Cbio A/S has received European regulatory clearance to begin a first-in-human trial of novoleucel, the company’s next-generation T-cell therapy, in late-stage cervical cancer. The phase I/IIa study will enroll patients with persistent or recurrent cervical cancer at Karolinska University Hospital.
Swarm Oncology Ltd. has emerged from stealth with a focus on advancing novel T-cell therapies to achieve long-term remission in patients with advanced solid cancers.
In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. While the programs and targets have yet to be disclosed, BMS is expanding its CAR T development, begun more than five years ago, with this deal.
In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. While the programs and targets have yet to be disclosed, BMS is expanding its CAR T development, begun more than five years ago, with this deal.
A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade.
Soligenix Inc. investors were extremely enthusiastic about the positive interim update for the company’s cancer therapy and light device, Hybryte, for treating for treating early stage cutaneous T-cell lymphoma. The Princeton, N.J.-based company’s stock (NASDAQ:SNGX) soared a whopping 464% before closing at a more modest but still massive of 271% increase to $7.42 each on July 9.
Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.
Tscan Therapeutics Inc.’s Wall Street-pleasing deal with Amgen Inc. in Crohn’s disease (CD) could expand into ulcerative colitis, but meanwhile is bringing $30 million up front with the potential for more than $500 million in preclinical, clinical, regulatory and commercial milestone payments, plus tiered single-digit royalties. Shares of Waltham, Mass.-based Tscan (NASDAQ:TCRX) closed May 9 at $3.40, up $1.25, or 58%, as the world learned of the multiyear collaboration with Amgen, of Thousand Oaks, Calif., that will use Tscan’s target discovery platform, Targetscan, to identify the antigens recognized by T cells in patients with CD.
Smart Immune SAS has received €17.5 million (US$19 million) in grant and equity funding from an EU innovation program to advance development of its “thymus in a dish” T-cell therapy.