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Evaxion announces last patient visit in one-year extension of phase 2 trial with personalized cancer vaccine EVX-01

On April 7, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported it has successfully completed the one-year extension of its phase 2 trial with personalized cancer vaccine EVX-01 with the last patient having now had last physician visit. Patients in the trial will continue to be monitored and data prepared for expected presentation in the second half of 2026.

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Designed with AI-Immunology, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). In the first two years of the phase 2 trial, patients were treated with EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, Keytruda (pembrolizumab).

In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect both as stand-alone and combination treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of induced immune response.

"We are pleased to have carried through the extension of the trial as planned and are looking forward to collecting, analysing and presenting the data. EVX-01 already has a very strong data package demonstrating the unique capabilities of AI-Immunology in cancer vaccine design. We hope to further enhance the data package with the three-year results," says Birgitte Rønø, CSO of Evaxion.

Encouraging data
Data from the first two years of the trial demonstrated an Objective Response Rate of 75%, as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed.

54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial.

In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology platform in accurately identifying neoantigens, which leads to detectable signals in patients.

Data also confirmed EVX-01 to be a well-tolerated treatment.

(Press release, Evaxion, APR 7, 2026, View Source [SID1234664204])

CRISPR Therapeutics to Present at the 25th Annual Needham Virtual Healthcare Conference

On April 7, 2026 CRISPR Therapeutics (Nasdaq: CRSP) reported that members of its senior management team will present at the 25th Annual Needham Virtual Healthcare Conference on Monday, Apr 13 at 2:15 p.m. ET.

A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

(Press release, CRISPR Therapeutics, APR 7, 2026, View Source [SID1234664203])

CORMEDIX TO PARTICPATE IN NEEDHAM VIRTUAL HEALTHCARE CONFERENCE

On April 7, 2026 CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that senior management will be participating in a fireside chat and investor meetings at the upcoming 25th Annual Needham Virtual Healthcare Conference taking place April 13 – 16, 2026.

25th Annual Needham Virtual Healthcare Conference
Date: April 14, 2026
Time: 3:00pm Eastern
Format: Fireside Chat
Webcast: Link to webcast

(Press release, CorMedix, APR 7, 2026, View Source [SID1234664202])

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.

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.

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])