Following a recent string of approvals for their jointly developed COVID-19 vaccine, BNT-162b2, Pfizer Inc. and Biontech SE said Monday that results from an ongoing German trial have helped illustrate "the multiple arms of the immune system that are activated" by the product to fight SARS-CoV-2. Separately, Moderna Inc. raised to 200 million the number of doses of its COVID-19 vaccine candidate, mRNA-1273, it will supply to the U.S. government while also confirming a new agreement to supply the vaccine to Singapore.

Let the vaccinations begin

A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup. With all the necessary greenlights, distributors began shipping 2.9 million vaccine doses across the U.S. early this morning. Fedex reportedly delivered its first vaccine shipment to a Massachusetts hospital before 6 a.m. today and anticipated making vaccine deliveries to nearly 80 different facilities before day’s end. UPS also is making vaccine deliveries, expediting them through Next Day Air to select hospitals, clinics and other medical facilities to inoculate health care workers. “This is undoubtedly a historic feat not only for vaccine development but also expedient deployment,” said Mike McDermott, president of Pfizer Global Supply.

Codagenix starts human study of COVID-19 vaccine; final Sputnik data unveiled

LONDON – The U.K. Medicines and Healthcare products Agency has given approval for the first-in-human study of Codagenix Inc.’s COVI-VAC, a live, attenuated whole virus COVID-19 vaccine, which is engineered to be structurally identical to wild type SARS-CoV-2, but is much slower to replicate. The study will evaluate safety and immunogenicity of intranasally administered COVI-VAC in 48 healthy volunteers, aged 18 to 30, at the quarantine facility in London run by the contract research organization Open Orphan plc. COVI-VAC is exactly the same as circulating SARS-CoV-2 at the amino acid level, meaning it looks the same as the wild type virus to the human immune system. It therefore has the potential to induce broad antibody, T cell and mucosal immunity with a single intranasal dose. The go-ahead for a phase I test of COVI-VAC in volunteers came as the Gamaleya National Center of Epidemiology and Microbiology in Russia announced its Sputnik V vaccine was 91.4% effective at the third and final interim analysis of the ongoing phase III trial.

A bigger bang: Astrazeneca acquires Alexion for $39B

In the biggest deal of a year packed with massive deals, Astrazeneca plc will buy Alexion Pharmaceuticals Inc. in a cash and stock transaction at $175 per share totaling $39 billion. Bringing Alexion into the Astrazeneca fold enhances its position in immunology and rare diseases. Astrazeneca, which is currently chasing a COVID-19 vaccine with its partner the University of Oxford, said it will build Alexion’s pipeline of 11 molecules in more than 20 clinical development programs. Astrazeneca officials said they expect the combined company to deliver double-digit average annual revenue growth through 2025.

Relay Therapeutics signs deal with Genentech for its SHP2 inhibitor

Cambridge, Mass.-based Relay Therapeutics Inc. has signed a lucrative worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development and commercialization of its compound, RLY-1971, a potent inhibitor of SHP2 that is being investigated in a phase I dose-escalation study in patients with advanced or metastatic solid tumors. In addition to a $75 million up-front payment, the company will be eligible to receive $25 million in additional near-term payments. The value of the downstream payments related to the deal will depend on whether it decides to opt into a 50-50 U.S. profit-cost share on RLY-1971. If Relay decides not to opt into the development program, it will be in line for up to $695 million in additional potential milestones, plus royalties on global net product sales.

Scineuro launches with $100M series A to target CNS

Scineuro Pharmaceuticals, based in Shanghai and Philadelphia, launched with a $100 million series A financing to focus on tackling central nervous system diseases. CEO Min Li told BioWorld the startup is now “building a CNS portfolio through a combination of internal R&D and strategic collaborations.” Lilly Asia Ventures Fund and Arch Venture Partners co-led the round.

Chimeric closes AU$35M IPO to progress CAR T made from scorpion toxin

PERTH, Australia – Chimeric Therapeutics Ltd. closed an IPO on the Australian Securities Exchange (ASX:CHM), raising AU$35 million (US$26.5 million) to fund its CAR T trial in glioblastoma. “The directors believe Chimeric will be the only company on the ASX conducting CAR T clinical trials, and possibly the only one in Australia,” the company’s prospectus said. The offer closed early on Dec. 10, and the Sydney-based company expects to begin trading on the ASX by Jan. 18, 2021.

Takeda wins China NMPA approval for Takhzyro for HAE prophylaxis

HONG KONG – Takeda Pharmaceutical Co. Ltd. has received Chinese approval for Takhzyro (lanadelumab), its fully human monoclonal antibody, delivered via subcutaneous injection, for prophylaxis to prevent attacks of hereditary angioedema in patients 12 and older.

China’s I-Mab progresses anti-CD47 monoclonal antibody, caps strong financial year

Three months after completing what it said was the largest development and commercialization deal by a Chinese biotech, I-Mab Biopharma Co. Ltd. is moving the monoclonal antibody at the heart of the deal deeper into the clinic. At the end of November, Chinese regulators gave it a green light to move forward with an open-label, multicenter trial for the anti-CD47 candidate, lemzoparlimab, in combination with azacitidine, a hypomethylating agent, in untreated acute myeloid leukemia or myelodysplastic syndrome.

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