FDA granted full approval to Padcev enfortumab vedotin-ejfv based on overall survival data from the confirmatory EV-301 trial. It also expanded the antibody-drug conjugate’s label to include patients with second-line locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy. In 2019, FDA granted accelerated approval for locally advanced or metastatic urothelial cancer patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery, or in a locally advanced or metastatic urothelial cancer setting.
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Padcev received regular approval in US and added a new indication
CLINICAL
Mersana initiated Phase 1 umbrella study to evaluated upifitamab rilsodotin in ovarian cancer
Mersana announced the initiation of patient dosing in UPGRADE Phase 1 dose escalation umbrella study to evaluate safety and efficacy of upifitamab rilsodotin (XMT-1536) in combination with other ovarian cancer therapies. To date, upifitamab demonstrated clinically meaningful activity and a differentiated tolerability profile without severe neutropenia, peripheral neuropathy or ocular toxicity in patients with heavily pretreated platinum-resistant ovarian cancer.
DEALS AND FINANCING
Keymed enters Hong Kong stock exchange with $2 billion post-money valuation
Keymed Biosciences gained HK$14.70 (28%) to HK$68, boosting its market cap to HK$18.4 billion ($2.4 billion). The company had sold a combined 58.3 million shares in its Hong Kong and international offerings, raising HK$3.1 billion, or about $400 million, at a postmoney valuation of HK$14.4 billion. The five-year-old company is seeking to develop treatments for autoimmune diseases and cancer, aided by its in-house platforms for discovery of antibodies as well as T cell-engaging bispecifics. Keymed’s most advanced program is CM310, which targets the α subunit of IL-4R to block both IL-4 and IL-13. The therapy is in Phase 2b testing for atopic dermatitis. Keymed’s pipeline also CM901, which the company believes is the first ADC targeting CLDN18.2 to reach clinical testing anywhere in the world.
ProfoundBio raised $55 million in Series A financing to advance its ADCs
ProfoundBio raised over $55 million in series A financing to advance its antibody-drug conjugate and immuno-oncology technology platforms. Lilly Asia Ventures and Lyfe Capital co-led the round, with participation from new investors Sequoia Capital China and Oriza Holdings and existing investors K2VC, Gaorong Capital and Chang'an Capital.
