REHEVA BIOSCIENCES SUCCESSFULLY COMPLETES RH324 PHASE I CLINICAL TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

2023-10-25

临床1期临床申请

Through new strategic partnerships, ReHeva hopes to implement new trials on other cancer types

COLUMBUS, Ohio, Oct. 25, 2023 /PRNewswire/ -- ReHeva Biosciences, a pioneering biopharmaceutical startup with the mission to help people live longer and healthier with cancer through naturally derived complex drugs, proudly announces the successful completion of its Phase I Safety Trial for its novel drug, RH324. This achievement marks a significant milestone for the company and its mission of advancing cancer treatment options and underscores ReHeva's commitment to revolutionizing patient care.

The Phase I trial was conducted in collaboration with Case Comprehensive Cancer Center University Hospitals and Case Western Reserve University in Cleveland. It evaluated the safety and tolerability of escalating doses of RH324 in patients diagnosed with advanced non-small cell lung cancer (NSCLC) who have failed prior treatments.

ReHeva Biosciences announces the successful completion of its Phase I Safety Trial for its novel drug, RH324.

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"At ReHeva, we are driven by a steadfast belief that cancer treatment can be transformed to help patients live longer and healthier with cancer. The completion of our Phase I clinical trial represents a tremendous milestone toward realizing this vision," said Dr. Zeenia Kaul, CEO, Co-Founder, and Chief Scientific Officer of ReHeva Biosciences. "By maximizing the potential of plant-derived agents to target multiple tissues and mechanisms of action, we are advancing the narrative of cancer treatment."

Furthermore, ReHeva's proprietary methods of drug preparation set it apart from its competitors.

Founded in 2016 by Dr. Kaul, ReHeva Biosciences draws upon more than two decades of pre-clinical research and development. The company's commitment to scientific integrity is underscored by studies published in prestigious peer-reviewed journals, cementing its role as a leading force in oncology research.

Receiving the FDA Investigational New Drug allowance (IND) in 2018 paved the way for ReHeva's Phase I Safety Study in advanced NSCLC patients designed to assess the safety and tolerability of RH324. This is an important step towards the goal of achieving an FDA approved indication for RH324 and its diverse and broad-spectrum potential benefits which empower the drug to effectively target various pathways implicated in cancer progression.

"Rigorous clinical trials evaluating naturally derived products created many of the treatments we use to fight cancer today," said Dr. Santosh Rao, Medical Oncologist and Director of Integrative Oncology at the University Hospitals, Cleveland.

Dr. Afshin Dowlati, Principal Investigator on ReHeva Study, Professor and Director of the Phase 1 Clinical Trials Program at University Hospitals Seidman Cancer Center added "Partnering with ReHeva Biosciences to evaluate the use of RH324 could provide patients with another treatment option for cancer with less toxicity."

Completion of the Phase 1 Safety and Tolerability trial means that future Phase 2 trials can address multiple cancer types. ReHeva Biosciences is looking forward to the RH324 clinical program.

The Power of Partnerships

One strategic partnership that is helping strengthen ReHeva Biosciences' mission is a pioneering vertical farming company based in Hamilton, Ohio. Recognizing the need for consistent and large-scale production of the botanical raw material is central to their research, ReHeva's collaboration with 80 Acres Farms bridges the gap between botanical drug manufacturing needs and scalable supply chain necessary for long term clinical development.

"To be successful, we need a consistent supply of high-quality botanical raw material," said Kaul. "That's why we turned to one of the most exciting new developments in agriculture—controlled environment agriculture (CEA), which promises ingredients that are clean, dependable, and unaffected by weather and the seasons. After researching the CEA space, we recognized that 80 Acres Farms had the technology platform to deliver what we need."

Utilizing cutting-edge controlled-environment agriculture CEA technology, 80 Acres Farms cultivates crops indoors, free from pesticides, while meticulously controlling growth conditions such as light, humidity, nutrients, and water. This precision results in optimal plants for clinical use, forming a reliable supply chain for ReHeva's groundbreaking research. This strategic partnership exemplifies ReHeva's commitment to innovation, as both entities collaborate to pioneer next-generation agricultural tools and technologies.

"As indoor farmers, we're invested in challenging conventional wisdom, when the data supports it," said Mike Zelkind, CEO and co-founder of 80 Acres Farms. "ReHeva is doing innovative work with plant-derived ingredients at the foundations of modern medicine. We can support that work by growing plants with pharmaceutical precision, year-round—enabling traceability, consistency, and scaling."

Partnerships play a critical role in ReHeva Biosciences work to leverage cutting-edge technology to explore the potential of botanical-based drugs in treating a range of conditions, including cancer. The company is currently exploring educational partnerships with universities including MD Anderson Cancer Center Cancer Center, The Ohio State University and Emory University. Through grants, ReHeva will be able to run additional clinical trials on other cancers to continue proving effectiveness and safety in treating this disease.

A testament to its groundbreaking endeavors, ReHeva Biosciences has garnered over $7 million in funding. To learn more about the transformative work at ReHeva Biosciences, visit ReHevaBiosciences.com.

About RH324

RH324 is an investigational new drug manufactured by ReHeva Biosciences. The botanical drug substance retains a "full spectrum" of the plant's natural constituents: proteins, amino acids, various fatty acids, carbohydrates, and vitamins, minerals, and phytochemicals. RH324 is being developed in accordance with the FDA Guidance for Industry for Botanical Drug Products (Chemistry June 2004/revised Dec 2016).

About ReHeva Biosciences

Founded in 2016, ReHeva Biosciences is a clinical-stage, biopharmaceutical company focused on discovering and developing naturally occurring complex drugs to help people live longer and healthier with cancer. ReHeva is committed to finding the ideal botanical raw material and drug development processes through rigorous and advanced agriculture practices.

SOURCE ReHeva Biosciences