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 AbbVie (NYSE: ABBV) reported it will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9, 2025 (Press release, AbbVie, SEP 2, 2025, View Source [SID1234655669]). Management will participate in a fireside chat at 9:00 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On September 2, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported that John Yu, MD, CEO and Chairman, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Kairos Pharma, SEP 2, 2025, View Source [SID1234655684]). The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

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Presentation Date:

September 5, 2025

Time:

Available on-demand starting at 7:00 AM Eastern Time

Webcast Link:

View Source

A webcast of the presentation can be accessed on the investor relations section of the Kairos Pharma website. A replay of the webcast will be archived and available following the event for 90 days.

View Source

Dr. Yu will be available for one-on-one meetings throughout the conference. To request a meeting and to register for the conference, click below:

View Source

On September 2, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the following investor conferences in September (Press release, CRISPR Therapeutics, SEP 2, 2025, View Source [SID1234655637]).

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H.C. Wainwright 27th Annual Global Investment Conference
Date: Monday, September 8, 2025
Time: 4:30 p.m. ET

Morgan Stanley 23rd Annual Global Healthcare Conference
Date: Tuesday, September 9, 2025
Time: 8:30 a.m. ET

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

On September 2, 2025 Servier, an independent international pharmaceutical group governed by a foundation, and IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported an exclusive license agreement to bring darovasertib, a promising treatment for a rare eye cancer, to patients worldwide (Press release, Servier, SEP 2, 2025, View Source [SID1234655670]). Under the agreement, Servier obtains the regulatory and commercial rights for darovasertib in all territories outside the United States. IDEAYA retains its rights for darovasertib in the United States. Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to broadly address primary and metastatic uveal melanoma (UM).

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"At Servier, our mission is to deliver transformative therapies to patients with significant needs. Our collaboration with IDEAYA is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide," said Arnaud Lallouette, Executive Vice-President Global Medical & Patient Affairs at Servier. "Today, there are limited treatment options and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network, and expertise in developing oncology targeted therapies, to make this groundbreaking treatment accessible to patients across the globe."

"Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide. This partnership enables IDEAYA and Servier to accelerate the global development for darovasertib across three Phase 3 registrational trials, aiming to improve patient outcomes in the neoadjuvant, adjuvant and metastatic settings," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"We believe Servier’s global footprint and proven track record in bringing novel therapies to patients in Europe and other key territories outside of the U.S. will ensure that this potentially life-changing treatment reaches as many patients as possible," said Daniel Simon, Chief Business Officer, IDEAYA Biosciences.

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomized trial evaluating darovasertib in combination with crizotinib in first line patients with HLA-A2-negative metastatic uveal melanoma (UM), for which the median progression free survival readout is anticipated from year-end 2025 to Q1 2026, and a Phase 3 randomized trial evaluating neoadjuvant darovasertib as a monotherapy in primary UM, independent of HLA status. IDEAYA and Servier will target to launch a global Phase 3 randomized clinical trial in 2026 to evaluate adjuvant darovasertib in primary UM, also in both HLA-A2-negative and -positive patients.

Uveal melanoma (UM) is a rare and aggressive form of eye cancer that originates in the uveal tract, which includes the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasize to other parts of the body, particularly the liver. Current treatment options include radiation therapy, surgical removal of the tumor, or removal of the eye (enucleation) in severe cases.

Darovasertib has received US FDA (Food and Drug Administration) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the US FDA in UM, including in metastatic UM.

Under the terms of the agreement, IDEAYA will receive an upfront payment of $210 million, and be eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib in all territories outside the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs.