On March 20, 2025 Santo Therapeutics, a biotechnology company focused on advancing gene therapies, reported the initiation of its first Investigator-Initiated Clinical Trial (IIT) in China for ST002. Santo’s ST002 is an innovative in vivo lentiviral gene therapy designed to treat tumours with NF2 gene mutations. This marks a major milestone as ST002 is the world’s first gene therapy targeting NF2 mutation-driven tumours to enter clinical trials.

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"We are excited to start this groundbreaking clinical trial," said Dr. Luke Zhou, CEO of Santo Therapeutics. "ST002 is the first gene therapy specifically targeting NF2-related schwannomatosis (NF2-SWN), and with our proprietary platform, we are introducing a mechanism that precisely targets both the tumour and its environment, providing a more effective solution for NF2-related tumours."

Nick Rodgers, Chairman of the Advisory Board of Santo, commented, "Currently, there is no cure for NF2 disease. Gene therapy is the only promising solution to offer a cure, and we are eager to see the potential of ST002. Having spent months in pre-clinical testing we are pleased to be working with The Cancer Institute and Hospital, Chinese Academy of Medical Sciences to validate our therapy in humans."

The first-in-human IIT for ST002 is now underway, with initial clinical data expected to be available in the second half of 2025. In preclinical studies, ST002 demonstrated notable anti-tumour effects in NF2 patient-derived-xenograft (PDX) models, significantly inhibiting tumour growth and showing high specificity and durability.

"We are excited to advance ST002 to the clinical stage and bring hope to patients suffering from tumours with NF2 mutations," Dr. Zhou added. "This therapy holds the potential to not only treat NF2-related tumours but also open new avenues for treating other rare genetic conditions. We look forward to sharing our progress and early results in the coming months."

About ST002
ST002 is an innovative lentiviral gene therapy that delivers precise genetic material directly to the tumour site. By targeting the tumour micro-environment and restoring NF2 gene function, ST002 inhibits tumour growth by blocking abnormal Schwann cell. As an off-the-shelf product, ST002 offers a cost-effective, scalable treatment option for patients with schwannoma and other NF2 related tumours.

(Press release, Santo Therapeutics, MAR 20, 2025, View Source [SID1234663856])

On March 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612 ) and recommended continuation of the ongoing study without any modifications (Press release, BriaCell Therapeutics, MAR 20, 2025, View Source [SID1234651956]). BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).

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"We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor (CPI) combination in metastatic breast cancer to date," stated Dr. William V. Williams, BriaCell’s President & CEO. "The DSMB’s second positive data review and recommendation to continue with patient enrollment in BriaCell’s pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need."

"Metastatic breast cancer is a devastating disease for patients and their families, and the DSMB’s positive review represents an important step forward towards our goal of transforming cancer care, and improving patients’ survival and quality of life outcomes," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We look forward to sharing additional updates from BriaCell’s pivotal Phase 3 trial in the coming months."

On March 20, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that it will host a fireside chat with Shaun Bagai, Chief Executive Officer, on Thursday, April 3, 2025, at 12:00 p.m. ET (Press release, Renovorx, MAR 20, 2025, View Source [SID1234651335]).

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Mr. Bagai will discuss RenovoRx’s continued momentum of its RenovoCath commercial efforts, including new purchase orders and reorders received from cancer center customers, and the realization of initial revenues.

Mr. Bagai will also discuss progress on RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating the Company’s lead drug-device combination product candidate (intra-arterial delivery of gemcitabine via the RenovoCath catheter), known as IAG which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). The combination product candidate (IAG), which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.

Fireside Chat Details:
Date: Thursday, April 3, 2025
Time: 12:00 p.m. ET
Webcast: View Source

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

On March 20, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, reported a peer-reviewed publication highlighting a potentially significant breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (NSCLC) patients (Press release, Kairos Pharma, MAR 20, 2025, View Source [SID1234651334]). Recent findings published in Drug Resistance Updates highlight the critical role of CD105 (endoglin) in mediating resistance to osimertinib, a frontline treatment for EGFR-mutant NSCLC. The study, titled, "CD105 blockade restores osimertinib sensitivity in drug-resistant EGFR-mutant non-small cell lung cancer," demonstrated that CD105 expression is upregulated as a mechanism of therapy resistance, correlating with poor prognosis in patients.

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"We believe our latest findings represent a paradigm shift in overcoming resistance to EGFR-targeted therapies in NSCLC," said Neil Bhowmick, Ph.D., Kairos Pharma Chief Scientific Officer. "Revealing this mechanism-of-action underscores our commitment to advancing precision oncology and bringing innovative therapies to patients in need."

In preclinical models, targeting CD105 with ENV105 (carotuximab), a CD105-neutralizing antibody successfully restored treatment sensitivity to EGFR-targeted therapies. Notably, combining osimertinib with ENV105 reinstated susceptibility to EGFR inhibition through metabolic reprogramming and enhanced chromatin accessibility. These findings confirm the efficacy of this novel combination therapy strategy in overcoming drug resistance in this model of non-small cell lung cancer.

Dr. John Yu, CEO, stated, "These findings in lung cancer corroborate data in prostate cancer, breast cancer and colon cancer, that point to CD105 being a central mechanism of cancer drug resistance. We believe ENV105 can reverse this resistance in cancer models, and our clinical trials are designed to definitively demonstrate its potential impact."

The global NSCLC treatment market is projected to reach $45 billion by 2030, driven by advancements in targeted therapies. However, drug resistance remains a major challenge. The ability of ENV105 to enhance EGFR-targeted therapy effectiveness positions it as a high-value asset in next-generation oncology treatment. Kairos Pharma is currently evaluating this transformative cancer therapy in ongoing clinical trials for EGFR-driven lung cancer patients. The study can be accessed here.

On March 20, 2025 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, reported its participation in the 5th Annual TPD and Induced Proximity Summit, taking place March 25-27, 2025, in London, UK (Press release, BPGbio, MAR 20, 2025, View Source [SID1234651333]). BPGbio executive Vivek K. Vishnudas, Ph.D., Chief Technology Officer and R&D Site Head, will present a session titled "Pioneering a Differentiated Approach to Targeted Protein Degradation Using the Ubiquitin Conjugating Enzyme (E2) Family." Dr. Vishnudas will speak on March 26 as part of the conference’s Pre-Clinical and Translation track, highlighting the latest advancements in BPGbio’s protein homeostasis program and the potential of E2-based therapeutics in oncology and neurology.

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"Our innovative approach to targeted protein degradation via the ubiquitin-conjugating enzyme (E2) family represents a breakthrough in drug development, allowing us to address previously undruggable targets and overcome resistance mechanisms inherent in traditional E3-based strategies," said Dr. Vishnudas. "We look forward to sharing our progress in developing E2-based bifunctional and glue degraders for oncology and neurodegenerative disorders."

In addition to its E2-focused approach, BPGbio’s protein homeostasis program incorporates a proprietary library of over 1,000 Ro3 fragments identified as potential ligands and seed compounds for E2 targets. The program also features proprietary ternary structures, a computational toolkit for E2 ligand design, and advanced assays designed to optimize selectivity and specificity.

BPGbio’s therapeutic pipeline includes drug candidates for glioblastoma (orphan drug), pancreatic cancer (orphan drug), primary CoQ10 deficiency (rare pediatric disease designated), epidermolysis bullosa (EB, orphan drug), squamous cell carcinoma (SCC, orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease (orphan drug), and Parkinson’s disease. The company’s diagnostic pipeline includes its prostate diagnostic test (pstateDx), as well as tests in development for the detection of Parkinson’s disease (parkinsonDx), pancreatic cancer (pancDx), breast cancer, and liver disease.