On September 2, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the complete response letter (CRL) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma (Press release, Replimune, SEP 2, 2025, View Source [SID1234655658]).

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The Company submitted a briefing book to the FDA addressing the points from the CRL, highlighting prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components. The briefing book also includes an additional analysis of data from the BLA and addresses comments about the phase 3 confirmatory trial design.

"We are eager to engage in a productive discussion with the FDA to reach a swift resolution for the accelerated approval of RP1 in advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "The melanoma community, including leading physicians and patient advocacy groups have emphasized the urgent need for access to RP1 based on the strength of the data and limited effective treatment options for this population. We remain steadfastly committed to patient access while we work with the FDA to secure regulatory approval for RP1, however, without accelerated approval based on the current application, continuation of the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, will not be viable."

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On September 2, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will participate at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Quince Therapeutics, SEP 2, 2025, View Source [SID1234655657]). Access to the company’s presentation will be available on Friday, September 5, 2025 beginning at 7:00 a.m. Eastern Time.

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A webcast of the presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On September 2, 2025 Philogen reported that Dr. Samuele Cazzamalli is presenting "From DNA-encoded chemistry to ACP3-targeted radioligand therapeutics against prostate cancer" (Press release, Philogen, SEP 2, 2025, View Source [SID1234655656]). In addition, Dr. Cristiano Pini will give an update on "Diagnostic Performance, Safety, and Pharmacokinetics of [68Ga]Ga-OncoACP3 in Prostate Cancer – Preliminary Results from a Prospective Phase I Clinical Trial" and Prof. Philippp Backhaus will give a presentation on "Theranostic targeting of the prostatic acid phosphatase (ACP3) with [68Ga]Ga-OncoACP3-DOTA and [177Lu]Lu-OncoACP3-DOTA in prostate cancer patients".

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Moreover, Dr. Fabrizia Gelardi will present "First-in-Human Phase I Study of [68Ga]Ga-OncoCAIX: Preliminary Results on Safety, Dosimetry, Pharmacokinetics, and Diagnostic Performance".

On September 2, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported an updated safety analysis of pelareorep, which has been administered in over 1,200 patients, including over 300 patients with various gastrointestinal tumors (Press release, Oncolytics Biotech, SEP 2, 2025, View Source [SID1234655654]).

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A previous analysis of safety data from studies involving pelareorep (link to the poster) in combination with multiple therapies in over 500 patients concluded that the most frequent adverse events were Grade 1 and 2 fever, chills, fatigue, nausea, vomiting, and diarrhea. Additionally, Grade 3 or 4 adverse events associated with chemotherapy do not appear to be modified by adding pelareorep to the treatment regimen. An updated analysis involving patients who received at least one intravenous dose of pelareorep demonstrates the existing favorable safety profile of pelareorep in combination with numerous treatment regimens across multiple tumor types.

"With over 1,200 patients dosed and a consistent safety profile, pelareorep represents one of the most de-risked immunotherapies that is not already approved as a treatment option in gastrointestinal tumors," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we move forward to registration-enabled studies, we are confident the safety data will be a positive characteristic for regulators and potential partners."

To date, over 300 gastrointestinal cancer patients across 8 clinical studies have received pelareorep. It has been evaluated in combination with new treatment regimens like modified FOLFIRINOX in metastatic pancreatic cancer and in other tumor types, including colorectal cancer and anal cancer. The most common adverse events associated with pelareorep in patients with gastrointestinal tumors are flu-like symptoms and neutropenia.

On September 2, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported a new clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) in metastatic breast cancer (Press release, Olema Oncology, SEP 2, 2025, View Source [SID1234655653]). The companies will evaluate in a Phase 1b/2 study the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

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"We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting. With OPERA-01, our first pivotal study of palazestrant, underway and our OPERA-02 ribociclib combination trial in frontline metastatic breast cancer anticipated to initiate this quarter, we remain focused on achieving our goal of transforming the metastatic breast cancer treatment paradigm."

Under the terms of the agreement, Pfizer will supply atirmociclib for use in the Phase 1b/2 study and Olema will lead the conduct of the study. All clinical data and inventions relating to the combined use of atirmociclib and palazestrant resulting from the study will be jointly owned, with Olema maintaining full global commercial and marketing rights to palazestrant.

This announcement represents Olema’s second clinical trial agreement with Pfizer. The companies’ previous agreement was established in November 2020 to evaluate palazestrant in combination with palbociclib (IBRANCE) in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.