On September 2, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported that two abstracts for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented at the World Conference on Lung Cancer (WCLC) 2025 Annual Meeting taking place September 6 – 9 in Barcelona, Spain (Press release, SystImmune, SEP 2, 2025, View Source [SID1234655671]). Iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

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The safety and efficacy results of iza-bren as a monotherapy and in combination with Osimertinib in patients with advanced stages of EGFR mutated Non-Small Cell Lung Cancer will be presented at WCLC. The data highlights the continued progress of iza-bren clinical development and builds upon the previously reported clinical activity in lung, breast, and bladder cancer patients at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), and SABCS in 2023, 2024 and 2025.

"These data further enhance our confidence in iza-bren’s clinical activity across a wide range of tumors," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are particularly excited by the potential of iza-bren in combination with osimertinib as a first-line treatment for EGFR-mutated NSCLC. This approach may offer the opportunity for deeper and more durable responses in newly diagnosed patients, and we remain committed to advancing its development to address unmet needs in lung cancer."

Details of the presentations at WCLC are below:
Phase I/II Study of iza-bren (BL-B01D1) as Monotherapy in Patients with pre-treated Locally Advanced or Metastatic EGFR Mutated NSCLC
Session Title: OA10 – Optimizing Systemic Therapy; Bridging New and Old
Presentation: OA10.03
Speaker: Wenfeng Fang (Guangzhou, China)
Session Date & Time: Monday, September 8th, 2025, 3:30 PM-4:45 PM CEST

Phase II Study of iza-bren (BL-B01D1) Combo with Osimertinib in EGFR Mutated Locally Advanced or Metastatic NSCLC Patients
Session Title: OA10 – Optimizing Systemic Therapy; Bridging New and Old
Presentation: OA10.04
Speaker: Fei Zhou (Zhengzhou, China)
Session Date & Time: Monday, September 8th, 2025, 3:30 PM-4:45 PM CEST

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3 targets that are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic payload is released causing genotoxic stress that leads to cancer cell death.

On September 2, 2025 Servier, an independent international pharmaceutical group governed by a foundation, and IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported an exclusive license agreement to bring darovasertib, a promising treatment for a rare eye cancer, to patients worldwide (Press release, Servier, SEP 2, 2025, View Source [SID1234655670]). Under the agreement, Servier obtains the regulatory and commercial rights for darovasertib in all territories outside the United States. IDEAYA retains its rights for darovasertib in the United States. Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to broadly address primary and metastatic uveal melanoma (UM).

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"At Servier, our mission is to deliver transformative therapies to patients with significant needs. Our collaboration with IDEAYA is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide," said Arnaud Lallouette, Executive Vice-President Global Medical & Patient Affairs at Servier. "Today, there are limited treatment options and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network, and expertise in developing oncology targeted therapies, to make this groundbreaking treatment accessible to patients across the globe."

"Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide. This partnership enables IDEAYA and Servier to accelerate the global development for darovasertib across three Phase 3 registrational trials, aiming to improve patient outcomes in the neoadjuvant, adjuvant and metastatic settings," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"We believe Servier’s global footprint and proven track record in bringing novel therapies to patients in Europe and other key territories outside of the U.S. will ensure that this potentially life-changing treatment reaches as many patients as possible," said Daniel Simon, Chief Business Officer, IDEAYA Biosciences.

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomized trial evaluating darovasertib in combination with crizotinib in first line patients with HLA-A2-negative metastatic uveal melanoma (UM), for which the median progression free survival readout is anticipated from year-end 2025 to Q1 2026, and a Phase 3 randomized trial evaluating neoadjuvant darovasertib as a monotherapy in primary UM, independent of HLA status. IDEAYA and Servier will target to launch a global Phase 3 randomized clinical trial in 2026 to evaluate adjuvant darovasertib in primary UM, also in both HLA-A2-negative and -positive patients.

Uveal melanoma (UM) is a rare and aggressive form of eye cancer that originates in the uveal tract, which includes the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasize to other parts of the body, particularly the liver. Current treatment options include radiation therapy, surgical removal of the tumor, or removal of the eye (enucleation) in severe cases.

Darovasertib has received US FDA (Food and Drug Administration) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the US FDA in UM, including in metastatic UM.

Under the terms of the agreement, IDEAYA will receive an upfront payment of $210 million, and be eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib in all territories outside the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs.

On September 2, 2025 AbbVie (NYSE: ABBV) reported it will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9, 2025 (Press release, AbbVie, SEP 2, 2025, View Source [SID1234655669]). Management will participate in a fireside chat at 9:00 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On September 2, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, reported that the Company’s president and CEO, Dave Lennon, PhD, will participate in a fireside chat during the following upcoming investor conferences in New York City, NY (Press release, Whitehawk Therapeutics, SEP 2, 2025, View Source [SID1234655668]):

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Morgan Stanley 23rd Annual Global Healthcare Conference on Monday, September 8, 2025. Fireside chat at 4:50 PM ET.

H.C. Wainwright 27th Annual Global Investment Conference on Tuesday, September 9, 2025. Fireside chat at 3:30 PM ET.
A live webcast of the fireside chat events can be accessed by visiting the Whitehawk Therapeutics IR website. These will be available for replay for approximately 30 days following the event.

On September 2, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, reported combined positive findings from multiple preclinical programs evaluating its precision antisense candidate HT-KIT, including compelling anti-tumor efficacy, a clean safety profile, and new GLP-validated bioanalytical results that exceeded internationally recognized regulatory thresholds (Press release, Hoth Therapeutics, SEP 2, 2025, View Source [SID1234655665]).

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Preclinical Efficacy & Safety Highlights

Rapid Tumor Kill: HT-KIT triggered significant tumor cell death in preclinical models of gastrointestinal stromal tumors (GIST) and systemic mastocytosis as early as 24 hours post-treatment, with statistically significant tumor shrinkage observed by day 8.
Strong KIT Suppression: In vitro, HT-KIT achieved over 80% knockdown of KIT expression, the oncogenic driver in multiple aggressive cancers.
Clean Safety Profile: Multi-dose in vivo studies confirmed no off-target toxicity across critical organs including liver, kidneys, spleen, bone marrow, and thymus.
Dose-Dependent Biological Signal: A preclinical safety study demonstrated proportional liver engagement (increase from 1.11g to 1.32g at 3.0 mg/kg) with zero gross pathology at any organ site.
GLP-Validated Bioanalytical Results

The study, conducted by Altasciences Company, Inc. under OECD, FDA, and EMA GLP standards, demonstrated that HT-KIT meets or exceeds strict bioanalytical benchmarks:

Regulatory-Grade Validation: All calibration curve, quality control, and dilution integrity requirements passed with high reproducibility.
Superior Data Integrity: 90.5% of Incurred Sample Reanalysis (ISR) values fell within ±30%, well above the 66.7% regulatory minimum.
Extended Stability: HT-KIT remained stable in serum for 37 days at -80°C, surpassing the validated 28-day stability period, with further studies ongoing.
Flawless Compliance: No protocol or SOP deviations impacted study reliability.
"These results combine a rare and powerful story — tumor kill within 24 hours, clean safety across all systems, and GLP-validated reproducibility beyond regulatory standards," said Robb Knie, CEO of Hoth Therapeutics. "We believe HT-KIT has the potential to transform outcomes in KIT-driven cancers, and these milestones accelerate our path toward IND submission and first-in-human trials."

Next Steps

Hoth expects to integrate this bioanalytical data into its formal GLP toxicology package and is preparing for an IND.

About HT-KIT

HT-KIT is a precision antisense oligonucleotide designed to silence mutant KIT mRNA, an oncogenic driver in gastrointestinal stromal tumors (GIST), systemic mastocytosis, and certain leukemias. By targeting KIT expression at the genetic level, HT-KIT seeks to overcome resistance to tyrosine kinase inhibitors while minimizing systemic side effects.