Executive Director/Vice President – Medical Lead

Crescent Biopharma, Inc. announces clinical pipeline momentum. Published on 10/15/2026 at 04:15 pm EDT S&P Capital IQ Crescent Biopharma, Inc. announced clinical pipeline momentum, including enrolling patients in cohorts combining CR-001, a PD-1 x VEGF bispecific antibody, plus standard of care chemotherapy regimens in its global Phase 1/2 ASCEND trial, as well as the initiation of additional antibody-drug conjugate (ADC) combination studies with CR-001. Crescent has completed dose escalation in the global Phase 1/2 ASCEND trial of CR-001, its investigational PD-1 x VEGF bispecific, developed in collaboration with Paragon Labs, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea. The Company plans to report initial monotherapy data from ASCEND in the first quarter of 2027, including preliminary antitumor response as measured by overall response rate (ORR) from a first-line NSCLC cohort of up to 12 patients. The Company plans to report initial monotherapy data from ASCEND in the first quarter of 2027, including safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naïve and previously-treated patients across multiple solid tumor types. Enrollment has commenced in the standard of care chemotherapy combination expansion cohorts of ASCEND. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including first-line (1L) NSCLC: CR-001 + paclitaxel and carboplatin (squamous) or pemetrexed and carboplatin (non-squamous). Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including 1L mismatch repair proficient (pMMR) /microsatellite stable (MSS) colorectal cancer (CRC): CR-001 + mFOLFOX6. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including third-line (3L) CRC: CR-001 + trifluridine and tipiracil. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including 1L biliary tract cancer: CR-001 + gemcitabine and cisplatin. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including 1L pMMR endometrial cancer: CR-001 + carboplatin and paclitaxel. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including 1L programmed cell death ligand 1 (PD-L1)-expressing gastric/gastroesophageal junction (GEJ) cancer: CR-001 + capecitabine and oxaliplatin. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including second-line (2L) PD-L1-expressing gastric/GEJ cancer: CR-001 + paclitaxel. Crescent plans to report initial data from the chemotherapy combination cohorts in mid-2027 (second quarter/third quarter). Data from these cohorts, along with monotherapy data from ASCEND, will inform future clinical development for CR-001. Trial in progress posters on the ASCEND study design will be presented during the European Society for Medical Oncology (ESMO) 2026 Congress being held October 23-27, 2026 in Madrid, Spain and at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting being held November 4-8, 2026 in Phoenix, Arizona. Both Kelun-Biotech and Crescent have rights to independently develop CR-001 in combinations, including with their respective ADC pipelines. Kelun-Biotech is conducting multiple trials in China evaluating CR-001 in combination with sacituzumab tirumotecan (sac-TMT), its TROP2-directed ADC, and additional ADC combination studies are planned. A Phase 2 trial of CR-001 (SKB118) and sac-TMT in participants with locally advanced or metastatic NSCLC is ongoing with initial data expected in mid-2027 (second quarter/third quarter). A Phase 2 trial of sac-TMT in combination with CR-001 (SKB118) is now enrolling participants with advanced solid tumors. A Phase 2 trial of sac-TMT in combination with CR-001 (SKB118) is initiating in epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy. A Phase 1/2 trial of CR-001(SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6 (ITGB6)-directed ADC, is expected to commence in the first half of 2027. Earlier this month, CR-002, Crescent?s topoisomerase inhibitor ADC targeting PD-L1, internally developed in collaboration with Paragon Labs, received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration. Crescent is on track to initiate the global Phase 1/2 APOLLO trial this quarter in patients with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. Initial data are expected in the second half of 2027. A Phase 1/2 trial of CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. Crescent plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105). (C) S&P Capital IQ - GlobeNewswire - 2026

Crescent Bio to raise USD 125m to provide oncology pipeline runway into 2028. July 15, 2026 Massachusetts-based Crescent Biopharma, Inc. (Nasdaq: CBIO) announced the pricing of an underwritten public offering of ordinary shares and pre-funded warrants, raising approximately USD 125 million in gross proceeds to fund the clinical advancement of its oncology pipeline, including its lead PD-1 x VEGF bispecific antibody and two ADC programs. The raise extends the company's cash runway, which stood at USD 189 million as of March 31, 2026 and was projected to fund operations into 2028 - a figure that the current offering materially supplements ahead of multiple anticipated data readouts in 2027. The offering comprises 8,094,793 ordinary shares priced at USD 14.50 per share, with pre-funded warrants to purchase up to 525,897 additional shares offered at USD 14.499 per warrant to certain investors in lieu of ordinary shares. Underwriters were granted a 30-day option to purchase up to an additional 1,293,103 ordinary shares at the offering price, which if exercised in full would increase total gross proceeds beyond the USD 125 million base. The offering was expected to close on July 16, 2026. Crescent's pipeline is built around three clinical or near-clinical assets, all developed in partnership with China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. under a bilateral licensing arrangement announced in December 2025 that included an USD 80 million upfront payment by Crescent for ex-China rights to CR-003 and a reciprocal grant to Kelun-Biotech of Greater China rights to CR-001. The lead asset is CR-001, a tetravalent bispecific antibody simultaneously blocking PD-1 and VEGF, currently being evaluated in the global Phase I/II ASCEND trial across multiple solid tumor types including non-small cell lung cancer and gastrointestinal and gynecological cancers. First patient dosing occurred in February 2026. Management has guided for proof-of-concept data - covering initial safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity - in Q1 2027, with combination data alongside standard-of-care chemotherapy expected by mid-2027. The first ADC combination trial pairing CR-001 with a Kelun-Biotech ADC is on track to initiate in H2 2026. CR-001 operates in a competitive space alongside ivonescimab, which demonstrated superiority over pembrolizumab in a large Phase III trial, though cross-trial comparisons remain constrained by differences in design and patient populations. CR-002, a PD-L1-targeted ADC with a topoisomerase I inhibitor payload, is on track for IND submission to the US FDA in mid-2026, with Phase I/II trial initiation planned for H2 2026 and proof-of-concept data anticipated in H2 2027. CR-003, an ITGB6-targeted ADC also carrying a topoisomerase I payload, is already in an ongoing Phase I/II trial in China under Kelun-Biotech's sponsorship, with proof-of-concept data expected in Q1 2027. A Phase I/II combination trial of CR-003 and CR-001 is expected to initiate in H1 2027. The current offering is Crescent's third significant capital raise since its June 2025 Nasdaq debut via reverse merger with GlycoMimetics, which was accompanied by a concurrent USD 200 million private placement. A second USD 185 million private placement closed in December 2025 alongside the Kelun-Biotech partnership. The July 2026 public offering represents a shift from institutional private rounds to a broader public equity raise, providing additional capital flexibility as the company approaches its first clinical data milestones. Q1 2026 net loss was USD 23.3 million on R\&D expenses of USD 17.9 million, reflecting accelerating clinical spend as ASCEND enrollment advances and IND preparations for CR-002 proceed. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/