On April 1, 2025 TAE Life Sciences (TLS), a leader in next-generation Boron Neutron Capture Therapy (BNCT) solutions, reported a distribution agreement with alphaXRT, a premier provider of advanced radiation therapy technologies (Press release, TAE Life Sciences, APR 1, 2025, View Source [SID1234651727]). Under this partnership, alphaXRT will distribute TAE Life Sciences’ Alphabeam BNCT system and novel boron drugs, while also providing associated services across Australia and New Zealand.

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As part of the agreement, alphaXRT will hold the regulatory certificate for BNCT in the region, ensuring compliance with local medical and regulatory standards. This collaboration will expand access to BNCT, offering patients with difficult-to-treat cancers an innovative and targeted radiation therapy option.

"This agreement with alphaXRT marks a significant step forward in making BNCT more accessible to patients in Australia and New Zealand," said Rob Hill, CEO of TAE Life Sciences. "With alphaXRT’s deep expertise in radiation oncology and regulatory affairs, we are confident that this partnership will drive adoption and establish BNCT as a key treatment modality in the region."

The Alphabeam BNCT system is a cutting-edge accelerator-based neutron source designed to deliver safe, effective, and precisely targeted radiation therapy. By leveraging boron-10 drugs, BNCT enables selective tumor destruction while preserving surrounding healthy tissue—making it a promising option for patients with recurrent or treatment-resistant cancers.

"TAE Life Sciences is at the forefront of BNCT innovation, and we are thrilled to be their distributor in Australia and New Zealand," said Richard Neale, Managing Director of alphaXRT. "We look forward to working closely with hospitals and cancer treatment centers to bring this transformative therapy to more patients."

This partnership further underscores TAE Life Sciences’ commitment to expanding global access to BNCT and advancing the future of radiation oncology.

On April 2, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Phase 1 dose escalation and backfill cohort clinical data for emiltatug ledadotin (Emi-Le; XMT-1660) will be presented in an oral session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 Annual Congress, which is being held from May 14-17, 2025, in Munich, Germany (Press release, Mersana Therapeutics, APR 1, 2025, View Source [SID1234651761]).

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Oral Presentation Details

Title: Clinical Activity of Emiltatug Ledadotin (Emi-Le), a B7-H4-Directed ADC, in Patients with TNBC who Received at Least One Prior Topoisomerase-1 Inhibitor (Topo-1) ADC

Session Title: Mini Oral Session 1

Date and Time: Thursday, May 15, 2025 from 8:30-10:00 a.m. CEST

Abstract Number: 298MO

Presenter: Erika Hamilton, M.D., Director Breast Cancer Research, Sarah Cannon Research Institute in Nashville, Tennessee

About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin payload with controlled bystander effect. This candidate is being investigated in a Phase 1 dose escalation and expansion trial in patients with solid tumors, including breast, endometrial and ovarian cancers as well as adenoid cystic carcinoma type 1. In the initial clinical data that were reported as of a December 13, 2024 data cutoff, Emi-Le was observed to be generally well tolerated with differentiated safety and tolerability profile. Additionally, confirmed objective responses were observed across all enrolled tumor types, including in patients with triple negative breast cancer (TNBC) who had previously been treated with a topoisomerase-1 inhibitor (topo-1) ADC.

The U.S. Food and Drug Administration has granted two Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including TNBC, who have received a prior topo-1 ADC. For more information about Mersana’s ongoing Phase 1 trial of Emi-Le, please visit clinicaltrials.gov (NCT05377996).

On April 1, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported its participation in the Jones Las Vegas Healthcare and Technology Innovation Conference, to be held on April 8-9, 2025, at The Venetian Resort in Las Vegas, Nevada (Press release, Anixa Biosciences, APR 1, 2025, View Source [SID1234651710]).

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Mike Catelani, President and CFO of Anixa, will deliver a presentation and be available for one-on-one meetings during the conference.

Details of the presentation are as follows:

Event: Jones Healthcare and Technology Innovation Conference
Date: April 9, 2025
Time: 4:30 PM PT
Location: The Venetian Resort
Webcast: View Source

The Jones Healthcare and Technology Innovation Conference will bring together a select group of innovative companies and institutional investors for a two-day event. The conference will be focused on one-on-one (1×1) meetings, fireside chats, panels, presentations, and signature networking events. Organized by Jones, with marketing support from B2i Digital, Inc., the event offers an opportunity for direct dialogue between senior company executives and investors seeking engagement with innovative management teams.

For more information, a list of participating companies and to submit registration requests about the Jones Las Vegas Healthcare and Technology Innovation Conference, visit their B2i Digital Featured Conference page.

On April 1, 2025 Merus N.V. (Nasdaq: MRUS), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Tuesday, April 8, 2025 at 8:45 a.m. ET (Press release, Merus, APR 1, 2025, View Source [SID1234651726]).

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The webcast of the presentation will be contemporaneously available on the Investors page of the Company’s website. The archived presentation will also be available there for a limited time after the event.

On April 1, 2025 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, reported that Applied DNA Clinical Labs (ADCL), its wholly-owned clinical laboratory subsidiary, is repositioning its TR8 PGx pharmacogenomics testing service to offer tailored subpanels for indication-specific use cases in addition to full panel testing (Press release, Applied DNA Sciences, APR 1, 2025, View Source [SID1234651711]). The first subpanel under ADCL’s new go-to-market strategy is for the pre-emptive testing of patients with genetic variants of the DPYD gene that correlate to potentially reduced or absent DPD enzyme activity necessary to metabolize fluoropyrimidines, specifically capecitabine (branded Xeloda) and fluorouracil (5-FU), two chemotherapy drugs that are widely used as part of the standard of care treatment for patients with certain cancers. The decision by ADCL follows a recent safety announcement by the Food and Drug Administration (FDA) in which the agency highlighted that patients with certain DPYD genetic variants are potentially poor or intermediate metabolizers of these two medications due to DPD enzyme deficiencies and risk drug overexposure and the potential to experience severe, and at times fatal, toxicities when taking them. ADCL’s TR8 PGx test, a 120-target pharmacogenomics panel approved by the New York State Department of Health as a laboratory-developed test comprising more than 33 drug metabolism-related genes, can identify individuals with DPYD genotypes that result in potentially reduced or absent DPD enzyme activity.

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Capecitabine and 5-FU are used for the treatment of colorectal, esophageal, stomach, pancreatic, breast, and cervical cancers. Approximately 924,000 prescriptions were written for fluorouracil and capecitabine in 2022, according to the most recent drug usage data available.1 Approximately 1 in 1,000 patients carry two copies of a variant in the DPYD gene, resulting in the absence of the DPD enzyme. Between 3 percent and 8 percent of the general population has one copy of a variant associated with lower levels of the DPD enzyme, showing up more frequently in African Americans.2 These genotypes are at higher risk of adverse side effects from fluorouracil and capecitabine.

"The FDA’s safety announcement underscores the value of genetic testing to guide treatment decisions and improve patient outcomes, and highlights the breadth of our TR8 PGx test and its potential to influence clinical decision-making across multiple therapeutic areas. To this end, we plan to introduce additional TR8 PGx subpanels that target indication-specific use cases where genetic testing has a high correlation with drug efficacy and safety, such as in oncology, cardiology, and psychiatry. We believe this revised go-to-market strategy can lower the barrier to adoption of our PGx testing services and provides enhanced utility to institutions, clinicians, and their patients," stated Dr. James A. Hayward, CEO of Applied DNA.

About TR8 PGx – Pharmacogenomic Testing
The TR8 PGx test analyzes 120 genetic targets across more than 33 genes to inform healthcare providers about how a patient may respond to a wide range of drug therapies used to treat a variety of conditions, such as cardiovascular, oncology, psychiatric, and pain management. Equipped with information about a patient’s genome-based response to medications, healthcare providers can make more informed decisions when selecting prescription medications, thereby optimizing healthcare quality and efficacy.

The test is administered via a simple cheek swab. The TR8 PGx testing service offered by ADCL was approved as a laboratory-developed test by the New York State Department of Health (NYSDOH) in June 2024.