On June 21, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported a new collaboration with HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data (RWD), that will expand Labcorp’s comprehensive, end-to-end drug development and clinical trial programs (Press release, LabCorp, JUN 21, 2022, View Source [SID1234616118]).

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HealthVerity’s IPGE platform, an integrated technology and RWD infrastructure, enables Labcorp Drug Development and other participating companies to access fully interoperable, HIPAA-compliant data from the U.S.’s largest ecosystem1 of health care and consumer data.

"This collaboration allows Labcorp to expand existing end-to-end solutions for drug and diagnostics development, commercialization and clinical trial efforts to include large-scale access to real-world data for research applications," said Dr. Paul Kirchgraber, CEO of Labcorp Drug Development. "By applying advanced analytics, Labcorp can help its clients improve their processes and reach better outcomes. Our substantial repository of test results can also help study sponsors more quickly and accurately assess patient eligibility for clinical trials, enroll patients faster and accelerate the availability of new medicines."

Now more than ever, study sponsors are seeing the potential of RWD to yield longitudinal patient insights before, during and after trials. With more predictive analytics and artificial intelligence applications requiring comprehensive and fully interoperable RWD, Labcorp can align de-identified patient data with ten times greater accuracy2 than industry alternatives by using the HealthVerity IPGE platform. In addition, access to HealthVerity’s RWD with on-demand de-identification and data linkage capabilities reinforces Labcorp’s ability to be a trusted source of information for its clients.

"Fragmentation of patient data is at an all-time high, and the goal is no longer just connecting this data," said Andrew Kress, CEO of HealthVerity. "Rather, the goal is making data more accessible and useful for gaining a detailed understanding of patient journeys. With analytics and applications requiring more frictionless access to the data itself, the HealthVerity IPGE platform stands alone in offering the ability to combine transaction-level patient data in a de-identified, fully interoperable manner, and delivering it directly into the client’s applications of choice."

Labcorp is an investor in HealthVerity through the Labcorp Venture Fund.

On June 21, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND AI (artificial intelligence) and data mining platform to discover and develop cell therapies with a focus on immuno-oncology, reported a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT (Press release, Kiromic, JUN 21, 2022, View Source [SID1234616135]).

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Kiromic expects to submit its first new investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022. The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with the expected beginning of trial activation by year-end. Deltacel consists of Gamma Delta T-cells (GDT) that are expanded, enriched, and activated through a proprietary method. Kiromic will also pursue INDs for its Procel and Isocel product candidates in combination with a standard antitumor modality in 2023.

These three additional IND filings will expand the Company’s pipeline to five allogeneic GDT clinical trials and three product candidates.

This reprioritization and expansion of Kiromic’s pipeline follows a recently announced sponsored research agreement to generate in vivo preclinical data. The Company believes that, through this agreement, we will be able to efficiently generate data for our GDT allogeneic therapies and other pre-clinical assets to support our anticipated IND filings.

"We are well positioned to prioritize Deltacel/KB-GDT in combination with a standard antitumor modality as our first IND, which we intend to submit to the FDA during the second half of this year with the expected beginning of trial activation by year-end. We believe that this shift both de-risks and accelerates our immediate path forward, enabling us to advance our non-viral, non-engineered product candidate while also reducing costs and mitigating current supply chain headwinds associated with a virus-based approach," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"Against the backdrop of a global cancer cell therapy market that’s expected to exceed $33 billion by 2027, Kiromic’s product pipeline now encompasses three additional Gamma Delta T-cell therapeutic candidates, Deltacel, Procel, and Isocel. Each is being developed to target solid tumors – which represent 90% of all cancers – and each is ideally positioned to address unmet medical needs. We look forward to advancing these candidates into the clinic with the goal of providing new treatment options to patients with cancer," added Mr. Bersani.

These three IND applications will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials (see accompanying graphic), including:

New IND #1: Deltacel in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the fourth quarter of 2022
New IND #2: Procel in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the second quarter of 2023
ALEXIS – PRO-1 Procel as a monotherapy, with clinical activation expected to begin by the end of second quarter 2023
New IND #3: Isocel in combination with a standard antitumor modality, targeting clinical activation to begin by the end of the fourth quarter of 2023
ALEXIS – ISO-1 Isocel as a monotherapy, targeting clinical activation to begin by the end of the fourth quarter of 2023

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."