On June 21, 2022 Immuneel Therapeutics (‘Immuneel’), India’s leading biotech start-up focused on creating access to Chimeric Antigen Receptor T cell therapy (CAR-T) and other cellular immunotherapies for the management and treatment of cancers, reported that it has begun patient dosing in a CAR-T trial named "IMAGINE" (Press release, Imuneel, JUN 21, 2022, View Source [SID1234618846]). This phase II trial is the first industry sponsored CAR-T trial in India and is now actively enrolling patients at Narayana Hrudayalaya, Bengaluru.
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Founded in 2019 by Biocon founder and chairperson Kiran Mazumdar-Shaw, Dr. Siddhartha Mukherjee, eminent U.S oncologist and author of the Pulitzer prize winning novel, "The Emperor of All Maladies: A Biography of Cancer", and Dr. Kush Parmar, Immuneel is on a mission to bring cell and gene therapy programs, especially with clinical data, to India at an affordable cost. With a focus on maintaining global standards, the company is developing cutting edge programs, delivered through partnerships with leading hospitals. In 2021, the company had established the first cGMP-approved integrated cell therapy development and manufacturing facility at the Mazumdar-Shaw Cancer Centre at Narayana Health City (Bengaluru).
"Today, we are extremely proud to be able to demonstrate our focus on scientific rigor as well as clinical and manufacturing excellence by bringing CAR-T therapy to the clinic through our IMAGINE trial. This trial marks an important step forward for us in delivering transformational cell-based immunotherapies to patients, truly enabling our patients with potential cure. IMAGINE opens a world of possibilities. With our successful Series A funding, we are excited to continue building our innovation and clinical delivery engine with our investors, given their excellent track record, particularly in global healthcare and innovation." commented Dr. Arun Anand, Director & Chief Operating Officer, Immuneel Therapeutics.
CAR-T therapies, previously not available in India, have shown promising results for patients who have exhausted all other means of treatment in a range of blood cancers. These therapies are available internationally at USD 350K+ per dose, making the IMAGINE trial the first step towards bringing affordable treatments with global quality and clinical data to patients in India. The IMAGINE trial is funded by Immuneel and will include up to 24 pediatric and adult cancer patients. Immuneel has exclusive rights to ARI-0001/IMN-003A (a CD-19 CAR-T cell therapy) from Hospital Clínic de Barcelona and Institut d’Investigacions Biomèdiques August Pi i Sunyer in Spain to develop, manufacture and commercialize in India via technology transfer. ARI-0001 is approved by the Spanish Drug Agency (AEMPS) and the data available compares very favorably with U.S FDA approved products.
Ms. Kiran Mazumdar Shaw, Co-Founder & Director, Immuneel Therapeutics reacted, "This milestone is significant in building an eco-system to accelerate and make cell therapies accessible to patients in India, in line with global standards at affordable and disruptive costs. Personalized cell therapies are in their nascency the world over and we have an opportunity to differentiate through partnerships and cutting-edge innovation." Page 2 of 3 "CAR-T cell therapy in the U.S started a decade ago and has proven to be advantageous for patients who relapse following leukaemia or lymphoma treatment despite its cost which is beyond the means of most people, including Indians. With Immuneel setting up India’s first integrated center and making CAR-T therapy here at Narayana Health City (Bengaluru), we hope to reach thousands of patients in need. I would like to thank Immuneel for partnering with us for the first Phase 2 CT in India and bringing this breakthrough cancer treatment to India affordably." added Dr. Devi Shetty, Chairman, Narayana Health.
Dr. Siddhartha Mukherjee, Co-founder & Director, Immuneel Therapeutics added: "This trial will demonstrate the success of cutting-edge breakthrough CAR-T cell therapy in cancer treatment and give hope to many patients in need. Now cancer patients in India can look forward to having access to CAR-T cell therapy manufactured in India which has revolutionized cancer treatment globally."
"IMAGINE has opened up doors to a second chance at life with potential cure, both for children and adults with terminal blood cancers, and we are very excited to have this opportunity to participate in this key trial with Indian patients for a global quality product," said IMAGINE’s Principal Investigators Dr. Sharat Damodar and Dr. Sunil Bhat at Narayana Health.
In April, this year, Immuneel successfully raised close to US$ 15 million in a Series A financing round, co-led by Eight Roads Ventures, True North Fund VI LLP and F-Prime Capital, along-with contributions from other existing investors. These funds will enable the company to advance its development pipeline and scale.
Commenting on the funding, Dr. Kush M Parmar, Co-founder, Immuneel Therapeutics added, "Our goal is to provide patients in India with potentially transformative therapies and enable affordable access to CAR-T and other complex therapies. As we advance our lead programs, this financing will also allow us to continue building a committed and quality enterprise for global innovators to consider partnering with us to enable access for patients in the region."
About CD19 CAR-T cell therapy CD19 CAR-T therapy is an adoptive autologous antitumor immunotherapy for patients with resistant or refractory CD19 positive leukemia or lymphoma. This autologous product consists of a suspension of T-cells obtained from a patient, activated & genetically modified to express a chimeric antigen receptor (CAR) on its surface, in this case CD19. CAR-Ts typically consist of a binding domain, a transmembrane domain, and co-stimulatory molecules. Four CD19 CAR-T products have been approved so far globally. IMN-003A is Immuneel’s CD19 CAR-T licensed from HCB/IDIBAPS with established Phase 1 safety & efficacy data in Spain.