On September 18, 2025 Immuto Scientific reported the closing of an oversubscribed $8 million Seed 2 financing round and a drug discovery collaboration with Daiichi Sankyo, a global pharmaceutical company. Immuto Scientific is applying its AI-enabled structural surfaceomics platform to a new approach in drug discovery (Press release, Immuto Scientific, SEP 18, 2025, https://www.businesswire.com/news/home/20250912125211/en/Immuto-Scientific-Announces-%248M-Seed-2-Financing-and-Daiichi-Sankyo-Collaboration-to-Uncover-a-New-Class-of-Therapeutic-Targets-with-Structural-Surfaceomics [SID1234656083]). Backed by the financing, the company will advance its internal oncology pipeline toward IND-enabling studies and extend the platform into additional areas such as immunology and inflammation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The greatest challenge in drug discovery today is not the lack of modalities; it’s the shortage of truly novel, disease‑specific targets," said Faraz A. Choudhury, Ph.D., co‑founder and CEO of Immuto Scientific. "The vast majority of drug targets overlap with healthy tissues, which drives toxicity and narrow therapeutic windows. Our data‑driven platform reveals a hidden dimension of the cell surfaceome that conventional omics approaches cannot see, opening new therapeutic opportunities across cancer and other diseases."

For its first drug discovery collaboration, Immuto will work with Daiichi Sankyo Research Institute Boston to discover new targets in solid tumors using its proprietary structural surfaceomics platform and to develop antibodies against these targets. Under the terms of the agreement, Daiichi Sankyo holds an option to license resulting assets. Financial terms were not disclosed.

"Our collaboration with Daiichi Sankyo underscores how exploring the structural conformations of cell‑surface proteins represents an untapped frontier in drug discovery," said Dan Benjamin, Chief Technology Officer of Immuto Scientific. "By targeting cancer‑specific surface structures, we have the opportunity to develop first‑in‑class therapies with truly differentiated precision and selectivity."

Building on its success collaborating with pharmaceutical and biotechnology partners in high‑resolution structural proteomics, Immuto applies its target discovery platform and structural epitope‑mapping engine to identify disease‑specific surface protein conformations that are invisible to other omics approaches, unlocking highly selective, novel therapeutic targets. The platform integrates high‑resolution structural proteomics, live‑cell protein structural assessment, and advanced AI‑enabled analytics to interrogate conformational differences across thousands of proteins simultaneously—even in heterogeneous, patient‑derived samples.

By identifying epitopes specific to disease states, the platform enables discovery of first‑in‑class targets ideally suited to highly disease‑specific modalities, providing opportunities for improved therapeutic indices and translational success. Immuto has demonstrated target identification in multiple tumor types and is advancing its lead program through in vivo studies.

"Immuto Scientific’s approach is highly differentiated, creating and leveraging data that no other group in the world has," said Spencer Maughan, Founder and Managing Partner, DYDX. "The company is driving a step‑change in predictive protein structure based on its data and AI engine. This opens a new world of targets for much‑needed therapies with exceptional specificity. We are excited to be partnering with Immuto and believe the company will be a key part of the new era of data‑driven drug discovery."

The financing was led by DYDX, a venture fund investing in the Data SuperCycle, with participation from WARF Ventures, Gravity Fund, Great Oaks Venture Capital, among others.

On September 18, 2025 Geneos Therapeutics, a clinical-stage biotherapeutics company developing personalized immunotherapies for cancer (PICs), reported that two patients with aggressive cancers – one with glioblastoma multiforme (GBM), and another with advanced hepatocellular carcinoma (HCC) treated in the second line – remain on personalized immunotherapy for cancer (PIC) monotherapy, recurrence free and healthy, after more than six years and five years of ongoing treatment, respectively (Press release, Geneos Therapeutics, SEP 18, 2025, View Source [SID1234656084]). Both achieved complete responses and neither has experienced any PIC-related adverse event greater than Grade 1 nor any PIC-related serious adverse event. Additional clinical trial patients with GBM and advanced HCC receiving PIC monotherapy continue to progress toward five years of recurrence-free survival.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Geneos’ PICs as monotherapy have now enabled patients with two distinct, difficult-to-treat, rapidly progressing cancers to live beyond five years, recurrence free and healthy – living rich, fulfilling lives," said Niranjan Sardesai, Ph.D., President and Chief Executive Officer of Geneos. "These cases, together with our broader clinical trial results, highlight the durability and tolerability we believe to be achievable with our DNA-based PIC therapy. These results are encouraging and we look forward to continuing to advance our clinical program so that we may bring this potential new treatment option to people living with aggressive cancers rapidly."

The U. S. Food and Drug Administration (FDA) recently released draft guidance identifying overall survival (OS) as a key endpoint in oncology trials. Geneos believes the long-term survival being seen in PIC-treated patients aligns with these regulatory expectations and strengthens the case for broader clinical development.

"Durable overall survival of five years or more in GBM and advanced HCC are uncommon, while recurrence-free survival is almost unheard of," said Ildiko Csiki, M.D., Ph.D., Geneos Chief Medical Officer. "If confirmed in larger datasets, we expect these results to align with FDA’s guidance on overall survival as a primary endpoint for registrational studies."

The patient with GBM presented at age 21 with an IDH-positive, methylated tumor. She received standard of care treatment of surgery, radiation, and temozolomide, as well as a single dose each of two experimental treatments. One year after diagnosis, the patient began PIC monotherapy. Median recurrence-free survival in this setting is 26 months and OS is 40 months. This patient has now reached 75 months of recurrence-free survival and is 87 months from surgical resection. She recently completed a master’s degree and works supporting other cancer patients.

The HCC patient presented at age 61 with a beta catenin mutated form of HCC, having progressed despite liver resection and treatment with an oncolytic virus and sorafenib. Upon enrollment in Geneos’ GT-30 Phase 1b/2a trial, the patient was treated for two years with the combination of PIC and pembrolizumab, after which, per protocol, she was converted to PIC monotherapy. Median OS for such PD-1 treated HCC patients averages 14 months with three-to-four months of progression-free survival. This patient has now reached 60 months of recurrence-free survival and recently welcomed her first grandchild.

PICs are DNA-based tumor-infiltrating lymphocyte (TIL)-inducing agents containing up to 43 of a patient’s specific cancer neoantigens. They have been shown to have a 100% success rate in patients at inducing CD8+ activated cytotoxic T effector memory cells which traffic to tumors, the first such immunotherapeutic ever to achieve this metric. Unlike experimental mRNA-based personalized immunotherapeutics generally administered for no more than nine months, the tolerability of PICs supports uninterrupted treatment over years to maintain TIL response and minimize the odds of recurrence or progression.

Geneos is actively preparing to advance PIC monotherapy development in the upcoming GT-31 Phase 2b randomized, controlled clinical trial as adjuvant immunotherapy of patients with HCC.

On September 18, 2025 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, reported the closing of its previously announced exercise of certain outstanding series A warrants to purchase up to an aggregate of 1,212,499 shares of common stock of the Company and series B warrants to purchase up to an aggregate of 1,212,499 shares of common stock originally issued in February 2025, having an exercise price of $3.00 per share, at a reduced exercise price of $0.915 per share (Press release, Enveric Biosciences, SEP 18, 2025, View Source [SID1234656065]). The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-284277). The gross proceeds to the Company from the exercise of the warrants were approximately $2.2 million, prior to deducting placement agent fees and estimated offering expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

In consideration for the immediate exercise of the warrants for cash, the Company issued new unregistered series C warrants to purchase up to 2,424,998 shares of common stock and new unregistered Series D warrants to purchase up to 2,424,998 shares of common stock. The series C new warrants have an exercise price of $0.915 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants and will expire five years thereafter. The series D new warrants have an exercise price of $0.915 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants and will expire eighteen months thereafter.

The Company intends to use the net proceeds from the offering for product development, working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

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 18, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the expansion of FLAMINGO-01 clinical trial to Ireland (Press release, Greenwich LifeSciences, SEP 18, 2025, View Source [SID1234656070]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company’s application to European regulators has been formally approved, adding Ireland as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 3,723 new cases of breast cancer were diagnosed in Ireland in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the 2nd leading cause of death from cancer in women in Ireland with 883 deaths in 2022.

The Company is collaborating with Dr. Janice Walshe, who will be serving as the national principal investigator in Ireland for FLAMINGO-01. She is a key member of Cancer Trials Ireland research group ensuring access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent’s University Hospital in Dublin, Ireland, she has served as national principal investigator for many important international trials in breast cancer. She served as a three-year member of ASCO (Free ASCO Whitepaper) Scientific Program Committee in triple negative breast cancer from 2013-2015. Her research has been presented at numerous international meetings and published in prestigious peer reviewed journals.

CEO Snehal Patel commented, "We have visited St. Vincent’s multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On September 18, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Kairos Pharma, SEP 18, 2025, View Source [SID1234656072]). Kairos Pharma is hosting a virtual KOL (key opinion leader) event to provide perspectives on this data at 5 p.m. ET / 2 p.m. PT today. Interested participants can sign-up to receive the webcast link here View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

All patients enrolled in the trial had already failed at least one other hormone therapy modality. This predetermined interim analysis covers the same 10 patients from the safety-arm of the trial, with all patients having failed at least one androgen receptor inhibitor hormone therapy prior to acceptance. Two of the ten patients withdrew from the trial for unrelated events. Of the eight remaining patients, the median progression-free survival was more than 13 months, with five of the eight patients continuing treatment without progression. Seven of nine patients demonstrated a decrease of their prostate-specific antigen (or PSA) from baseline.

The interim efficacy analysis of the trial demonstrated that ENV105, a first-in-class CD105 antagonist, in combination with standard of care hormone therapy apalutamide demonstrated a progression-free survival (PFS) of 13 months. Notably, the trial is powered to show a 45% improvement in the PFS. This translates to an increase in PFS from 3.7 to 6.7 months. This mark was far exceeded by the ENV105/ Apalutamide combination. The four-month timeframe is significant as 2nd or 3rd line standard of care hormone therapy has a 3.7 month median efficacy, as reported by the CARD trial (New Eng J. Med [2019] 381:2506). The same study also showed the use of chemotherapy (cabazitaxel) provided eight months’ PFS, by imaging, accompanied with greater toxicity.

"Our therapeutics, targeting cancer resistance, continue to showcase the potential to revolutionize the way we treat cancer patients," said Dr. John Yu, CEO of Kairos Pharma. "While this is only interim data, we are excited to bring together the principal investigators and other industry experts for an important event this afternoon to lay out the primary benefits of our compound, and demonstrate the clinical need filled by ENV105."

The randomized Phase 2 trial aims to enroll 100 patients in total and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV105, a CD105 antagonist, in men whose disease has progressed following standard hormone-based therapies.

The interim safety analysis of the same trial, announced in July of this year, demonstrated that ENV105 was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first 10 enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or Grade 4 toxicities were observed.

Kairos Pharma will host a premier KOL event later today at 5 p.m. ET / 2 p.m. PT to discuss diverse perspectives on the interim efficacy results. Speakers at the KOL event include Dr. Neil Bhowmick, President and Chief Scientific Officer at Kairos Pharma; Dr. Umang Swami, Associate Professor in the Division of Oncology, Department of Internal Medicine at the Huntsman Cancer Institute; Dr. Richard Lee, Clinical Co-Director, The Claire and John Bertucci Center for Genitourinary Cancers at Massachusetts General Hospital, Harvard Medical School; and Dr. Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute.

With one million men in the US diagnosed with prostate cancer each year, and millions more worldwide, the development of resistance to current hormone therapies has created a growing unmet need with an increasingly aging population. Castration-resistant prostate cancer refers to tumors that grow despite receiving hormone blocking agents. Treatment options remain limited after hormone therapies fail. Kairos Pharma seeks to provide a safe and effective alternative for these patients with ENV105.