Sana Biotechnology Inc. has outlined the status of its pipeline following a portfolio prioritization. The company remains on track to file an IND this year for SC-291, the company's HIP-modified, CD19-targeted allogeneic chimeric antigen receptor (CAR) T therapy, with initial clinical data expected next year.
Astrazeneca plc is beefing up its cell therapy capabilities in immuno-oncology by acquiring Neogene Therapeutics BV for an initial outlay of $200 million. There’s up to $120 million more on the table for undisclosed milestones and what the companies called a “non-contingent consideration.” Even without the additional earnouts, the deal represents a profitable return for Neogene’s shareholders. The Amsterdam-based firm had raised $110 million in a series A round in 2020, which represented the largest A round in Europe that year. Since then, it has started to move its first program, an autologous engineered T-cell receptor (TCR) T-cell therapy directed against up to five neoantigens, toward a phase I trial in patients with solid tumors.
Affimed NV and Artiva Biotherapeutics Inc. have entered into a new strategic partnership to jointly develop, manufacture and commercialize a combination therapy comprised of Affimed's Innate Cell Engager (ICE) AFM-13 and Artiva's cord blood-derived, cryopreserved off-the-shelf allogeneic natural killer (NK) cell product candidate, AB-101.
Shares in Affimed AG gained as much as 28% during trading on Nov. 3 as the company unveiled continued good news from a phase I/II combination trial in CD30-positive lymphoma of its CD30-directed innate cell engager, AFM-13, and allogeneic natural killer (NK) cell therapy, as well as a clinical development partnership with Artiva Biotherapeutics Inc., which will provide it with access to a commercially scalable source of NK cells as the program matures.
Word from Talaris Therapeutics Inc. of a patient death in its phase III study called Freedom-1 with allogeneic cell therapy FCR-001 renewed speculation about the company’s odds in living donor kidney transplant patients, where Medeor Therapeutics Inc. also is advancing a late-stage candidate.
The changes continue at GSK plc as the pharma giant stepped away from its NY-ESO cell therapy program in moves that touch two collaborators. The company is terminating its three-year partnership with Lyell Immunopharma Inc. to develop candidates targeting NY-ESO-1, including the second‑generation product candidates, Lyell’s genetic and epigenetic reprogramming technologies (LYL-132 and LYL-331), and some other second-generation approaches GSK was considering.
There’s further drama at troubled Belgian biotech Bone Therapeutics SA, but its CEO told BioWorld that its partner’s decision to return rights to cell therapy platform Allob is a blessing in disguise that could allow it to negotiate a more favorable deal, after a lifeline merger was delayed.
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.