Novavax Inc., of Gaithersburg, Md., is on the receiving end of $1.6 billion in government funding after being selected to participate in Operation Warp Speed, a taxpayer funding drive to deliver a COVID-19 vaccine in 2021. Novavax is now taxed with completing the late-stage clinical development, testing, manufacturing and delivery of 100 million doses of NVX-CoV2373, the company’s candidate engineered from the genetic sequence of SARS-CoV-2, by the end of this year. Novavax stock (NASDAQ:NVAX) reacted well to the news as shares ratcheted solidly upward 30% in midday trading Tuesday.

Corvus shares soar on COVID-19 immunotherapy bid’s progress

Shares of Burlingame, Calif.-based Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) were trading midday at $5.58, up $2.84, or 103%, on word of a phase I study starting to investigate an immunotherapy approach for patients with COVID-19. The first cohort of five patients enrolled in the study was treated at Temple University Hospital in Philadelphia. Expected to enroll up to 30 patients at several sites in the U.S., the experiment is testing an agonistic humanized monoclonal antibody, CPI-006, which in in vitro and in vivo studies in cancer patients showed binding to various immune cells and the inducement of a humoral adaptive immune response – B-cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin (IgM and IgG) antibodies. Administration of CPI-006 has also led to increased levels of memory B cells, the company said. Especially intriguing was news of a recently enrolled patient with advanced metastatic non-small-cell lung cancer who was diagnosed with concomitant COVID-19 and remained asymptomatic from the virus following treatment with CPI-006.

India’s first COVID-19 vaccine to enter human trials

Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has already been granted permission by the Drug Controller General of India and Ministry of Health & Family Welfare to initiate phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.

Deal values rise with 15 above $1B in 2020’s second quarter

Despite the SARS-CoV-2 pandemic, biopharma dealmaking values in the second quarter of 2020 increased by 22.4% since the first quarter, and M&A values – thanks to Abbvie Inc. completing in May its $63 billion buyout of Allergan plc – are at a four-year high. A total of 529 deals reported had projected values of nearly $49 billion, a step up from the 471 deals and $40.8 billion value of the first quarter. In comparing 2020 to each of the previous three years, the second quarter has had the highest volume and value for any of the past 14 quarters. Abbvie’s purchase of Allergan, the fourth largest M&A in BioWorld’s database, accounted for about 85% of the $74 billion total from 39 completed M&As in the second quarter.

Patient death in Cellectis CAR T trial triggers clinical hold

Cellectis SA said the FDA has placed a clinical hold on a phase I study of UCART-CS1A, an allogenic CAR T-cell therapy it has been testing in patients with relapsed or refractory multiple myeloma, after one person enrolled in the study died from a case of treatment-emergent cardiac arrest. Clinical evaluation of the case is underway, the company said. U.S.-listed shares of the Paris-based biotech (NASDAQ:CLLS) fell 14.3% by midday to $16.26.

Gesynta raises $21M to test novel mechanism in systemic sclerosis

DUBLIN – Gesynta Pharma AB raised SEK190 million (US$20.6 million) in new funding to move GS-248, a selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), into a phase IIa trial in systemic sclerosis. The study is due to get underway toward the year end. “It’s going to be in the second half of the fourth quarter,” Patric Stenberg, CEO of Lund, Sweden-based Gesynta told BioWorld. “It’s the microvascular dysfunction we’re targeting in patients,” he said. “It’s the major debilitating feature of systemic sclerosis.”

Free access to BioWorld coronavirus articles

The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. Note that we have added three critical tables which are constantly updated:

• Vaccines and therapeutics in development

• Diagnostics on the market and in development

• Clinical trials of biopharma and med-tech products affected by COVID-19

Also in the news

7 Hills, Accudata Solutions, Akers, Aldeyra, Algernon, Allovir, Annovis, Apellis, Arca, Artisan, Ascendis, Azzur, Biothera, Boehringer Ingelheim, Byondis, Cabaletta, Cellectis, Cellenkos, Clarametyx, Cohbar, Corvus, Curis, Cybin, Cybrexa, Cyteir, Cytoagents, Diffusion, Editas Medicine, Elasmogen, Endo International, Entera, Evive, Evolus, Hemostemix, Hepion, Hibercell, Inmed, Innovation, Insmed, Intelgenx, Inventiva, Lipidor, Maia, Mallinckrodt, Merck KgaA, Molecular Partners, Nasus, Neurogene, Novartis, Novocure, Numab, Onconova, Oryzon, Otonomy, Outlook, Pacgen, Pear, Plakous, Poseida, Predictive Oncology, Premas, Prolynx, Quantitative Medicine, Rakuten Medical, Regeneron, Reven, Revolution Medicines, Senhwa, Sunovion, Tenax, Tessera, Therapeutic Solutions, Theratechnologies, Tonix, Turning Point, Viiv, Vor, Zai Lab