On October 17, 2025 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) reported the oral presentation of the first disclosure of the safety and efficacy data from the global phase I US-Lung-101 study (NCT05983432) of iza-bren (BL-B01D1), a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany. Iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of Mainland China. In August 2025, iza-bren was granted breakthrough therapy designation by U.S. FDA for patients with previously treated EGFR-mutated NSCLC based on the data from China studies and this global study.

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This study evaluated the safety and efficacy of iza-bren in global patients with heavily pre-treated metastatic or unresectable advanced non-small cell lung cancer (NSCLC) and other solid tumors. At the data cut-off (DCO) of July 23, 2025, iza-bren has demonstrated:

Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including EGFR mutant and wildtype NSCLC
Manageable safety profile, with hematologic adverse events effectively managed by standard medical measures, and no interstitial lung disease was observed
In the study, 107 patients with advanced solid tumors were treated, including non-small cell lung cancer (NSCLC) patients with and without EGFR mutations. Most had received several prior therapies. The most common side effects were blood-related, such as neutropenia. These were generally manageable and rarely led to dose reductions or serious complications. No new safety concerns were identified, and no cases of interstitial lung disease were seen. Mandatory preventive measures for neutropenia have been added in ongoing global studies.

For patients receiving 2.5 mg/kg (Days 1 and 8 every 3 weeks), 55% (11 of 20) showed a confirmed response, with a median progression-free survival of 5.4 months. Confirmed responses were also seen in both the subgroup with EGFR-mutated NSCLC (3 of 10 patients) and those without the mutation (3 of 4 patients).

Global registrational studies of first line metastatic TNBC (IZABRIGHT-Breast01, NCT06926868), second line metastatic EGFRmt NSCLC (IZABRIGHT-Lung01, NCT05983432) and second line metastatic Urothelial Cancer (IZABRIGHT-Bladder01, NCT07106762) are ongoing, with studies in other indications planned.

"The first global presentation of iza-bren builds on the compelling data initially observed in Chinese patients, showing consistent efficacy in a heavily pre-treated global population," said Jonathan Cheng, M.D., Chief Medical Officer, SystImmune. "These results support iza-bren’s potential as a bispecific ADC treatment option across multiple tumor types, and we are excited to continue advancing this important program through our global collaboration with Bristol Myers Squibb."

"We are committed to developing first-in-class and best-in-class medicines that can meaningfully improve outcomes for patients with difficult-to-treat cancers," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy, Bristol Myers Squibb. "The encouraging activity observed with iza-bren in this early global study reinforce our confidence in its potential, and we look forward to the ongoing registrational studies across lung, breast, and urothelial cancers."

About the BL-B01D1-LUNG-101 Phase I clinical trial
BL-B01D1-LUNG-101 (NCT05983432) is a global, multi-center, Phase I study to evaluate the safety, tolerability, pharmacokinetics, and initial efficacy of iza-bren in participants with metastatic or unresectable NSCLC and other solid tumors. This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day 1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a continuous 21-day treatment cycle. The primary endpoint includes safety. Secondary endpoints include objective response rate (ORR) by RECIST 1.1 criteria, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OR) and PK analysis.

About EGFRmt NSCLC
Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases, which remains the leading cause of cancer-related death worldwide. Among patients with NSCLC, 10% to 15% in Western populations and up to 50% in Asian populations harbor activating EGFR mutations. These tumors, most commonly of non-squamous histology, initially respond to EGFR TKIs such as osimertinib. However, resistance is nearly universal, often occurring after about 18 months, and treatment options beyond TKIs and platinum-based chemotherapy provide limited clinical benefit with significant toxicities, highlighting the critical need for new, effective therapies.

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, which 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/or HER3 signals to cancer cells, reducing cancer cell proliferation and survival. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

(Press release, Bristol-Myers Squibb, OCT 17, 2025, View Source;and-Bristol-Myers-Squibb-Announce-First-Global-Phase-I-Results-of-Iza-bren-an-EGFR-x-HER3-Bispecific-Antibody-Drug-Conjugate-in-Patients-with-Advanced-Solid-Tumors-at-ESMO-2025/default.aspx [SID1234656729])

On October 17, 2025 Artios Pharma Limited ("Artios"), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response ("DDR") in cancer, reported the first clinical data from its Phase 1/2a study (NCT05898399) of its novel DNA polymerase Theta (Polθ) inhibitor, ART6043. The data were featured in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin by Principal Investigator Dr. Timothy A. Yap, VP and Head of Clinical Development in the Therapeutics Discovery Division at The University of Texas MD Anderson Cancer Center. The results highlighted ART6043 in combination with the PARP inhibitor, olaparib, in patients with advanced solid tumors harboring mutations in a DNA damage response pathway.

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ART6043 targets Polθ, a key DNA repair enzyme that is overexpressed in many cancers but present at low levels or absent in most healthy tissues. Cancer cells rely on Polθ as a backup DNA repair mechanism to survive when their primary homologous recombination (HR) DNA repair pathway is defective or when they acquire resistance to DNA-damaging therapies such as PARP inhibitors. By blocking Polθ, ART6043 is designed to shut down this alternative repair route, rendering tumors unable to effectively repair DNA damage and thereby enhancing anti-tumor activity.

"The emerging clinical data validate our approach to inhibit Polθ to selectively cripple tumor cells and exploit a cancer’s dependency on DNA repair," said Ian Smith, Chief Medical Officer of Artios. "The initial data and efficacy signals in the relevant genetic background are encouraging, and we look forward to advancing ART6043’s clinical development to realize its potential to increase the effectiveness of PARP inhibition, where resistance to standard of care has become increasingly prevalent."

Summary of Key Clinical Results:

Baseline characteristics

ART6043 Monotherapy: 19 patients; median age: 58 years; prior treatment with PARP inhibitor: 37%
ART6043+olaparib: 42 patients; median age: 65.5 years; prior treatment with PARP inhibitor: 31%
All patients received a median of 4 prior therapies

Highlights of clinical data presented at ESMO (Free ESMO Whitepaper) 2025

ART6043 demonstrated an expected, benign tolerability profile as a monotherapy, with no additional toxicity to that of olaparib when combined
Pharmacokinetic data support convenient and oral once-daily dosing, and no drug-drug interaction (DDI) between ART6043 and olaparib was observed
Pharmacodynamic engagement of ART6043 alone was enhanced in combination with olaparib in patients, and was similar to preclinical models where tumor regressions were seen

"The first-in-class Polθ inhibitor, ART6043, represents a much-needed therapeutic option for patients with advanced, hard-to-treat cancers where resistance to existing treatments is a major clinical challenge," said Dr. Timothy A. Yap, Principal Investigator of the study. "The initial clinical signals observed to date reinforce the potential of ART6043 to address this significant unmet need for patients who currently have limited treatment options. I look forward to the further evaluation of Polθ inhibition as additional clinical data become available."

ART6043 continues to be evaluated in a first-in-human Phase 1/2a study in patients with advanced solid tumors. ART6043 has the potential to advance into dedicated Phase 2 trials to assess efficacy across molecularly selected cohorts and expand its potential into new combinations and disease settings.

The full abstracts will be published in the ESMO (Free ESMO Whitepaper) Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology‑mediated end joining (MMEJ) to exploit tumor dependence on error‑prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA‑damaging modalities. Artios’ differentiated approach is evaluating ART6043 with olaparib in molecularly defined solid tumors, including settings of BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

(Press release, Artios Pharma, OCT 17, 2025, View Source [SID1234656728])

On October 16, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported it has received a notification of allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the AI-built algorithm and flow cytometry platform that analyzes cell populations in sputum leading to detection of lung cancer.

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"Artificial intelligence was integral to the development of our CyPath Lung test and has resulted in the detection of lung cancer at its earliest Stage 1A, a potentially curative stage," said Maria Zannes, President and CEO of bioAffinity Technologies. "A quarter of a million Americans are expected to receive a lung cancer diagnosis in 2025, representing the leading cause of cancer death. Harnessing AI with our novel flow cytometry platform has resulted in a diagnostic that produces high-precision, standardized, data-driven results."

The patent, titled "Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning," covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples. CyPath Lung’s advanced flow cytometry process detects changes in the lung linked to cancer, including populations of immune cells, apoptotic cells and cancer and cancer-related cells labeled by the Company’s proprietary TCPP porphyrin. CyPath Lung’s AI-driven analysis combines these variables with patient age to predict cancer in the lung.

CyPath Lung can be utilized by physicians to determine next steps for patients with pulmonary nodules requiring follow-up. The noninvasive test is designed to perform with high sensitivity and specificity and seeks to deliver valuable diagnostic insight while alleviating patient anxiety, preventing unnecessary invasive procedures and reducing costs to the healthcare system.

This newly allowed U.S. patent complements bioAffinity’s expanding global patent estate, which now includes 18 awarded and 33 pending patents. bioAffinity Technologies holds patents in the U.S., Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden, and the United Kingdom.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

(Press release, BioAffinity Technologies, OCT 16, 2025, View Source [SID1234656722])

On October 16, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a multi-year collaboration with Whitehawk Therapeutics, Inc. (NASDAQ: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugates (ADC) cancer treatments. The collaboration aims to leverage Tempus’ proprietary real-world dataset to advance biomarker-driven research and support the development of Whitehawk Therapeutics’ oncology pipeline.

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Under the agreement, Whitehawk Therapeutics will apply Tempus’ de-identified multimodal database to support the biotech’s clinical trial designs by focusing on the right patient population(s) with the highest level of demonstrated real-world unmet need. The collaboration will center on powering research spanning Whitehawk Therapeutics’ ADC portfolio, which includes three assets designed to target clinically validated proteins (PTK7, MUC16 and SEZ6) that are broadly expressed in high-potential cancer indications, such as lung and gynecological cancers.

"Tempus’ comprehensive, multimodal data, paired with Whitehawk’s ADC drug development expertise, create a powerful foundation to validate the potential of their portfolio in a promising class of targeted cancer therapeutics," said Ryan Fukushima, Chief Operating Officer at Tempus. "We’re committed to working in tandem with our biotech collaborators to uncover actionable insights from our AI platform so they can make smarter, faster decisions throughout the drug development process."

"A proactive approach to our biomarker strategy ensures our programs are guided by data-driven insights," said Dave Lennon, PhD, President and CEO, Whitehawk Therapeutics. "By partnering with Tempus, our goal is to better understand the expression of our ADC protein targets to inform indication prioritization for our clinical development programs and better exploit the full potential of our pipeline. An important aspect of this partnership will be continuing to establish the concordance between RNA and IHC expression of our targets. Because RNA testing is objective, reproducible and scalable, establishing it as a reliable alternative to the more subjective IHC methods could enhance our ability to readily identify appropriate patients for our ADC therapies."

(Press release, Tempus, OCT 16, 2025, View Source [SID1234656721])

On October 16, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal, is a useful tool in assessing the maintenance treatment response post-CRT in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

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The new LAURA analysis will be presented at the ESMO (Free ESMO Whitepaper) 2025 Conference in Berlin, Germany, demonstrating key findings for NeXT Personal:

Treatment monitoring: Osimertinib treatment led to MRD clearance in most patients with post-chemoradiotherapy (post-CRT) MRD, demonstrating the utility of ctDNA for monitoring the maintenance therapy response
Lead time to progression: NeXT Personal detected MRD progression with a median lead time of 5 months ahead of Blinded Independent Central Review (BICR) assessed disease progression
"This study from AstraZeneca shows how ultrasensitive ctDNA detection enabled by NeXT Personal enables precise tracking of the maintenance treatment response post-CRT during clinical trials. It is a good example of how AstraZeneca and our other biopharma partners are taking advantage of our ultrasensitive assay to gain new insights into their clinical studies," said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis.

The LAURA trial (NCT03521154) is a global, randomized, placebo-controlled, double-blind, multi-center study of osimertinib following chemoradiation for patients with unresectable EGFRm NSCLC.

This collaboration also builds on previous work with AstraZeneca, showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence. This includes a recent publication of Phase 3 CALLA cervical cancer study results showing that NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging, and a recent presentation at the IASLC 2025 World Conference on Lung Cancer on the NeoADAURA study demonstrating that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting.

(Press release, Personalis, OCT 16, 2025, View Source [SID1234656720])