On July 23, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported a key opinion leader (KOL) webinar featuring leading physicians in the fields of oncology and immunotherapy discussing pelareorep’s robust clinical data and how it fits in the evolving treatment landscape for pancreatic and gastrointestinal (GI) cancers (Press release, Oncolytics Biotech, JUL 23, 2025, View Source [SID1234654491]). The KOLs provided individual presentations and then participated in a roundtable Q&A discussion. A replay of the full conversation can be found by clicking here.

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A selection of key takeaways includes:

The meaningful survival benefit demonstrated by pelareorep-based treatment combinations in first-line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC) patients across randomized and single-arm clinical studies necessitates evaluating pelareorep in a registration-enabling study in 1L mPDAC.
Immunotherapies have not yet been approved to treat mPDAC patients, illustrating an unmet need, which provides an opportunity for an immunologically active agent like pelareorep to deliver an impactful clinical benefit in this challenging indication.

The combination of pelareorep and chemotherapy would be an appealing treatment option for 1L mPDAC patients, even with the presence of RAS inhibitors in the treatment paradigm.
Translational data from multiple mPDAC and colorectal cancer clinical trials validate pelareorep’s mechanism of action, showing that it replicates in tumors, stimulates chemokine expression, and induces the expansion of tumor-infiltrating lymphocytes (TILs), which correlates with a reduction in tumor size.
"I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, Chief Executive Officer of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers."

On July 23, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it will host an in-person and virtual R&D Day on September 8, 2025 from 8:00am to 10:00am ET in New York City to present multiple clinical data updates across the pipeline and highlight the next key drivers of growth and upcoming milestones (Press release, Ideaya Biosciences, JUL 23, 2025, View Source [SID1234654492]).

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"This year marks IDEAYA’s ten-year anniversary since our founding, and we look forward to providing multiple clinical data updates across our potential first-in-class pipeline, and highlight our strategic vision, priority areas of scientific focus, and emerging clinical pipeline that will drive the next phase of our growth as a global leader in precision medicine oncology," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Speakers will include members of IDEAYA’s senior leadership team and key opinion leader(s).

Registration for this event can be accessed here or at the investors section of the IDEAYA website at View Source

On July 22, 2025 Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2 trials at the International Association of the Study of Lung Cancer’s (IASLC) 2025 World Conference on Lung Cancer (WCLC), to be held September 6-9, 2025, in Barcelona, Spain (Press release, Taiho, JUL 22, 2025, View Source [SID1234654476]).

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The abstracts accepted for mini oral presentations include updated efficacy and safety data from the Phase 2b REZILIENT1 trial, focusing on patients with EGFR ex20ins NSCLC previously treated with amivantamab, as well as the preliminary efficacy and safety results from the Phase 2 parallel cohort REZILIENT2 trial in patients with advanced or metastatic NSCLC harboring uncommon non-ex20ins EGFR mutations.

"Previously, zipalertinib has demonstrated clinical activity against ex20ins and preclinical activity against uncommon, non-ex20ins EGFR-mutant NSCLC," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to sharing updated data from the REZILIENT1 and REZILIENT2 trials at the upcoming 2025 World Conference on Lung Cancer, suggesting the potential for zipalertinib to make a meaningful difference in the lives of patients with certain types of NSCLC."

"Despite advances in the treatment landscape, there remains significant unmet need for NSCLC patients with EGFR exon 20 insertion mutations and for those with uncommon non-ex20ins EGFR mutations," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Taken together, the updated results from REZILIENT1 and new data from the REZILIENT2 study highlight the potential of zipalertinib to play an important role in the evolving treatment landscape for patients with NSCLC harboring less common EGFR mutations."

Session titles and information for the two abstracts are listed below. Full abstract details will be available via the conference website at 1 p.m. EDT August 13, 2025.

Title: Zipalertinib in NSCLC Patients (Pts) With EGFR Exon 20 Insertion (Ex20Ins) Mutations Who Received Prior Amivantamab
Session Name: MA08 – Common and Uncommon EGFR Mutations, New Treatments in the Horizon
Session Type: Mini Oral Presentation
Session Date: Tuesday, September 9, 2025
Session Time: 11:30 a.m. – 12:45 p.m. CEST
Presenter: Zofia Piotrowska, MD

Title: Phase 2 Interim Results of Zipalertinib in Patients With NSCLC Harboring Uncommon Non-Exon 20 Insertion EGFR Mutations
Session Name: MA08 – Common and Uncommon EGFR Mutations, New Treatments in the Horizon
Session Type: Mini Oral Presentation
Session Date: Tuesday, September 9, 2025
Session Time: 11:30 a.m. – 12:45 p.m. CEST
Presenter: Hibiki Udagawa, MD, PhD

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

On July 22, 2025 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory and infectious diseases, reported detailed results from a Danish validation study, published in the Journal of Surgical Oncology (Press release, SkylineDx, JUL 22, 2025, View Source [SID1234654477]). The study demonstrates that SkylineDx’s Merlin Assay (CP-GEP) can identify cutaneous melanoma patients, in particular pT1 and pT2 patients, that have a low risk for nodal metastasis and therefore may forgo Sentinel lymph node biopsy (SLNB) surgery. Merlin is a genomic test to guide treatment decisions in early-stage melanoma.

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In the independent blinded multicenter study, primary cutaneous melanoma tissue from a cohort of 536 newly diagnosed pT1-pT3 melanoma patients who had undergone SLNB between 2010 and 2015 was collected and analyzed with CP-GEP. Merlin’s outcome labels were compared to patients’ sentinel lymph node status and a nomogram that is widely used on an international basis for SLN metastasis risk.

Key findings of the study include:

The potential SLNB reduction rate was highest for the pT1-subgroup at 72.7% (NPV 94.5%) In pT1-pT3 melanoma, 41% of patients were classified as CP-GEP Low-Risk and could have forgone SLNB surgery, which is in line with previous validation studies.
Comparison with an internationally recognized nomogram showed that CP-GEP would result in a notably larger SLNB reduction rate compared to the internationally recognized nomogram (44.2% vs. 7.8%) particularly for T1- T3 patients.
"The Merlin test is a promising and well-validated non-invasive tool for refining SLNB selection, with consistent findings across several independent cohorts," said First Author Dr. Marie B.-M. Weitemeyer from Copenhagen University Hospital-Herlev and Gentofte. "In our Danish cohort, Merlin demonstrated the potential to reduce unnecessary SLNB procedures by more than 40%."

"Merlin performance is consistent with previous study cohorts," said SkylineDx Chief Scientific Officer, Jvalini Dwarkasing, PhD. "Compared to the internationally recognized nomogram, CP-GEP demonstrated a significantly higher SLNB reduction rate while maintaining a high NPV, underscoring its potential for greater clinical benefit."

SLNB is the gold standard in staging primary melanoma patients. According to current guidelines, patients with pT1b melanoma and higher may be eligible for SLNB surgery. However, approximately 85% of these patients will not show SLN metastasis while undergoing this invasive procedure, under general anesthesia, with the risk of potential surgical complications. Also, SLNB poses a substantial burden on healthcare resources. Therefore, tools are warranted beyond clinical guidelines to stratify patients based on their risk of nodal metastasis. SkylineDx’s CP-GEP is currently the only GEP-based prediction tool specifically developed to identify melanoma patients at low risk of SLN metastasis.

About the Merlin Assay (CP-GEP)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.

On July 22, 2025 Alloy Therapeutics Co. Ltd. ("Alloy Japan") reported the signing of a Memorandum of Understanding (MOU) with the Kansai Startup Academia Coalition ("KSAC"), represented by Kyoto University, to foster the global expansion of university-affiliated life science startups across Japan (Press release, Alloy Therapeutics, JUL 22, 2025, View Source [SID1234654446]). This strategic collaboration is designed to accelerate research and development (R&D) activities by providing critical support and connecting academic innovations with the global biopharmaceutical industry.

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KSAC is a coalition of more than 90 academic institutions located in western Japan, formed under the leadership of Kyoto University and with support from Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT). KSAC’s mission is to bridge academia and industry by managing GAP funds for research, delivering entrepreneurship education, supporting digital workshop networks, and showcasing early-stage technologies through events and exhibitions both domestically and internationally.

Alloy Therapeutics Inc. ("Alloy") is a Boston-based biotechnology ecosystem company that democratizes access to foundational biologics discovery technologies. Through its suite of platform technologies and discovery services as well as its venture studio, 82VS, Alloy enables scientists and entrepreneurs around the world to accelerate the discovery of medicines. Alloy recently launched its Japan subsidiary, Alloy Japan, which is focused on iPS cell therapy development and is continuing to broaden its offerings by supporting ecosystem growth throughout Japan and greater Asia.

Through this MOU, Alloy Japan and KSAC will collaborate to connect promising academic seeds from Japan to global Biopharma markets, while also bringing valuable insights from the global community back to strengthen Japan’s startup ecosystem. Together, they aim to enrich critical capabilities across Japan’s academic and entrepreneurial communities to foster the development of globally competitive life science startups.

"Alloy’s capabilities and global network bring a highly complementary strength to our mission of empowering academic startups to compete internationally. Alloy Japan offers a highly distinct and complementary contribution to our activities with Global Incubators and Venture Capital firms," said Koji Murota, Director-General of the Office of Institutional Advancement and Communications at Kyoto University, representing KSAC. "By collaborating with ecosystem builders like Alloy Japan, we can provide our researchers and entrepreneurs with access to additional scientific resources, global Biopharma insights, and opportunities to scale their innovations beyond Japan."

As a first step, Alloy Japan will support KSAC’s GAP Fund program, which provides funding to selected academic projects within the KSAC network. Over the three-year term of the MOU, the collaboration is expected to expand to additional KSAC initiatives aimed at building a globally integrated and innovation-driven biotech community.

"Our collaboration with KSAC builds on Alloy Japan’s commitment to deep, sovereign partnerships that nurture innovation at the academic and early translational stages," said Victor Stone (Yoshihide Ishii), CEO of Alloy Japan. "By working alongside KSAC and its network of universities, we aim to strengthen the bridge between Japanese academic excellence and the Biopharma ecosystem, accelerating the global growth of life science startups."