There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of its Smartkine cytokine drug platform.
As the American Society of Clinical Oncology meeting nears, presenters are talking up their prospects, including Biomea Fusion Inc. with early data from experiments testing BMF-219, an oral, irreversible covalent menin inhibitor – one in an intriguing class that has sparked efforts by various developers.
Juniper Biologics Pte. Ltd. has added another candidate to its pipeline in the space of less than a month. In the latest deal, the Singapore-based company inked an exclusive licensing agreement with Switzerland’s Helsinn Healthcare SA, gaining rights to develop and commercialize oncology drug infigratinib in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa.
Hansoh Pharmaceutical Group Co. Ltd. has acquired greater China rights to oncology candidate NKT-2152 from Nikang Therapeutics Inc. in a deal worth up to $218 million. Jiangsu, China-based Hansoh picked up exclusive rights to develop and commercialize the candidate in mainland China, Hong Kong, Macau and Taiwan. In turn, Nikang is eligible to receive $15 million up-front cash payment, as well as up to $203 million in potential development, regulatory and sales-based milestone payments, and tiered royalties.
Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Chimera Bioengineering Inc. has been selected as the winner of the Asian Fund for Cancer Research's (AFCR) 2021 BRACE Award Venture Competition, contributing $500,000 as part of a recent $7.5 million capital infusion and bringing to $26 million the company’s total amount raised to date.
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
South Korean companies Ubix Therapeutics Inc. and SK Biopharmaceuticals Co. Ltd. are partnering to develop targeted protein degradation cancer therapies.
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