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])

On October 20, 2025 Kivu Bioscience, a biotechnology company advancing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported that it will present new preclinical activity and safety data for KIVU-107, a best-in-class PTK7-targeting ADC, at the 16th World ADC San Diego, held November 3-6, 2025. The data will be featured in both an oral and poster presentation highlighting the unique biophysical and therapeutic properties of KIVU-107, and its potential to set a new standard among next-generation ADCs.

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KIVU-107 is a PTK7-targeting ADC generated via site-specific GlycoConnect and HydraSpace conjugation technologies. It is designed to be highly stable in circulation, with negligible free payload release, maximizing on-tumor activity while minimizing off-target toxicity. The ADC leverages an exatecan payload (SYNtecan E) with an optimized drug-antibody ratio (DAR), resulting in a wider therapeutic index and deeper, more durable responses in preclinical tumor models.

"These preclinical data highlight the potential of KIVU-107 as a next-generation ADC designed to deliver enhanced efficacy, superior stability, and improved tolerability," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "In preclinical studies, KIVU-107 is both highly potent and exceptionally well-tolerated, a combination that’s rare among ADCs. We look forward to initiating our Phase 1 clinical trial this quarter."

Both the oral and poster presentations feature preclinical data highlighting KIVU-107’s strong anti-tumor activity, and excellent safety profile. KIVU-107 demonstrated potent antigen-specific cytotoxicity with rapid internalization in vitro and. in mouse xenograft models, durable complete tumor regressions were observed after a single dose. KIVU-107 also showed robust activity in combination with olaparib and in ADC-resistant patient-derived xenograft models, supporting its potential to overcome resistance mechanisms seen with current ADC therapies.

Repeat-dose GLP toxicology studies in non-human primates demonstrated favorable pharmacokinetics, minimal unconjugated exatecan exposure, and an exceptional tolerability profile supporting a potential higher starting dose for first-in-human evaluation. Together, these findings confirm a wide therapeutic index and a best-in-class potential for efficacy, stability, and safety.

The preclinical data collectively demonstrate that KIVU-107 combines precision targeting with a potent and controllable payload, resulting in a differentiated ADC profile with a remarkably wide therapeutic index.

Presentation Details:

Oral Presentation

Title: Striving for Kinder and Gentler ADCs: Spotlight on Solid Tumor Target and Preclinical Development of KIVU-107
Presenter: Mohit Trikha, Ph.D.
Session: Discovery Biology
Date/Time: Tuesday, November 4, 3:00 PM PT
Poster Presentation

Title: Preclinical Efficacy and Safety of KIVU-107, a Novel PTK7-Targeting Antibody-Drug Conjugate (ADC)
Authors: N. Viller, L. Zhang, X. Jiang, A. MacLaren, M. Trikha
Session: Day 2 Poster Session
Poster Number: 84
Date/Time: Wednesday, November 5, 8 AM – 6 PM PT

(Press release, Kivu Bioscience, OCT 20, 2025, View Source [SID1234656841])