On October 20, 2025 Tallac Therapeutics reported that the U.S. Food and Drug Administration has granted Fast Track designation to TAC-001 for the treatment of previously treated, locally advanced unresectable or metastatic cholangiocarcinoma.

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Cholangiocarcinoma (CCA) is an aggressive malignancy of the biliary tract with a poor overall prognosis and limited treatment options. The majority (~70%) of patients are diagnosed late at advanced stages and have a 5-year survival rate of less than 10%. Current treatment options, particularly for patients who relapsed after prior systemic treatment, are limited. The designation highlights TAC-001’s potential to address this urgent medical need.

Building on encouraging safety and efficacy Ph1 data in solid tumors, the Fast Track designations will greatly support the clinical development strategy to advance TAC-001, a next-generation antibody-drug conjugate (ADC) designed to safely and efficiently engage both the innate and adaptive anti-tumor immune response.

(Press release, Tallac Therapeutics, OCT 20, 2025, View Source [SID1234656825])

On October 20, 2025 Sona Nanotech Inc., (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported the completion of its first-in-human clinical study treating patients with histologically confirmed, immunotherapy-resistant cutaneous metastatic melanoma using Sona’s Targeted Hyperthermia Therapy ("THT"). Ten advanced-stage patients, all of whom were failing to respond to standard immunotherapy treatment, were recruited into this early feasibility study. Under the study protocol, patients had up to four tumors treated with Sona’s THT on days one and eight of the study. By day 15, 8/10 patients experienced a significant clinical response to treatment with a majority (6/8) showing no detectable residual melanoma in representative, biopsied tumors, and two patients showing no response.

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David Regan, Sona’s CEO, commented, "These favorable results—demonstrated in the majority of treated patients—show that Sona’s THT therapy has successfully eliminated melanoma in tumors where leading treatments had previously failed. This outcome has exceeded our expectations and delivered on our commitment to investors to produce human efficacy data quickly. Based on findings from this study, we are preparing for a Canadian clinical trial that will provide deeper insights into the biological potential of our THT as we prepare to expand its clinical application into a broader range of solid tumor cancers. An application for an investigational testing authorization ("ITA") has been made to Health Canada to permit this next clinical study for which we have already received research ethics board approval."

The study’s principal investigator, Dr. Carlos Rojas, Executive Director of the Bradford Hill Clinical Cancer Research Center commented, "We were very impressed by the rapid and measurable responses observed in patients who had exhausted standard immunotherapy options. These outcomes have provided meaningful hope for the patients enrolled."

Dr. Carman Giacomantonio, Sona’s CMO, commented, "These tremendous results validate our earlier, published preclinical findings and provide compelling clinical evidence of the efficacy and tolerability of Sona’s novel Targeted Hyperthermia Therapy in human cancer. Although this study was not powered to determine response rates, eight out of ten patients experienced responses in a treated tumor with six out of those eight patients’ biopsied tumors showing a complete response – commands one’s attention. Equally impressive is the observation that these responses were confirmed after only two weeks from the initial treatment. This, to my knowledge, is unprecedented."

Safety and tolerability data also showed favourable results. One stage IV patient reported a serious adverse event during the trial that investigators determined to be unrelated to THT, which ultimately resolved. Also, two stage IV patients expired shortly following completion of the study period due to distant disease progression. Another aim of the study was to capture clinician-reported and patient-reported experience with the physical delivery of THT with a view to improving the overall clinical delivery of Sona’s THT. To this end, significant data was captured highlighting opportunities for design and application enhancement that will be applied and evaluated in future studies.

The Company also announces that its Chief Scientific Officer, Len Pagliaro, PhD. Is stepping back from an operational role. "Developing a powerful but gentle cancer therapy that uses nanotechnology to stimulate the immune system, and has the potential to transform lives, has been the focus of the past 16 years of my career." said Dr. Pagliaro. "These remarkable first-in-human results mark the fulfillment of that vision. I now look forward to continuing to support the Company as a member of Sona’s board of directors."

Investor Webinar details:

The Company is also pleased to announce that it will host a webinar on Monday, October 20th at noon EST to discuss these results in more detail and outline plans for the coming year. Interested parties can register here: http://bit.ly/3JcFls5. A recording of the webinar will be made available following the webinar in the Investor Information section of the Company’s website."

(Press release, Sona Nanotech, OCT 20, 2025, View Source [SID1234656823])

On October 20, 2025 Sairopa, a clinical-stage biotechnology company developing innovative cancer immunotherapies, reported new clinical data on ADU-1604, its differentiated CTLA-4 blocking antibody, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21, 2025 in Berlin, Germany.

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The company presented a scientific poster showcasing significant clinical advances with ADU-1604 in melanoma patients who had previously failed PD-1 inhibitor therapy (n=27). The poster presentation featured the full results from the SRP-21C101 Phase 1 combined dose escalation and dose expansion clinical trial. Clinical efficacy was observed in 4/27 patients indicative of efficacy similar to other CTLA-4 inhibitors. Importantly, ADU-1604 showed a significantly milder safety profile as compared to existing CTLA-4 inhibitors, as evidenced by the reduced severity of immune-related adverse events.

"We are excited to share the clinical results from ADU-1604 in PD1 relapse/refractory melanoma with the international oncology community at ESMO (Free ESMO Whitepaper) Congress," said Laura Lassouw-Polman, Chief Operating Officer at Sairopa. "ADU-1604’s milder safety profile as compared to other CTLA-4 blocking agents will support its future use as combination agent, with PD-1 blocking agents and/or other agents. We are grateful to all patients, their families and investigators that supported our study."

(Press release, Sairopa, OCT 20, 2025, View Source [SID1234656822])

On October 20, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.

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"We are pleased the agency has accepted the resubmission of our BLA for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit."

During the past few months, Replimune has been working to address agency feedback. Additional information, data and analyses were included in the resubmission which will be part of the BLA review. The FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, OCT 20, 2025, View Source [SID1234656821])

On October 20, 2025 Redhill Biopharma, a specialty biopharmaceutical company, reported the signing of a strategic partnership with Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) ("Cumberland"), a specialty pharmaceuticals company with a strong gastrointestinal market presence, whereby Cumberland will invest $4 million for a 30% ownership stake in RedHill’s global Talicia business. The companies will share in the financial performance and operational support for the Talicia brand with RedHill retaining 70% ownership and joint control. All other aspects of RedHill’s business remain unchanged.

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RedHill and Cumberland have also entered into a U.S. Talicia co-commercialization agreement with an equal sharing of the product’s net revenues. Cumberland commits to significant additional investment to support Talicia’s U.S. business, providing the strength of its national sales force to feature and further enhance the brand’s marketing and promotional activities. The partnership is designed to deliver economies of scale and cost reductions through shared responsibility for Talicia’s U.S. sales, marketing, manufacturing, supply, regulatory and administrative operations.

"This strategic partnership provides an excellent growth opportunity for RedHill and for Cumberland, a highly capable and driven partner with a strong gastroenterology market presence, adding a market-leading approved product to its portfolio. We believe Cumberland can help drive prescriptions and deliver revenue growth, further strengthening Talicia’s U.S. market leadership," said Dror Ben-Asher, RedHill’s CEO. "The transaction highlights the significant standalone value and commercial strength of the Talicia business, and positions RedHill to accelerate growth, reinforce its financial position and reduce costs, while continuing to advance our broader strategic objectives."

"Talicia has an outstanding product profile and represents an excellent strategic fit for Cumberland, providing us with an important growth opportunity," said A.J. Kazimi, Cumberland’s CEO. "These arrangements with RedHill provide us with the only FDA-approved all-in-one, low-dose rifabutin-based therapy to address H. pylori antibiotic resistance in support of patient care. We can build on the excellent foundation RedHill has created for the product, representing a strong growth opportunity for both companies, and we are delighted to be working with them to pursue this potential."

"There is a real problem with H. pylori antibiotic resistance, with eradication treatment failure rates of up to 40% associated with clarithromycin-containing therapies3. Leading U.S. H. pylori treatment guidelines are explicit on the need to avoid using clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing," said Rick Scruggs, RedHill’s Chief Commercial Officer. "Moreover, H. pylori is a key risk factor for gastric cancer, a cause of approximately 11,000 U.S. deaths4 a year. This is despite it being reported that eradication of H. pylori can lead to a 75% decreased gastric cancer risk.5 The need for effective H. pylori treatment designed to address antibiotic resistance is clear."

The transaction also supports RedHill’s plan to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and maintain its continued listing, supporting access to capital and long-term financial stability. Accordingly, as a result of this transaction, as of the date of this press release, the Company believes it has stockholder’s equity in excess of the $2.5 million requirement for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). The Company intends to notify Nasdaq of its compliance status so that Nasdaq can make a determination as to whether the Company has regained compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. However, there can be no assurance that Nasdaq will determine that the Company has regained compliance with the Nasdaq continued listing standards.

RedHill is committed to expanding patient access to Talicia globally. This month we announced the licensing of Talicia for new Middle East markets in a deal worth potentially $1.8 million plus sales royalty payments, with efforts to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams ongoing.

Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.

About H. pylori

H. pylori is a bacterial infection that affects approximately 35% of the U.S. adult population6 (an estimated 1.6 million U.S. patients are treated annually) rising to more than 50% globally7. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually8 and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases)9 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma10. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies11.

About Talicia

Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health.

(Press release, RedHill Biopharma, OCT 20, 2025, View Source [SID1234656819])