Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting
Crinetics Pharmaceuticals (NASDAQ: CRNX) announced two key presentations at NANETS 2024, showcasing advancements in their neuroendocrine tumor pipeline. The company will present preclinical data for CRN09682, a first-in-class nonpeptide drug conjugate targeting SST2-expressing tumors, planned for IND submission in early 2025. Additionally, they will share Phase 2 trial results for paltusotine, demonstrating reduced frequency and severity of carcinoid syndrome symptoms in patients with functional NETs. The presentations include data from all 36 trial participants, supporting further clinical development. A company-sponsored symposium will feature both drug candidates and their novel nonpeptide approaches to treating carcinoid syndrome and neuroendocrine tumors.
Crinetics Pharmaceuticals (NASDAQ: CRNX) ha annunciato due presentazioni chiave al NANETS 2024, evidenziando i progressi nel loro pipeline di tumori neuroendocrini. L'azienda presenterà dati preclinici per CRN09682, un farmaco coniugato non peptidico di prima classe che mira a tumori che esprimono SST2, con una richiesta di IND prevista per l'inizio del 2025. Inoltre, condivideranno i risultati della fase 2 della sperimentazione per paltusotine, dimostrando una riduzione della frequenza e della gravità dei sintomi della sindrome carcinoide in pazienti con NET funzionali. Le presentazioni includeranno dati da tutti i 36 partecipanti allo studio, supportando ulteriori sviluppi clinici. Un simposio sponsorizzato dall'azienda presenterà entrambi i candidati farmacologici e i loro approcci non peptidici innovativi al trattamento della sindrome carcinoide e dei tumori neuroendocrini.
Crinetics Pharmaceuticals (NASDAQ: CRNX) anunció dos presentaciones clave en NANETS 2024, mostrando los avances en su línea de investigación sobre tumores neuroendocrinos. La compañía presentará datos preclínicos de CRN09682, un conjugado de fármaco no peptídico de primera clase que tiene como objetivo los tumores que expresan SST2, con la solicitud de IND planificada para principios de 2025. Además, compartirán los resultados del ensayo de fase 2 para paltusotine, que demuestra una reducción en la frecuencia y gravedad de los síntomas del síndrome carcinoide en pacientes con NET funcionales. Las presentaciones incluirán datos de los 36 participantes del ensayo, apoyando el desarrollo clínico adicional. Un simposio patrocinado por la empresa contará con ambos candidatos a fármacos y sus enfoques no peptídicos innovadores para el tratamiento del síndrome carcinoide y los tumores neuroendocrinos.
크리네틱스 제약 (NASDAQ: CRNX)가 NANETS 2024에서 신경내분비 종양 파이프라인의 발전을 선보이는 두 가지 주요 발표를 했습니다. 이 회사는 SST2 발현 종양을 표적으로 하는 최초의 비펩타이드 약물 접합체인 CRN09682에 대한 전임상 데이터를 발표할 예정이며, 2025년 초에 IND 제출을 계획하고 있습니다. 추가로, 기능성 NET 환자에서 카르시노이드 증후군 증상의 빈도와 심각성을 감소시키는 것을 보여주는 팔투소틴의 2상 시험 결과를 공유할 것입니다. 발표에는 모든 36명의 시험 참가자로부터의 데이터가 포함되어 있으며, 이는 추가적인 임상 개발을 지지합니다. 회사 후원 심포지엄에서는 두 가지 약물 후보와 카르시노이드 증후군 및 신경내분비 종양 치료를 위한 새로운 비펩타이드 접근 방식이 소개될 것입니다.
Crinetics Pharmaceuticals (NASDAQ: CRNX) a annoncé deux présentations clés lors de NANETS 2024, mettant en avant les avancées de son pipeline sur les tumeurs neuroendocrines. L'entreprise présentera des données précliniques sur CRN09682, un médicament conjugué non peptidique de première classe ciblant les tumeurs exprimant SST2, dont la soumission d'IND est prévue pour début 2025. De plus, ils partageront les résultats des essais de phase 2 pour paltusotine, démontrant une réduction de la fréquence et de la gravité des symptômes du syndrome carcinoïde chez les patients présentant des NET fonctionnels. Les présentations incluront des données de tous les 36 participants à l'essai, soutenant le développement clinique ultérieur. Un symposium sponsorisé par l'entreprise mettra en avant les deux candidats médicamenteux et leurs approches non peptidiques novatrices pour traiter le syndrome carcinoïde et les tumeurs neuroendocrines.
Crinetics Pharmaceuticals (NASDAQ: CRNX) hat zwei wichtige Präsentationen bei NANETS 2024 angekündigt, die Fortschritte in ihrer Pipeline für neuroendokrine Tumoren präsentieren. Das Unternehmen wird präklinische Daten zu CRN09682 vorstellen, einem erstklassigen nicht-peptidischen Arzneimittelkonjugat, das auf SST2-exprimierende Tumoren abzielt, mit einer IND-Einreichung, die für Anfang 2025 geplant ist. Darüber hinaus werden sie die Ergebnisse der Phase-2-Studie für Paltusotin teilen, die eine Verringerung der Häufigkeit und Schwere der Symptome des Karzinoid-Syndroms bei Patienten mit funktionellen NETs zeigt. Die Präsentationen beinhalten Daten von allen 36 Studienteilnehmern und unterstützen die weitere klinische Entwicklung. Ein von dem Unternehmen gesponsertes Symposium wird beide Arzneimittelkandidaten und deren neuartige nicht-peptidischen Ansätze zur Behandlung des Karzinoid-Syndroms und der neuroendokrinen Tumoren vorstellen.
- Phase 2 trial results show paltusotine successfully reduced carcinoid syndrome symptoms
- CRN09682 demonstrated potent and selective anti-tumor activity in preclinical studies
- Paltusotine was well-tolerated in clinical trials
- None.
Insights
The upcoming NANETS conference presentations highlight two significant pipeline developments for Crinetics: CRN09682 and paltusotine. The novel nonpeptide drug conjugate CRN09682 represents an innovative approach to targeting SST2-expressing tumors, offering potential advantages over traditional antibody-drug conjugates through improved tumor penetration and simpler manufacturing. The platform's design for selective binding and controlled drug release could minimize off-target effects while maximizing therapeutic impact.
The Phase 2 data for paltusotine in carcinoid syndrome shows promising efficacy in symptom reduction. As a once-daily oral treatment, it could offer significant advantages over current injectable therapies. The completion of this study with 36 participants and positive tolerability data strengthens the drug's development trajectory. These advancements position Crinetics to potentially capture significant market share in the neuroendocrine tumor therapeutic space.
Novel Nonpeptide Drug Conjugate Platform to be Debuted, Featuring Preclinical Profile of Lead Candidate CRN09682 Targeting SST2-Expressing Tumors, which is on Track for IND Submission Early 2025
Data From Phase 2 Trial of Paltusotine in Carcinoid Syndrome to be Highlighted in Crinetics Symposium and Two Presentations
SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced two abstracts from its transformative, in-house discovery and development programs will be presented at the upcoming North American Neuroendocrine Tumor Society Multidisciplinary NET Medical Symposium (NANETS 2024), taking place November 21-23, 2024, in Chicago.
“We are eager to share our latest pipeline progress at NANETS 2024. Crinetics is committed to the neuroendocrine tumor community, and we are now utilizing our world class drug discovery and development capabilities to support people living with both functional and non-functional NETs,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We are excited to present preclinical data from our groundbreaking nonpeptide drug conjugate platform for our lead candidate CRN09682, an investigational anti-tumor therapy targeting SST2-expressing tumors, including NETs. We will also present data from the Phase 2 clinical study of our investigational drug candidate paltusotine, highlighting its ability to reduce the frequency and severity of carcinoid syndrome symptoms in patients with functional NETs.”
CRN09682, is a first-in-class, somatostatin receptor 2 (SST2) targeted, nonpeptide drug conjugate (NDC). Built upon the well-validated concept of antibody-drug conjugates, Crinetics’ NDCs use a highly optimized small molecule G protein coupled receptor (GPCR) ligand, instead of an antibody, to deliver a potent anti-cancer agent to tumor cells with high selectivity and efficiency. CRN09682 was designed to provide enhanced tumor penetration, selectively bind to SST2 expressing tumor cells, induce internalization, and intracellularly release a potent anti-tumor agent, while minimizing systemic exposure and associated toxicities. In addition, CRN09682 is manufactured by traditional chemical synthesis methods, avoiding the complex and heterogeneous manufacturing methods required for antibody drug conjugates. Preclinical data to be presented at NANETS 2024 demonstrate the potent and selective anti-tumor activity of CRN09682, potentially providing a novel alternative for the treatment of NETs and other SST2-expressing tumors.
Another abstract will be featured as both an oral and poster presentation, which includes follow-up from an open-label Phase 2 carcinoid syndrome study of investigational candidate paltusotine, a once-daily, oral, nonpeptide, selective SST2 agonist being developed for the treatment of acromegaly and carcinoid syndrome. The NANETS presentation includes findings from all 36 trial participants, with new analyses that show paltusotine reduced the frequency and severity of carcinoid syndrome symptoms and was well tolerated, justifying further clinical development.
Data for paltusotine and CRN09682, along with additional information on NDCs, will also be featured in a Crinetics-sponsored symposium titled “Paltusotine and CRN09682: Novel Nonpeptide Approaches to Treating Carcinoid Syndrome and Neuroendocrine Tumors” at the conference on Thursday, November 21, from 12:15-1:15 p.m. CT. Featured speakers include Scott Struthers and Dr. Aman Chauhan, leader of Neuroendocrine Oncology and Co-Leader Radiopharmaceutical Drug Development at Sylvester Comprehensive Cancer Center, University of Miami Health System.
Details on the abstracts to be presented at NANETS are shown below:
| Title: | A Novel Nonpeptide Drug Conjugate (NDC) for the Treatment of Somatostatin Receptor 2-Expressing Tumors |
| Date/Time: | Poster: November 22 from 5:15 – 6:30 pm CT |
| Title: | Once-daily Oral Paltusotine in the Treatment of Patients With Carcinoid Syndrome: Results From a Phase 2, Randomized, Parallel-Group Study |
| Date/Time: | Oral: November 22 from 3:10 – 3:22 pm CT Poster: November 22 from 5:15 – 6:30 pm CT |
The poster presentations will be made available on the Crinetics website at the time of presentation in accordance with the NANETS embargo policy.
ABOUT CRN09682
CRN09682 is an investigational, potentially 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 (NETs) and potentially for use in other solid tumors that express SST2. The SST2 ligand on the NDC molecule binds to SST2 on the tumor cell surface and is internalized in 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, selectively bind to specific GPCR expressing tumor cells, induce internalization, 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 ADCs. 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 PALTUSOTINE
Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is in Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. It was designed by Crinetics with the goal of providing a once-daily, oral option for reliable and consistent control of acromegaly and carcinoid syndrome. In Phase 3 studies, once-daily, oral paltusotine maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Results from the Phase 2 study in carcinoid syndrome provide supporting data and rationale for paltusotine to initiate a Phase 3 trial for another important indication related to the treatment of carcinoid syndrome in patients with neuroendocrine tumors.
ABOUT CRINETICS PHARMACEUTICALS
Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is in Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics is also developing atumelnant (CRN04894), an investigational, first-in-class, oral ACTH antagonist, that is currently completing Phase 2 clinical studies for the treatment of congenital adrenal hyperplasia and Cushing’s disease. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease (including thyroid eye disease), 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 paltusotine and CRN09682, including the therapeutic potential and clinical benefits or safety profile thereof; and IND-enabling studies for CRN09682; plans to develop CRN09682; 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. 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 known and unknown risks, uncertainties and assumptions, including, without limitation, initial or topline data that we report may change following a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, the possibility of unfavorable new clinical data and further analyses of existing clinical data, and the U.S. Food and Drug Administration and other regulatory authorities may not agree with our interpretation of such results; 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 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 and nonclinical studies; regulatory developments 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; 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, 2023 and its Quarterly reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements. 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.
Contact:
Investors:
Gayathri Diwakar
Head of Investor Relations
gdiwakar@crinetics.com
(858) 345-6340
Media:
Natalie Badillo
Head of Corporate Communications
nbadillo@crinetics.com
(858) 345-6075
FAQ
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