On June 21, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Press release, BeiGene, JUN 21, 2022, View Source [SID1234616150]).

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The sBLA is supported by data from an interim analysis from the global RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In China, gastric cancer (GC) has become the third most common canceri and adenocarcinoma represents the major histologic subtype of GC, over 90% of reported cases across the worldii.

Lai Wang, Ph.D., Global Head of R&D at BeiGene said, "Gastric cancer is the second leading cause of cancer-related deaths in China and there are few options to treat metastatic disease. We are pleased that our rigorous clinical development program has demonstrated a survival benefit with tislelizumab and chemotherapy treatment in patients whose tumors express PD-L1 and look forward to working with regulators to bring forward this potential new treatment option."

Tislelizumab is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC. In January 2021, BeiGene announced a collaboration with Novartis to accelerate the clinical development and marketing of tislelizumab in North America, Europe, and Japan. Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for nine indications and this sBLA is the 10th regulatory submission for tislelizumab in China. Tislelizumab is not approved for use outside of China.

About RATIONALE 305 (NCT03777657)
RATIONALE 305 is a randomized, double-blind, placebo-controlled, global Phase 3 trial comparing the efficacy and safety of tislelizumab combined with platinum and fluoropyrimidine chemotherapy and placebo combined with platinum and fluoropyrimidine chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint of the trial is overall survival (OS). Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety. A total of 997 patients from 13 countries and regions across the world were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy.

About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. In January 2021, BeiGene announced a collaboration with Novartis to accelerate the clinical development and marketing of tislelizumab in North America, Europe, and Japan.

BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: View Source

BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

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 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."