Cullinan Oncology to Introduce Revolutionary New Immune Activator for Cancer Treatment in U.S.

Cullinan Oncology and Harbour BioMed have teamed up to make a revolutionary breakthrough in cancer treatments, introducing CLN-418/HBM7008- a B7H4 x 4-1BB bispecific immune activator developed from the HBICE® platform. Now in Phase 1 clinical trials in the US and Australia, CLN-418/HBM7008 is set to revolutionize the treatment of advanced solid tumors and is exclusively licensed to Cullinan Oncology for the US.

Cullinan Oncology is proud to announce the acquisition of CLN-418, a pioneering bispecific immune activator in its clinical stage. With this strategic move, the company is taking a major step forward in bispecific antibody development for solid tumors. This transaction places Cullinan among the leading companies in the field and adds a valuable clinical-stage asset to its pipeline. Thanks to the agreement with Harbour BioMed, Cullinan is now on track to have potentially six clinical-stage assets in its portfolio by 2023. CEO Nadim Ahmed commented: “This is an exciting opportunity for us to expand our pipeline and deploy capital strategically. The financial terms of the agreement will provide us with a multi-year cash runway to fund our ongoing development efforts and deliver data from multiple clinical programs.”

Cullinan Oncology has entered into an agreement with Harbour BioMed to gain exclusive rights to develop and commercialize CLN-418/HBM7008 in the United States. In exchange, Harbour BioMed stands to receive an upfront license fee of $25 million, plus up to $148 million in development and regulatory milestones, along with up to $415 million in sales-based milestones and tiered royalties up to the high teens on potential U.S. commercial sales.

Harbour BioMed is thrilled to announce that it has entered into an exclusive collaboration with Cullinan Oncology to develop and commercialize CLN-418/HBM7008, a first-in-class potential therapy to treat a wide range of solid-tumor cancers. This agreement is a testament to Harbour BioMed’s technology platforms and innovation capabilities and further cements their position as a leader in the field. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed expressed his excitement in working with Nadim and his team to move this program forward. With Cullinan Oncology’s seasoned clinical development team, strong capabilities in oncology drug development, and robust infrastructure, CLN-418/HBM7008 is well-positioned for a successful development and commercialization.

About CLN-418/HBM7008

The CLN-418/HBM7008 bispecific immune activator is unique in that it combines two highly sought-after targets – B7H4 and 4-1BB – to create an innovative new therapy. By combining these two distinct immunological pathways, researchers are hoping to unlock a powerful new approach to immune activation. This groundbreaking research is already being tested in clinical studies, so the future is looking bright for this promising new therapy.

B7H4 is an exciting tumor associated antigen that is highly expressed on several types of cancer, including triple negative breast cancer, ovarian cancer and lung cancer, yet minimally present in normal tissues. By targeting this coinhibitory immune checkpoint in the B7 family, which has minimal overlap with the PD-L1 pathway, we can potentially extend immunotherapies to cancer types that have been largely unresponsive to PD-L1-based treatments.

The potential of the 4-1BB pathway has been validated biologically, yet safety concerns such as hepatic toxicity persist. To address this issue, researchers are exploring a novel approach of conditional activation of 4-1BB in the tumor microenvironment dependent on B7H4 expression. CLN-418/HBM7008, a strict TAA crosslinking dependent T-cell activator, could potentially provide a safer therapeutic window while harnessing the power of both targets.

CLN-418/HBM7008, an innovative intravenous drug, is being evaluated in a Phase 1 trial (NCT05306444) for its potential to treat advanced solid tumors. This open-label, multicenter study is taking place in the US and Australia, with up to 108 participants. The trial’s purpose is to identify the maximum tolerated dose and the recommended Phase 2 dose of the drug, with initial clinical data potentially available in 2024. With this trial, researchers are hopeful that CLN-418/HBM7008 may offer an exciting new treatment option for those suffering with advanced solid tumors.

About Cullinan Oncology

At Cullinan Oncology, Inc. (NASDAQ: CGEM), we are on a mission to develop transformative therapeutics that can provide new standards of care for cancer patients. Our approach is powered by a novel research model that helps us identify and rapidly develop the most promising cancer therapies. We leverage our expertise in immuno-oncology and translational cancer medicine to create differentiated ideas, explore unique targets, and develop therapeutics across various cancer indications. Our diversified pipeline is strategically built to activate the immune system or inhibit oncogenic drivers through small molecules, biologics, and other modalities, with the goal of being the best or first in their class. We partner with academics and industry to explore the boundaries of cancer therapy, from candidate selection to potential commercialization. Our commitment is to bring hope to cancer patients through innovative therapies.

About Harbour BioMed

Harbour BioMed is a global biopharmaceutical company that is revolutionizing the future of healthcare. With a focus on oncology and immunology, the company is dedicated to the discovery, development, and commercialization of innovative antibody therapeutics. Harbour BioMed is expanding their portfolio and pipeline through their own R&D capabilities, strategic collaborations, and strategic acquisitions. By doing so, the company is committed to providing patients with the highest quality of care.

Harbour BioMed is revolutionizing the therapeutic antibody landscape with its proprietary Harbour Mice® antibody technology platform. Generating fully human monoclonal antibodies in four different formats – H2L2, as well as HCAb – Harbour Mice® allows for the development of powerful and innovative HCAb-based immune cell engagers (HBICE®). These HBICE® engagers can deliver unprecedented tumor killing effects that traditional combination therapies simply cannot match. Combining Harbour Mice®, HBICE®, and the single B cell cloning platform, Harbour BioMed’s antibody discovery engine is a one-of-a-kind, highly efficient engine for discovering next-generation therapeutic antibodies.

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