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Here is an interesting article about Sorrento's COVI-MSC! The pivotal Brazil phase 2 is complete...news any day.
UCSF Fresno Study: Stem Cell Treatment Aids COVID Patients with Damaged Lungs
A UCSF Fresno study of the safety and efficacy of adipose-derived stem cells as a potential treatment for COVID -19 patients who have serious lung damage has shown promising benefits and has prompted further study internationally and at UCSF Fresno.
UCSF Fresno was selected as the only site for the phase 1 of this study, COVID-19 Stem Cell Therapy: A Phase 1 Study of Intravenous Administration of Allogenic Adipose Stem Cells. The study, led by Eyad Almasri, MD, a faculty member at UCSF Fresno, enrolled 10 patients with acute respiratory distress syndrome (ARDS) who had moderate or severe illness. Each received three intravenous infusions of stem cells on three separate days.
These COVID-19 patients all had serious and life-threatening ARDS and were struggling to breathe. With ARDS, tiny air sacs in the lungs fill up with fluid, reducing the lungs’ ability to transport oxygen into the blood. And in severe cases, the body’s immune system responds by flooding the lungs with inflammatory cells and proteins, further restricting passage of oxygen into the blood and to organs.
The hope is the adipose stem cells, collected from an adult donor, will reduce lung inflammation when infused in a patient. Studies have shown allogenic mesenchymal stem cells (MSC) — adult stem cells that are present in bone marrow but can also be obtained from fat tissue — may be effective at stopping an inflammatory overreaction (called a cytokine storm) in the lungs. MSC cells “work like a sponge to absorb the inflammatory proteins and reduce the inflammation cascade in the lung,” said Dr. Almasri, a UCSF associate clinical professor and faculty member at the Department of Internal Medicine — Pulmonary and Critical care and Sleep Medicine who also serves as the assistant dean for research at UCSF Fresno.
Patients for the study were chosen who were not on mechanical ventilation yet but whose lung functions were severely compromised by ARDS. “This was presented as a potential option for people who are not improving or people who are getting worse quickly,” Dr. Almasri said.
No Deaths Among Study Participants
Mortality for patients with severe ARDS who require mechanical ventilation is as high as 39%. The expected mortality for patients with moderate ARDS is 20-30% and of the 10 patients with ARDS enrolled in the UCSF study, two or three would be expected to die, Dr. Almasri said.
“We had no deaths,” he said. All 10 patients were discharged from Community Regional Medical Center after completing treatment with stem cells and were followed for three months. “Our last patient just passed his 90-day safety check,” he said.
A 53-year-old from Fresno was one of 10 patients enrolled in the UCSF Fresno Phase 1 stem cell study. The patient thought a cough that wouldn’t go away at New Year’s was the flu, but a test for COVID-19 came back positive and within days the virus had attacked his lungs. He couldn’t breathe, even on home oxygen borrowed from his mother. His family called for an ambulance and he was taken to Community Regional.
The patient had no hesitation about joining the UCSF Fresno stem cell study. “I’ll do anything. I’m trying to get better. And anything that might work for me is good,” he said.” Three days after the stem cell infusions, his oxygen requirement dropped from 6 liters per minute to 2 per minute and he was sent home on 2 liters of oxygen.
The swift turnaround surprised the research team, Dr. Almasri said. “He had very clear, quick and more than expected improvement.”
Dr. Almasri cautioned the UCSF Fresno study is a small sample and conclusions cannot be drawn from it because it could be pure chance. “But the mortality was lower than what we would have expected,” he said.
Phase 2 of Study Gets Green Light
Results from the UCSF Fresno study have sparked interest among other researchers. Based on two case studies from the UCSF Fresno clinical trial presented to the U.S. Food and Drug Administration and from testimony by Dr. Almasri before the Brazilian Health Regulatory Agency, a Phase 2 COVID-19 stem cell clinical trial won approval to begin in Brazil this June.
Evidence from the Phase 1 trial at UCSF Fresno also was enough for the Food and Drug Administration to give a green light to UCSF Fresno to submit a proposal for a Phase 2 clinical trial that will be a double-blinded randomized study, meaning some patients will receive stem cell infusions and others will receive a placebo. Dr. Almasri and the research team will not know which patients receive the stem cells.
The Phase 2 stem cell study is one of the latest in a string of COVID-19-related research projects at UCSF Fresno. Many of the studies have been led by Dr. Almasri and others at UCSF Fresno.
This July 2021 press release says SEMDEXA already has FAST TRACK designation. And they expected all data would be available in Q4 2021. The Breakthrough Designation request is something new! They KNOW they have great data...and are acting accordingly.
Scilex Holding Company, a Sorrento Company, Announces Complete Enrollment on Non-Opioid Injectable SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program For Sciatica Pain Management
July 20, 2021 12:53 ET | Source: Sorrento Therapeutics, Inc.
Scilex Holding Company, a commercial-stage, non-opioid biopharmaceutical pain management company, announced complete enrollment of its SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program for its novel, non-opioid, corticosteroid formulation, injectable dexamethasone sodium phosphate viscous gel product for the treatment of lumbosacral radicular pain (sciatica). SP-102 has received Fast Track status from the FDA. Top-line data from the study is expected in Q4 2021.
Previous Phase 1/2 trial data supported preclinical results, confirming an extended product residency time at the site of injection. In that study, a single epidural injection of SP-102 resulted in sustained analgesic effect in lumbosacral radicular pain patients, lasting over the entire observational period of one month.
A Phase 2 trial to characterize the pharmacodynamics and safety of repeat dose SP-102 in subjects with lumbosacral radicular pain (sciatica), showed all subjects experienced rapid reduction of leg and back pain following an initial and repeat SP-102 injection treatment, with group median for average pain in the affected leg reduced by over 50% throughout 28 days (100% response rate). The lack of cumulative effect and rapid resolution of hypothalamic-pituitary-adrenal (HPA) suppression suggests that consideration of HPA pharmacodynamics are not clinically relevant when making decisions regarding repeat dosing. There were no serious adverse events observed.
Scilex expects SP-102 to be the first FDA-approved non-opioid epidural injection for sciatica with the potential to replace the current 10 to 12 million off-label epidural steroid injections administered each year in the U.S.
PALO ALTO, Calif., July 20, 2021 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a wholly-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), today announced complete enrollment of SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program, a corticosteroid injectable dexamethasone sodium phosphate gel for the treatment of lumbosacral radicular pain, or sciatica. SP-102 has received Fast Track status from the FDA.
Scilex’s SP-102 (SEMDEXA™) is currently being evaluated in a pivotal Phase 3 clinical trial in the U.S. in patients with lumbosacral radicular pain (sciatica). Scilex intends to use the results from this pivotal Phase 3 trial to discuss with the FDA a licensure application for the high unmet need sciatica indication for which no treatments have been approved in the U.S. and which is responsible for millions of people suffering in the U.S. Scilex has extensive clinical and pre-clinical data (including multiple Phase 2 clinical trials) with the novel viscous gel formulation of SP-102, which was designed to provide extended non-opioid pain relief for sciatica patients. Scilex expects to present the robust data collected over the course of the company’s multi-year clinical development program to the U.S. FDA as part of a New Drug Application (NDA).
The Phase 3 trial, known as the C.L.E.A.R. trial, randomized 400 lumbosacral radicular pain/sciatica patients at 40 sites across 25 states in the U.S. and is the largest double-blind randomized controlled Phase 3 epidural steroid injection clinical trial in sciatica. The primary endpoint of the study is mean change in the Numeric Pain Rating Scale for leg pain, with SP-102 epidural injection compared to injection of placebo over four weeks. The trial is 90% powered to support product registration. In addition, the trial is designed to prospectively evaluate secondary endpoints including other measures of pain at 4 and 12 weeks, such as back pain, time to repeat injection of SP-102, safety and function, which could significantly enhance the differentiated clinical profile of SP-102.
SP-102 is the first non-opioid novel injectable corticosteroid gel formulation product in development for the treatment of lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates. If approved by the FDA, the SP-102 formulation will be available in a pre-filled syringe and will be administered by epidural injection. Based on preclinical and clinical studies, it extends the residency time at the site of injection and does not show the safety concerns that led the FDA to warn against using other injectable steroid formulations by the epidural route of administration.
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.
MOST small biotechs have been hammered in the past year! However Sorrento has three sources of revenue to fuel a turnaround. COVISTIX, ABIVERTINIB and SEMDEXA are each blockbusters.
1. COVISTIX revenue is ramping up each quarter. Q4 2021 will show some revenue. Q1 2022 will show large revenue. Production near term will be 30 million monthly increasing to 100+ million monthly by year end.
2. ABIVERTINIB "teaser " deal will bring in Multi-billions in up-front, milestone and royalty revenues. It is over 8 months since Sorrento stated that it was seeking a partnership. That is about the timeframe expected for a large partnership!
3. SEMDEXA non-opioid sciatica pain sales projections of $5-10 billion in the US alone with an additional 50-200% increase with label expansions. They have Fast Track status and are applying for Breakthrough Designation. FDA must respond within 60 days of application. A sales crew is already in the field. Revenue stream could begin Mid-2022!
And look for news about COVI-MSC, COVISHIELD, Mpro oral antiviral and VIREX
viral and cancer tests! A lot of news and a lot of revenue in 2022!
Sorrento are asking for Breakthrough Designation for non-opioid SEMDEXA for sciatica. FDA must respond to this request in 60 days after application. If granted, sales could begin in US mid-year 2022! Sales force is already in place. US sales are estimated between $5-10 billion annually, and with label expansion, additional 50-200%. This is a game changer!
Dr. Ji says they filed Feb.1 for latest Covid/Omicron antibody. Will partner Abivertinib. Apply for Breakthrough status for SEMDEXA.
https://finance.yahoo.com/video/sorrento-therapeutics-ceo-details-covishield-203816195.html?contentType=VIDEO
Personalized Stem Cells Announces Brazilian Clearance of Long-Haul COVID Study Licensed to Sorrento Therapeutics
Personalized Stem Cells announces Brazilian authorization for Phase 2 long-haul COVID stem cell clinical trial.
We are incredibly proud to see our hard work to develop and secure approval for the initial COVID-19 trial come to fruition in the form of multiple clinical trials.— PSC CEO, Dr. Bob HarmanPOWAY, CA, US, February 1, 2022 /EINPresswire.com/ --
Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces the Brazilian Health Regulatory Agency (Anvisa) authorized a Phase 2 stem cell clinical trial for patients suffering with persistent pulmonary compromise as a result of COVID-19 (aka “long-haul COVID”). PSC has licensed this technology to Sorrento Therapeutics (Nasdaq: SRNE, "Sorrento"). According to the Centers for Disease Control and Prevention (CDC), long-haul COVID is a term used to describe a wide range of new, returning, or ongoing health problems that people can experience four or more weeks after first being infected with COVID-19.
The clinical trial, which is being conducted by Sorrento, is a multi-center, randomized, placebo-controlled Phase 2a study to evaluate the safety and efficacy of adipose-derived allogeneic (donor-derived) stem cells for patients experiencing respiratory issues recovering from a COVID-19 infection at least three months prior to enrollment. Sorrento expects to enroll 60 patients in the study and will use improvement in the 6-minute walk distance test as the primary outcome measure.
The new study is in addition to an ongoing Phase 2 COVID-19 stem cell clinical trial that is also being conducted in Brazil by Sorrento. Both trials are the result of a successful Phase 1b trial conducted in California at UCSF Fresno. In the initial Phase 1b study, ten patients that were hospitalized and required oxygen supplementation due to COVID-19, were all discharged from the hospital shortly after completing treatment with stem cells.
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 inflammatory diseases, including osteoarthritis and traumatic brain injury, granted 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 received an upfront payment and will be due royalties upon commercialization. PSC founder and CEO, Dr. Bob Harman, stated, “We are incredibly proud to see our hard work to develop and secure approval for the initial COVID-19 trial come to fruition in the form of multiple clinical trials. Sorrento has also worked very hard to secure rapid approvals for these additional clinical trials and we look forward to seeing positive results.”
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.
The Virex acquisition is great! Low cost 5 minute testing for...
* Covid and its variants
* Flu A/B and other viruses
* inflammation and hormone levels
* Cancer detection...liver, prostate, pancreatic, ovarian etc. all need early detection!
* Can be read in a glucometer...nearly 10% of homes already have these meters for diabetics!
TEN February/March potential news items/34 top programs/70+ total pipeline.
1. ABIVERTINIB $61 Billion global market partnership(s). There will be multi-billion upfront, milestone and royalty payments. They announced partnering intentions about 7 months ago! Remember the Genentech/Roche scenario!
2. SCILEX SPINOFF. More SEMDEXA data is due any day. This new treatment could gross $6-10 billion annually in the US alone!.
3. COVISTIX REVENUE STREAM. Sales have recorded in Q4 of 2021 and are ramping up in Q1 of 2022. Mexico leads the way and Europe, Central and South America, Canada, Japan and the US will follow. 30 million monthly test production near term!
4. COVIDROPS, COVI-MSC, COVISHIELD, SEMDEXA, ABIVERTINIB(cancer and Covid) news is expected in Q1 2022 and more EUA's. SEMDEXA and ABIVERTINIB revenue in 2H of 2022?
5. COVIDROPS is in phase 2 in the US and UK. Soon to enter a pediatric trial in Mexico. An Interim analysis of the UK out-patient trial any day.
6. COVI-MSC is in phase 2 trials in the US and Brazil The Brazilian study is pivotal. In Brazil it is followed by a trial for long-haul Covid patients.
7. ORAL MP18 based PAN-COVID ANTI-VIRAL. A peer-reviewed publication was released showing strong pan-Covid activity (including Omicron). A prestigious European journal made it front page news. This could enter the clinic in Q1 or Q2.
8. In Cancer Sorrento has more than 10 fully human antibodies in the clinic or late pre-clinical(PD-1, PD-L1, CD38, CD123, CD47,BCMA, TROP2, LAG3, CTLA-4 and CD137). An allogenic DAR-T, an anti-TROP2 ADC and a second generation oncolytic virus(Seprehvec) will enter the clinic with several ADNAB(Mayo Clinic) drugs.
9. Non-opioid RTX is in phase 2 for arthritic knee pain and will enter phase 2 for epidural delivery for severe cancer pain in Q1.
10. Sofusa will report on a phase 1 arthritis treatment in Q1. Also is being tested in delivering cancer therapies including a collaboration with the Mayo Clinic to test lymphatic delivery.
And have a look at the top 34 portfolio items from the SRNE website. No wonder Blackrock holds over 20 million shares!
https://sorrentotherapeutics.com/research/pipeline/
And here is a look at the entire pipeline.(70+prorams)
***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.China NDA filed for cervical cancer.
4. Erbitux biosimilar
5. Xolair biosimilar
6. Remicade biosimilar(approved in China. SRNE holds ROW rights!)
7. SP-102 sciatica + back pain. Marketing in 2H 2022.
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application(approval in Mexico, Brazil and Europe...15 millions shipped to Mexico. WHO and Canada coming soon. DOD CRADA
11. Sofusa Enbrel phase 1b
12. 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 phase 2 US, UK and Mexico. 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 to prevent intubation Brazil and US.
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 (46+ 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. Covid mRNA vaccine(Sofusa delivery)
38.low cost C1 based multivalent vaccine(rights to 60% of world population)...can this deal be expanded?
39. Salicyn-30 oral antiviral
40.MP18 oral antiviral MPro inhibitor
41.Combination oral antiviral drug cocktail
42.RESPISTIX Combination Covid/seasonal flu tests
43.Combination Covid/seasonal flu vaccine
44 advanced Animal Health subsidiary
45. 1,000,000+ small molecule library
46. Twenty quadrillion antibody library
FUNDING? Sorrento has invested wisely and has millions of shares of Celularity and ImmuneOncia. These are worth many hundreds of millions and the PSS binding arbitration could be settled with very large potential gains. It has many attractive programs to partner for upfront, milestone and royalty payments! The first of many EUA's are producing revenue in Mexico and Brazil. COVISTIX production ramping up to over 30 million per month near term. Outstanding ABIVERTINIB(COVID) results in Brazil and US. Giant ABIVERTINIB centered partnership(s) coming soon! And SEMDEXA sales will begin in 2022 with multi-billion potential. Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
You find it a bit dramatic to say that hospital beds taken up by the unvaccinated are slowing or denying treatments to cancer patients. Too bad. It is true. I know cancer patients who have been affected!
And no one said that vaccines are a panacea. No vaccines are 100% effective. No vaccines are without side effects. But vaccines have saved hundreds of millions of lives. I have had many vaccines as I have travelled around the world many times. I look forward to further advances in vaccines as we need better protection from malaria, dengue fever etc.
I look forward to the day when there are effective vaccines to treat cancers. Indeed I look forward to the day when there are more vaccines to PREVENT cancer.
The original reason I invested in SORRENTO was because of its cancer portfolio. I not only support further development of Covid vaccines but also therapeutic and preventive cancer vaccines!
You can believe whatever you want. The flat earth society welcomes members!
You might like to read what an Israeli newspaper reports!
"14% of Israeli Adults Are Unvaxxed. They Account for 100% of ECMO Patients
As the omicron variant spreads like wildfire in Israel, a clear pattern emerges: Israelis who are unvaccinated against COVID, less than a fifth of adult population, are quickly filling up Israel's hospital beds
A much milder form of disease among vaccinated COVID patients early in the omicron wave is indisputable, Israeli experts are saying as the new variant is spreading uncontrollably across the country.
Overall in Israel, according to Health Ministry data, only 14 percent of Israelis over 20 are unvaccinated, yet they account for 45 percent of serious COVID cases. The numbers are even more clear when examining the use of life-saving measures such as ECMO machines and ventilators.
“Right now there are 13 very severe cases in which the patients are on ECMO machines – 100 percent of those patients are not vaccinated,” added Prof. Nadav Davidovitch, a health policy specialist at Ben-Gurion University, referring to the machines that support the heart and lungs in the worst respiratory cases.
“We also see that 81 percent of patients in the hospital on ventilators are either not vaccinated at all or only partially vaccinated. And among our 57 severely ill patients who are younger than 60 years old, 43 are unvaccinated.”
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The differences are even more stark when examined based on patients' age groups. Among Israelis between the ages 60-69, there are 40 severe cases per 100,000 people among the unvaccinated, but only 2.8 severe cases per 100,000 people among the vaccinated. Among those aged 70-79, the ratio is 46.6 severe cases per 100,000 people among unvaccinated, versus 6.8 among the vaccinated.
Serious cases per 100,000 people as of January 11, 2021.
These statistics have slowed Israel’s march toward offering a fourth vaccine dose to people under 60, said Prof. Hagai Levine, chairman of the Israeli Association of Public Health Physicians.
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“What we are seeing is that the risk of severe disease among people who received three doses of vaccine and are under the age of 60 is extremely low,” Levine said. “That’s putting a question mark on the need for the fourth dose for people under 60.”
The correlation in Israel between disease severity and vaccination status seems to be following the pattern of the United States, where omicron hit full force several weeks earlier, according to Dr. Oren Kobiler, a researcher in immunology and clinical microbiology at Tel Aviv University. In New York, almost 90 percent of COVID hospitalizations are of unvaccinated people, Kobiler notes.
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“While we can see that more vaccinated people are getting infected in this wave than in the past, they are affected much less severely than the unvaccinated,” he said. “This is what we were hoping for in terms of offering evidence that vaccinations work.”
Kobiler has a theory on countries where there is less of a correlation between vaccination and severity of disease during the omicron wave.
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“There are some places where many of those counted as unvaccinated include many people who previously recovered from infection,” he said. “Both South Africa and the United Kingdom, for example, encountered huge COVID waves earlier in the pandemic during which they weren’t able to keep up when it came to recording who got infected.”
These people may be listed as unvaccinated when they have actually recovered, and thus possess antibodies similar to those resulting from a vaccine.
“That somehow contaminated the data, because recovered people are like the vaccinated in many ways – you don’t see a lot of purely unvaccinated people in these countries,” Kobiler said.
In Britain when omicron began, the percentage of people who were both unvaccinated and not recovered from COVID is estimated to be as low as 5 percent, Kobiler said – compared with 20 to 30 percent in the United States.
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“These are the people we really need to watch for the onset of severe disease and learn from them. We’re seeing that omicron behaves differently – it seems to be less pathogenic to the lungs and there is less need for oxygen and ventilation,” he said.
“Still, the number of severely ill patients is rising, and most of them have the omicron variant – we still don’t have clear data. But we definitely see that the most severe omicron infections happen when people are unvaccinated or have a defective immune system that renders the vaccine ineffective.”
In Israel, Kobiler warns, it is far too early to say the hospitals are not in danger of another inundation of severe COVID cases.
“The massive numbers have just begun in the last few days, and it takes a week before disease turns severe. Also, in Israel the waves have started with people coming from abroad bringing in a variant like delta or omicron, and the travelers come from higher socioeconomic backgrounds. These are the people who are more likely to be vaccinated, along with the people they come into contact with,” he said.
“For that reason, what we have seen before with delta and will likely see in the omicron is that at the beginning of the wave there are wealthier and more-vaccinated people getting infected. Only later do we see people from the lower socioeconomic levels who are unvaccinated, and that’s when we may begin seeing the problems in the hospitals.”
Levine says the far higher risk of severe illness in this wave crosses all age groups, so “we still need to push those who didn’t get vaccinated to get vaccinated as much as possible. The vaccine provides good protection against severe disease across age groups, and our unvaccinated population is still at risk for a severe case – even during omicron.”
Experts say Israel is seeing a slow increase in the vaccination rate among children under 12, as with people getting their third or fourth doses.
While the current low death rate may stem from omicron’s more mild nature, Levine notes that most of Israel’s vulnerable population is fully vaccinated.
“The current risk for mortality is definitely lower than it was in the past when the population was not vaccinated and the dominant variant was more virulent,” he said.
Did Whiney die when she got Covid? No.
Unvaccinated in Canada are about 10% of the population but they are 50-70% of the hospitalized, ICU patients and dying!
The unvaccinated are taking up hospital beds and infusion clinics and ICUs. Cancer patient treatments are being delayed and they are dying!
Selfishness and stupidity are not a good guide for public policy.
What a country? Good question. Look at the neighbours.
90% of Canadians are double vaccinated.
68% of Mexicans are double vaccinated.
60% of Americans are double vaccinated.
No wonder other countries are worried about American visitors!
I'm not worried. The Orange haired one told us years ago that there were only 15 cases and it would disappear in the following summer.
Sorrento's Mpro inhibitor is safer than Pfizers drug. It also works against Omicron and ALL previous variants. And "Particularly, STI-1558 showed improved human liver metabolic stability as compared to nirmatrelvir, and its oral bioavailability does not depend on the ritonavir co-administration. Without the need to co-administer Ritonavir, STI-1558 potentially avoids significant adverse drug-drug interactions."
This technology licensed from Texas A&M has huge potential...we will be hearing more!
I love this PIPELINE(and so do Big Pharmas!). There are 8 programs in phase 3, pivotal or marketed! And 4 more in phase 2. Partnerships are coming with upfront, milestone and royalty payments. Revenues growing exponentially Quarter after Quarter. No wonder BlackRock has 22 million shares!
PIPELINE
Sorrento’s R&D is focused on driving innovation in COVID-19, cancer treatment, full pain control and autoimmune diseases.
COVID-19 Programs
Key Programs:
*COVISTIX™ (diagnostic)FDA EUA
*COVIDROPS™ (treatment)Ph II
*COVI-AMG™ (treatment)Ph II
*COVISHIELD™ (treatment) Preclinical
*ABIVERTINIB (treatment)Ph III
*COVI-MSC (treatment)Ph III
*Mpro Inhibitor (oral pill) (anti-viral) Preclinical
*Omicron mRNA Vaccine (vaccine) Preclinical
Immunotherapy
Key Programs:
*Abivertinib (NSCLC) Ph III
*Abivertinib (B Cell Lymphomas) Ph II
*Abivertinib (Prostate) Preclinical
*Abivertinib (Lupus) Preclinical
*Abivertinib (MS) Preclinical
*Abivertinib (GvHD) Preclinical
*PD-L1 (Socazolimab)*(SCLC) Ph III
*PD-L1 (STI-3031)** (Cervical Cancer) Ph III
*CD47 (Solid Tumors) Ph I
*CD38 CAR-T (Multiple Myeloma) Ph I
*CD38 ADC (Amyloidosis, Multiple Myeloma, T-ALL, and esophageal) Ph I
*TROP2 ADC* (Solid Tumors)
Ph I
*Seprehvec™ oncolytic virus (Solid Tumors; CNS Tumors)
PH I
*BCMA ADC (Liquid Tumors) Preclinical
*Bevacizumab-ADNAB™ (Endometrial Cancer) Ph I
*Bevacizumab-ADNAB™ (Ovarian Cancer) Ph I
*Rituximab-ADNAB™ (B-cell Lymphomas) Ph I
Pain
Key Programs:
*ZTlido™ 1.8% (Postherpetic Neuralgia - PHN) FDA Approval
*SP-102 (Lumbar Radicular / Sciatica Pain) Ph III
*SP-103 (Acute Back Pain) Ph I
*SP-104 (Fibromyalgia) Preclinical
*RTX (resiniferatoxin) Epidural injection (Intractable Pain in Advanced Cancer) Ph II
*RTX (resiniferatoxin) Intra-articular route (Moderate to Severe OA Knee Pain) Ph II
Lymphatic Delivery
Key Programs:
*Sofusa® anti-TNF (Autoimmune RA) Ph I
*Sofusa® anti-PD-1 (Cutaneous T-Cell Lymphoma (CTCL)) Ph I
*Sofusa® anti-PD-1 (Melanoma) Ph I
Instead of spreading disinformation gained from "Animal Politico" you might do some research!
Sorrento Receives Purchase Order for 10 Million Covistix Tests From Its Subsidiary Sorrento Mexico for February Delivery in Mexico
January 24, 2022 at 9:00 AM EST
Download PDF
*As COVID-19 cases spike in Mexico, Sorrento Therapeutics Mexico (“Sorrento Mexico”) won the first tender offer in 2022 by the Mexico City Government for COVISTIX tests, which were delivered in the same week of the tender purchase.
*Sorrento Mexico has received emergency use authorization (EUA) approval under its own name from the Mexican regulatory agency, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), for direct importation, sales and distribution of COVISTIX in Mexico..
That seems reasonable.
In Q3 here's the choice:
$1,000 Big Pharma nAb infused over 3-4 hours(ineffective vs. Omicron)
or
$250 Sorrento nAb* nasal in 1 minute(effective vs. Omicron and all variants)
*Dr. Ji said it could be priced in $100 to $500 range. I split the difference.
I know some politicians like to demonize Dr. Fauci and other scientists...but I think the scientists are more trustworthy than the politicians...so I'll share an article about the 5 stages of Covid that makes sense to me...and explains why Sorrento's drugs will be needed for many years.
"Dr. Anthony Fauci, the top medical adviser to President Biden, said this week that we are still in the first of five stages of the pandemic, and he cautioned against thinking we are further along than we actually are.
The first phase of the pandemic—or the “the truly pandemic,” according to Fauci—is “where the whole world is really very negatively impacted as we are right now,” he said Monday at the World Economic Forum’s Davos Agenda online conference.
The following four steps are deceleration, control, elimination, and finally eradication.
Here are the characteristics of the other four stages.
Deceleration
After the first phase comes deceleration—a slowdown in the number of newly confirmed cases.
Omicron cases have risen steeply and then dropped off in many countries where the variant took hold. In South Africa, the fourth Omicron-fueled COVID wave lasted only a total of three weeks, and COVID hospitalizations in England have already begun to recede, just one month after the almost-vertical climb starting mid-December.
Scientists from the U.K.’s Scientific Advisory Group for Emergencies (SAGE) have built models that show there may be a fresh wave of Omicron cases in early summer as people resume social activities and immunity wanes, but they argue cases are unlikely to rise as they did with Omicron, with the latest modeling noting another worst-case scenario of 4,000 people hospitalized a day is very unlikely to occur.
Some people are optimistic that natural immunity will cause the number of new cases to subside, but Fauci notes it is too soon to tell, and there could always be a new variant just around the corner.
“It is an open question as to whether or not Omicron is going to be the live virus vaccination that everyone is hoping for, because you have such a great deal of variability with new variants emerging,” he said.
Control
The next phase, following deceleration, is the control phase of the pandemic—or what some are referring to as endemicity. That means that COVID-19 would become integrated into the broad range of infectious diseases we commonly experience, like the flu or the common cold.
“Control means you have it present, but it is present at a level that does not disrupt society,” Fauci says.
He noted that he hopes this will be the case, but he added that it would be possible only if another variant that eludes the immune response does not emerge. Whether or not COVID will be endemic in 2022, Fauci responded: “The answer is, we do not know.”
Governments like Spain and Switzerland have already said that COVID-19 is becoming an endemic disease countries can manage like the flu.
But for COVID to become endemic, there can’t be any more surprises on the transmissibility and its virulence of the virus or any of its future variants.
“I don’t think there is anything predictable about coronavirus,” Lawrence Young, a virologist and professor of molecular oncology at Warwick Medical School, told Fortune.
“Entering an endemic phase is very different from what we’re experiencing at the moment,” Young said. “I think a lot of it is wishful thinking.”
Elimination
The elimination of a pandemic occurs when the virus still exists in the world but it has been eradicated from certain regions or countries. Fauci gives the example of polio, which has been eradicated from many countries in the Global North.
The world is still far from achieving that with COVID, scientists say.
"For a lot of people there has been this hope that there will be a day where victory will be declared. They will say, ‘Today was the end of COVID, and tomorrow we will live in a COVID-free world again.’ I think that is really unrealistic, and not feasible,” Dr. Wafaa El-Sadr, professor of epidemiology and medicine at Columbia University, previously told Fortune.
Eradication
The last stage, eradication, is nearly impossible to reach. Fauci notes smallpox was the only infectious human disease that has ever been eradicated, and he said outright that regarding COVID, “That’s not going to happen with this virus.”
Dr Max Gomez talking about Sorrento on NBC - They have the nasal antibody that works against all variants -
https://newyork.cbslocal.com/video/category/health-and-fitness/
For those who would like to see pallets of COVI-STIX in Mexico. Ole!
https://www.reddit.com/r/srne/comments/sbo73n/to_those_who_asked_for_photos_of_pallets_of/
First order 1 million COVISTIX. Next order 5 million COVISTIX. NOW another 10 million order for COVISTIX. And this is only Mexico. Wait until the wordwide orders start to come in. They have already said they will soon have 30 million a month production on line. And are ramping up to over a hundred million a month.
COVISTIX alone can fund the entire Sorrento pipeline.
COVIDROPS, COVISHIELD, COVI-MSC, MP18 news still to come.
And don't forget about SEMDEXA and ABIVERTINIB! 2022 is the year of Sorrento...the Year of the TIGER!
Lets say PSS has to pay SRNE $1-3 billion. That will be very nice.
COMPARE that to the ANNUAL revenue potential of SRNEs full portfolio.
Several years from now $30, $40, $50 billion revenue year after year!
PAIN...SEMDEXA, RTX, SP-103....
CANCER...Abivertinib, ADNABs, DAR-Ts, PD-L1, SOFUSA....
COVID...STIX, COVI-MSC, DROPS, SHIELD, MP18....
Lets keep our eye on the ball!
So much for her pretending to be a shareholder!
Your wrong again. It was a NEWS item on the local TV station.
I am invested in Sorrento for the amazing science in Covid, cancer and non-opioid pain. Whenever the PSS settlement comes it will be nice...but for me only a side event to the upcoming revenue streams from all 3 parts of the portfolio. Great buying opportunity!
When you look at the ABC10 News video, look closely at Ji, Brunswick and Royal. Do they look worried?
No... they are happy, confident and enthusiastic!
Why wouldn't they be? They have a nAB that deals powerfully with ALL variants-past and present. "Best-in-Class!"
Do you think the US military might be interested?
A new powerpoint presentation about COVISHIELD is now on Sorrento website.
https://investors.sorrentotherapeutics.com/static-files/ef4904ac-5a52-48da-99cb-25e6b25bbb72
IT concludes with this slide information:
STI-9167 GMP Master Cell Bank generation completed
? IND-enabling preclinical safety and toxicology studies completed
• Phase 1 clinical trials planned in healthy individuals and infected patients for both intranasal formulation (COVIDROPS)
and intravenous formulation (COVISHIELD)
• IND submission in early February
? STI-9167 GMP Drug Product to supply Phase 1/2 studies formulated for intranasal and intravenous dosing has been F/F
? Already manufactured enough drug substance for 100,000’s of intranasal doses
Here is the BIG PICTURE:
"COVISHIELD (STI-9167) neutralizing antibody (nAb) was discovered by scientists from the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”) and further optimized and engineered by Sorrento scientists.
A preprint manuscript is published online at biorxiv.org: https://biorxiv.org/cgi/content/short/2022.01.19.476998v1
Sorrento has obtained worldwide exclusive license rights from Icahn Mount Sinai as previously announced on March 9, 2021 (https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-and-mount-sinai-health-system-enter-exclusive-license).
Compared to available published literature and head-to-head experiments, STI-9167 nAb is a potentially “Best-in-Class” nAb against the Omicron variant of SARS-CoV-2 and the first reported nAb with high potency against Omicron (+R346K mutation) and has demonstrated highly potent neutralization activities in vitro (IC 50 of 25 ng/mL for Omicron live virus, 14.8 ng/mL and 23.9 ng/mL for Omicron and Omicron (+R346K mutation) pseudovirus, respectively), in addition to potent neutralizing activities against the SARS-CoV-2 virus and all of its variants of concern (VOCs).
STI-9167 nAb demonstrated strong protection in vivo following Omicron virus challenge in a preclinical model of COVID-19, preventing weight loss and reducing virus titers in the lungs to levels below the limit of detection.
GMP drug product manufacturing in support of large clinical development is in place at Sorrento GMP facilities.
Sorrento is evaluating in-house GMP manufacturing and is in negotiations with major global CMOs for commercial scale manufacturing to secure capacity to manufacture and supply tens of millions of doses. Sorrento currently has in-hand sufficient cGMP drug substance for 100,000’s of doses at the projected intranasal dose of STI-9199, the intranasal formulation of STI-9167.
INDs to be submitted in the US, UK and Mexico within a month for use as either a small volume intravenous push or intranasal instillation."
By: Derek Staahl transcipt Posted at 5:03 PM, Jan 20, 2022
SAN DIEGO (KGTV) — A San Diego biotech announced promising new results Thursday in its push to develop the first nasal drop treatment for COVID-19.
Sorrento Therapeutics has been conducting phase II clinical trials on COVIDROPS since last summer. The trials are underway in the U.K., Mexico, and the U.S. to assess the drug’s safety and effectiveness. The one-dose nasal drops are intended to prevent severe disease in people with a recent infection.
Since the arrival of omicron, the company has been exploring an updated formula for the neutralizing antibody treatment. Antibody drugs bind to a virus and disable it, mimicking natural defenses made by the immune system.
On Thursday, Sorrento announced the results of lab tests showing that one of its antibodies named STI-9167, initially discovered last year, far exceeds the viral blocking power of any currently authorized antibody treatment against omicron.
In pre-clinical experiments, the antibody was at least 10 times more potent against omicron than sotrovimab, said Sorrento CEO and founder Dr. Henry Ji.
Sotrovimab is an antibody infusion treatment for people in the early stages of COVID. It’s in short supply across the country because it is currently the only authorized monoclonal antibody treatment that still works against omicron.
Because it’s administered as an IV, sotrovimab infusions require medical staff and a lot of time.
“They have to be in an infusion center and that is approximately 3 to 4 hours of time to get that,” said Sorrento Senior VP Dr. Mark Brunswick. “A nose drop would be given in about a minute.”
Lab tests and animal experiments show STI-9167 is not only more potent against omicron, it’s also powerful against all previous variants of concern, the company said.
Sorrento will have to prove that in human trials, but Sorrento chief medical officer Dr. Mike Royal says there are plenty of reasons to think that nose drops will be a better early treatment than an IV needle in the arm.
“Since we know omicron tends to largely replicate in the upper airways, our intranasal approach targets the virus exactly where it’s taking up housekeeping,” he said.
Sorrento isn’t alone. Several companies are trying to be the first to release an intranasal treatment for COVID. The method can deliver high doses to drug to the lungs and airways, but it doesn’t penetrate other parts of the body as well, Dr. Royal said.
The question now is whether an intranasal treatment can stack up against other next-generation antivirals, like Pfizer’s pill Paxlovid.
Dr. Brunswick points out that Paxlovid is not available to all patients.
“Certain drugs can’t be taken in combination with the Pfizer pill,” he said. “The Pfizer pill is not available for kids. Not for pregnant women. All sorts of restrictions. This would be no restrictions.”
Sorrento is already testing its original formula of COVIDROPS on kids in a clinical trial in Mexico. The company hopes to start clinical trials on the updated formula in March.
If all goes well, COVIDROPS could be on the market during the third quarter of this year, Dr. Ji said.
https://www.10news.com/news/in-depth/in-depth-san-diego-company-making-covid-nasal-drops-says-new-formula-potent-against-omicron?_amp=true
TEN January/February potential news items/34 top programs/70+ total pipeline.
1. ABIVERTINIB $61 Billion global market partnership(s). There will be multi-billion upfront, milestone and royalty payments. They announced partnering intentions about 7 months ago! And look to the partnership partners to become the eventual buyout actors. Remember the Genentech/Roche scenario!
2. SCILEX SPINOFF. More SEMDEXA data is due in January. This new treatment could gross $6-10 billion annually in the US alone!. The partner is a wealthy Singapore based venture capital firm.
3. COVISTIX REVENUE STREAM. Sales have recorded in Q4 of 2021 and are ramping up in Q1 of 2022. Mexico leads the way and Europe, Central and South America, Canada, Japan and the US will follow. 30 million monthly test production near term! And now they have acquired a new technology which can produce new tests at one tenth the cost!
4. COVIDROPS, COVI-MSC, COVISHIELD, SEMDEXA, ABIVERTINIB(cancer and Covid) news is expected in Q1 2022 as are more EUA's. SP-102 and ABIVERTINIB revenue expected in 2H of 2022.
5. COVIDROPS is in phase 2 in the US and UK. Soon to enter a pediatric trial in Mexico. An Interim analysis of the UK out-patient trial is expected in Jan/Feb.
6. COVI-MSC is in phase 2 trials in the US and Brazil The Brazilian study is pivotal. In Brazil it is now followed by a trial for long-haul Covid patients.
7. ORAL MP18 based PAN-COVID ANTI-VIRAL. A peer-reviewed publication was released showing strong pan-Covid activity (including Omicron). A prestigious European journal made it front page news. This could enter the clinic in Q1 or Q2. A world-wide development and marketing partner might be expected. Look for something better than Merck or Pfizer's drugs!
8. In Cancer Sorrento has more than 10 fully human antibodies in the clinic or late pre-clinical(PD-1, PD-L1, CD38, CD123, CD47,BCMA, TROP2, LAG3, CTLA-4 and CD137). An allogenic DAR-T, an anti-TROP2 ADC and a second generation oncolytic virus(Seprehvec) will enter the clinic as well as several additional ADNAB(Mayo Clinic) drugs.
9. Non-opioid RTX is in phase 2 for arthritic knee pain and will enter phase 2 for epidural delivery for severe cancer pain in Q1.
10. Sofusa will report on a phase 1 arthritis treatment in Q1. Meanwhile it is being tested in delivering cancer therapies including a collaboration with the Mayo Clinic to test lymphatic delivery.
And have a look at the top 34 portfolio items from the SRNE website. No wonder Blackrock holds over 20 million shares!
https://sorrentotherapeutics.com/research/pipeline/
And here is a look at the entire pipeline.(70+prorams)
***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.China NDA filed for cervical cancer.
4. Erbitux biosimilar
5. Xolair biosimilar
6. Remicade biosimilar(approved in China. SRNE holds ROW rights!)
7. SP-102 sciatica + back pain. Marketing in 2H 2022.
8. RTX Osteo Arthritis
9. RTX cancer pain
10. Covi-Stix EUA application(approval in Mexico, Brazil and Europe...15 millions shipped to Mexico. WHO and Canada coming soon. DOD CRADA
11. Sofusa Enbrel phase 1b
12. 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 phase 2 US, UK and Mexico. 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 to prevent intubation Brazil and US.
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 (46+ 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. Covid mRNA vaccine(Sofusa delivery)
38.low cost C1 based multivalent vaccine(rights to 60% of world population)...can this deal be expanded?
39. Salicyn-30 oral antiviral
40.MP18 oral antiviral MPro inhibitor
41.Combination oral antiviral drug cocktail
42.RESPISTIX Combination Covid/seasonal flu tests
43.Combination Covid/seasonal flu vaccine
44 advanced Animal Health subsidiary
45. 1,000,000+ small molecule library
46. Twenty quadrillion antibody library
FUNDING? Sorrento has invested wisely and has millions of shares of Celularity and ImmuneOncia. These are worth many hundreds of millions and the PSS binding arbitration could be settled with very large potential gains. It has many attractive programs to partner for upfront, milestone and royalty payments! The first of many EUA's are producing revenue in Mexico and Brazil. COVISTIX production ramping up to over 30 million per month near term. Outstanding ABIVERTINIB(COVID) results in Brazil and US. Giant ABIVERTINIB centered partnership(s) coming soon! And SP-102 sales will begin in 2022 with multi-billion potential. Huge portfolio AND huge assets! Sorrento is in the early days of becoming(or being acquired by...) a Big Pharma!
Merck, Pfizer or Samsung? Do you think they are interested in partnering ABIVERTINIB? But how about SEMDEXA or the increasingly interesting Covid portfolio? I can see a Genentech/Roche style partnership followed by Buyout. Why single out these three? You are correct. There are many other potential partners... but these three could do it in a blink of the eye!
COVISHIELD IS NEEDED NOW!
* It works against Omicron and Omicron variants.
* It works as a nasal spray or 2 minute injection.
* No need for overcrowded 3-4 hour infusion centers.
* Great for children and needle fearers!
* INDs in US, UK and Mexico within a month.
* This potential best-in-class drug is a result of collaboration with Mt. Sinai.
* Another attractive reason for partnerships!
TEN January/February potential milestone news items
1. ABIVERTINIB $61 Billion global market partnership(s). There will be multi-billion upfront, milestone and royalty payments. They announced partnering intentions about 7 months ago! And look to the partnership partners to become the eventual buyout actors. Remember the Genentech/Roche scenario!
2. SCILEX SPINOFF. More SEMDEXA data is due in January. This new treatment could gross $6-10 billion annually in the US alone!. The partner is a wealthy Singapore based venture capital firm.
3. COVISTIX REVENUE STREAM. Sales have recorded in Q4 of 2021 and are ramping up in Q1 of 2022. Mexico leads the way and Europe, Central and South America, Canada, Japan and the US will follow. 30 million monthly test production near term! And now they have acquired a new technology which can produce new tests at one tenth the cost!
4. COVIDROPS, COVI-MSC, COVISHIELD, SEMDEXA, ABIVERTINIB(cancer and Covid) news is expected in Q1 2022 as are more EUA's. SP-102 and ABIVERTINIB revenue expected in 2H of 2022.
5. COVIDROPS is in phase 2 in the US and UK. Soon to enter a pediatric trial in Mexico. An Interim analysis of the UK out-patient trial is expected in Jan/Feb.
6. COVI-MSC is in phase 2 trials in the US and Brazil The Brazilian study is pivotal. In Brazil it is now followed by a trial for long-haul Covid patients.
7. ORAL MP18 based PAN-COVID ANTI-VIRAL. A peer-reviewed publication was released showing strong pan-Covid activity (including Omicron). A prestigious European journal made it front page news. This could enter the clinic in Q1 or Q2. A world-wide development and marketing partner might be expected. Look for something better than Merck or Pfizer's drugs!
8. In Cancer Sorrento has more than 10 fully human antibodies in the clinic or late pre-clinical(PD-1, PD-L1, CD38, CD123, CD47,BCMA, TROP2, LAG3, CTLA-4 and CD137). An allogenic DAR-T, an anti-TROP2 ADC and a second generation oncolytic virus(Seprehvec) will enter the clinic as well as several additional ADNAB(Mayo Clinic) drugs.
9. Non-opioid RTX is in phase 2 for arthritic knee pain and will enter phase 2 for epidural delivery for severe cancer pain in Q1.
10. Sofusa will report on a phase 1 arthritis treatment in Q1. Meanwhile it is being tested in delivering cancer therapies including a collaboration with the Mayo Clinic to test lymphatic delivery.
And have a look at the top 34 portfolio items from the SRNE website. No wonder Blackrock holds over 20 million shares!
https://sorrentotherapeutics.com/research/pipeline/
I can't answer these very good questions. I hope Sorrento will put out a press release, hold a conference call or attend a few retail investor Conferences. IR are very poor...too bad as the portfolio is very good!
They could be right. I could be wrong. I like this acquisition for the technology! If they can produce a fast, accurate test at one tenth the cost it is a big deal!Sorrento has great record at making very important acquisitions...eg. SEMDEXA and ABIVERTINIB!
I am not aware of any manufacturing capacity. Virex recently received a $510,000 grant from Mass. state government to develop their technology...to
"Accelerate development of its low-cost, rapid point of care diagnostic that utilizes a glucometer and novel glucometer-based test strip."
Sorrento has bought up Virex Health who developed a new Covid test with new technology out of Boston University. It is easy to use,low cost,rapid and "...based on a novel electrochemical amplification technology." THEY CLAIM IT IS ONE TENTH THE COST OF OTHER TESTS !
https://www.virexhealth.com/
I expect results from the COVI-MSC ARDS pivotal trial VERY SOON!
WOW! Up to 30% of patients recovering from Covid may suffer from the very serious Long-hauler effects. These are very serious health issues. Brazilian officials and Sorrento must be aware of very favourable ARDS trearment results to go ahead with this Long-hauler study. I look forward to more good news from the pivotal COVI-MSC trial very soon!
I like Chuck's list, and especially that we could get all these items, beginning this week and over the next 6 weeks.
"1) results of AMG and DROPS trials with > 90% reduced hospitalization along with announced full efficacy against omicron
2) results of MSC trial with greater than 95% survival of late stage ARDS
3) full readouts on SP-102 and submission for NDA
4) approval in China of Abivertinib for NSCLC
5) approvals for Lee Pharma biobetter
6) global partnerships for Abivertinib
7) manufacturing registration of SRNE for STIX and EUA by FDA
8) partnership with amgen on Sofusa LDS
9) IND on MPI8 and phased multiple trials for P1, P2, P3 progression
10) many others…so many items are on deck for near terms pivotal results…"