Boehringer Ingelheim Obtains Novel Preclinical Oncology Program from Accent Therapeutics

On October 8, 2025 Accent Therapeutics reported an asset purchase agreement with Boehringer Ingelheim for a preclinical, potentially first-in-class small molecule program. This innovative asset offers a new strategy for treating tumors with high interferon-stimulated gene (ISG) expression, representing a meaningful addition to Boehringer’s portfolio of cancer cell–directed and immuno-oncology therapies.

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"We are delighted that Boehringer Ingelheim will now advance this leading preclinical program with the potential to address tumors with high unmet need," said Shakti Narayan, Chief Executive Officer, Accent Therapeutics. "This strategic transaction sharpens our focus on advancing our lead clinical assets through their ongoing Phase 1/2 studies and delivering on our commitment to patients."

Notably, the acquired program is designed to stimulate antitumor immunity and its unique mechanism positions it as a strong candidate for combination with cancer immunotherapies – a cornerstone of Boehringer’s research strategy.

Accent Therapeutics will receive an upfront payment and is entitled to success-based preclinical milestone payments under the terms of the agreement. Boehringer Ingelheim will assume global responsibility for research, development, manufacturing, and commercialization of the program, advancing it toward clinical evaluation.

Source: Press release, Boehringer Ingelheim, OCT 8, 2025, View Source

Aptevo Presenting Scientific and Clinical Updates at SITC and ASH, also Participating in Leading Financial and Industry Conferences in the Fourth Quarter

On October 8, 2025 Aptevo Therapeutics ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, reported its participation in upcoming key financial, industry, scientific and medical conferences this fall, providing the opportunity to highlight continued momentum and recent developments among a broad range of stakeholder audiences (Press release, Aptevo Therapeutics, OCT 8, 2025, View Source [SID1234656521]).

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These conferences include:

4th Annual ROTH Healthcare Opportunities Conference
October 9, 2025 – Metropolitan Club, New York City, New York

Aptevo will participate in a panel on Acute Myeloid Leukemia titled "Novel AML Therapies Showing Clear Clinical Progress," discussing progress and recent trial outcomes of its lead asset, mipletamig, and sharing emerging evidence of its differentiated clinical profile in frontline AML-where strong safety, tolerability, and early efficacy continue to demonstrate meaningful potential for improved patient outcomes

Biotechnology Innovation Organization (BIO)-Europe 2025 – 31st Annual International Partnering Conference
November 3-5, 2025 (in-person); Digital Partnering Days: November 11-12, 2025 – Messe Wien Exhibition & Congress Center, Vienna, Austria

The Business Development Team will be on-site and actively participating in meetings at the largest biotechnology meeting in Europe

Society of Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2025 – 40th Anniversary Annual Meeting
November 5-9, 2025 – Gaylord National Resort & Convention Center, National Harbor, Maryland

Aptevo’s R&D Team will present a poster highlighting a novel trispecific targeting Nectin-4, CD3 and CD40 to overcome the immunosuppressive the tumor microenvironment

American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
December 6-9, 2025 – Orange County Convention Center, Orlando, Florida

Interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for the treatment of AML, will be presented in a poster session by the clinical team.

Sapu Nano Unveils First-in-Human Clinical Trial of Sapu-003 at 8th Australian Translational Breast Cancer Research Symposium

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."

Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval

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.

TransCode Therapeutics (RNAZ) announces the acquisition of Polynoma and a $25 Million strategic financing by a subsidiary of CK Life Sciences to form a first-in-class unique immuno-oncology and metastatic prevention oncology company

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.