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FDA approved Anktiva for treatment of non-muscle invasive bladder cancer

Sotio Biotech

14/5/2024 | 3 minutes to read

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ImmunityBio announced that FDA has approved Anktiva (N-803) plus BCG for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Antkiva, a first-in-class IL-15 agonist immunotherapy for NMIBC, received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses and duration of complete response.


ImmunityBio announced FDA approval of Anktiva in non-muscle invasive blader cancer

The 77 evaluable patients in this single-arm, multicenter trial received Anktiva with BCG maintenance therapy for up to 37 months. The tumor status was assessed with cystoscopy and urine cytology and will continue for up to five years after each patient began their participation in the trial. The CR rate for the 77 evaluable patients was 62% with the upper end of the confidence interval being 73%. The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. The prolonged duration of complete response results beyond 24 months with Anktiva and BCG exceed the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group.

Obsidian presented positive safety and efficacy data of OBX-115 in melanoma

Obsidian provided an update on its Phase 1 first-in-human study of OBX-115 tumor-infiltrating lymphocyte cell therapy in patients with advanced or metastatic melanoma, including 25-week median study follow-up safety data and newly detailed efficacy data, during a presentation at AACR meeting. OBX-115 was well-tolerated, with a differentiated safety profile from non-engineered TIL cell therapy, including no dose-limiting toxicities and no Grade 4 or higher non-hematologic events. OBX-115 induced deep and durable responses with a 50% objective response rate, including a 33% complete response rate. Median PFS had not been reached.

Medicenna presented updated Phase 1/2 results of MDNA-11 at AACR

Medicenna Therapeutics presented updated clinical results from the monotherapy dose escalation and ongoing expansion portions of the Phase 1/2 ABILITY-1 study evaluating MDNA11, a long-acting beta-enhanced not-alpha IL-2 super-agonist, in patients with advanced solid tumors at AACR. With response rate and clinical benefit rate increasing to 29% and 50% (4 PR, 3 SD), respectively, MDNA11 continues to demonstrate compelling single-agent activity in the ABILITY-1 study amongst high-dose phase-2 eligible patients (N=14) who have failed checkpoint inhibitor therapies. MDNA11 is generally well tolerated with no dose-limiting toxicities or vascular leak syndrome reported in any of the dose escalation cohorts.


Asher Bio closed $55 million Series C financing to advance lead program into Phase 1 trials

Asher Biotherapeutics, a biotech developing precisely targeted immunotherapies for cancer, autoimmune, and infectious diseases, announced the closing of a Series C financing, which raised $55 million. The financing was led by RA Capital and included new investors AstraZeneca and BMS, along with existing investors Janus Henderson, Third Rock Ventures, Wellington and Boxer Capital and other undisclosed institutional investors. Asher Bio plans to use the proceeds from this financing to advance the clinical development of its lead program, AB248, a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. AB248 is currently being investigated in a Phase 1a/1b study, which is evaluating AB248 as a monotherapy and in combination with Keytruda, in patients with recurrent locally advanced or metastatic solid tumors, including melanoma, RCC, NSCLC and SCCHN, previously treated with a PD1 or PD-L1 checkpoint inhibitor.

Obsidian announced oversubscribed $161 million Series C financing to drive OBX-115 development

Obsidian Therapeutics, a clinical-stage biotech pioneering engineered cell and gene therapies, has closed a significantly oversubscribed $161 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington. Additional new investors participating in the financing include Foresite, Janus Henderson Investors, Novo, Paradigm, RTW, T. Rowe Price and Woodline Partners. Existing investors Atlas Venture, Blue Owl Healthcare, BMS, Deep Track, Logos, RA Capital, TCGX, Samsara and Surveyor Capital also participated in the financing. Proceeds from the financing will advance Obsidian’s lead investigational cytoTIL15 program, OBX-115, in its ongoing trials for patients with melanoma and NSCLC.

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