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Many people wonder why Sorrento is meeting delays from the FDA. The FDA has the important job of seeing that drugs are both safe and effective. But why do big companies like Abbott get rapid approval on very inaccurate test kits while Sorrento seems to struggle to advance superior tests? And the recent approval of Biogen's questionable Alzheimer drug against the advice of a panel of experts has shaken the confidence in the FDA's fairness.
Meanwhile Sorrento is providing more and more advanced technologies and will progress in Latin America, Europe and perhaps India...to meet the ongoing worldwide Covid crisis. Hopefully the FDA will catch up soon.
Based on probable revenue projections I look for a $100+ share price THIS YEAR.
CoviStix, CoviDrops, and CoviMSC EUA's in Mexico, Brazil, Latin America, UK, Europe, India and US THIS YEAR.
NDA for SP-102 in US and Abivertinib for NSCLC in China and US THIS YEAR.
IMO any buyout offers would have to be multiples of this (2-3 times) as I don't think Dr. Ji wants to sell!
I don't know who prepares this list but it is always interesting.
"Sorrento Therapeutics Boom List
1. Covi-Stix approved in Mexico- June 2021- Expecting large revenues, Brazil and US to follow.
2. ACEA owned- full ownership of Abivertinib, multiple pipeline additions and a large manufacturing facility.
3. License Partner, Kelun, Phase I Study of Safety and Pharmacokinetics of A166, a Novel HER2 ADC for Advanced HER2 Positive Breast Cancers released positive results Jun 21.
4. Q1 2021 results show strong revenue growth and swing in to profit!
5. COVI-MSC- Phase 1b tests complete 10/10 patients recovered from mechanical ventilation and leaving hospital after a week!!! Phase 2 PIVOTAL Approved in Brazil May 2021
6. Sofusa DoseConnect multiple Ph1b trials Jan 2021. Drug already approved – this is all about the delivery. Results started May 2021 and were very positive. Multiple drugs can be dosed this way and used to extend patents! June 2021 1b trial delivery patients with Melanoma- first of many with Mayo C.
7. ANP Acquisition nearing completion will open Sorrento to significant advances in testing
8. COVISHIELD Ramping up development in partnership with Mount Sinai. This will speed up the development of combination antibody along with STI-2020 to combat the SA variant with higher efficacy. Sorrento will licence multiple antibodies and pay in stock subject to FDA approval milestones.
9. Lee’s Pharmaceutical Anti-PD-L1 Antibody Socazolimab, licensed from Sorrento ph3 approval in China. Not only treats Lung cancer, trials planned for other types. Approval in China could open Sorrento to expedited approval elsewhere.
10. Fortune Bio (Sorrento Manufacturer in China) Confirmed Covi-Stix being made with CE approval certificate. This and Respi-Stix listed for sale. http://www.fortunetest.com/. Setting up manufacturing in US and moving Fortune Bio Technology to fulfil this (believed to be pre requisite for FDA approval and Government Contract. Confirmed in a job description. “ready to produce tens of millions per month” -Ji
11. 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
12. Covi-Trace application submitted- Brunswick mentioned they are submitting a low nasal swab version
13. Last year we acquired multiple companies. We own 25% of Celulatory who are listing for approx. $2bn due to merger with GX Acquisition Corp
14. STI-6643 Ph1 Trial approved for multiple cancer type treatments “Basket Trial”
15. Sorrento Therapeutics entered into an Exclusive Licensing Term Sheet with Aardvark Therapeutics to Acquire Its ARD-301 For the Treatment of Chronic Pain, Fibromyalgia, and Chronic Long Haul Covid Syndrome- Ph2 already approved to proceed
16. 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- April 2021 FDA Clearance to Proceed with Phase 2 Study for Sti-3031, an Anti-Pd-L1 Antibody, for Advanced Urothelial Carcinoma
17. DARPA funding of at least $34m to bring STI 2020 to the end of P2 trials and beyond. Three phase 2 trials of COVI-AMG being delivered to 1000 patients. STI2020 is a refined version of 1499 with increased potency and requires smaller dosage.
18. Abivertinib - Cures Covid at late stages. Stage 2 trials complete results soon. Ji hinted test are over 50% success. Israel announced they have repurposed a cancer drug with similar positive response.
19. Institutions buying in and own 28% of stock: BlackRock 6% Vanguard 5% and State Street 3.5%
20. Covi-Drops STI2099 (Refined version of 1499) nasal antibody spray kills all Covid in early stages and can be administered in doctors surgery, maybe at home. PH1b FDA approved March 2. PH2 trial in the UK
21. 11 Covid programs in progress with strong potential- Vaccines removed from pipeline to focus on these, however T-VIVIA-19 could come back to beat mutations if others fail.
22. Multiple cancer and pain relief plays which triggered BO offers of $7 a year ago before we started developing for Covid.
23. Yes, we only have one drug approved (ZTildo) but sales are growing massively
24. Immunity Bio and NK merger completed resulting in us owning 8.19m shares in the new company $IBRX. PSS is chairman of NK making it more likely our Cynviloq case has been settled. Expecting $1bn in stock or cash as part of the settlement. Our stake at launch $317m+
25. Four analysts have us at $20-35 which is very conservative.
26. Testing Lab approved in California for Covid (will speed up in house testing and provide source of revenue)
27. CEO only gets share options if he maintains SP above $17-130 for six consecutive months
28. We have been heavily shorted due to a scam by Hindenburg (top 30 most shorted) and now we are poised for a massive short squeeze.
29. SP-102 Ph3 trial results-potentially the first FDA approved ..."
COVISTIX INDIA video. WHAT'S NEXT?
COVISTIX MEXICO,
COVISTIX BRAZIL,
COVISTIX EUROPE,
COVISTIX US?
Can you say "Multi-billions".
(and COVIDROPS and COVI-MSC will follow!)
With the Mexican COVI-STIX EUA approval it's time for another Sorrento program update! With over 64 programs in the portfolio there is a lot happening investors want to know more about! Karolinska, Mayo Clinic, Mt. Sinai, ACEA, SmartPharm partnerships and acquisitions. Sorrento has become a well-funded world-class holding company! Share price = Triple digits very soon.
Phase 3, close to EUA or close to market (13 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(approval in Mexico!)
11. Covi-Trace EUA application
12. Sofusa Enbrel
13. Cynviloq (part of PSS lawsuit)
Phase 2 (13 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. COVIDROPS EUA potential
5. Covi-Track EUA pre-validation
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential
10. Abivertinib prostate cancer ph.2 IND
11. Abivertinib Lupus ph.2 IND
12. Abivertinib hairy cell leukemia
13. CD47 partnered
Phase 1, IND filed or pre-IND (38+ 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. Sofusa anti-PD1 and anti-CTLA4
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. A166 HER2 ADC phase 1
36. Karolinska off-the-shelf DAR-NK pre-IND
37. 1,000,000+ small molecule library
38. 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! The first of many EUA's will produce revenues within weeks(Mexico). Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
Some interesting information about the SOFUSA drug delivery system....
"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.
Sorrento has eight (8) potential Covid Emergency Use Authorization candidates...all Blockbusters! Covi-Stix, Covi-Drops, Abivertinib and Covi-MSC are progressing in several jurisdictions... revenue THIS YEAR beginning with Mexico. Here's a partial overview.
1. Covi-Stix rapid accurate virus test(EUA granted MEXICO, more coming soon)
2. Covi-Track rapid accurate antibody test
3. Covi-push 2020 injection
4. Covi-Drops 2020 nose drops(trials in US, UK and Mexico)
5. Covi-Vax 2020 lipid DNA injection($34 million DARPA funding)
6. Abivirtinib ARDS prevention(Brazil and US results any day)
7. Covi-MSC Stem Cell ARDS treatment(trials in US, UK and others)
8. Covi-Shield antibody cocktail(to deal with latest variants)
Each of these EUA's could be accompanied by multi-billion dollar international sales. Additionally there could be multi-billion dollar worldwide marketing partnerships. Dr.Ji says there is "humungous" interest from Mexico, Brazil and Europe.
Get the big picture. Read carefully what Dr. Ji said.
Transcript of the January 20, 2021 Riley Oncology Conference. Loaded with important information for investors.
https://seekingalpha.com/article/4400090-sorrento-therapeutics-inc-srne-ceo-henry-ji-presents-b-riley-virtual-oncology-conference?utm_source=dowjonesnewswire.com&utm_medium=referral
COVIDROPS could be huge...
'These variants include the UK/Alpha and the India/Delta variants of concern.....
The results of this Phase 2 trial in the UK will be combined with the results of the US and Mexico Phase 2 trials and should the results of these studies demonstrate that COVI-DROPS is both safe and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the US, India, UK, Mexico and European Union as well as other territories."
ANP would be a great acquisition. I recall that the equally attractive ACEA acquisition took some months to be finalized. There is a mountain of legal work to be done. I wouldn't be surprised to see the ANP acquisition finalization set the stage for a nice advance in the share price. Dr. Ji has done great acquisitions over many years. I completely trust his judgment.
On May 19 Sorrento announced some very impressive results from the first arthritic patient dosed with Enbrel using the SOFUSA trandermal infusion technology. The company said...
"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.(Mayo Clinic collaboration announced June 11!)
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...."
"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."
Treatments for Cancer, Rheumatoid Arthritis, Multiple Sclerosis and Psoriasis can be delivered with lower doses, concentrated on the lymphatic system, with a longer duration and fewer side effects. Now the Cancer application is going ahead in the Mayo Clinic! This technology has blockbuster potential!
The following post by Paul is worth reading. My only response is that the alleged "valuation" is like valuing McDonald's and omitting earnings from hamburgers and fries!
"Here is a DAWSON JAMES research update from Dec 10, 2020. The conclusion at the time was a very conservative $21 price target, and they applied a 30% discount rate. They also assumed a success rate of just 50% for COVI-SHIELD and RTX.
-SP102 (fast tracked) approval first quarter next year was not included
-Abivertinib (NSCLS) approval first quarter next year was not included
-Abivertinib (NSCLS) China approval second or third quarter this year was not included
-Abivertinib other indications in various stages of study were not included or ACEA BO and whatever else it brought to the table
-AMG not included (FDA filing was accepted at the time, but it had yet to begin trials. Now in P2. DARPA.
-COVIDROP not FDA accepted until 2021. Now in P2 in UK & US.
-STIX Mexico EUA, and probability for other Latin America markets; Europe (CE); US?
-MSC (not included) Brazil Pivotal P2 and likely EUA this year. EUA US?
-Abivertinib (covid) P2 data rollout at anytime, and potential EUA. Not included.
-I am leaving out licensing agreements, potential ANP BO, shares in other companies, potential arbitration ruling, partnerships, various other trials, antibody library, etc…
So folks, when I hear it will take 2-3 years before a revenue stream or I’m selling when the SP hits $20-30 dollars this year, I just laugh at the manipulation. At the investor unwilling to do their dd or should I say trader instead of investor. Looking for the quick buck when there’s a bag of gold near by. While the cream of the cream institutional investors are lifting their shares, all that some retail investors can see is a few quick easy dollars. The SP will rise well over $21 this year, and continue into next year. Triple digits. Yes. Maybe some folks should do their dd.
https://dawsonjames.com/wp-content/uploads/2020/12/SRNE.DJ_.12.10.2020.1.pdf?fbclid=IwAR1mxz-f-hDvM0N3G_cbvynm_a7HaVvAti39FHGdEu2QR6tlv8_yVk86Wog
Now that the Mexican COVISTIX EUA has been approved...what's next? Could it be ...?
1. COVISTIX EUA BRAZIL
2. COVISTIX EUA EUROPE
3. COVISTIX EUA US
4. COVIDROPS EUA MEXICO
5. COVIDROPS EUA BRAZIL
6. COVIDROPS EUA EUROPE
7. COVIDROPS EUA US
8. COVI-MSC EUA MEXICO
9. COVI-MSC EUA BRAZIL
10. COVI-MSC EUA EUROPE
11. COVI-MSC EUA US
12. COVI-SHIELD EUA MEXICO
13. COVI-SHIELD EUA BRAZIL
14. COVI-SHIELD EUA EUROPE
15. COVI-SHIELD EUA US
16. ABIVERTINIB EUA MEXICO
17. ABIVERTINIB EUA BRAZIL
18. ABIVERTINIB EUA EUROPE
19. ABIVERTINIB EUA US
20. ABIVERTINIB APPROVAL NSCLC CHINA
21. ABIVERTINIB APPROVAL NSCLC US
Or does Dr. Ji have more surprises for us!
Interesting Big Picture view from Robert S ....
In "Why The Relaxation In Lockdowns Is Expected To Drive The Demand For COVID-19 Diagnostics Market
A recent report from Polaris Market Research said that the global COVID-19 diagnostics market was valued at USD 19.41 billion in 2020 and is expected to reach USD 23.67 billion by 2027 to grow at a CAGR of 2.9% during the forecast period. Active healthcare stocks in the markets this week include Novavax, Inc. (NASDAQ: NVAX), Global WholeHealth Partners Corp (OTCPK: GWHP), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Moderna, Inc. (NASDAQ: MRNA), Pfizer Inc. (NYSE: PFE).
https://www.prnewswire.com/news-releases/why-the-relaxation-in-lockdowns-is-expected-to-drive-the-demand-for-covid-19-diagnostics-market-301304896.html
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced that the Mexican Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the health regulatory authority for Mexico, has listed COVI-STIX on its official government website list of rapid antigen tests approved for emergency use in Mexico. COVI-STIX is a rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients ("Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2").
An independent study conducted by the government's epidemiological department, Instituto de Diagnóstico y Referencia Epidemiológicos (InDRE), confirmed the validity of the test in 465 nasopharyngeal samples from symptomatic (7 days or less) or uninfected people, which yielded the following results: Positive Predictive Value (PPV): 95.77%; Negative Predictive Value (NPV): 98.42%. Among all the products listed currently, COVI-STIX outperformed for both Sensitivity (91.89%) and Specificity (99.23%).
We're now listed with some of the largest Pharmaceutical Companies in the World. Know what you own my friends. BlackRock, Vanguard, and State Street invented over $250M in Sorrento stock. They didn't invest only to short the stock. They have a long term 3 year plan. If you have patience and willing to wait it out. Sorrento will be a $200B - $300B company before you know it. Please do your DD and invest what you can afford. In my best opinion Sorrento Therapeutics is by far the next Regeneron Pharmaceuticals X10.
For some of you that don't know on this board. My wife and I invested in Regeneron over 27 years ago. We became millionaires investing with REGN. Follow the money trial and you all will become millionaires someday. Don't be shaken or insulted or scared by paid short traders on this board. It's their job to disrupt and make you angry and leave. Don't let them win. Purchase your shares and forget you own the stock. That's what my wife and I did over 27 years ago. Thank you for listening."
It's time for another Sorrento program update! With over 64 programs in the portfolio there is a lot happening investors want to know more about! Karolinska, Mayo Clinic, Mt. Sinai, ACEA, SmartPharm partnerships and acquisitions. Sorrento has become a well-funded world-class holding company! Share price = Triple digits very soon.
Phase 3, close to EUA or close to market (13 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. Sofusa Enbrel
13. Cynviloq (part of PSS lawsuit)
Phase 2 (13 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. COVIDROPS EUA potential
5. Covi-Track EUA pre-validation
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential
10. Abivertinib prostate cancer ph.2 IND
11. Abivertinib Lupus ph.2 IND
12. Abivertinib hairy cell leukemia
13. CD47 partnered
Phase 1, IND filed or pre-IND (38+ 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. Sofusa anti-PD1 and anti-CTLA4
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. A166 HER2 ADC phase 1
36. Karolinska off-the-shelf DAR-NK pre-IND
37. 1,000,000+ small molecule library
38. 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! The first of many EUA's will produce revenues within weeks(Mexico). Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
Sorrento keeps coming up with BETTER treatments! Better safety. Better efficacy.
"Compared to its commercial competitors, A166 demonstrated a better safety profile in the initial study and potentially better efficacy, as shown in the overall response rate (ORR) of 71.4% (A166) at 6.0 mg/kg vs DS-8201, which has an ORR of 60.9% (DS-8201) at 5.4 mg/kg."
Can you imagine the power potential of an off-the-shelf DAR-NK? Dr. Ji has said DAR-T is 10-100 times as powerful as CAR-T. DAR-NK could be amazing. Partnerships with Mayo Clinic, top hospitals and universities ...and now the world famous Karolinska Institutet. World class! Brilliant leadership Dr.Ji. Thank you!
Why do I think Sorrento share price will go over $125 THIS YEAR and over $250 NEXT YEAR?
BY THE END OF THIS YEAR Sorrento could have 8 Covid products approved with billions in sales. Sorrento will become a worldwide household known brand name. It will be identified with saving lives.
AND LATER THIS YEAR Sorrento's world class cancer franchise could begin "anchored" by sales of Abivertinib. CAR-T,DAR-T, ADNAB, SMARTPHARM provide a world class portfolio depth.
AND NEXT YEAR Sorrento's best-in-class non-opioid pain franchise will hit the market with sp-102 and RTX ... two blockbuster life changing technologies.
AND IF REDDIT GETS BEHIND IT...all predictions are off!
Important thoughts by Robert...
"We had 2 significant PR's and while the STIX approval in Mexico was a nice "monkey off our backs" moment-- the closing of ACEA was even bigger. Abivertinib as our "Franchise Molecule" and the foundation for the creation of a "Major Oncology Franchise"-- has tremendous potential to be a first and second line treatment option for numerous indications in NSCLC, prostate cancer, multiple sclerosis, systemic lupus, and hairy cell leukemia-- which the latter has already been granted an orphan drug designation from the FDA.
There were also 2 new trials posted today for MSC that show Sorrento is going all in on MSC and must be confident in their ability to manufacture and scale-- which Ji is still holding that particular card very close.
MSC for non-COVID ARDS is huge as we've discussed multiple times but now we have confirmation that they are indeed moving forward with this. The other P2 MSC trial posted was for COVID long haul syndrome-- specifically those that continue to have breathing issues post recovery. This particular subset of COVID long haulers are dealing with the remaining scar tissue left in their lungs once the virus has been eliminated from their body. If these trials are successful this will show that MSC has the ability to reverse and repair the scarred lung tissue. MSC as regenerative medicine will unlock the gates to a plethora of new indications and the acceleration of what I believe is an inevitable paradigm shift to cellular medicine-- from both a regulatory and industry perspective. You can bet Dr. Hariri of Celularity is paying very close attention to these MSC trials.
The strategy is unreal and their ability to potentially corner the COVID long haul market with both SP-104 (ARD-301) and now MSC is huge. Add to that MSC as a life-saving rescue treatment/cure for all things ARDS. The ability to take both these candidates to a greater reach for huge unmet needs outside of COVID for both non-COVID ARDS and chronic pain/fibromyalgia coupled with the ACEA Oncology Franchise will be the foundation for a juggernaut BP.
Toss in STIX, TRACK, DROPS, ADNIC/ADNAB, SmartPharm, Scilex, CAR/DAR-T, several P3 completed biosimilar/biobetters, and the G-Mab library to that foundation. Oh, did I mention RTX??? The future is bright folks. Long and strong!"
Rows 12 and 13:
https://clinicaltrials.gov/ct2/results?cond=&term=sorrento&cntry=&state=&city=&dist=
Sorrento is a diversified holding company. Three divisions.
1.NON-OPIOID PAIN. Already producing revenue. Blockbuster revenues next year from sp-102 and RTX.
2.COVID. 9 Potential EUA's. MEXICO is just the first. Revenue this month. Multi-blockbusters.
3.CANCER. Abivertinib revenue in China likely this year. DAR-T, ADNAB, lipid DNA all first and best-in-class. Several phase 3 already. Many phase 2. Several blockbusters.
WIN.WIN.WIN.
Now that Covi-Stix has a Mexican EUA we must remember that Sorrento has at least nine (9) potential Covid Emergency Use Authorization candidates...all Blockbusters! Here's a partial overview.
1. Covi-Stix rapid accurate virus test (Mexican EUA!!!)
2. Covi-Track rapid accurate antibody test
3. Covi-Trace
4. Covi-push 2020 injection
5. Covi-Drops 2020 nose drops
6. Covi-Vax 2020 lipid DNA injection($34 million DARPA funding)
7. Abivirtinib ARDS prevention
8.. Covi-MSC Stem Cell ARDS treatment
9. Covi-Shield antibody cocktail(to deal with variants)
Each of these EUA's could be accompanied by government grants and multi-billion dollar international sales. Additionally there could be multi-billion dollar worldwide marketing partnerships. Dr.Ji says there is "humungous" interest from Mexico, Brazil and Europe and Sorrento is open to partnerships.
Timing? Covi-Stix in Mexico is only the beginning. More EUA's could come in days. Some in weeks. Others in several months. Don't let anyone steal your shares! The best is yet to come!
Now it must fill the gap to $20.
Two days ago I posted the following...and did not list Abivertinib PARTNERSHIP(S) OR COVI-STIX approval! Add those this list!
"Some have suggested a $135- $185 share price within a year. Is that possible? In that timeframe there could be many exciting events including ...
1. PSS lawsuit settlement ($1 billion plus)
2. SP-102 approval
3. Abivertinib NSCLC approval
4. Celularity IPO
5. Scilex IPO
6. EUA Abivertinib ARDS
7. EUA COVI-MSC
8. EUA COVIDROPS
9. EUA COVI-AMG
10. EUA COVI-TRACE
11. EUA COVI-TRACK
12. EUA COVISHIELD
$135-$185 within a year? As many, indeed most, of these events could happen over the next 6 months these prices could come sooner than many expect! Care for a Short Squeeze anyone?
WHAT WILL THESE PARTNERSHIPS BE WORTH?
"Sorrento is seeking major global partnership(s) to co-develop and co-commercialize Abivertinib."
Lung and other cancers, lupus and ARDS etc. potential!
Worldwide. Upfront. Milestones. Royalties. Mega-Millions!
Personalized Stem Cells announces Brazilian authorization for Phase 2 COVID-19 stem cell clinical trial licensed to Sorrento Therapeutics.
POWAY, CALIFORNIA, US, June 1, 2021 /EINPresswire.com/ -- Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces the Brazilian Health Regulatory Agency (Anvisa) authorized a Phase 2 COVID-19 stem cell clinical trial. This approval comes shortly after the completion of a Phase 1b trial conducted in California at UCSF Fresno. The trial, which is being conducted by Sorrento Therapeutics (Nasdaq: SRNE, "Sorrento"), will be a Phase 2 pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of allogeneic mesenchymal stem cell therapy for the treatment of acute respiratory distress syndrome (ARDS) as a result of COVID-19 infection.
In the initial Phase 1b study, ten patients that were hospitalized and required oxygen supplementation, were all discharged from the hospital shortly after completing treatment with stem cells. These promising results helped secure approval for the Phase 2 study in Brazil. Sorrento expects to enroll 100 patients in the new study, with 33 placebo and 67 treated patients. The stem cell treatments, which were developed by PSC and then licensed to Sorrento, will be administered every other day for a total of three infusions.
FDA approval for the Phase 1b clinical trial conducted in the United States was secured by PSC in July 2020. PSC, which primarily focuses on orthopedics, went on to grant global rights to its adipose derived allogeneic mesenchymal stem cell (MSC) program, including the COVID-19 therapy candidate, to Sorrento Therapeutics in October 2020. PSC contracted Performance Cell Manufacturing to manufacture stem cells for use in the clinical trial.
As discussed in a peer-reviewed scientific article published by PSC and collaborating scientists on the rationale behind using stem cells to treat COVID-19, MSCs have demonstrated the capacity to inhibit lung damage, reduce inflammation, dampen immune responses and aid with alveolar fluid clearance. Additionally, MSCs produce molecules that are antimicrobial and reduce pain. Recently, the application of MSCs in the context of ongoing COVID-19 disease and other viral respiratory illnesses has demonstrated reduced patient mortality and, in some cases, improved long-term pulmonary function.
About Personalized Stem Cells, Inc.
Personalized Stem Cells was formed in 2018 to advance human regenerative medicine by securing FDA approval for autologous stem cells for serious diseases with limited treatment options. This privately held biopharmaceutical enterprise, based near San Diego (California), is conducting clinical trials and developing stem cell products in the areas of orthopedics, pain, and traumatic brain injury. PSC has licensed a portfolio of patents and applications in the field of regenerative medicine which includes patent applications covering treatment of lung diseases including COVID-19.
Michael Dale, President/COO
Personalized Stem Cells, Inc
+1 833-772-3557
Top three institutional investors..
Blackrock..
Last year 7,293,000 shrs.
This year 19,409,333 shrs.
Vanguard..
Last year 6,224,110 shrs.
This year 13,554,519 shrs.
State Street..
Last year 4,655,210 shrs.
This year 9,786,760 shrs.
Do you think these big funds might know something?
Some have suggested a $135- $185 share price within a year. Is that possible? In that timeframe there could be many exciting events including ...
1. PSS lawsuit settlement ($1 billion plus)
2. SP-102 approval
3. Abivertinib NSCLC approval
4. Celularity IPO
5. Scilex IPO
6. EUA Abivertinib ARDS
7. EUA COVI-MSC
8. EUA COVIDROPS
9. EUA COVI-AMG
10. EUA COVI-TRACE
11. EUA COVI-TRACK
12. EUA COVISHIELD
$135-$185 within a year? As many, indeed most, of these events could happen over the next 6 months these prices could come sooner than many expect! Care for a Short Squeeze anyone?
1776...I could see some Sorrento acquisitions in the stem cell area!
Enrollment Milestone Reached in COVID-19 Clinical Trial Using Stem Cells Manufactured by Performance Cell Manufacturing
by valethealth | May 13, 2021
Performance Cell Manufacturing was contracted to manufacture stem cells for an FDA-approved stem cell clinical trial to treat COVID-19 induced acute respiratory distress syndrome (ARDS). The clinical trial, which was developed by Personalized Stem Cells, Inc. (PSC) and licensed to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), recently reached its target enrollment of ten patients.
The first positive results from the clinical trial came in January, followed by updated results in March. The latest announcement from Sorrento confirmed that target enrollment was reached, and all ten clinical trial participants were discharged from the hospital.
According to Sorrento, all ten patients were in the hospital with low oxygenation and required oxygen supplementation. Within three days of their last stem cell infusion, all ten patients were discharged from the hospital and sent home. The clinical trial called for the patients to receive one intravenous infusion of stem cells every other day for a total of three infusions however the final patient was discharged after only two injections with oxygen saturations in the high 90s.
The objective of this non-randomized, Phase 1b study is to evaluate the safety and preliminary efficacy of adipose-derived stem cell therapy for the treatment of ARDS resulting from infection with COVID-19. There were no infusion-related adverse events reported in any of the patients. Data from the clinical trial will be used to support a planned placebo-controlled pivotal study which is expected to take place across multiple sites in the UNITED STATES AND BRAZIL.
The stem cell platform and FDA approval for the clinical trial were secured by Personalized Stem Cells shortly after COVID-19 was declared a global pandemic. Personalized Stem Cells granted global rights to its adipose-derived allogeneic mesenchymal stem cell (MSC) program, including the COVID-19 therapy candidate, to Sorrento in October 2020.
Thanks to Robert S for this about Sorrento's CRO in Brazil.
"THE KEY TO BRAZIL - WATCH THE FULL VIDEO - SYNOVA HEALTH
https://www.synovahealth.com/
Synova Health has been contracted to run the https://clinicaltrials.gov/ct2/show/NCT04528667?term=NCT04528667&draw=2&rank=1
Please scroll down to #48 on the list. file:///C:/Users/hudsonvalleylimo/Downloads/Ensaios%20Cl%C3%ADnicos%20autorizados%20para%20COVID-19%20pela%20Anvisa_28.05.2021.pdf
After watching this video I have learned that Synova Health is the largest Contract Clinical Research Company in Latin America. With over 1000 sites in latin America
I feel even more confident that Sorrento Therapeutics is on the right path to success. Know what you own. This is a once in a life time opportunity to invest in a Company building to be worth $200B - $300B in the next 3 to 5 years."
We can forget the suffering of the patients and the courage and love of front line workers. They should be remembered on Memorial Day. This news item from Oregon is a reminder!
"In Bend, COVID-19 patients flood hospital, ICU; 98% unvaccinated
Updated 10:40 AM; Today 10:40 AM
Emily Kroytz, a registered nurse in St. Charles Bend’s intensive care unit, ended a 16-hour shift this week and came home in tears.
Kroytz and the other ICU nurses have not seen this many COVID-19 patients at once in six months. As of Thursday, all 24 beds were full in the ICU, including five patients with the virus. Three of the infected patients are on ventilators.
Another 36 COVID-19 patients were being treated in the hospital.
”It takes an emotional toll,” Kroytz said.
The full capacity in the ICU is due to the ongoing spread of COVID-19, but also an increase in patients who put off medical treatment during the pandemic and are now showing up to the emergency room with neglected illnesses. In addition, the hospital is seeing heart attacks and major injuries that will likely increase through the summer.
”We are seeing a lot more suffering,” Kroytz said. “We are seeing patients that need beds.”
A COVID-19 outbreak at a central Oregon high school that required nearly half its students and staff into quarantine has prompted school officials to send students back to online learning for nearly two weeks.
Debbie Robinson, chief nursing officer at St. Charles Bend, said the hospital is bringing in available nurses from around the state and nation to help with the overcrowding of patients. Outside of the ICU, all other hospital beds were full Thursday, and 15 people were waiting in the emergency room for beds, Robinson said.
Robinson is encouraging people to stay safe from injury and COVID-19 over Memorial Day weekend, which is traditionally a busy time for the emergency room, she said.
The best way to avoid the virus is to get vaccinated, social distance and wear masks when necessary, Robinson said.
”I want the community to know we are absolutely not behind this pandemic,” Robinson said.
Dr. Louis Davignon, who works in the St. Charles Bend ICU, sees the benefits of getting the vaccine. Since March, 98% of infected patients were not vaccinated, he said.”
And even the (vaccinated) patients that get admitted do much better,” he said.
On Thursday, Davignon monitored one of the COVID-19 patients on a ventilator. Davignon watched as three nurses, a medical assistant and respiratory therapist rotated the unconscious middle-aged man from his stomach to his back.
Rotating patients helps take pressure off of their lungs and allows them to breathe better. In serious COVID-19 cases, the virus hardens the lungs and doesn’t allow oxygen to reach the bloodstream and causes organs to fail, Davignon said.
”If we see that stiffening, then we know we are in trouble,” he said.
Kroytz, who has worked as a nurse since 2001, said the majority of COVID-19 cases recently are from family gatherings that led to multiple family members getting infected, including younger people in their 30s.
For those patients who survive and return home, they can face long-term health issues. They usually feel weak and have difficulty doing regular activities such as mowing a lawn or shopping for groceries, Kroytz said.
”They are exhausted, and their lungs are damaged,” Kroytz said.
The unconscious patient Thursday has been on a ventilator for two weeks. He has stayed in a room that does not allow visitors and requires nurses to wear masks, gloves and full-body suits.
”This patient has not seen a family member since he has been in the ICU,” Kroytz said. “A family member has not been able to touch or see him.”
ICU nurses use iPads to allow family members to see their loved ones. The nurses hold the iPad screen over the patient, who is often not awake, and let the family visit with them.
”A lot of us have had to hold the iPad so they can say goodbye to their loved ones,” Kroytz said.
Having a patient die is always difficult for the nurses, Kroytz said. The ICU nurses work 12- to 16-hour days, three to five days a week. In that time, they grow close with their patients.
“We bond with them,” Kroytz said. “It’s hard to come to work and not see them again.”
Despite the current crisis with capacity at the hospital, Kroytz is optimistic if people continue to get vaccinated. Having the protection of the vaccine has helped the nurses feel safe, she said.
”We feel more confidence because we are vaccinated,” Kroytz said. “It’s encouraging and brings comfort to be vaccinated.”
It's time for another Sorrento program update! With over 60 programs in the portfolio there is a lot happening investors want to know more about!
Phase 3, close to EUA or close to market (13 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. Sofusa Enbrel
13. Cynviloq (part of PSS lawsuit)
Phase 2 (13 programs)
1. Seprehvir Oncolytic virus
2. Covi-MSC EUA potential
3. Covi-AMG EUA potential
4. COVIDROPS EUA potential
5. Covi-Track EUA pre-validation
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential
10. Abivertinib prostate cancer ph.2 IND
11. Abivertinib Lupus ph.2 IND
12. Abivertinib hairy cell leukemia
13. 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. Sofusa anti-PD1 and anti-CTLA4
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!
A COVIDROPS Phase 2 trial in the UK?
"Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)"
There is already a trial in the US and soon in Brazil.
COVI-AMG, COVIDROPS, Abivertinib and COVI-MSC all in phase 2 in several jurisdictions. Phase 1 must have been positive in all cases.
Paul posted a link pointing out the worldwide shortage of liquid oxygen...
" There will be a huge demand for MSC and Abivertinib worldwide. Don’t let the manipulation fool you. I can definitely see a Brazilian EUA for Abivertinib and MSC by June or July no matter how things proceed in the States."
https://apple.news/AMpwSTttxQFKa4TOy20z7cQ
We know Abivertinib is a powerful anti-cancer drug! But if it can prevent ARDS and if COVI-MSC can quickly cure ARDS... there will be a huge demand around the world. Save lives and open the world economy!
Patent application for an ADC utilizing derivatives of amanitin(from Green Death Cap Mushroom )
Antibody drug conjugates having derivatives of amatoxin as the drug
May 31, 2017 - Sorrento Therapeutics, Inc.
There is disclosed derivatives of amanitin conjugated to a targeting antibody to form an ADC (antibody drug conjugate).
This patent application claims priority to U.S. provisional patent application 62/343,825, filed May 31, 2016, the contents of which are incorporated herein by reference.
TECHNICAL FIELD
The present disclosure provides derivatives of amanitin conjugated to a targeting antibody to form an ADC (antibody drug conjugate).
BACKGROUND
The amatoxins are rigid bicyclic peptides having eight amino acid units. These compounds are isolated from a variety of mushroom species (e.g., Amanita phalloides (also known as green death cap mushroom), Galerina marginata, Lepiota brunneo-incamata) or are prepared synthetically. Different mushroom species contain varying amounts of different Amatoxin family members. A member of this family, alpha-amanitin, is known to be an inhibitor of eukaryotic RNA polymerase II (EC2.7.7.6) and to a lesser degree, RNA polymerase III, thereby inhibiting transcription and protein biosynthesis. Wieland (1983) Int. J. Pept. Protein Res. 22(3):257-276. Alpha-amanitin binds non-covalently to RNA polymerase II and dissociates slowly, making enzyme recovery unlikely. Prolonged inhibition of transcription is thought to induce cellular apoptosis.
Exemplary amatoxins include
The use of antibody-drug conjugates (ADCs) for the local delivery of cytotoxic or cytostatic agents, including drugs that kill or inhibit tumor cells, allows targeted delivery of the drug moiety to tumors, and intracellular accumulation therein. Syrigos and Epenetos (1999) Anticancer Res. 19:605-614; Niculescu-Duvaz and Springer (1997) Adv. Drug Delivery Rev. 26:151-172; U.S. Pat. No. 4,975,278; Baldwin et al. (1986) Lancet (Mar. 15, 1986):603-05; Thorpe (1985) “Antibody Carriers of Cytotoxic Agents in Cancer Therapy: A Review,” in Monoclonal Antibodies '84: Biological and Clinical Applications, A. Pinchera et al. (eds.), pp. 475-506. This type of delivery mechanism helps to minimize toxicity to normal cells that may occur from systemic administration of unconjugated drug agents. The toxins may cause their cytotoxic and cytostatic effects through a variety of mechanisms including tubulin binding, DNA binding, or topoisomerase inhibition. Both polyclonal antibodies and monoclonal antibodies have been reported as useful in these strategies. Rowland et al. (1986) Cancer Immunol. Immunother. 21:183-87. Toxins used in antibody-toxin conjugates include radioisotopes, bacterial toxins such as diphtheria toxin, plant toxins such as ricin, fungal toxins such as amatoxins (WO2010/115629, WO2012/041504 or WO2012/119787), and small molecule toxins such as geldanamycin (Mandler et al. (2000) J. Natl. Cancer Inst. 92(19):1573-1581; Mandler et al. (2000) Bioorg. Med. Chem. Lett. 10:1025-1028; Mandler et al. (2002) Bioconjugate Chem. 13:786-791), maytansinoids (EP 1391213; Liu et al. (1996) Proc. Natl. Acad. Sci. USA 93:8618-8623), calicheamicin (Lode et al. (1998) Cancer Res. 58:2928; Hinman et al. (1993) Cancer Res. 53:3336-3342), daunomycin, doxorubicin, methotrexate, and vindesine (Rowland et al. (1986), supra).
Several antibody-drug conjugates have shown promising results against cancer in clinical trials, including ZEVALIN® (ibritumomab tiuxetan, Biogen/Idec), an antibody-radioisotope conjugate composed of a murine IgG1 kappa monoclonal antibody (directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes) connected with an 111In or 90Y radioisotope via a thiourea linker-chelator.
The use of antibody-drug conjugates (ADCs) for the local delivery of cytotoxic or cytostatic agents, including drugs that kill or inhibit tumor cells, allows targeted delivery of the drug moiety to tumors, and intracellular accumulation therein. This type of delivery mechanism helps to minimize toxicity to normal cells that may occur from systemic administration of unconjugated drug agents. The toxins may cause their cytotoxic and cytostatic effects through a variety of mechanisms including tubulin binding.
As such, there remains a need for potent RNA polymerase inhibitor antibody conjugates with desirable pharmaceutical properties.
SUMMARY
The present disclosure provides improved amatoxin derivatives used in an ADC (antibody drug conjugate) structure.
Today we learned COVI-DROPS is approved by FDA for phase 2! COVI-AMG has been in clinic for some time. If AMG succeeds I expect it would receive an EUA...and COVI-DROPS might be approved after an interim analysis. The DROPS are simply the nasal delivery of AMG! It too would warrant an EUA. Abivirtinib and COVI-MSC are for later stages of Covid and are in phase 2 in the US and Brazil. ALL four are greatly needed around the world. All four would warrant rapid EUA approval. This would likely be followed by manufacturing in the US and Brazil(per agreements with Brazil's ANVISA). Sorrento can play a huge role in taking the pressure off the worlds hospitals and ICU's! Save lives and open up the world economy!
I wonder how much of it is institutional investors? They can easily hold the price down as they accumulate shares. Blackrock is steadily buying...now has more than 19 million shares! They always know more than us small investors !
All the big pharmas are looking for new drugs to fill their portfolios as the patents run out. And they prefer to add an entire platform if they can. Sorrento has several extremely productive platforms! I expect Dr.Ji to hold on...but hostile attempts are not unheard of in the Pharma world.
Can you name a Big Pharma that would like to add to its portfolio?
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 Sofusa
15. CTLA-4 (Yervoy)Sofusa
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!
Paul found this article from Brazil. Glad to see Sorrento is working harmoniously with Brazilians to save lives
Achal PrabhalaJorge Bermudez, Achal Prabhala May 7 2020, 3:30 a.m.
In this April 16, 2020 photo, Jonas Sena, suspected of suffering from COVID-19 disease, waits on a stretcher to be allowed in the 28 de Agosto hospital in Manaus, Amazonas state, Brazil. Manaus’ health care system, already strained before the coronavirus crisis, is buckling under the current onslaught of coronavirus patients.
AS BRAZIL CONFRONTS the coronavirus pandemic, it is hard to imagine how things could get any worse. At least 8,500 people have died as new infections continue to climb. Meanwhile, Brazilian President Jair Bolsonaro refuses to take the crisis seriously and is battling his own administration. He has opposed plans to shut down the economy, fired his health minister, and endangered citizens by encouraging public meetings. The explosive resignation of his justice minister, Sergio Moro, led to calls for his impeachment. Now, the Supreme Court has approved an investigation into Bolsonaro on multiple violations, including obstruction of justice.
In the middle of a global health crisis, a handful of companies in the U.S. and Europe will decide whether we should live or die.
In all this chaos, it is reasonable to hope that the crisis will ease when coronavirus treatments emerge. Unfortunately, the crisis may only get worse for Brazil when we finally have medicine and vaccines for the coronavirus — unless the National Congress acts immediately.
A majority of the potential treatments for Covid-19 and all the vaccines under development will be brought to market by big pharmaceutical corporations who hold monopoly power over them through patents, which are temporary monopolies granted by national law. This power will result in an outrageous situation: In the middle of a global health crisis, a handful of companies in the U.S. and Europe will decide whether we should live or die.
This problem is not Brazil’s alone. In the last three decades, millions of people from poor countries have died because they could not afford the medicines they needed to live. But, as a “middle-income” country in a long recession, Brazil faces a unique and immediate threat: the inability of the public health system — Sistema Único de Saúde, or SUS — to do its job and keep people alive.
In 2016, Brazil’s Constitutional Amendment 95 froze federal budgets for 20 years, including for public health. In this environment of austerity, with no wiggle room and SUS straining to accommodate growing health demands, the absurd cost of monopoly medicine has the potential to break the system.
WHILE THE THREAT is supercharged in the current coronavirus pandemic, monopoly medicines have been threatening the viability of SUS over the last three decades. Two cases stand out.
In 1996, Brazil made history by providing universal treatment for HIV/AIDS, becoming the first developing country in the world to do so. Less known is that this victory was almost undermined by monopoly medicine prices. Of the cocktail of medicine required to treat HIV/AIDS, some were being manufactured in Brazil, including by Farmanguinhos, the government-owned medicine producer located at Fiocruz in Rio de Janeiro. But other medicines were available only under monopoly from big pharmaceutical corporations — and their price made the HIV/AIDS treatment program unviable. Brazil threatened to issue compulsory licenses, which would have suspended the patents and allowed cheaper, local production. The corporations responded by caving and lowered their prices. In 2007, the HIV/AIDS treatment program was again threatened by Merck’s monopoly price on efavirenz, a key medicine in the program. When Merck refused to lower prices, then-President Luiz Inácio Lula da Silva issued a compulsory license on the advice of his health minister, José Gomes Temporão. As a result, over the next five years, SUS saved nearly $500 million reals in expenses by buying generic versions of efavirenz for use in the country.
In contrast, Brazil’s experience with sofosbuvir, the first effective treatment for hepatitis C, is tragic. When the medicine first came to market in 2013, it promised to be a lifeline for the more than a million Brazilians suffering from a debilitating and fatal disease with no cure. There was just one problem: The full course of sofosbuvir cost $84,000 in the U.S. and the pharmaceutical giant Gilead Sciences owned the monopoly on the medicine. Gilead offered a discount to SUS, but at $6,000 per course, the price was still 60 times more than the cheapest generic version of the medicine. After a long tussle over the validity of Gilead’s patents — they were challenged multiple times — the corporation eventually won and immediately increased the price of the medicine by 1,421 percent — no, that’s not a mistake. As a result, in the last six years, SUS could only afford to treat a minuscule number of people who have the disease, even as several thousands of others died from it.
Our only access to the one existing treatment for Covid-19 will be entirely dependent on the compassion of a giant multinational pharmaceutical corporation that has shown no sign it has any.
How is this relevant? Consider the antiviral medicine remdesivir, also brought to market by Gilead and originally targeted at Ebola. The U.S. Food and Drug Administration just certified remdesivir for use against Covid-19; it is the first treatment to have been approved. Gilead has multiple patents over remdesivir in 70 countries around the world, including Brazil. These patent monopolies last until the year 2038. Apart from one vague statement, Gilead has not committed to making this medicine affordable or available in sufficient quantity. Instead, early in March, Gilead sought “orphan drug” incentives in the U.S. for the use of remdesivir against Covid-19, which would have given them additional monopolies and tax benefits of $40 million. The word “orphan” in the designation refers to rare diseases that affect less than 200,000 people. Over 3 million people have been infected with the coronavirus. When this was pointed out, Gilead backtracked.
To recap: As things stand, for the next 18 years, our only access to the one existing treatment for Covid-19 will be entirely dependent on the compassion of a giant multinational pharmaceutical corporation that has shown no sign it has any.
WE HAVE TWO ways out of the monopoly trap. The first is a multilateral solution, which depends on a proposal by the World Health Organization coming to fruition. Prompted by Costa Rica, WHO is exploring the creation of a Covid-19 technology “patent pool”: a mechanism by which monopoly producers of protective equipment, tests, medicines, and vaccines could voluntarily suspend their monopolies for global public use. The proposal is gaining steam. However, Brazil’s middle-income status — a senseless category that confuses the needs of a poor majority with the wealth of a rich minority — has meant that it is excluded from a similar arrangement offered by the Medicines Patent Pool, whose benefits only extend to poor countries, regardless of where the disease they are trying to solve is prevalent. A new global patent-pooling solution will only work if it explicitly includes middle-income countries like Brazil.
The second way is a national solution. In this moment, an assertion of sovereignty is the only solution that is guaranteed to work. Countries as diverse as Canada, Germany, Israel, Chile, Peru, and Ecuador have taken swift action in the last few weeks, either suspending key patents or enacting legislation to suspend all monopolies on technologies related to the coronavirus pandemic. Brazil must join them.
Last month, a multiparty group of 11 members of Brazil’s Congress introduced a bill to amend the Industrial Property Law. The proposal builds on existing provisions in Brazilian patent law to respond to the crisis. It would create a fast, simple, and legal process by which the government can deal with the coronavirus pandemic (as well as any other health emergency) by suspending monopolies that affect the lives of its citizens, whether on equipment and tests or medicines and vaccines. The National Health Council — Conselho Nacional de Saúde, or CNS — immediately came out in favor of the bill. Strong international support followed. However, despite a request made in Congress to debate the bill with urgency, hearings have not yet begun.
Pedro Villardi, speaking for Grupo de Trabalho sobre Propriedade Intelectual, one of the civil society organizations that advocated for the bill, explained its purpose: “The point is to increase the government purchase options, with the agility for distribution that a health emergency requires.” Noting the delay, he added, “The approval of this bill is urgent. We need to ensure maximum responsiveness to save lives. Any delay or high prices during times like these is inconceivable.”
This is a time for solidarity, a time for cooperation and care. In order to survive the coronavirus pandemic, Brazil must take decisive steps to protect SUS. We can secure our future by learning from the past. When we have confronted medicine monopolies, we have saved lives, saved money, and improved the human and financial health of the country. And when we have succumbed to pharmaceutical corporations, we have lost lives and damaged the fabric of society. In the long term, there is much more we can do to save our SUS. In the short term, we have a pandemic and a path that leads us out of it. We must take it.