On January 16, 2023 Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company focused on the development of a new class of targeted therapies, N-myristoyltransferase inhibitors (NMTi) for the treatment of hematologic and solid tumor cancers, reported that the results of its Phase 1 dose escalation safety and tolerability study for zelenirstat, an investigational NMT inhibitor and Pacylex’s lead product candidate, in refractory/ relapsed colorectal and other cancers, will be presented January 20, 2024, at the upcoming ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (Press release, Pacylex Pharmaceuticals, JAN 16, 2023, View Source [SID1234645053]).

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The Phase 1 dose escalation safety and tolerability study was conducted in 29 heavily pre-treated solid tumor and lymphoma patients who averaged 4 prior lines of therapy on which they relapsed or were refractory (R/R). Eight colorectal, two pancreatic, and one appendiceal cancer patients were among those included in the study. The most common treatment related adverse events identified in the trial were mild to moderate gastrointestinal side effects which were self-limiting and occurred in a minority of patients. A recommended Phase 2 dose (RP2D) for expansion studies was established. Zelenirstat prolonged progression free and overall survival in Phase 1 solid tumor patients receiving the RP2D. Prolonged Stable Disease was observed in patients with colorectal (320 + days on treatment and continuing with non-RECIST criteria reductions of approximately 50% in CEA (carcinoembryonic antigen) and tumor volumes) and appendiceal (160+ days on treatment and continuing with stable disease) cancer treated with the RP2D. The Company has initiated dosing in a Phase 2a expansion study of patients with B-cell non-Hodgkin lymphoma.

A poster describing the Company’s Phase 1 study safety results and efficacy signals, particularly in gastrointestinal cancer patients, will be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium on January 18-20, 2024, in San Francisco, CA. The Company’s CEO, Dr. Michael Weickert, will be available during the poster session and for one-on-one meetings.

"The extended benefits observed in patients with heavily pre-treated GI cancers has been an exciting clinical study finding," said Dr. John Mackey, Chief Medical Officer for Pacylex and a practicing oncologist. "Those patients have received the Phase 2 dose of zelenirstat for longer than anyone and the reductions in disease burden in the colorectal patient is very encouraging."

On January 16, 2023 AIGEN Sciences reported that it signed a research cooperation agreement with Yuhan Corporation to identify the mechanism of action of a new artificial intelligence (AI)-based anticancer drug (Press release, AIGEN Sciences, JAN 16, 2023, View Source [SID1234643564]).

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This agreement aims to identify the mechanism of action of Yuhan Corporation’s new anticancer drug candidate by applying Igen Science’s proprietary artificial intelligence platform.

Under this contract, Eisen Science predicts the mechanism of action of anticancer drug candidates being developed by Yuhan Corporation by utilizing its own artificial intelligence platform based on transcriptome data that can derive the drug’s potential target and mechanism of action. A target is derived. Yuhan Corporation plans to verify the target and mechanism of action proposed by Eisen Science and then accelerate the follow-up development of a differentiated new anticancer drug.

An official from Eisen Science said, "We are developing innovative new drug candidates through our own and joint development projects using artificial intelligence technology based on cell-level transcriptome data," adding, "Even before the research cooperation agreement with Yuhan Corporation, we were developing domestic anticancer drugs and antibody-drug conjugates. "We have signed contracts with (ADC) development companies and are conducting research to discover candidate substances," he said.

On January 16, 2023 Iscaffpharma reported that the company and collaborators receive funding for Eurostars project with a total budget of 1.24 M€ (Press release, Iscaff Pharma, JAN 16, 2023, View Source [SID1234626837]).

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Gothenburg University, RISE and Iscaffpharma received the prestigious grant support and are partnering with AstraZeneca (LSE/STO/Nasdaq: AZN), for a project to develop synthetic 3D-models that recapitulate the tumour microenvironment for cancer drug discovery.

The project has been assessed by Eureka in strong competition with other applications from all over Europe. The research project proposed by the consortium received excellent ratings by Eureka, in regards to technological uniqueness and potential future application in cancer drug development.

"We are proud that our technology has received acknowledgement from Eurostars and it shows the high innovation and market potential for our technology mimicking human cancer microenvironment. Our synthetic scaffolds have the possibility to dramatically change how preclinical research in cancer is made in the future." says Per Setterberg, CEO Iscaffpharma
The purpose of the project is to deliver novel synthetic 3D-growth models for cancer drug discovery and optimization based on unique information obtained from studies of patient derived scaffolds (PDS) from primary cancer samples. Sets of defined inks will be developed and formed into 3D-structures mimicking typical primary cancer microenvironments and used for optimization of cancer therapies with an initial focus on CAR-T cells targeting various cancer subtypes. The 3D-models will provide information about cancer cell type, specific killing of cancer cell lines and organoids as well as infiltration capacities of various types of CAR-T cells in proper human-like microenvironmental contexts.

The project will run over a period of 2 years starting in February 2023

"The human cancer microenvironment indeed influences aggressive features in cancer and our research using patient derived and synthetic scaffolds show that this pioneering technique can be essential in many activities in cancer research and development. The technology can also be used for identifying novel cancer drug targets as well be part of the important screening and validation processes of candidate drugs. In the end patients will benefit from better cancer drugs but also from the fact that we in the future can individualize each patient treatment by including analyses of the cancer microenvironment." says Professor Göran Landberg, Sahlgrenska Center for Cancer Research, University of Gothenburg
For more information please contact:

Per Setterberg CEO Iscaffpharma

Telephone: +46 702159928

E-mail: [email protected]

On January 16, 2023 Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi) and the Foundation for Biomedical Research and Innovation at Kobe (Headquarters: Kobe, Japan, President: Tasuku Honjo, hereinafter ‘FBRI’) reported the discovery of a novel anti-PD-1 agonist monoclonal antibody, which can induce immunosuppressive effect, through their collaborative research on "Treatment of inflammatory diseases, including autoimmune diseases, through the immunosuppressive activity of PD-1" (HBI* Innovation Program) conducted at the FBRI’s Dept. of Immunology, Institute of Biomedical Research and Innovation (Professor: Akio Ohta) (Press release, Meiji, JAN 16, 2023, View Source [SID1234626291]). Part of the findings from the above research was published in "Science Immunology**" issued on January 13, 2023 (Eastern Standard Time). For more information, please visit the FBRI website (URL: View Source).

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Meiji Seika Pharma and FBRI are working together to develop the above PD-1 agonist monoclonal antibody as therapeutic candidate for autoimmune diseases.

PD-1 is a molecule expressed on activated lymphocytes and has the function as a suppressor of immune responses. Antibodies that inhibit the function of PD-1 (anti-PD-1 blocking antibodies) can enhance anti-tumor immunity, so that they have been applied to cancer treatment as "immune checkpoint inhibitors."
Through the above joint research supervised by Program Director Tasuku Honjo, Nobel laureate in 2018, Meiji Seika Pharma and FBRI discovered the conditions necessary for inducing immunosuppression by stimulating the function of PD-1 with antibodies. "Anti-PD-1 agonist antibody" is expected to be applied as a novel therapeutic for inflammatory diseases such as autoimmune diseases caused by excessive immune reactions.

Meiji Seika Pharma and FBRI continue to progress the joint research on "anti-PD-1 agonist antibody" and strive to the early contribution of this antibody as a therapeutic agent for autoimmune diseases.

On January 16, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported the publication in Nature Biotechnology of preclinical data showing the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123 (Press release, Innate Pharma, JAN 16, 2023, View Source [SID1234626269]). The studies were conducted by Innate and Sanofi and published in Nature Biotechnology on January 12, 2023.

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The study shows that expression of CD64 on AML blasts confers resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and redirecting NK cells against cancer targets through binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE specifically target NK cells and has potent antitumor activity against primary AML blasts; it induces NK cell activation and cytokine secretion only in the presence of AML cells. In vivo, its antitumor activity in a mouse tumor model exceeds that of the comparator anti-CD123 antibody. The efficacy of CD123-NKCE in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates was associated with the induction of low pro-inflammatory cytokine release and no signs of toxicity.

These results support clinical development of CD123-NKCE. A Phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR’579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).

Eric Vivier, DVM, PhD, Chief Scientific Officer of Innate Pharma:

"The activity, safety, pharmacokinetic and pharmacodynamics data provided here demonstrate the superiority of CD123-NKCEs over comparator cytotoxic antibodies in terms of antitumor activity, and their favorable safety profiles relative to T cell therapies for the treatment of AML. IPH6101/SAR’579 is a multi-specific NKCE targeting CD123 currently in a Phase 1 trial in AML sponsored by Sanofi. At Innate Pharma, we are developing a broad portfolio of NK Cell Engager programs via our proprietary platform ANKETTM that can address different types of cancer."

Valeria Fantin, Ph.D., Global Head of Oncology Research at Sanofi:

"At Sanofi, we are building a diverse oncology portfolio including next-generation NK-based assets and bringing new approaches to fighting cancer. We’re pleased with our productive collaboration with Innate Pharma, and data like this reinforce our confidence in proceeding to clinical evaluation of this novel NK cell engager."

About ANKETTM

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and an interleukin-2 receptor (via an IL-2 variant, IL-2v) via a single molecule.