Bicycle Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference

On April 1, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Tuesday, April 8, at 12:45 p.m. ET (Press release, Bicycle Therapeutics, APR 1, 2025, View Source [SID1234651712]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

Applied DNA Positions TR8 PGx Testing Service as Pre-emptive Testing for Safety of Fluoropyrimidine-Based Cancer Therapeutics Following Publication of Food and Drug Administration Safety Announcement

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Anixa Biosciences to Present at the Jones Las Vegas Healthcare and Technology Innovation Conference on April 9th

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On April 1, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, APR 1, 2025, View Source [SID1234651709]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 31, 2025, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to six individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 23,700 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.

Apollomics and LaunXP Announce Development and Commercialization Agreement for Vebreltinib

On March 31, 2025 Apollomics Inc. (Nasdaq: APLM) ("Apollomics"), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, and LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd. (TWO: 6876) ("LaunXP"), reported that the parties have entered into an agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) (the "LaunXP Territory") of vebreltinib (Press release, Apollomics, MAR 31, 2025, View Source [SID1234654275]). Apollomics’ proprietary c-Met inhibitor, in combination with an EGFR inhibitor ("EGFRi") for the treatment of NSCLC. The EGFRi class of targeted kinase inhibitors is currently a foundational targeted therapy for the treatment of NSCLC and other tumor types.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted to partner with LaunXP, who share our vision for the commercial opportunity for vebreltinib. EGFRi is currently the frontline treatment for many patients with NSCLC, and combining it with our c-Met inhibitor vebreltinib is expected to transform the standard of care," said Dr. Guo-Liang Yu, CEO of Apollomics. "We believe that LaunXP can advance this development program rapidly in this patient population, bringing us closer to potentially improving outcomes for many patients with NSCLC. We will continue to seek opportunities to maximize the global opportunity for vebreltinib, both as a single agent and in combination approaches for the treatment of cancers."

"We are thrilled to announce this collaboration with Apollomics. We believe the preclinical and clinical data supporting the combination of a c-Met inhibitor with an EGFRi is compelling," said Dr. Chiu-Heng Chen, Chairman and President of LaunXP. "By delaying the emergence of mutations which cause EGFRi resistance, we hope to demonstrate clinically that better patient outcomes can be achieved."

Under the terms of the agreement, Apollomics is to receive upfront payments totaling $10 million within 60 days of the date of the agreement. Apollomics is also eligible for regulatory and other pre-commercial milestones up to $50 million, and royalties on net product sales. LaunXP will be primarily responsible for the development of vebreltinib in combination with an EGFRi in the LaunXP territory for the treatment of NSCLC.

About Vebreltinib

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-MET inhibitor. It works by inhibiting the aberrant activation of the HGF/c-MET axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies such as osimertinib. By targeting c-MET dysregulation, vebreltinib has demonstrated strong tumor inhibitory effect in a variety of preclinical c-MET dysregulated human gastric, hepatic, pancreatic and lung cancer xenograft animal models and patient-derived xenograft models (PDX).

Details on the Phase 1/2 SPARTA global clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is developing vebreltinib as single-agent cancer therapy in a variety of tumor types and actively assessing the potential of vebreltinib in combination with novel therapies. Avistone, Apollomics’ partner in China, has received conditional approval from the National Medical Products Administration (NMPA) of China for vebreltinib for multiple indications. Vebreltinib is currently under clinical investigation and not approved for any use in any other regions in the world.