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As usual PaulSnowman makes a lot of sense!...
"You can look back at previous Quad Witching dates, and see the volume wasn’t anywhere near yesterday’s 57M. Yes there was a big money option’s battle over $2.61, but some HF’s got caught with their pants down with the Sclilex SP102 final results PR. The Sorrento PR wasn’t a flub like Abivertinib, and the follow up PR on the Sclilex website was even better. Ji/ BOD seemed to have learned not to overstate, maybe thats the Sclilex management rubbing off on them, and instead are understating.
Apply for SP102 NDA in 2023? Definitely understating. We should see approval in the 4th quarter 2022 / 1st quarter 2023. Vickers merger in 3rd quarter? The full readout is out, and the only thing out of their control are when the multiple peer review are done. When the reviews are released and as expected are strongly positive you can also expect a Vickers PR release on a shareholders merger voting date soon after. Lastly, with sales reps in all 50 states and SP102 being fast tracked, well tolerated, non opioid (image the press when released on a non opioid drug when approved), and the only drug thats not black labeled (which by the way both doctors / hospital lawyers and insurers will be extremely happy when it comes to litigation) you can expect a fast roll out. This is a 99.9% no brainer. No wonder Ji made that Sclilex share grab. I’m buying both Sorrento shares at these levels, and post Sclilex shares. BP’s will want to be invited to the dance when it comes time to licensing deals outside the US."
Even the FOOL says...
"The trial results were certainly encouraging, particularly given that Semdexa is a non-opioid treatment and thus does not carry the risks associated with that class of medicines. It should stand a good chance of winning FDA approval."
Yahoo shows over 56 million shares traded today.
Something big is happening.
Guess we might find out next week!
SEMDEXA has multi-Billion dollar potential for Sciatica. And other uses may increase revenue by 50-200%. Here is the Scilex overview from December 2021.
https://www.scilexholding.com/wp-content/uploads/2021/12/Scilex-Holding-confidential-presentation-December-2021-Final-Public-003.pdf
I got a kick out of u/Henry's post about SEMDEXA...
" SEMDEXA: The 10-K confirms the complete six-months data analysis is expected this month and SRNE to submit request to FDA for Breakthrough Therapy Designation that will expedite NDA approval. Remember a 10-K is a very conservative document, there’s pages and pages of every imaginable risk, e.g. sky is falling, use 2 condoms, etc. While SRNE says they expect to submit a pre-NDA meeting request to FDA in 1H22, I still see FDA approval happening in late Q4. The opioid crisis because of the enormous death toll is foremost a political crisis and FDA responds to politics. Once SEMDEXA’s results become widely known thanks to publication in JAMA, NEJM, and the (4) major pain conferences Scilex will sponsor in 2022, don’t be surprised some morning NBC Today Show, etc. are talking about SEMDEXA! That’s when we know SRNE has arrived. The tiny hairline crack in the Hoover Dam suddenly starts to get bigger as the soccer moms (hydrostatic pressure) light up congressmen’s offices, who in turn pound the FDA, who are back blowin’ big pharma again (structural failure) when the dam bursts!! SEMDEXA NDA approval is about as sure a thing as we’ll ever see. Know what you own !!"
I like the Scilex portfolio
https://www.scilexholding.com/technology/pipeline/
WHY SEMDEXA IS NEEDED...
"More than 60% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP)1 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. In 2018, more than 67,000 drug overdose deaths occurred in the United States5 of which almost 47,000 (70%) were opioid-related. Over 70% of the 70,630 deaths in 2019 involved an opioid. Provisional data released by the Centers for Disease Control and Prevention showed drug overdose deaths rose by nearly 29% over a 12-month period ending in April 2021, to an estimated 100,306."
And SEMDEXA approval process is getting close. The 10K said...
"The SP-102 pivotal Phase III trial 12-week data demonstrated a highly statistically significant greater effect over placebo for primary and secondary endpoints with no safety risks identified. The complete six-months data analysis is expected by March 2022. Based on the current results, we plan to submit a request to the FDA for Breakthrough Therapy Designation, which will help expedite the overall development program and potential market approval. We also expect to submit a pre-NDA meeting request to the FDA in the first half of 2022."
Sorrento already has Fast Track designation for SEMDEXA but Breakthrough Designation and priority review(WITHIN 6 months) requests can be expected.
The Scilex US marketing team is in place and late 2022 or early 2023 sales are not out of the question. Sales could be $4-6 Billion in the US and even more in ROW!
Dawson James has a $16 price target for Sorrento. That is based in part on its assumption of a 70% probability of success of its therapies. But the amazing part is in exhibit 1, its revenue model, it ascribed ZERO (0) revenue to any therapy in 2022! Sorrento already has some COVISTIX revenue in Q1 of 2022, with a lot more to come as production ramps up. And there are several other Covid products(eg.COVI-MSC) which could produce significant revenue in 2022. Most of us would be pleased with $16 a share this year, but the chances are that the share price would far exceed that if the analysis actually included revenue WE ALREADY KNOW HAS BEEN ACHIEVED!
Very conservative Dawson James target $16.
https://dawsonjames.com/wp-content/uploads/2022/03/SRNE.3.14.22.v1-RB-SA-Approved.pdf
16 REASONS I LIKE SORRENTO (in alphabetical order A-Z)
ABIVERTINIB
ADNAB (Mayo Clinic)
CAR-T
CELU 20.4 million shares
COVI-GeneMab
COVI-MSC
COVISHIELD
COVI-STIX
DAR-T
Mpro oral antiviral
SEMDEXA sciatica
SEPREHVEC oncolytic virus
SOFUSA drug delivery
RTX non-opioid pain
VIREX low cost tests
ZTlido pain
MOST are potential blockbusters. MANY are potential Multi-Blockbusters.
Glad FDA acted quickly on COVISHIELD!
Sorrento Announces FDA Authorization to Proceed With Phase 1 Study Of Intranasal STI-9199 (COVISHIELD), a Potent Neutralization Antibody Against Covid-19 Viruses
March 2, 2022 at 11:24 AM EST
FDA granted IND clearance today for STI-9199 (COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers.
Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients.
STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the Omicron strain BA.1, Omicron BA.1+R346K and Omicron BA.2.
8 UPDATES FROM THE 10K that most interested me.
1. Sorrento has 20.4 million shares of CELU ...currently valued at about $200 million. Can you name another small biotech with a better investment!
2. COVISTIX EUA applications to WHO, Canada and US FDA "have been completed." Q1 sales revenue from Mexico and Brazil will be significant.
3. SEMDEXA is preceding well. It currently has Fast Track and will be requesting Breakthrough Designation and Priority Review. Marketing network is in place for late 2022 to mid-2023 sales. Multi-Billion Sciatica sales potential.
4. COVI-MSC for ARDS data from US and Pivotal Brazil study available any day now. To be followed by Covid LongHauler study. Both are potential blockbusters.
5. MAYO CLINIC ADNAB drug conjugate program advancing into several programs. Potentially over a dozen combinations targeting many cancer combinations. Both ADNAB and DAR-T will leverage the huge antibody library beginning with PD-1, PD-L1, CD38, CD47, BCMA, CTLA-4, CD123, CD47, LAG3, ROR1, VEAGFR2, CR2 and CD137 among others!
6.DAR-T off the shelf enters clinic. Dozens of potential targets. Preclinical results point to being safer and more powerful than CAR-T!
7.COVISHIELD is now in phase 1 in healthy volunteers. Nose drops and 2 minute injections which treat all past, present and expected variations.
8. COVI-GeneMAb IND this year. $34 million DARPA grant will fund testing for both treatment and prevention of Covid. Effect is expected to last over several months.
I forsee a dramatic revenue increase in 2022 with a stunning portfolio of Covid, Cancer and non-opioid pain products!
SEMDEXA approval process is getting close. The 10K said...
"The SP-102 pivotal Phase III trial 12-week data demonstrated a highly statistically significant greater effect over placebo for primary and secondary endpoints with no safety risks identified. The complete six-months data analysis is expected by March 2022. Based on the current results, we plan to submit a request to the FDA for Breakthrough Therapy Designation, which will help expedite the overall development program and potential market approval. We also expect to submit a pre-NDA meeting request to the FDA in the first half of 2022."
Sorrento already has Fast Track designation for SEMDEXA but Breakthrough Designation and priority review(WITHIN 6 months) requests can be expected.
The Scilex marketing team is in place and late 2022 or early 2023 sales are not out of the question IMO.
I was pleased to see what the 10K said about COVISTIX.
"EUA submissions HAVE BEEN COMPLETED and are awaiting regulatory clearance from WHO, Canada(Health Canada), and the FDA."(p.7)
COVISTIX revenues will start to appear in the Q1 2022 report(about 2 months from now). I agree with those who predict the 2022 full year revenues should at least reach $750 million.
And I look for a lot of partnering in 2022. While Scilex will market non-opioid pain products in the US I look for a lot of marketing partnerships for ROW!
“With the exception of our subsidiary, Scilex Holding, we currently do not have any sales capabilities. We intend to license to, or enter into strategic alliances with, larger companies in the biopharmaceutical businesses or use the services of contract sales organizations (“CROs”), which are equipped to, market and/or sell our products, if any, through their well-developed marketing and sales teams and distribution networks. We intend to license some or all of our worldwide patent rights to more than one third party to achieve the fullest development, marketing and distribution of any products we develop.”
SEMDEXA revenues in the US could exceed a billion dollars in 2023 but with Fast Track and possibly Accelerated Approval could that revenue stream begin in late 2022? The sales team is already in the field in the US. And worldwide marketing partnerships should be expected in 2022 IMO! They could include upfront payments, milestone payments and licensing agreements.
COVISTIX, SEMDEXA, Scilex and a very exciting cancer portfolio will provide a lot of worldwide partnering opportunities! And we still have over 20.4 million CELU shares worth about $200 million(and rising) and an impressive portfolio which many Big Pharmas would love to have!
https://investors.sorrentotherapeutics.com/static-files/ded13448-aa64-4405-a2d9-de644cfe9dfc
Interesting discussion about new Covid variant. COVISHIELD and COVI-MSC will likely be needed for years to come against these variants.
https://ca.news.yahoo.com/covid-19-ba2-variant-mask-rules-204748489.html
We have income from 1 and 5 now but I expect all 5 will be contributing either later this year or next year!
Why would this be of interest?
Quote:
"Friday 10-K expected but if it goes to next week, I would be shocked but very interested."
I don't expect much from Q4. It is Q1 of 2022 that interests me.
I used to think of Sorrento as having 3 major categories...NON-OPIOID PAIN, COVID and IMMUNOTHERAPY.
1. NON-OPIOID PAIN has near term blockbuster potential in SEMDEXA for sciatica. This is followed by non-opioid drugs for back pain, fibromyalgia, cancer and arthritic pain.
2. COVID therapies includes COVI-MSC for ARDS and LongHaulers, COVI-SHIELD for injection and nasal drops and Mpro an oral broad spectrum anti-viral.
3.IMMUNOTHERAPY includes both Cancer and Inflammation. Abivertinib for many cancers, lupus, and MS, several PD-L1, many ADNAB(Mayo Clinic), DAR-Ts, ADCs and an oncolytic virus.
I now think we should acknowledge two more categories. LYMPHATIC DELIVERY and TESTS>
4.LYMPHATIC DELIVERY also includes both Cancer and Inflammation. In both cases SOFUSA delivers drugs to the lymphatic system in lower, safer and
more effective doses.
5. The TESTS portfolio is driven by exponentially increasing COVISTIX revenues. The acquisition of FORTUNE and VIREX can allow Sorrento to produce affordable, near PCR quality, rapid tests for many viruses and cancers.
ALL 5 CATEGORIES HAVE SEVERAL POTENTIAL BLOCKBUSTER PRODUCTS!
Experienced investors know volume increases often precede share price increases. Over 12 million shares traded each day both yesterday and today. We all know there is a lot of news coming. Sometimes some know more than others. All I know is that there is a lot of Covid, Cancer and non-opioid Pain news coming! If the general market settles ...Sorrento should make some nice gains!
With increasing COVISTIX and ZTlido revenues and the CELU investment worth about $200 million(and rising!) I look forward to all 3 areas of Sorrento's portfolio advancing this year. I do not know another small biotech that has as many shots on goal!
1. COVISTIX for affordable rapid accurate Covid testing followed by 2 minute COVISHIELD nasal drops or injections with COVI-MSC to prevent ARDS and treat LongHaul Covid are all very timely. And Mpro oral wide spectrum anti-viral with no drug/drug interaction limitations could be revolutionary!
2. SEMDEXA for sciatica, RTX for arthritic and cancer pain, SP-103 for acute back pain and SP-104 for fibromyalgia all hold great promise as non-opioid alternatives. And all are potential blockbusters!
3. Sorrento's cancer portfolio is second to none. Abivertinib, CAR-Ts, DAR-Ts, ADCs, ADNABs and a second generation oncolytic virus are only the beginning. Many are first-in-class and best-in-class! And they treat literally dozens of specific cancer indications!
And Sorrento's January 2022 Slide Presentation is worth a look. A lot of focus on Scilex non-opioid pain products. 2022 will be a pivotal year!
https://investors.sorrentotherapeutics.com/static-files/ded13448-aa64-4405-a2d9-de644cfe9dfc
Another thoughtful PaulSnowman post!...
"Look at the Science. Not at the SP. What would you say if Celularity received Orphan drug status for its NK cell therapy(it has), STIX brought in 750M-1B revenue for 2022, SP102 had a kick ass full readout with multiple glowing peer reviews and approval in 2022/2023, MSC (Covid) received Brazil/USA EUA 2022 (topline data due anytime) and Long Haul EUA/Approval 2022/2023? In a multiple universe, bag holder day dreaming you say, or maybe closer then you think to reality? When the light switch flips on are you going to say in public you knew the SP was going to blowup all along, but when your alone are your going to regret having to sell your shares to pay your bills or because you let the long manipulation game play you?"
PaulSnowman makes some good points!
"Right now Sorrento is lumped in with the rest of the overcrowded Biotech sector with no revenue. Even though unlike most small Biotechs they have revenue from Ztildo and STIX. In STIX case a projected 2022 revenue between 750M-1B might not be far off the mark. We’ll see both a top line readout for MSC (Covid) and full readout / multiple peer reviews for SP102 in the near future. The switch can flip in an instant for a Biotech. Some say its crazy to buy with the SP suppression and downward spiral. I say its crazy not to load up at these levels. Time and patience. See you on the other side."
And...."SP102 will get approval this year or next. Estimated annual revenue for US alone is projected between 6-11B, but lets say 3B. Thats for US alone. Are you with me so far? 3B times 5=15B MC. Following me? Sorrento MC is currently 756M, and SP is 2.20. So with 15B MC the SP would be $43. Thats at a conservative 3B annually for SP. Not including whatever other pipeline items get approval / EUA / partnership / asset sold / licensing / etc… Ji made a grab at Sclilex shares for a reason. its because SP102 is well tolerated, non opioid, and the only non black label, and its 99,9% to get approved. Tutes are loading up, and so should any investor with powder, time, and patience. You can lead a horse to water… Your choice."
WE should not let ourselves assume that Omicron will be the last widespread variant. I am glad to see that Sorrento is working on broad spectrum anti-virals. And Sorrento tests and treatments like COVISHIELD and COVI-MSC will be needed for years to come.
Another variant...not Omicron...flares up in China.
China reports most new daily Covid-19 cases in more than two months
CHINA
Sunday, 06 Mar 2022
2:09 PM MYT
Residents queue outside a Covid-19 vaccination center in Beijing, China, on Friday, March 4, 2022. China will likely announce its lowest economic growth target in more than three decades when top leaders gather Saturday for a key political meeting, putting pressure on the government to step up fiscal stimulus to spur demand and jobs. - Bloomberg
BEIJING, March 6 (Bloomberg): China reported the highest number of new daily Covid-19 cases in more than two months as the eastern coastal city of Qingdao detected surging infections.
A total of 175 locally transmitted symptomatic cases were found on Saturday (March 5), 88 of them in Qingdao, according to the National Health Commission. Outbreaks in north-eastern Jilin and southern Guangdong continue to spread, with both provinces reporting dozens of new cases.
China has persisted with its "Covid-zero" strategy after more than two years of fighting the virus.
This policy has increasingly isolated the world's most populous country from the rest of the world as western nations pivoted to living with the virus and gradually opening up.
The origins of the flareup in Qingdao were traced to people who became infected after receiving mail from other virus-hit provinces and transmitted the virus further at a small family gathering, the city's local health commission said in a statement on Sunday.
The strain of the virus has yet to be identified but it has been established that is not the Omicron variant, according to the statement.
Qingdao has placed more than 2,500 close contacts of the patients under quarantine and has embarked on mass testing among people in its sub-tier city Laixi, where most of the cases have been found.
Schools in the city ramped up control measures after finding some of the earliest clusters of the outbreak.
The city has closed cinemas, bars and other entertainment venues in order to reduce transmission. - Bloomberg
COVI-MSC UPDATE DUE SOON. Brazil pivotal completed. Fresno phase 2 should be too!
UCSF Fresno Study: Stem Cell Treatment Aids COVID Patients with Damaged Lungs(Sept. 2021)
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.
Nice to see Schwab increasing its shares in Sorrento...but they are small holders compared to these as of Dec.31 2021...Bet they have more since then!
Blackrock Inc. 21,775,865
Vanguard Group, Inc. (The) 15,692,730
State Street Corporation 14,595,754
Geode Capital Management, LLC 5,301,256
JP Morgan Chase & Company 3,574,317
Northern Trust Corporation 2,940,000
Shaw D.E. & Co., Inc. 2,447,050
Sabby Management, LLC 2,189,700
Charles Schwab Invest. 2,143,094
Sen.Rick Scott has revealed a great plan! Tax the poor. Get rid of social programs. At least he is honest! Make America Great Again like it was 100 years ago...or how about 200 years ago. Slavery was OK for white folks!
Nobody at this point can say how long the COVISHIELD treatment or preventive protection may last. This was observed in animal studies. The phase 1 trial in healthy volunteers may shed some light but it is an intriguing question.
People would love to boost their immunity before going on a cruise, or out visiting friends or family. And if a family find one has Covid, it would be great to be able to give nose drops to all other family members! And wouldn't DARPA be interested? If there was an outbreak on an aircraft carrier the rest of the crew could be given this protection!
They plan to do pivotal studies in the US, the UK and Mexico. The FDA's rapid approval of the phase 1 trial may indicate that they are interested and supportive. This would be a great development!
Sorrento Announces COVISHIELD (STI-9199) Antibody Nasal Drops Prevent Productive SARS-CoV-2 Infections When Given 24 Hours Prior to Virus Exposure
March 2, 2022 at 11:37 AM EST
Download PDF
STI-9199 neutralizing antibody (nAb) nasal drops prevent productive infections when given to animals 24 hours before they are exposed to COVID.
This intranasal STI-9199 may potentially give the option to take a dose of STI-9199 to prevent spread of infection within a home and to allow travel or attendance at a social event with added protection from infection.
SAN DIEGO, March 02, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that new preclinical results demonstrate that pretreating an animal with intranasal neutralizing antibody (STI-9199) twenty-four (24) hours prior to being exposed to SARS-CoV-2 virus prevents productive infection in the treated animals. These data suggest that an individual who is at high risk of exposure to the SARS-CoV-2 virus could potentially be protected by taking STI-9199 nasal neutralizing antibody. For example, if a member of a household becomes infected, the others in the house could be treated with intranasal STI-9199 to potentially prevent them from being infected. This prevention could work in vaccinated and unvaccinated individuals but needs to be confirmed in clinical studies. Other potential use cases for this intranasal STI-9199 include pretreatment of front-line healthcare workers, individuals in long-term care facilities or students in schools, where treatment could potentially provide blanket coverage. In addition, travelers on a plane could be pre-treated, which would potentially allow for air and ocean cruise travel with added protection when mask-wearing is not required.
These options will be fully evaluated in clinical studies starting with household prevention and healthcare workers, and the results from these studies will be informative for other blanket protection opportunities.
Sorrento previously announced that this antibody (STI-9167) has a broad neutralizing activity against the SARS-CoV-2 virus and all of its major variants of concern, including the Omicron strain BA.1, Omicron BA.1+R346K and Omicron BA.2.
The IND for the intranasal STI-9199 (COVISHIELD) product was cleared by the FDA today to proceed.
Sorrento Announces FDA Authorization to Proceed With Phase 1 Study Of Intranasal STI-9199 (COVISHIELD), a Potent Neutralization Antibody Against Covid-19 Viruses
March 2, 2022 at 11:24 AM EST
Download PDF
FDA granted IND clearance today for STI-9199 (COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers.
Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients.
STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the Omicron strain BA.1, Omicron BA.1+R346K and Omicron BA.2.
SAN DIEGO, March 02, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received clearance from the FDA for its investigational new drug application (IND) for intranasal (IN) STI-9199 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers.
The Phase 1 study will be at a single clinical site in San Diego and will be followed by multinational (USA, UK and Mexico) Phase 2/3 trials. Sorrento plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization (EUA), if the trials meet the efficacy end-points of the pivotal study.
I usually ignore The State of the Union stuff. Too partisan on both sides! But I was glad to see unity vs Russian aggression. And Bi-partisan concern on CANCER and advancing non-opioid drugs and keeping drug prices reasonable(Insulin costs are outrageous! The discovers of Insulin refused to profit from it!)! On Covid, the virus will set the agenda! I expect to see Sorrento portfolio advancing nicely on at least 10 items!
1. Increasing COVISTIX sales as increased production allows for bidding on larger orders.
2. COVISTIX approvals in Canada and US, with sales following rapidly.
3. ABIVERTINIB(cancer) and PD-L1 marketing approvals in China.
4. COVI-MSC results from Brazil. If they are good they might wait for the US results and apply for EUAs in Brazil and US. Or they may just apply for Brazil approval and await the US results.
5. ABIVERTINIB approval for ARDS in intermediate Covid patients in Brazil.
6. COVIDROPS approval in UK and/or Mexico.
7. Mpro oral, broad spectrum anti-viral enters clinic. Will this be partnered?
8. SEMDEXA gains US FDA Breakthrough Designation. SCILEX deal advances!
9. RTX advances in phase 2 in cancer pain and arthritic knee pain.
10. SOFUSA advances in phase 2 autoimmune and cancer lymphatic drug delivery.
And the really big news would be a PARTNERSHIP! It is some 9 months since Sorrento announced they were seeking a worldwide ABIVERTINIB centered partnership. Or could there be a broader partnership/buyout agreement following the Genentech/Roche model? Big partnership often take 9-12 months to be completed. They can be complex and there could be several interested Big Pharma.
All of this could happen in Q1 or spill over into Q2. We will just have to wait...but I like our chances!
Sorrento's January 2022 Slide Presentation is worth a look. A lot of focus on Scilex non-opioid pain products. 2022 will be a pivotal year!
https://investors.sorrentotherapeutics.com/static-files/ded13448-aa64-4405-a2d9-de644cfe9dfc
COVIDROPS UK study completed in MARCH 2022 (if not earlier!).
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
Actual Study Start Date : July 18, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022
The last update on the 6 hospital, 100 patient, Brazilian study of COVI-MSC treatment for ARDS was Nov. 26, 2021.
The Estimated Study Completion Date was listed as FEBRUARY 2022.
NEWS DUE ANY TIME!
https://clinicaltrials.gov/ct2/show/NCT04903327
SP-102(SEMDEXA) is a multi-blockbuster...and with steady revenue growth from ZTlido and COVISTIX...2022 is a pivotal year!
I always find PaulSnowman's posts worth reading...
" The plus Sorrento has is revenue from ZTlido and STIX. Most small Biotechs don’t have that. Add in the shares of Celularity. Then there’s the eventual approval this year of MSC (Covid), Socazolimab (China NMPA), SP102 (yes this year. For once Ji has learned his lesson and is understating the timeline to approval in my opinion), and probably a couple of more things in the pipeline (I’m looking at you Abivertinib). But for sure SP102 is a no brainer at around 99.9% chance of approval."
Correct me if this is wrong...but over the past 5 years the Q4 results from the previous year are usually available in March. Any where from March 21 to March 02. The only exception was last year when they were released February 19. But that February release was the exception!
So when will we see them this year?
Apparently anytime between next week to next month sometime.
I don't really care when they are released. IT IS Q1 AND Q2 of this year that interest me. Lots of news to come.
There are about 5 weeks left in Q1 2022. What good news might we expect? Some possibilities include...
1. Increasing COVISTIX sales as increased production allows for bidding on larger orders.
2. COVISTIX approvals in Canada and US, with sales following rapidly.
3. ABIVERTINIB(cancer) and PD-L1 marketing approvals in China.
4. COVI-MSC results from Brazil. If they are good they might wait for the US results and apply for EUAs in Brazil and US. Or they may just apply for Brazil approval and await the US results.
5. ABIVERTINIB approval for ARDS in intermediate Covid patients in Brazil.
6. COVIDROPS approval in UK and/or Mexico.
7. Mpro oral, broad spectrum anti-viral enters clinic. Will this be partnered?
8. SEMDEXA gains US FDA Breakthrough Designation.
9. RTX advances in phase 2 in cancer pain and arthritic knee pain.
10. SOFUSA advances in phase 2 autoimmune and cancer lymphatic drug delivery.
And the really big news would be a PARTNERSHIP! It is some 9 months since Sorrento announced they were seeking a worldwide ABIVERTINIB centered partnership. Or could there be a broader partnership/buyout agreement following the Genentech/Roche model? Big partnership often take 9-12 months to be completed. They can be complex and there could be several interested Big Pharma.
All of this could happen in Q1 or spill over into Q2. We will just have to wait...but I like our chances!
"The crisis has deepened during the coronavirus pandemic, with U.S. opioid-related deaths reaching a high of more than 76,000 in the 12 months that ended in April 2021, largely because of the spread of fentanyl and other lab-made drugs. A recent report from a commission by The Lancet medical journal projected that 1.2 million Americans could die of opioid overdose between 2020 and 2029 without policy changes.
John F. Kelly, a professor of psychiatry in addiction medicine at Harvard Medical School, said he wants to see money from the settlements go not just for treatment, recovery and support efforts but also to build systems designed to prevent this sort of epidemic from happening again.
“Some kind of national board or organization could be set up ... to prevent this kind of lack of oversight from happening again -- where industry is allowed to create a public health hazard,” he said."
$26 Billion Big Pharma opioid settlement(more to come!) highlights value of Sorrento's non-opioid pain program! SEMDEXA, SP-103, SP-104 are all potential blockbusters.
https://www.msn.com/en-ca/money/topstories/j-j-distributors-finalize-26b-landmark-opioid-settlement/ar-AAUiluW?ocid=msedgdhp&pc=U531