Corbus Pharmaceuticals Announces FDA Clearance to Initiate TEMPO-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer

On July 28, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company") a clinical-stage company focusing on developing new therapies in oncology and obesity, reported that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study ("TEMPO-1") of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC).

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TEMPO-1 is a randomized controlled study (n=250) designed to evaluate the efficacy and safety of CRB-701 compared with investigator’s choice of capecitabine, cetuximab or docetaxel. The study’s primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval.

The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment and approximately 7,000 patients are estimated to succumb to the disease in the United States alone.

The FDA’s decision to allow the registrational study to proceed was supported by results from Corbus’ ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing).

"The data presented at ASCO (Free ASCO Whitepaper) provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "Unfortunately, current treatment options have shown limited efficacy underscoring the need for additional therapeutic options. OPSCC represents a significant commercial opportunity."

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.

(Press release, Corbus Pharmaceuticals, JUL 28, 2026, View Source [SID1234669456])

Vergent Bioscience Announces Publication in The Annals of Surgical Oncology Demonstrating Abenacianine with Intraoperative Molecular Imaging Improved Tumor Visualization During Lung Cancer Surgery

On July 28, 2026 Vergent Bioscience, a clinical-stage biotechnology company developing a tumor-targeted imaging platform, reported that data published in The Annals of Surgical Oncology (ASO) demonstrated clinical utility of abenacianine, the company’s investigational intraoperative molecular imaging (IMI) agent. The results showed the intraoperative molecular imaging agent’s ability to visualize tumors during lung cancer surgery, and the potential to optimize resection by localizing primary and metastatic tumors and minimizing removal of normal tissue. These data support findings from earlier clinical trials suggesting abenacianine helped surgeons see tumors in real time during minimally invasive and robotic-assisted surgical procedures.

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"As lung cancer surgery continues to advance, the need for technologies that help surgeons see cancer in real time to inform their intraoperative decision-making is critical," said Adam Gridley, president and chief executive officer at Vergent Bioscience. "We believe abenacianine has the potential to fundamentally improve how surgeons approach tumor visualization in the lung, facilitating complete and confident resections, with the opportunity to extend this approach across a broad range of solid tumors. We are excited to progress our ongoing Phase 3 trial to further evaluate the potential of abenacianine for cancer in the lung including additional infusion timing flexibility out to four days before surgery."

The Phase 2B, multicenter, open-label VISUALIZE trial enrolled 89 individuals undergoing surgery for suspected or known cancer in the lung at six clinical investigative sites in the United States and Australia. Each patient in the trial received abenacianine preoperatively by intravenous infusion. Following an attempt to localize the patient’s target lung lesion using standard surgical techniques, investigators used commercially available surgical near infrared (NIR) imaging systems with abenacianine to visualize the lesion, which was then assessed by pathology.

The primary efficacy endpoint was the proportion of patients with at least one clinically significant event (CSE) defined as localization of lesions not found by standard surgical techniques, identification of additional cancers, identification of inadequate surgical margins confirmed by pathology, and detection of cancerous lymph nodes.

Of the 89 patients included in the trial, 40 (45%) of the patients had at least one CSE; meaning that, in 45 percent of surgical cases, the addition of abenacianine provided actionable information to surgeons resulting in improved surgical outcomes.

Tumors visualized by IMI with abenacianine included primary lung cancers (adenocarcinoma, squamous cell carcinoma, neuroendocrine tumor) and cancers that metastasized to the lung (breast, colorectal, prostate, thymoma, renal cell, sarcoma). Abenacianine appeared safe and well tolerated with no drug-related serious adverse events observed.

"While surgery remains the foundation of treatment of lung cancer, surgeons continue to face challenges in identifying small lesions and ensuring complete tumor removal," said clinical trial investigator and senior author Sunil Singhal, M.D., chief of the Division of Thoracic Surgery in the Perelman School of Medicine at the University of Pennsylvania. "These results further strengthen the growing body of evidence supporting intraoperative molecular imaging with abenacianine as a means to enhance tumor visualization during surgery, enabling more precise resection and helping to reduce the risk of leaving cancer behind."

To further evaluate the efficacy of abenacianine, Vergent is currently conducting the Phase 3 multicenter VISUALIZE-2 clinical trial (NCT07499674). Enrollment in this trial is advancing rapidly with a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) planned in 2027.

About the VISUALIZE Clinical Trial
The Phase 2B, multicenter, open-label VISUALIZE trial (NCT06145048) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the trial received 0.32 mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques alone, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. The primary efficacy endpoint included localization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

About Abenacianine for Injection
Invented in Dr. Matt Bogyo’s lab at Stanford University School of Medicine, abenacianine is a tumor-activated intraoperative imaging platform designed to deliver molecular insight during surgery by revealing malignant tissue undetectable under white light. Administered via a short intravenous infusion several hours to several days before surgery, abenacianine binds covalently to cathepsins, a family of proteases overexpressed across a broad range of solid tumors. The agent incorporates the near-infrared (NIR) dye indocyanine green (ICG), which is compatible with commercially available NIR imaging systems widely used in minimally invasive and robotic surgery. This compatibility and dosing flexibility enable seamless integration into existing surgical workflows.

(Press release, Vergent Bioscience, JUL 28, 2026, View Source [SID1234669473])

IDEAYA Biosciences Announces IDE892, a Potential Best-in-Class MTA-Cooperative PRMT5 Inhibitor, Initiates Part 2 Monotherapy Expansion in the Phase 1/2 Study in MTAP-Deleted Pancreatic and Lung Cancers

On July 27, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that initiation of Part 2 monotherapy expansion has been achieved in its Phase 1/2 clinical trial evaluating IDE892, a potential best-in-class methylthioadenosine (MTA)-cooperative inhibitor of PRMT5, in MTAP-deleted solid tumors, with a focus on non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). IDE892 Phase 1/2 monotherapy expansion has been initiated at projected efficacious target human exposures where 24-hours target EC90 coverage have been achieved. The IDE892 maximum tolerated dose (MTD) has not yet been reached in the ongoing dose escalation.

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"We are excited to initiate monotherapy expansion evaluating IDE892 in MTAP-deleted PDAC and NSCLC. We designed IDE892 to be a potential best-in-class PRMT5 inhibitor, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding, lack of brain penetrance, and favorable drug-like properties intended to maximize its therapeutic window as both a monotherapy agent and in combination. We are well positioned to have the industry’s deepest MTAP-deletion pipeline, with IDE892, MAT2A inhibitor IDE397 in Phase 2, and the potential first-in-class CDKN2A lead molecule advancing in preclinical toxicology studies for a target IND in the first half of 2027," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Loss of MTAP leads to the accumulation of MTA and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397, where the first-patient-in (FPI) was achieved in mid-2026. IDEAYA also entered into a clinical collaboration with Roche evaluating IDE892 in combination with RG6505, Roche’s Phase 1 pan-RAS inhibitor, in MTAP-deleted pancreatic ductal adenocarcinoma (PDAC) to target the genetic co-alterations of MTAP and KRAS in this indication. Next, IDEAYA is advancing a third proprietary and potential first-in-class program for MTAP-deleted solid tumors targeting CDKN2A, the most common co-alteration of MTAP-deletion, through ongoing preclinical toxicology studies to support an investigational new drug (IND) application in the first half of 2027. IDEAYA anticipates that rational combination doublets may be pursued with IDEAYA’s CDKN2A lead molecule and IDE892 to target the co-alterations of MTAP and CDKN2A, and pan-RAS inhibitors, as the key tumor suppressor gene CDKN2A has been reported to be deficient in approximately 70% of PDAC.

MTAP deletion is estimated to occur in approximately 15% of all solid tumors, including 15 to 20% of NSCLC and up to 40% of PDAC. There are no approved therapies for MTAP-deleted cancers, highlighting the significant unmet need and opportunity for new precision therapies for these patients.

IDE892 has potential best-in-class properties, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding and lack of brain penetrance intended to maximize its therapeutic window, and favorable drug-like properties to enable rational combinations with IDE397, pan-RAS inhibitors, KRAS G12D therapies, and IDEAYA’s CDKN2A lead molecule. IDE892 has a CYP3A4 IC50 greater than 45 micromolar and did not show time dependent inhibition of any of the 7 major cytochrome P450s (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4) based on full kinetic CYP inactivation assays, positioning IDE892 as a potential best-in-class MTA-cooperative PRMT5 combination partner.

(Press release, Ideaya Biosciences, JUL 27, 2026, View Source [SID1234669438])

Harbour BioMed and Sinopharm Enter Strategic Collaboration to Establish Innovation R&D Consortium

On July 27, 2026 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported that it has entered into a strategic collaboration with China National Pharmaceutical Group Co., Ltd. ("Sinopharm"). The two parties will establish the Sinopharm – Harbour BioMed Innovation Consortium (the "Innovation Consortium") to advance collaborative research and development of innovative biologics.

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Under the terms of the agreement, Harbour BioMed and Sinopharm will collaborate across the full research and development lifecycle of innovative biologics, with a strategic focus on oncology, immune-mediated inflammatory diseases and other therapeutic areas. Harbour BioMed will leverage its globally leading Harbour Mice fully human antibody technology platform and AI-enabled drug discovery capabilities to drive the discovery and optimization of antibody candidates together with Sinopharm. Sinopharm will contribute their expertise in clinical development, large-scale manufacturing and commercialization, and will be responsible for developing commercial-scale manufacturing processes, producing clinical trial materials, and commercializing products arising from the collaboration. The two parties will jointly fund the research and development activities and share product rights in accordance with mutually agreed terms.

"We are delighted to establish this strategic partnership with Sinopharm," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. "Harbour BioMed is committed to becoming a leading platform-driven biopharmaceutical group. Leveraging our globally differentiated Harbour Mice fully human antibody technology platform and continuously expanding AI-enabled antibody discovery capabilities, we have established strategic collaborations with leading global pharmaceutical companies, including AstraZeneca, Bristol Myers Squibb and Pfizer. This partnership with Sinopharm represents another important step in advancing our ‘platform + pipeline’ strategy in China. Sinopharm is a leading pharmaceutical and healthcare group that covers the entire industry chain—from R&D and manufacturing to distribution. With strong R&D capabilities, robust industrial-scale production capacity, proven commercial execution, and an extensive market network, we look forward to deeply integrating the strengths of our technology platform with Sinopharm’s full-industry-chain capabilities to jointly accelerate the R&D and accessibility of innovative medicines."

Sinopharm commented: "As the national team in the pharmaceutical and healthcare sector, Sinopharm has always placed scientific and technological innovation at the core of its development strategy and is accelerating the establishment of a new paradigm that synergizes independent innovation with open collaboration. Harbour BioMed is a world-leading platform-driven biopharmaceutical company, equipped with a rare fully human antibody technology platform and AI-powered antibody discovery capabilities that are at the forefront in China. The establishment of an innovation R&D consortium with Harbour BioMed represents a key move by Sinopharm to optimize resource allocation and enhance R&D efficiency. We look forward to both parties fully leveraging our respective strengths in technology, talent, platforms, and industrial chains to jointly advance the R&D and industrialization of innovative drugs, and to provide patients with more high-quality and affordable treatment options."

(Press release, Harbour BioMed, JUL 27, 2026, View Source [SID1234669439])

Everest Medicines Announces Participation in Upcoming Investor Conferences

On July 27, 2026 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, reported that Ian Woo, President and Chief Financial Officer, will participate in the upcoming investor conferences.

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Morgan Stanley Biotech Without Borders Series
Date: Tuesday, July 28, 2026
Time: US: 10:00am – 10:30am ET / 10:00pm – 10:30pm HKT
Format: Fireside chat
Webcast: View Source;tp_key=ca5039df5f

2nd Annual Evercore China Biotech Summit
Date: Tuesday, August 18, 2026
Time: 11:00am HKT
Format: Presentation and Q&A
Location: The Ritz-Carlton Shanghai, Pudong

(Press release, Everest Medicines, JUL 27, 2026, View Source [SID1234669440])