On September 4, 2025 Vaxiion Therapeutics reported completion of the dose escalation segment of its ongoing multicenter Phase 1 study evaluating the safety and efficacy of VAX014 as monotherapy along with initiation of the Phase 1b dose expansion segment of the study (Press release, Vaxiion Therapeutics, SEP 4, 2025, View Source [SID1234655782]). The dose expansion segment will implement an adaptive trial design to evaluate the safety and efficacy of VAX014 in combination with investigator’s choice of pembrolizumab or nivolumab in patients with solid tumors that have progressed on prior PD-1 blockade.

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VAX014 is a novel, first-in-class, pan-tumor targeted, oncolytic immunotherapy using bacterial minicells and was specifically designed for optimal activity in STING and/or RIG-I positive tumors to overcome this biological limitation of oncolytic virus-based therapies. Provided as a sterile product, VAX014 eliminates the need for BSL-2 biocontainment, dramatically increasing patient access in comparison to oncolytic viruses.

Eighteen heavily pretreated solid tumor patients were treated with VAX014 across five dose levels in the dose escalation segment of the study. In the first nine patients, a single tumor was injected with a fixed dose volume whereas the last nine patients were allowed to have multiple tumors injected. Across dose levels, VAX014 was well tolerated as monotherapy and provided strong evidence of immune-mediated antitumor activity in both injected and non-injected tumors.

The Phase 1b dose expansion study (NCT05901285) is open and enrolling at eight sites across the United States and utilizes an adaptive trial design in patients with solid tumors who have progressed after prior PD-1 directed immune checkpoint blockade. Based on current enrollment rates, the Company anticipates enrolling up to 30 patients in the next 12 months.

"The monotherapy data with VAX014 is promising and I am eager to see how it performs in combination with pembrolizumab or nivolumab," said study Principal Investigator Dr. Elizabeth Buchbinder of the Dana-Farber Cancer Institute. "Having a locally administered oncolytic immunotherapy option that doesn’t require special handling and biocontainment considerations has been really nice."

"We are happy to report the initiation of the dose expansion segment of this ongoing study and are encouraged by the safety and efficacy data as well as the positive investigator and patient feedback from the dose escalation study." said Vaxiion CEO, Matt Giacalone. "The Phase 1b dose expansion will continue to build on our hypothesis that VAX014 facilitates development of robust antitumor T cell responses to potentiate the effectiveness of immune checkpoint blockade."

On September 4, 2025 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that its latest research has been accepted for poster presentation at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC), taking place September 6–9 in Barcelona, Spain (Press release, OncoHost, SEP 4, 2025, View Source [SID1234655780]).

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The study, "Distinct Clinical and Biological Features of Five SCLC Subtypes Identified by Plasma Proteomic Analysis," highlights the company’s innovative use of plasma proteomic profiling to advance precision medicine in small cell lung cancer (SCLC).

Poster Presentation
Title: Distinct Clinical and Biological Features of Five SCLC Subtypes Identified by Plasma Proteomic Analysis
Presenter: David Gandara, MD (UC Davis Medical Center, Sacramento, CA, USA) Session Date: September 8, 2025 | Poster Hall
Abstract Number: 3247

Study Highlights and Conclusions
SCLC is increasingly recognized as a heterogeneous disease, with distinct disease characteristics thought to reflect different mechanisms of therapeutic resistance. One strategy for patient stratification involves molecular subtyping based on transcription factor expression in tumor samples. These subtypes exhibit unique biological features and gene expression profiles that give rise to subtype-specific therapeutic vulnerabilities. Emerging evidence therefore suggests that integrating SCLC subtyping into clinical decision-making may support personalized treatment, improve biomarker-guided trial design, and ultimately enhance patient outcomes.

However, current subtyping approaches face two major limitations. First, tumor heterogeneity can lead to variability in test results across different biopsy sites. Second, recent studies indicate a significant risk of subtype shifting during treatment, reflecting tumor plasticity and therapeutic adaptation. Accordingly, there is a need for a non-invasive subtyping method that enables longitudinal monitoring of a patient’s subtype.

By analyzing pre-treatment plasma samples from 79 patients with extensive-stage SCLC treated with immune checkpoint inhibitors and chemotherapy, the research team at OncoHost identified five distinct proteomic subtypes, each marked by unique molecular features and clinical outcomes. The subtypes display differential survival profiles for ICI-based treatment.

Proteomic profiling uncovered 469 differentially expressed proteins between the patients’ subtypes, grouped into four major expression clusters enriched for pathways linked to cell cycle regulation, splicing, inflammation, and additional processes. The subtypes further differ in neuroendocrine and NOTCH signaling pathways, which play a critical role in SCLC progression and treatment response. These insights indicate that plasma proteomics-based subtyping can provide a minimally invasive approach to overcome the limitations of tissue biopsies, enable dynamic monitoring of disease, and identify new therapeutic opportunities – paving the way for more precise and personalized treatment strategies in SCLC.

"Small cell lung cancer remains one of the most challenging malignancies to treat due to its complexity and poor prognosis," said Michal Harel, PhD, VP Translational Medicine at OncoHost. "Our findings show that plasma proteomics can identify clinically meaningful SCLC subtypes and reveal new biological pathways that may serve as therapeutic targets."

Ofer Sharon, MD, CEO of OncoHost, added: "By integrating proteomic profiling and AI-driven capabilities to SCLC, we are uncovering actionable insights that have the potential to transform how we approach treatment decision-making. These results reinforce our mission to empower oncologists with predictive tools that improve patient outcomes in some of the most aggressive cancers."

On September 4, 2025 Aethlon Medical, Inc. ("Aethlon" or the "Company") (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported the pricing of a public offering of an aggregate of 5,000,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 5,000,000 shares of common stock at a combined public offering price of $0.90 per share (or pre-funded warrant) and accompanying warrant (Press release, Aethlon Medical, SEP 4, 2025, View Source [SID1234655779]). The warrants will have an exercise price of $0.90 per share, will be exercisable immediately upon issuance and will expire on the fifth anniversary of the original issuance date. The closing of the offering is expected to occur on or about September 5, 2025, subject to the satisfaction of customary closing conditions.

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Maxim Group LLC is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $4.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, capital expenditures, and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-289745), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 4, 2024. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at www.sec.gov and may also be obtained by contacting Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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.

On September 4, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported they have enrolled their first patient with non-small cell lung cancer (NSCLC) in the ongoing Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2a) inhibitor, and Trodelvy (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with methylthioadenosine phosphorylase (MTAP)-deletion solid tumors (Press release, Ideaya Biosciences, SEP 4, 2025, View Source [SID1234655778]). IDEAYA is conducting the trial pursuant to a clinical study collaboration and supply agreement with Gilead, where the initial focus was in MTAP-deletion urothelial cancer (UC). In April 2025, the companies announced expansion of the combination trial into MTAP-deletion NSCLC.

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"We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort. This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion," said Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.

"MTAP-deletion is found in up to 20% of non-small cell lung cancer and remains an area with no approved targeted therapies. We’re pleased to expand our collaboration with IDEAYA and explore the potential of this novel combination in a patient population with limited treatment options," said Bilal Piperdi, MD, Vice President, Clinical Development Oncology at Gilead Sciences.

Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor, and Gilead will provide the supply of Trodelvy to IDEAYA.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

The use of Trodelvy in MTAP-deletion NSCLC and UC is investigational, and the safety and efficacy of this use have not been established. IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

On September 4, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported the pricing of a public offering of an aggregate of 5,999,999 of the Company’s American Depositary Shares (ADSs) (or pre-funded warrants in lieu thereof), with each ADS representing 200 ordinary shares, and short-term warrants to purchase up to 11,999,998 ADSs, at a combined public offering price of $1.00 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrants (Press release, Purple Biotech, SEP 4, 2025, View Source;id=363034&p=2399526&I=1206939-c7Z3G6f3m8 [SID1234655773]). The short-term warrants will have an exercise price of $1.00 per ADS, will be exercisable immediately upon issuance and will expire twenty-four months from the date of issuance. The closing of the offering is expected to occur on or about September 5, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $6 million. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $12 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for development of its oncology therapeutic candidates and for general working capital and corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form F-1 (File No. 333-289927), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 4, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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.