Aminex Therapeutics Announces Multiple Sites Activated for Phase 1b/2 Clinical Trial of Novel Investigational Cancer Treatment AMXT 1501 and DFMO in Patients with Breast Cancer or Melanoma

On February 4, 2026 Aminex Therapeutics, Inc., a private clinical-stage biotechnology company focused on developing novel therapies for rare and difficult-to-treat cancers, reported the initiation of a Phase 1b/2 clinical trial of AMXT 1501 in combination with difluoromethylornithine (DFMO) in patients with breast cancer or metastatic melanoma.

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!

"Initiating this study is an important milestone for Aminex and for patients facing advanced cancers with limited treatment options," said Mark Burns, PhD, Chief Scientific Officer and President of Aminex. "This trial builds on our foundation of pre- and early clinical data demonstrating the potential of AMXT 1501 plus DFMO to block the polyamine metabolism—a pathway that drives tumor growth and suppresses immune responses. We are advancing this program, in collaboration with leading investigators and pediatric oncologists, targeting eight tumor types."

The multicenter, open-label trial (NCT07287917) will evaluate the safety, tolerability and preliminary efficacy of oral AMXT 1501 in combination with oral DFMO together with standard of care in metastatic melanoma or in pre- and post-menopausal women with ER+ HER2- breast cancer who have progressed after prior therapies. The study will include safety and dose expansion cohorts.

In addition to this trial, Aminex is partnering with The Beat Childhood Cancer Consortium at Penn State College of Medicine on a randomized Phase 1/2 clinical trial of AMXT 1501 plus DFMO in pediatric patients with neuroblastoma, diffuse intrinsic pontine glioma, atypical teratoid rhabdoid tumor, embryonal tumor with multilayer rosettes, ewing sarcoma, and osteosarcoma. (NCT06465199) Aminex also recently announced the receipt of Orphan Drug Designation from the FDA for AMXT 1501 plus DFMO for the treatment of patients with neuroblastoma.

About AMXT 1501 and DFMO
AMXT 1501 is a novel polyamine transport inhibitor designed to block the uptake of polyamines, which are essential for tumor growth and survival. DFMO is an established inhibitor of polyamine biosynthesis. Together, the combination aims to comprehensively inhibit polyamine metabolism and tumor growth.

(Press release, Aminex Therapeutics, FEB 4, 2026, View Source [SID1234662486])

Third Arc Bio Announces $52M Series A Extension to Expand Oncology and Immunology & Inflammation Portfolio

On February 4, 2026 Third Arc Bio Inc., a clinical stage biotech company developing novel multifunctional antibodies for a range of oncology and immunology & inflammation (I&I) indications, reported the closing of a $52 million Series A extension.

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!

New investor Andreessen Horowitz (a16z) joined Third Arc Bio’s existing world-class investor syndicate to further validate the company’s approach to deliver transformational therapies for patients. As part of the financing, a16z General Partner, Jorge Conde, joins Third Arc Bio’s Board of Directors. Proceeds from the financing will enable Third Arc Bio to accelerate its I&I portfolio and deliver additional oncology programs into the clinic.

"Third Arc represents a shift toward more precise immune modulation—moving beyond systemic exposure to therapies designed to deliver highly controlled biological effects at sites of disease," said Jorge Conde, General Partner at a16z. "The company’s platforms, combined with a team that has repeatedly translated complex immunology into approved medicines, reflect a rigorous, patient-driven approach to building biologics that can improve both efficacy and safety across oncology and immune-mediated disease."

Since its launch in 2022 with seed financing from Omega Funds, Third Arc Bio has assembled a highly experienced team with a proven track record of drug discovery and development, alongside an innovative platform and a pipeline of multispecific antibodies. The company’s lead asset, ARC101, is a bispecific T cell engager targeting CLDN6 currently in Phase 1 dose escalation in patients with advanced solid tumors.

"This financing allows us to maintain momentum across our expanding oncology portfolio while rapidly advancing our next-generation I&I assets into first-in-human studies," said Peter F. Lebowitz, MD, PhD, Chief Executive Officer of Third Arc Bio. "By parallel-tracking programs, we can more efficiently validate the full potential of our platforms, rapidly generate proof-of-concept data, and deliver innovative therapies for patients with significant unmet need."

Third Arc Bio’s approach to I&I is anchored by its ARCTag (Tethered Agonist) Platform, which leverages multispecific antibodies to localize immune modulation directly to sites of disease. This targeted activity represents a meaningful advance beyond conventional systemic autoimmune therapies, offering the potential for enhanced efficacy and therapeutic index.

(Press release, Third Arc Bio, FEB 4, 2026, View Source;inflammation-portfolio-302678506.html [SID1234662485])

Providence Therapeutics Announces World-First Personalized Pediatric mRNA Cancer Vaccine Trial

On February 4, 2026 Providence Therapeutics, a Canadian clinical-stage mRNA biotechnology company, reported a world-first clinical trial evaluating personalized mRNA cancer vaccines for children with advanced and treatment-resistant brain tumors.

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!

The PaedNEO-VAX trial, funded by Providence Therapeutics, in combination with the Australian Government and a host of philanthropic donors, is the first multi-site pediatric study to test individualized mRNA vaccines designed specifically for each child’s cancer.

The trial is co-led by The University of Queensland and the South Australian Health and Medical Research Institute (SAHMRI) and will begin in March 2026 across seven pediatric hospitals in Queensland, South Australia, New South Wales, Victoria, and Western Australia. It is sponsored by the Australia & New Zealand Children’s Haematology and Oncology Group (ANZCHOG).

Providence Therapeutics is contributing its proprietary mRNA vaccine platform and manufacturing expertise to support the creation of personalized vaccines tailored to each patient’s tumor biology.

A New Frontier for Pediatric Brain Cancer

PaedNEO-VAX is open to children and adolescents with relapsed or refractory high-grade brain tumors, including high-grade glioma, diffuse midline glioma, medulloblastoma, and ependymoma.

Phase I will establish safety and optimal dosing, while Phase II will evaluate clinical outcomes such as disease progression, survival, and quality of life for patients and families.

Using genome sequencing and advanced data analysis, tumor-specific targets will be identified for each child. Customized mRNA vaccines will then be manufactured in Australia by Southern RNA, with an expected turnaround of approximately 10 weeks from enrollment to dosing.

"Where Hope and Science Intersect"

Providence’s interest in pediatric brain cancer is deeply rooted and personal.

"In 2013, my 13-year-old son Adam was diagnosed with glioblastoma multiforme (GBM) and given about 12 months to live. We were fortunate that we were able to get him into remission, and in 2015 I founded Providence Therapeutics with the mission to be ready if his cancer came back." said Brad Sorenson, Founder and CEO of Providence Therapeutics. "In early 2024 that horrible day came when his GBM recurred in his brainstem and throughout his spine, and we rushed to make a personalized vaccine for him. Adam was the first person to receive a Providence cancer vaccine, and he responded remarkably well. It is a rare good-news story, and he is still doing well today. Providence’s mission today is to see Adam’s success shared as widely as possible."

"This trial embodies our mantra of ‘Where Hope and Science Intersect.’ After more than a decade of scientific work, Providence is honoured to help bring hope to families facing devastating diagnoses. We are proud to support this world-first pediatric trial in Australia and hopeful that it will pave the way for similar initiatives in Canada and throughout the world."

An Open Invitation to Canada and the USA

Providence Therapeutics views this landmark trial as both a scientific breakthrough and a model for collaboration.

Following the Australian example, Providence welcomes dialogue with Canadian and USA leaders, cancer foundations, and cancer research organizations interested in exploring how similar cancer vaccine programs could be advanced in Canada and the USA.

This trial demonstrates what is possible when public investment, clinical leadership, and patient-driven innovation align — offering children and families facing the most aggressive cancers something profoundly needed: Hope.

(Press release, Providence Therapeutics, FEB 4, 2026, View Source [SID1234662484])

Beyond Cancer Abstract Featuring Phase 1 Data on Intratumoral Ultra-High Concentration Nitric Oxide (UNO) in Solid Tumor Metastases to be Presented at the AACR Annual Meeting 2026

On February 4, 2026 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ: XAIR), reported being selected to present an abstract featuring data from the Phase 1 trial of intratumoral UNO in solid tumor metastases at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, which is scheduled to be held from Friday, April 17th, through Wednesday, April 22nd, at the San Diego Convention Center in San Diego, California. The original submitted abstract titles and text are scheduled to be published in an Online Itinerary Planner on March 17, 2026 at 4:30 PM ET / 1:30 PM PT.

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!

AACR Annual Meeting 2026 Abstract Details:
Presenter: Amichay Meirovitz, MD, Soroka University Medical Center, Beersheba, Israel
Session Category: Experimental and Molecular Therapeutics
Session Title: Innovative Therapeutic Modalities and Translational Platforms
Session Start: April 19, 2026 at 5:00 PM ET / 2:00 PM PT
Session End: April 19, 2026 at 8:00 PM ET / 5:00 PM PT
Location: Poster Section 13, San Diego Convention Center
Poster Board Number: 22
Poster Number: 304

(Press release, Beyond Air, FEB 4, 2026, View Source [SID1234662483])

Rezolute to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported that management will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026, taking place February 11-12, 2026 in New York.

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!

Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim representative.

(Press release, Rezolute, FEB 4, 2026, View Source [SID1234662482])