On August 25, 2022 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases reported 2022 interim results and major company updates (Press release, Innovent Biologics, AUG 25, 2022, View Source [SID1234618686]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "This year was a watershed year of Innovent for next decade of development. For the past decade, Innovent has developed itself with an established platform foundation, sustained strong execution and favorable financial position. In 2022 to date, we continue to make remarkable progress in commercialization, product development, business collaboration and CMC under adherence to our long-term strategy of global innovation. Meanwhile, as one of China’s leading innovative biopharmaceutical start-ups, Innovent made a pioneering deployment to explore and develop a more sustainable business model via optimizing organizational structure and enhancing refined management capabilities, with aim to support our company’s long-term strategies more efficiently. We will continue to enhance drug R&D capability, expand global R&D team and promote global innovation and development, meanwhile expanding our commercial portfolio and improving business benefits and performance to create sustainable value for patients, employees, shareholders and the society."

Business Highlight Overview

For the first half of 2022: RMB2,240million total revenue, including RMB2,041million product revenue at 10.0% growth compared with the same period of prior year
– Commercial portfolio increased to seven products; new approvals of additional indications and in new territories attained for marketed products.
– TYVYT is successfully included in the updated National Reimbursement Drug List (NRDL) for three additional first-line indication for major types of cancer in beginning of 2022; and is approved for first-line treatment of two additional indications, i.e. esophageal cancer (ESCC) and gastric cancer (GC) in June 2022.
Upgrading commercial model and platform to 2.0 stage, actively seek to establish a more agile and lean organization with more refined, systematic and scientific management, aiming to further increase output and improve efficiency.
Unleashing the platform value and unique competitive advantages, solicit more in-depth strategic collaborations with global pharmaceutical companies such as Lilly and Sanofi to accelerate the pace of innovation.
Insisting on global innovation strategy with acceleration of clinical development and data readout
– 7 molecules at NDA or late clinical stage
– Oncology pipeline achieved preliminary positive Proof of Concept (PoC) data readouts for multiple global innovative molecules
– The non-oncology field entered into the harvest period with encouraging Phase 2 studies data readouts and registraitional clinical trials in plan for two potentially Best-in-Class molecules
Commercial – Product Sales Volume Fast Ramp-up and Commercial Platform Upgraded

Expansion of commercial portfolio into seven approved products, including: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, NAILIKE and CYRAMZA.
Product revenue RMB2,041 million in H1 2022: an increase of 10.0% compared with the same period of the prior year with fast ramp-up of product volume and synergic value unleashing.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 people.
Upgraded commercial model and platform to 2.0 stage:
– Upgraded the commercialized business structure, operated in a more professional and precise BU model, and gradually established a more efficient marketing system.
– Created a good operational capability and model, which will effectively increase the sales scale while improving efficiency and revenue, thereby better supporting the company’s long-term sustainable business development.
Pipeline – 34 Valuable Assets, Data Readout for High-Potential Molecules

Valuable pipeline consisted of 7 products approved for marketing in China, 3 assets under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 20 molecules in clinical studies

Oncology: Robust pipeline with 25 assets covering broad cancer types

TYVYT as leading brand in PD-(L)1 market:
– 3 additional indications successfully included in the NRDL, including non-squamous non-small cell lung cancer (NSCLC), squamous NSCLC, and hepatocellular carcinoma (HCC).
– 2 additional indications approved for 1L ESCC and 1L GC.
Two NDA stage and multiple pivotal stage assets:
– Retsevmo (selpercatinib), NDA accepted
– IBI-326 (BCMA CAR-T), NDA accepted
– IBI-310 (CTLA-4)
– IBI-344 (ROS1/NTRK)
– IBI-376 (PI3Kδ)
– IBI-126 (CEACAM5 ADC)
Multiple global innovative molecules rolled out preliminary positive data:
– IBI-110 (LAG3): 1L sqNSCLC, 1L GC
– IBI-188 (CD47): 1L MDS
– IBI-351 (KRASG12C): NSCLC, CRC
– IBI-344 (ROS1/NTRK): NSCLC
Non-Oncology: Differentiated 9 molecules represents long-term growth potential

One NDA accepted and expected to be the second non-oncology product:
– IBI-306 (PCSK9), NDA accepted
Robust Phase 2 studies data readout and registrational trials in plan for two potential Best-in-Class molecules:
– IBI-362 (GLP-1/GCGR): Phase 2 studies data readout in obesity and type 2 diabetes, showing robust efficacy in weight loss, blood glucose lowering and multiple metabolic benefits. Plan to initiate Phase 3 studies for both indications in late 2022 to early 2023.
– IBI-112 (IL-23p19): observed significant efficacy signal in the Phase 2 study for psoriasis with long-acting potential and long dosing interval convenience. Plan to initiate Phase 3 study in the second half of 2022.
R&D: Global Innovation Continues as Long-term Strategy

Innovent US and global product development team enhancement:
– Full operation of Innovent US: 300 Scientists of Innovent Academy based in China and the US work closely in the preclinical research project with focus on global innovation and cutting edge technologies, sustainably providing novel molecules into clinical development stage.
– Full-function overseas development and registration team established: as important part of the company’s global product development platform, the team join and undertake the long-term strategy of global pipeline development.
Continue to progress global clinical development projects:
– First-in-human clinical studies to initiate in Australia for IBI-363 (PD-1/IL2) and IBI-343 (CLDN18.2 ADC) in H2 2022
– IND approved by the US FDA for the Phase 1 platform study for the treatment of melanoma
Breakthrough achievement for oversea market access:
– BYVASDA (Indonesian trademark: Bevagen) was approved by the Indonesian Food and Drug Administration (BPOM) and is expected to be the first Chinese anti-body drug to be commercialized and locally manufactured in Southeast Asia markets.
BD: Unique Competitive Advantages to Solicit More In-Depth Strategic Cooperation

Entered into strategic collaboration with Sanofi to benefit more patients in China and initial equity investment of EUR300 million made by Sanofi in Innovent. Both companies are committed to accelerating the development and commercialization of clinical Phase 3 stage SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody drug conjugates) and clinical Phase 2 stage SAR444245 (non-alpha IL-2) in China.
Expanded oncology strategic partnership with Lilly: Innovent obtained the sole commercialization right of Cyramza (ramucirumab) and Retsevmo (selpercatinib) in Mainland China, and the right of the priority negotiation for future commercialization of Pirtobrutinib (BTK inhibitor) in Mainland China.
CMC: High-Quality and Scalable Manufacturing Capabilities

60,000L production capacity which is currently the largest stainless steel production capacity in China with more capacity construction in plan
Quality compliance to GMP and cost advantage further strengthen market competitiveness
Financial Highlights for H1 2022

Total revenue was RMB 2,240 million, an increase of 15.3% compared to the same period of the prior year.
R&D expenses were RMB1,078 million, an increase of 22.5% compared to the same period of the prior year.
Loss for the year was RMB1,085 million, mainly due to continuous investment in R&D.
Cash on hand and short-term financial assets was approximately USD1.5 billion, which enables strategical focus on the long-term development.[1]

On August 25, 2022 CDx Diagnostics, Inc. reported that the WATS3D diagnostic platform has been incorporated in the American Gastroenterological Association (AGA) Clinical Practice Update (CPU) on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review, published in Clinical Gastroenterology and Hepatology (Press release, CDx Diagnostics, AUG 25, 2022, View Source [SID1234618685]). WATS3D uses a unique wide-area sampling instrument, proprietary 3D imaging with AI analysis, and expert pathologists to reliably identify abnormal cells to help physicians prevent esophageal cancer.

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"The CPU is based on a thorough review of the existing clinical literature and expert opinion. It includes several Best Practice Advice statements intended to provide gastroenterologists with real-world, actionable, practical advice on the management of BE," said Vivek Kaul, MD, FACG, FASGE, AGAF, Segal-Watson Professor of Medicine, Division of Gastroenterology, University of Rochester Medical Center. "The inclusion of WATS3D in this update is an important addition and presents an opportunity for clinicians to potentially increase their detection of BE and esophageal dysplasia, both endoscopically treatable precursors to one of the fastest growing and most fatal cancers in the United States."

WATS3D technology helps overcome the limitations associated with traditional upper endoscopy screening and surveillance methods. The CPU highlights some WATS3D clinical evidence, which demonstrated an increased yield for dysplasia detection, and that pathologic interpretation of these specimens has been shown to have significantly higher interobserver agreement, with a kappa of 0.86.

"CDx is committed to providing physicians with an AI-based diagnostic solution that empowers them to prevent esophageal cancer," said Bill Huffnagle, CEO of CDx Diagnostics. "The clinical value of adding WATS3D to the upper endoscopy screening and surveillance protocol has now been recognized by 4 major medical societies (AGA, ASGE, AFS, and SAGES). This is a significant accomplishment for CDx which underscores the clinical value of WATS3D and its continued role in preempting this potentially life-threatening disease, one patient at a time."

On August 25, 2022 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) reported development of a novel immunotherapy for treatment of solid tumors (Press release, Regen BioPharma, AUG 25, 2022, View Source [SID1234618684]). Current cellular approaches to kill cancer involve administration of a specific type of modified T cell called "chimeric antigen receptor" (CAR) T cell . Despite significant progress being made in using CAR-T cells to treat leukemia, little progress has been made in solid tumors such as those found in lung, brain, breast, prostate and colon. It is believed that solid tumors possess an abnormal "microenvironment" which physically prevents T cells from entering the tumor, as well as inactivating T cells that do manage to enter. The microenvironment consists of surrounding blood vessels, immune cells, fibroblasts, signaling molecules and an extracellular matrix. The solid tumor is surrounded by its microenvironment and constantly interacts with it.

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The current approach developed by the Company, for which a provisional patent application has been submitted, involves initial treatment of the tumor microenvironment with cells of the innate immune system called CAR-M and CAR-NK cells. These cells, which also begin to attack the tumor, are able to "normalize" the tumor microenvironment, thus allowing CAR-T cells to enter and attack the tumor.

"The company believes that taking this two-step approach – first softening up the target with CAR-M and CAR-NK cells and then bringing in the heavy artillery (CAR-T cells) will allow solid tumors to be successfully targeted by these cell therapies, thus greatly expanding the CAR-T market and ultimately saving people’s lives," said Dr. David Koos, CEO and Chairman of the Company.

On August 25, 2022 IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Engineering in Medicine and Biology Society (EMBS), reported the publication of a report that demonstrates how a new 3D screening tool can help accelerate the development of cancer treatments through a new testing method that increases the number of tests on solid tumor samples by up to 50 times and potentially facilitates larger-scale testing of innovative immunotherapies (Press release, IEEE, AUG 25, 2022, View Source [SID1234618683]). The report, derived from research led by the University of Strathclyde in Glasgow, Scotland, has been published in IEEE Open Journal of Engineering in Medicine and Biology, and is freely available for open access and full-text viewing by all readers around the world.

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The report, "Assessment of CAR-T Cell-Mediated Cytotoxicity in 3D Microfluidic Cancer Co-Culture Models for Combination Therapy," which also is available in the IEEE Xplore digital library, details a more-than-two-year study of screening 3D tumor models with a miniaturized technology platform to evaluate the toxicity of genetically engineered Chimeric Antigen Receptor T (CAR-T) cells used in immunotherapies. Researchers at the University of Glasgow and the Cancer Research UK Beatson Institute in Glasgow also contributed to the study.

"Our study illustrates the promise of our microfluidic technology platform to accelerate the development of leading-edge therapies by enabling 20 to 50 times more experiments to be performed on a solid tumor sample," said Dr. Michele Zagnoni, a reader in Strathclyde’s Department of Electronic and Electrical Engineering, who led the study along with doctoral student Karla Paterson. "CAR-T cell development is typically very expensive, and our research indicates that the miniaturized 3D modeling we employed, which is not yet widely established in the pharma industry, could facilitate significantly more effective and cost-efficient developmental immunotherapies. We look forward to seeing its life-saving impact in preclinical drug testing and, ultimately, precision medicine in the clinic."

Solid tumors are complex environments including both cancerous and noncancerous cells. The IEEE Open Journal of Engineering in Medicine and Biology report details how the microfluidic technology in the study effectively enabled visualization and quantification of the ability of CAR-T cells to rapidly kill the cancer cells without significantly harming the other cells in a tumor sample. The research also revealed that the efficacy of chemotherapies can be improved when combined with CAR-T cell treatment. The deep look into how CAR-T cells do their work was enabled by the 3D models used in the Strathclyde study, which more closely reproduce the complexity of actual tumor microenvironments in the human body than is possible via legacy 2D modeling.

"This report is of equally keen interest to engineers and scientists in medicine and biology. We look forward to further spurring the conversation with more papers of this type and in this topic area," said Paolo Bonato, editor-in-chief of IEEE Open Journal of Engineering in Medicine and Biology. "IEEE EMBS has a valuable transdisciplinary dimension with substantial interaction among expertise across diverse technology areas, and, so, we publish papers both where the main emphasis is on methodology and technology and where the main emphasis is on science. Bridging these two worlds with an open-access journal is crucial to advancing innovative research into concrete, real-world benefit to society."

On August 25, 2022 Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with cancer and autoimmune disease by harnessing the power of single-cell RNA sequencing and human biology at scale, reported the appointment of Sarah Grant, M.D., as chief medical officer (Press release, Celsius Therapeutics, AUG 25, 2022, View Source [SID1234618682]). In this role, Dr. Grant will lead the company’s clinical strategy and development of its pipeline of therapies for autoimmune disease and cancer, including its potential first-in-class TREM1 antibody program for inflammatory bowel disease.

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"I am delighted to welcome Sarah as our first chief medical officer," said Tariq Kassum, M.D., president and CEO of Celsius. "Sarah brings deep translational and clinical medicine expertise to Celsius, with more than two decades of experience working across multiple therapeutic areas and all stages of drug development, which will be instrumental as Celsius transitions into a clinical-stage company. We look forward to her important contributions in advancing our pipeline of precision medicines in autoimmune disease and cancer."

Dr. Grant is an accomplished physician-scientist who brings to Celsius more than 20 years of experience in translational medicine, early and late-stage drug development, and clinical medicine. Prior to Celsius, Dr. Grant spent nine years at Novartis in multiple senior leadership roles, most recently as the chief of staff and strategic assistant for the head of global drug development. Previously at Novartis, she was head of respiratory discovery within translational medicine. She began her career at Novartis leading multiple early-stage clinical programs focused in pulmonary and immunology indications. Prior to Novartis, Dr. Grant was on the faculty at Harvard Medical School and was an attending physician at the Brigham and Women’s Hospital. Dr. Grant completed her internship and residency at the Brigham and Women’s Hospital. She holds an M.D. from Stanford University School of Medicine and an A.B. from Harvard University.

"Through deep analysis of proprietary and meticulously curated datasets from human tissue samples, Celsius has pioneered a new path to understand the cells that drive disease progression for heterogeneous diseases with complex disease biology," said Dr. Grant. "This approach unlocks novel insights into targets and patient subsets, with the potential to deliver the right therapeutics to the right patients. I am so excited to join Celsius at this important time as the company translates these novel insights into its first clinical programs."