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COVID-19 roundup: BioNTech, Pfizer co-developing vaccine, plus updates from Regeneron, Novartis, CureVac, Fujifilm and CanSino

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Biopharma companies stretching from Asia to the U.S. and Europe Tuesday announced a flurry of deals, new initiatives and clinical updates for therapeutic and vaccine approaches to address the COVID-19 pandemic, including a partnership between BioNTech and Pfizer that sent the German mRNA player’s value up nearly $7 billion.

BioNTech SE (NASDAQ:BNTX) climbed $26.60 (67%) to $66.60 on Tuesday, giving it a market cap of nearly $17 billion, after announcing a co-development agreement with Pfizer Inc. (NYSE:PFE) for BNT162, the biotech’s mRNA-based COVID-19 vaccine candidate. The urgency to develop the program is marked by the fact the partners expect to start the collaboration immediately while financial terms of the deal are finalized over the coming weeks. The companies partnered in 2018 to develop an influenza vaccine.

The deal comes one day after BioNTech said BNT162 would start clinical testing in late April, and the company partnered with Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196) to jointly develop the vaccine in China (see “BioNTech Starting Trial, Enters Deal with Fosun”).

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) announced plans to start large-scale manufacturing of an antibody cocktail to treat COVID-19 by mid-April and said clinical trials could start by early summer. The company, whose shares gained $50.86 (12%) to $491.69, said it will choose two antibodies for the cocktail based on potency, SARS-CoV-2 spike protein binding affinity and “other desirable qualities.” According to Regeneron spokesperson Alexandra Bowie, for the third criterion, the company is primarily searching for mAbs that are non-competing and bind different epitopes.

Bowie also told BioCentury potency will be evaluated in cell culture using pseudovirus cell entry and viral replication assays; and in animal tests with weight loss, lung inflammation and mortality as readouts.

The antibodies will be selected from hundreds of human antibodies that neutralize SARS-CoV-2, generated against the novel coronavirus via Regeneron’s transgenic VelocImmune mice platform, and the anti-SARS-CoV-2 antibodies it isolated from COVID-19 patients who have recovered.

To enable clinical mAb production immediately after lead antibodies are chosen, Regeneron will prepare manufacturing-ready cell lines using its VelociMab platform.

Novartis AG (NYSE:NVS; SIX:NOVN) unveiled a series of initiatives Tuesday, including the creation of the Novartis COVID-19 Response Fund. The fund will provide $20 million in grants, each for up to $1 million, for public health initiatives including funding for additional medical personnel and drug and medical equipment sourcing; establishing digital platforms for data collection, remote delivery of healthcare and public health information dissemination; and creation or enhancement of community health programs related to the outbreak.

Novartis also joined a COVID-19 partnership organized by the Innovative Medicines Initiative (IMI) and a collaboration among The Bill & Melinda Gates Foundation, the Wellcome Trust and Mastercard to fund a COVID-19 Therapeutics Accelerator (see “Gates, Wellcome Trust and Mastercard Commit $125M to COVID-19 Therapies”).

Additionally, the Swiss pharma will make available several compounds from its libraries that are suitable for in vitro antiviral testing and is determining whether any of its existing products can be repurposed to treat COVID-19.

The European Commission is providing German biotech CureVac AG an EU-guaranteed €80 million ($88.0 million) EIB loan to expand its COVID-19 mRNA vaccine manufacturing capacity. Deputy CEO Franz-Werner told investors on Tuesday that the company has more than a year of cash runway, but expects to have additional funding come in from other parties to support development of its vaccine.

The company plans to begin clinical development in early summer.

Favipiravir, marketed as Avigan by Fujifilm Holdings Corp. (Tokyo:4901), has shown efficacy in COVID-19 patients according to state-run newspaper China Daily. The Third People’s Hospital of Shenzhen showed improvement of lung symptoms as detected by chest imaging in 91% of treated patients vs. 62% of control patients; patients receiving favipiravir were also quicker to test negative for the virus. Researchers have recommended the viral RNA polymerase inhibitor be included in China’s treatment guidelines for the coronavirus outbreak.

In February, China’s National Medical Products Administration (NMPA) approved a generic form of favipiravir from Zhejiang Hisun Pharmaceutical Co. Ltd. (Shanghai:600267) to treat influenza infection and a clinical trial application from the company for COVID-19. Sihuan Pharmaceutical Holdings Group Ltd. (HKSE:460) began clinical testing of favipiravir for the coronavirus in early February. In a March regulatory filing on the Hong Kong stock exchange, the company said that if approved, it would provide the drug to COVID-19 patients free of charge.

CanSino Biologics Inc. (HKEX:6185) and the Academy of Military Medical Sciences have submitted a pre-IND review application to regulatory authorities and are preparing for clinical trials evaluating a COVID-19 vaccine in healthy volunteers. The vaccine candidate is an adeno-associated virus serotype 5 (AAV5) vector encoding the SARS-CoV-2 spike protein.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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