Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer

On April 7, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, reported broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company’s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Corbus also announced that Dr. Dominic Smethurst, MA, MRCP is stepping down from his role as Chief Medical Officer; his last day with the company will be June 30, 2026.

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The agreed upon second-line registrational study designs for CRB-701 include:

HNSCC: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice chemotherapy with potential accelerated approval using objective response rate (ORR) as the primary endpoint and potential full approval granted on overall survival (OS) benefit.
Cervical cancer: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice of chemotherapy or Tivdak with potential accelerated approval using ORR as the primary endpoint and potential full approval granted on OS benefit.
Continued interactions with the FDA planned to finalize the protocols and statistical analysis plans for the registrational studies.

Updated clinical data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 29 – June 2 in Chicago. Data will include clinical response durability as well as HNSCC patient subgroup analysis. Corbus previously presented dose optimization data from the study, including encouraging efficacy and safety findings, at the 2025 European Society for Medical Oncology Congress (ESMO 2025). The company also anticipates reporting data with CRB-701 in combination with Keytruda in first-line HNSCC patients in Q4 2026 to support potential further registration-enabling trials.

"We’re pleased to share this important regulatory update as we continue to progress CRB-701 as a novel oncology therapeutic to address unmet medical needs for patients. We look forward to sharing updated monotherapy data on CRB-701 at ASCO (Free ASCO Whitepaper) and expect to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

Dr. Cohen continued, "This milestone marks an important transition from clinical proof of concept to pending late-stage registrational development and the potential for regulatory submission of CRB-701. This year we will be adding several key new senior leaders to best prepare us for this critical next phase. We are very grateful for Dr. Smethurst’s contributions to advance our pipeline programs through early development, well positioning Corbus for continued success."

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

(Press release, Corbus Pharmaceuticals, APR 7, 2026, View Source [SID1234664201])

bioAffinity Technologies’ CyPath® Lung to be Featured at Cleveland Clinic Annual “Advances in Early Lung Cancer Detection” Symposium April 16

On April 7, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, reported that its CyPath Lung test will be featured at the invitation-only "Advances in Early Lung Cancer Detection" symposium at the Cleveland Clinic in Cleveland, Ohio, on April 16, 2026. Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer, will be one of three panelists discussing lung nodule management and highlighting the benefits of using CyPath Lung to aid in the early detection of lung cancer in high-risk patients.

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The seventh annual Cleveland Clinic symposium brings together global leaders in the field of lung cancer, including physicians, advocacy organizations, researchers and industry, to accelerate the development and implementation of new technologies and methods to find lung cancer at the earliest stages when it is most treatable. This is bioAffinity Technologies’ seventh invitation to present before symposium attendees.

This year’s agenda addresses lung cancer risk assessment, emerging diagnostic technologies, screening biomarkers and artificial intelligence (AI) as well as the changing epidemiology of lung cancer.

"As the number of indeterminate pulmonary nodules discovered incidentally and by lung screening continues to grow, so does the accompanying need for noninvasive, scalable diagnostic solutions," Dr. Downie said. "CyPath Lung directly addresses many of the issues that will be discussed at the Cleveland Clinic’s symposium. Using our sputum-based diagnostic as an adjunct to the current standard of care for newly discovered non-calcified pulmonary nodules helps guide difficult clinical discussions, accelerates diagnosis and prevents unnecessary invasive procedures. Adding CyPath Lung to the diagnostic pathway provides actionable results to physicians, eases anxiety for patients, and can reduce costs to the healthcare system."

CyPath Lung is a noninvasive, cost-effective diagnostic test that uses flow cytometry and AI to analyze the lung microenvironment and identify cancer and cancer-related cells. Clinical data and case studies have shown its potential to detect cancer as early as Stage 1A, while a negative result can help avert unnecessary and often risky invasive procedures.

With both high sensitivity and specificity, CyPath Lung is a balanced test that supports clinical decision-making and is broadly applicable in high-risk patients, regardless of nodule size or prior cancer history. Initially designed to assist in the evaluation of indeterminate pulmonary nodules identified through screening or incidental imaging, CyPath Lung can also be used to monitor lung cancer survivors for recurrence.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to aid in the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that may indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. CyPath Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. Results may vary in broader clinical use.

(Press release, BioAffinity Technologies, APR 7, 2026, View Source [SID1234664200])

Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference

On April 7, 2026 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, reported that it will present at the 25th Annual Needham Virtual Healthcare Conference, April 13 – 16, 2026. President and Chief Executive Officer Christopher U. Missling, PhD and his management team will present the Company scheduled at 1:30 PM (ET) on Tuesday, April 14th, 2026.

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A live audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com. An archived edition of the session will be available later that day.

(Press release, Anavex Life Sciences, APR 7, 2026, View Source [SID1234664199])

Alloy Therapeutics Enters into Multi-Target Collaboration and License Agreement with Biogen for Use of Alloy’s AntiClastic™ ASO Platform

On April 7, 2026 Alloy Therapeutics Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting-edge drug discovery technologies, reported a collaboration and license agreement with Biogen Inc. for the use of Alloy’s novel and proprietary AntiClastic ASO Platform. Through this collaboration, Biogen will apply the platform to advance antisense therapeutics against multiple undisclosed targets. Alloy will receive an upfront payment and is eligible for additional milestone payments and tiered royalties on any products resulting from the collaboration.

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The collaboration and license agreement brings together Biogen’s scientific leadership and experience in advancing innovative medicines with Alloy’s proprietary antisense discovery capabilities. Alloy’s AntiClastic ASO platform enables drug developers to realize the full potential of antisense therapeutics by reaching intracellular disease targets at the RNA level. The platform is specifically designed to address potency and therapeutic index challenges that have historically held back the promise of antisense drugs due to limited biodistribution and, therefore, efficacy.

"Biogen has built an extraordinary reputation for scientific leadership and for translating breakthrough research into impactful therapies," said Errik Anderson, CEO and Founder of Alloy Therapeutics. "We value our long-standing relationship and are honored to support their world-class teams with access to our AntiClastic ASO Platform and broader technology ecosystem, helping enable the continued pursuit of innovative treatments that have the potential to change patients’ lives."

"This collaboration reflects Biogen’s commitment to pushing the boundaries of scientific innovation and exploring novel approaches to address complex diseases," said Jane Grogan, Ph.D., Executive Vice President and Head of Research at Biogen. "Partnering with Alloy allows us to expand our research strategies and continue advancing programs with the potential to benefit patients worldwide."

Alloy’s capabilities span an integrated ecosystem of drug discovery platforms designed to accelerate the development of innovative therapeutics. The company continues to integrate advanced technologies, including computational and AI-enabled approaches, to enhance discovery and optimization across its programs.

About the Alloy Therapeutics Genetic Medicines AntiClastic ASO Platform

The AntiClastic ASO platform designs novel oligonucleotide formats, exclusively available through partnerships with Alloy’s Genetic Medicines division, to overcome potency and therapeutic index challenges that have historically limited the promise of antisense drugs. Dr. Sudhir Agrawal invented the core technology, which combines improvements in the primary sequence with a proprietary spatial conformation of nucleic acid drugs to promote the delivery of antisense to target RNA, mitigate the inflammatory response, and improve a drug’s therapeutic index. The resulting drug candidates have shown a significant increase in potency compared to gapmer antisense formats. Partners can apply this format to existing antisense sequences or partner to discover new AntiClastic oligonucleotide molecules to precisely deliver therapeutic payloads to their intended target.

(Press release, Alloy Therapeutics, APR 7, 2026, View Source [SID1234664198])

RS Research Announces Successful Completion of Phase 1 Clinical Trial of RS-0139 in Solid Tumors

On April 6, 2026 RS Research, a biotechnology company developing smart nanomedicines for oncology, reported the successful completion of the Phase 1 clinical trial of its lead investigational candidate RS-0139 in patients with solid tumors. Designed on the company’s proprietary Sagitta platform to selectively deliver docetaxel to tumor tissue and improve therapeutic index, RS-0139 has now generated early clinical evidence supporting not only its own continued advancement, but also the broader translational potential of the Sagitta platform. This milestone marks an important inflection point for RS Research as it prepares for the next stage of development, including international clinical expansion, strategic partnering and future financing discussions.

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The completed Phase 1 clinical study was a multicenter, open-label, two-step Phase 1a/1b trial conducted to determine the optimum dose and characterize pharmacokinetic, safety and tolerability profile of RS-0139 in patients with recurrent, locally advanced or metastatic solid tumors. The study generated the initial clinical dataset needed to assess how Sagitta-enabled targeted delivery may translate into an improved therapeutic index in a real-world oncology setting.
Key findings from the Phase 1 trial include:

• markedly improved hematologic safety compared with conventional chemotherapy,
• an encouraging overall safety and tolerability profile,
• promising early signals of antitumor activity.

RS Research is currently consolidating the full clinical dataset and completing the relevant procedural steps in preparation for future scientific and corporate disclosure of additional details.

Prof. Rana Sanyal, Co-Founder and CSO of RS Research, and Grand Prize Laureate of the EIC European Prize for Women Innovators, said: "These results are the product of years of rigorous science, persistence and translational focus. More importantly, they provide early clinical validation of our Sagitta platform, supporting our confidence that targeted delivery can meaningfully improve the therapeutic index of oncology treatments. This milestone strengthens our conviction in advancing additional candidates built on the same platform."

Sagitta is RS Research’s proprietary drug delivery platform, designed to improve therapeutic index by selectively directing cytotoxic payloads to tumor tissue and addressing the longstanding efficacy-toxicity trade-off in solid tumors.

Gülsah Nomak, MD, Medical Director of RS Research, stated: "The successful completion of the Phase 1 program provides the clinical foundation for our next stage of development. It supports our plans to advance RS-0139 into an international Phase 2 program designed to further define its therapeutic potential in solid tumors."

Dr. Sena Nomak, Co-Founder and COO of RS Research, added: "This milestone marks an important point of transition for RS Research as we move from early clinical validation toward broader international development. We have secured over 20 million USD backing so far from pharma, VC and non-dilutive funding sources. It strengthens our position in ongoing strategic discussions around the company’s global growth trajectory and comes at a meaningful time as we prepare for our upcoming Series B financing round."

(Press release, RS Research, APR 6, 2026, View Source [SID1234664623])