On April 6, 2022 Lunit reported the presentation of two abstracts featuring its AI research on cancer treatment at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Lunit, APR 6, 2022, View Source [SID1234611545]). The meeting will be held from April 8 to 13 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. This year marks Lunit’s fourth time presenting its findings at AACR (Free AACR Whitepaper).

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As a leading provider of state-of-the-art cancer diagnostic technology, Lunit has focused on developing novel AI biomarkers for application in immunotherapy. Since 2019, the company has released groundbreaking findings based on its AI-powered tissue analysis platform, ‘Lunit SCOPE,’ demonstrating the software’s predictive value in identifying patients eligible for immunotherapy. The upcoming AACR (Free AACR Whitepaper) presentations will showcase Lunit’s AI biomarker platform, Lunit SCOPE IO—part of the Lunit SCOPE product line.

Lunit SCOPE IO analyzes a patient’s cancer tissue slide image by observing the distribution of tumor-infiltrating lymphocytes (TIL)—one of the representative immunocytes that fight cancer cells. Based on the spatial distribution pattern of TILs and cancer cells in the tumor microenvironment, Lunit SCOPE IO identifies the tissue sample as one of three immune phenotypes: inflamed, immune-excluded, and immune-desert.

In one of its abstracts, Lunit presents the correlation between its AI-based immune phenotype method and aberrant transforming growth factor-beta (TGF-B) pathways in pan-carcinoma.

For TILs to fight cancer cells, they must be located in proximity to each other. The aberrant TGF-B pathway in the tumor environment has been highlighted as one of the core resistance pathways that inhibit immunotherapy by excluding TILs from the tumor area. This type of distribution is classified as the immune-excluded phenotype, in which TILs are separated from the cancer cells.

Upon conducting a large-scale, pan-carcinoma analysis, Lunit’s research team found that an aberrant TGF-B pathway is indeed associated with the immune-excluded phenotype, as well as increased proportions of cancer stroma.

"This was a multi-omics study incorporating genome-based analysis that shows a direct correlation between immune phenotypes with the TGF-B pathway," said Chan-Young Ock, Chief Medical Officer at Lunit. "By developing our AI to analyze TIL and their spatial relationship with cancer stroma, Lunit was able to initiate the first study that directly compares immune phenotypes and TGF-B expression on a large-scale database."

The company will also deliver an oral presentation on the distinct clinical outcomes and molecular profiles among immune phenotypes in endometrial cancer.

Lunit’s studies thus far first focused on the validity of immune phenotyping as a biomarker for advanced non-small cell lung cancer (NSCLC). However, this study demonstrates that similar AI-based spatial analysis can bring clinically significant results as a biomarker in endometrial cancer.

The study aimed to analyze the differences between the three immune phenotypes in endometrial cancer using clinical data, pathological slides, and genetic expression registered in the National Cancer Institute’s "The Cancer Genome Atlas" (TCGA). Results indicated that the inflamed phenotype (TILs located close to cancer cells) showed the best overall survival outcome. Furthermore, this particular phenotype was associated with the highest expressions of PD-L1 and CTLA4—immune checkpoint proteins that act as important biomarkers in predicting immunotherapy response.

"Given the significant differences in survival outcome depending on each phenotype, AI-based tumor microenvironment classification using Lunit SCOPE IO may serve as a clinically significant, prognostic biomarker in endometrial cancer," said Brandon Suh, CEO of Lunit. "We plan to expand the range of our research to validate the efficacy of Lunit SCOPE IO in all cancer types originating from the epithelium."

The Lunit team will be exhibiting at AACR (Free AACR Whitepaper), at booth 1364.

On April 6, 2022 Biocytogen subsidiary Eucure Biopharma reported the first patient dosing for a phase I clinical trial (No. YH003005) of YH003 (anti-CD40 monoclonal antibody, mAb) in combination with YH001 (anti-CTLA-4 mAb) and pembrolizumab (anti-PD-1 mAb) in Australia (Press release, Eucure, APR 6, 2022, View Source [SID1234611543]).

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The study is an open-label, dose-escalation study designed to evaluate the safety, tolerability and efficacy of YH003 in combination with YH001 and pembrolizumab in patients with advanced solid tumors. Pharmacokinetics and immunogenicity of YH003 will also be evaluated.

"Previous phase I clinical trials of YH003/Toripalimab (anti-PD-1 mAb) combination therapy and YH001/Toripalimab combination therapy indicate desirable safety profiles and preliminary efficacy for both products," said Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma. "The combination of CTLA-4, PD-1 and CD40 mAbs is based on their different but complementary biological mechanisms; we hope that the three-drug combination study can further strengthen the antitumor efficacy to benefit patients."

About YH003

YH003 is a humanized IgG2 agonistic CD40 antibody. Whether used as a single agent or in combination with anti-PD-1 mAb drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicate that YH003 significantly increased the infiltration of anti-tumor T cells into tumors.

About YH001

YH001 is an anti-CTLA-4 monoclonal antibody. CTLA-4 is a key target for tumor immunotherapies, due to the potential to enhance the immune response to tumor cells and promote removal of regulatory T cells (Treg) from the tumor microenvironment. Blocking the inhibitory signals from both CTLA-4 and PD-1 to enhance the anti-tumor responses is considered a promising tumor immunotherapy, as they control the different types of T cells.

On April 6, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that it has entered into a memorandum of understanding for a partnership with China Resources Pharmaceutical Group Limited (HKEX 3320.HK, "CR Pharma") with the intent to establish an independent company ("the mRNA Co.") focused on the discovery, development and commercialization of messenger RNA ("mRNA") vaccines (Press release, Everest Medicines, APR 6, 2022, View Source [SID1234611541]).

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CR Pharma is a subsidiary of China Resources (Holdings) Co., Ltd, a key state-owned enterprise overseen by China’s State-owned Assets Supervision and Administration Commission of the State Council (SASAC). CR Pharma is an integrated pharmaceutical company in China, engaging in the R&D, manufacturing, and distribution of pharmaceutical products. Their products include chemical drugs, traditional Chinese medicine, biological drugs and supplements, which cover a wide range of treatment fields, including the cardiovascular system, digestive tracts, metabolism, large-volume intravenous infusion, pediatrics, the respiratory system, Coagulation disorders and immune diseases, etc.

Through this proposed partnership with CR Pharma, the mRNA Co. will be well-positioned to advance its potentially best-in-class mRNA vaccine candidates through Chinese regulatory pathways and into commercialization. Under the terms of the MOU, the mRNA Co. will be a fully functional, independent operating company, by assuming the rights under the existing collaboration with Providence Therapeutics Holdings Inc. ("Providence"), including the full technology platform, as well as Everest’s mRNA manufacturing infrastructure. Everest will be the majority and controlling shareholder of the mRNA Co.

The mRNA Co. will accelerate the late-stage development and registration of its potentially best-in-class mRNA COVID-19 vaccine candidate, PTX-COVID19-B, and continue the development of a second-generation COVID-19 vaccine with broad spectrum activity designed to be effective against but not limited to the Omicron variants, as well as two Collaboration Project with Providence that target new mRNA based vaccines. The mRNA Co. will also continue to advance the construction of Everest’s global GMP manufacturing site in Jiashan, Zhejiang Province, which is expected to be operational by the end of 2022. Once complete, the first phase of manufacturing will be dedicated to PTX-COVID19-B, with an expected annual capacity of 700-800 million doses.

CR Pharma comments that through this cooperation with Everest Medicines, the two companies intend to work together in the development of mRNA COVID-19 vaccine and the development of other potential products using the mRNA technology platform, so as to contribute to China’s public health.

"We are pleased with Everest’s ability to continually grow the business, as well as its industry leadership and reputation, by executing strategic collaborations and partnerships with key stakeholders like CR Pharma, which provide valuable expertise and resources to critical ventures such as this," said Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group. "This potential collaboration propels forward the development of Everest’s mRNA vaccines, and shows our commitment to bring highly sought-after mRNA vaccines to China."

The lead vaccine candidate for development under Everest’s mRNA technology platform is PTX-COVID19-B, a potentially best-in-class lipid nanoparticle formulated mRNA vaccine with strong immunogenicity and tolerability profiles and has been shown to generate high titer neutralization against the original and variant strains of SARS-CoV-2 in an S protein-typed pseudovirus assays. Based on data from the Phase 1 trial, neutralizing antibody levels at Day 42 were 8.6 times and 23 times higher than convalescence sera in the 40μg and 100μg dose levels, respectively.

Everest’s licensing partner Providence is currently evaluating PTX-COVID19-B in a head-to-head clinical trial against Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. Everest and Providence expect to report top line data in mid-2022, and if positive, this study together with a required safety dataset can support emergency marketing authorization with a stringent Western regulatory authority. Everest and Providence also plan to initiate a registrational booster vaccine trial in 2022 to further expand the indication of PTX-COVID19-B.

About PTX-COVID19-B

PTX-COVID19-B is an mRNA vaccine in Phase 2 development for the treatment of COVID-19, which encodes the full-length S protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (LNP). Interim data from Providence’s Phase 1 study showed that PTX-COVID19-B generated strong virus neutralization activity and produced a level of antibodies in participants in the treatment arm that compare favorably to those produced by other mRNA vaccines that have been approved for use against COVID-19. The treatment was generally safe and well tolerated.

In September 2021, Everest entered into a strategic partnership with Providence Therapeutics Holdings Inc. ("Providence") to advance mRNA vaccines and therapies. Under the terms of the agreement, Everest owns the rights Providence’s mRNA vaccine candidates, including PTX-COVID19-B, in Greater China, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Pakistan, Philippines, Singapore, Thailand, Timor-Leste and Vietnam. Everest and Providence also entered into a 50/50 global collaboration under which Everest is enabled to create and develop products using Providence’s mRNA platform for product discovery across a broad range of other prophylactic and therapeutic areas.

On April 6, 2022 Harbour BioMed ("HBM", "the Company", HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported a global out-license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for CLDN18.2xCD3 bispecific antibody (HBM7022), a novel bispecific antibody generated from HBM’s HCAb Based Immune Cell Engagers (HBICE) Platform (Press release, Harbour BioMed, APR 6, 2022, View Source;301519595.html [SID1234611539]). This license agreement and recognition by an industry-leading global biopharmaceutical company marks a major milestone in HBM’s business development, validating the potential of the Company’s technology platform and innovation capabilities.

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HBM7022 is a bispecific antibody, currently in pre-clinical stage, that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (Claudin18.2) and CD3, and thus leads to potent T cell activation and tumor elimination.

Upon the execution of the license agreement and subject to terms and conditions thereof, AstraZeneca will be granted an exclusive global license for research, development, registration, manufacturing, and commercialization of HBM7022 and shall be solely responsible for all costs and activities associated with its further development and commercialization.

Pursuant to the license agreement and subject to the terms and conditions thereof, HBM shall receive an upfront payment of US$25 million with the potential for additional payments up to US$325 million pending achievement of certain development, regulatory and commercial milestones. HBM is also eligible to receive tiered royalties on net sales.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, said, "HBM7022, one of our representative innovative bispecific antibodies generated from the HBICE platform, has significant potential value on a global basis. We are happy to reach this agreement with AstraZeneca, a leading innovator in oncology with a diverse portfolio and pipeline of life-changing medicines. We are very confident that AstraZeneca will maximize the value of HBM7022 to realize the potential of the molecule."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "We are excited to enter into this agreement with Harbour BioMed for the development of the next-generation bispecific antibody HBM7022. This molecule is designed to harness the body’s immune system T cell response, with potential for strong efficacy across solid tumors including gastric and pancreatic cancers, both of which comprise large populations of patients with major unmet medical need."

About HBM7022

HBM7022 is a bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (Claudin18.2) and CD3 and thus leads to potent T cell activation and tumor elimination. By using bivalent high affinity anti-Claudin18.2 and monovalent low affinity anti-CD3, HBM7022 has demonstrated potent cytotoxicity but low cytokine release syndrome risk. Preclinical studies have shown that it can treat not only wild type Claudin18.2 positive gastric cancer, but also pancreatic cancer and mutated Claudin18.2 gastric cancer. HBM7022 is one of the fully human bispecific antibodies developed from the HBICE Platform of the Company. Building on this unique platform technology, HBM7022 exhibits an encouraging safety profile, pharmacokinetics (PK) and potential for clinical development. With the unique HBICE molecule design and promising preclinical data, we believe that HBM7022 will lead the next generation of T cell engager therapy for solid tumors in future clinical trials.

About HBICE

Harbour HCAb platform can generate diverse and stable fully human Heavy Chain only Antibodies (HCAbs) and derived human VH single-domain moieties, enabling us to make novel multi-specific and multi-valent antibodies in simplified structures with relatively smaller molecule size and fewer number of polypeptide chains. On top of this, we have established proprietary HBICE (HCAb Based Immune Cell Engagers) platform to quickly develop multi-specific antibodies that redirect immune cells to the tumor microenvironment to eradicate tumors.

HBICE molecules recognize and bind both specific tumor-associated antigens on tumor cells and co-stimulatory molecules on immune cells such as T cells or NK cells, resulting in efficient and selective activation of immune cells specifically in the TME, thereby preventing non-specific or systemic activation of peripheral immune cells. Besides, HBICE technology provides the flexibility to generate molecules with different architectures and avidity profiles to achieve desired mechanisms of action that are usually unachievable by combo therapies.

On April 6, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies, will present at the 21st Annual Needham Virtual Healthcare Conference on April 13, and Chardan’s 6th Annual Genetic Medicines & Cell Therapy Manufacturing Summit on April 26 (Press release, SQZ Biotech, APR 6, 2022, View Source [SID1234611533]). Presentation times and webcast information are available below.

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PRESENTATION DETAILS

Wednesday, April 13
21st Annual Needham Virtual Healthcare Conference
9:30-10:10 am ET
Webcast

Tuesday, April 26
Chardan’s 6th Annual Genetic Medicines & Cell Therapy Manufacturing Summit
10:00-10:25 am ET
Webcast

Conference webcast details and the company’s most recent corporate overview presentation will be available on the Investors section of the SQZ website.