On June 23, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, JUN 23, 2025, View Source [SID1234654047]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt") under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt, the principal investigator.

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The fourth cohort in the trial will receive a dose of three million CAR-positive cells per kilogram of body weight, representing a thirtyfold increase from the first cohort. No dose-limiting toxicities were observed in the third cohort, enabling advancing to the fourth dosage cohort. This planned escalation marks a key step in assessing the safety and therapeutic effect of CAR-T cell therapy in patients with ovarian cancer.

Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With no dose-limiting safety issues observed in the third cohort, we have advanced to a higher dose level that is thirty times greater than the starting dose. Although the study is primarily focused on safety at these early, low-dose levels, we have seen promising signs of potential efficacy. "

On June 23, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported new preclinical data from its first-in-class, non-PSMA targeting radiotherapy prostate cancer candidate ATNM-400, that leverages the potent alpha-particle emitter Actinium-225 (Ac-225) isotope, at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting being held June 21st – 24th, 2025, in New Orleans, Louisiana (Press release, Actinium Pharmaceuticals, JUN 23, 2025, View Source [SID1234654066]). The data presented at SNMMI showed ATNM-400 has superior potency compared Xtandi (enzalutamide) and is highly efficacious in Xtandi resistant prostate models. Xtandi is an androgen receptor inhibitor (ARPI) therapy developed and marketed by Astellas and Pfizer that is approved for three stages of prostate cancer and generated sales of $5.9 billion in 2024. Actinium also presented additional new data showing ATNM-400 is more efficacious than PSMA-617 labeled with both Lutetium-177 (Lu-177) and Ac-225 and that ATNM-400 also overcomes resistance to Pluvicto (Lu-177-PSMA-617). Pluvicto is developed and marketed by Novartis and generated sales of $1.4 billion in 2024. ATNM-400 represents a transformational therapeutic candidate being developed to overcome limitations of current prostate cancer therapies such as Xtandi and Pluvicto and improve outcomes over what is currently achievable. Key data and highlights from the ATNM-400 SNMMI presentation include:

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ATNM-400 Target Expression Profile and Disease Biology

The ATNM-400 target is implicated in prostate cancer disease biology and contributes directly to disease progression, with expression correlating with shorter time to castration resistance and poorer survival in castrate resistant prostate cancer (CRPC) patients making it differentiated from PSMA, which serves primarily as a surface marker

The target for ATNM-400 is also reported to be elevated in prostate cancer patients who develop resistance to the ARPI therapy Xtandi

ATNM-400 shows consistent tumor uptake, rapid clearance from the blood and clearance from vital organs including intestines, liver, and kidneys

Target expression is retained post Pluvicto treatment in prostate cancer models
ATNM-400 Compared to Xtandi (enzalutamide)

ATNM-400 exhibited potent killing of all Xtandi resistant prostate cancer cells that remained following treatment with Xtandi, with Xtandi only killing 50% of the resistant prostate cancer cells

ATNM-400 monotherapy and in combination with Xtandi had superior anti-tumor efficacy in vivo compared to Xtandi alone in a prostate cancer model; all treatments were well-tolerated with no change in body weight

ATNM-400 inhibited tumor growth of Xtandi resistant tumors whereas re-treatment with Pluvicto or additional enzalutamide did not

ATNM-400 Compared to PSMA targeted Radiotherapy

ATNM-400 was more potent than both Pluvicto (177Lu-PSMA-617) and 225Ac-PSMA-617 in prostate cancer cell killing

At therapeutically relevant doses, ATNM-400 exhibited more efficacious tumor growth inhibition compared to both Pluvicto and 225Ac-PSMA-617 in prostate cancer in vivo model

As previously reported, ATNM-400 was able to overcome Pluvicto resistance, halting tumor growth in prostate cancer tumors that failed Pluvicto therapy and producing potent tumor cell killing

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are committed to advancing ATNM-400 to address the high unmet needs that remain in prostate cancer. These new data presented at SNMMI demonstrate the therapeutic potential of ATNM-400 as both a monotherapy and in combination with both androgen receptor inhibitors and PSMA radiotherapy, two leading prostate cancer treatment modalities. With ATNM-400’s target being a disease-driving protein involved in tumor progression and therapeutic resistance combined with the potency and precision of the Ac-225 isotope payload, we believe ATNM-400 has a transformational profile rooted in prostate cancer disease biology, which is strongly supported by our data. We are thrilled to highlight ATNM-400’s first-in-class data at SNMMI and highly encouraged by the strong interest from KOL’s across the prostate cancer and nuclear medicine communities. As Actinium continues to advance our efforts with novel targeted radiotherapies, ATNM-400 is the ideal cornerstone of our emerging solid tumor pipeline."

The ATNM-400 SNMII presentation is available for viewing on the Presentations & Webinars page of Actinium’s website HERE.

Title: First-in-class antibody radioconjugate ATNM-400 exhibits potent anti-tumor activity and overcomes resistance to enzalutamide and 177Lu-PSMA-617 in prostate cancer models

About ATNM-400

ATNM-400 is a highly innovative, first-in-class prostate cancer candidate in comparison to Pluvicto and the majority of radiotherapies in development for prostate cancer which target PSMA and are either non-differentiated or barely differentiated, as it targets a distinct non-PSMA receptor. The receptor specifically targeted by ATNM-400 is highly expressed in metastatic castration-resistant prostate cancer (mCRPC), contributes directly to disease progression and poorer survival outcomes, and continues to be expressed at a high level even after androgen receptor inhibitor and Pluvicto treatment. ATNM-400 leverages the alpha-particle emitter Ac-225, which is more potent than Lu-177, can cause lethal irreversible double-stranded DNA breaks, and has a shorter path length that could result in fewer off-target effects.

On June 23, 2025 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation, reported promising results from two novel nanomedicine radiotracers at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place June 21 – 24, 2025 in New Orleans (Press release, Ashvattha Therapeutics, JUN 23, 2025, View Source [SID1234654048]).

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The two agents are designed to address key gaps in neuroinflammation and cancer imaging by targeting activated microglia and macrophage, respectively.

Neuroinflammation Imaging Validation
Data presented in the poster titled "[18F]F-Flurimedrimer, a Novel Nanomedicine Radiotracer, Selectively Targeting Activated Microglia in Human Brain" showed that flurimedrimer (FMD), an investigational radiotracer engineered to selectively target activated microglia within the human brain, provided important validation of selective brain targeting. FMD is constructed from a hydroxyl dendrimer Generation 4 (HD4) with superior blood brain barrier penetration in regions of neuroinflammation compared to larger HDs (HD5 or HD6). The [18F]F-FMD was safe and well tolerated with rapid renal clearance, no tissue retention, and no brain uptake in healthy volunteers. [18F]F-FMD demonstrated selective uptake in areas of neuroinflammation in a primary progressive multiple sclerosis patient while showing no uptake in age-matched healthy volunteers, highlighting its specificity for activated microglia. These results support the agent’s potential for precise imaging of neuroinflammatory conditions.

Novel Cancer Imaging Approach
Data presented in the poster titled "A Novel Nanomedicine Radiotracer, Selectively Targeting Tumor Associated Macrophages" showed that hydroxyl dendrimers Generation 6 (HD6)-NOTA, a radiotracer with superior tumor-associated macrophage (TAM) uptake compared to other hydroxyl dendrimers of smaller size (HD4 or HD5), achieving 41.6% ID/g peak tumor uptake at 48 hours post-dose in tumor-bearing mice. TAMs are immune cells known to promote tumor growth and treatment resistance and can constitute a significant portion of tumor mass. The radiotracer successfully targeted macrophages throughout tumor structures, supporting its potential for diagnostic oncology imaging. A follow-on study using a therapeutic isotope with HD6 will be presented at a future conference.

"These results highlight the ability to tune our hydroxyl dendrimer platform to selectively target key cell populations in neurology and oncology," said Jeff Cleland, PhD, CEO of Ashvattha Therapeutics. "FMD’s (HD4) selective brain uptake in regions of neuroinflammation demonstrates the potential to image and treat neurological diseases with neuroinflammation. For cancer, our tuned nanomedicine, HD6-NOTA, has selective TAM uptake enabling cancer imaging, and the potential to selectively kill TAMs with a therapeutic isotope. Together, they underscore our platform’s unique ability to leverage our nanomedicine for precision targeting of activated cells – without relying on traditional targeting ligands."

On June 23, 2025 Astrazeneca reported Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy (Press release, AstraZeneca, JUN 23, 2025, View Source [SID1234654067]).

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This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The approval follows Priority Review and Breakthrough Therapy Designation by the Food and Drug Administration (FDA) based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial.

Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute and investigator in both trials, said: "Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available. The US approval of datopotamab deruxtecan introduces a novel and needed treatment option to patients with advanced disease."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation. We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, said: "With today’s accelerated approval, Datroway is now the first TROP2-directed medicine available for certain patients in the US living with lung cancer. We remain committed to our extensive clinical development programme to further identify where Datroway may be used in other types of lung and breast cancer."

Andrea E. Ferris, President and CEO, LUNGevity, said: "For people with advanced EGFR-mutated non-small cell lung cancer whose disease progresses on initial treatments, additional options are limited. Today’s approval of Datroway offers a new treatment option for patients whose disease has progressed following treatment with an EGFR-directed therapy and chemotherapy."

In TROPION-Lung05 and TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% (95% confidence interval [CI]: 35-54) in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC (n=114) as assessed by blinded independent central review (BICR). Complete responses were seen in 4.4% of patients and partial responses were seen in 40% of patients. The median DoR was 6.5 months (95% CI: 4.2-8.4).

The safety profile of Datroway was evaluated in a pooled analysis of 125 patients in the TROPION-Lung05, TROPION-Lung01 and TROPION-PanTumor01 trials. The safety profile observed across these trials was consistent with the known profile of this medicine with no new safety concerns identified.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR-mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

Financial considerations
Following approval in the US, an amount of $45 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the locally advanced or metastatic EGFR-mutated NSCLC indication. Sales of Datroway in the US are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from July 2020.

Notes

Advanced non-small cell lung cancer
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.1 Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 87% of cases.2 Approximately 10 to 15% of patients with NSCLC in the US and Europe, and 30 to 40% of patients in Asia have an EGFR mutation.3,4 The majority of EGFR mutations occur in tumours of nonsquamous histology.5 TROP2 is a protein broadly expressed in the majority of NSCLC tumours.6

For patients with tumours that have an EGFR mutation, the established 1st-line treatment in the metastatic setting includes EGFR-directed therapy with or without platinum-based chemotherapy.7 While these therapies have improved outcomes in earlier lines of treatment, most patients eventually experience disease progression and receive subsequent therapies.8-11

TROPION-Lung05
TROPION-Lung05 is a global, multicentre, single-arm, open-label Phase II trial evaluating the efficacy and safety of Datroway in patients with locally advanced or metastatic NSCLC with actionable genomic alterations who have progressed on at least one EGFR-directed therapy and platinum-based chemotherapy. Patients receiving up to four prior lines of treatment with tumours with one or more genomic alterations including EGFR, ALK, ROS1, NTRK, BRAF, RET or MET were eligible for the trial.

The primary endpoint of TROPION-Lung05 is ORR as assessed by BICR. Secondary efficacy endpoints include DoR, disease control rate (DCR), clinical benefit rate, PFS, time to response (TTR), OS and safety. TROPION-Lung05 enrolled 137 patients globally in Asia, Europe and North America. For more information, visit ClinicalTrials.gov.

Primary results from TROPION-Lung05 were published in the Journal of Clinical Oncology in January 2025.

TROPION-Lung01
TROPION-Lung01 is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy and safety of Datroway versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

The dual primary endpoints of TROPION-Lung01 are PFS as assessed by BICR and OS. Key secondary endpoints include investigator-assessed PFS, ORR, DoR, TTR, and DCR as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled 590 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov.

Primary results from TROPION-Lung01, as presented at the ESMO (Free ESMO Whitepaper) 2023 Congress, showed Datroway demonstrated a statistically significant improvement in PFS over docetaxel. OS results were presented at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and simultaneously published in the Journal of Clinical Oncology in September 2024.

TROPION-PanTumor01
TROPION-PanTumor01 is a first-in-human, open-label, two-part, multicentre Phase I trial evaluating the safety and preliminary efficacy of Datroway in patients with advanced solid tumours that have relapsed or are refractory to standard treatment or for which no standard treatment is available. The dose escalation portion of the trial enrolled patients with NSCLC to assess the safety and tolerability of Datroway to determine the recommended dose for expansion (6mg/kg). The dose expansion part of TROPION-PanTumor01 enrolled several different cohorts including patients with NSCLC, triple-negative breast cancer (TNBC), HR-positive, HER2-negative breast cancer, small cell lung cancer, urothelial, gastric, pancreatic, castration resistant prostate and oesophageal cancer.

Safety endpoints include dose-limiting toxicities and serious adverse events. Efficacy endpoints include ORR, DoR, TTR, PFS and OS. Pharmacokinetic, biomarker and immunogenicity endpoints also are being evaluated. TROPION-PanTumor01 enrolled 890 patients in Asia and North America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 30 countries worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway is approved in Russia for the same population.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and HR-positive, HER2-negative breast cancer. The programme includes eight Phase III trials in lung cancer and five Phase III trials in breast cancer evaluating Datroway as a monotherapy and in combination with other anticancer treatments in various settings.

On June 23, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported its plans to commence an underwritten public offering, subject to market and other conditions, to issue and sell $250.0 million of shares of its common stock (Press release, Cidara Therapeutics, JUN 23, 2025, View Source [SID1234654049]). All of the shares are being offered by Cidara. In connection with the proposed offering, Cidara expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the public offering. There can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

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J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor are acting as joint book-running managers for the proposed offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.