On September 3, 2025 Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported it will present new pre-clinical NSCLC data for its lead drug candidate, IAM1363, at the IASLC 2025 World Conference on Lung Cancer (Press release, Iambic Therapeutics, SEP 3, 2025, View Source [SID1234655747]).

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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. New IAM1363 data show potent anti-tumor activity and significant tumor regression across a panel of HER2-amplified and HER2-mutant NSCLC models, including greater anti-tumor activity compared to currently approved therapies. Importantly, IAM1363 demonstrated robust anti-tumor activity with prolonged survival in an intracranial model of brain metastasis. Finally, treatment with IAM1363 resulted in striking tumor enrichment in a HER2 exon 20-mutant NSCLC model with strong tumor regression.

IAM1363 is currently advancing in an ongoing Phase 1/1b clinical trial.

Poster: IAM1363 Is a Potent, Selective, and Irreversible HER2 and Pan-HER2 Mutant Small Molecule Inhibitor for the Treatment of HER2-Driven NSCLC

Session and Presentation: Tumor Biology – Translational Biology, #P3.03.29

Presenter: John Huang, PhD, VP of Biology, Iambic Therapeutics

Time and Location: Tuesday, September 9, 2025, 10:00 AM CEST, Fira de Barcelona Convention Center, Exhibit Hall

On September 3, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that John Celebi, President and Chief Executive Officer, will participate in 1×1 investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, September 8, 2025 (Press release, Sensei Biotherapeutics, SEP 3, 2025, View Source [SID1234655734]).

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An on-demand corporate presentation will be available here on September 5, 2025, at 7:00 a.m. ET. A replay of the webcast will be available in the Investors section of the Sensei website for approximately 90 days following the event.

On September 3, 2025 Treeline Biosciences (or Treeline) reported the initiation of Phase 1 trials for two internally discovered programs, TLN-121 and TLN-372, and a third in-licensed program, TLN-254 (Press release, Treeline Biosciences, SEP 3, 2025, View Source [SID1234655748]). TLN-121, a BCL6 degrader, and TLN-254, an EZH2 inhibitor, are both being studied in patients with lymphoma. TLN-372, a pan-KRAS inhibitor, is being studied in patients with cancers expressing certain KRAS mutations. The company also announced the close of a $200 million Series A extension, bringing total funding to $1.1 billion.

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"We aspire to create the next great enduring biopharma company," said Josh Bilenker, M.D., Treeline’s Co-Founder and CEO. "Our funding mandate has allowed us to recruit proven scientists, rigorously test assumptions and curate a pipeline from parallel discovery efforts. BCL6 and KRAS are formidable targets that required difficult chemistry and novel assay development. We hope these programs deliver for patients and create momentum for our next set of clinical entries."

Go here to read more of Josh’s perspective on today’s news.

Treeline Facts

Co-founded by CEO Josh Bilenker and CSO Jeff Engelman, both oncologists with experience leading R&D teams. Josh previously founded Loxo Oncology, which developed three FDA-approved medicines. Jeff was director of thoracic oncology at Massachusetts General Hospital and later global head of oncology at the Novartis Institutes for BioMedical Research.
Internal R&D team uses leading-edge computational tools to prioritize workflow and accelerate timelines.
Therapeutic areas include cancer, neurological and autoimmune diseases.
Programs include small molecules, degraders and glues, and targeted therapy ADCs (TT-ADCs).
Team and pipeline were built for scaled invention and company longevity.
$1.1 billion raised to-date, including a recent $200M Series A extension; investors include: AI Life Sciences, an affiliate of Access Industries; ARCH Venture Partners; OrbiMed; GV; KKR; accounts advised by T. Rowe Price Associates, Inc.; Ajax Health/Zeus; Casdin Capital; Fidelity Management & Research Company; Aisling Capital; Rock Springs Capital; and Exor.
Medicines in the Making

Treeline’s founding team has worked extensively in cancer R&D, and its first three clinical programs reflect this hard-won experience:

TLN-121 — BCL6 Protein Degrader for Lymphomas
BCL6 is a naturally occurring protein that certain lymphoma cells exploit to silence genes that would otherwise block their growth and survival. TLN-121 is a protein degrader designed to remove BCL6 from cancer cells while avoiding off-target effects that could cause toxicity, potentially enabling combination use with standard-of-care lymphoma therapies. The Phase 1 trial (NCT07082803) is enrolling patients with B-cell and T-cell lymphomas.

TLN-372 — Pan-KRAS Inhibitor for Solid Tumors
Approximately one in four adult cancers harbor a KRAS alteration. While there are FDA-approved medicines for G12C mutations, other KRAS variants remain unaddressed by targeted therapies. TLN-372 is a small molecule inhibitor with novel chemistry designed for deep, continuous pan-KRAS inhibition, and possesses favorable drug-like properties. The Phase 1 trial will enroll patients with KRAS-altered solid tumors.

TLN-254 — EZH2 Inhibitor for Lymphomas
EZH2 regulates gene expression and is often overexpressed or mutated in cancers. TLN-254 is a small molecule inhibitor that was in-licensed after Phase 2 testing in refractory lymphoma. The Phase 1 trial (NCT06733441) is enrolling patients with peripheral and cutaneous T-cell lymphomas.

On September 3, 2025 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that the first patient has been enrolled and has begun dosing in the company’s new pancreatic cancer trial (Press release, Amplia Therapeutics, SEP 3, 2025, View Source [SID1234655735]). The trial is exploring the combination of Amplia’s best-in-class FAK inhibitor narmafotinib with the chemotherapy FOLFIRINOX in newly diagnosed advanced pancreatic cancer patients.

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The trial is being conducted at two (2) sites in Australia that are already open and recruiting patients, and four (4) sites in the US that will shortly be open once final site approvals are obtained. The first stage of this trial will explore the safety, tolerability and pharmacokinetics of increasing daily doses of narmafotinib when combined with FOLFIRINOX given on its conventional two (2) week cycle. The dose-escalation is anticipated to be completed in Q1 2026.

Dr Chris Burns, Amplia’s CEO and Managing Director commented: "With dosing of the first patient, this trial is now officially underway. This is an important milestone in the development of narmafotinib and we thank everyone who has worked tirelessly to get us to this point." This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently being investigated in the ACCENT clinical trial where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its desired outcome
in achieving a response rate of 31%, superior to chemotherapy alone. In particular, one (1) complete response and one (1) pathological complete response have been recorded in this study.

About the FOLFIRINOX Trial

This trial investigates narmafotinib in combination with the modified FOLFIRINOX chemotherapy regimen to explore the safety, tolerability, efficacy and pharmacokinetics of the combination in newly-diagnosed patients with advanced (metastatic) pancreatic cancer. The trial is entitled ‘A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of narmafotinib in Combination with modified FOLFIRINOX in Pancreatic Cancer Patients’ and is being conducted under an open IND from the US FDA.

Designed as a single-arm, open-label study, the trial will proceed in two parts, incorporating the principles of the FDA’s Project Optimus guidance for developing new oncology therapies1. Part A will explore a range of oral daily doses of narmafotinib (AMP945) in combination with modified FOLFIRINOX (administered every 14 days), for safety, tolerability, and pharmacokinetics. Part B of the trial is designed to identify the optimal daily dose of narmafotinib for future studies, by comparing two (2) doses identified from Part A, for safety, tolerability and efficacy.

The trial is being conducted initially at sites in Australia and the US. More information about the trial can be found at the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT07026279.

The Company has previously presented data from preclinical studies demonstrating that the addition of narmafotinib to FOLFIRINOX improves survival in animal models of pancreatic cancer compared to animals treated with FOLFIRINOX alone.

On September 3, 2025 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral gene therapy company, reported it has achieved its target enrollment milestone of 100 patients for the pivotal cohort of its ongoing, open-label, multi-cohort Phase 2 LEGEND trial of detalimogene voraplasmid ("detalimogene" and previously EG-70) in patients with high-risk, non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, SEP 3, 2025, View Source [SID1234655749]). LEGEND’s pivotal Cohort 1 is studying detalimogene in patients with high-risk NMIBC with carcinoma in-situ (CIS) with or without concomitant papillary disease. Patients in the screening process remain eligible for potential enrollment in the trial. The Company expects to overenroll in its pivotal cohort resulting in an adjustment in guidance for a BLA submission to 2H 2026.

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"Achieving our target enrollment goal for detalimogene in LEGEND’s pivotal cohort represents an important milestone for enGene. It brings us a step closer to our goal of providing patients and physicians with the first non-viral gene therapy that offers a unique balance of efficacy, safety, and ease-of-use," said Ron Cooper, Chief Executive Officer of enGene. "We are grateful to study participants, investigators, and our clinical organization for their contributions to advancing the development of detalimogene."

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of approximately 100 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.