Privately held Amphista Therapeutics Ltd. has cut massive deals with two biopharma giants, Merck KGaA and Bristol Myers Squibb Co. (BMS), that together could bring the company up to $2.25 billion. The companies will use Amphista’s Eclipsys platform to generate protein degrader-based therapeutics. Merck is looking to discover and develop small-molecule protein degraders for treating cancer and immune disease. Indications in the BMS deal were not announced.
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.
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).
Engimmune Therapeutics AG has raised CHF15.5 million (US$16.7 million) in a seed round, as it prepares to address efficacy and safety shortcomings that currently constrain T-cell receptor and soluble TCR cancer therapies. The Basel, Switzerland-based company’s technology brings together genome editing, functional screening, deep mutational sequencing and machine learning, to engineer synthetic T-cell receptors that are highly specific to a chosen tumor antigen, increasing affinity and safety and avoiding off-target effects.
Tubulis GmbH has added considerable momentum to its effort to build a pipeline of novel antibody-drug conjugates (ADCs) by closing a €60 million (US$63.2 million) series B round. CEO and co-founder Dominik Schumacher told BioWorld the cash would enable the Munich-based firm to generate clinical proof of concept, build a clinical pipeline and continue development of its platform technologies.
Dragonfly Therapeutics Inc. added Gilead Sciences Inc. to its roster of partnerships in a deal that gives the Waltham, Mass.-based company $300 million up front, with opt-in payments, milestones and up to 20% royalties down the road. In exchange Foster City, Calif.-based Gilead gets exclusive, worldwide rights to DF-7001, a preclinical-stage immunotherapy, as well as rights to additional NK cell engager programs generated by Dragonfly’s TriNKET (Trispecific NK Engager) platform.
The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies.
After raising $17 million in seed funding, immunotherapy-focused biotech company, LTZ Therapeutics Inc., is announcing plans for the fledgling company whose acronym stands for “Lift to Zenith.” CEO and co-founder Robert Li told BioWorld that the company’s three-tiered immunotherapy platform will focus on reducing immunosuppression, reprogramming innate immunity and modulating adaptive immunity.
For Kevin Friedman, the secret to making newly emergent Kelonia Therapeutics Inc. a success is reducing complexity and keeping everything as simple as possible. The Boston-based company just raised $50 million in series A funding to further its development of genetic medicines encompassing a range of diseases.
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.
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