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 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 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company (Press release, Akeso Biopharma, JUL 23, 2025, View Source [SID1234654490]). The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer.

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Pancreatic cancer remains one of the most challenging types of tumors to find effective treatments for. While immunotherapies have demonstrated significant efficacy in different types of of solid tumors, pancreatic cancer’s unique immune evasion mechanisms and its highly immunosuppressive tumor microenvironment (TME) have rendered it resistant to current therapies. As a result, previous Phase III studies on using immunotherapies as first-line treatments for metastatic pancreatic cancer have mostly failed. To date, no immunotherapy has been approved for first line metastatic pancreatic cancer.

Ivonescimab, in combination with chemotherapy and/or ligufalimab, has the potential to address the current lack of effective options in first-line immunotherapy for metastatic pancreatic cancer. This randomized, controlled, multi-center Phase III trial is a key component of Akeso’s broader strategy to address the significant unmet clinical needs in global oncology.

Pancreatic cancer is an extremely aggressive form of malignancy that often result in poor patient prognosis. Its global incidence is on the rise, and the mortality rate closely mirrors the incidence, resulting in alarmingly low overall survival rates. In 2022, approximately 511,000 new cases of pancreatic cancer were diagnosed worldwide, and 467,000 deaths were recorded. Early diagnosis remains challenging, with around 80% of patients being diagnosed at an advanced stage. Even those diagnosed with early-stage or locally advanced disease may see progression to metastatic pancreatic cancer within a year following surgery or other treatments. Current first-line treatments are predominantly chemotherapies and have showed very limited success, with a median overall survival (OS) of less than one year.

PD-1 and VEGF are often co-expressed in the tumor microenvironment. As a PD-1/VEGF bispecific antibody, Ivonescimab can accumulate in the TME and effectively block both the PD-1 and the VEGF signaling pathways. While these pathways are independently active, they are also complementary. Inhibition of both PD-1 and VEGF enhances immune cells’ ability to target and destroy tumor cells. In addition, ligufalimab binds to CD47 on tumor cells, disrupting the interaction with signal regulatory protein alpha (SIRPα) on phagocytic cells. This process boosts phagocytosis and inhibits tumor growth. The combination of ivonescimab with ligufalimab is expected to synergistically enhance anti-tumor activity, offering a potential breakthrough in the first-line treatment for metastatic pancreatic cancer.

Professor Yu Xianjun, Director of Fudan University Shanghai Cancer Center, Professor Ying Jie’er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital are the co-principal investigators of HARMONi-GI2 study.

On July 23, 2025 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported a statement to address questions about the status of its ongoing Exclusive License and Collaboration Agreement with Sarepta Therapeutics. Arrowhead continues to conduct clinical and non-clinical studies as stipulated in the agreement, and it expects Sarepta to continue to meet its required financial obligations (Press release, Arrowhead Pharmaceuticals, JUL 23, 2025, View Source [SID1234654489]). Sarepta has provided no indication of any intention to fail to fulfill any of its obligations, however if that occurs there are clear termination provisions that would cause assets and associated intellectual property to be returned to Arrowhead. Arrowhead believes its strong balance sheet and multiple opportunities for additional near- and mid-term business development would be sufficient to support existing and future advancement of these potentially impactful therapies through clinical and preclinical development. Below is an overview of the agreement.

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Upon closing of the agreement in February 2025, Arrowhead received a $500 million upfront payment and $325 million through the purchase by Sarepta of Arrowhead common stock priced at $27.25 per share. Arrowhead will also receive $250 million to be paid in annual installments of $50 million over 5 years, with the first $50 million payment due in February 2026. Arrowhead is eligible to receive $300 million in near-term payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study of ARO-DM1. Arrowhead believes it is on track to earn the first $100 million soon and the remaining $200 million by the end of the year. Arrowhead is also eligible to receive a further $10 billion in potential milestones and tiered royalties on commercial sales up to low double digits. Included in the agreement were four clinical-stage drug candidates, three pre-clinical programs, and up to six additional targets outside Arrowhead’s pipeline.

Sarepta has recently experienced setbacks in products and programs unrelated to those licensed from Arrowhead. These setbacks led Sarepta to conduct a strategic restructuring plan that included cost cutting measures and a pipeline review that prioritizes the funding, development, and commercialization of programs licensed from Arrowhead. Sarepta has clearly stated that it believes this represents the future of their company and has taken measures to ensure they meet their financial obligations.

Should Sarepta fail to make either the $100 million or $200 million near-term payment associated with enrollment of ARO-DM1 cohorts, Arrowhead would have the right to terminate the agreement with respect to ARO-DM1, and the program and all associated intellectual property would revert back to Arrowhead. Similarly, should Sarepta fail to make any development or commercial milestone payment, Arrowhead would have the right to terminate the agreement with respect to the asset for which the payment was owed, and the program and all associated intellectual property would revert back to Arrowhead. If Sarepta fails to make any of the annual $50 million payments, Arrowhead would have the right to terminate the entire agreement and all of Arrowhead’s intellectual property rights that have been licensed to Sarepta under all of the programs would revert to Arrowhead. In such cases, Arrowhead would have no obligation to return any consideration Sarepta had already paid.

On July 23, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro (daratumumab) co-formulated with ENHANZE, as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma (Press release, Halozyme, JUL 23, 2025, View Source [SID1234654488]).

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"This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease."

SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. The current standard of care for SMM, even in high-risk cases, is active monitoring (or "Watch and Wait") to track for signs of biochemical progression and/or end-organ damage. This means therapeutic intervention is only offered when the disease progresses.

The EC approval is supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM. For more information on the study and its findings, please view Johnson & Johnson’s press release issued on July 23, 2025.