Link Cell Therapies begins clinical dosing and expands Series A to $90M
Link Cell Therapies has initiated clinical dosing of its lead CAR-T candidate, LNK001, while increasing its Series A financing from $60 million to $90 million. The company is developing logic-gated CAR-T therapies designed to improve the ability of cell therapies to distinguish tumour tissue from healthy tissue, with an initial focus on solid tumours.
LNK001 is being evaluated in a Phase 1 study at MD Anderson Cancer Center in patients with advanced or metastatic clear cell renal cell carcinoma. The therapy uses an AND-gated approach, requiring the co-expression of two tumour-associated antigens, CAIX and ENPP3, to activate the CAR-T cells. The strategy is intended to address the on-target, off-tumour toxicity that has limited conventional CAR-T approaches targeting CAIX alone, as CAIX is also expressed in healthy biliary tissue.
The additional $30 million in financing will support clinical and preclinical development of further logic-gated CAR-T programs, including a second solid tumor program targeting colorectal cancer. Link expects to begin a first-in-human study in colorectal cancer in 2027.
Read more via PR Newswire
Adicet reports encouraging allogeneic CAR-T data in lupus
Adicet Bio has reported positive Phase 1 data from its study of prula-cel, an investigational allogeneic gamma delta CAR-T therapy, in patients with systemic lupus erythematosus (SLE) with or without lupus nephritis.
Among 22 efficacy-evaluable patients, 54% achieved DORIS remission at 12 months, while 50% of evaluable patients with lupus nephritis achieved a complete renal response. The company reported that all patients discontinued immunosuppressants, with all but one tapering background steroids to 5 mg or less of prednisone equivalent per day. Responses observed at 12 months remained ongoing through 12 to 21 months of follow-up, with one exception.
Prula-cel is an allogeneic gamma delta CAR-T targeting CD20, with the off-the-shelf approach designed to avoid the bespoke manufacturing process associated with autologous CAR-T therapies. Adicet plans to begin start-up activities for a pivotal lupus nephritis study in the fourth quarter of 2026 and will discuss the potential inclusion of patients with SLE without nephritis with the FDA.
Read more via Biopharma Dive
Beam sues over alleged IP theft
Beam Therapeutics has filed a lawsuit against former scientist Zi Jun “Emma” Wang, YolTech Therapeutics and Serapha Bio, alleging that confidential information taken from Beam was used to develop a competing base-editing therapy.
According to Beam's allegations, Wang worked at the company between March 2021 and January 2022 and subsequently co-founded YolTech, which developed YOLT-202, a base-editing candidate targeting alpha-1 antitrypsin deficiency. Beam claims the program bears significant similarities to its own BEAM-302, including the target disease, genetic mutation and aspects of the delivery system.
YolTech's program subsequently entered the US through Serapha Bio, which launched in June with $230 million in backing from investors including RA Capital Management and RTW Investments. Serapha has categorically rejected Beam's allegations and said it will defend itself against the claims.
Read more via https://firstwordpharma.com/story/8143691
Ray Therapeutics secures $8M CIRM grant for Stargardt gene therapy
Ray Therapeutics has been awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to advance RTx-021, its investigational gene therapy for Stargardt disease. The funding will support the ongoing Phase 1/2 clinical trial as well as manufacturing activities required to prepare the program for later-stage development.
RTx-021 is an optogenetic gene therapy, delivered by a single intravitreal injection, that makes surviving retinal ON-bipolar cells light-sensitive. The aim is to restore visual function regardless of the underlying genetic mutation, which matters for patients who have lost most of their photoreceptors. Stargardt is the most common form of juvenile macular degeneration, affects about 40,000 people in the US and has no approved treatments. CIRM's Grants Working Group placed the application in its highest funding tier, with all 13 scientific reviewers recognising its merit and potential impact.
The grant also reflects the role of non-dilutive funding in advancing CGT programs through clinical development. For companies working in rare diseases and other areas with significant development costs, grants can provide capital to progress clinical and manufacturing activities while reducing reliance on traditional venture financing.
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