On September 12, 2025 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported new plixorafenib results from the previously completed Phase 1/2a clinical trial that demonstrate treatment with plixorafenib in patients with BRAF-altered papillary thyroid cancer (PTC) and anaplastic thyroid cancer (ATC) resulted in durable disease control that appears very favorable compared with historical data with standard treatment options (Press release, Fore Biotherapeutics, SEP 12, 2025, View Source [SID1234655946]). The data also demonstrate an encouraging safety profile consistent with previously reported results following treatment with plixorafenib. The data are being presented at the American Thyroid Association (ATA) 2025 Annual Meeting, taking place September 10-14, 2025 in Scottsdale.

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"These results presented at ATA 2025 demonstrate durable clinical benefit in both V600 mutated and BRAF fusion thyroid tumors, and durable disease control in patients with stable disease. These new findings continue to support the strong clinical profile of plixorafenib as well as the potential to benefit patients with BRAF-altered thyroid cancers," said Eric J. Sherman, M.D., Head and Neck Cancer Medical Oncologist at the Memorial Sloan Kettering Cancer Center, and Principal Investigator for the ongoing FORTE Phase 2 plixorafenib study. "Patients with differentiated thyroid cancer, including papillary thyroid cancers which account for about 80% of all thyroid cancers, are in dire need of new treatment options. BRAF V600E alterations occur in approximately 60% of papillary thyroid cancers, underscoring the need for development of a targeted therapy such as plixorafenib that addresses the mechanistic drivers of these tumors along with the compelling clinical efficacy and safety profile demonstrated by treatment with plixorafenib."

"We are excited to share these data that show additional evidence of strong and durable clinical activity of plixorafenib, in both BRAF V600 mutant and BRAF fusion thyroid cancers," said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. "The data also demonstrate a high duration of response in MAPKi-naïve patients, highlighting the unique mechanism of action of plixorafenib that avoids paradoxical MAPK pathway activation and delivers differentiated results as a single therapeutic agent in BRAF altered cancers. We continue to advance our ongoing registrational FORTE basket study, which includes BRAF V600 altered thyroid cancers, as we aim to generate further data to inform treatment and help patients with BRAF driven tumors."

The results presented at ATA 2025 are from 21 patients with thyroid cancer, 16 with PTC and 5 with ATC, treated with plixorafenib in a previously completed Phase 1/2a study that treated a total of 113 patients with advanced, unresectable solid tumors that were intolerant to standard therapy or had no standard therapy available. All 21 patients with thyroid cancer received prior radiation therapy, nearly all underwent prior surgery, and the majority had received prior systemic anticancer therapies. The safety profile of treatment with plixorafenib in patients with ATC or PTC was consistent with previously reported results from the Phase 1/2a study.

Treatment with plixorafenib with and without cobicistat in MAPK-inhibitor naïve patients with a BRAF V600 mutation demonstrated an encouraging clinical benefit with a differentiated duration of response and support plixorafenib’s paradox breaker mechanism of action in BRAF-altered tumors, including a median progression free survival (mPFS) of 63.9 months and a clinical benefit rate (CBR: response or stable disease ≥ 24 weeks) of 85.7% (6 of 7 patients). Four MAPK-inhibitor naïve PTC patients remained on treatment for over 5 years, including one partial response (PR) of 59.2 months (treatment duration=7.6 years) and a second PR of 30.9 months (treatment duration=8.3 years). In four ATC patients with a BRAF V600 mutation, all of whom were MAPK-inhibitor naïve, the mPFS was 16.1 months, with one confirmed PR lasting 17.8 months and two patients reaching stable disease. In the three PTC patients that received prior MAPK inhibition therapy as well as at least one prior BRAF inhibition therapy, all three patients reached stable disease, with a CBR of 33.3%. Clinical benefit was also observed in patients with BRAF fusion PTC, with one of three patients achieving a PR lasting 12.9 months (treatment duration=25 months, continued post-study completion), and one patient with ATC having stable disease.

The results presented at ATA 2025 demonstrate a differentiated and durable clinical benefit in BRAF altered anaplastic and papillary thyroid cancers, compared to historical results of approved and investigational therapies, including BRAF, MEK, and pan-RAF inhibitors. Plixorafenib’s novel mechanism of action does not induce paradoxical activation of the MAPK pathway, thereby not requiring combination with a MEK inhibitor and potentially improving upon safety, efficacy, and durability compared with treatments containing prior generation RAF inhibitors.

FORE is advancing the registration-intended FORTE Master Protocol, a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are BRAF V600 progressive or recurrent primary CNS tumors, rare BRAF V600 mutated advanced solid tumors, including ATC, and solid tumors with BRAF fusions, including PTC and ATC. BRAF v600E alterations occur in 45% of ATC and approximately 60% of PTC, representing a differentiated potential future development opportunity for plixorafenib.

Poster Presentation Details:

Title: Clinical Activity and Safety of Novel BRAF Inhibitor (BRAFi) Plixorafenib (FORE8394; PLX8394) in Advanced Thyroid Cancers (TC) Harboring BRAF Alterations
Lead Author & Presenter: Eric J. Sherman, M.D., Memorial Sloan Kettering Cancer Center
Poster Session: Clinical Thyroid Diseases & Cancer
Date and Time: Friday, September 12, 2025, 3:00 – 4:00 p.m. MT
Poster Number: 300

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 12, 2025 Alkermes plc (Nasdaq: ALKS) reported the appointment of Joshua Reed as Chief Financial Officer (CFO), effective Monday, Sept. 15, 2025 (Press release, Alkermes, SEP 12, 2025, View Source [SID1234655943]). Mr. Reed will report to Richard Pops, Chief Executive Officer of Alkermes, and will join the company’s management committee.

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"I’m delighted to be joining Alkermes and look forward to working with Richard and the team to build on Alkermes’ strong financial foundation and advance its strategic priorities with a financial strategy that supports continued innovation, operational excellence and long-term growth," said Mr. Reed.

Mr. Reed brings over 30 years of financial leadership experience, with a strong focus in the biotechnology and pharmaceutical sectors. Most recently, he served as CFO of Omega Therapeutics, a then publicly-traded biotechnology company. Prior to that, he was the CFO at Aldeyra Therapeutics. Earlier in his career, Mr. Reed spent more than a decade at Bristol Myers Squibb, culminating in his role as Vice President and Head of Finance Operations for the U.S. and Puerto Rico. His experience also includes roles at JPMorganChase, Credit Suisse First Boston, and Chase Manhattan Bank.

Mr. Reed currently serves on the board of directors of Scholar Rock Holding Corporation, a publicly-traded biotechnology company. He earned a Bachelor of Science in Finance from Rutgers University and a Master of Business Administration from the University of Michigan’s Ross School of Business.

"We are pleased to welcome Joshua to Alkermes at such an exciting time in our company’s evolution," said Mr. Pops. "Joshua brings a wealth of financial expertise and strategic insight from his extensive experience in the biopharmaceutical industry. We gain his financial acumen and dedication to excellence as we continue to focus on driving strong performance across our commercial business, advancing our pipeline, and delivering long-term shareholder value. I look forward to the positive impact he will have across our organization."

On September 12, 2025 Alkermes plc (Nasdaq: ALKS) reported the appointment of Joshua Reed as Chief Financial Officer (CFO), effective Monday, Sept. 15, 2025 (Press release, Alkermes, SEP 12, 2025, View Source [SID1234655943]). Mr. Reed will report to Richard Pops, Chief Executive Officer of Alkermes, and will join the company’s management committee.

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"I’m delighted to be joining Alkermes and look forward to working with Richard and the team to build on Alkermes’ strong financial foundation and advance its strategic priorities with a financial strategy that supports continued innovation, operational excellence and long-term growth," said Mr. Reed.

Mr. Reed brings over 30 years of financial leadership experience, with a strong focus in the biotechnology and pharmaceutical sectors. Most recently, he served as CFO of Omega Therapeutics, a then publicly-traded biotechnology company. Prior to that, he was the CFO at Aldeyra Therapeutics. Earlier in his career, Mr. Reed spent more than a decade at Bristol Myers Squibb, culminating in his role as Vice President and Head of Finance Operations for the U.S. and Puerto Rico. His experience also includes roles at JPMorganChase, Credit Suisse First Boston, and Chase Manhattan Bank.

Mr. Reed currently serves on the board of directors of Scholar Rock Holding Corporation, a publicly-traded biotechnology company. He earned a Bachelor of Science in Finance from Rutgers University and a Master of Business Administration from the University of Michigan’s Ross School of Business.

"We are pleased to welcome Joshua to Alkermes at such an exciting time in our company’s evolution," said Mr. Pops. "Joshua brings a wealth of financial expertise and strategic insight from his extensive experience in the biopharmaceutical industry. We gain his financial acumen and dedication to excellence as we continue to focus on driving strong performance across our commercial business, advancing our pipeline, and delivering long-term shareholder value. I look forward to the positive impact he will have across our organization."

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])