On October 7, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company dedicated to addressing resistance to current cancer therapeutics, reported that it has been selected to present at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Kairos Pharma, OCT 7, 2025, View Source [SID1234656481]). Kairos’s presentation, titled, "Preliminary safety and clinical activity from a Phase 2 study of apalutamide and carotuximab in advanced, castration-resistant prostate cancer" will take place in Berlin, Germany on October 17–21, 2025.

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Prostate cancer remains one of the most diagnosed cancers in men, with over a million new cases annually in the U.S. alone. Resistance to androgen-targeted therapies represents a major clinical challenge in patients with metastatic castration-resistant prostate cancer (mCRPC).

The presentation will highlight results from an interim analysis of the randomized Phase 2 trial evaluating ENV105 (carotuximab), a first-in-class CD105 antagonist. The trial is enrolling 100 men at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute at the University of Utah with mCRPC who had progressed on prior hormone therapies. Patients are randomized to receive apalutamide in the presence or absence of ENV105.

"The data we will be presenting at the 2025 ESMO (Free ESMO Whitepaper) Congress demonstrates encouraging safety and early efficacy findings from our Phase 2 trial," said Neil Bhowmick, PhD, Kairos Pharma CSO. "This is an important venue for us to share the therapeutic potential of ENV105 for patients with few remaining treatment options after hormone therapy resistance develops."

On October 7, 2025 Adicet Bio, Inc. ("Adicet") (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the pricing of an underwritten registered direct offering of 70,001,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 10,000,000 shares of common stock (Press release, Adicet Bio, OCT 7, 2025, View Source [SID1234656497]). The shares of common stock are being sold at a price of $1.00 per share, and the pre-funded warrants are being sold at a price of $0.9999 per pre-funded warrant, which represents the per share price of the common stock less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $80.0 million. All of the securities in the offering are to be sold by Adicet. The offering is expected to close on or about October 8, 2025, subject to customary closing conditions.

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Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering. Truist Securities is also acting as a joint bookrunner. Wedbush PacGrow and H.C. Wainwright & Co. are acting as lead managers for the offering.

The securities described above are being offered by Adicet pursuant to a shelf registration statement on Form S-3 (File No. 333-285609) that was previously filed with, and subsequently declared effective on March 14, 2025 by, the U.S. Securities and Exchange Commission ("SEC"). A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offered securities may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

On October 7, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported an exclusive collaboration and in-licensing agreement (the "Agreement") with QIMR Berghofer for a first-in-class PD-L1 degrader program (Press release, Kazia Therapeutics, OCT 7, 2025, View Source [SID1234656482]). The lead optimized compound, NDL2, is an advanced PD-L1 protein degrader currently in development and represents a new and innovative frontier of cancer immunotherapy.

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About PD-L1 Degradation and NDL2

Cancer cells frequently express PD-L1 protein to evade immune attack. When PD-L1 on a tumor cell surface binds to PD-1 on a T cell, the T cell becomes inactivated and loses its ability to destroy the cancer. Traditional checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) use monoclonal antibodies to block this surface interaction, helping to restore T-cell activity.

However, research has shown that PD-L1 also exists in post-translationally modified forms that are enriched in patients who fail or relapse on checkpoint inhibitor therapy. These modified proteins are found on the cell surface as well as in the cytoplasm and nucleus, where they contribute to resistance and tumor progression.

NDL2 takes a fundamentally different approach. This novel bicyclic peptide degrader, discovered and developed by Professor Sudha Rao, is designed to specifically recognize and degrade these resistant, post-translationally modified forms of PD-L1. By binding PD-L1 and recruiting the cell’s natural protein disposal machinery, NDL2 drives the breakdown and clearance of the modified PD-L1 across all cellular compartments. Targeting these resistant PD-L1 pools that antibody therapies cannot reach offers the potential to overcome immunotherapy resistance and restore durable immune activity against tumors.

We believe this comprehensive degradation strategy has the potential to offer two major clinical advantages: (1) Overcoming resistance in both primary non-responders and patients who relapse on antibody therapies, and (2) Providing durable immune reactivation by restoring cytotoxic T-cell function and reducing T-cell exhaustion in the tumor microenvironment.

NDL2 Preclinical Evidence

In preclinical models of aggressive triple-negative breast cancer (TNBC), NDL2 monotherapy, as well as in combination with anti-PD-1 therapies, achieved significant tumor growth reduction. Importantly, treated tumors showed reduced T-cell exhaustion and enhanced immune activity, consistent with NDL2’s dual mechanism of action. Across the preclinical work to date, no toxicity has been observed. Professor Rao and QIMR Berghofer are working in parallel with a number of world-leading oncology peptide manufacturers to optimize the stability, potency, pharmacokinetics and pharmacodynamics of the NDL2 formulation.

Development Pathway and Combinations

The program will initially target advanced breast cancer and non-small cell lung cancer (NSCLC), where PD-1/PD-L1 immunotherapies are widely used but resistance remains common. IND-enabling studies are expected to commence within six months, with a goal of initiating first-in-human studies within approximately 15 months. Kazia also intends to explore synergistic opportunities to combine NDL2 with its existing pipeline assets, including paxalisib (a pan-PI3K/mTOR inhibitor) and EVT801 (a selective VEGFR3 inhibitor), given their complementary mechanisms of action in modulating the tumor microenvironment.

Dr. John Friend, Chief Executive Officer of Kazia Therapeutics, commented:

"This Agreement positions Kazia at the forefront of next-generation immuno-oncology. NDL2 is a truly first-in-class asset, representing an advanced PD-L1 degrader, and what we believe one of the most exciting innovations in targeted protein degradation. This program complements our existing pipeline, with clear opportunities for synergy with other immunotherapies as well as paxalisib and EVT801, and we are positioned to rapidly advance it toward the clinic."

Professor Sudha Rao, Principal Investigator at QIMR Berghofer and inventor of the PD-L1 degrader program, added:

"NDL2 has the potential to redefine immunotherapy by targeting all functional pools of PD-L1 protein, not just the surface expression blocked by current antibodies. By eliminating PD-L1 throughout the cell, we can address resistance and other pathways that drive aggressive cancers like TNBC and NSCLC. We are thrilled to partner with Kazia to potentially translate this novel science into a transformative therapy for patients."

Collaboration and Licensing Terms

Under the terms of the collaboration Agreement, Kazia will make a one-time payment of approximately $1.39 million 15 business days after signing and is responsible for all development costs. Kazia will share a percentage of commercialization revenue, which includes any out-licensing payments received from third parties.

On October 7, 2025 Eradivir Inc., a clinical-stage biotechnology company that harnesses the power of the immune system to target and treat disease, reported the recent closing of a $10 million private financing round (Press release, Eradivir, OCT 7, 2025, View Source [SID1234656498]). The investment will support continued clinical development of the company’s lead antiviral therapeutic for influenza, EV25, and advancement of a second molecule, EV148, for the treatment of respiratory syncytial virus (RSV).

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A significant amount of the $10 million raised came from previous investors, reflecting their continued confidence in Eradivir’s platform and vision.

"The funding marks a pivotal moment for Eradivir as we prepare to share EV25 Phase 2a results and underscores the confidence investors have in our ability to build out our toolkit of small molecule immunotherapies," said Martin Low, Chief Executive Officer of Eradivir. "We’ve minimized dilution by raising our first $30 million in milestone-based tranches. This disciplined financing strategy has preserved shareholder value while driving meaningful progress in our lead programs."

The funds have been used to complete the EV25 Phase 2a influenza challenge study and will also support IND-enabling studies of Eradivir’s RSV development candidate, EV148. The results from the EV25 Phase 2a challenge study will be publicly released in the coming weeks.

EV25 and EV148 were built on Eradivir’s BAiT (Bispecific Antigenic immuno-Therapy) platform that combines the simplicity of small molecules with the efficacy of antibodies. The simplicity of the platform’s technology provides the opportunity to address multiple diseases, including additional viruses and cancer, by switching the targeting ligand to another that binds specifically to a pathological cell.

On October 7, 2025 Daiichi Sankyo (TSE: 4568) reported it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab for the treatment of patients with HER2 positive unresectable or recurrent breast cancer.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

HER2 targeted therapies have improved outcomes in HER2 positive metastatic breast cancer; however, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with taxane, trastuzumab and pertuzumab (THP), which has been the standard of care for more than a decade.

The sNDA is based on data from the DESTINY-Breast09 phase 3 trial presented during a special latebreaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting.

"In DESTINY-Breast09, ENHERTU plus pertuzumab demonstrated a median progression-free survival of more than three years, which represents an impressive improvement over the current standard of care," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "Following the recent approval of ENHERTU in Japan for the treatment of HER2 low or HER2 ultralow metastatic breast cancer, this new submission of ENHERTU plus pertuzumab for the first-line treatment of patients with HER2 positive disease underscores the commitment of Daiichi Sankyo to bring ENHERTU to as many patients as possible in this region across certain subtypes of metastatic breast cancer."

A supplemental Biologics License Application for ENHERTU plus pertuzumab based on data from DESTINY-Breast09 was granted Priority Review in the U.S. under the Real-Time Oncology Review program. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in July 2025.

About DESTINY-Breast09

DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is progression-free survival (PFS) as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America, and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.5 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.5 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed and 17,600 deaths in 2022. 6 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.8 HER2 protein overexpression may occur as a result of HER2 gene amplification.1 Approximately one in five cases of breast cancer are considered HER2 positive.9 3 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.10 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.1,2,3,4 Further, approximately 25% to 30% of patients do not receive any treatment following first-line therapy due to discontinuation or death.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, OCT 7, 2025, View Source [SID1234665027])