Shares of Erasca Inc. (NASDAQ:ERAS) tumbled to $9.02, down $10.13, or 52%, on phase I dose-escalation data with ERAS-0015, a potentially best-in-class, pan-RAS molecular glue, in RAS-mutant solid tumors, specifically non-small-cell lung and pancreatic ductal adenocarcinoma. The findings are from Erasca’s ongoing Auroras-1 study in the U.S. and the JYP0015M101 experiment underway in China by Joyo Pharmatech Co. Ltd., from which Erasca licensed the compound. Wall Street was likely reacting to a reported patient death from pneumonitis.

Biggest overhaul of UK clinical trials rules in 20 years comes into force

New U.K. clinical trials regulations coming into force today, April 28, aim to reduce the time taken to get approval for studies and introduce a category of lower risk trials which will be automatically assessed in 14 days. The key measure to cut timelines is the Combined Review, under which sponsors will be able to submit a single application for regulatory review by the Medicines and Healthcare products Regulatory Agency (MHRA) and ethics review by the Health Research Authority, the body responsible for managing ethics committees.

Adcoms off to sluggish start with ODAC meet on Astrazeneca drugs

After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet Thursday to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR-positive/HER2-negative, locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic castration-resistant prostate cancer. The meeting marks the first drug or device adcom of the year, the first convening of the ODAC since FDA’s longtime oncology lead Richard Pazdur resigned and just the third ODAC meet since Marty Makary became FDA commissioner.

Thermo Fisher sells microbiology business for $1B

Thermo Fisher Scientific Inc. agreed to sell its microbiology business to Astorg, a private equity firm, for approximately $1.075 billion, consisting of cash and a $50 million seller note. The business unit provides antimicrobial susceptibility testing and culture media solutions for clinical, pharmaceutical and food safety testing.

Nervonik raises $52.5M to advance PNS system

Nervonik Inc. raised $52.5 million in a series B financing round for its peripheral nerve stimulation (PNS) system, which will treat patients with chronic pain and other neurological conditions. The funds will be used to support the continued development Nervonik's PNS system, including enhancements to the system’s sensing capabilities, as well as preparations for commercialization.

Chinabio 2016: Chinese biotechs gain leverage as partners in dealmaking

China’s biotech ecosystem has crossed an inflection point, and Chinese biotechs are gaining leverage in dealmaking, executives from multinational companies said during the Chinabio Partnering Forum in Shanghai April 28. China is no longer seen as simply a source for lower-cost, faster-developed assets. Instead, Chinese companies are increasingly negotiating from a position of strength, retaining rights, and sharing commercialization profits and entering longer-term platform and ecosystem alliances. That evolution comes as global pharma companies expand local teams and venture arms in China to gain earlier access to innovation.

Pilatus PLT-012 takes immunometabolic approach to reprogram TME

Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.” The biotech is advancing a novel class of metabolic checkpoint inhibitors, including lead asset PLT-012, designed to modulate pathways that immune cells rely on for survival and function in nutrient‑depleted tumor microenvironments (TME). PLT-012 is a potential first‑in‑class humanized IgG4 monoclonal antibody designed to inhibit CD36, a multifunctional receptor that helps mediate fatty acid uptake within the TME.

Takeda takes rusfertide’s US rights; Protagonist opts out for cash

More than two years after signing a $1.7 billion deal with Takeda Pharmaceutical Co. Ltd., Protagonist Therapeutics Inc. has opted out of a 50-50 U.S. profit-and-loss sharing arrangement for its hepcidin mimetic peptide rusfertide, a priority review drug developed to treat adults with polycythemia vera (PV). The opt-out means Protagonist becomes eligible for up to $400 million for the opt-out election and the U.S. FDA approval for PV, a rare blood cancer, with a decision expected in the third quarter; an additional $75 million milestone payment; and up to $975 million in milestone payments and tiered royalties on worldwide net sales. In total, by opting out, the deal is worth up to $1.45 billion to Protagonist. Takeda gains U.S. rights on top of the ex-U.S. rights attained in the original agreement.

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