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VIVA MEXICO! Talk about government co-operation! And a new multi-valent mRNA Vaccine is coming to hit the latest variants! One-stop-shop indeed!
And a clear signal the Abivertinib trials went well and COVITRACK IS COMING!
*COVITRACK™: COVID-19 antibody detection diagnostic test for vaccinated people;
*STI-2020 (COVI-AMG™): Affinity matured neutralizing antibody against SARS-CoV-2 for outpatient COVID patients;
*STI-2099 (COVIDROPS™): Intranasal neutralizing antibody version of COVI-AMG for newly diagnosed COVID patients;
*COVISHIELD™: Cocktail of neutralizing antibodies against variants of concern of SARS-CoV-2;
*STI-5656 (Abivertinib): BTK inhibitor for the treatment of acute respiratory distress syndrome (ARDS) in hospitalized COVID patients;
*STI-8282 (COVI-MSC™): Allogeneic mesenchymal stem cells for the treatment of COVID-associated ARDS in severe COVID patients; and
*Multivalent mRNA Vaccines: mRNA-based multivariant vaccines protecting against SARS-CoV-2 virus, Alpha, Beta, Delta and Gamma variants of concern.
Why does Blackrock(the worlds largest asset management company) hold 19.4 million Sorrento shares? Why is the analyst price target $30? Why does Sorrento have the worlds largest Covid portfolios and one of the largest cancer portfolios?
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(approved in China. SRNE holds ROW rights!)
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application(approval in Mexico...25million shipped!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
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 ph.1
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 IND granted in China...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, 20.4 million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS binding arbitration will 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)as 25 million testkits are being shipped. Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
I invested in Sorrento before Covid FOR THE CANCER TREATMENTS! DAR-T is amazing. It is safer than CAR-T and DR,JI said at the Riley Conference that it is "ten-fold or maybe 100-fold more potent."
And they have a dozen different DAR-T ready to go!
"DAR-T technology is readily adaptable to dozens of cancer targets and Sorrento has developed a preclinical product pipeline with specific fully human antibodies discovered from Sorrento’s G-MAB™ library. Sorrento expects to file additional IND applications now that the first DAR-T Phase 1 trial has been cleared to proceed by the FDA."
This is great news for cancer patients and Sorrento investors.
The 4th wave Delta Covid variant has to be confronted! Is there any hope?
Yes... Sorrento antibodies! Effective and can be delivered on an out-patient basis!
"COVIDROPS is administered as a simple intranasal instillation into each nostril to recently infected subjects. The neutralizing antibody drug substance is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection. The antibody is active in vitro and in animal models of COVID-19 infection against the SARS-CoV-2 variants of concern (VoCs) currently infecting the UK and the US, including the highly transmissible and virulent India/Delta variant, as well as the UK/Alpha variant and the original SARS-CoV-2 virus. Sorrento is developing a second neutralizing antibody with potential activity against all VoCs, including the Beta (South Africa) and Gamma (Brazil), for entry into the clinic and is intended for use as a cocktail for both intranasal and intravenous administration to augment the coverage of prevailing VoCs. Variants of interest, such as Lambda (Peru) and others are constantly evaluated in Sorrento’s active surveillance program."
After reading this post I am going out to drive on any side of the road I want, at any speed I want! It may kill a few people but I have my rights! With my face painted blue (like my Scots ancestors) I will shout "FREEDOM"!
For those who like to opine on timing...here's Chucks guess ...
"The final trial endpoint for Brazil is 45 days after last participant dosing. The report on full enrollment was June 22 so the completion target is 2nd week of August for ‘Unblinding’ data for analysis. The US leg ended sooner but has a longer duration.
Analysis of top line data and initial readouts should be available mid to latter August as should SP-102 and some of the AMG, DROPS, and MSC results.
August and September should ROCK!"
Here's a condensed explanation of the use of SOFUSA to fight cancer and inflammatory diseases from the latest patent application!
"The lymphatic system plays an important role in transporting body fluids and particulate materials throughout the body. The lymphatic system comprises several lymph organs (e.g., the spleen and thymus) in addition to lymph nodes, lymph vessels and lymph capillaries. The vessels transport lymph fluid around the body in a single direction in either the superficial vessels or the deep vessels (i.e., the lymphatic vasculature). Drainage begins in blind capillaries which gradually develop into vessels. These vessels then travel through several lymph nodes. The lymph nodes contain both T and B lymphocytes in addition to other cells associated with the immune system. Antigens and other foreign particles are filtered out in the lymph nodes. The lymph vessels eventually end in either the right lymphatic duct which drains into the right internal jugular vein or the thoracic duct which drains into the subclavian vein. It is a one-way system where the lymph fluid (also referred to a lymph) is eventually returned to the circulatory system of the patient.
Transdermal delivery apparatus are capable of administering medicaments at a substantially constant rate over an extended period of time. Some devices are capable of delivering a medicament directly into the lymphatic system of a patient. One such device is the Sofusa.TM. drug delivery platform available from Sorrento Therapeutics, Inc.
Metastasis is thought to be directly or indirectly responsible for more than 90% of all cancer deaths, and the lymphatic system plays a significant role in cancer metastasis. Malignant cells may enter the lymphatic system and are captured by lymph nodes where secondary tumors can be produced. Eventually the whole of the lymph chain can become involved. The lymphatic system is also often involved in the spread of tumors to other parts of the body (i.e., metastasis).... Thus, there is a need to be able to selectively deliver a medicament to specific lymph nodes in order to treat and/or kill malignant cells.
Tumor necrosis factor alpha (TNF-.alpha.) has become a significant therapeutic target in connection with a large variety of medical conditions, including rheumatoid arthritis (RA), juvenile arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis (UC), and Crohn's disease. Multiple drugs that specifically target TNF-.alpha. have received FDA approval.... Because TNF-.alpha. plays an important role in the immune system, altering TNF-.alpha. activity makes a patient more susceptible to secondary infections or some cancers. As such, there is need to develop a dosing regimen or method that maintains a therapeutically effective dose of the therapeutic agent in a patient while reducing the overall patient exposure to the therapeutic agent."
SOFUSA IS BEING TESTED TO DELIVER BOTH ANTI-CANCER AND ANTI-INFLAMATORY DRUGS TO THE LYMPHATIC SYSTEM. Very large underserved need.
50% only because I have seen no data. Cytokine storm is a difficult indication. If it is successful in the Covid cytokine storm indication there are many other very large cytokine storm indications! It would be a huge winner...just as it is in several cancer indications! I have 100% confidence in Abivertinib in cancer indications...look forward to data release on Covid cytokine storm!
I LIKE OUR CHANCES!
1. We should be hearing about Abivertinib's efficacy against Covid cytokine storm in a few weeks. We already have strong evidence of its safety and efficacy in several cancer indications. Based largely on the fact that there is no publicly accessible data on its efficacy against Covid cytokine storm I give it a 50% chance of success.
2. However we have had some early data on the dramatic effects of COVI-MSC in getting severely ill Covid patients out of the hospital within days of treatment. I give COVI-MSC at least an 80% chance of approval.
3. Similarly we have seen COVIDROPS advance in the clinic in several countries with remarkable speed. Surely this is because of solid success in phase one trials. Again I would give COVIDROPS an 80% chance of approval.
4. Meanwhile COVISTIX EUA approval in Mexico and the initial 25 million test shipment is only the beginning. I expect substantial sales in the coming weeks and EUA's in several more countries in the next few weeks.
5. Abivertinib, COVI-MSC, COVIDROPS and COVISTIX are each potential multi-billion dollar technologies. And they are only the beginning. There are more tests and drugs in the pipeline ... some with even greater potential!
I LIKE OUR CHANCES!
This UK study is important. Accurate inexpensive home testing followed by rapid nasal Covidrops would revolutionize Covid treatment and take pressure off hospitals! Looking forward to results!
Sorrento is hiring someone to..."Lead marketing efforts to successfully commercialize Sorrento’s emerging diagnostics portfolio (COVISTIX™, COVITRACE™, COVITRACK™, RESPISTIX™)...
COVISTIX is a highly sensitive rapid antigen test for detecting SARS-CoV-2 that has demonstrated superior sensitivity at low levels of detection. Sorrento is also building a a robust pipeline of additional diagnostic tests, including COVITRACK (SARS-CoV-2 antibody serology test), COVITRACE (RT-LAMP colorimetric test for SARS-COV-2), and RESPISTIX (multiplexed SARS-CoV-2 and Flu A/B test)...
With Sorrento’s capability to rapidly screen and develop highly selective and potent antibodies, it is committed to being a leader in pandemic preparedness, bringing accurate, simple, and low-cost diagnostics to address current and future public health biothreats."
COVISTIX IS ONLY THE BEGINNING. The Mexican COVISTIX EUA is only the beginning. The 25 million shipment of COVISTIX test kits to Mexico is only the beginning. Mexico, Brazil, Latin America, Africa, India, Asia, the UK, Europe and even the US will need these tests! Billions of highly accurate, reasonably priced tests are needed NOW and for years to come!
Updated repost: With the Mexican COVI-STIX EUA approval(and 25 million shipped) and DOD CRADA for 4 potential near term EUA's there's a need for another Sorrento program update! With over 64 programs in the portfolio there is a lot happening investors want to know more about! With Karolinska, Mayo Clinic, Mt. Sinai, ACEA, SmartPharm partnerships and acquisitions Sorrento has become a well-funded world-class holding company! Share price triple digits potential.
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(approved in China. SRNE holds ROW rights!)
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application(approval in Mexico...25million shipped!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
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 IND granted in China...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, 20.4 million shares of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS binding arbitration will 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)as 25 million testkits are being shipped. Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
Despite the fact that India has the largest number of
vaccinated people in the world (over 300 million), that is only 25% single dosed and 7% double dosed! That is not nearly enough to deal with variants, keep the hospitals from being severely overcrowded and far from community immunity. Sorrento Covid portfolio is needed there NOW! I hope they are aware of the huge need in India...a partnership or subsidiary in India is needed. The demand for accurate tests, Covi-Drops and Covi-MSC would be enormous!
The Santa Fe fault lines run very close to San Diego. One big cataclysmic event and San Diego, Sorrento and a lot of southern California could end up in the Pacific ocean ! But I don't invest on possibilities but on probabilities ... and I love Sorrento's portfolio, collaborations, investments and great potential. I simply do not know of a better small biotech! All the best to you in your investment decisions!
With the Mexican COVI-STIX EUA approval(and 25 million shipped) and DOD CRADA for 4 potential near term EUA's there's a need for another Sorrento program update! With over 64 programs in the portfolio there is a lot happening investors want to know more about! With Karolinska, Mayo Clinic, Mt. Sinai, ACEA, SmartPharm partnerships and acquisitions Sorrento has become a well-funded world-class holding company! Share price triple digits potential.
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(approved in China. SRNE holds ROW rights!)
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application(approval in Mexico...25million shipped!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
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 IND granted in China...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% share of Celularity and 35% of ImmuneOncia. These are worth many hundreds of millions and the PSS lawsuit will 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!
Arbitration moved back to November. I invested for the pipeline...the arbitration is only a side-dish IMO!
"Post arbitration hearing rescheduled to 11/30/2021
11/30/2021 at 08:45 AM in Department 14 at 111 North Hill Street, Los Angeles, CA 90012
Post-Arbitration Status Conference
07/21/2021 Stipulation and Order (to Continue Post-Arbitration Status Conference as to All Cases)
Filed by Henry Ji (Cross-Defendant); Sorrento Therapeutics, Inc. (Cross-Defendant)"
Sorrento Announces That Its Subsidiary Levena and Its Partner Escugen Have Received Clearance to Begin Clinical Trials With Anti-TROP-2 Antibody Drug Conjugate For Multiple Solid Tumors
July 21, 2021 at 2:09 PM EDT
Anti-TROP-2 coupled to SN38 (a DNA polymerase inhibitor) (ESG-401) has received approval to begin clinical trials.
ESG-401 addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.
SAN DIEGO, July 21, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today its partner Escugen Biotechnology Co, Ltd. (“Escugen”) and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. (“Levena”) have received an approval letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate.
The TROP-2 ADC (ESG-401) was jointly developed by Shanghai-based Escugen and Levena, and the two companies jointly own the domestic and international patents for this ADC and share global rights for the product.
ESG-401 has potentially distinct differentiating advantages over its competitors in terms of safety, effectiveness and process robustness. Using an innovative, highly stable and cleavable linker, this ADC demonstrated in a series of preclinical studies that it releases very little free toxin during circulation, highly enriches in tumor tissues and rapidly endocytoses, thereby effectively killing tumor cells and inhibiting tumor growth. In the preclinical studies, ESG-401 demonstrated excellent safety, with no off-target or off-tumor toxicity observed in those high-dose, repetitively administered non-human primates. Additionally, ESG-401 showed significant antitumor activity in a variety of tumor models expressing TROP-2, with a low effective dosage and long inhibition time on tumor growth. ESG-401 potentially addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.
Sorrento intends to file a US IND for this ESG-401 before the end of the year.
Current population of India is about 1.4 billion. Africa is 1.3 billion. And Sorrento's ACEA could market to China's 1.44 billion!
WHAT'S THE COVIDROPS POTENTIAL IN INDIA AND AFRICA? Huge need!
Notice the wide international approach and attack on new variants!
"A previously completed safety study conducted in the US at doses up to 60 mg in healthy subjects showed a comparable safety profile to placebo with all reported adverse effects being mild in severity. The UK study will complement Phase 2 trials currently being started in the US and should the results of these studies demonstrate that COVIDROPS is both safe and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the US, UK, Canada, India, Mexico and European Union as well as other territories.
COVIDROPS is administered as a simple intranasal instillation into each nostril to recently infected subjects. The neutralizing antibody drug substance is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection. The antibody is active in vitro and in animal models of COVID-19 infection against the SARS-CoV-2 variants of concern (VoCs) currently infecting the UK and the US, including the highly transmissible and virulent India/Delta variant, as well as the UK/Alpha variant and the original SARS-CoV-2 virus. Sorrento is developing a second neutralizing antibody with potential activity against all VoCs, including the Beta (South Africa) and Gamma (Brazil), for entry into the clinic and is intended for use as a cocktail for both intranasal and intravenous administration to augment the coverage of prevailing VoCs. Variants of interest, such as Lambda (Peru) and others are constantly evaluated in Sorrento’s active surveillance program."
25 million Covi-Stix test kits is a nice start. But the size the Latin American market in 2021 is 616,805,553. For comparison, the size of the US market is 331,500,000. Good times ahead for Sorrento investors!
Dr.Ji at January Riley Conference estimated sales of $5-6 billion...and a huge step to prevent opioid abuse crisis!
"More than 50% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP)9-11 despite the fact that opioids are associated with serious and potentially life-threatening side effects and have not demonstrated efficacy in the treatment of CLBP.11,12,13 In 2018, more than 67,000 drug overdose deaths occurred in the United States14 of which almost 47,000 (70%) were opioid-related. Over 70% of the 70,630 deaths in 2019 involved an opioid.15
“We are anxiously awaiting a new injectable gel formulation of dexamethasone and submission of data to the FDA for the treatment of radicular pain based on the results of a large, randomized, placebo-controlled, multi-center trial. If approved by the FDA, SP-102 would be the first corticosteroid with an indication for epidural administration in the U.S., resulting in rapid pain relief and addressing safety issues with off-label steroid preparations. SP-102 would be a welcome addition to the armamentarium of interventional pain physicians, providing a non-surgical, non-opioid alternative for a condition affecting millions of people,” said Dr. Steven P. Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology, Physical Medicine & Rehabilitation, and Psychiatry & Behavioral Sciences at the Johns Hopkins School of Medicine, and a Professor of Anesthesiology and Physical Medicine & Rehabilitation at Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.
"We are very pleased to have achieved this important milestone and would like to commend the experienced investigators and advisors of the C.L.E.A.R. trial for their persistence and diligence in enrolling sciatica patients through the COVID-19 pandemic and enabling Scilex to achieve a landmark milestone following treatment of 400 sciatica patients in the C.L.E.A.R. trial. The clinical results for the pivotal SP-102 Phase 3 trial may provide encouraging news for the many millions of people worldwide who are confronting painful radicular pain (sciatica) and we look forward to sharing results later this year. We believe that SP-102 could be the first FDA-approved epidural steroid gel injection product for patients suffering from this common, very painful condition,” said Jaisim Shah, President and Chief Executive Officer of Scilex Holding Company.
“SEMDEXA™ is awaited by patients and physicians. The significant contribution of the interventional pain community is helping us with our goal of completing the C.L.E.A.R. trial and obtaining results. If positive, we plan to request a meeting with the US Food and Drug Administration (FDA) by the first half of 2022 to negotiate NDA filing," commented Dr. Dmitri Lissin MD, Chief Medical Officer of Scilex Holding Company.
By 2022, the overall estimated number of epidural steroid injection (ESI) procedures in the U.S. is expected to be 12.1 million across all Medicare and private coverage patients, with lumbar radiculopathy/sciatica procedures comprising approximately 88% of all ESIs administered, according to a proprietary study by Syneos Health. Despite widespread utilization of ESIs, concerns persist in the market about particulate steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. As a result, a significant unmet medical need exists within the market for a potent, non-particulate ESI formulation that demonstrates safety and effectiveness in controlled clinical trial evaluations.7
In the U.S., more than 30 million people live with low back and radicular pain, with this population expected to grow as the overall population ages.1,2 Many patients experience moderate to severe pain with intolerance of and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs).3,4 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.2 Opioid prescriptions account for about 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternate pain therapies without the medical and societal challenges.2,5
Chronic pain affects 116 million Americans and costs the U.S. as much as $635 billion each year, according to a recent report from the Institute of Medicine (IOM) that called for changes in how chronic pain is managed6 and nearly 30 million patients suffer from lower back pain in the U.S.8 Government agencies, physicians, patients, and payers are looking for alternatives to opioids to reduce the risk of dependency or addiction, and serious side effects (such as respiratory depression and constipation), while still offering potent solutions for people living with chronic pain."
REMICADE BIOBETTER APPROVED IN CHINA. SORRENTO US AND RIGHTS WORTH BILLIONS.
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(approval in China. Sorrento has US and Europe rights)
7. SP-102 sciatica
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application(approval in Mexico!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
10. Abivertinib prostate cancer ph.2 IND
11. Abivertinib Lupus ph.2 IND
12. Abivertinib hairy cell leukemia
13. CD47 partnered
I am not selling a single share of Sorrento if we get the lawsuit results on Thursday...or two weeks from Thursday! There is far too much Covid, pain and cancer news coming over the next month or two. I won't sell anything for less than triple digits!
Overview of the company from the latest Sorrento Prospectus ...
"At our core, we are antibody-centric and leverage our proprietary G-MAB™ library and targeted delivery modalities to generate the next generation of cancer therapeutics. Our fully human antibodies include PD-1, PD-L1, CD38, CD123, CD47, CTLA-4, CD137 and SARS-CoV-2 neutralizing antibodies, among others. We also have programs assessing the use of our technologies and products in autoimmune, inflammatory, viral and neurodegenerative diseases.
Our vision is to leverage these antibodies in conjunction with proprietary targeted delivery modalities to generate the next generation of cancer therapeutics. These modalities include proprietary chimeric antigen receptor T-cell therapy, or CAR-T, dimeric antigen receptor T-cell therapy, or DAR-T, antibody drug conjugates, or ADCs, as well as bispecific antibody approaches. We acquired Sofusa®, a drug delivery technology, in July 2018, which delivers biologics directly into the lymphatic system to potentially achieve improved efficacy and fewer adverse effects than standard parenteral immunotherapy. Additionally, our majority-owned subsidiary, Scilex Holding Company, acquired the assets of Semnur Pharmaceuticals, Inc., or Semnur, in March 2019. Semnur’s SEMDEXATM (SP-102) compound has the potential to become the first Food and Drug Administration, or FDA, -approved epidural steroid product for the treatment of sciatica. In response to the global SARS-CoV-2, or COVID-19, pandemic, we are utilizing the Bruton’s tyrosine kinase, or BTK, inhibitor (which we acquired from ACEA Therapeutics, Inc.) in a U.S. Phase II study of cytokine storm associated with a COVID-19 infection and in a Phase II trial in Brazil in mild, moderate and severe COVID-19 patients. We are also internally developing potential coronavirus antiviral therapies and vaccines, including ACE-MABTM, COVIDTRAPTM, COVI-MABTM, COVIGUARDTM, COVISHIELDTM, COVI-AMGTM and T-VIVA-19TM; and diagnostic test solutions, including COVITRACKTM, COVISTIXTM and COVITRACETM.
With each of our clinical and pre-clinical programs, we aim to tailor our therapies to treat specific stages in the evolution of a disease, from elimination, to equilibrium and escape. In addition, our objective is to focus on tumors that are resistant to current treatments and where we can design focused trials based on a genetic signature or biomarker to ensure patients have the best chance of a durable and significant response. We have several immuno-oncology programs that are in or near to entering the clinic. These include cellular therapies, oncolytic viruses (SeprehvecTM) and a palliative care program targeted to treat intractable cancer pain. Our cellular therapy programs focus on CAR-T and DAR-T for adoptive cellular immunotherapy to treat both solid and liquid tumors.
From the start of the COVID-19 pandemic, our mission has been to leverage our deep expertise in developing targeted antibodies for cancer immunotherapy to create best-in-category treatments and diagnostics to ease suffering and assist in the global response to COVID-19. We have leveraged, and continue to leverage, our G-MAB library and antibody development engineering capabilities to advance a number of promising diagnostics and neutralizing antibody candidates to test and treat COVID-19 and the immune reactions associated with SARS-CoV-2 infection.
Our first generation SARS-CoV-2 neutralizing antibody was STI-1499 (COVIGUARDTM), which was engineered to prevent antibody dependent enhancement. This antibody was then optimized to produce the highly potent STI-2020, which is currently being developed in two outpatient formations: COVI-AMG (IV-push injection) and COVIDROPS (nasal). COVI-AMG has been cleared by the FDA for a Phase I study of healthy volunteers, a Phase II study in outpatients with COVID-19 and a Phase II study in hospitalized patients with moderate or severe COVID-19, and we are awaiting FDA clearance for a Phase I study of COVIDROPS of healthy volunteers and patients with mild COVID-19. Sorrento also has developed two promising potential rescue treatments with Abivertinib, an oral next generation dual EGFR/BTK inhibitor, to treat moderate to severe hospitalized COVID-19 patients and COVI-MSC™, a human allogeneic adipose-derived mesenchymal stem cells for patients suffering from COVID-19-induced acute respiratory distress (ARD). Both have been cleared by the FDA and are in Phase Ib clinical studies. We are also working with Brazilian regulators (ANVISA) to conduct a COVID-19 study with Abivertinib and potentially with COVI-AMG TM. In pre-clinical development, we are rapidly screening new neutralizing antibodies to address the multiple emerging variants of SARS-CoV-2 to potentially add to STI-2020 in a cocktail (COVISHIELDTM) and exploring novel mechanistic approaches such as soluble recombinant fusion protein traps (COVIDTRAPTM) to potentially inhibit the binding of SARS-CoV-2’s spike protein with host ACE2 receptors, thereby potentially preventing viral cell entry.
In furtherance of our goal to develop products across the entire continuum of COVID-19 solutions, we are further developing a number of highly sensitive and rapid diagnostic tests. COVI-STIX™ is a lateral flow antigen test that uses a proprietary platinum-based colloid and antibody combination, resulting in high sensitivity and accuracy. This is a simple and rapid (15-minute) test with a shallow nasal swab and is designed for point-of-care and at-home use. COVI-TRACK™ is a rapid SARS-CoV-2 IgG/IgM antibody test kit intended for use initially in clinical laboratories and in point of care settings to quickly identify individuals with anti-SARS-CoV-2 antibodies post-infection or post-vaccination. COVI-TRACE™ was licensed from Columbia University as a rapid single step on-site colorimetric detection test for SARS-COV-2 genomic RNA from a saliva sample using targeted nucleic acid amplification for high throughput point-of-care situations.
We have reported early data from Phase I trials of our carcinoembryonic antigen, or CEA, -directed CAR-T program. We have treated five patients with stage 4, unresectable adenocarcinoma (four with pancreatic and one with colorectal cancer) and CEA-positive liver metastases with anti-CEA CAR-T. We successfully submitted an Investigational New Drug application, or IND, for anti-CD38 CAR-T for the treatment of refractory or relapsed multiple myeloma, or RRMM, obtained clearance from the FDA and commenced a human clinical trial for this indication in early 2018. We have dosed eleven patients. We intend to close this study to further enrollment and start up a similar anti-CD38 CAR-T construct without the myc-tag (which cannot be used in Europe), and to continue treating RRMM patients in a Phase Ib/IIa study, which will begin enrollment in the first quarter of 2021. We filed INDs for our CD47 mAb and the first of our DAR-T platform product candidates in the first quarter of 2021.
Broadly speaking, we believe we are one of the world’s leading CAR-T and DAR-T companies today due to our investments in technology and infrastructure, which have enabled significant progress in developing our next-generation non-viral, “off-the-shelf” allogeneic DAR-T solutions. With “off-the-shelf” solutions, DAR-T therapy can truly become a drug product platform rather than a treatment procedure.
With respect to our ADC program, we began enrolling patients in the first quarter of 2021 in a Phase Ib ascending dose study of our CD38 ADC for systemic Amyloid light-chain amyloidosis. Based upon our recently announced exclusive license from Mayo Clinic for its antibody-drug-nanoparticle albumin-bound (ADNAB) platform, the next generation in ADC technology, we intend to file several INDs to treat various cancer targets.
Outside of immuno-oncology programs, as part of our global aim to provide a wide range of therapeutic products to meet underserved markets, we have made investments in non-opioid pain management. These include resiniferatoxin, or RTX, which is a non-opioid-based toxin that specifically targets transient receptor potential vanilloid-1, or TRPV1, which, depending on the site of injection, can ablate, or destroy, nerves expressing TRPV1 or temporarily defunctionalize them. TRPV1 is responsible for the noxious chronic and inflammatory pain signaling that occurs post injury or trauma, but leaves other nerve functions intact. RTX has been granted orphan drug status for the treatment of intractable pain with end-stage cancer and two Phase Ib trials (intrathecal and epidural routes) in that indication have or will soon be completed. A Phase Ib trial studying tolerance and efficacy of RTX for the control of moderate to severe osteoarthritis knee pain was initiated in late 2018 and intermediate results have shown efficacy with no dose limiting toxicities. The osteoarthritis trial enrolled the last patient in the first quarter of 2020, and we expect to release the final safety clinical data by the middle of 2021. We plan to start knee arthritis registrational trials after the completion of required preclinical studies.
Also, in this area, we have developed in-house and acquired proprietary technologies to responsibly develop next generation, branded pharmaceutical products to better manage patients’ medical conditions, maximize the quality of life of patients and assist healthcare providers. The flagship product of our majority-owned subsidiary, Scilex Pharmaceuticals Inc., or Scilex Pharma, ZTlido® (lidocaine topical system 1.8%), or ZTlido, is a next-generation lidocaine delivery system, which was approved by the FDA for the treatment of postherpetic neuralgia, a severe neuropathic pain condition, in February 2018, and was commercially launched in October 2018. Scilex Pharma has now built a full commercial organization, which includes sales, marketing, market access and medical affairs. ZTlido has demonstrated superior adhesion in comparative head-to-head studies as compared to Lidoderm and is manufactured by our Japanese partner in their state-of-the-art manufacturing facility.
With the Mexican COVI-STIX EUA approval and DOD CRADA for 4 potential near term EUA's 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!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
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!
Should we be excited about the potential PSS settlement ...be it half a billion or $1 and 1/2 billion? The reason I like it is because it will fund the large cancer program. SP-102 will soon bring in billions as will the Covid portfolio . But the PSS settlement will provide an excellent cash base to accelerate the cancer program NOW! CAR-T, DAR-T, ADNAB, DAR-NK and plasmid DNA all are world-class innovative programs. I look forward to their addition to the Abivertinib cancer franchise!
HC Wainwright Reiterates Buy Rating for Sorrento Therapeutics (NASDAQ:SRNE)$30 target
Wednesday, July 7, 2021 | MarketBeat
Sorrento Therapeutics (NASDAQ:SRNE)'s stock had its "buy" rating restated by investment analysts at HC Wainwright in a research note issued to investors on Wednesday, TipRanks reports. They currently have a $30.00 target price on the biopharmaceutical company's stock. HC Wainwright's target price suggests a potential upside of 255.03% from the company's current price.
Time to Join Sorrento Therapeutics on its Next Leg Up
Shares of NASDAQ:SRNE traded down $1.05 during trading on Wednesday, hitting $8.45. 373,191 shares of the stock were exchanged, compared to its average volume of 8,720,759. Sorrento Therapeutics has a 1-year low of $5.17 and a 1-year high of $19.39. The stock has a market capitalization of $2.51 billion, a P/E ratio of -8.89 and a beta of 2.37. The company has a fifty day moving average price of $8.22. The company has a quick ratio of 2.75, a current ratio of 2.77 and a debt-to-equity ratio of 0.35.
Sorrento Therapeutics (NASDAQ:SRNE) last announced its quarterly earnings data on Wednesday, May 5th. The biopharmaceutical company reported $0.01 earnings per share for the quarter, missing the Thomson Reuters' consensus estimate of $0.24 by ($0.23). Sorrento Therapeutics had a negative return on equity of 133.68% and a negative net margin of 496.04%. The firm had revenue of $14.26 million for the quarter, compared to analyst estimates of $17.25 million. As a group, analysts forecast that Sorrento Therapeutics will post 1.59 earnings per share for the current year.
Is Sorrento Therapeutics (NASDAQ:SRNE) More Than Just A COVID-19 Play
Several large investors have recently made changes to their positions in SRNE. BlackRock Inc. boosted its stake in Sorrento Therapeutics by 10.2% in the 1st quarter. BlackRock Inc. now owns 19,409,333 shares of the biopharmaceutical company's stock valued at $160,515,000 after buying an additional 1,789,655 shares in the last quarter. JPMorgan Chase & Co. boosted its stake in Sorrento Therapeutics by 74.9% in the 1st quarter. JPMorgan Chase & Co. now owns 2,383,287 shares of the biopharmaceutical company's stock valued at $19,709,000 after buying an additional 1,020,991 shares in the last quarter. Schroder Investment Management Group acquired a new stake in Sorrento Therapeutics in the 1st quarter valued at $3,567,000. Geode Capital Management LLC boosted its stake in Sorrento Therapeutics by 11.7% in the 1st quarter. Geode Capital Management LLC now owns 4,054,313 shares of the biopharmaceutical company's stock valued at $33,529,000 after buying an additional 423,072 shares in the last quarter. Finally, Citigroup Inc. boosted its stake in Sorrento Therapeutics by 393.2% in the 1st quarter. Citigroup Inc. now owns 483,066 shares of the biopharmaceutical company's stock valued at $3,995,000 after buying an additional 385,115 shares in the last quarter. 26.90% of the stock is currently owned by institutional investors.
Sorrento Therapeutics Company Profile
Sorrento Therapeutics (NASDAQ:SRNE) Quietly Moves Higher On COVID News
Sorrento Therapeutics, Inc, a clinical stage and commercial biopharmaceutical company, develops therapies for cancer, autoimmune, inflammatory, viral, and neurodegenerative diseases. It operates through two segments, Sorrento Therapeutics and Scilex. The company provides cancer therapeutics by leveraging its proprietary G-MAB antibody library and targeted delivery modalities, which include chimeric antigen receptor T-cell therapy (CAR-T), dimeric antigen receptor T-cell therapy, and antibody drug conjugates, as well as bispecific antibody approaches; and Sofusa, a drug delivery technology that delivers biologics directly into the lymphatic system.
Here's what the company website says about RTX...
"RTX (resiniferatoxin) is a unique neural intervention molecule that is highly selective and may be applied peripherally (e.g., nerve block, intra-articular) or centrally (e.g., epidural), to control chronic pain across multiple conditions including arthritis and cancer.
RTX has the potential to be a first-in-class drug addressing currently intractable pain in a novel and unique way, by targeting the nerves responsible for the chronic debilitating pain signal transmission.
RTX strongly binds to TRPV1 receptors and forces open calcium channels located in the end-terminal of the nerve or the soma of the neuron (depending upon the route of administration). This in turn generates a slow and sustained cation influx that rapidly leads to the deletion of TRPV1-positive cells.
RTX directly interacts with afferent nerve cells without affecting sensations such as touch, pressure, acute prickling pain, vibration sense or muscle coordination function.
Administration at the peripheral nerve ending results in a sustained temporal effect to treat pain associated with arthritis of the knee.
RTX can potentially help patients with terminal cancer pain, after a single epidural injection, by permanently blocking the pain signal transmission from the tumor tissue to the dorsal root ganglion (DRG) in the spinal cord, without the undesirable side effects associated with high and repeated doses of opioids. If opioids remain part of the therapeutic arsenal for these patients, RTX has the potential to significantly reduce the amount and frequency of opioid use.
RTX has been granted Orphan Drug Status by the US Food and Drug Administration for the treatment of end-stage diseases, including intractable cancer pain.
Sorrento has successfully completed a positive Phase Ib clinical proof of concept trial with the National Institutes of Health under a Cooperative Research and Development Agreement (CRADA) which showed improved pain and reduced opioid consumption after intrathecal administration (directly into the spinal cord space).
The company will be initiating pivotal studies in 2020 and is aiming for an NDA filing in 2022."
Sorrento is ready for a historic short squeeze! With the Mexican COVI-STIX EUA approval and DOD CRADA for 4 potential near term EUA's it's time for another Sorrento program update! With over 65 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!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
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 (39+ 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. Salicyn 30 oral antiviral
38. 1,000,000+ small molecule library
39. 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 could be settled July 22 with potential Billion dollar 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 owns 20% of Celularity. IPO expected in Q3.
Celularity Announces Expansion of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) Phase 1 Trial in Patients with Acute Myeloid Leukemia
06/29/2021 | 08:26am EDT
No dose limiting toxicity to date with outpatient administration of three doses (Days 0, 7 and 14) at total dose levels of 1.8, 3.6, and 5.4 Billion CYNK-001 cells, respectively
Achievement of minimal residual disease (MRD) Negative status at highest CYNK-001 cell dose level with documented persistence of CYNK-001 cells in bone marrow and peripheral blood at 28 days post Day 0 Infusion
Will Expand Phase 1 Trial to begin in Relapsed Refractory AML and to continue CYNK-001 dose escalation in both patient cohorts of MRD Positive and Relapsed Refractory AML
FLORHAM PARK, N.J., June 29, 2021 (GLOBE NEWSWIRE) -- Celularity Inc. (“Celularity”), a clinical-stage biotechnology company leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum human placenta, today announced expansion of its ongoing Phase 1 clinical trial of CYNK-001 in AML (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients with MRD.
“The absence of dose limiting toxicity to date in the Phase 1 trial enables us to continue with our scheduled dose escalation and to expand the trial to include patients with r/r AML,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “In addition, the demonstrated ability to deliver a total NK cell dose of 5.4 billion cells in the outpatient setting without dose limiting toxicity and the observation of achieving a conversion from a MRD positive to MRD negative state on bone marrow examination with CYNK-001 cells persisting in bone marrow and blood at 28 days after Day 0 infusion, is compelling and supports our trial dose escalation and indication expansion.”
• The patient that received a total of 5.4 billion CYNK-001 cells in the outpatient setting without a dose limiting toxicity and experienced conversion from MRD positive to MRD negative on bone marrow exam had good risk cytogenetics, NPM-1 positive FLT-3 negative AML. After failing primary induction with 7 + 3 chemotherapy, second induction followed by high dose ARA-C consolidation resulted in a complete clinical response, but persistent MRD that did not clear despite over 4 months of azacytidine therapy. After a washout period from azacytidine, MRD persistence was confirmed on a marrow biopsy and the patient entered trial and received lymphodepletion followed by outpatient administration of 1.8 billion CYNK-001 cells on Days 0, 7 and 14 (a total of 5.4 billion CYNK-001 cells). A bone marrow assessment performed on day 28 confirmed conversion from a MRD positive to a MRD negative state, and CYNK-001 cells on Day 28 were present in both bone marrow and peripheral blood.
• In six total patients enrolled, there have been no dose limiting toxicities observed at any dose level to date including total dose levels of 1.8, 3.6 and 5.4 billion CYNK-001 cells.
• Upon completion of the 5.4 billion total dose level cohort, Celularity intends to continue dose escalation in the MRD indication to 9.0 billion total CYNK-001 cells and to expand to include patients with r/r AML.
• To further enhance CYNK-001 persistence, the expansion arms in MRD and r/r AML will include an augmented lymphodepletion protocol of Cytoxan 3600 mg divided over 4 days (versus current 900 mg divided over 3 days) and fludarabine 120 mg divided over 4 days (versus current 75 mg divided over 3 days) to increase post lymphodepletion IL-15 levels and to add subcutaneous IL-2 (6 million international units administered sub-cutaneous for 7 doses every other day starting with Day 0 infusion of CYNK-001).
About CYNK-001
Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. CYNK-001 is a cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
About Celularity
Celularity, headquartered in Florham Park, N.J., is a clinical-stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including unmodified NK cells, genetically modified NK cells, T cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs) targeting indications across cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures biomaterials derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.
In January 2021, Celularity entered into a definitive merger agreement with GX Acquisition Corp. to create a publicly listed leader in allogeneic cellular therapy. GX Acquisition Corp. is listed on Nasdaq under the ticker symbol “GXGX.” Upon closing of the business combination, expected to be completed in the third quarter of 2021, shares of the combined company will be listed on Nasdaq under the ticker symbol “CELU.”
Dawson James Executive Managing Director Jason Kolbert reports on Sorrento's continuum of care.
"The Treatment of COVID-19 Requires Understanding Immune Status – Prevention, Arresting Progression, and Reversal.
When looking to treat a complex disease, such as COVID-19, which involves multiple systems in the human body, one
must have the tools to evaluate each patient as an individual, as well as understand the stage of the disease and the
immune status of the patient, according to Dr. Henry Ji, chairman of the board and CEO of Sorrento Therapeutics. Doing
so, Dr. Ji said, will impact the therapeutic approach, which may range from preventive therapies, monitoring diagnostics
that move beyond binary diagnostics (yes – positive, no – negative but what, where and how much), acute intervention
(arrest and control), and later stage rescue therapies (reverse and repair).
With these concepts in mind, Sorrento Therapeutics is approaching the development of solutions for COVID-19. Sorrento
is leveraging its understanding of the activated immune pathways and their subsequent interactions with organ systems
by understanding the fingerprints associated with biochemical markers at various stages of the disease.
Sorrento’s approach begins with COVI-STIX, a rapid antigen detection system to reveal the incidence of the SARS-CoV-2
virus. This quick test (two to five minutes) determines the presence of viral antigens, with a high degree of specificity
and accuracy. If a patient is positive and in the early stages of infection, Sorrento believes that the administration of a
neutralizing antibody that can bind to the virus, arrest replication and signal the body’s immune system to prevent further
damage and eliminate the infectivity of the virus (so that the patient cannot transmit the virus to others).
Sorrento is evaluating this approach with three distinct modes of administration: intravenous drip, intravenous push and
nasal drops. Each approach has certain nuances and, as such, allows the treatment to be tailored based on the patient’s
immune status as a result of viral exposure.
Intravenous infusion is a slow and gradual introduction that can be adjusted over time based on the
patient’s changing immune status. Rapid intravenous push (two to five minutes) allows a defined
dose to be rapidly administered. Intranasal drops block virus replication in the cells of the nose’s
epithelial layer, thus preventing it from entering and spreading to the lungs.
Sorrento is even working on a novel way to prevent infection and transmission of the virus
through the use of DNA plasmids. The encoded plasmid (genetic material) is directly
introduced into the patient’s muscle cells. These cells then learn how to express a neutralizing
antibody to the target viral mutant strain(s). Such treatments can also be based on multiple
antibodies, which will allow a patient’s body to express neutralizing antibodies that block
multiple variants.
We can see how this approach, an armamentarium of physician options, allows the treatment of
patients across the disease continuum associated with COVID-19. For example, if a patient is
already infected and develops the disease in a mild to moderate form, they could be tested as an
outpatient via rapid home antigen testing and then referred via telemedicine for Sorrento’s intranasal
agent or intravenous push treatment.
For a patient with moderate to severe symptoms, the therapeutic goals can be adjusted. Here, the goal is to prevent
the much-talked-about cytokine storm. For these patients, Sorrento has developed an oral Bruton tyrosine kinase (BTK)
inhibitor which is now in clinical trials in the U.S. and Brazil. If successful, this treatment could lead to quick discharge
times for hospitalized patients.
Lastly, for patients with severe COVID-19 who require mechanical ventilation in an ICU, Sorrento is developing a rescue
therapy that will build on all of the prior agents and enhance the body’s natural ability to fight infection while stopping the
infection’s deleterious effects on an over-stimulated immune system. This novel approach utilizes mesenchymal stem
cell (MSC) therapy derived from adipose tissue and is being evaluated at three doses. This treatment has already shown
exciting results from early clinical trials.
Sorrento believes that in the case of COVID-19, each patient is unique in the way his or her immune system interacts
with the virus. Through an assortment of therapeutic options, the spectrum of COVID-19 diseases can be prevented,
halted and reversed."
I like this summary of Sorrento's future by Paul. "Whatever right or wrongs, the vaccines became caught up in a political tug of war. What a shame. Either way, the vaccines were never an end all. As long as a majority of the world is unvaccinated, which in all honesty was going to happen no matter what, the virus was going to spread and multiply in variants.
Covidrops is less costly, easier to use, less drama in regards to refrigeration, no taking up hospital beds, easy for kids to take, and those vehemently against vaccines, etc, etc, etc… Plus because of potency, less batches, more cost efficient. Damn I could go on and on. The world will want to order it, and as much as the FDA wants to hand big pharma’s this on a platter as well, Sorrento has the best in class therapeutic. Hence CARDA, and Trials in UK, US, and Mexico. This one item will make Sorrento multi billions in sales yearly for the foreseeable future.
But of course Sorrento is not a one trick pony. Many items of their Covid pipeline will receive EUA (Just ask the DOD (Navy)). Plus we have Blockbuster (SP102–Fast Track) and Super Blockbuster (Abivertinib-NSCLS) that will be approved no later then first quarter next year. RTX (Cancer-Orphan Status), which is another Super Blockbuster could get approval as early as last quarter next year. Super Blockbuster is considered $10B plus folks. Know what you own, and thank the stupidity (yes I said it) of the uninformed and greedy for keeping this wonderful diamond of a company’s SP down through manipulation. The institutional investors weren’t the only ones to raise their shares. Right my fellow long investors? "
Sorrento Receives EUA Approval and Import License From Mexico Authority COFEPRIS For COVI-STIX™ (COVID-19 Virus Rapid Antigen Detection Test) and Plans Product Launch With Initial Shipments in July
June 24, 2021 at 1:13 PM EDT
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Sorrento received official EUA registration and product import license: COFEPRIS EUA registration number “OFICIO: CAS/10720/2021”.
Sorrento is establishing its “Sorrento Mexico Ltd” subsidiary to enable commercialization of COVI-STIX™ and future COVID-19 related products in the country.
Sorrento expects the first shipments for initial COVI-STIX test orders to be delivered in July.
SAN DIEGO, June 24, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that following its receipt of EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number “OFICIO: CAS/10720/2021”, it is establishing a local “Sorrento Mexico Ltd” subsidiary to manage commercial operations in Mexico.
COVI-STIX is a sensitive and 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"). COFEPRIS issued Emergency Use Authorization (EUA) approval and an importation permit for COVI-STIX on June 14, 2021.
Sorrento will commercially launch the COVI-STIX test in Mexico with the first shipments expected to be delivered in July.
With the Mexican COVI-STIX EUA approval and DOD CRADA for 4 potential near term EUA's 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!)DOD CRADA
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 DOD CRADA
4. COVIDROPS EUA potential DOD CRADA
5. Covi-Track EUA pre-validation DOD CRADA
6. PD-L1 partnered
7. Herceptin delivery partnered
8. Abivertinib Lymphoma
9. Abivertinib Covid 19 EUA potential as soon as August
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 has eight (8) potential Covid Emergency Use Authorization candidates...all Blockbusters!... revenue THIS YEAR beginning with Mexico. US Department of Defense funding and/or collaboration(CRADA)for 5 programs! Here's a partial overview.
1. Covi-Stix rapid accurate virus test(EUA granted MEXICO, more coming soon)DOD CRADA
2. Covi-Track rapid accurate antibody test DOD CRADA
3. Covi-push 2020 injection DOD CRADA
4. Covi-Drops 2020 nose drops(trials in US, UK and Mexico)DOD CRADA
5. Covi-Vax 2020 lipid DNA injection($34 million DARPA funding)
6. Abivirtinib ARDS prevention(Brazil and US results as soon as August)
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. NOW A MULTI-YEAR DOD CRADA for 4 of these programs!
FIRST there's a $34 million grant from DARPA to develop COVI-PLASMID DNA.
NOW a multi-year deal with another branch of DOD for four more programs. "Initial focus of the collaboration is to improve infectious disease readiness through surveillance and clinical diagnostic validation activities for COVISTIX/COVITRACK Diagnostic Tests and COVIDROPS/COVI-AMG neutralizing antibody treatments for COVID-19 patients."
This is a clear sign that the DOD has done due diligence and like what they see. This is only the beginning of a growing relationship.
Sorrento has Covid covered! All are phase 2(where most EUA's are granted)
COVISTIX for early rapid detection.(Mexican EUA granted)
COVIDROPS for early intervention.
Abivertinib to prevent cytokine storm.
COVI-MSC to ensure rapid and healthy recovery from ARDS.
ARD-301 to treat long haul Covid.
No other company(large or small) has this complete program.
If Sorrento has the answer to Covid cytokine storm it is huge news! NEARLY 500 PATIENTS, IF POSITIVE, WOULD MEAN POTENTIAL EUA!
"Closing enrollment for both studies is a significant milestone. IN TWO TO THREE MONTHS the company expects to be able to disclose top-line data. If positive, the results of the two parallel and independently run clinical trials should provide valuable insights into the ability of Abivertinib to help patients with pulmonary distress associated with cytokine storm induced by COVID-19.
“We are very satisfied with the progress made by our team and we are eager to review the results of these two parallel trials,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “By combining our efforts in the US and Brazil, we were able to optimize patient exposures, reduce clinical trial costs, explore the potential benefits of two promising therapeutic regimens, and most importantly, accelerate data generation for regulators to assess the use of Abivertinib in COVID-19 patients with the potential of seeking an emergency use request(EUA!).”
Sorrento is developing COVIDROPS which will be the intranasal formulation of COVI-AMG™. WHY ARE PHASE 2 TRIAL OF COVIDROPS PROCEEDING SO RAPIDLY IN SO MANY JURISDICTIONS? Here's what Sorrento says...
"A few highlights of the preclinical animal data from the most recent STI-2099 study include:
Intravenously-dosed animals recovered from the infection with noticeable differences in weight loss between the Control IgG and COVI-AMG-treatment groups reaching a maximum at Day-5 after infection.
Intranasally-COVIDROPS-treated animals remarkable showed evidence, as early as Day-2 into the experiment, of prevention of disease progression with limited weight loss in the very early stages of infection and reduced duration of disease symptoms as compared to COVI-AMG IV-treated animals.
Current neutralization antibodies in development(by other companies) are administered in large amounts that require infusions over several hours in a hospital setting.
Sorrento’s intravenous COVI-AMG nAb (STI-2020) may require only an intravenous slow push(2 minutes) due to the high potency demonstrated in animal models to date.
Intranasal COVIDDROPS (STI-2099) may be able to be administered as simple intranasal drops, which would avoid the need for IV infusion or injection and a hospital visit for treatment."