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Very interesting technology. Deserves a board.
There could be a lot of news in November 2022 IMO!
I can think of at least half a dozen potential announcements.
All the best to all the patient longs!
About Sorrento Therapeutics Sofusa Business Unit
The Sofusa Business Unit is a wholly owned division of Sorrento based in Atlanta, Georgia and is focused on lymphatic drug development with pre-clinical, analytical, clinical development, and device manufacturing capabilities. The Sofusa platform is a novel microneedle technology that delivers both small and large molecule drugs through the skin and into lymphatic capillaries resulting in significantly higher drug concentrations to immune system drug targets over greater time periods than traditional injections or infusions. Drug targets for many diseases of the immune system (e.g., autoimmune diseases and cancer) reside in the lymphatic system and lymph nodes. In multiple pre-clinical models, Sofusa's proprietary nanotopography-draped microneedle system has consistently demonstrated the ability to improve therapeutic responses by delivering over 40-fold increases in drug concentration to targeted lymph nodes when compared to traditional subcutaneous injections or intravenous infusions. The Sofusa Business Unit is currently conducting human proof of concept studies in autoimmune disease and in cancer.
One of the biggest world problems is China's zero Covid policy. It's massive shut-downs hurt both the Chinese and world economies. In this context I was very pleasantly surprised to see the Mpro trial in China.
"A phase 1 trial in participants infected with SARS-CoV-2 has been initiated in China (MPR-COV-101CN), and a total 56 participants will be enrolled to assess the safety, tolerability, and efficacy in 3 MAD dose cohorts (300 mg BID, 600 mg BID and 800 mg BID daily for 7.5 days). Eight participants infected with SARS-CoV-2 in the first MAD dose cohort of 300 mg BID have been dosed."
As the Australian trials were in healthy volunteers, this is the first trial in Covid patients! I have no doubt that if this phase 1 trial is successful the phase 2/3 will proceed rapidly in China. What a dramatic impact Mpro could have on China and thereby on the rest of the world's economies!
Mpro does not have the drug/drug interaction problem or the high cost of its Pfizer competition. Sales in the 1.5 billion China market and the 600 million Latin America market could be substantial to say the least!
The Pfizer drug has $22 billion in sales. Worldwide Mpro sales could possibly exceed that figure...SEMDEXA and ABIVERTINIB are big...Mpro could be even bigger!
Hi XW, I think the RedHill patent applies to late treatment of ARDS. I see a lot more potential in Sorrento's early treatment antiviral Mpro. Glad to see pivotal phase 2/3 being organized...wonder if and when it might be partnered.
In regard to the PSS arbitration...my opinion is that it might be settled any time...avoiding court.
Might Pfizer be interested in partnering or buying out Sorrento? PFE has 3.9 BILLION SHARES of Treasury Shares…so in addition to the $24 Billion of cash, they’ve got over $100 BILLION worth of their own shares that they can issue if they so choose. MONEY IS NO OBJECT.
Just a thought!
Pfizer's PAXLOVID has done a lot of good and sales exceed $22 Billion this year. But if the costs are not covered by government it is costly ($500+ for a course of treatment) and there are health warnings.
Sorrento's Mpro should be far cheaper (it is far less costly to produce) and it appears not to require the drug/drug interaction warnings that accompany Paxlovid. Here are some of the warnings...
"Do not take PAXLOVID if:
You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID.
You are taking any of the following medicines:
alfuzosin
amiodarone
apalutamide
carbamazepine
clozapine
colchicine
dihydroergotamine
dronedarone
eletriptan
eplerenone
ergotamine
finerenone
flecainide
flibanserin
ivabradine
lomitapide
lovastatin
lumacaftor/ivacaftor
lurasidone
methylergonovine
midazolam (oral)
naloxegol
pethidine
phenobarbital
phenytoin
pimozide
primidone
propafenone
quinidine
ranolazine
rifampin
St. John’s Wort (hypericum perforatum)
sildenafil (Revatio®) for pulmonary arterial hypertension
silodosin
simvastatin
tolvaptan
triazolam
ubrogepant
voclosporin
Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works.
These are not the only medicines that may cause serious side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary while you are taking PAXLOVID. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.
Possible side effects of PAXLOVID are:
Allergic Reactions. Allergic reactions can happen in people taking PAXLOVID, even after only 1 dose. Stop taking PAXLOVID and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction:
hives
trouble swallowing or breathing
swelling of the mouth, lips, or face
throat tightness
hoarseness
skin rash
Liver Problems. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach area (abdominal) pain.
Resistance to HIV Medicines. If you have untreated HIV infection, PAXLOVID may lead to some HIV medicines not working as well in the future.
Other possible side effects include:
altered sense of taste
diarrhea
high blood pressure
muscle aches
abdominal pain
nausea
feeling generally unwell
These are not all the possible side effects of PAXLOVID. Not many people have taken PAXLOVID. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all of the risks are not known at this time.
There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID. For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk from the treatment. It is recommended that you use effective barrier contraception or do not have sexual activity while taking PAXLOVID. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.'
I don't agree with those who think Covid is not a serious problem or simply just hope it will go away. I am glad Sorrento has developed Mpro, COVISHIELD and COVIDROPS. They may all be needed around the world over the coming years! Scientists are still concerned.
Fauci says fast-spreading COVID variants BQ.1 and BQ.1.1 are ‘pretty troublesome’
Chloe Taylor
Tue, October 18, 2022 at 5:13 AM·....
New COVID variants BQ.1 and BQ.1.1 are gaining traction in the U.S. at a “troublesome” rate, according to the White House’s top medical advisor Dr. Anthony Fauci.
In the week ending Oct. 15, BQ.1 and its offspring BQ.1.1 were closing in on the position of second most widely circulating COVID variant in the United States, according to projections from the Centers for Disease Control and Prevention (CDC).
On Friday, Fauci sounded the alarm on the new variants, which accounted for an estimated 11.4% of new COVID cases in the United States as of Oct. 15—double the proportion of infections they caused a week earlier.
“When you get variants like that, you look at what their rate of increase is as a relative proportion of the variants, and this has a pretty troublesome doubling time,” Fauci said in an interview with CBS News.
Alongside BQ.1 and BQ.1.1’s rapid infection rates, he voiced concern about the latter’s apparent ability to evade antibody treatments being used for patients at risk of developing severe COVID symptoms.
“That's the reason why people are concerned about BQ.1.1, for the double reason of its doubling time and the fact that it seems to elude important monoclonal antibodies,” Fauci told CBS.
The BA.5 variant is currently still dominant in the U.S., accounting for around 68% of cases, while BA.4.6—which accounted for 12.2% of cases as of Oct. 15—is the second most common variant.
However, BQ.1 and BQ.1.1 have rapidly become more widespread in the U.S. in recent weeks, while BA.5 has been responsible for a smaller proportion of cases.
Despite the rise of the new variants, the latest data from the Centers for Disease Control and Prevention (CDC) paints a somewhat encouraging picture, with hospitalizations and new cases of the virus steadily declining over the past month.
Some epidemiologists and public health experts have warned, however, that Americans should brace for a resurgence of COVID infections in the coming fall and winter months—particularly with the Omicron variant continuing to evolve. Fauci backed those warnings during his interview with CBS....."
We have had very good news on SEMDEXA, ABIVERTINIB, PD-L1 and Mpro in past weeks. The first 3 have very excellent phase 2 and/or 3 data. Mpro is now moving rapidly into worldwide phase 2/3 studies in a $20+billion market. All 4 could each be producing billions in revenue beginning in 2023.
There should also be news about COVIMARK and VIREX within the next month or two. VIREX technology will be a worldwide rapid testing gamechanger.
And PSS arbitration updates could come at any time!
That leaves room for updates on the progress of
SOFUSA,
RTX,
DAR-T and
ADNAB....each of which also are of blockbuster potential!
We have a lot of good news coming. Long and Strong!
Pfizer's Paxlovid had very good results for Covid patients who took the drug within 3 days of infection in the clinical study. Here is an excellent article from Yale with the plus/minus of Paxlovid. $22 Billion in sales is impressive. Sorrento's Mpro appears to avoid the drug/drug interaction problem. It also should be significantly cheaper. We must await the efficacy results from the worldwide phase 2/3 trials which are being lined up right now. Great potential to say the least!
https://www.yalemedicine.org/news/13-things-to-know-paxlovid-covid-19#:~:text=But%20people%20should%20stop%20taking%20Paxlovid%20and%20call,4%20throat%20tightness%205%20hoarseness%206%20skin%20rash
Pfizer's antiviral sales are over $22 Billion this year.
If Sorrento's Mpro drug is safer, better and cheaper than their antiviral might Pfizer want to buy it?
If Sorrento sells the Mpro drug to Pfizer what do we expect?
If the sales are some $20 Billion a year ... can we expect at least $60 Billion? More?
What would they pay for Mpro, ABIVERTINIB and Semdexa package? Or the entire company? Hmmm!
What could Sorrent's Mpro sales reach per year? Pfizer's drug is not as safe and likely more expensive...but here is how it is doing...
" Chief Executive Albert Bourla said final sales for its oral COVID-19 antiviral, Paxlovid, could be "way bigger" than what Pfizer has forecast since its current outlook only included contracts that have been or are close to being signed.
Pfizer currently expects $22 billion in 2022 sales of the treatment, compared with Wall Street estimates of $22.88 billion.
"Clearly, this is only a fraction of the 120 million treatments that we are right now preparing to manufacture" this year, Bourla told analysts on a conference call.
The company is selling 20 million courses of Paxlovid to the United States at around $530 a course, but Bourla said that was a special price because of the size of the order."
We can expect SEMDEXA news any day now. But we should examine the good news about ABIVERTINIB and Mpro.
All three of these drugs have multi-billion sales potential.
And all 3 could produce revenue beginning in 2023.
But the interesting thing about ABIVERTINIB and Mpro is that they both have advanced studies in China. Mpro is already in Covid patients in China and ABIVERTINIB is very close to marketing approval in China!
Sorrento's strategy is to market both in China (1.5 billion population) and Latin America (600 million population) before moving on to Europe (700 million population) and the US (333 million population).
But WHO WILL BE Sorrento's MARKETING PARTNER in all these territories? And which cash rich BP might be interested in a buyout to acquire these 3 large income producers as early as next year? We have been told partnering discussions about ABIVERTINIB have been going on for some time. It is unlikely that the discussions have not expanded to the wider portfolio IMO!
HUGE NEWS! MULTI-BILLION POTENTIAL $$$$$
"Sorrento Successfully Completes Phase 1 Study and Is Proceeding to Implement Global Registrational Trials with STI-1558, an Oral Mpro Inhibitor as a Standalone Oral Treatment and Prevention of COVID-19 without the Need for a Ritonavir Booster....
Global registrational Phase 2/3 trials of STI-1558 as a standalone treatment of COVID-19 are proceeding and are expected to be implemented rapidly in the US, Mexico, China, Australia and other regions.....
A phase 1 trial in participants infected with SARS-CoV-2 has been initiated in China (MPR-COV-101CN), and a total 56 participants will be enrolled to assess the safety, tolerability, and efficacy in 3 MAD dose cohorts (300 mg BID, 600 mg BID and 800 mg BID daily for 7.5 days). Eight participants infected with SARS-CoV-2 in the first MAD dose cohort of 300 mg BID have been dosed....
A large Phase 2 registrational study is planned in Mexico that could support an Emergency Use Authorization (EUA) in Mexico with potential for distribution throughout Latin America. Registrational Phase 2/3 trials in US, China and other major regions have also been planned."
THIS AIMS TO BE A SAFER and CHEAPER ANTIVIRAL! And look for other uses and a marketing partnership at the least, or a buyout. This has multi-BILLION potential!
The Oct.12 presentation on NSCLC and ABIVERTINIB is interesting although I found some hard to understand but if I got it right ABI seems to have a lower ORR rate than OSI (although it is 57%!) but it produces a 5% CR rate compared to none! And it has a superior 28+ month OS rate! And it is a far less costly drug which is important to both health care systems and patients!
It looks like the first approvals could come in Mexico and Latin America followed by China and Europe with the US trailing although the cost issue may hasten worldwide approvals. And we must not think that these other markets are insignificant. Latin America(600 million), China(1.5 billion) and Europe(700 million) are all larger than the US(333 million).
https://onlinexperiences.com/scripts/Server.nxp?LASCmd=AI%3A4%3BF%3AQS%2110100&ShowUUID=1DF26B36-EA1A-4E30-8FC3-7FFC6EF6026B
I have never counted on the PSS arbitration results.
However the recent short term loan makes me agree with those who suggest that some big income source will appear very soon.
Could it be the PSS settlement?
Could it be an ABIVERTINIB partnership?
Could it be a PD-L1 partnership?
Could it be a Mpro partnership?
Could there be a SEMDEXA partnership?
Could some cash rich Big Pharma needing a pipeline refill make a buyout offer?
There are so many possibilities....and any could occur any time now.
Ji's numerology based insider buys and the Huge Institutional purchases are very bullish signals!
I expect news on ...
SEMDEXA,
ABIVERTINIB,
PD-L1,
Mpro,
COVIMARK , and
VIREX within the next month or two.
PSS arbitration updates could come at any time as could news on....
SOFUSA,
RTX,
DAR-T and
ADNAB.
Dr.Ji's very large insider buying along with large Institutional buying are usually bullish signals...news on 2 or 3(or more?) of these items would be very positive.
I am a senior and I know dozens of seniors who get regular injections in their arthritic knees!
These injections have a market of over 50 million patients and a 2020 market value of $7 Billion!
RTX also is in trials for intractable cancer pain. Huge potential for reducing suffering.
Another overlooked value for Sorrento!
SORRENTO is pregnant and ready to pop over the next few months!
She could have Octuplets!
The first 4 are...
SEMDEXA,
ABIVERTINIB,
Mpro and
PSS arbitration settlement.
And there could be 4 more...
COVIMARK,
VIREX,
SOFUSA and
PD-L1.
Most of these could involve worldwide marketing partnerships.
Double digits are coming for those who wait IMO!
COVISHIELD, COVIDROPS and Mpro could be important in early treatment of ongoing and future variants of Covid! People are still getting sick and some are still dying.
Henry-M138 posted this recently. Any one of these global partnerships would be huge. 2 would be enormous! ... and the first could come anytime.
"SRNE is primed / teed up for between 1 - 3 BP global partnership opportunities:
1. Abivertinib ..SRNE told us they're requesting pre-NDA meetings with FDA and it's counterparts in major worldwide markets
2. Mpro/STI-1558 ..P1 results from Oz and China will be known by year end
3. SEMDEXA ..Scilex IPO keeps getting moved back because Scilex is liking waiting for an answer from FDA, gotta be coming soon !!!
A partnership would come with a large upfront milestone payment, and include multiple other milestones structured around CT success, NDA approval, min. percentage sales royalty, etc.
What would be the impact of one BP partnership to SRNE's SP ? I believe our chances for at least two partnership deals in the next 6-9 months are very good."
At this point no-one has said that Sorrento is a major player in the the field. However they are mentioned in the report you posted.
"Companies Mentioned
3M
Zosano Pharma
Becton-Dickinson Technologies
Nanopass Technologies
Corium
Valeritas
Microdermics
TheraJect Inc.
LTS Lohmann Therapie-Systeme AG
BioSerenTach (BT)
Sorrento Therapeutics
Debiotech
Raphas Co. Ltd.
QuadMedicine
SNvia
NanoBiosciences"
Lymphatic system is vital to good health!
https://www.cancercenter.com/lymph-nodes
SOFUSA is a big deal!
"Drug targets for many diseases of the immune system (e.g., autoimmune diseases and cancer) reside in the lymphatic system and lymph nodes. In multiple pre-clinical models, Sofusa’s proprietary nanotopography-draped microneedle system has consistently demonstrated the ability to improve therapeutic responses by delivering over 40-fold increases in drug concentration to targeted lymph nodes when compared to traditional subcutaneous injections or intravenous infusions. "
Only 2 trading days until Morgan Stanley 20th Annual Global Healthcare Conference.
Location: New York City
Dates: September 12 - 14, 2022
Company Presentation: September 14, 2022, at 8:00 am Eastern time
The August Corporate Presentation does seem to highlight ABIVERTINIB, Mpro, Virex and SEMDEXA.
But we know that beside these top 4 multibillion $ programs they are advancing many other high potential programs. e.g. PD-L1, ADNAB, DAR-T, RTX, SOFUSA!
My assumption is that the top 4 programs are closest to market...but it would be nice to also hear something about the others.
https://investors.sorrentotherapeutics.com/static-files/ded13448-aa64-4405-a2d9-de644cfe9dfc
It is great to see Ji's significant insider share purchases and the tutes very large accumulations. The Sept. 14 presentation is long overdue! But better late than never!
Sorrento Therapeutics to Participate in Morgan Stanley 20th Annual Global Healthcare Conference September 12-14
September 8, 2022
SAN DIEGO, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that Henry Ji, Ph.D.,
Chairman, President and Chief Executive Officer, and members of Sorrento’s executive team will participate the 20 th Annual Morgan Stanley Global
Healthcare Conference:
Morgan Stanley 20th Annual Global Healthcare Conference
Location: New York City
Dates: September 12 - 14, 2022
Company Presentation: September 14, 2022, at 8:00 am Eastern time
CEO Fireside Chat Format and Available for 1x1 Investor Meetings
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments),
autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immunooncology platforms, including key assets such as next-generation tyrosine kinase inhibitors (TKIs), fully human antibodies (“G-MAB™ library”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential
antiviral therapies and vaccines against coronaviruses, including STI-1558, COVISHIELD™ and COVIDROPS™; and diagnostic test solutions,
including COVIMARK™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist)
non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel)
(SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica,
and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II
trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial
C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in
March 2022. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com
Is Abivertinib anti-ARDS still alive?
Myra's boy sums it up...
" Veru down 20% after scheduled Oct 6 advisory committee meeting with FDA on their late stage covid drug EUA . To discuss the high placebo mortality rate and limited participation in trials among other things. Abivertinib and MSC are competing treatments. "
None of us little retail guys know what the big tutes know! Here are 6 reasons they are loading up...over 40% ownership now!
1. SEMDEXA completed PHASE 3 with excellent results.
2. ABIVERTINIB completed PHASE 3 with excellent results.
3. Anti-PD-L1 enrollment for a multi-regional PHASE 3 has completed after outstanding phase 2 results.
4. Mpro broad spectrum oral anti-viral to initiate PHASE 2/ 3 this year. Could include Australia, China, Mexico and US. Scientists expect Covid variants to persist.
5. VIREX prototype field testing for regulatory approval Q3/Q4 2022.
6. RTX two PHASE 2 studies are currently enrolling.
All 6 of these programs are potential blockbusters.
Jesspro...Yeah the big tutes have to own over 40% by now...they know what they are doing.
Here are 6 Sorrento programs which are advancing nicely.
*SEMDEXA completed PHASE 3 with excellent results.
*ABIVERTINIB completed PHASE 3 with excellent results.
*Anti-PD-L1 enrollment for a multi-regional PHASE 3 has completed.
*Mpro to initiate PHASE 2/ 3 this year. Could include Australia, China, Mexico and US.
*VIREX prototype field testing for regulatory approval Q3/Q4 2022.
*RTX two PHASE 2 studies are currently enrolling.
Mpro (STI-!558) could be a worldwide gamechanger. Trials now in Australia and China and Phase 2/3 planned for US and Mexico. Obviously one of Sorrento's priorities.
• Targeting the virus main protease (Mpro): interrupting virus replication
• STI-1558 is designed with the following properties:
• STI-1558 is a prodrug, and its active form AC1115 binds to Cys-145 of catalytic domain of Mpro , which is highly conserved in all SARS-CoV-2 variants and achieves a broad-spectrum anti-SARS-CoV-2 activity, including against the original SARS-CoV-2 strain as well as the predominant variants of concern (VOCs), such as Delta and
Omicron.
• STI-1558 is also a Cathepsin L inhibitor, which may block effective viral entry into host cells without accelerating viral mutations.
• Oral bioavailability up to 85% with fast absorption and enhanced drug exposure in plasma allowing early treatment of COVID at home by oral administration.
• Avoids the use of a potent CYP3A4 inhibitor (e.g., ritonavir) as booster to increase the plasma exposure allowing for standalone treatment with low risk for drug interaction.
• A drug product with robust formulation, stability and large-scale drug substance manufacture with controlled cost allowing for global accessibility and application.
See: Jeong, G. U., et al. (2020). "Therapeutic Strategies Against COVID-19 and Structural Characterization of SARS-CoV-2: A Review." Frontiers in Microbiology 11(1723).
The August Corporate Presentation does seem to highlight ABIVERTINIB, Mpro, Virex and SEMDEXA.
But we know that beside these top 4 multibillion $ programs they are advancing many other high potential programs. e.g. PD-L1, ADNAB, DAR-T, RTX, SOFUSA!
My assumption is that the top 4 programs are closest to market.
https://investors.sorrentotherapeutics.com/static-files/ded13448-aa64-4405-a2d9-de644cfe9dfc
I don't recall Henry doing much insider buying...is this a signal?
https://www.conferencecalltranscripts.com/summary/?id=11231787
August 2022 Corporate Presentation...very well done.
ABIVERTINIB, Mpro, VIREX and SEMDEXA are looking good!
https://investors.sorrentotherapeutics.com/static-files/ded13448-aa64-4405-a2d9-de644cfe9dfc
Share price if only SEMDEXA, ABIVERTINIB, Mpro and DAR-T succeed?
1. SEMDEXA
2. RTX
3. COVIMARK
4. VIREX
5. Mpro
6. OQORY(COV-MSC)
7. FUJOVEE (Abivertinib) cancer
8. DAR-T cancer
9. ADNAB cancer
10. PD-L1 in China and US
11. SOFUSA, and the special case,
12. PSS arbitration settlement
SORRENTO is not a one trick pony!
I agree with those who think SEMDEXA will be a big winner.
But don't underestimate the cancer portfolio. The ABIVERTINIB long term data is outstanding. The ADNAB partnership with MAYO clinic is exciting. Several PD-L1's look great and DAR-T has huge potential!
And COVID variants mean COVIMARK and Mpro and Virex could have very big news next fall and winter.
SORRENTO is not a one trick pony!
Here is the background about DAR-T from last years press release.
Sorrento Receives FDA Authorization to Start Phase 1 Clinical Trial of Proprietary, "Off-the-Shelf", Allogeneic anti-CD38 DAR-T (Dimeric Antigen Receptor-T) Cell Therapy to Treat Relapsed or Refractory Multiple Myeloma
August 2, 2021 at 9:00 AM EDT
*First allogeneic, off-the-shelf anti-CD38 DAR-T cell therapy cleared for Phase 1 clinical trial in Relapsed or Refractory Multiple Myeloma.
*CD38 DAR-T is the first allogeneic, off-the-shelf clinical-stage cellular therapy product candidate based on Sorrento’s proprietary Dimeric Antigen Receptor (DAR) – T cell platform.
*DAR-T product candidates enabled by Sorrento’s proprietary KOKI technology offer potential advantages over conventional Chimeric Antigen Receptor (CAR) – T cell therapies, including improved target specificity and functionality, which may reduce potential undesirable side effects and toxicity.
*Sorrento has built a product pipeline of over a dozen potential DAR-T cell product candidates targeting hematologic and solid tumors using its proprietary KOKI engineering and manufacturing approach, paving the way for the rapid advancement of DAR-T product candidates into clinical testing.
SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the FDA has authorized Sorrento’s IND application for the Phase 1 clinical testing of its allogeneic anti-CD38 Dimeric Antigen Receptor (DAR) - T Cell therapy for relapsed or refractory multiple myeloma. The proprietary CD38 DAR-T cell therapy candidate demonstrated strong cytotoxic activity in preclinical studies. DAR-T product candidates are produced using Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology, which potentially allows for improved specificity, stability and potency, and enables an off-the-shelf treatment approach, thereby eliminating the need for patients to undergo leukapheresis and undesirable treatment delays to perform cell harvesting, manufacturing and release prior to treatment for each individual cancer patient.
Sorrento’s KOKI-enabled DAR-T platform uses DAR-modified T cells from a normal healthy donor which are engineered to be specific to the cell surface marker of interest, in this case CD38, a clinically validated antigen in myeloma, to target tumor cells. The combination of KOKI and DAR-T technologies offers potential advantages over conventional CAR-T therapies, including removing the ability for DAR-expressing T cells to illicit undesired immune reaction to the cancer patient, thereby reducing or eliminating the possibility of graft versus host disease (GvHD) following treatment. Additionally, once DAR-T cells are manufactured, they can be stored at the clinic site, allowing patients to be screened and treated within days. This is compared to existing approved CAR-T therapies, which typically require 6-8 weeks of screening, cell production and qualification before a patient can receive treatment. Because of this timeframe, it is not unusual for cancer patients to no longer be eligible for CAR-T treatment due to disease progression. Also, autologous CAR-T cells pose several manufacturing challenges, including issues that relate to quality control and single-lot-release, and often do not meet the release criteria following the manufacturing process. DAR-T technology is designed to potentially provide a significant advancement to the timeliness and potency of treatments for patient populations who have already undergone multiple rounds of chemotherapy and are suffering from persistent disease.
DAR-T technology is readily adaptable to dozens of cancer targets and Sorrento has developed a preclinical product pipeline with specific fully human antibodies discovered from Sorrento’s G-MAB™ library. Sorrento expects to file additional IND applications now that the first DAR-T Phase 1 trial has been cleared to proceed by the FDA.
“This FDA clearance of our first allogeneic DAR-T cell therapy is a seminal event for our cutting-edge KOKI and DAR-T technologies,” said Henry Ji, Ph.D., Chairman and CEO of Sorrento. “We foresee the first “Off-the-Shelf" DAR-T trial will open the door to numerous other DAR-T cell therapies for other indications to follow.”
About the DAR-T™ Platform
Sorrento’s DAR-T technology is a proprietary, next-generation cell therapy platform that offers potential advantages over conventional Chimeric Antigen Receptor (CAR) T cell therapy:
The proprietary DAR construct utilizes a natural antibody Fab (antigen-binding fragment) structure instead of an artificial scFv (single-chain variable fragment) sequence.
Preclinical in vitro and in vivo studies have demonstrated that DAR-T cells provide better target specificity and functionality, due to higher inherent stability of the Fab and stronger affinity of DAR vs. CAR receptors on the T cell surface.
DAR-T cells may reduce potential undesirable side effects, such as CAR-T induced cytokine release syndrome (CRS) and graft-versus-host disease (GvHD).
About KOKI™ Technology
Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology provides DAR-T cells with several potential benefits over virus-based transduction currently used for CAR-T therapies:
“Off-the-Shelf": DAR-T cells are cryo-preserved engineered T cells designed to be delivered to patients on-demand without delays in treatment due to the lengthy and individualized manufacturing process for CAR-T.
“Allogeneic”: DAR-T cells are produced from pre-screened healthy volunteers; while autologous CAR-T cells are patient-specific and made from and for individual cancer patients.
“Mass Production”: DAR-T cell manufacturing is scalable (potentially hundreds to thousands of doses per manufacturing run) and can meet high demand while autologous CAR-T cell therapy requires a single-lot-release process that can only be performed one patient at a time.
DAR-T news coming?