Crescent Biopharma to Present Preclinical Data for CR-001, a PD-1 x VEGF Bispecific Antibody, at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting
Crescent Biopharma (NASDAQ: CBIO) will present preclinical data for CR-001, a tetravalent PD-1 x VEGF bispecific antibody, at the Society for Immunotherapy of Cancer 40th Annual Meeting on November 7-9, 2025.
Key points: CR-001 showed cooperative pharmacology in vitro with increased PD-1 binding in the presence of VEGF, augmented PD-1/PD-L1 blockade, enhanced T-cell activation, potent anti-tumor activity in a xenograft model, and good tolerability plus robust PD-1 receptor occupancy in non-human primates. Crescent says an IND submission is on track for Q4 2025 to support a global Phase 1 trial planned to begin in Q1 2026. The poster (Abstract 1185) will be available on SITC and on Crescent’s website beginning 9:00 a.m. ET on the presentation day.
Crescent Biopharma (NASDAQ: CBIO) presenterà dati preclinici su CR-001, un anticorpo bispecifico tetravalente PD-1 x VEGF, al 40° Congresso Annuale della Society for Immunotherapy of Cancer dal 7 al 9 novembre 2025.
Punti chiave: CR-001 ha mostrato farmacologia cooperativa in vitro con un aumento dell'associazione a PD-1 in presenza di VEGF, un incremento della blocco PD-1/PD-L1, attivazione delle cellule T potenziata, potente attività antitumorale in un modello xenograft e buona tollerabilità più un robusto occupancy del recettore PD-1 nei primati non umani. Crescent afferma che la presentazione IND è in linea con il Q4 2025 per supportare uno studio globale di fase 1 previsto per iniziare nel Q1 2026. Il poster (Abstract 1185) sarà disponibile su SITC e sul sito di Crescent a partire dalle 9:00 ET del giorno della presentazione.
Crescent Biopharma (NASDAQ: CBIO) presentará datos preclínicos sobre CR-001, un anticuerpo bispecífico tetravalente PD-1 x VEGF, en la 40ª Reunión Anual de la Society for Immunotherapy of Cancer del 7 al 9 de noviembre de 2025.
Puntos clave: CR-001 mostró farmacología cooperativa in vitro con un mayor acoplamiento a PD-1 en presencia de VEGF, un aumento del bloqueo PD-1/PD-L1, activación de células T mejorada, potente actividad antitumoral en un modelo xenograft y buena tolerabilidad junto con una ocupación robusta del receptor PD-1 en primates no humanos. Crescent indica que la presentación de IND está en camino para el 4º trimestre de 2025 para apoyar un ensayo global de fase 1 previsto para comenzar en el primer trimestre de 2026. El póster (Abstract 1185) estará disponible en SITC y en el sitio web de Crescent a partir de las 9:00 a. m. ET del día de la presentación.
Crescent Biopharma (NASDAQ: CBIO)는 2025년 11월 7일~9일에 열리는 암 면역치료 학회 SITC의 40회 연례 회의에서 CR-001에 대한 전임상 데이터를 발표할 예정입니다. CR-001은 PD-1 x VEGF 이중 특이 항체로서 tetravalent 구조를 가집니다.
핵심 요점: CR-001은 VEGF 존재 하에서 PD-1 결합이 증가하고 PD-1/PD-L1 차단이 강화되며 T세포 활성화가 증가하고 이종 이식 모델에서 강력한 종양 억제 활성을 보였으며 비인간 영장류에서 PD-1 수용체 점유가 견고하고 내약성도 양호했습니다. Crescent는 글로벌 1상 시험을 지원하기 위해 2025년 4분기에 IND 제출이 순조롭게 진행 중이며, 2026년 1분기에 시작될 예정인 글로벌 1상 시험을 지원합니다. 포스터(Abstract 1185)는 발표 당일 ET 오전 9:00부터 SITC 및 Crescent 웹사이트에서 공개될 예정입니다.
Crescent Biopharma (NASDAQ: CBIO) présentera des données précliniques sur CR-001, un anticorps bispénique tetravalent PD-1 x VEGF, lors de la 40e Réunion annuelle de la Society for Immunotherapy of Cancer, du 7 au 9 novembre 2025.
Points clés : CR-001 a montré une pharmacologie coopérative in vitro avec une augmentation de l'interaction PD-1 en présence de VEGF, un renforcement du blocage PD-1/PD-L1, une activation des cellules T accrue, une activité anti-tumorale puissante dans un modèle xenograft et une bonne tolérance ainsi qu’une occupation robuste du récepteur PD-1 chez des primates non humains. Crescent indique qu'une soumission IND est en bonne voie pour le quatrième trimestre 2025 afin de soutenir un essai de phase 1 global prévu pour commencer au premier trimestre 2026. Le poster (Abstract 1185) sera disponible sur SITC et sur le site de Crescent à partir de 9h00 H.E.T. le jour de la présentation.
Crescent Biopharma (NASDAQ: CBIO) wird CR-001, einen tetravalenten PD-1 x VEGF bispezifischen Antikörper, auf der 40. Jahrestagung der Society for Immunotherapy of Cancer vom 7. bis 9. November 2025 präsentieren, einschließlich präklinischer Daten.
Schlüsselpunkte: CR-001 zeigte in vitro eine kooperative Pharmakologie mit erhöhter PD-1-Bindung in Gegenwart von VEGF, eine verstärkte PD-1/PD-L1-Hemmung, eine verbesserte T-Zell-Aktivierung, eine potente Antitumor-Aktivität in einem Xenograft-Modell und eine gute Verträglichkeit sowie eine robuste PD-1-Rezeptorbesetzung bei Nicht-human-Primaten. Crescent erwähnt, dass der IND-Einreichungstermin im Q4 2025 liegt, um eine globale Phase-1-Studie zu unterstützen, die voraussichtlich im Q1 2026 beginnt. Das Poster (Abstract 1185) wird ab 9:00 Uhr ET am Präsentationstag auf SITC und der Crescent-Website verfügbar sein.
Crescent Biopharma (NASDAQ: CBIO) ستقدم بيانات قبل الإكلينيكية لـ CR-001، وهو جسم مضاد ثنائي الخصائص رباعي التكافؤ PD-1 x VEGF، في الاجتماع السنوي الأربعين لجمعية المناعة العلاجية للسرطان (SITC) في الفترة من 7 إلى 9 نوفمبر 2025.
النقاط الرئيسية: أظهر CR-001 دواءً فسيولوجياً تعاونياً داخل المختبر مع زيادة ارتباط PD-1 في وجود VEGF، وتحصين PD-1/PD-L1، وتفعيل الخلايا التائية بشكل معزز، ونشاط مضاد للأورام قوي في نموذج كائن حي طَفْري، وتحمل جيد إلى جانب إشغال قوي لمستقبل PD-1 في الرئيسيات غير البشرية. تقول Crescent إن تقديم IND سيكون في المسار الصحيح للربع الرابع من 2025 لدعم تجربة مرحلية أولى عالمية من المخطط أن تبدأ في الربع الأول من 2026. سيصبح الملصق (Abstract 1185) متاحاً على SITC وعلى موقع Crescent الإلكتروني بدءاً من الساعة 9:00 صباحاً بتوقيت شرق الولايات المتحدة في يوم العرض.
- Preclinical cooperative PD-1/VEGF pharmacology demonstrated in vitro
- Potent anti-tumor activity observed in xenograft mouse model
- Well-tolerated in non-human primates after single IV dose
- Robust PD-1 receptor occupancy measured in non-human primates
- IND submission on track for Q4 2025 to support Phase 1
- Data are limited to preclinical models; no clinical efficacy yet
- Phase 1 start remains conditional on IND acceptance and regulatory clearance
Insights
Preclinical data support IND timing and a Phase 1 start in
Crescent reported that CR-001, a tetravalent PD-1 x VEGF bispecific antibody, showed cooperative pharmacology in vitro with increased PD-1 binding in the presence of VEGF, enhanced PD-1/PD-L1 signaling blockade, augmented T-cell activation, potent anti-tumor activity in a xenograft mouse model, and tolerability plus robust PD-1 receptor occupancy after a single IV dose in non-human primates. The company states its IND submission is on track for the fourth quarter of 2025 and plans to initiate a global Phase 1 trial in patients with solid tumors in
The business mechanism is clear from the disclosed facts: combining checkpoint inhibition (PD-1 blockade) with VEGF neutralization aims to pair immune reactivation with modulation of the tumor microenvironment, and the reported in vitro cooperativity and in vivo tumor reduction are the specific preclinical signals supporting clinical entry. Risks and dependencies are procedural and data-driven: IND acceptance, clinical safety in humans, and whether the preclinical tolerability and receptor occupancy translate to human dosing and pharmacology. Watch near-term milestones explicitly stated here: the IND submission in
CR-001 Demonstrated Cooperative Pharmacology and Robust Anti-Tumor Activity
IND Submission for CR-001 On Track for Fourth Quarter of 2025 to Support Initiation of Global Phase 1 Trial in Patients with Solid Tumors
WALTHAM, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that preclinical data from CR-001, its PD-1 x VEGF bispecific antibody being developed for solid tumors, will be presented at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting being held November 7-9, 2025 in National Harbor, Maryland.
CR-001 is a tetravalent bispecific antibody combining two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. In data to be presented at SITC, CR-001 demonstrated cooperative pharmacology in vitro with increased binding to PD-1 in the presence of VEGF, augmenting the PD-1/PD-L1 signaling blockade and enhancing T-cell activation. This cooperativity was consistent with preclinical evaluation of ivonescimab, another tetravalent PD-1 x VEGF bispecific antibody, which demonstrated superior efficacy compared to the current market leader, pembrolizumab, in a large, third-party Phase 3 trial in non-small cell lung cancer.1,2 CR-001 also showed potent anti-tumor activity in a xenograft mouse model, and was well-tolerated in non-human primates after a single intravenous dose with robust PD-1 receptor occupancy.
“These data highlight the cooperative mechanism of CR-001 and its ability to reduce tumor growth in vivo, reinforcing its potential as a next generation immuno-oncology therapy,” said Jan Pinkas, Ph.D., chief scientific officer of Crescent. “We are on track to advance CR-001 into the clinic and plan to initiate our global Phase 1 trial in patients with solid tumors in the first quarter of 2026.”
Details of the poster presentation are as follows:
Title: Preclinical development of CR-001, a novel tetravalent PD-1 x VEGF bispecific antibody with cooperative pharmacology and potent anti-tumor activity
Abstract Number: 1185
Presentation Date: Friday, November 7, 2025
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
The abstract is available on SITC’s website ahead of the presentation. The poster will be available in the Presentations & Publications section of Crescent’s website beginning at 9:00 a.m. ET on the day of the presentation.
About CR-001
CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with Crescent’s antibody-drug conjugates (ADCs) in development.
About Crescent Biopharma
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Crescent’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Crescent’s ability to achieve the expected benefits or opportunities with respect to CR-001, including the expected timelines of regulatory filings, regulatory filing acceptance, global trial commencement, and initial clinical data for CR-001, the potential for CR-001 to replicate the cooperative pharmacology of ivonescimab in clinical trials, the potential of CR-001 as a next generation immuno-oncology therapy to address a range of solid tumors, and the potential for CR-002 and CR-003 to act in combination with CR-001. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "strategy," "target," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "plan," "possible," "project," "should," "will," "would" and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Crescent will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Crescent’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to those uncertainties and factors more fully described in Crescent’s most recent filings with the Securities and Exchange Commission (including its Quarterly Report on Form 10-Q and registration statement on Form S-4, most recently amended on May 12, 2025 and declared effective by the SEC on May 14, 2025), as well as risk factors associated with companies, such as Crescent, that operate in the biopharma industry. Should one or more of these risks or uncertainties materialize, or should any of Crescent’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Crescent does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Crescent.
References:
1. Zhong T, et al. iScience. 2024; 28(3):111722.
2. Xiong A, et al. Lancet. 2025; 405(10481):839-849.
Contact:
Amy Reilly
Chief Communications Officer
amy.reilly@crescentbiopharma.com
617-465-0586
FAQ
What preclinical results for CR-001 will Crescent Biopharma (CBIO) present at SITC on November 7, 2025?
When does Crescent expect to file the IND for CR-001 (CBIO) and start its global Phase 1 trial?
Where can investors access Crescent Biopharma’s (CBIO) CR-001 poster from SITC 2025?
Did Crescent report any safety or tolerability findings for CR-001 (CBIO)?
How does Crescent describe CR-001’s mechanism compared with existing PD-1 therapies for investors in CBIO?
