CStone and Pfizer announce China approval of sugemalimab in lung cancer

 

• The National Medical Products Administration approved sugemalimab for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy
• Sugemalimab became the first anti-PD-1/PD-L1 monoclonal antibody approved for stage III NSCLC following concurrent or sequential chemoradiotherapy. It's also the only anti-PD-(L)1 monoclonal antibody approved for both stage III and stage IV NSCLC
• This is the eighth approved new drug application (NDA) for CStone

https://www.biospace.com/article/releases/cstone-and-pfizer-announce-nmpa-approval-of-sugemalimab-in-patients-with-unresectable-stage-iii-non-small-cell-lung-cancer/

BioNTech Personalized Therapy Safe In Pancreatic Cancer in Early Data

 

• BioNTech SE (NASDAQ: BNTX) announced initial data from the Phase 1 study of mRNA-based individualized neoantigen-specific immunotherapy (iNeST), autogene cevumeran.

• The study assesses cevumeran combined with Tecentriq (atezolizumab) and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC).

• The preliminary results showed a favorable safety profile and encouraging signs of clinical activity.

• Autogene cevumeran is the lead candidate from BioNTech's iNeST platform, jointly developed with Genentech, a unit of Roche Holdings AG (OTC: RHHBY), in multiple solid tumor indications.

• 19 PDAC patients underwent surgery and were given Genentech's Tecentriq. Sixteen were then given BioNTech's jab at 9.4 weeks post-surgery.

• The combo treatment was well-tolerated, noting one patient had a Grade 3 fever and hypertension due to the vaccine. There were no other Grade 3, or higher adverse events reported.

• The combo also induced new neoantigen-specific T cell response in eight of the 16 patients, BioNTech reported.

• The companies plan to move toward a randomized study of autogene cevumeran as a post-primary treatment for pancreatic cancer.

• The cancer vaccine is also being tested in a Phase 2 trial as an adjuvant treatment for post-operative circulating tumor DNA-positive, surgically resected colorectal cancer.

• Another Phase 2 study is testing the vaccine in combination with Merck & Co Inc's (NYSE: MRK) Keytruda as a first-line treatment for advanced melanoma.

https://finance.yahoo.com/news/early-data-shows-biontechs-personalized-111131164.html

Lilly Stock Gains On Impressive Data From Jardiance Diabetes Drug Trial

 Eli Lilly  (LLY) - Get Eli Lilly and Company Report shares moved higher Monday after the drugmaker published final data from a major clinical trial that showed a reduction in heart failure risk for patients with type-2 diabetes. 

The five-year study found that Jardiance, which Eli Lilly is developing with Germany's Boehringer Ingelheim, showed a 40% reduction in "relative risk of all-cause mortality", compared to patients using standard DPP-4 inhibitors, as well as a 12% reduction in the risk of the myocardial infarction, or stroke risks in adults with type 2 diabetes in routine care.

Jardiance, which was first approved as a diabetes treatment by the U.S. Food and Drug Administration in 2014, generated around $420 million in sales for Eli Lilly last quarter, a 34% increase from the same period last year. 

https://www.thestreet.com/markets/eli-lilly-stock-gains-on-impressive-data-from-diabetes-drug-trial

Intercept Update on NASH Regulatory Timeline

 Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral liver diseases, today announced an update on the timing of its pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the potential resubmission of its nonalcoholic steatohepatitis (NASH) New Drug Application (NDA) based on an interim analysis of the REGENERATE trial in patients with fibrosis due to NASH. The pre-submission meeting, previously scheduled in June, has been moved to July following a recent request from the FDA that topline data from REGENERATE be provided to the agency for its review prior to the meeting.

Intercept anticipates that topline data from REGENERATE will be available and made public in July.

https://finance.yahoo.com/news/intercept-provides-nash-regulatory-timeline-103000629.html

Adicet Bio: Strong interim Phase 1 survival rates reported at ASCO

 ADI-001 demonstrated 75% CR and ORR rate across all dose levels with favorable safety and tolerability profile in patients with relapsed/refractory high grade aggressive Non-Hodgkin’s Lymphoma (NHL), as of May 31, 2022 data-cut date

80% ORR and CR rate at dose levels 2 and 3 combined

100% ORR and CR rate in three anti-CD19 CAR-T relapsed patients

50% of evaluable patients with at least six months follow-up remain cancer free

Dose-related increase of ADI-001 exposure observed in blood

Company expects to identify recommended Phase 2 dose in second half of 2022 and initiate at least one potentially pivotal study in first half of 2023

https://finance.yahoo.com/news/adicet-bio-reports-emerging-data-110000994.html

Quoin: 1st Invisicare Product to Receive U.S. FDA Application Acceptance

 Skinvisible, Inc. ("Skinvisible") (OTCQB:SKVI), is pleased to announce that its licensee Quoin Pharmaceuticals, Inc. ("Quoin") (NASDAQ:QNRX), has received U.S. FDA acceptance of its Investigational New Drug (IND) application for its licensed formulation which uses Skinvisible's Invisicare® proprietary drug delivery technology. The topical formulation "QRX003" was developed to treat Nethertons Syndrome, a debilitating hereditary disorder that affects the skin, hair and the immune system. There currently is no cure or approved treatment for Netherton Syndrome.

"This is the first IND approval by the FDA which includes our Invisicare technology as the delivery platform, and it further reinforces our vision of developing topical therapeutics for a number of key indications. It is an important milestone for Skinvisible and could potentially lead to other indications receiving approval," said Terry Howlett, President and CEO, Skinvisible. "With the IND approved, the clinical trial will be underway shortly. We look forward to assisting Quoin in their success and potential FDA approval as well as potentially bringing a treatment to patients suffering from Nethertons Syndrome."

Skinvisible granted Quoin an exclusive, royalty-bearing license to its technology for use in select Orphan Rare Skin Diseases and for the right to use its proprietary formula as well as its technology to develop products that will target a number of rare skin related indications. Quoin is responsible for obtaining all FDA and other regulatory body approvals necessary to market the products in the US and other countries. Upon the successful completion of various clinical and regulatory milestones, Skinvisible is entitled to receive a milestone payment of $5 million and ongoing royalties from sales.

https://finance.yahoo.com/news/skinvisible-announces-first-invisicare-delivery-120000428.html

Praxis Precision Medicines: Negative Results from Study in Major Depression

 Aria Study did not achieve statistical significance on the primary endpoint

Strategic realignment to focus resources on Movement Disorders and Epilepsy franchises extends cash runway into 2024

https://finance.yahoo.com/news/praxis-precision-medicines-reports-negative-114500212.html