Crinetics Announces First Patient Dosed in Phase 1/2 Trial Evaluating CRN09682 for the Treatment of Neuroendocrine Tumors and Other Somatostatin Receptor 2-Expressing Tumors
SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from Crinetics' proprietary nonpeptide drug conjugate (NDC) platform, which leverages the company's expertise in GPCR drug discovery and small molecule design to develop a pipeline of modular targeted therapies for endocrine and endocrine-related tumors.
"We developed CRN09682 to address the need for a more efficacious, safer, and convenient targeted therapy for patients with SST2-expressing tumors," said Stephen Betz, Ph.D., Chief Scientific Officer and Co-Founder of Crinetics. "Dosing the first patient in the Phase 1/2 study marks a major milestone for CRN09682 and our NDC platform as a whole. CRN09682 is the first clinical exploration of this new modality, which we believe has the potential to unlock a new generation of receptor-targeted therapies to treat tumors with precision."
CRN09682 was designed to bind selectively and with high potency to SST2-expressing tumor cells, promoting rapid receptor internalization and linker cleavage to release a potent cytotoxic payload directly within the tumor. This targeted approach is intended to concentrate treatment at the tumor site, by optimizing tumor penetration and limiting systemic exposure and related toxicities. NDCs are manufactured by traditional chemical synthesis methods, eliminating manufacturing constraints and specialized handling required by most antibody drug conjugates and radiopharmaceuticals.
The Phase 1/2 BRAVESST2 trial is a first-in-human, open-label, dose-escalation study with a dose expansion phase designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CRN09682. The Phase 1 portion will enroll patients in escalating dose cohorts to determine the maximum tolerated dose and recommended dose for the expansion phase. Phase 2 will further evaluate and characterize CRN09682 in selected SST2-expressing tumor types. Up to 150 participants are expected to be enrolled across both phases. Eligible patients must have metastatic or locally advanced disease progression following standard therapies and SST2-expressing tumors confirmed by somatostatin receptor imaging.
For more information about the BRAVESST2 trial, visit https://bit.ly/4hMl8qc
ABOUT CRN09682
CRN09682 is an investigational, first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 (SST2) agonist with the cytotoxic drug monomethyl auristatin E (MMAE) via a spacer and a cleavable linker for the treatment of neuroendocrine tumors and other solid tumors that express SST2. The ligand on the CRN09682 binds to SST2 on the tumor cell surface and is internalized into the cell whereby enzymes cleave the MMAE and release it within the cell. MMAE is known to cause microtubule disruption leading to cell arrest and death. The NDC approach is intended to enhance tumor penetration and intracellularly release a potent anti-tumor agent, while minimizing systemic exposure and associated toxicities. Additionally, NDCs are manufactured by traditional chemical synthesis methods, avoiding the limitations of fermentation, bioconjugation, and heterogeneous manufacturing methods required by most antibody drug conjugates. NETs are generally incurable when metastatic, regardless of tumor grade. Overall survival rates vary significantly by stage, grade, age at diagnosis, primary site, and time period of diagnosis.
About Crinetics Pharmaceuticals
Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.
Crinetics' lead product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics' deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome. Additional discovery programs address a variety of endocrine conditions such as neuroendocrine tumors, Graves' disease (including Graves' hyperthyroidism and Graves' orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of CRN09682 including studies to evaluate whether it is an efficacious or safe therapy for patients with SST2-expressing tumors; whether the Company's NDC platform will lead to the precision treatment options or the potential for our development candidates to transition to clinical development; In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential," "upcoming" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects, complications and/or drug interactions or inadequate efficacy of the Company's product candidates that may limit their development, regulatory approval and/or commercialization; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics' clinical studies and nonclinical studies; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics' drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company's periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading "Risk Factors" in Crinetics' periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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