On October 9, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported that ONO-4578, an EP4 antagonist, in combination with Opdivo, an anti–PD-1 antibody and chemotherapy which is one of the standard treatments in this setting met the primary endpoint in the Phase 2 clinical trial (ONO-4578-08 study) in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) (Press release, Ono, OCT 9, 2025, View Source [SID1234656550]).

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In the trial, ONO-4578 in combination with Opdivo and chemotherapy demonstrated a statistically significant prolongation of progression-free survival (PFS) compared with placebo in combination with Opdivo and chemotherapy. In addition, no new safety concerns were identified in the trial. Ono will publish the results at an upcoming academic meeting.

About ONO-4578-08 study

ONO-4578-08 study is a multicenter, randomized Phase 2 clinical trial, conducted in Japan, South Korea and Taiwan in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer. ONO-4578 in combination with Opdivo and chemotherapy (S-1 + oxaliplatin or capecitabine + oxaliplatin) was compared with placebo in combination with Opdivo and chemotherapy. In this trial, patients received 40 mg of ONO-4578 once daily and 360 mg of Opdivo every 3 weeks in combination with chemotherapy until disease progression or unacceptable toxicity was observed. The primary endpoint of this trial is PFS.

About Gastric cancer

It is estimated that approximately 126,000 new cases with gastric cancer are diagnosed per year in Japan1) (approximately 968,000 cases worldwide2)) and approximately 43,000 deaths per year in Japan1) (approximately 660,000 deaths worldwide2)) resulting from gastric cancer, which is the third most common type of cancer following colorectal cancer and lung cancer in Japan. Combination therapies with anti–PD-1 antibody and chemotherapy have been approved for the first-line treatment of HER2-negative unresectable advanced or recurrent gastric cancer as the standard treatment. However, unresectable gastric cancer remains incurable, and a new treatment option is needed for patients with gastric cancer.

About ONO-4578

ONO-4578 is a selective, oral antagonist of EP4, which is one of the prostaglandin E2 (PGE2) receptors, developed by Ono. PGE2, which is produced by cancer cells, suppresses the action of cancer immunity through EP4 receptors expressed on various immune cells3)~5). ONO-4578 is expected to exert antitumor effect by suppressing EP4-mediated effects of PGE2 and by restoring cancer immunity6). In the phase 1 clinical trial in patients with unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) after the third- or later-line treatment, a combination therapy with ONO-4578 and Opdivo showed antitumor effect and a manageable safety profile7). Currently, Ono is conducting several clinical trials of ONO-4578, including a global phase 2 clinical trial in patients with colorectal cancer.

On October 9, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX Investor Conference from October 19 – 21, 2025 at the Hotel Del Coronado in San Diego, California (Press release, CytoDyn, OCT 9, 2025, View Source [SID1234656533]).

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Presentation Date: Tuesday, October 21, 2025

Time: 9 a.m. PDT

Register to view presentation: Webcast Link

Mr. Hoffman will be available for one-on-one meetings with conference attendees. To request a meeting to discuss the Company’s current development strategy and upcoming milestones, please contact [email protected].

On October 8, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) ("TransCode or the "Company") reported that it entered into a definitive agreement to acquire Polynoma LLC, a privately-held biotechnology immuno-oncology company (Press release, TransCode Therapeutics, OCT 8, 2025, View Source [SID1234656516]). Polynoma is developing a late-stage candidate, seviprotimut-L, a novel polyvalent shed antigen vaccine for the adjuvant treatment of stage IIB and IIC melanoma.

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Concurrent with the Polynoma acquisition, TransCode announced a $25 million investment from CK Life Sciences Int’l., (Holdings) Inc. ("CK Life Sciences") to be used primarily to advance clinical development of TransCode’s lead microRNA asset, TTX-MC138, into a Phase 2 clinical trial.

Philippe Calais, PharmD, PhD, has been appointed as TransCode’s Chief Executive Officer and remains Chairman of the Board of Directors, but has stepped down from his positions on the Board’s Audit Committee and Compensation Committee. Tom Fitzgerald steps down as Interim Chief Executive Officer but remains Chief Financial Officer and a member of the Board Directors. There are no other changes to the executive team. TransCode expects to retain several finance, development and manufacturing professionals from Polynoma. Elizabeth Czerepak, MBA, has been selected as a new independent board member and becomes Chairperson of the Audit Committee, effective as of the closing of the transaction.

Dr. Philippe Calais stated that "I am very honored to deepen my commitment and lead TransCode’s transformation into a one-of-a-kind leading oncology company at this critical time. We are grateful for CK Life Sciences’ investment and their support of our miRNA candidate, TTX-MC138, as we now have the funding in place to fully execute our upcoming TTX-MC138 Phase 2. This acquisition allows us to create a unique and broader pipeline with Phase 3 ready seviprotimut-L, and potentially realize synergies between both technologies, for the ultimate benefit of patients suffering from cancer and metastases. Between the two programs, we see a unique potential to augment seviprotimut-L’s focus with our microRNA lead program, TTX-MC138, by addressing the micrometastases in stage IIB and IIC melanoma patients."

"Finally, I express my gratitude to Tom Fitzgerald for his remarkable dedication and commitment as he steps down from the Interim Chief Executive Officer position to revert to his previous role as Chief Financial Officer. I extend a warm welcome to all our new colleagues transitioning from Polynoma and to Elizabeth Czerepak, our new Independent Board member. All the ingredients are now in place to fully execute on our ambitious plan and deliver value to our shareholders" said Dr. Calais.

TransCode’s Proprietary Expanded Pipeline:

Clinical stage Programs:

· TTX-MC138 targets microRNA-10b, believed to be a master regulator of metastatic cancer across multiple indications
· Seviprotimut-L is a novel polyvalent shed antigen vaccine aimed at melanoma patients that have limited options in stage IIB and IIC

Pre-clinical Programs:

· R&D exploration of combining TTX-MC138 and seviprotimut-L technologies
· TTX-siPDL1, siRNA-based modulator of PD-L1
· TTX-RIGA, RNA-based agonist of RIG-I
· TTX-siMYC, RNA-based inhibitor of c-MYC

About the Acquisition and Financing

Pursuant to the definitive agreement, the sole stockholder of Polynoma, an indirect wholly-owned subsidiary of CK Life Sciences, will receive an aggregate of 83,285 shares of common stock and 1,152.9568 shares of non-voting Series A convertible preferred stock (with a 1:10,000 conversion ratio of preferred to common) (the "Series A Preferred Stock"). Concurrent with the acquisition, TransCode entered into an investment agreement with a subsidiary of CK Life Sciences in which that entity has purchased in a private placement an aggregate of 223.7337 shares of non-voting Series B convertible preferred stock (with a 1:10,000 conversion ratio of preferred to common) (the "Series B Preferred Stock, and together with the Series A Preferred Stock," the "Preferred Stock") for an aggregate consideration of $25 million, consisting of $20 million in cash and a promissory note with an aggregate principal amount of $5 million. Both transactions are expected to close on October 8, 2025. This represents, on a fully diluted basis, approximately 91% for CK Life Sciences and approximately 9% for the pre-acquisition stockholders of TransCode (including transaction fees) and a combined fully diluted equity value of approximately $165 million. Additional conditional payments totaling $95 million may be payable to the CK Life Sciences subsidiary upon the achievement of clinical, regulatory and commercial milestones for seviprotimut-L. The issuance of shares of common stock upon conversion of the Preferred Stock issued in the acquisition and the financing shall be subject to stockholder approval in compliance with the rules of the Nasdaq Stock Market where applicable. A non-transferrable CVR will be distributed to TransCode stockholders of record as of October 20, 2025 to receive certain proceeds received by TransCode, if any, related to future upfront, development or regulatory milestone payments resulting from a corporate partnering transaction of TTX-MC138.

Tungsten Advisors served as the exclusive financial advisor and sole placement agent to TransCode. Orrick, Herrington & Sutcliffe, LLP is serving as legal counsel to TransCode. Freshfields US LLP served as legal counsel to CK Life Sciences and its subsidiaries.

On October 8, 2025 Xspray Pharma reported to have received a CRL from the U.S. Food and Drug Administration (FDA) concerning the Company’s New Drug Application (NDA) for Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) (Press release, Xspray, OCT 8, 2025, https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/ [SID1234656517]).

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The FDA’s decision is based on GMP (Good Manufacturing Practice) observations at the Company’s contract manufacturer. No observations were directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the facility while corrective actions are being implemented. The manufacturer has confirmed that a remediation plan is already in place and that a meeting with the FDA is scheduled for December.

"It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date," said Per Andersson, CEO of Xspray Pharma. "We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed."

The FDA has also requested information demonstrating that the discussed product information is appropriate and data confirming the outcome of previously implemented corrective actions at the production line.

Other programs
Xspray’s other development programs are progressing according to plan. The review of the NDA for XS003 (nilotinib) is expected to be initiated by the FDA shortly, with an anticipated PDUFA date in June 2026.

On October 8, 2025 Sapu Nano reported the presentation of its poster, "Sapu-003: Novel Intravenous Deciparticle Everolimus Entering Phase 1 Study in Australia," at the 8th Australian Translational Breast Cancer Research Symposium (ATBCR 2025) (Press release, Sapu Bioscience, OCT 8, 2025, View Source [SID1234656520]). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

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Sapu-003 is the first intravenous (IV) Deciparticle formulation of everolimus, an mTOR inhibitor widely used in oncology. While oral everolimus (Afinitor) has demonstrated efficacy in breast cancer, renal cell carcinoma, and neuroendocrine tumors, its broader use has been constrained by low bioavailability, variable systemic exposure, and gastrointestinal toxicities.

Global Development Partnership
The trial is being conducted in collaboration with SOCRU, a leading Phase 1 clinical unit in Australia; Ingenū, a clinical research organization with deep early-phase expertise; and Medicilon, Sapu Nano’s strategic partner for preclinical drug development. Together, these partnerships ensure robust clinical execution, regulatory alignment, and high-quality product supply for the study.

Call to Patients and Physicians
The trial (ACTRN12625001083482) is now open for enrollment at leading oncology centers across Australia. Eligible participants include adults with advanced HR+/HER2- breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies. Physicians are encouraged to refer patients who may benefit from participation.

"Sapu-003 represents a significant advance in the delivery of mTOR-targeted therapies," said Vuong Trieu, PhD, Chief Executive Officer of Sapu Nano. "Through the combined expertise of SOCRU, Ingenū, and Medicilon, we are positioned to accelerate development and bring this next-generation treatment option to patients with advanced cancers."