On October 13, 2025 SystImmune, Inc., a clinical-stage biotechnology company, reported the treatment of the first patient in the IZABRIGHT-Breast01 study (NCT06926868), a global Ph2/3 registrational study of izalontamab brengitecan (iza-bren) in previously untreated triple negative breast cancer ineligible for anti-PD(L)1 drugs (Press release, SystImmune, OCT 13, 2025, View Source [SID1234656603]). This milestone triggered a one-time payment of $250 million by Bristol Myers Squibb (NYSE: BMY), pursuant to the 2023 collaboration and exclusive license agreement between SystImmune and Bristol Myers Squibb. SystImmune is further eligible to receive up to an additional $250 million in contingent near-term payments and additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones.

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Iza-bren is a potential first-in-class bispecific topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) that targets both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is being developed by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in China and jointly developed by SystImmune and Bristol Myers Squibb in territories outside of China.

"This milestone marks a significant step forward in the global clinical development of iza-bren," said Dr. Yi Zhu, Chairman, SystImmune. "The robust data generated from our China-based trials have played an important role in accelerating development timelines and informing global strategy. We are encouraged by the achievement of this milestone and Bristol Myers Squibb’s commitment to this program. We look forward to bringing iza-bren to patients worldwide under our shared vision with Bristol Myers Squibb."

"Together with Bristol Myers Squibb, we have made significant progress in developing iza-bren globally. We remain deeply committed to delivering this potentially transformative therapy to patients with triple negative breast cancer and other solid tumors," said Dr. Jie D’Elia, CEO, SystImmune. "This $250 million milestone not only reflects the progress of our collaboration but also significantly reinforces our financial position, enabling us to accelerate the global development of our differentiated ADC portfolio."

Iza-bren is currently being evaluated in multiple ongoing clinical trials, including BL-B01D1-LUNG-101 (NCT05983432), IZABRIGHT-Lung01 (NCT07100080), IZABRIGHT-Bladder01 (NCT07106762), and studies in China conducted by Biokin. The program recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with previously treated advanced EGFR-mutated non-small cell lung cancer.

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

On October 13, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported that it has entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $60.0 million private investment in public equity ("PIPE") financing (Press release, ADC Therapeutics, OCT 13, 2025, View Source [SID1234656602]). In the PIPE, ADC Therapeutics is selling 11.3 million common shares at $4.00 per share and pre-funded warrants to purchase 3.8 million common shares at $3.90 per pre-funded warrant, which is the price per common share in the PIPE minus the exercise price of CHF 0.08 per pre-funded warrant.

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The PIPE is led by TCGX and includes participation from Redmile Group and other existing investors.

Gross proceeds from the PIPE financing are anticipated to be approximately $60.0 million before deducting placement agent fees and offering expenses. The PIPE is expected to close on October 27, 2025, subject to customary closing conditions. ADC Therapeutics intends to use the net proceeds from the PIPE to invest in the commercial expansion of ZYNLONTA and strengthen the balance sheet, in addition to funding working capital and general corporate purposes.

"This financing enhances our ability to prepare for and execute the potential relaunch of ZYNLONTA in 2027 and further strengthens our balance sheet relative to our previously disclosed cash runway into 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We believe we are well-positioned to accelerate our trajectory towards long-term sustainable growth for our company. We look forward to upcoming data catalysts later this year and throughout 2026."

The company expects net product revenues from sales of ZYNLONTA to be approximately $15.8 million for the third quarter ended September 30, 2025, with cash and cash equivalents totaling $234.7 million as of September 30, 2025. Giving effect to the estimated net proceeds from the PIPE financing of approximately $57.6 million (after deducting placement agent fees and estimated offering expenses), the Company would have had approximately $292.3 million of cash and cash equivalents as of that date.

The offer and sale of the foregoing securities are made in a transaction not involving a public offering, and the foregoing securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or applicable state securities laws, and are being offered and sold in reliance on Section 4(a)(2) of the Securities Act. The securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and other applicable securities laws. ADC Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the common shares to be sold in the PIPE and the common shares issuable upon exercise of the pre-funded warrants to be sold in the PIPE.

Jefferies is acting as placement agent for the PIPE. Davis Polk & Wardwell LLP and Homburger AG are acting as legal advisors to ADC Therapeutics.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The Company has uploaded an updated corporate presentation to the Investor portion of its website.

About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On October 13, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company’s lead program across major jurisdictions (Press release, Atossa Therapeutics, OCT 13, 2025, View Source [SID1234656601]). The Israeli patent (No. 304863), titled, "Methods for Making and Using Endoxifen," was granted on July 2, 2025, with priority to multiple U.S. provisional applications filed in 2017–2018.

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The allowed claims in Israel include oral, delayed-release (enteric) dosage forms comprising at least 90% by weight Z-endoxifen, with optional impurity limits (<2%), defined release characteristics in gastric and intestinal media, dose strengths (e.g., 1–4 mg and 8 mg), and pharmacokinetic performance targets (e.g., plasma exposures and steady-state levels). The claims also cover manufacturing methods that enrich the Z-isomer via stepwise crystallization and solvent control. These protections align with Atossa’s quality-by-design approach to deliver a consistent, high-purity Z-endoxifen product.

In parallel, Atossa received a Certificate of Patent Renewal from the Israel Patent Office confirming fee payment and renewal status for Patent No. 304863, further supporting the life-cycle management of Z-endoxifen IP in this jurisdiction.

"Strong, durable patents are foundational to our Z-endoxifen strategy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics Chairman and CEO. "This new protection in Israel, together with our broader global filings, covers what we believe are the critical elements of product quality, performance, and manufacturing needed to bring Z-endoxifen to patients and to create long-term value for shareholders."

About the Patent Scope in Israel
The granted patent includes: (i) enteric oral formulations with ≥90% Z-endoxifen; (ii) optional impurity and residual-solvent limits; (iii) stability and delayed-release attributes (acid resistance and intestinal release); (iv) dose ranges including 1–4 mg and 8 mg; (v) PK targets such as steady-state plasma levels and exposure ranges; and (vi) a multi-step crystallization process to enrich the Z-isomer. Collectively, these claims support Atossa’s global protection for Z-endoxifen composition, performance, and process.

On October 13, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 22-26, 2025 in Boston (Press release, Nuvalent, OCT 13, 2025, View Source [SID1234656600]).

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Details of the poster presentation are as follows:

Title: Preclinical intracranial activity of NVL-330, a selective HER2 tyrosine kinase inhibitor
Abstract Number: B057
Authors: Yuting Sun*1, Kristin L. Andrews1, Anupong Tangpeerachaikul1, Michael J. Walsh1, Nancy E. Kohl2, Joshua C. Horan1, Henry E. Pelish1
Session: Poster Session B
Session Date and Time: Friday, October 24, 2025, 12:30-4:00 p.m. ET
Location: Exhibit Hall D

*Presenter, corresponding author; 1Nuvalent, Inc., Cambridge, MA, USA; 2Kohl Consulting, Wellesley, MA, USA

On October 13, 2025 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC), has been published as an abstract released by the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, Compugen, OCT 13, 2025, View Source [SID1234656599]).

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The abstract focuses on a pooled analysis of 60 evaluable patients with platinum resistant ovarian cancer from prior COM701 Phase 1 clinical trials. The analysis characterizes the outcomes of patients who derived clinical benefit including progression free survival data. An additional year of follow-up will be included in the poster. The poster will be presented at ESMO (Free ESMO Whitepaper) in Berlin, Germany on October 18, 2025, by Oladapo Yeku, M.D., Ph.D., FACP, FASCO, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, MA, and an investigator in Compugen’s ovarian cancer trials.

"The pooled analysis demonstrates that COM701 was well tolerated and showed consistent, durable responses in patients with heavily pretreated platinum-resistant ovarian cancer – particularly in those without liver metastases, representing patients with lower disease burden and potentially less immunosuppressive tumor microenvironment," said Dr. Oladapo Yeku. "The results of the analysis support the rationale for evaluating COM701 as maintenance therapy in earlier lines of treatment. I look forward to discussing this data along with the ongoing MAIA-ovarian trial in Berlin at ESMO (Free ESMO Whitepaper) on Saturday, October 18, 2025."

"There is a gap in care for women with platinum sensitive ovarian cancer who respond to chemotherapy but are ineligible for or cannot tolerate additional maintenance treatment," said Eran Ophir, Ph.D., President, and Chief Executive Officer of Compugen. "These patients have a less compromised immune system, providing the opportunity to harness the unique mechanism of action of COM701 to potentially change the disease trajectory and improve progression free survival. Compugen is currently conducting the MAIA-ovarian trial link assessing COM701 monotherapy as maintenance treatment in relapsed platinum-sensitive ovarian cancer."

Dr. Ophir added, "An interim analysis of the MAIA-ovarian trial is planned once data from approximately 60 participants enable assessment of median progression free survival. Sites have been activated in the U.S. and Israel. To further support enrollment, we recently initiated the activation of sites in France from the French oncology cooperative group ARCAGY-GINECO renowned for a number of recent platinum sensitive ovarian cancer trials. Based on the anticipated enrollment rate, the Company currently estimates interim analysis results at year end 2026. As we continue to focus on execution of our pipeline programs, we anticipate that our cash will support our operating plans well into 2027."

Access the Abstract

The abstract is now available on the publication section of Compugen’s website. The poster will be available on the publication section of Compugen’s website on Saturday October 18, 2025.

Additional ESMO (Free ESMO Whitepaper) Highlights

ESMO 2025 will also feature presentations from companies with differentiated Fc-reduced TIGIT programs, including two oral presentations from Compugen’s partner AstraZeneca with rilvegostomig- Fc reduced PD1/TIGIT bispecific, the TIGIT component of which is derived from Compugen’s clinical stage, COM902.