On July 1, 2023 SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of BL-B01D1 in the Investigational New Drug (IND) application on June 30, 2023 (Press release, SystImmune, JUL 1, 2023, View Source [SID1234633013]). This milestone paves the way for Phase 1 clinical trials of BL-B01D1 in subjects with metastatic or unresectable Non-Small Cell Lung Cancer (NSCLC) in the United States.

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 clearance of this IND application marks a significant milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Yi Zhu, Chief Executive Officer of SystImmune, commented, "Our mission at SystImmune is to invent therapies that offer meaningful clinical benefit to patients, and the FDA green light of our IND application for BL-B01D1 is a testament to our commitment. Together, with all our clinical partners, trial treatment centers, and global regulatory agencies, we hope to provide significant and global contributions to the cancer treatment landscape."

"We are excited to receive FDA clearances for the IND application of Bl-B01D1, the first-in-class bi-specific ADC. This novel therapy holds tremendous promise in addressing the urgent need for improved treatment options for patients with advanced NSCLC," stated Dr. Martin S. Olivo, Chief Medical Officer at SystImmune. "Following encouraging results from clinical studies involving over 100 patients in the China-based first-in-human study, we eagerly anticipate commencing the clinical investigation of BL-B01D1 in diverse global population groups."

About BL-B01D1

BL-B01D1 is a first-in-class bispecific antibody-drug conjugate (ADC) developed by SystImmune, targeting both EGFR and HER3, proteins that are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 possesses two binding domains blocking each Growth Factor Receptor, which both drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 effectively blocks EGFR and HER3 signals to cancer cells, thereby reducing proliferation and survival signals. Upon antibody-mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.

The two targets of BL-B01D1 are broadly expressed in epithelial tumors, including NSCLC, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Gastrointestinal tumors, Gynecological tumors, and others. The therapeutic conjugated toxin of BL-B01D1 comprises SystImmune’s Ex-0115 linker-payload platform, a proprietary Top1 inhibitor conjugated to the bi-specific antibody by a stable, cleavable linker. Each BL-B01D1 carries 7-8 units of SystImmune’s proprietary ED-04 toxin.

Clinical studies conducted thus far have demonstrated compelling results for BL-B01D1. In subjects with EGFR-mutated NSCLC that have progressed on up to three lines of Standard of Care (SOC) treatments, BL-B01D1 achieved an overall response rate (ORR) exceeding 40%. Furthermore, in subjects with NSCLC with mutated EGFR, BL-B01D1 exhibited an ORR of over 60%. These findings were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023, and the abstract of the clinical study can be accessed at the following link: BL-B01D1 ASCO (Free ASCO Whitepaper) Abstract. These results underscore the potential of BL-B01D1 as an effective treatment option for patients with different molecular profiles.

On July 1, 2023 Hamlet Pharma reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Alpha1H, a highly selective synthetic peptide for treatment of non-muscle invasive bladder (NMIBC) (Press release, HAMLET Pharma, JUL 1, 2023, View Source;utm_medium=rss&utm_campaign=fda-clearance-of-ind-application-for-alpha1h-for-the-treatment-of-non-muscle-invasive-bladder-cancer [SID1234633007]). Working closely with their US based partner, Target Health LLC, a New Jersey-based, full-service CRO, the FDA’s ‘Study May Proceed’ letter begins a hopeful new chapter for the treatment of NMIBC patients globally. Studies with Alpha1H show a combination of a lack of toxicity with a high selectivity for cancerous cells, resulting in massive cell shedding in solid 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!

" This milestone for Alpha1H underscores the urgency of our mission to bring this innovative therapy to unmet needs in the treatment of NMIBC patients. The FDA’s clearance of the Hamlet IND bolsters our plans to expand clinical research in the future for this important compound." says Catharina Svanborg, Chairman of the Board/Founder, Lead Researcher.

About the Alpha1H Clinical Program – The clinical trial, now open with the US FDA, clears the path to next phases with possible future trials in the US and other international markets.

Treatment of non-muscle-invasive bladder cancer includes transurethral resection of bladder tumor (TURBT) followed by intravesical BCG immunotherapy. Alpha1H treatment acts as an ablative-type treatment for early-stage patients and is administered during the period after diagnosis and prior to TURBT. This period is usually a non-interventional period, and Alpha1H would be considered an adjuvant treatment which could benefit patients awaiting TURBT and improve outcomes.

With no toxicity detected in studies to date, Alpha1H acts as an anti-cancer therapeutic, based on a synthetic-variant of the protein-lipid complex in human breast milk, alpha-lactalbumin and oleic acid. The alpha-lactalbumin protein, known to be essential for the survival of lactating mammals, targets and killing tumor cells with great precision, Hamlet Pharma is developing this peptide-based molecular approach as an effective cancer drug pipeline with a high degree of selectivity against a variety of cancers.