Obsidian Therapeutics, Inc.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Obsidian Therapeutics, Inc. , a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor (ICI) therapy. OBX-115 is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with membrane-bound IL15 (mbIL15) that is pharmacologically regulated using FDA-approved small molecule drug acetazolamide. This second FDA designation follows a July 2024 announcement of Fast Track designation for OBX-115. “RMAT designation for OBX-115 highlights the unmet need in ICI-resistant melanoma and OBX-115’s potential to provide patient-centric, transformative care in this setting,” said Parameswaran Hari, M.D., Chief Development Officer of Obsidian. “In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, initial Phase 1 data showed that OBX-115 exhibited a favorable safety profile relative to what has been observed historically from IL2-dependent non-engineered TIL cell therapy, encouraging efficacy in patients with heavily pre-treated disease, and compatibility with non-surgical core needle biopsy tumor tissue procurement . We look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in both melanoma and non-small cell lung cancer (NSCLC).” Established under the 21st Century Cures Act, RMAT designation is a dedicated program that includes the benefits of Fast Track and Breakthrough Therapy designations and is designed to expedite the development and review processes for certain promising drug candidates, including cell therapies. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. RMAT designation provides early and frequent interactions with the FDA, including intensive guidance on efficient drug development. Candidates receiving RMAT designation may also be eligible for Accelerated Approval and Priority Review. About OBX-115 Obsidian’s lead investigational cytoTIL15™ program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in a multicenter trial in patients with advanced melanoma or relapsed / refractory NSCLC ( NCT06060613 ). About Obsidian Therapeutics Obsidian Therapeutics, Inc. is a clinical-stage biotechnology company pioneering engineered cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s proprietary cytoDRiVE® technology is designed to precisely regulate the timing and level of protein function by using FDA-approved small-molecule drugs. Obsidian is headquartered in Cambridge, MA. The Company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals. For more information, please visit www.obsidiantx.com and follow us on LinkedIn.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors (ICI). “FDA Fast Track Designation underscores the ongoing unmet need for patients with melanoma that has progressed on or after ICI therapy, agnostic of mutational status, and that OBX-115 may have the potential to address that unmet need,” said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. “OBX-115 is poised to be a transformative treatment option due to its patient-centric focus, including compatibility with core needle biopsy tumor tissue procurement and positively differentiated safety and tolerability pro to non-engineered TIL cell therapy. We are highly encouraged by the most recent safety and efficacy data presented at the 2024 American Society of Clinical Oncology Meeting. With this designation, we look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in the broad post-ICI setting.” Fast Track Designation is intended to facilitate development and expedite the review of new drug candidates that address serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review. OBX-115 is being investigated in a multicenter trial in advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT06060613). Enrollment has been completed for the first-in-human, single-center study of OBX-115 (NCT05470283). About OBX-115 Obsidian’s lead investigational cytoTIL15™ program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing clinical trials in advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT05470283 and NCT06060613). About Obsidian Therapeutics Obsidian Therapeutics, Inc. is a clinical-stage biotechnology company pioneering engineered cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s proprietary cytoDRiVE® technology is designed to precisely regulate the timing and level of protein function by using FDA-approved small-molecule drugs. Obsidian is headquartered in Cambridge, MA. The Company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals. For more information, please visit and follow us on LinkedIn.

Foresite Capital, an investment firm that backs life sciences and healthcare companies, has raised a $900 million fund.The fund, Foresites sixth, will invest in companies focused on precision medicine, healthcare delivery and life sciences infrastructure, the San Francisco-based firm said in a statement Wednesday. In drug developers, specifically, the firm is looking for those using genetics and machine learning to identify potential therapies, managing director Vik Bajaj told BioPharma Dive.Foresite first launched in 2011 and now has some $3.5 billion under management. Over that time, the firm says it has backed around four dozen companies that eventually went public, among them Regenxbio, Sage Therapeutics and more recently, CG Oncology.Foresite also formed a startup incubator called Foresite Labsthat helped nurture Alumis, which filed for an initial public offering last week.The firms most recent fund has closed during a cautiously optimistic time for drug startups. There are signs of a recovery, with recent data from the Biotechnology Innovation Organization suggesting venture fundings may be stabilizing to pre-pandemic norms after a prolonged pullback. Dealmaking has also surged, with buyouts of private biotechs at their fastest pace in at least six years, BioPharma Dive data show.Still, investors remain more selective than they were during the markets peak a few years ago. BIOs data showed a drop in fundings going to preclinical companies, reflecting venture firms redirecting more cash to surer bets. Foresite, for instance, is spreading investments around,looking at companies that emphasize product development, are focused on single programs or are testing big ideas,Bajaj said.The firm co-led a $1 billion funding round for AI drug discovery biotech Xaira Therapeutics in April. But it also this year participated in Series C rounds for Alumisand Obsidian Therapeutics, both of which have drugs in clinical testing.“It's an even better investment environment, there are more opportunities to deploy capital at all stages of the productive development life cycle, Bajaj said.Foresite joins a number of other biotech investors to have recently closed, or are in the process of raising new funds. ORI Capital, Sands Capital and NewVale Capital are among those to have debuted funds since the start of the year, while Arch Venture Partners and Flagship Pioneering outlined plans, in regulatory filings, to amass their latest funds. '