The Daily Biotech Pulse: Veru Seeks Emergency Use Nod For COVID-19 Therapy, Vincerx Cuts Workforce, Moderna Starts Dosing In Flu Vaccine Study

Zinger Key Points
  • Ginkgo Bioworks has collaborated with Novo Nordisk to unlock the potential of expression systems.
  • Moderna has dosed the first participants in a Phase 3 study of its seasonal influenza vaccine candidate.

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 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 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 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 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 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. IMTX and Editas Medicine Inc 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 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 DNA has collaborated with Novo Nordisk A/S 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 PDSB: Preliminary Phase 2 results of PDS0101 and pembrolizumab combo in recurrent or metastatic head and neck cancer.

Elevation Oncology Inc ELEV: Initial efficacy and safety of seribantumab in solid tumors harboring NRG1 fusions.

Jazz Pharmaceuticals plc JAZZ: Efficacy and safety of intramuscular recombinant Erwinia asparaginase in acute lymphoblastic leukemia or lymphoblastic lymphoma.

Offering

Evaxion Biotech A/S 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 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 AIKI reverse stock split at a ratio of 1 for 17 effective at 12:01 a.m. ET today.

Posted In: CoronavirusCovid-19John RakowRupert D'SouzaBiotechNewsPenny StocksHealth CareSmall CapFDAManagementStock SplitGeneral

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