FDA received complete response letter from FDA for Columvi in DLBCL

CLINICAL AND REGULATORY 

FDA received complete response letter from FDA for Columvi in DLBCL

Based on the CRL, the STARGLO data does not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population. STARGLO was also intended as a postmarketing confirmatory study to convert the accelerated approval of Columvi in third-line or later DLBCL in the US to full approval. Columvi remains under accelerated approval for people with third-line or later DLBCL. Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells.

Replimune received complete response letter from FDA for RP1 for the treatment of melanoma

Replimune announced that FDA has issued a Complete Response Letter (CRL) regarding the BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The CRL indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised. RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

DEALS AND FINANCING 

AbbVie and Ichnos Glenmark enter a global licensing deal for trispecific antibody

AbbVie and IGI Therapeutics, a wholly owned subsidiary of Ichnos Glenmark Innovation (IGI), announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, developed using IGI's proprietary BEAT® protein platform, for oncology and autoimmune diseases. AbbVie will receive exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan and Greater China. Subject to regulatory clearance, IGI will receive an upfront payment of $700 million and is eligible to receive up to $1.225 billion in development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales.

CStone signs exclusive license agreement with Istituto Gentili for sugemalimab in Western Europe

CStone announced an exclusive partnership with Gentili to commercialize sugemalimab across Western Europe and the UK. Gentili will receive exclusive commercialization rights for sugemalimab in 23 European countries, including 18 EEA countries. CStone is eligible to receive up to $192.5 million in total consideration, comprising an upfront payment and payments tied to regulatory and commercial milestones. Additionally, CStone will supply sugemalimab and recognize close to 50% of net sales from the licensed territories as revenue, while Gentili will lead all local regulatory and commercial operations in the covered regions. 

Leads Biolabs lists on HKEX, raising $189 million through IPO

Nanjing Leads Biolabs is now listed on Hong Kong Stock Exchange. The clinical-stage biotech company priced its IPO at HKD 35 per share, offering 36.86 million shares. The deal included a Hong Kong public tranche of 16.03 million shares (43% of the total) and an international placement of 20.84 million shares (57%). Gross proceeds totaled approximately $189 million. Leads Biolabs' R&D is powered by multiple proprietary technology platforms that feature integrated, AI-powered and diversified antibody engineering capabilities, including LeadsBody (a CD3 T-cell engager platform), X-body (a 4-1BB engager platform) and its linker-payload platform for ADC development. These platforms have demonstrated clinical proof-of-concept, particularly with bispecific antibody combinations.