Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Veru Files Emergency Use Application For Its COVID-19 Treatment
Veru Inc (NASDAQ:VERU) has submitted an emergency use authorization application to the FDA for the use of sabizabulin for COVID-19 treatment.
The application covers moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome.
Shares are up 3.98% at $14.11 during the premarket session.
Delcath Systems Eye Cancer Trial Data Update At ASCO Meeting
Delcath Systems Inc (NASDAQ:DCTH) announced further details regarding presentations relating to its proprietary percutaneous hepatic perfusion (PHP) system.
The CHOPIN trial assessed ipilimumab plus nivolumab (IPI+NIVO) combined with Delcath's proprietary liver-targeted PHP treatment in metastatic uveal melanoma patients.
The poster reports a Best Overall Response of 1 complete response, five partial responses, and one stable disease accounting for an Objective Response Rate of 85.7%.
Adverum's CFO Resigns
Adverum Biotechnologies Inc's (NASDAQ:ADVM) CFO Rupert D'Souza, advised the company that he was resigning, effective immediately.
John Rakow, General Counsel of Adverum, became senior vice president and acting CFO.
Vincerx Streamlines, Realigns Resources
Vincerx Pharma Inc (NASDAQ:VINC) is prioritizing Phase 1b VIP152 studies to focus on double-hit diffuse large B-cell lymphoma and chronic lymphocytic leukemia.
The company will continue to advance the next-generation modular bioconjugation platform. IND filings for VIP236 in 2H22 and VIP943 in 2H23 remain on track.
Vincerx will cut 33% of its workforce. Streamlining and realigning resources will extend the estimated cash runway into late 2024.
Related Link: The Week Ahead In Biotech (June 5-11): Adcom Test For Novavax, ASCO Presentations, Enzo Biochem Earnings And More
Kiromic Stock Surges On Research Pact For Gamma Delta T cell Product Pipeline
Kiromic BioPharma Inc (NASDAQ:KRBP) has entered into a two-year sponsored research agreement (SRA) with Principal Investigator James Welsh of The University of Texas MD Anderson Cancer Center.
In vivo preclinical data will be generated from Kiromic's Gamma Delta T cell allogeneic therapies.
This SRA will evaluate efficacy and patient safety outcomes to support three new investigational drug applications (for Procel, Isocel, and Deltacel) to the FDA.
Shares are surging 159% at 73 cents during the premarket trading.
Immatics, Editas Medicine Ink Cancer Therapy Pact
Immatics N.V. (NASDAQ:IMTX) and Editas Medicine Inc (NASDAQ:EDIT) have entered into a strategic research collaboration and licensing agreement to combine gamma-delta T cell adoptive cell therapies and gene editing cancer therapies.
Immatics gains non-exclusive rights to Editas Medicine's CRISPR technology and intellectual property as part of the licensing agreement.
Specific deal terms were not disclosed.
Moderna Starts Dosing In Flu Vaccine Study
Moderna Inc (NASDAQ:MRNA) has dosed the first participants in a Phase 3 study of its seasonal influenza vaccine candidate (mRNA-1010).
The trial is expected to enroll approximately 6,000 adults in Southern Hemisphere countries.
The Phase 3 randomized, observer-blind study evaluates the safety and immunological non-inferiority of mRNA-1010 as a licensed seasonal influenza vaccine in adults.
Ginkgo Bioworks, Novo Nordisk Collaborate For Expression Hosts For Pharmaceutical Products
Ginkgo Bioworks Holdings Inc (NYSE:DNA) has collaborated with Novo Nordisk A/S (NYSE:NVO) to unlock the potential of expression systems, which may accelerate and enhance the discovery and development of Novo Nordisk's biological medicines.
Under the terms of the partnership, Ginkgo and Novo Nordisk will launch a multi-year collaboration. Ginkgo will receive an upfront R&D fee and is eligible to receive milestone payments.
Clinical Readouts/Presentations
American Society of Clinical Oncology (ASCO) Presentations
PDS Biotechnology Corp (NASDAQ:PDSB): Preliminary Phase 2 results of PDS0101 and pembrolizumab combo in recurrent or metastatic head and neck cancer.
Elevation Oncology Inc (NASDAQ:ELEV): Initial efficacy and safety of seribantumab in solid tumors harboring NRG1 fusions.
Jazz Pharmaceuticals plc (NASDAQ:JAZZ): Efficacy and safety of intramuscular recombinant Erwinia asparaginase in acute lymphoblastic leukemia or lymphoblastic lymphoma.
Offering
Evaxion Biotech A/S (NASDAQ:EVAX) has secured equity financing of up to $40 million from Lincoln Park Capital Fund.
Evaxion had cash and cash equivalents of $31.4 million at the end of Q1 and expects its cash position, without proceeds from the Agreement, to be sufficient to fund the operations through at least the next 12 months.
Shares are up 5.11% at $1.85 during the premarket trading session.
On The Radar
Adcom Calendar
The Vaccines and Related Biological Products Advisory Committee meeting to discuss Novavax Inc's (NASDAQ:NVAX) emergency use authorization request for its vaccine to prevent COVID-19 in individuals 18 years of age and older.
Stock Split
AIkido Pharma Inc (NASDAQ:AIKI) reverse stock split at a ratio of 1 for 17 effective at 12:01 a.m. ET today.
