On October 20, 2025 Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported clinical data for IAM1363, a brain-penetrant HER2 small-molecule tyrosine kinase inhibitor (TKI), which showed anti-tumor activity in heavily pretreated patients across multiple disease types, encompassing HER2-amplified, HER2-overexpressing, and HER2-mutant tumors. The data are being presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin.

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"IAM1363 marks one of the first clear demonstrations of a drug candidate with compelling clinical activity and safety from a TechBio company," said Tom Miller, PhD, Co-Founder and CEO of Iambic. "This milestone not only reinforces the potential of IAM1363 as a best-in-class TKI for HER2-driven cancers but also validates the power of our platform to translate model predictions into meaningful clinical impact. With this foundation, we are advancing a robust pipeline of development candidates for both Iambic and our partners, redefining what’s possible in drug discovery and development."

IAM1363 is a potent, irreversible type II HER2 inhibitor, highly differentiated by its target selectivity (>5,000-fold HER2 vs. EGFR selectivity), brain penetrance, pan-mutant activity, and tumor enrichment. Initial clinical data show activity in patients with HER2-mutant NSCLC and HER2-positive breast and gastric cancers, as well as indications lacking approved HER2-directed TKIs or antibodies, such as HER2-mutant renal cell cancer and HER2-amplified NSCLC and ovarian cancer. Best overall response (BOR) data in participants with HER2-targetable alterations dosed at ≥960 mg qd, as assessed by RECIST 1.1 and RANO-BM, showed partial responses in 28% (N=18) with measurable systemic disease and in 33% (N=3) with measurable intracranial tumors.

The data further validate Iambic’s AI platform and clinical execution, with the novel molecule advancing from program start to clinical trial initiation in just two years, and initial proof of concept clinical data now reported just over a year later.

"We are encouraged by IAM1363’s safety and pharmacokinetic profile and, importantly, to see tumor reductions in patients who had exhausted all standard-of-care options," said Neil Josephson, MD, Iambic’s Chief Medical Officer. "These promising data support our plans to evaluate IAM1363 in both monotherapy and combination cohorts."

The Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 in patients with advanced HER2 cancers. The study, which has multiple sites in the U.S., recently opened in the EU and will continue to expand into additional sites across the U.S. and EU and into the UK and APAC in Q4 2025.

(Press release, Iambic Therapeutics, OCT 20, 2025, View Source [SID1234656844])

On October 20, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany.

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An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline.

"The positive safety profile and initial clinical benefit we’ve seen through our extensive interim analysis validates the comprehensive mechanism of action studies that preceded this clinical study, demonstrating how ENV-105 restores a patient’s ability to respond to hormone therapy," said Dr. Neil Bhowmick, CSO of Kairos Pharma.

Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute, leads the randomized Phase 2 trial that is currently accruing up to 100 patients at Cedars-Sinai Medical Center, City of Hope Cancer Center, and the Huntsman Cancer Institute. The 13.7 median PFS (progression free survival) achieved by imaging with the ENV-105 and apalutamide combination reported would suggest an improvement over current alternatives of chemotherapy and radioligand therapy, in terms of disease control as well as tolerability. Kairos Pharma seeks to provide a safe and effective therapy with ENV-105 for the over 3 million men with hormone-resistant prostate cancer worldwide.

(Press release, Kairos Pharma, OCT 20, 2025, View Source [SID1234656843])

On October 20, 2025 Valink Therapeutics Inc. ("Valink"), a private biotechnology company developing next-generation oncology therapeutics with a focus on bispecific antibody-drug conjugates (bsADCs) and complementary modalities for improved patient outcomes, reported the closing of a $11.8 million funding round and the expansion of its U.S. presence, with headquarters in Cambridge, Massachusetts. Proceeds from the financing will be used to advance Valink’s pipeline of first-in-class treatments designed to deliver enhanced efficacy, safety and precision in the treatment of cancer and other diseases.

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Valink’s bsADC technology aims to address key limitations of current ADCs by integrating novel targeting strategies with improved payload delivery. The company is also exploring complementary therapeutic modalities to broaden its impact across multiple cancer indications.

The financing was led by European venture capital fund redalpine, with participation from new investors LongeVC and Oxford Science Enterprises. Existing investors, including RV Invest, p53 Invest, and Hoxton Ventures also contributed to the round.

"We are grateful to redalpine and our syndicate of new and existing investors for their confidence in our vision and strategy," said Arne Scheu, DPhil, Co-founder and Chief Executive Officer of Valink Therapeutics. "This financing strengthens our position as a leader in next-generation bispecific ADCs and supports the advancement of our oncology pipeline toward key milestones. Our V-gate approach and proprietary drug discovery engine expand the frontier of antibody drug conjugates, offering the potential for first-in-class medicines to address areas of high unmet need in oncology and beyond."

"At redalpine, we back technologies that reshape paradigms. Valink’s discovery platform and V-gate approach represent a compelling advancement on traditional ADC strategies – unlocking new therapeutic possibilities by fusing programmable biology and a novel framework for target synergy," said Michael Sidler, redalpine founding partner and member of Valink Therapeutics board of directors. "We’re excited to lead this round and support Valink’s mission to address real-world disease biology with precision and adaptability."

(Press release, Valink Therapeutics, OCT 20, 2025, View Source [SID1234656842])

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])

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])