FDA approves Keytruda in adjuvant setting for melanoma

CLINICAL AND REGULATORY

FDA’s Committee to discuss PD-1 inhibitor Tyvyt in February

FDA has set a date of February 10, 2022 for its Oncologic Drugs Advisory Committee to discuss Tyvytsintilimab from Innovent Biologics. The pharma submitted a BLA for the PD-1 inhibitor for the first line treatment of patients with Stage IIIB, IIIC, or Stage IV non-squamous NSCLC with no EGFR or anaplastic lymphoma kinase genomic tumor aberration in combination with pemetrexed and platinum-based chemotherapy. In China, Tyvyt is approved for several oncology indications, including non-squamous NSCLC, and priced at a “meaningful discount” to the US wholesale acquisition cost of current PD-1s.

CStone’s PD-L1 is China’s newest approved checkpoint inhibitor

CStone Pharmaceuticals said China’s National Medical Products Administration approved Cejemlysugemalimab plus chemotherapy to treat Stage IV NSCLC, making it the first PD-L1 inhibitor approved to treat first-line, metastatic squamous and non-squamous NSCLC; an NDA is under review in China for Stage III disease as well. Discounted therapeutics developer EQRx, newly public in the US, holds Cejemly’s rights outside of Greater China under an October 2020 deal.

DEALS AND FINANCING

After premium-priced STAR listing, BeiGene slips in first day

Beigene’s listing onthe Shanghai STAR Market netted ¥22 million ($3.4 billion) as the company became making it the first biotech firm to be listed on Nasdaq, the Hong Kong Stock Exchange, and the Shanghai STAR Market. About ¥15.3 million of the proceeds will be used for development of candidates in both preclinical and clinical trials. The company has so far won marketing approval for three of its self-developed drugs, namely zanubrutinib, tislelizumab, and pamiparib. It now expects more to be greenlighted and at a faster pace.BeiGene commanded a postmoney valuation of about $40.4 billion as it priced an offering on Shanghai’s STAR market, after which the oncology-focused biotech’s shares fell sharply. Shares of BeiGenewere down 16%, after the company sold 115.1 million shares at RMB192.60 in the offering. But that loss may be tied more to investor nervousness around the Omicron variant, several analysts suggested.The triple-listed company’s Shanghai offering price represented a 41% premium over BeiGene’s price per ADS on NASDAQ, and a 34% premium over its Hong Kong price. Underwriters are China International Capital, Goldman Sachs Gao Hua Securities, J.P. Morgan Securities (China), CITIC Securities and Guotai Junan Securities.

OncoMyx raised $50 million in Series B financing round

OncoMyx Therapeutics has raised a $50 million series B round, co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and the company’s Series A investors Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison Partners. Co-founded by Grant McFadden, Steve Potts and Michael Wood, OncoMyx is developing myxoma-based oncolytic viruses. Funds will be used to further develop the company’s platform and advance its lead candidate into clinical trials.

Bionaut andCandel partner on delivery of oncolytic viral immunotherapies

Bionaut Pharmaceuticals and Candel Therapeutics will collaborate to study Bionaut’s remote-controlled microscale robots for the precision delivery of Candel’s oncolytic viral immunotherapy agents to specific brain tumors. The agreement enables both parties to retain unencumbered rights to their respective platforms and rights for future clinical development together; financial details were not disclosed. Bionaut launched last March. Candel raised $79 million in a July IPO.