Sesen Bio trial marred by misconduct — report; Bristol Myers picks up development of AI outfit's immunology drug
Sesen Bio said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum. But the rejected filing included thousands of violations and investigator misconduct, STAT News reported Wednesday.
The 130-patient study had more than 2,000 violations, 215 of which were classified as major, STAT said. Independent monitors also reported three investigators to the FDA for a “serious noncompliance” that “placed subjects at risk of harm.” A patient died in 2016 of liver failure related to the drug, and two years later, the company said that there were no drug-related deaths at a urology conference.
The company saw its stock crash, as it entered a halt at $6 per share last Friday and emerged battered with a $0.86 price.
In June CEO Thomas Cannell said that the drug was on its way to generating between $1 billion and $3 billion. Then Monday, he blamed “toxic” and critical media coverage of the FDA’s approval of Biogen’s Alzheimer’s treatment Aduhelm for the CRL. — Josh Sullivan
Bristol Myers picks up development of AI outfit’s immunology drug
Bristol Myers Squibb has opted to pick up the development of an immune-modulating drug as part of a research collaboration with UK-based AI discovery outfit Exscientia, the partners said Wednesday.
Exscientia will receive a $20 million milestone payment as part of the pick up with additional milestones and tiered royalties possible. Details on the drug were scarce, but the partners said it targets “a critical immunological kinase.”
“We are pleased to in-license our first drug candidate resulting from our strategic collaboration with Exscientia,” Rupert Vessey, Bristol Myers’ president of early R&D said in a release. “Artificial intelligence and machine learning continue to play important roles in drug discovery and Exscientia has delivered a promising development candidate in the field of immunology. We look forward to our continued collaboration and further advancing this candidate for the potential benefit of patients with unmet medical need.” — Kyle Blankenship
Werewolf hops aboard the Keytruda train with Merck trial collaboration
Werewolf Therapeutics and Merck are teaming up for a new clinical trial.
Looking at Werewolf’s WTX-124 candidate targeting IL-2, the pair will collaborate on a Phase I study evaluating the program’s safety and efficacy in solid tumors, the companies announced Wednesday. Researchers will examine WTX-124 both as a monotherapy and in combination with Merck’s Keytruda.
“The clinical benefit of targeting IL-2 as a treatment for cancer has long been established; however, its utility has been limited by challenging toxicities,” Werewolf CMO Randi Isaacs said in a statement. “We believe WTX-124 has the potential to enhance therapeutic options for cancer patients as a monotherapy and when combined with checkpoint inhibitors like Keytruda.”
Werewolf says it plans to submit an IND for the WTX-124 program in the first half of 2022. Should the IND be cleared, the Phase I study will start “promptly,” though no timeline was specified. — Max Gelman
Penny stock sees shares jump at Phase II topline data
Penny stock player AzurRx got a significant bump Wednesday after it reported topline data for a Phase II study.
Evaluating the company’s MS1819 program for the treatment of severe exocrine pancreatic insufficiency in patients with cystic fibrosis, AzurRx said the candidate in combination with standard of care resulted in an average 6.57-percentage point gain from baseline in the Coefficient of Fat Absorption, which the company says is a clinically meaningful result.
Previous literature had said anything above a five-percentage point improvement is clinically meaningful. Data from Wednesday’s results come from 20 patients.
“Topline data clearly show that combining MS1819 to the daily dose of PERT [standard of care] had clinical benefits for all patients and improved quality of life,” CEO James Sapirstein said in a statement. “Our next step with the MS1819 program is to finalize development of a new enteric-coated microbead formulation, which we believe will enable more of the medication to reach the small intestine thereby enhancing its therapeutic potential.”
AzurRx shares $AZRX skyrocketed 46% in pre-market trading Wednesday, settling in the 35% to 40% range after the opening bell.
The formulation work for the new enteric-coated microbead tech is expected to be completed by the end of the year. AzurRx plans to launch a bridging study in 2022 evaluating the formulation as a monotherapy. — Max Gelman
SomaLogic does the Twist
SomaLogic and Twist Bioscience have agreed to a new collaboration, announced Wednesday morning. The deal will allow Twist access to SomaLogic’s platform to discover new antibodies and drug targets.
No financial terms were disclosed for the deal.
“We intend to use the antibodies discovered for our internal pipeline, moving the most promising candidates through preclinical development and then potentially outlicensing to a partner,” Twist CEO Emily Leproust said in a statement. — Max Gelman
Biotech developing anti-inflammatory COPD treatment lands €20M Series A
An Icelandic biotech that focuses on treating chronic obstructive pulmonary disease has secured a European Series A financing round, the company announced Wednesday.
EpiEndo raised has €20 million, or $23.4 million. The round was led by Flerie Invest and Iðunn Venture Fund. Existing investor ABC Ventures participated, as well as the European Innovation Council Fund.
Funds will go toward moving EP395 through clinical trials through Phase IIa. The drug entered Phase I trials in April.
“This financing is a major step for EpiEndo, not only funding our lead compound through clinical development in patients with COPD, but also enabling exploration of other important potential therapeutic application areas such as dermatology and gastrointestinal disorders, where compromised epithelial integrity is known to contribute to disease pathophysiology,” CEO Maria Bech said in a press release.
Scientists seek to make EP395 the first disease modifying non-antibiotic macrolide that can be used as a long-term treatment for COPD. It works by reducing inflammation in the epithelial barrier, and in the future, the company will try the candidate on patients with asthma, bronchiectasis and diffuse pan-bronchiolitis. — Josh Sullivan