On September 12, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that new preclinical results on its bispecific antibody ATOR-4066 will be presented today at the 9th International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON25), jointly organized in Utrecht, by the Cancer Research Institute (CRI), the European Network for Cancer Immunotherapy (ENCI), and other leading partners (Press release, Alligator Bioscience, SEP 12, 2025, View Source [SID1234655945]). The poster presentation (Poster #253) will take place during Poster Session B, from 12:00–15:00 CEST.

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Summary of results
ATOR-4066 is a bispecific antibody designed to activate the immune system against CEACAM5-positive cancers, such as colorectal and gastric cancer. The new preclinical data, in the presentation "ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces strong myeloid and T cell dependent tumor immunity and synergizes with PD-1 blockade," show that ATOR-4066 strongly stimulates both myeloid cells and T cells inside tumors, leading to powerful and durable anti-tumor effects. In preclinical models, ATOR-4066 eliminated established tumors, showed limited immune activation outside the tumor, and demonstrated enhanced efficacy in combination with PD-1 blockade. These findings provide strong support for advancing ATOR-4066 into further development.

"We are excited to present these new preclinical findings demonstrating that ATOR-4066 triggers potent, dual-acting immune responses that translate into strong anti-tumor activity," said Peter Ellmark, CSO at Alligator Bioscience. "ATOR-4066 represents the next step in our mission to develop best-in-class CD40-based therapies and builds directly on the promising clinical progress made with mitazalimab. The data to be presented at CICON25 support the continued development of ATOR-4066 as a differentiated bispecific candidate with potential to transform treatment outcomes in solid tumors."
The poster will be made available on Alligator’s website, following the presentation.

On September 11, 2025 Cellectar Biosciences, Inc. (Nasdaq: CLRB, "Cellectar"), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, and ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported a supply agreement for Actinium-225 (Ac-225). The agreement will support the clinical development of Cellectar’s actinium-labeled phospholipid ether (PLE) radiopharmaceutical candidates, including its Phase 1-ready compound, CLR 121225, for the treatment of solid tumors.

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CLR 121225 (225Ac-CLR 121225), a novel actinium-labeled PLE, is under investigation for the treatment of solid tumors, including pancreatic cancer. Cellectar’s proprietary PLE delivery platform allows for the design and development of novel radiopharmaceuticals that can selectively target and eradicate cancer cells. ITM is leveraging its two decades of medical isotope manufacturing to scale supplies of Ac-225 to ensure rapid, reliable isotope delivery.

"Our lead alpha-emitting program, CLR 121225, has demonstrated excellent anti-tumor effects in preclinical studies, especially in pancreatic cancer," said James Caruso, chief executive officer of Cellectar. "Our agreement with ITM supports our strategic approach to ensure continuous, high-quality supply of Actinium-225 we need to advance our pipeline candidates and to fully explore the potential benefits of this targeted alpha therapy for cancer patients."

Ac-225 is an important isotope for the development of next-generation radiopharmaceuticals, serving as a powerful alpha-emitting isotope used in targeted cancer therapies. The scarcity of high-quality Ac-225 has slowed the advancement of research and development of Ac-225 based programs. To overcome this challenge and support the timely advancement of its pipeline, Cellectar has constructed a network of Ac-225 suppliers ensuring access to a sufficient supply.

"This agreement reflects our strategic commitment to advancing global access to radiopharmaceuticals," said Dr. Andrew Cavey, chief executive officer of ITM. "We value our partnership with Cellectar and our shared belief in the potential of innovative radiopharmaceutical therapies to significantly improve outcomes for patients with cancer. With more than two decades of leadership in the field, a fully vertically integrated model, and our joint venture, Actineer, ITM is uniquely positioned to meet the growing global demand for this critical isotope."

Under the terms of the agreement, ITM will supply Cellectar with the required quantities to facilitate the clinical development of its therapeutic medical grade radioisotope, Ac-225, produced by Actineer Inc., the joint venture between ITM and Canadian Nuclear Laboratories. Reliable, scalable production sites are crucial to meet the growing demand for Ac-225, given limited supply and manufacturing complexities surrounding the isotope.

(Press release, ITM Isotopen Technologien Munchen, SEP 11, 2025, View Source [SID1234661162])

On September 11, 2025 Eli Lilly and Company (NYSE: LLY) reported it will participate in the Bernstein’s 2nd Annual Healthcare Forum on September 25, 2025. Lucas Montarce, executive vice president and chief financial officer, will take part in a fireside chat at 8 a.m., Eastern time (Press release, Eli Lilly, SEP 11, 2025, View Source [SID1234655931]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On September 11, 2025 Ferring Pharmaceuticals Co., Ltd. reported that the PMDA has accepted the NDA for nadofaragene firadenovec for review, following submission on August 27th, 2025 (Press release, Ferring, SEP 11, 2025, View Source [SID1234655932]). This non-replicating gene therapy, administered intravesically, offers patients with NMIBC a bladder-sparing treatment option. Nadofaragene firadenovec’s quarterly dosing eliminates the burden of frequent treatments, while delivering a non-chemotherapy mechanism of action through interferon gene therapy. The NDA acceptance further highlights Ferring’s ongoing commitment to establish the new standard of care for high-risk BCG- unresponsive NMIBC.

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Professor Keiji Inoue, M.D., Ph.D., Department of Urology, Kochi Medical School, stated: "Nadofaragene firadenovec represents an option for those who failed NMIBC treatment. As the first choice after BCG failure, this bladder sparing gene therapy offers patients a non-chemotherapy option that transforms their own bladder cells into interferon-producing factories. The 75% complete response rate achieved with convenient quarterly dosing provides hope for patients who previously faced limited treatment options."

The NDA for nadofaragene firadenovec is based on results from a Phase 3 trial conducted in Japan.1 The primary outcome of a complete response (CR) rate of 75% at 3 months, following a single dose in 20 high-risk Japanese patients with carcinoma in situ (CIS), with or without concomitant high-grade Ta or T1 papillary lesions, was presented at the 112th Annual Meeting of the Japanese Urological Association (JUA, April 17-19, 2025, Fukuoka). All treatment-related adverse events were limited to Grade 1 (84.2%) or Grade 2 (15.8%), with zero Grade 3, 4, or 5 adverse events reported – confirming the therapy’s favourable safety and tolerability profile.1

These results are consistent with independent US real-world data presented by the Mayo Clinic, which demonstrated 79% complete response rate.2 The results from the Mayo Clinic were achieved following a single quarterly dosing, representing clinical and convenience advantages over existing therapies, without requiring re-induction protocols.2 Patients who achieved complete response continued quarterly maintenance dosing.

Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals stated "Traditionally, when BCG therapy proved insufficient, patients had no choice but to undergo highly invasive treatments such as radical cystectomy or risk cancer progression. Nadofaragene firadenovec is expected to offer a new bladder-sparing treatment option. At Ferring, we are committed to addressing the unmet needs in bladder cancer treatment by providing urologists with critical insights that enable effective, personalized, and groundbreaking therapies."

"Our ambition is to establish nadofaragene firadenovec as the new standard of care and the backbone therapy for NMIBC treatment," said Bipin Dalmia, Global Head, Uro-Oncology & Urology Franchise. "High-risk NMIBC patients who no longer respond to BCG have endured decades of little progress and currently face bladder removal as their primary option. This PMDA acceptance validates our strategic commitment to bring this treatment to Japanese patients."

About nadofaragene firadenovec
Nadofaragene firadenovec represents the first and only FDA-approved intravesical non-replicating gene therapy for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

As the first choice therapy following BCG failure, this non-chemotherapy approach utilises a non-replicating adenovirus vector-based therapy containing the interferon alfa-2b gene. Administered locally as convenient monotherapy by catheter directly into the bladder once every three months only, the mechanism transforms bladder wall cells into interferon microfactories, creating high and transient local expression of interferon alfa-2b protein – amplifying the body’s natural cancer-fighting capabilities through gene therapy rather than traditional chemotherapy approaches.

This therapeutic approach has been investigated through comprehensive clinical evaluation including 157 patients in the US with high-risk BCG-unresponsive NMIBC who demonstrated inadequate BCG response (full inclusion criteria published on clinicaltrials.gov: NCT02773849). 5-year follow-up data confirmed 80% overall survival rate and 49% cystectomy-free survival rate in adult patients with high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumours (±Ta/T1), and in patients with high-grade Ta/T1 without CIS. Long-term safety profile maintained with most treatment emergent AEs remaining transient Grade 1 or 2 (66% of all patients studied), and 4% experiencing Grade 3 AEs3.

In the real world setting, between November 2023 and October 2024, 45 patients across three Mayo Clinic locations in the US were treated with nadofaragene firadenovec for BCG-unresponsive NMIBC. Out of 45 treated patients, 29 were included in the analysis.2 After a median follow-up of 8.2 months: 72% of patients showed a complete response or were free from high-grade recurrence at 3 months. 62% maintained this response at 6 months. 94% avoided bladder removal surgery (cystectomy). 100% were still alive at 6 months.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC affects the superficial bladder layer without deeper invasion or metastatic spread. Bladder cancer represents a major clinical challenge as the 13th most commonly diagnosed cancer in Japan and ninth globally,4 with 75% presenting as NMIBC in 2022.4 While intravesical BCG remains first-line standard care for high-risk NMIBC, over 50% of patients experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease requiring radical intervention.5

Current treatment options remain limited for BCG-unresponsive patients, with JUA guidelines recommending only radical cystectomy or clinical trial participation6. Nadofaragene firadenovec offers the first choice non-chemotherapy gene therapy option for these patients, providing an alternative to immediate radical surgery.

On September 11, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported that it will host a premier KOL event on Thursday, Sept. 18th at 5 p.m. ET / 2 p.m. PT to discuss diverse perspectives on the Company’s interim efficacy results from a Phase 2 trial of its lead candidate, ENV105, in treating advanced prostate cancer patients (Press release, Kairos Pharma, SEP 11, 2025, View Source [SID1234655933]). Registration is required to participate in the webcast. Interested participants can sign-up to receive the webcast link here.

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"The safety results of the trial are an important catalyst as we prepare for the announcement of our interim efficacy results in treating prostate cancer patients. This predetermined efficacy analysis occurs four months after start of combination therapy of ENV105 and apalutamide in the last safety lead-in patient. We hope to lay out the primary benefits of our compound, and to clearly demonstrate the clinical need filled by ENV105," said Dr. John Yu, CEO of Kairos Pharma. "This distinguished panel of experts will provide participants with a renewed understanding of the importance of these data and the role ENV105 can have in targeting cancer drug resistance."

Speakers in 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 Samuel Oschin Comprehensive Cancer Institute.

The interim safety analysis of the trial, announced in July of this year, demonstrated that ENV105, a first-in-class CD105 antagonist, 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 4 toxicities were observed.

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 is 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 ENV-105.