UPDATE: Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting
Crinetics Pharmaceuticals (NASDAQ: CRNX) will present two abstracts at NANETS 2024, showcasing advancements in neuroendocrine tumor treatments. The company will debut its nonpeptide drug conjugate platform, featuring CRN09682, a lead candidate targeting SST2-expressing tumors, with IND submission planned for early 2025. The presentation includes preclinical data demonstrating CRN09682's potent and selective anti-tumor activity. Additionally, Phase 2 trial data for paltusotine, an oral SST2 agonist for carcinoid syndrome treatment, will be presented, showing reduced symptom frequency and severity across 36 trial participants.
Crinetics Pharmaceuticals (NASDAQ: CRNX) presenterà due abstract al NANETS 2024, evidenziando i progressi nei trattamenti per i tumori neuroendocrini. L'azienda debutterà la sua piattaforma di farmaci coniugati non peptidici, con CRN09682, un candidato principale progettato per bersagliare i tumori che esprimono SST2, con una sottomissione IND prevista per all'inizio del 2025. La presentazione include dati preclinici che dimostrano l'attività antitumorale potente e selettiva di CRN09682. Inoltre, verranno presentati i dati della fase 2 dello studio per paltusotine, un agonista orale di SST2 per il trattamento della sindrome carcinoide, che mostrano una riduzione della frequenza e della gravità dei sintomi tra 36 partecipanti allo studio.
Crinetics Pharmaceuticals (NASDAQ: CRNX) presentará dos resúmenes en NANETS 2024, mostrando avances en los tratamientos para tumores neuroendocrinos. La compañía debutará su plataforma de conjugados de fármacos no péptidos, con CRN09682, un candidato principal dirigido a tumores que expresan SST2, con una presentación IND planeada para principios de 2025. La presentación incluirá datos preclínicos que demuestran la potente y selectiva actividad antitumoral de CRN09682. Además, se presentarán datos del ensayo de fase 2 para paltusotine, un agonista oral de SST2 para el tratamiento del síndrome carcinoide, que muestra una reducción en la frecuencia y gravedad de los síntomas en 36 participantes del ensayo.
크리네틱스 제약 (NASDAQ: CRNX)는 NANETS 2024에서 두 개의 초록을 발표하여 신경내분비 종양 치료의 발전을 선보일 예정입니다. 이 회사는 CRN09682를 포함한 비펩타이드 약물 접합체 플랫폼을 처음으로 선보이며, SST2를 발현하는 종양을 표적하는 주요 후보로, 2025년 초에 IND 제출이 계획되어 있습니다. 발표에서는 CRN09682의 강력하고 선택적인 항종양 활성을 입증하는 전임상 데이터를 포함합니다. 또한, 팔투소틴의 2상 시험 데이터가 발표되어, 36명의 시험 참가자 간에 증상의 빈도와 심각성이 감소했음을 보여줍니다.
Crinetics Pharmaceuticals (NASDAQ: CRNX) présentera deux résumés à NANETS 2024, mettant en avant les avancées dans les traitements des tumeurs neuroendocrines. La société dévoilera sa plateforme de conjugués médicamenteux non peptidiques, avec CRN09682, un candidat phare ciblant les tumeurs exprimant SST2, avec une soumission IND prévue pour début 2025. La présentation inclura des données précliniques démontrant l'activité anticancéreuse puissante et sélective de CRN09682. De plus, des données de l'essai de phase 2 pour paltusotine, un agoniste oral de SST2 pour le traitement du syndrome carcinoïde, seront présentées, montrant une réduction de la fréquence et de la gravité des symptômes chez 36 participants à l'essai.
Crinetics Pharmaceuticals (NASDAQ: CRNX) wird auf der NANETS 2024 zwei Abstracts präsentieren, die Fortschritte in der Behandlung neuroendokriner Tumoren zeigen. Das Unternehmen wird seine Plattform für nicht-peptidische Arzneimittelkonjugate vorstellen, die CRN09682 umfasst, einen führenden Kandidaten zur gezielten Behandlung von SST2-exprimierenden Tumoren, mit einer IND-Einreichung, die für Anfang 2025 geplant ist. Die Präsentation umfasst präklinische Daten, die die potente und selektive antitumorale Aktivität von CRN09682 demonstrieren. Darüber hinaus werden Daten aus der Phase-2-Studie zu Paltusotin, einem oralen SST2-Agonisten zur Behandlung des Karzinoidsyndroms, präsentiert, die eine reduzierte Symptomhäufigkeit und -schwere bei 36 Studienteilnehmern zeigen.
- CRN09682 demonstrates potent and selective anti-tumor activity in preclinical trials
- Phase 2 trial data shows paltusotine successfully reduced carcinoid syndrome symptoms
- Paltusotine was well-tolerated by trial participants
- CRN09682 offers simplified manufacturing through traditional chemical synthesis methods
- None.
Insights
This conference presentation news is not impactful for immediate stock market considerations. While the company will present data from their pipeline at NANETS 2024, including their nonpeptide drug conjugate CRN09682 and paltusotine Phase 2 results, this is a routine scientific conference presentation that doesn't include new, market-moving data.
The key programs mentioned - CRN09682 targeting SST2-expressing tumors and paltusotine for carcinoid syndrome - were already known to investors. The IND submission timeline for CRN09682 in early 2025 was previously disclosed. While the Phase 2 paltusotine data sounds promising in reducing carcinoid syndrome symptoms, detailed efficacy figures aren't provided in this announcement.
Investors should wait for the actual data presentation at NANETS and subsequent detailed trial results for a better assessment of these programs' potential market impact.
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. 14, 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 21, 5:15 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 21, 5:15 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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