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Inhibikase Therapeutics Announces Appointment of David McIntyre as Chief Financial Officer

On April 14, 2025 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company innovating small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension ("PAH"), reported the appointment of David McIntyre as Chief Financial Officer, effective April 14, 2025 (Press release, Inhibikase Therapeutics, APR 14, 2025, View Source [SID1234651911]).

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"David has extensive experience in financial strategy and corporate governance, as well as an established reputation within the life sciences capital markets sector, and we are thrilled to welcome him as our new Chief Financial Officer," said Mark Iwicki, Chief Executive Officer of Inhibikase Therapeutics. "We look forward to leveraging his expertise as we continue to advance IkT-001 for PAH patients."

Mr. McIntyre has over two decades of executive experience in the life sciences sector, having held numerous C-suite level roles at both public and private biotech and medical device companies, including Anthos Therapeutics, Inc., HeartWare International, Inc., AVITA Medical, Inc., Tessa Therapeutics, Inc., and Braeburn, Inc. In addition to his executive leadership roles, Mr. McIntyre spent nearly a decade as a Partner at Apple Tree Partners, a multi-billion-dollar life sciences venture capital and growth equity fund. Prior to entering the life sciences industry, he practiced as a senior attorney at Baker McKenzie and KPMG, specializing in mergers and acquisitions, initial public offerings, and corporate law. He also held senior finance positions at multinational corporations and high-growth companies, including Rio Tinto.

Mr. McIntyre holds a Bachelor of Economics (Accounting) from the University of Sydney, a Bachelor of Laws from the University of Technology, Sydney, and a Master of Business Administration from Duke University’s Fuqua School of Business, where he was recognized as a Fuqua Scholar. He is also a Certified Practicing Accountant and is admitted as a legal practitioner of the Supreme Court of New South Wales and the High Court of Australia.

JAMA Oncology Publication Strengthens Evidence for Oncotype DX® Test Reliability Across Racial and Ethnic Groups

On April 14, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported the publication of a comprehensive review in JAMA Oncology that strengthens the evidence supporting the Oncotype DX Breast Recurrence Score test (Press release, Exact Sciences, APR 14, 2025, View Source [SID1234651912]). The peer-reviewed article titled, "Genomic Assays for Breast Cancer in Diverse Populations: Prognostic and Predictive Insights," affirms that the Oncotype DX test provides accurate and reliable information to help guide breast cancer treatment decisions across all racial and ethnic groups.

While breast cancer mortality has declined overall, non-Hispanic Black women continue to face a 40% higher mortality rate compared to non-Hispanic White womenI. The publication acknowledges these disparities and the need to better understand the complex factors behind them. Despite the prognostic differences between racial and ethnic minority groups, the Oncoytpe DX Breast Recurrence Score test accurately predicts chemotherapy benefit regardless of race or ethnicity. While these disparities highlight the need for broader systemic change, advancing precision oncology remains critical and tools like the Oncotype DX Breast Recurrence Score test ensure treatment decisions are guided by reliable data for every patient.

The largest real-world SEER registry analysis to date—spanning more than 171,000 breast cancer patients and presented at ASCO (Free ASCO Whitepaper) 2024—provides powerful new evidence that the Oncotype DX test accurately predicts chemotherapy benefit across all racial and ethnic groups. In this study, which is not part of the JAMA Oncology review, the Recurrence Score result predicted chemotherapy benefit in Hispanic, non-Hispanic Black and non-Hispanic White patientsII. These findings add to the body of evidence from key clinical trials—including NSABP*-B20 and SWOG†-8814—which confirm that Oncotype DX is the only genomic test proven to predict chemotherapy benefit, the utility of which was further confirmed in randomized clinical trials including TAILORx and RxPONDER III,IV. With no racial or ethnic differences shown in its predictive value, the Oncotype DX test remains a trusted tool to help guide breast cancer treatment decisions for all patients.

"This study helps deepen our understanding of the multifaceted factors driving disparities in breast cancer outcomes," said Dr. Yara Abdou, assistant professor of medicine and breast cancer clinical trial program leader at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill and the first author of the paper. "By building on insights from landmark clinical trials, we further validate the utility of genomic tests across diverse populations. Our findings reinforce the value of using genomic assays to help guide treatment decisions for all racial and ethnic groups."

Key Highlights:

This publication reinforces the Oncotype DX test’s value in helping guide treatment decisions—providing precise estimates of distant recurrence risk and accurately identifying which breast cancer patients may or may not benefit from chemotherapy, regardless of race or ethnicity.
Secondary analyses of TAILORx and RxPONDER, which included the Oncotype DX Breast Recurrence Score test, confirm consistent chemotherapy benefit across racial and ethnic groups, highlighting that worse prognostic outcomes do not necessarily translate to greater chemotherapy benefitV.
The paper suggests that continued research is essential to understanding the biological, social, and systemic drivers of disparities in breast cancer outcomes—and to ensuring equitable access to genomic tools like the Oncotype DX test.
"At Exact Sciences, we’re proud that the Oncotype DX test continues to stand alone as the only genomic test validated to predict chemotherapy benefit in randomized trials—and that it performs consistently across racial and ethnic groupsV," said Dr. Rick Baehner, chief medical officer of Precision Oncology at Exact Sciences. "We remain deeply committed to partnering with global clinical leaders to reduce disparities and ensure every patient has access to the Oncotype DX test."

* National Surgical Adjuvant Breast and Bowel Project
† SWOG is part of the National Cancer Institute’s National Clinical Trials Network

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma

On April 14, 2025 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, reported dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma (Press release, Aulos Bioscience, APR 14, 2025, View Source [SID1234651905]). This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer.

Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress.

"We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. "Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma."

AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells.

Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting later this month.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About AU-007
AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

Anixa Biosciences Receives Notice of Allowance from U.S. Patent and Trademark Office for CAR-T Technology, Further Strengthening its Robust Intellectual Property Portfolio

On April 14, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application covering its chimeric antigen receptor-T cell (CAR-T) technology (Press release, Anixa Biosciences, APR 14, 2025, View Source [SID1234651904]).

The allowed claims in this patent encompass core methods and compositions that are fundamental to Anixa’s innovative CAR-T approach. Anixa’s CAR-T platform is specifically designed to address the long-standing challenges of applying CAR-T therapies to solid tumors, positioning the program as a potential breakthrough in immuno-oncology. This patent, along with others, was granted to The Wistar Institute and exclusively licensed to Anixa Biosciences. Anixa’s CAR-T technology is currently in a clinical trial at Moffitt Cancer Center, treating recurrent ovarian cancer patients.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "This Notice of Allowance further strengthens our growing intellectual property portfolio and reinforces the potential of our robust CAR-T program. Securing foundational patent protection is a vital step in supporting the program’s future success and in driving the development of next-generation immunotherapies with the potential to deliver transformative outcomes for patients."

AdvanCell Proudly Announces $18M in Federal Funding from the Medical Research Future Fund (MRFF) Frontiers Initiative for ‘Defeating Prostate Cancer with Targeted Alpha Therapy

On April 13, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, reported $18M in Australian Federal Government Funding from the Medical Research Future Fund (MRFF) Frontiers Initiative for ‘Defeating Prostate Cancer with Targeted Alpha Therapy’ (Press release, Advancell, APR 13, 2025, View Source [SID1234651896]).

One out of eight men develops prostate cancer. With the support from the Medical Research Future Fund (MRFF) Frontiers Initiative, the goal of the multidisciplinary multi-institutional investigator team is to transform the clinical management of prostate cancer by leveraging leading therapeutic radiopharmaceutical technology paired innovative clinical development and a deep understanding of tumour biology to improve the lives of patients with prostate cancer.

The research program is enabled by AdvanCell’s proprietary (Lead-212) 212Pb alpha isotope production technology along with the delivery of a first-in-field clinical platform trial to accelerate the translation of 212Pb-based targeted alpha therapies, one of the most exciting breakthroughs in cancer treatment.

Dr. Anna Karmann MD PhD, AdvanCell Chief Medical Officer said: "On behalf of all Co-Investigators, I would like to thank the Australian Government and MRFF Frontiers Initiative committee for this prestigious award. Targeted alpha therapies are among the most promising in oncology. We believe this MRFF-funded research can be practice changing and have a lasting positive impact on the lives of patients with prostate cancer. We highly value the support and opportunity this funding provides to fast-track translation and accelerate the development of novel combination therapies in an industry-academic partnership."

AdvanCell is collaborating with world-leading experts in Australia and globally, underpinning the transformative nature of the important clinical research. The clinical PIs include internationally renowned physician scientists Prof. Louise Emmett (St Vincent’s Hospital, Sydney and University of New South Wales) and Prof. Shahneen Sandhu (Peter MacCallum Cancer Centre, Melbourne).

Prof. Louise Emmett: "This collaborative Frontiers grant gives us the tools to deeply evaluate optimal combinations with targeted alpha therapy in prostate cancer – aiming for longer better lives using great technology in a smart way."

Prof. Shahneen Sandhu: "Our MRFF grant will accelerate the development of innovative targeted alpha therapy combinations designed to enhance patient care and clinical outcomes."

Scientific investigators include Prof. Richard Payne (The University of Sydney), Prof. Matt Trau, Dr. Alain Wuethrich, Dr. Kevin Koo (The University of Queensland), Dr. Scott Lovell (University of Bath), A/Prof. Serigne Lo (Melanoma Institute Australia) and Dr. Thomas Kryza and Dr. Simon Puttick (AdvanCell).

Prof. Stephen Rose, Head of Translational Medicine and Clinical Science at AdvanCell, highlighted the importance of the MRFF funding. "The MRFF funding supports Australian innovation to drive the establishment of sovereign manufacturing capabilities to accelerate clinical translation of 212Pb-targeted alpha therapy."