivered Enbrel, we hope to clearly evaluate the safety and efficacy benefits associated with delivering biologic drugs directly into the lymphatics,” noted Brian Cooley, Senior Vice President, Sofusa Lymphatic Drug Delivery Systems.
Study participants with Rheumatoid Arthritis must be on a stable dose and non-responding on Enbrel 50 mg once weekly for at least 12 weeks before inclusion in the study. Patients start on a Sofusa-delivered Enbrel dose of 25 mg (50% of the normal dose) during the induction phase of the study and may be increased to a Sofusa-delivered Enbrel dose of 50 mg after 4 weeks, if necessary, during the dose escalation phase of the study. Sofusa-delivered Enbrel is administered once weekly for 12 weeks.
The primary objective of this study is the safety and tolerability of the Sofusa Lymphatic Delivery System with Enbrel administered once weekly in patients with Rheumatoid Arthritis. Pilot efficacy is also measured in this study using various composite scores for disease activity, including the DAS28 score, where DAS stands for “disease activity score” and the 28 refers to the 28 joints that are examined in each assessment. “The first patient meeting the inclusion criteria of the study enrolled with a baseline assessment, including ESR value of 6, having a total count of swollen joints of 7 and tender joints of 11, Patient Global Assessment of Disease Activity of 52, and a DAS28 score of 4.58. After just 4 weekly doses of Enbrel 25mg with Sofusa delivery, the patient’s DAS score improved to 3.1, with a total of 5 swollen joints and 6 tender joints, ESR value of 2, and a Patient Global Assessment of Disease Activity of 44. In addition, no serious adverse events have been observed. While this is just the first patient in an open label study, this initial result is quite encouraging and in the right direction. We are looking forward to enrolling more patients into this study,” said Dr. Roel N. Querubin, Principal Investigator, Atlanta Research Center for Rheumatology.
As an exploratory endpoint, this study is also evaluating lymphatic pumping rates via near infrared fluorescence (NIRF) imaging. Improper lymphatic function and reduced lymphatic pump rates have been implicated in several autoimmune conditions1. “In Collagen Induced Arthritic pre-clinical models, we have seen an improvement in lymphatic pumping when delivering Enbrel with Sofusa vs subcutaneous injections. Our hypothesis is that poor lymphatic function may be associated with non-response to systemic treatment. By delivering biologic drugs directly into the lymphatic system, we may improve lymphatic function and provide more direct and sustained exposure to therapeutic targets known to modulate immune responses,” noted Russell Ross, Chief Technical Officer of Sofusa Lymphatic Delivery Systems.
1 Rahimi et. al., Arthritis Research and Therapy, “Lymphatic imaging to assess rheumatoid flare: mechanistic insights and biomarker potential” (2016) 18: 194.
An article in May 18 2021 Scientific American asks why Monoclonal Antibodies aren't more widely used to treat Covid? Sorrento has the answers! The article concludes...
"For monoclonals to be more widely distributed, the possibility of administering them subcutaneously or intramuscularly rather than intravenously should be explored. We should also move their administration from the clinic into pharmacies and testing sites where it can be more easily and readily done.
As long as we continue to have cases of COVID, vaccination should not be the only strategy we implement for control. While progress has been made vaccinating high-risk populations in the U.S., we still need to increase access to effective therapies that can prevent disease progression, hospitalization and death among those who get infected with SARS-CoV-2."
Covi-AMG, Covi-Drops and Covi-plasmid DNA are needed now! $34 million DARPA funding shows Defense Department knows what Sorrento has!
'Why Monoclonal Antibody COVID Therapies Have Not Lived Up to Expectations. The drugs used to treat Donald Trump have not been widely administered to other patients, but they still have a role to play"
By Carlos del Rio on May 18, 2021
I originally bought Sorrento early last year as a cancer play. I sold another cancer play at about $4 and bought Sorrento at about $2. The other cancer play is now at about $3 and Sorrento is about $7.
What did I like about Sorrento? I liked RTX for intractable cancer pain. But I especially liked Sorrento's CAR-T, DAR-T and combination cancer treatment potential. Sorrento's acquisition of SmartPharm, ADNAB and ACEA have been pleasant surprises. The cancer portfolio is now world-class! I now can see 15-20 new cancer drugs entering the clinic each year.
I don't underestimate the importance of the pain portfolio! RTX against cancer and arthritic pain is huge! And SP-102 should certainly be a near-term blockbuster.
But those who write off the Covid portfolio are mistaken IMO. I take a worldwide view. Look at India, South America, Africa and the 40% of Americans who aren't vaccinated. And no vaccine is 100% effective and variants are arising every day. Many of Sorrento's technologies are in phase 2 and close to EUA approval IMO. They have 11 shots on the Covid goal...more than any other biotech in the world.
And I am amazed at Sorrento's financial strength! The PSS lawsuit looks good! But the very wise investments in Celularity, IBRX and several other smaller plays are worth hundreds of millions to finance corporate growth into the future. And partnership upfront , milestone and royalty payments will grow steadily. A strong portfolio with strong finances. A year from now I expect a dramatically higher share price!
When I first invested in Sorrento early last year it didn't register that Sorrento had investments in Celularity, ImmunityBio and ImmuneOncia that would be worth many hundreds of millions of dollars a year later. And it was before Sorrento had acquired SmartPharm, ADNAB(Mayo Clinic technology) and ACEA(Abivertinib etc.). I like the investments, acquisitions and portfolio that Sorrento has built. It is now well funded and has world class programs in Covid, cancer and non-opioid pain technologies. I expect the news flow to begin over the next few weeks and extend into next year. With more than 60 drug programs including many first-in-class, best-in-class blockbusters ... I look forward to a great time for longs! Don't let the critics scare you...they simply want your shares!
Languages are important. Greek, Latin and Hebrew all help us understand the roots of Western Civilization...and of what justice means. I hope PSS receives the just consequences of his actions. It could mean that Sorrento receives $1+ billion. That would go a long way in funding Sorrento's portfolio until it's exciting programs start producing a large revenue stream.
Although I am not a lawyer I did sleep at a Holiday Inn. "Something" is happening May 18 and July 22.
July 22, 2021 Hearing
Post-Arbitration Status Conference
July 22, 2021 Hearing
Hearing on Motion to be Admitted Pro Hac Vise
May 18, 2021 Hearing
Post-Arbitration Status Conference
https://trellis.law/case/19STCV11328/SORRENTO-THERAPEUTICS-INC-VS-PATRICK-SOON-SHIONG-ET-A
The PSS lawsuit is interesting. This article discusses some significant aspects of PSS's predicament.
https://www.poynter.org/locally/2021/could-patrick-soon-shiong-sell-los-angeles-times-alden-global-capital/
Dr.Ji has said Sorrento's DAR-T is 10-100 times as effective as CAR-T. For those following the science, someone posted....
"This:
https://www.prnewswire.com/news-releases/global-car-t-therapy-pipeline-market-analysis-report-2021-2030-featuring-novartis-kite-pharma-pfizer-juno-therapeutics-celgene-carsgen-therapeutics-sorrento-therapeutics-and-legend-biotech-301289750.html
is a recent market analysis of the CAR-T therapy market up to 2030. It mentions Sorrento as one of the leaders of this multi billion market.
First, it's pretty telling that the report itself is for sale for U$5000. So, if the report is that valuable, we can get an idea of the value of this market moving forward.
In Sorrento's pipeline we find this technology presently in the CD38 products, currently in phase 1 trials scheduled to end between Dec 21 and Feb 22.
Sorrento is also developing an even more advanced technology. In SRNE site it states:
" Sorrento utilizes a proprietary knock-out knock-in (KOKI) technology to modify normal healthy donor derived T cells to genetically engineer them to express the dimeric antigen receptor into T-cell receptor (TCR) alpha chain constant region (TRAC). In this manner, TRAC is knocked out and antigen is knocked into its locus.
The Dimeric Antigen Receptor (DAR) utilizes a Fab instead of the scFv used by traditional Chimeric Antigen Receptor (CAR) T cells. We believe this DAR has been demonstrated in preclinical studies greater specificity, stability and potency.”
Let’s “translate” this so everyone can understand what it actually means and why Sorrento’s future is bright.
“Translation”:
SRNE uses a technology developed and owned by the company.
A gene of one organism is "knocked out" (made inoperative) and is substituted by a substitute gene, also known as a knock-in.
This technology uses a type of white blood cell called T cell, which are dominant cells in the part of the immune system that fights and eliminates pathogens, the organisms that can produce a disease. The T-cells used, originate from a blood donation of a healthy living person.
Those T-cells are then genetically engineered, essentially making a modification to their DNA. .
These T-cells are transformed into a dimer (a type of molecule) that then becomes the antigen-receptor. An antigen is more or less the outer layer of the pathogen, the disease-causing organism. The antigen is the part of the pathogen that our immune system can bind with, connect with, to neutralize or kill.
So here, through genetic engineering, we take a cell that has this immune system abilities, modify it so that it can connect with the specific intruder and kill or stop it, and to do so, we are able to transform this T-cell into a molecule that has the characteristics of a dimer (therefore it's a dimeric antigen receptor).
Of course it isn't that simple, actually this modified t-cell becomes part of a protein chain, the alpha chain, related to our blood cell antibodies. In fact, it becomes part of a specific portion of the alpha chain, the constant region portion, that is known as the Fragment Antigen Binding chain (or a FAB).
The FAB, as you might guess, is related to the ability of binding, connecting, with the antigen (the intruder) and eliminating it.
So the regular TRAC (The T Cell Alpha Chain) is knocked out, in favor of a modified gene sequence that knocks the antigen into a "locus control region", basically, a "control room" that will take care of the antigen.
So, the Dimeric Antigen Receptor (DAR T, T stands for T-cell) technology used by SRNE is an enhancement, an improvement, of the next-generation therapy known as Chimeric Antigen Reception (CAR T). The difference is that the DAR is using a Dimer, (specific type of molecule) and Chimeric actually stands for the general application of bringing in a modified gene to help.
CAR T uses single chain variable fragments (scFV), basically a protein used by joining two separate genes, which, let's put it this way, had different codes to begin with.
The dimeric technology, so to speak, uses a molecule that is already formed by two molecules that naturally have the ability to react with another molecule.
Maybe because of this natural trait, the dimeric technology seems to give better, stronger and more stable results.
So Sorrento isn’t just one of the leaders of a new type of technology worth billions, it is already developing the next generation of this technology, using an idea that is exclusive to SRNE. If you are long, that translates to: Sorrento is ahead of the pack in using a technology that grows by the billions each year."
Sorrento now has over 60 programs + Extremely strong investment portfolio!
Phase 3, close to EUA or close to market (12 programs)
1. Abivertinib NSCLC NDA filed China
2. Abivertinib NSCLC ph.3 completed US
3. PD-L1 SCLC partnered
4. Erbitux biosimilar
5. Xolair biosimilar
6. Remicade biosimilar
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application
11. Covi-Trace EUA application
12. Cynviloq (part of PSS lawsuit)
Phase 2 (12 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. Covi-Track EUA pre-validation
5. PD-L1 partnered
6. Herceptin delivery partnered
7. Abivertinib Lymphoma
8. Abivertinib Covid 19
9. Abivertinib prostate cancer ph.2 IND
10. Abivertinib Lupus ph.2 IND
11. Abivertinib hairy cell leukemia
12. CD47 partnered
Phase 1, IND filed or pre-IND (36+ programs)
1. Seprehvec Oncolytic Virus
2. CD 38 CAR-T ph.1
3. CEA CAR-T ph.1
4. CD38 DAR-T IND
5. BCMA DAR-T pre-IND
6. PD-L1(C/DAR-T) pre-IND
7. CyCART-19 partnered
8. Covi-GeneMab pre-IND $34 million DARPA funding
9. PD1-GeneMab pre-IND
10. ERT (Enzyme Replacement Therapy) several pre IND programs
11. IL2Teff pre-IND
12. IL2Treg pre-IND
13. Covi-Drops ph.1
14. TNF-a (Enbrel) ph.1
15. CTLA-4 (Yervoy)
16. CD47 ph.1 basket trial partnered
17. TROP2 pre-IND partnered
18. BCMA ADC pre-IND
19. ROR1 ADC pre-IND
20. CD25 ADNAB pre-IND
21. CD20 ADNAB (Rituxan) IIT-ph.1
22. VEGF(Avastin) ADNAB IIT-ph.1
23. PD-L1 ADNAB pre-IND
24. VEGFR2 ADNAB pre-IND
25. CBD immune diseases pre-IND
26. CBD insomnia pre-IND
27. CBD Parkinsons pre-IND
28. CBD CNS diseases pre-IND
29. PD-L1 CAR-NK partnered
30. CD38 CAR-NK to be partnered
31. CD38 ADC AL Amyloidosis
32. AC0058 ph.1b lupus
33. AC0058 pre-IND MS
34. AC0939 pre-IND CNS indications
35. 1,000,000+ small molecule library
36. Twenty quadrillion antibody library
FUNDING? Sorrento has invested wisely and has 8.2 million shares of ImmunityBio, 20 million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS lawsuit will soon be settled with very large potential gains. And it has many attractive programs to partner for upfront, milestone and royalty payments! Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
We all know small biotechs thrive on news! What news might we expect from Sorrento this year? (Some this month, some next month, some this fall). Here's a partial list of what I look forward to...
1. ANP merger completed
2. Covi-Stix EUA
3. Covi-Track EUA
4. Abivirtinib EUA cytokine storm
5. Abivirtinib China NSCLC market approval
6. Covi-MSC EUA
7. Covid Vaccibody EUA (DARPA backing)
8. 2020 Covid cocktail injection and nosedrops EUA
9. success in PSS lawsuit
10. Celularity Covi EUA
11. Celularity IPO
12. ImmuneOncia IPO
13. SP-102 market application
14. RTX studies completed
15. first DAR-T enters clinic
16. first combination oncolytic virus enters clinic
17. news from Mayo Clinic ADNAB portfolio
18. news from SmartPharm plasmid DNA portfolio
Feel free to add more that I have overlooked! If even HALF of these events occur we could all be looking at double or triple digit share prices IMO!
Tam...today the DOW was down 680 and NASDAQ down 358...great time to claim the sky is falling.
The shorters enjoy attacking small biotechs on days when the entire market is down. They want to take cheap shares from weak hands! It is a good time for intelligent investors to load up. And why is Sorrento a good choice?
NAME ANOTHER SMALL BIOTECH WITH....
1. over 60 drug programs
2. potential blockbusters in Covid, cancer and non-opioid pain, and
3. a strong financial base. Sorrento has invested wisely and has 8.2 million shares of ImmunityBio, 20+ million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS lawsuit will soon be settled with very large potential gains. And it has many attractive programs to partner for upfront, milestone and royalty payments! Huge portfolio AND huge assets! And after the $34 million DARPA grant look for more to fund the battle against viral variants!
I love the smell of a short squeeze in the morning!
I found this recent video to be very interesting and encouraging ... cancer research is close to many breakthroughs IMO.
munhoi...it seems you are a lawyer. If that's the case I'd love to hear your opinion of the PSS case as it proceeds. It is likely Sorrento will do well IMO...but I'm not a lawyer.
Sorrento now has over 60 programs + Extremely strong investment portfolio!
Phase 3, close to EUA or close to market (12 programs)
1. Abivertinib NSCLC NDA filed China
2. Abivertinib NSCLC ph.3 completed US
3. PD-L1 SCLC partnered
4. Erbitux biosimilar
5. Xolair biosimilar
6. Remicade biosimilar
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application
11. Covi-Trace EUA application
12. Cynviloq (part of PSS lawsuit)
Phase 2 (12 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. Covi-Track EUA pre-validation
5. PD-L1 partnered
6. Herceptin delivery partnered
7. Abivertinib Lymphoma
8. Abivertinib Covid 19
9. Abivertinib prostate cancer ph.2 IND
10. Abivertinib Lupus ph.2 IND
11. Abivertinib hairy cell leukemia
12. CD47 partnered
Phase 1, IND filed or pre-IND (36+ programs)
1. Seprehvec Oncolytic Virus
2. CD 38 CAR-T ph.1
3. CEA CAR-T ph.1
4. CD38 DAR-T IND
5. BCMA DAR-T pre-IND
6. PD-L1(C/DAR-T) pre-IND
7. CyCART-19 partnered
8. Covi-GeneMab pre-IND $34 million DARPA funding
9. PD1-GeneMab pre-IND
10. ERT (Enzyme Replacement Therapy) several pre IND programs
11. IL2Teff pre-IND
12. IL2Treg pre-IND
13. Covi-Drops ph.1
14. TNF-a (Enbrel) ph.1
15. CTLA-4 (Yervoy)
16. CD47 ph.1 basket trial partnered
17. TROP2 pre-IND partnered
18. BCMA ADC pre-IND
19. ROR1 ADC pre-IND
20. CD25 ADNAB pre-IND
21. CD20 ADNAB (Rituxan) IIT-ph.1
22. VEGF(Avastin) ADNAB IIT-ph.1
23. PD-L1 ADNAB pre-IND
24. VEGFR2 ADNAB pre-IND
25. CBD immune diseases pre-IND
26. CBD insomnia pre-IND
27. CBD Parkinsons pre-IND
28. CBD CNS diseases pre-IND
29. PD-L1 CAR-NK partnered
30. CD38 CAR-NK to be partnered
31. CD38 ADC AL Amyloidosis
32. AC0058 ph.1b lupus
33. AC0058 pre-IND MS
34. AC0939 pre-IND CNS indications
35. 1,000,000+ small molecule library
36. Twenty quadrillion antibody library
FUNDING? Sorrento has invested wisely and has 8.2 million shares of ImmunityBio, 20 million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS lawsuit will soon be settled with very large potential gains. And it has many attractive programs to partner for upfront, milestone and royalty payments! Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
You asked "... what is the status with ACEA, our source of Abivertinib? Is that a confirmed acquisition? Where can we find a statement to that effect, besides just inferring it?" Here is the news release you must have missed.
Sorrento Enters Into Merger Agreement to Acquire Late-Stage Oncology Company ACEA Therapeutics
April 5, 2021 at 9:00 AM EDT
Download PDF
ACEA’s major assets include:
Abivertinib (in oral capsule form), a next generation, dual EGFR mutant and BTK inhibitor (BTKi) with a completed NSCLC registrational/Phase 3 trial, Phase 1 B-cell lymphoma study, and ongoing Phase 2 trials in COVID-19 patients with ARDS, and Phase 2 studies for prostate cancer, systemic lupus erythematosus and the ultra-orphan indication of hairy cell leukemia.
AC0058, a brain-penetrating, next generation BTK inhibitor in a Phase 1b Lupus trial and IND-enabling studies for multiple sclerosis.
AC0939, a next generation FLT-3 inhibitor, is near completion of IND-enabling studies for potential CNS indications.
A 1,000,000+ compound library of small molecules and proprietary discovery platform for screening and optimizing potent drug candidates for potential indications in oncology, autoimmune diseases, CNS diseases and infectious diseases.
A biopharma campus of over 23 acres of land with cGMP facilities for producing APIs and capsules for existing and future drug products.
An experienced team of research, development and manufacturing staff for global drug development.
SAN DIEGO, April 05, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced the signing of a merger agreement pursuant to which Sorrento will acquire ACEA Therapeutics, Inc. (“ACEA”). The acquisition will include late clinical stage drug Abivertinib, clinical stage candidate AC0058, preclinical stage candidate AC0939, and ACEA’s extensive proprietary library of small molecules (over 1,000,000 compounds), which potentially have applications for numerous human disease indications, including non-small cell lung cancer (NSCLC), B cell lymphomas, systemic lupus, rheumatoid arthritis, multiple sclerosis and viral infections. These compounds are being actively studied in clinical trials and/or preclinical models to advance the most promising candidates rapidly to clinical stage development. Abivertinib, a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both a mutant form of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK), was originally identified from ACEA’s compound library. Abivertinib has the potential to improve outcomes in resistant prostate cancer, systemic lupus erythematosus, and various B cell lymphomas in addition to NSCLC, an indication for which a registrational/Phase 3 trial has been completed. It is currently being studied as a Phase 2 treatment for COVID-19-induced respiratory compromise in the US and Brazil. A second clinical candidate, AC0058, is a next generation BTK inhibitor, currently in a Phase 1b trial for Lupus patients in the US, which can potentially be expanded to other autoimmune diseases such as multiple sclerosis.
The acquisition will also include ACEA’s state of the art cGMP facility located in Quzhou, China, on a 23-acre campus with five buildings. This facility has successfully manufactured multiple batches of the active pharmaceutical ingredient (API) and final product in capsules for Abivertinib and AC0058 for clinical studies. The ACEA facility currently has capacity to manufacture up to 5,000 kg/year of APIs and 50,000,000 capsules of final drug product.
The ACEA next generation BTKi and other TKI small molecule drug candidates are highly synergistic with Sorrento’s broad biological product pipelines in therapeutic antibodies, antibody drug conjugates (ADCs), autologous chimeric antigen receptor-T (CAR-T) and allogeneic dimeric antigen receptor-T (DAR-T) cell therapies, oncolytic viruses and IL-2 immune modulators. The synergy will potentially enable Sorrento to develop many life-saving, combinational drugs for difficult-to-treat human illness in oncology, autoimmune and infectious diseases.
Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, “The ACEA acquisition will bring us a step closer to developing into a major biopharmaceutical company and we look forward to welcoming the ACEA team into the Sorrento family.”
As previously announced on October 16, 2020, Sorrento and ACEA entered into a letter of intent setting forth the terms and conditions by which Sorrento would acquire ACEA. In consideration for the acquisition, at the closing of the merger, ACEA’s equity holders will receive up to an aggregate of $38 million in shares of Sorrento common stock, subject to certain adjustments, based on a price per share calculated in accordance with the merger agreement. In addition to the foregoing consideration, and subject to the achievement of certain clinical and sales milestones (as described below), Sorrento will also pay the ACEA equity holders (i) up to $450,000,000 in additional payments, subject to the receipt of certain regulatory approvals and achievement of certain net sales targets with respect to the assets acquired in the merger and (ii) with respect to specified royalty-bearing products, five to ten percent of the annual net sales thereof, in each case in accordance with the terms of an earn-out agreement. The amount referenced in clause (i) of the preceding sentence includes the amounts that would have otherwise been due to ACEA under that certain License Agreement, dated July 13, 2020, which agreement will terminate in its entirety at the effective time of the merger.
The merger is expected to close in the second quarter of 2021, subject to customary closing conditions and regulatory approval. If the proposed merger is consummated, the issuance of the shares of Sorrento common stock would be made in accordance with an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) thereof and Regulation D and Regulation S thereunder. Such shares of Sorrento common stock would not be registered under the Securities Act and could not be offered or sold without registration unless an exemption from such registration is available. This press release does not constitute an offer to sell or the solicitation of an offer to buy, any shares of Sorrento common stock.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com.
About ACEA Therapeutics Inc.
ACEA Therapeutics is committed to developing and delivering innovative treatments to improve the lives of patients with life-threatening diseases. ACEA has expanded drug discovery efforts to encompass development in both targeted and immunotherapy areas. Alongside a robust R&D organization, ACEA has established drug manufacturing and commercial capabilities in China to support its long-term growth. This infrastructure provides ACEA greater control over drug supply chain to make sure products are delivered to patients on-time and at the highest quality. ACEA is well positioned to deliver on its promise to bring innovative treatments to patients living with life-threatening diseases while creating value for shareholders, employees, and society.
For more information visit www.aceatherapeutics.com
How clever is Dr.Ji? He acquired SmartPharm for $20 million. SmartPharm then received $34 million in DARPA funding to produce a Covid fighting plasmid DNA. SmartPharm said, "We have used our tool box to create a scalable and cost-effective solution for creating pop-up immunity in people against coronavirus that has the capability to be rapidly scaled to deliver millions of doses. Our solution starts with our novel DNA plasmid that can express protein in muscle for weeks. This plasmid will be used to express an antibody capable of binding to and neutralizing the SARS-CoV-2 virus. This type of DNA plasmid has already been produced for other products in a fully cGMP-compliant manner and at significant quantities."
But this is only the beginning. Sorrento explained the wider implications saying..."The platform in synergy with Sorrento’s industry-leading fully human G-MAB™ antibody library has the potential to be the engine for the next-generation, cost-effective in vivo production of antibody therapeutics in patients. By encoding the antibody sequence into a plasmid, a single injection into someone’s muscle could potentially lead the person to make their own antibodies in vivo for months, instead of relying on repeat administrations of an externally manufactured antibody.
“We are very encouraged by the preclinical data generated thus far by our STI-2020dna plasmid candidate against COVID-19,” said Henry Ji, Ph.D., CEO of Sorrento Therapeutics. “But beyond STI-2020dna the integration of the plasmid DNA technology with our existing antibody products has the potential to make antibody therapy much more accessible and affordable for patients, and is applicable to a multitude of indications ranging from cancer to infectious diseases.”
Simply put Sorrento can now look forward to combining hundreds of different Mabs with SmartPharm's technology to fight hundreds of different cancers! ONE INJECTION TO PROVIDE A STEADY MULTI-MONTH STREAM OF MAB ACTIVITY INSTEAD OF COSTLY TIME CONSUMING WEEKLY INFUSIONS! This would revolutionize cancer treatments!
Very little attention has been paid to SmartPharms work on a whole host of Orphan enzyme replacement diseases. This a very important future market...with undeniable blockbuster potential.
"Enzyme replacement therapy is the standard therapy for a number of inherited diseases but is mainly used in treating lysosomal storage diseases. Lysosomes are cellular organelles responsible for the metabolism of many different macromolecules and proteins within the cell. The lysosomes utilize enzymes to break down these macromolecules, which are then recycled or disposed of. If genetic mutations prevent the production of certain enzymes used in the lysosomes, this often leads to a buildup of the substrate within the body. The accumulation of substrate can result in a variety of symptoms, many of which are severe and can affect the skeleton, brain, skin, heart, and the central nervous system. Increasing the concentration of missing enzyme in the blood provides cells the ability to correctly process these substrates. There are more than 50 lysosomal storage diseases, each of which is considered to be a rare/orphan disease with a prevalence of less than 1 out of 50,000 people. Lysosomal storage diseases for which enzyme replacement therapy is already approved or in late clinical development include:
Alpha Mannosidosis
Fabry Disease
Gaucher Disease
Mucopolysaccharidosis Type 1 (MPS 1)
Mucopolysaccharidosis Type II (MPS II or Hunter syndrome)
Mucopolysaccharidosis Type 4A (MPS 4A)
Mucopolysaccharidosis Type 6 (MPS 6)
Mucopolysaccharidosis Type 7 (MPS 7)
Neuronal Ceroid Lipofuscinosis Type 2 (NCL2)
Niemann-Pick Type B
Pompe Disease
For more information go to https://smartpharmtx.com
"pop-up immunity" is immunity developed within days rather than weeks. This is important in fighting pandemics. Plasmid DNA injections offer protection that starts earlier and last longer than traditional vaccinations . These are reasons the military are interested!
One of the most interesting Sorrento acquisitions is SmartPharm. They have received a $34 million grant from DARPA to develop a plasmid DNA version of the powerful 2020 Mab. Here's what SmartPharm says about this program.
"We have used our tool box to create a scalable and cost-effective solution for creating pop-up immunity in people against coronavirus that has the capability to be rapidly scaled to deliver millions of doses. Our solution starts with our novel DNA plasmid that can express protein in muscle for weeks. This plasmid will be used to express an antibody capable of binding to and neutralizing the SARS-CoV-2 virus. This type of DNA plasmid has already been produced for other products in a fully cGMP-compliant manner and at significant quantities.
We plan to combine this DNA with a new, GMP-compliant polymer solution that may significantly enhance DNA expression in skeletal muscle. This polymer has been demonstrated to have the kind of safety profile to make it appropriate for use in humans. These two components would be delivered together through a standard hypodermic needle—a standard approach typically used in vaccines. Our approach eliminates the need for electroporation devices, which are currently being used in the delivery of these types of DNA-based antibody treatments."
Someone's done a nice analysis of Gomez interview.
"Summary of Dr. Henry Ji's presentation at the 5th Intl. Vatican Conference
This was Dr. Ji's best presentation to date. He was easy to understand, straight to the point, promoted Sorrento's products, painted a very positive picture for the near future and highlighted the best advantages of the pipeline. Here is the summary point by point:
1. Sorrento is presented as the leader of a breakthrough technology defined as "a revolution in pharmacologic chemistry". The most advanced use of this technology is considered "the next blockbuster therapy". Sorrento is identified as the reference for this biotechnology. Encouraging and promising.
2. This technology is a solution for illnesses that up until now were untreatable. Its potential revenue is off the charts.
3. Off the bat, Dr. Ji mentions Covi-stix. Perhaps the most important news from this presentation: the EUA is alive and well. Dr. Ji did an excellent job applying pressure on the FDA, making clear that an approval would bring worldwide benefits. This throws out of the window all the theories about the EUA having been rejected, etc. If Dr. Ji wasn’t confident about the outcome of the EUA approval, he wouldn't mention. Excellent news.
4. Sorrento has a solution for each phase of covid, and each solution is the most effective for that phase. For patients with symptoms but clean lungs, Sorrento’s treatment is highly effective, less invasive and shorter, so much more comfortable for the patient. I thought Dr. Ji was excellent at pointing out these advantages. Good marketing.
5. Major fact: Sorrento received a government defense production act grant (a dpa grant) for promoting this treatment that tackles covid (as well as other health issues, see below). This grant basically means the gov’t is willing to help the company shorten the process of approval so make the product available asap. See below revenue implications.
6. With it's high-tech solutions, Sorrento can tackle and control any covid variant, whether current or one that will develop in the future. Again, Dr. Ji highlighted the good news that the public wants to hear.
7. Sorrento has the ability to treat covid even for ICU patients needing a ventilator. Dr. Ji promotes the treatment with a lot of confidence and clarifies that not only are the results excellent, but also immediate. A patient goes from the ICU to being released within 24 hours (!!). That's definitely Sorrento showing some muscle. Very Impressive.
8. The host asks about Sorrento's ability to apply its technology beyond covid. This allowed Dr. Ji to go off topic (he was invited to talk about covid) and he does that very well. He says: we have developed a technology that allows the patient to create antibodies against the virus that is attacking him. It's clear that this technology can be applied to a very vast array of patients and illnesses. Huge revenue implications.
Dr. Ji here stresses that this type of treatment will allow constant and immediate new solutions for multiple, specific illnesses, reason for which the government is giving Sorrento the DPA grant.
9. A side dish of more good news: besides the enrollment of 140 patients in Brazil and the USA, Sorrento will also start a big trial in Mexico.
10. Dr Ji goes into numbers, a bold move. He says without filters: we have a technology that can generate over 60 billion dollars in revenue, we have a grant to make it available asap, this will be a game-changer in the entire industry. You have to be very confident to say that. On that sentence alone, really, if this was a stock that behaves bullishly (which sadly it’s not), the price of Sorrento would need to double.
11. Question: considering Sorrento’s pipeline is so big, and there is only so much money and personnel to go around, what do you prioritize? Awesome answer: Hey, FDA give us the EUA ! I loved that, as mentioned before. Then he says: many of these products are fast track products that do not need lengthy approval processes. They can all be approved this year and create more revenue. (So 1st part of his answer: we’re on the verge of creating revenue, the money to develop the entire pipeline . The 2nd part of his answer is also reassuring: we already have money, our financial situation is solid, we can develop several programs simultaneously. Great news for any investor.
Bottom line: excellent presentation, lots of good news, EUA still very much alive, CEO very confident that he has a massive billion dollar company in the making. It hurts watching Sorrento’s price go down 3-5 percent three times a week, it does. But this ticker is going three digits way earlier than people imagine. Whomever holds will be rewarded and then some!"
Jess I too was pleased by this overview of the Covid programs. All the major programs are in phase 2 and most EUA's are granted with successful phase 2 results! People tend to forget that Sorrento could potentially have as many as 8 EUA's. Covid variants could be around for years. Most of the world is only 2% vaccinated...and 30-40% of the US say they won't be vaccinated...so the virus variants have lots of room to breed. Sorrento could play a big role in the next couple of years.
Here's text of Max Gomez interview of Dr. Ji released by Vatican today.
"Few companies have as large a presence in the small molecule therapeutic and diagnostic
space as Sorrento Therapeutics. Henry Ji, Sorrento's president and CEO, joins us now to
discuss their technology.
Max Gomez, PhD:
Henry Ji, chairman and president and CEO of Sorrento Therapeutics, welcome. Henry, this
is really an exciting time for your company and in research here in general. I know that
Sorrento is involved in diagnostics, prevention, early intervention, rescue therapies for a
variety of different diseases if you will, but let's talk about the hot one at the moment. What's
your approach, a comprehensive solution if you will, for COVID-19?
Henry Ji, PhD:
So, hey, thanks, Max. And our solution to it is detect early, treat timely. Treat timely means
that at different stages of COVID-19 disease, you treat with different measures or treatment
solutions. So, for example, we have the COVID-19 rapid antigen detection system called
COVISTIX, and we can detect whether you have the infection in as short a time as 2-5
minutes. Moreover, if your test remains negative for 15 minutes, you can proceed with your
normal activities. With COVISTIX, we can detect virus in patients between symptomatic
days 1 and 7. The moment you have symptoms, you say, "Okay, I’m infected. Now what's
the solution? What’s the next step?" The next step in treatment of infected individuals we
are developing at Sorrento is a neutralizing antibody. Neutralizing antibody treatment is
among the most effective ways to treat the COVID-19 infection because the antibody binds
and prevents viruses from entering cells, which potentially results in decreased virus
replication and spread within an infected person.
We are developing three ways to administer neutralizing antibodies. One way is to deliver
the antibodies by IV. Our IV administration is designed to require only 2-5 minutes, which
will conserve the hospital resources currently required for one hour or five hour infusions.
The idea is to provide treatment solutions that are easily delivered in an outpatient setting.
Our second form of neutralizing antibody administration currently in clinical trials makes use
of nasal drops. This allows direct delivery of the antibodies into your nose, blocking the virus
entry into the cells of the epithelial layer in the nose, and potentially inhibiting viruses from
replicating in this area and spreading into other regions of the respiratory tract.
A third means of delivering neutralizing antibody to patients currently in development at
Sorrento is by injection of a DNA plasmid encoding the antibody into your muscle. The cells
that make up your muscle would then express the neutralizing antibody in your body. We
are currently completing work supported by government contracts for this this program.
DNA-encoded antibodies provide a very rapid means of addressing the treatment
challenges posed by emerging variants of concern during a pandemic. Public health officials
are focused on the worldwide circulation of virus variants of concern first identified in the
UK, Brazil, South Africa, and India. We recently finalized an exclusive licensing deal with
Mount Sinai to co-develop antibodies that cover each of the known variants of concern. We
are combining the neutralizing properties of antibodies discovered at Sorrento and Mt. Sinai
to develop a cocktail of two antibodies in each of our three delivery systems for treatment of
infected individuals.3
Max Gomez, PhD:
Henry, let me ask you the diagnostic part of it. How was that administered? What do you
use for that now?
Henry Ji, PhD:
Oh, the test is very simple. You do a quick nose swab. It's not a deep nose swab, but rather
shallow. You then place the swab into a lysis buffer and pour the resulting mixture into a
detection cassette. The test provides your positive or negative result within a few short
minutes.
Max Gomez, PhD:
So you mentioned also then that this cocktail that you're testing, that can be administered a
variety of different ways. How is it that this can cover all of the different variants then, since
we keep hearing that the variants are very specific for the vaccines? How is it that this
covers the different variants?
Henry Ji, PhD:
Because we have tested our antibodies for neutralizing activity against the variants. We
have each of the viruses considered variants of concern, or VOCs, and we have their
respective Spike proteins expressed as a recombinant protein. If any antibody in our
collection binds and neutralizes one or more variant of concern, we can use that antibody
as a component of a two-antibody cocktail that provides coverage against all of the virus
variants of concern. We are already pushing a cocktail through development that potently
neutralizes each of the known variants of concern. This cocktail contains two antibodies,
STI-2020 and STI-5041, and these two antibodies provide potent neutralizing coverage for
all of the currently identified VOCs. We know the virus will continue to evolve as infection
numbers increase, so we are focusing our efforts on developing a full panel of antibodies to
potentially provide coverage against future virus variants.
Max Gomez, PhD:
And as new variants pop up, do you manufacture these new antibodies or how do you then
decide what to put into the cocktail?
Henry Ji, PhD:
We believe right now we have an antibody cocktail that provides potent neutralizing activity
against each of the current variants of concern. Manufacturing of the antibodies in this
cocktail is ongoing. As new variants emerge, we will continue to monitor for gaps in
coverage by our antibody cocktail and explore new antibody combinations from our current
collection of preclinical candidates to address those gaps. We can initiate manufacturing
activities for any antibody in our collection within weeks, and we can use this capability to
enable our antibody delivery systems and meet the treatment challenges associated with
any emerging variants of concern. Our treatments and diagnostics for mild and moderate
COVID-19 will include those that you could access at your local pharmacy and those that 4
are administered in an outpatient setting. Our vision is to allow those who receive a positive
COVISTIX result to access COVIDROPS or COVI-AMG neutralizing antibodies to treat their
infection.
It’s worth mentioning here our work on therapeutics for use in treatment of moderate to
severe COVID-19 cases in the ICU. Oral administration of Abivertinib, a Bruton’s tyrosine
kinase inhibitor, is designed to decrease the effects of cytokine storm in the context of
COVID-19. We are currently conducting Phase I clinical trials with Abivertinib, and we have
enrolled over 300 patients in both U.S. and Brazil, thus far. We are also in discussions with
the government of Mexico around extension of these trials into hard-hit regions of the
country. We are working to determine if Abivertinib can help to more quickly discharge
COVID-19 patients experiencing moderate to severe COVID-19 from the hospital. In clinical
situations where ICU patients require oxygen and intubation on the ventilator, Sorrento is
investigating the clinical safety and efficacy of treatment using adipose-derived
mesenchymal stem cells. To date, each of the ten patients who has undergone this
treatment, which requires three infusions, has been discharged from the ICU. After the first
infusion, many of the patients’ conditions improved; they reported feeling much better and
they required less supplemental oxygen. After the third infusion, some patients were
immediately released from the hospital. We're talking about patients being discharged from
ICU and discharged from hospital on the same day. Very impressive.
Max Gomez, PhD:
This sounds obviously very exciting. And it sounds like you have the capability to develop
some of this for other viruses or even other diseases, infectious diseases, and going on to
cancer. How else will you use this platform?
Henry Ji, PhD:
We have taken a human antibody library approach. This approach does not require the use
of recovered patient samples. Rather than relying on B cells isolated from infected patients
to identify candidate antibodies, we can use our molecular libraries that already encode
billions of antibodies to screen potentially neutralizing antibodies for any pandemic threat
pathogen target.
Let's say that in response to an actual outbreak or as part of a pandemic readiness
program, a decision is made to develop antibodies that neutralize Nipah virus. We can
screen against Nipah virus proteins and isolate candidate neutralizing antibodies within a
two-week timeframe. These antibodies can be developed as traditional protein therapeutics
or we can encode the antibody sequences on DNA plasmids for intramuscular
administration. DNA plasmids of this type can be manufactured very quickly, and within a
month we could have a therapeutic ready for use in the clinic. This type of rapid response
capability is aligned with the mission at DARPA and they have supported us with a contract
to develop this technology as a COVID-19 response that could readily translate into use for
protection and treatment of existing or emerging pandemic threat pathogens.
Of course, this technology can also be used for protein therapeutics in the oncology and
metabolic disease spaces. Use of DNA plasmid-based technology to express immune
checkpoint inhibitors or enzyme replacement therapies would provide innovative options
over the established use of manufactured protein for these purposes.
Plasmid DNA directed expression of biological therapeutics in patients can be a novel and valuable
means of achieving long-term treatment solutions while minimizing the burden of treatment
on patients and health care providers.
Max Gomez, PhD:
You have so many different possibilities here within the company, how do you decide what
to focus on? You know, the saying that a Jack of all trades is a master of none. How do you
decide where to really put your energies as a company?
Henry Ji, PhD:
We have a great deal of energy and drive at Sorrento. We have a healthy portfolio of
projects and strong support from public equity, cash holdings, and government contracts to
support multiple ongoing efforts to bring products to market. This has allowed us to develop
products that are now at various stages of clinical development. On the diagnostic side, we
have already submitted our EUA for COVISTIX. If the FDA give us a green light to proceed,
we are ready to enter the market, which should provide us a revenue stream. Our
neutralizing antibody is currently in Phase 2, as is Abivertinib, and our mesenchymal stem
cell therapeutic. EUA approval around any one of these programs will serve to further
increase our revenue and fuel our push to master the trade of developing therapeutic and
diagnostic solutions across a wide selection of human disease areas.
Max Gomez, PhD:
So you can chew gum and walk at the same time.
Henry Ji, PhD:
Exactly. That's the plan.
Max Gomez, PhD:
Henry Ji, thank you so much for your time. It sounds very exciting."
Someone accused Paul of being a "bagholder". I had to chuckle at Paul's reply.
"I’m a very happy bag holder, if that means doing my dd enough to know that by this year or next there will be probably be three blockbuster drug approvals. Abivertinib (10B-Super Blockbuster), SP102 (5-6B-Blockbuster), and RTX cancer (taking into account OA Knee and other indications 15-20B). I gave you a discount and didn’t include the Covid pipeline, shares of ImmuneOncia, ImmunityBio, or Celularity. I didn’t include SOON arbitration. I didn’t include value of library or any licensing, royalties, etc… I didn’t include BO’s of ACEA or ANP. I didn’t include ADNAB or a potential Scilex minority IPO. Damn I’m trying to help you out with me being a bag holder, but my bag is full ??????"
Interesting COVI-STIX information from Europe. Getting close?
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2009
Reuters: World to Spend $157BL on COVID-19 Vaccines through 2025
(This is the reason SRNE has 11 separate Covid programs. While the bulk of revenue likely goes to PFE, MRNA, JNJ, etc. a few percentage points = billions in revenue for SRNE.)
"Total global spend on COVID-19 vaccines is projected to reach $157 billion by 2025, driven by mass vaccination programs underway and "booster shots" expected every two years, according to a report by U.S. health data company IQVIA Holdings Inc released on Thursday.
IQVIA, which provides data and analytics for the healthcare industry, said it expects the first wave of COVID-19 vaccinations to reach about 70% of the world's population by the end of 2022. Booster shots are likely to follow initial vaccinations every two years, the report said, based on current data on the duration of effect of the vaccines.
The United States is preparing for the possibility that a booster shot will be needed between nine to 12 months after people receive their first full inoculations against COVID-19, a White House official said earlier this month. Pfizer has also said boosters may be needed within 12 months.
Vaccine spending is expected to be highest this year at $54 billion with massive vaccination campaigns underway around the world. It is expected to decrease after that eventually to $11 billion in 2025, as increased competition and vaccine volumes drive down prices, said Murray Aitken, a senior vice president at IQVIA.
The forecast for such meteoric growth in sales for a new class of drugs or vaccines is unmatched, but reminiscent of the $130 billion spent on the new hepatitis C cures between 2014 to 2020 due to pent up demand, Aitken said in an interview.
The spending forecast for COVID-19 vaccines represents 2% of the roughly $7 trillion forecast for all prescription medicines during that time period, IQVIA said. Excluding the cost of COVID-19 vaccines, overall medicine spending is forecast to be $68 billion lower over the six years from 2020 to 2025 than it would have been without the pandemic, according to the report.
The pandemic caused major disruptions to doctor visits, procedures and medicine use, leading to some stockpiling in the early days for some medications and then a return to a more normal trend, the report said.
"While COVID-19 vaccines will cost $157 billion over the next five years," Aitken said, "that is a very small price to pay relative to the human cost of the pandemic."
KARADAJIAN explains how important Abivertinib is!
"Understanding Abivertinib:
Some people seem to be unsure about how legit SRNE chances are of actually generating revenue. So let's take a look at the drug in the most advanced stage of it's pipeline: Abivertinib
Ok, so 1st of all, we are explaining Abivertinib as it relates to its original use target: lung cancer.
Lung cancer is the most common cancer worldwide, so drugs that can successfully treat it have a huge market.
Abivertinib isn't useful for all types of lung cancer patients, most probably for about 15-20% at most. Still, this is a big market, even before we get into covid.
Abivertinib is a 3rd generation EGFR inhibitor. Now, what does that mean?
1st, it means this is a relatively new type of drug. It's not a breakthrough in itself, but the effectiveness of Abivertinib seems to be. So, one thing we know, it's high tech, so to speak.
2nd, the advantage of it not being totally new: similar 3rd generation inhibitors have been approved by the FDA. So part of the approval process has already been overseen and these inhibitors have proved their worth.
Now, what does it actually do? Well, to explain it simply:
A certain drug is given to patients with lung cancer, that works. But after several months (up to a year), the drugs are no longer effective.
To make them effective, 2nd generation inhibitors are used (remember, Abivertinib is 3rd generation). But, these 2nd generation, have an issue: all these inhibitors (from all generations) inhibit a certain type of protein that helps the cancer spread. By inhibiting the protein, they halt the spread of the tumor. But, the 2nd generation drugs, they also inhibit the "good proteins", so the dosage has to be low. In other words, there is only so much of those 2nd generation drugs that can be given to the patient. It's a problem.
So 3rd generation inhibitors where created and received approval. What makes these special: they are able to inhibit only the "bad protein" without inhibiting "good protein". Or at least, way more effectively than 2nd generation at doing that.
Why is Abivertinib special? First of all, it's more effective. It does its job better. In trials, it is more powerful than all current 3rd generation inhibitors.
Also, it seems to use a different "approach" to inhibiting, called a different "path". So it's actually doing something that hasn't been seen before. And doing it really well, while also being less toxic.
Now, how does this relate to covid? Well, as we all know, covid attacks the lungs. And one way to treat it is using inhibitors. These are called BTK inhibitors. Which basically means, they inhibit a different type of protein that helps covid spread its attack. So to speak.
The problem has been that the current BTK inhibitors in the market, which were a big hope for treating covid, failed. They just didn't work.
And yes, you guessed it, Abivertinib IS a BTK inhibitor, which currently seems to be far and away the best option out there for treating covid. Really, it is. In trials, Abivertinib is working very, very well in a very small but significant sample.
This does/did two things. One, it opened up the option for Sorrento to offer this drug as an EUA for covid. We are not there yet, but the FDA is interested in exactly the type of solution Abivertinib could offer: a new drug, that isn't a totally new drug, just an improvement on something that has already been tested. A EUA request can happen in the next couple months.
And 2nd: this development opened the doors for Abivertinib to also eventually be used for treatment of certain types of leukemia and lymphomas. Larger market options.
Bottom line: by all current indications Abivertinib is a better option than any other 3rd generation EGFR inhibitor and the best hope for an inhibitor that works against covid.
For perspective: Targisson (the product) an approved 3rd generation drug which most resembles Abivertinib but by all standards seems to be less effective, is Astra-Zenaca's top selling drugs with sales of over 4 billion dollars per year.
This is just ONE of the drugs Sorrento (SRNE) has in it's pipeline. Just one. This stock is undervalued in a way that people just wouldn't imagine...
If you find this interesting/useful, let me know and I'll highlight some other stuff in their pipeline in a simple to understand way. Some of the stuff there is pretty amazing."
** 13 Catalysts (from Reddit):
1 EUA-1 Covi-Stix (May) $20 31-May
2 Celularity IPO - (June)
3 EUA-2 5656 (June) $30 30-Jun
4 PSS Settlement - (July)
5 EUA-3 MSC - (Aug)
6 SP-102 P3 topline read out (Aug) $60 31-Aug
7 EUA-4 AMG-2020 (Nov) $75
8 EUA-5 Covi-Trace / Tracks (Nov) $90
9 RTX P3 cancer / arthritis - read out (Nov)
10 Scilex IPO /SP-102 NDA filing (Nov) $130 30-Nov
11 EUA Covi-Shield (Dec)
12 EUA-6 Drops-2099 (Dec) $140
13 NDA Abiver / NSCLC (Dec) $170 31-Dec
** Abivertinib, SP102, and RTX cancer drugs are the golden tickets and nows the chance to >10X….
There's a LOT of news coming! Do your dd. Here's a start. I expect this will be a triple digit stock. These are the early days.
Phase 3, close to EUA or close to market (12 programs)
1. Abivertinib NSCLC NDA filed China
2. Abivertinib NSCLC ph.3 completed US
3. PD-L1 SCLC partnered
4. Erbitux biosimilar
5. Xolair biosimilar
6. Remicade biosimilar
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application
11. Covi-Trace EUA application
12. Cynviloq (part of PSS lawsuit)
Phase 2 (12 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. Covi-Track EUA pre-validation
5. PD-L1 partnered
6. Herceptin delivery partnered
7. Abivertinib Lymphoma
8. Abivertinib Covid 19
9. Abivertinib prostate cancer ph.2 IND
10. Abivertinib Lupus ph.2 IND
11. Abivertinib hairy cell leukemia
12. CD47 partnered
Phase 1, IND filed or pre-IND (36+ programs)
1. Seprehvec Oncolytic Virus
2. CD 38 CAR-T ph.1
3. CEA CAR-T ph.1
4. CD38 DAR-T IND
5. BCMA DAR-T pre-IND
6. PD-L1(C/DAR-T) pre-IND
7. CyCART-19 partnered
8. Covi-GeneMab pre-IND $34 million DARPA funding
9. PD1-GeneMab pre-IND
10. ERT (Enzyme Replacement Therapy) several pre IND programs
11. IL2Teff pre-IND
12. IL2Treg pre-IND
13. Covi-Drops ph.1
14. TNF-a (Enbrel) ph.1
15. CTLA-4 (Yervoy)
16. CD47 ph.1 basket trial partnered
17. TROP2 pre-IND partnered
18. BCMA ADC pre-IND
19. ROR1 ADC pre-IND
20. CD25 ADNAB pre-IND
21. CD20 ADNAB (Rituxan) IIT-ph.1
22. VEGF(Avastin) ADNAB IIT-ph.1
23. PD-L1 ADNAB pre-IND
24. VEGFR2 ADNAB pre-IND
25. CBD immune diseases pre-IND
26. CBD insomnia pre-IND
27. CBD Parkinsons pre-IND
28. CBD CNS diseases pre-IND
29. PD-L1 CAR-NK partnered
30. CD38 CAR-NK to be partnered
31. CD38 ADC AL Amyloidosis
32. AC0058 ph.1b lupus
33. AC0058 pre-IND MS
34. AC0939 pre-IND CNS indications
35. 1,000,000+ small molecule library
36. Ten quadrillion antibody library
FUNDING? Sorrento has invested wisely and has 8.2 million shares of ImmunityBio, 20 million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS lawsuit will soon be settled with very large potential gains. And it has many attractive programs to partner for upfront, milestone and royalty payments! Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
chey... I've never been a Cramer fan. He states the obvious often...but then doesn't understand the implications. It is obvious that there is news coming. In fact there is a LOT of news coming. And it will obviously have a large financial impact on the company! Getting out after a $3-4 dollar gain is really bad advice IMO. He really needs to do some in depth dd...which apparently he doesn't do!
Some stem cell Covid ARDS trials have already failed! Mesoblast was thought to be a leader. I understand their stem cells were Bone Marrow derived. PSC claims adipose stem cells are more easily procured, less likely to be damaged, and are very durable.
"Mesoblast Fails to Meet Primary Endpoint in COVID-19 Trial; Dec.20,2020
Mesoblast, on Friday, reported a failure in achieving the 30-day mortality reduction endpoint during its COVID-19 ARDS (acute respiratory distress syndrome) trial. However, no safety concerns were noted during the trial. Shares plunged 32% in after-hours trading.
Mesoblast (MESO) is a regenerative medicine company based in Australia.
The trial featured 300 patients, targeting a 43% reduction in mortality at 30 days, for treatment with remestemcel-L in addition to maximal care.
Remestemcel-L is an investigational therapy involving culture-expanded MSCs (Mesenchymal stem cells) derived from the bone marrow of an unrelated donor."
The company disclosed that 223 patients have completed the trial. They will be kept under observation for 60 days to analyze the impact of the treatment on the secondary endpoints. The endpoints include mortality rate without mechanical ventilation, intensive care and hospitalization duration, organ damages, and other requisite evaluations.
The above outcomes will be analyzed by Mesoblast and Novartis (NVS) in order to come to a conclusion regarding the relevance of remestemcel-L in the treatment of non-COVID ARDS.
Regarding stem cell availability Paul replied...
"PSC can manufacture up to 8,000 stem cell treatments(Covi-MSC) for patients per month as per Dr. Harman back on April 13, 2020. I read somewhere else they have been stock piling them so they have a large supply by now. My thought is EUA in May or June latest. Overall I like the Reddit post.
PSC was asked by the White House Task Force to apply to the FDA for expedited review of their IND application for treating COVID-19 patients with stem cells. PSC submitted its emergency assistance application to the FDA March 30th and its formal IND submission this week. PSC has FDA-inspected stem cell manufacturing facilities that are already in production of stem cell doses for clinical trials and compassionate use.
“Stem cell doses can be released for clinical trial use in May, depending on FDA clinical trial approval,” said Dr. Bob Harman, CEO of PSC. The first trial will be conducted in San Diego, California in a limited number of patients hospitalized locally, but compassionate use could allow for many more patients to be treated.
Calidi Biotherapeutics is a San Diego oncology company that provided the stem cell lines to PSC, giving PSC a running start in the stem cell drug manufacturing process. “We are proud to have provided these pre-tested stem cell lines for PSC to accelerate their manufacturing to provide stem cells to patients afflicted with COVID-19,” said Calidi CEO Allan Camaisa. “We have a long-standing relationship with Calidi and were already in the manufacturing process since January with these disease-screened stem cell lines. Calidi’s generosity and collaboration saved us valuable weeks in this race to get stem cells into clinical trials,” says Dr. Harman.
After this initial FDA trial is started, PSC will apply to FDA for a wider compassionate use approval and could also ship cells internationally. PSC is already ramping its manufacturing but is constrained by capital for critical supplies used in making these cells. “With adequate capital (investors or philanthropy), we could manufacture stem cell treatments for up to 8,000 patients per month,” said Dr. Harman.
PSC is an essential services company and is running at full speed. “Our team is following our very rigorous personal protection program to keep our employees safe, while executing the mission with amazing passion to bring these stem cells to critical patients. I am humbled every day and work all the harder to support our team in this mission. As always, small business is ready to shoulder any task. This is a war and we are using every resource possible to support the front-line doctors trying to save patients’ lives every day. We are even hiring new stem cell manufacturing technicians, doing our part to keep the economy running,” says Dr. Harman.
https://personalizedstemcells.com/covid-19-emergency-stem-cell-treatment-collaboration-in-san-diego/
This was an interesting post by Henry M on investor village. This evening.
" (13) Catalysts the Path to SRNE Becoming a $100/stock in 2021
STI-5656 (Abivertinib) is a small molecule oral pill, should be easy to produce / scale in massive industrial quantities to meet global demand, 5656 has ENORMOUS financial potential: Covid, NSCLC, plus multiple other cancers, etc. Versus say MSC-8282 that thus far has spectacular early trial results but being a stem cell based biologic will likely be more difficult to produce and scale.
These are my SRNE price targets for the rest of the year, and if I'm half wrong I'll be a very happy investor!!
13 Catalysts:
\#1 EUA-1 Covi-Stix (May) $20 31-May
\#2 Celularity IPO - (June)
\#3 EUA-2 5656 (June) $30 30-Jun
\#4 PSS Settlement - (July)
\#5 EUA-3 MSC - (Aug)
\#6 SP-102 P3 topline read out (Aug) $60 31-Aug
\#7 EUA-4 AMG-2020 (Nov) $75
\#8 EUA-5 Covi-Trace / Tracks (Nov) $90
\#9 RTX P3 cancer / arthritis - read out (Nov)
\#10 Scilex IPO /SP-102 NDA filing (Nov) $130 30-Nov
\#11 EUA Covi-Shield (Dec)
\#12 EUA-6 Drops-2099 (Dec) $140
\#13 NDA Abiver / NSCLC (Dec) $170 31-Dec"
I appreciate Pauls update on May!
"A lot happening in May. I’m curious to find out how many more shares the Institutional and Mutual Fund Investors have purchased. BlackRock went from 11-12M to 17M plus shares last time around. The Vatican Conference is a giant soapbox with media from around the world reporting. With Celularity and Sorrento being only two of six Industry Collaborators I’m sure there will be a interviews lined up before, during, and after the conference. That type of exposure is priceless. Speaking of Celularity. The planned merger is scheduled for the second quarter so basically that announcement can happen anytime. MSC, Abivertinib, STIX EUA’s can drop anytime between now and June. At least one, if not two will happen before the end of May. There’s a reason we are not hearing anything about AMG. DARPA is involved, and sooner or later they will be taking over the trial. Notice I’ve only spoken about the COVID pipeline. Sorrento will have NDA’s and approvals for at least SP102 and Abivertinib by year end or first quarter next year. SP102 is a blockbuster with projected 5-6 B revenue, and Abivertinib with both covid and cancer is a super blockbuster with a projected 10 B plus. RTX, ANP BO, etc... so much going on and with 56M shares shorted and the volume pretty much low everyday while everyone is waiting for a pin to drop there’s not an exit strategy big enough for shorts to evade a squeeze. So sit back and relax fellow investors. Take your hand off of the sell button. Laugh at the memes, and hug your loved ones because this is going to be fun. At least for those who have done their dd and are patient."
I bought my first Sorrento shares early in 2020 so I can't complain about the 300+% gain. But the best is yet to come! The brilliant acquisitions are just starting to pay off, as are the great investments! This is a much stronger company than it was a year ago.
After the ACEA acquisition Sorrento now has over 60 drug programs!
Phase 3, close to EUA or close to market (12 programs)
1. Abivirtinib NSCLC NDA filed China
2. Abivirtinib NSCLC ph.3 completed US
3. PD-L1 SCLC partnered
4. Erbitux biosimilar
5. Xolair biosimilar
6. Remicade biosimilar
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application
11. Covi-Trace EUA application
12. Cynviloq (part of PSS lawsuit)
Phase 2 (12 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. Covi-Track EUA pre-validation
5. PD-L1 partnered
6. Herceptin delivery partnered
7. Abivirtinib Lymphoma
8. Abivirtinib Covid 19
9. Abivirtinib prostate cancer ph.2 IND
10. Abivirtinib Lupus ph.2 IND
11. Abivirtinib hairy cell leukemia
12. CD47 partnered
Phase 1, IND filed or pre-IND (36+ programs)
1. Seprehvec Oncolytic Virus
2. CD 38 CAR-T ph.1
3. CEA CAR-T ph.1
4. CD38 DAR-T IND
5. BCMA DAR-T pre-IND
6. PD-L1(C/DAR-T) pre-IND
7. CyCART-19 partnered
8. Covi-GeneMab pre-IND $34 million DARPA funding
9. PD1-GeneMab pre-IND
10. ERT (Enzyme Replacement Therapy) several pre IND programs
11. IL2Teff pre-IND
12. IL2Treg pre-IND
13. Covi-Drops ph.1
14. TNF-a (Enbrel) ph.1
15. CTLA-4 (Yervoy)
16. CD47 ph.1 basket trial partnered
17. TROP2 pre-IND partnered
18. BCMA ADC pre-IND
19. ROR1 ADC pre-IND
20. CD25 ADNAB pre-IND
21. CD20 ADNAB (Rituxan) IIT-ph.1
22. VEGF(Avastin) ADNAB IIT-ph.1
23. PD-L1 ADNAB pre-IND
24. VEGFR2 ADNAB pre-IND
25. CBD immune diseases pre-IND
26. CBD insomnia pre-IND
27. CBD Parkinsons pre-IND
28. CBD CNS diseases pre-IND
29. PD-L1 CAR-NK partnered
30. CD38 CAR-NK to be partnered
31. CD38 ADC AL Amyloidosis
32. AC0058 ph.1b lupus
33. AC0058 pre-IND MS
34. AC0939 pre-IND CNS indications
35. 1,000,000+ small molecule library
36. Ten quadrillion antibody library
FUNDING? Sorrento has invested wisely and has 8.2 million shares of ImmunityBio, 20 million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS lawsuit will soon be settled with very large potential gains. And it has many attractive programs to partner for upfront, milestone and royalty payments! Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!