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.

On September 2, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conference (Press release, Nkarta, SEP 2, 2025, View Source [SID1234655651]):

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H.C. Wainwright 27th Annual Global Investment Conference
September 9, 2025
8:30 a.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On September 2, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that Company management will participate in a fireside chat at following conference (Press release, Nanobiotix, SEP 2, 2025, View Source [SID1234655650]):

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H.C. Wainwright 27th Annual Global Investment Conference
Date: Tuesday, September 9th, 2025
Time: 9:00 am EDT / 3:00 pm CEST
Location: New York, NY
Presenters: Laurent Levy, Chief Executive Officer of Nanobiotix & Bart van Rhijn, Chief Financial & Business Officer of Nanobiotix
Webcast link: Click here

The fireside chat will be webcast live from the events page of the Investors section of the Company’s website. The replay of the webcast will be available following the event.

On September 2, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on Monday, Sept. 8, 2025, at 2:35 p.m. EDT (Press release, Merck & Co, SEP 2, 2025, View Source [SID1234655649]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.