On September 4, 2025 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported that following a strategic review by executive management, the Company is sharpening its focused investment on its most important assets (Press release, AC Immune, SEP 4, 2025, View Source [SID1234655753]). These include its three clinical-stage active immunotherapy programs, two of which are in ongoing pharma collaborations, and its most promising small molecule programs targeting NLRP3 and Tau. As a result, the Company will reduce its workforce by around 30% and extend its cash for operations to the end of Q3 2027.

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are making meaningful progress with our product candidates to treat and prevent neurodegenerative diseases and are eagerly approaching multiple potentially transformational milestones over the next two years. This is true both in our ongoing collaborations with Janssen, Takeda and Lilly, and in our wholly-owned programs where progress will further strengthen opportunities for more partnering.

The actions we are taking now extend our cash runway to the end of Q3 2027, excluding anticipated business development milestone payments from existing or potential new business deals. It has been a challenging and carefully considered decision and I want to recognize all our colleagues whose professionalism, expertise and passion have resulted in many invaluable contributions to our mission over the years.

Going forward, we will focus our resources on our Phase 2 active immunotherapies and the development of our most exciting novel therapeutics targeting intracellular mechanisms of neurodegenerative diseases, including NLRP3 and Tau."

AC Immune maintains its guidance on previously announced timelines with interim clinical data from both ACI-7104.056 and ACI-24.060 expected in H2 2025 and H1 2026, respectively.

In accordance with Swiss employment law a consultation process with employees has been initiated. Upon completion of the consultation process, the Company will offer affected employees support. This will include, but will not be limited to, severance packages, and support in seeking new employment, coaching or training opportunities. AC Immune foresees the full implementation of these changes enacted by the end of 2025 and the reduction of costs to become fully effective early in 2026.

On September 3, 2025 First Ascent Biomedical (FA), an innovative biotech company specializing in transforming cancer treatment through functional precision medicine, reported a new collaboration with the Fight Colorectal Cancer Foundation (Fight CRC) to launch a prospective feasibility study aimed at transforming colorectal cancer treatment (Press release, First Ascent Biomedical, SEP 3, 2025, https://firstascentbiomedical.com/first-ascent-biomedical-and-fight-colorectal-cancer-foundation-announce-groundbreaking-study-to-advance-precision-oncology-for-colorectal-cancer-patients/?utm_source=rss&utm_medium=rss&utm_campaign=first-ascent-biomedical-and-fight-colorectal-cancer-foundation-announce-groundbreaking-study-to-advance-precision-oncology-for-colorectal-cancer-patients [SID1234655876]). Funded by a $350,000 grant from Fight CRC, and spearheaded by Anjee Davis, chief executive officer, this innovative study will leverage First Ascent’s cutting-edge xDRIVE tumor profiling technology to deliver rapid, personalized treatment insights for patients fighting colon cancer in Minnesota.

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"Fight CRC is committed to empowering patients through innovation," said Davis. "This grant underscores our strategic focus on enhancing care through advanced research, particularly for those with limited treatment options."

The study, set to begin enrollment in April or May 2025, will focus on 25 patients with metastatic colorectal cancer. By integrating functional drug testing, genetic analysis, and artificial intelligence, First Ascent’s xDRIVE platform will provide oncologists with detailed tumor profiling data and tailored treatment options, aiming to enhance patient outcomes.

Leading the clinical efforts are Hao Xie, MD, PhD, a gastrointestinal cancer specialist and precision medicine expert, and Dr. Boardman, whose work in cancer genetics and early detection has advanced the field of colorectal cancer care. Noah Berlow, PhD, First Ascent’s Chief Technology Officer and the study’s principal investigator, brings his expertise in AI-driven cancer research to oversee the project. Together, this team is poised to demonstrate the power of rapid, individualized tumor profiling to better understand each patient’s unique cancer.

"This collaboration with the Fight Colorectal Cancer Foundation is another important step in transforming how we approach cancer treatment," said Jim Foote, founder and chief executive officer, First Ascent Biomedical. "We are honored to be part of this effort."

The study is expected to complete enrollment within nine months and will provide actionable data to oncologists for patients requiring advanced treatment options. Patients interested in participating must be seen in Rochester, MN. Information will soon be available on ClinicalTrials.gov.

On September 3, 2025 First Ascent Biomedical (FA), an innovative biotech company specializing in transforming cancer treatment through functional precision medicine, reported a new collaboration with the Fight Colorectal Cancer Foundation (Fight CRC) to launch a prospective feasibility study aimed at transforming colorectal cancer treatment (Press release, First Ascent Biomedical, SEP 3, 2025, https://firstascentbiomedical.com/first-ascent-biomedical-and-fight-colorectal-cancer-foundation-announce-groundbreaking-study-to-advance-precision-oncology-for-colorectal-cancer-patients/?utm_source=rss&utm_medium=rss&utm_campaign=first-ascent-biomedical-and-fight-colorectal-cancer-foundation-announce-groundbreaking-study-to-advance-precision-oncology-for-colorectal-cancer-patients [SID1234655876]). Funded by a $350,000 grant from Fight CRC, and spearheaded by Anjee Davis, chief executive officer, this innovative study will leverage First Ascent’s cutting-edge xDRIVE tumor profiling technology to deliver rapid, personalized treatment insights for patients fighting colon cancer in Minnesota.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Fight CRC is committed to empowering patients through innovation," said Davis. "This grant underscores our strategic focus on enhancing care through advanced research, particularly for those with limited treatment options."

The study, set to begin enrollment in April or May 2025, will focus on 25 patients with metastatic colorectal cancer. By integrating functional drug testing, genetic analysis, and artificial intelligence, First Ascent’s xDRIVE platform will provide oncologists with detailed tumor profiling data and tailored treatment options, aiming to enhance patient outcomes.

Leading the clinical efforts are Hao Xie, MD, PhD, a gastrointestinal cancer specialist and precision medicine expert, and Dr. Boardman, whose work in cancer genetics and early detection has advanced the field of colorectal cancer care. Noah Berlow, PhD, First Ascent’s Chief Technology Officer and the study’s principal investigator, brings his expertise in AI-driven cancer research to oversee the project. Together, this team is poised to demonstrate the power of rapid, individualized tumor profiling to better understand each patient’s unique cancer.

"This collaboration with the Fight Colorectal Cancer Foundation is another important step in transforming how we approach cancer treatment," said Jim Foote, founder and chief executive officer, First Ascent Biomedical. "We are honored to be part of this effort."

The study is expected to complete enrollment within nine months and will provide actionable data to oncologists for patients requiring advanced treatment options. Patients interested in participating must be seen in Rochester, MN. Information will soon be available on ClinicalTrials.gov.

On September 3, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management will present at the H.C. Wainwright 27th Annual Global Investment Conference on Tuesday, Sept. 9, 2025 at 1:00 p.m. Eastern Time (Press release, Immunome, SEP 3, 2025, View Source [SID1234655750]).

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

On September 3, 2025 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral gene therapy company, reported it has achieved its target enrollment milestone of 100 patients for the pivotal cohort of its ongoing, open-label, multi-cohort Phase 2 LEGEND trial of detalimogene voraplasmid ("detalimogene" and previously EG-70) in patients with high-risk, non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, SEP 3, 2025, View Source [SID1234655749]). LEGEND’s pivotal Cohort 1 is studying detalimogene in patients with high-risk NMIBC with carcinoma in-situ (CIS) with or without concomitant papillary disease. Patients in the screening process remain eligible for potential enrollment in the trial. The Company expects to overenroll in its pivotal cohort resulting in an adjustment in guidance for a BLA submission to 2H 2026.

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"Achieving our target enrollment goal for detalimogene in LEGEND’s pivotal cohort represents an important milestone for enGene. It brings us a step closer to our goal of providing patients and physicians with the first non-viral gene therapy that offers a unique balance of efficacy, safety, and ease-of-use," said Ron Cooper, Chief Executive Officer of enGene. "We are grateful to study participants, investigators, and our clinical organization for their contributions to advancing the development of detalimogene."

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of approximately 100 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.