Another PD-1 antibody is about to hit the U.S. market, following the FDA’s accelerated approval of dostarlimab (TSR-042) from partners Anaptysbio Inc. and Glaxosmithkline plc. But dostarlimab, branded Jemperli, will be only one of two PD-1 drugs indicated for endometrial cancer, going up against Merck & Co. Inc.’s Keytruda (pembrolizumab).
OS Therapies LLC, the developer of a listeria-based cancer vaccine to prevent metastasis and increase overall survival in young people with osteosarcoma, has closed on a $6 million series A financing led by Noble Capital Markets and Tichenor Ventures. The funds will help the company advance its lead candidate, OST-HER2, into a phase IIb trial this year with hopes of a potential FDA filing by in 2022.
Persistent U.S. drugs supply chain vulnerabilities, troublesome even before the COVID-19 pandemic, are drawing new attention in Washington. Now, with growing calls to increase supply chain resilience and a Biden administration executive order calling for an assessment of the situation, experts are looking for new paths to limit the risk of drug shortages, protect patient health, and to address pandemic preparedness and other national and health security threats.
A collection of CAR T-cell programs originally licensed by Precision Biosciences Inc. to Baxalta Inc. in a $1.6 billion deal are, after handoffs to Shire and Servier SAS, back where they began. Precision said April 15 it would reacquire all development and commercial rights to the programs, including two clinical-stage CD19-targeting allogeneic CAR T candidates, from Servier for $1.25 million in cash, plus the waiver of earned but as-yet unpaid milestones totaling $18.75 million.
Phase I data on immune responses induced by Inovio Inc.'s COVID-19 DNA vaccine candidate, INO-4800, showed it induced neutralizing antibodies and T-cell responses against all spike protein variants tested in a phase I study, including those first detected in the U.K., South Africa and Brazil. A preliminary report on the analysis, published on bioRxiv, preceded the reporting of phase II data on the candidate expected later this quarter as well as a potential move to phase III testing, pending resolution of a partial clinical hold on the study first announced in September 2020.
Less than a year after landing a multibillion-dollar deal expansion with partner Gilead Sciences Inc., targeted cancer drug developer Tango Therapeutics Inc. is making moves to go public via a merger with Boxer Capital LLC-sponsored special purpose acquisition company BCTG Acquisition Corp.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
Theseus Pharmaceuticals Inc., a startup developing new tyrosine kinase inhibitors to overcome treatment-resistant cancer mutations, has raised $100 million in a series B financing led by Foresite Capital. Co-founded at the health care investment firm Orbimed with former Ariad Pharmaceuticals Inc. scientists who pioneered the development of pan-variant kinase inhibitors, the company's lead candidate is THE-630, a next-generation pan-variant KIT inhibitor for the potential treatment of refractory gastrointestinal stromal tumors.
In a move that Sanofi SA said will bring it an mRNA-based research platform with applications in oncology, immunology and other diseases, the company has acquired Tidal Therapeutics Inc. for $160 million up front and up to $310 million in milestone payments. The preclinical startup, led by Merrimack Pharmaceuticals Inc. and Torque Therapeutics Inc. co-founder Ulrik Nielsen, is based in Cambridge, Mass.
After climbing nearly 37% since the start of the week, shares of Greenwich Lifesciences Inc. (NASDAQ:GLSI) gained another 6% on April 9 as it disclosed new data bolstering the case for its cancer immunotherapy candidate, GP2. The data, to be presented at the American Association for Cancer Research annual meeting on Saturday, showed that when HER2-positive breast cancer patients had GP2 added to standard-of-care Herceptin (trastuzumab, Roche Holding AG) following breast cancer surgery, no recurrences of their cancer were observed, even after a median follow-up of five years.
