On June 21, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early, when it can be cured, and Fountain Health Insurance ("Fountain Health") reported a partnership that will offer Galleri, GRAIL’s multi-cancer early detection (MCED) blood test, to Fountain Health customers at 100% coverage as part of its annual wellness benefits (Press release, Grail, JUN 21, 2022, View Source [SID1234616151]).

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"Our partnership with GRAIL is an outstanding opportunity to change the health story for thousands of people by finding cancer early so we can improve outcomes. However, saving the life of an employee or loved one is what truly will make this transformative. What better gift could you give to your employees?" says Robert J. Rossiter, chief executive officer at Fountain Health.

The Galleri test is a first-of-its-kind MCED blood test. In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also determines the origin of the cancer signal, which can then guide diagnostic workup. Early detection of cancer has been demonstrated to improve cancer outcomes, yet today, the majority of cancers are detected in late stages because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers.

"We applaud Fountain Health for its commitment to proactive care and finding cancer earlier, when treatment is more likely to be successful," said Bob Ragusa, chief executive officer at GRAIL. "By offering the Galleri test and covering it at 100%, Fountain Health is helping ensure more people have access to critical health information that could give a better chance of surviving cancer, which still claims the lives of more than 600,000 people annually in the U.S."

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.

On June 21, 2022 Phynova Group Ltd and Ingredients Plus reported a distribution partnership for Reducose, for use in Supplement applications to customers in Oceania (Press release, Phynova, JUN 21, 2022, View Source [SID1234616120]). Reducose is Phynova’s patented and clinically researched White Mulberry leaf extract that supports significant lowering of post-meal blood sugar and insulin response as well as enabling food and beverage applications to become Low GI.

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Stephane Ducroux, CEO at Phynova, said: "We are delighted to have a distribution partnership with Ingredients Plus. Phynova’s strategy is to partner with market focused experts such as Ingredients Plus, who have a proven track record of building deep customer relationships and using ingredients with a strong science like Reducose.

Peter Schwarczer, Business Manager at Ingredients Plus said: "We are excited to partner with Phynova by bringing a unique ingredient into the ANZ market and we look forward to a long-term and fruitful cooperation."

On June 21, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported the publication of a peer-reviewed journal article in Clinical and Experimental Vaccine Research (Press release, Anixa Biosciences, JUN 21, 2022, View Source [SID1234616136]). The article is titled, "Formulation of an ovarian cancer vaccine with the squalene-based AddaVax adjuvant inhibits the growth of murine epithelial ovarian carcinomas." This paper authored by Suparna Mazumder, Ph.D., Valerie Swank, MS, Nina Dvorina, MD, Justin M. Johnson, Ph.D. and Vincent K. Tuohy, Ph.D. of Cleveland Clinic, discusses pre-clinical studies of a preventative ovarian cancer technology that has been licensed to Anixa.

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This ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. However, AMHR2-ED is expressed again in the majority of ovarian cancers.

The journal article highlights study data demonstrating formulation of the AMHR2-ED vaccine with AddaVax adjuvant induced high serum titers of immunoglobulin G and significant inhibition and destruction of epithelial ovarian cancer with significantly enhanced overall survival of animals in both prevention and therapeutic protocols.

Anixa’s CEO, Amit Kumar, Ph.D., stated, "We are pleased by the publication of this scientific paper authored by our partners at Cleveland Clinic. This unique technology has the potential to be the first vaccine to prevent ovarian cancer, which remains one of the most aggressive and difficult-to-treat cancers." Dr. Kumar added, "Preclinical work to advance the vaccine is ongoing with support from the PREVENT Program at the National Cancer Institute (NCI), which supports preclinical innovative interventions and biomarkers for cancer prevention and interception."

The Clinical and Experimental Vaccine Research article is available to view at the following link: View Source

On June 21, 2022 Novocure (NASDAQ: NVCR) reported the first patient has been enrolled in its phase 2 pilot KEYNOTE-B36 study, conducted in collaboration with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA (Press release, NovoCure, JUN 21, 2022, View Source [SID1234616152]). KEYNOTE-B36 is designed to evaluate the safety and effectiveness of Tumor Treating Fields (TTFields) together with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, for the first-line treatment of locally advanced or metastatic intrathoracic non-small cell lung cancer (NSCLC) that expresses PD-L1 .

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"This is an important next step for our thoracic program," said William Doyle, Novocure’s Executive Chairman. "KEYNOTE-B36 represents one of Novocure’s five ongoing clinical trials exploring the potential of Tumor Treating Fields to complement immunotherapy agents. We look forward to continuing our studies in partnership with Merck in hopes of treating many more patients in need."

KEYNOTE-B36 is a single arm, open-label phase 2 pilot study expected to enroll 66 patients. The primary endpoint of the study is objective response rate. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate and frequency and severity of adverse events.

About Non-small Cell Lung Cancer
Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S.

Physicians use different combinations of surgery, radiation therapy and systemic therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy has been the first-line standard of care for locally advanced NSCLC and systemic therapy alone for those with metastatic disease. Certain immune checkpoint inhibitors have recently been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 24,000 patients have been treated with TTFields therapy.

The NovoTTF-200T is an investigational device for the treatment of NSCLC. Safety and efficacy have not been established for this indication.