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 Samsung Bioepis Co., Ltd. and Phrontline Biopharma, a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), reported that the companies have entered into a global collaboration agreement to develop, manufacture and commercialize two ADC assets: TJ108, bispecific and dual-payload ADC, and another asset to be named. In addition, Samsung Bioepis will receive an exclusive license from Phrontline for one topoisomerase-1 inhibitor (TOP1i) payload which is applied to Samsung Bioepis’ ADC pipeline.

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Phrontline’s TJ108 is TOP1i and tubulin inhibitor-based ADC directed against Epidermal Growth Factor Receptor (EGFR) and Human Epidermal Growth Factor Receptor 3 (HER3), targets that are overexpressed in a variety of cancers, which contribute to aggressive growth and metastasis.i,ii

Under the terms of the agreement, Phrontline will receive an upfront payment and will be eligible to receive additional milestone payments tied to development and regulatory achievements.

"We are excited to partner with Phrontline in developing and advancing differentiated ADCs that target a broad range of indications," said Kyung-Ah Kim, President and Chief Executive Officer, at Samsung Bioepis. "We will continue to explore new business opportunities to address unmet needs of patients, leveraging our proven development platforms."

"Phrontline has honed its bispecific targeting technology to enhance payload delivery efficiency and has advanced an innovative dual-linker payload (DLP) platform that enables the simultaneous delivery of two payloads with balanced potency and distinct mechanisms of action through a branched-linker architecture, while supporting scalable and efficient one-step conjugation. This partnership accelerates our vision to establish bispecific, dual-payload ADCs as a new class of precision oncology medicines," said Zhaoyuan ‘Tony’ Chen, Founder and Chief Executive Officer of Phrontline Biopharma. "Together with Samsung Bioepis, we will scale the DLP platform — beginning with TJ108 — to address resistance, heterogeneity, and durability challenges that limit today’s single-payload, single-target ADCs."

Samsung Bioepis is expanding its pipeline beyond biosimilars to fulfill its mission of broadening patient access to treatments in the areas of unmet therapeutic needs. The development of ADCs could add into the company’s broad spectrum of therapeutic portfolio that covers immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology.

(Press release, Phrontline Biopharma, OCT 20, 2025, View Source [SID1234656839])

On October 20, 2025 Faeth Therapeutics, a clinical-stage biotechnology company advancing therapies that systematically target tumor metabolism, reported the advancement of its lead PIKTOR regimen in endometrial cancer and a $25 million strategic raise, bringing total capital raised to $92 million. The financing was led by S2G Investments with participation from existing investors Khosla Ventures, Future Ventures, Digitalis Ventures, KdT Ventures and Cantos, plus new investors B Capital Group, Avicella and THO Seed Fund. Clinical data from sapanisertib in combination with paclitaxel, one component of the PIKTOR regimen, have been selected for a late-breaking oral presentation at the ESMO (Free ESMO Whitepaper) 2025 Congress.

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Faeth’s phase 1b study of serabelisib + sapanisertib ("PIKTOR") with paclitaxel demonstrated an 80% overall response rate in endometrial cancer patients, with a median progression-free survival of 11 months versus historical 3-4 months with chemotherapy alone. The strength of these results led the Gynecologic Oncology Group (GOG) Foundation, one of the premier U.S. clinical trial networks, to initiate a phase 2 trial (GOG-3111; NCT06463028), now enrolling patients. The study also includes a predefined substudy testing whether protocolized insulin control under trial conditions through precision nutrition enhances clinical outcomes.

Endometrial cancer is one of the highest-need solid tumors and illustrates how Faeth’s approach can change outcomes in diseases where PI3K/AKT/mTOR are implicated. This signaling axis is among the most frequently altered across solid tumors, including endometrial, breast, lung, and ovarian. Current single-node inhibitors often fail due to feedback reactivation and mutations elsewhere in the pathway that limit durability. These inhibitors can only target a small fraction of patients with pathway mutations.

Faeth’s approach is different: it delivers selective multi-node inhibition at PI3Kα, mTORC1, and mTORC2 while controlling the nutrient supply tumors depend on. Multi-node inhibition of the PI3K/AKT/mTOR pathway has already shown clinical benefit in phase 3 studies, confirming the value of pathway-level control in both mutant and wild-type tumors. Faeth’s selective approach builds on this validation while targeting specific nodes to improve the therapeutic window compared to pan-pathway inhibitors, offering less toxic, more convenient treatment options. In preclinical models, this multi-node approach achieved more complete pathway shutdown than single-agent inhibition.

"We’ve achieved the optimal balance in PI3K pathway inhibition, comprehensive enough to prevent resistance, selective enough to avoid immunosuppression," said Anand Parikh, CEO of Faeth Therapeutics. "The 80% response rate, 11-month progression-free survival, initiation of a trial by the GOG Foundation, and recognition as a late-breaking oral presentation at ESMO (Free ESMO Whitepaper) show that Faeth is executing as a clinical-stage company positioned to expand across the solid tumors where PI3K alterations drive disease."

"I believe recent phase 3 studies are showing validation of multi-node targeting," said S2G Managing Partner Sanjeev Krishnan. "In my view, insider participation in this financing reflects conviction in Faeth’s progress, while new investors recognize metabolism as a category entering the clinic. Based on emerging evidence, Faeth’s selective multi-node approach appears well suited to capture value as metabolism gains recognition as a potential new pillar of cancer treatment."

The $25 million will advance the phase 2 endometrial cancer program through a full data readout in Q3 2026 and expand throughput for the company’s MetabOS platform. The financing also supports a phase 1 study in locally advanced rectal cancer for Faeth’s non-essential amino acid restricted program and initiation of Faeth’s first non-oncology program in Hereditary Tyrosinemia Type 1 (HT1), a rare pediatric metabolic disorder, with IND-enabling studies targeting Q4 2026 clinical entry.

Beyond blocking growth signals, Faeth’s approach recognizes that tumors have significantly elevated metabolic demands and require specific nutrients to survive. The MetabOS platform integrates genomic, gene expression, and tumor microenvironment data to identify metabolic dependencies and exploit them clinically. Funding will expand MetabOS throughput, enabling Faeth to simulate and validate more regimens designed to address metabolic escape.

"If the cell is the unit of life, then metabolism is the first verb in its sentence," said Siddhartha Mukherjee, co-founder of Faeth Therapeutics. "Faeth is intervening where cellular decisions are made fastest: at the metabolic switches tumors rely on to adapt, long before mutations accumulate. That is why metabolism is emerging alongside the genome and immunogenicity as a therapeutic discipline."

In addition to its oncology programs, Faeth has initiated translational work to treat HT1, an ultra-rare disorder affecting 1 in 100,000 births, where toxic metabolites accumulate due to an enzyme deficiency. While current treatment prevents liver failure, patients still face unmet medical needs. The company is applying MetabOS to develop metabolic therapeutic approaches for this condition. This program is the first demonstration of MetabOS applied outside of oncology and establishes the platform’s ability to identify and address metabolic dependencies across diseases.

(Press release, Faeth Therapeutics, OCT 20, 2025, View Source [SID1234656840])

On October 20, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), reported it will participate at the 2025 Maxim Growth Summit, taking place October 22-23, 2025 in New York, NY. This prestigious event brings together industry leaders, innovators, and premier institutions to explore the latest trends and advancements across several industries.

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As part of the conference, members of management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. To view the Company’s Maxim Growth Summit presentation slide deck, please visit the Presentations page on aimimmuno.com.

For more information and a complete agenda of the Maxim Growth Summit, please visit www.maximgrp.com/2025-growth-summit.

(Press release, AIM ImmunoTech, OCT 20, 2025, View Source [SID1234656809])

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])