Merck is expanding its oncology pipeline, paying $400 million for rights to a preclinical SciBrunch Therapeutics drug candidate addressing a promising target associated with many types of cancer.
The deal has already closed, Merck announced Monday. The pharmaceutical company how holds global rights to develop and commercialize SciBrunch’s drug, SPR2015, a small molecule designed to block a protein called KRAS G12D.
Mutated RAS proteins are a known driver of many types of cancer. The first RAS inhibitors, small molecule drugs marketed by Amgen and Bristol Myers Squibb, block particular form of RAS called KRAS G12C. Revolution Medicines (RevMed) recently won FDA approval for Rasonque for pancreatic cancer. This drug is designed to block multiple RAS variants.
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Shanghai-based SciBrunch designed its drug to inhibit KRAS G12D, which is the most common RAS mutation in cancers. RAS proteins act like an on/off switch to regulate cell growth. SPR2015 inhibits mutated KRAS G12D stuck in the “on” position, continuously sending the cell proliferation signals that drive cancer growth. Preclinical data presented in April during the American Association for Cancer Research annual meeting showed the SciBrunch drug administered as a monotherapy led to significant anti-tumor efficacy against colorectal cancer.
“This agreement complements and diversifies our expanding pipeline of precision targeted candidates with SPR2015, a potent engineered inhibitor for one of the most prevalent mutant forms of KRAS found in human cancers,” George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories, said in a prepared statement.
Licensing SciBrunch’s molecule brings Merck into a group of companies developing KRAS G12D-targeting drugs. RevMed’s zoldonrasib is in late-stage clinical development for pancreatic and non-small cell lung cancers. BBO-11818 from BridgeBio Oncology is a pan-KRAS inhibitor that addresses mutated versions of the protein in both the “on” and “off” states with particular potency against KRAS G12D and KRAS G12V. This BridgeBio drug is in early clinical testing in solid tumors. Verastem Oncology’s VS-7375 is a KRAS G12D on/off inhibitor in mid-stage clinical testing for pancreatic, lung, and colorectal cancers.
Merck already has experience with RAS-blocking molecules. MK-1084, an inhibitor of KRAS G12C proteins in the “off” state, is in late-stage clinical testing for colorectal and non-small cell lung cancers and in Phase 2 testing for solid tumors.
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SciBrunch was founded in 2024 by CEO Tao Hu, a veteran of Wuxi AppTec. In January of this year, the startup announced the close of $35 million in financing, bringing its total raised to $65 million. At the time, SciBrunch said the proceeds would support clinical development of a PARP1 inhibitor as well as the investigational new drug application-enabling preclinical work on its RAS inhibitors.
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The $400 million that Merck paid for SPR2015 is an upfront payment. Achieving milestones could bring the total payout to as much as $2.13 billion.
A Setback for Merck, Daiichi Sankyo Lung Cancer Drug
Merck and Daiichi Sankyo won’t get accelerated FDA approval for a therapy developed for extensive-stage small cell lung cancer but this antibody drug conjugate (ADC) is not yet completely out of the running for a regulatory decision.
The application seeking accelerated approval for ifinatamab deruxtecan (I-DXd) has been withdrawn, Merck announced after Friday’s market close. The move comes ahead of the expected October date for a regulatory decision. According to Merck, the agency said data from the open-label Phase 2 trial submitted in the application do not satisfy the requirements for an accelerated approval. The main goal of the open-label Phase 2 test was measuring the objective response rate.
A larger and longer pivotal clinical trial is ongoing with a main goal of measuring overall survival. If positive, data from this trial could support an application seeking traditional regulatory approval. The open-label Phase 3 test is comparing the study drug against the physician’s choice of chemotherapy. Separate Phase 3 tests are also underway evaluating I-DXd in castration-resistant prostate cancer and esophageal squamous cell carcinoma.
I-DXd is an ADC designed to target a cancer protein called B7-H3. While this protein is overexpressed on the surface of many types of cancer cells, no drugs are yet available for this target. Other companies with clinical-stage ADCs for this target include GSK and Roche.
I-DXd was discovered and developed from a Daiichi Sankyo ADC platform technology. In 2023, Merck paid $4 billion up front to begin a collaboration on three of the Japanese company’s ADCs, including I-DXd. The deal calls for the two companies to share in the development and commercialization of the partnered drugs.
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