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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On January 16, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the company will participate at the Redeye Fight Cancer Day on January 19, 2023 (Press release, Medivir, JAN 16, 2023, View Source [SID1234626268]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CEO Jens Lindberg will present the company and its plan for the ongoing clinical study with fostroxacitabine bralpamide (fostrox) at 13.35 CET.

The presentation is live broadcasted and can be followed at the event page;
View Source

On January 16, 2023 CARsgen Therapeutics Holdings Limited (2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, and Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine; SZ: 000963), reported a collaboration for the commercialization of CARsgen’s BCMA CAR-T product CT053 in mainland China (Press release, Carsgen Therapeutics, JAN 16, 2023, View Source [SID1234626267]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CT053, zevorcabtagene autoleucel ("zevor-cel"), is CARsgen’s lead drug candidate and an autologous CAR T-cell product treating relapsed/refractory multiple myeloma (R/R MM). CT053 NDA was submitted to NMPA in October 2022. With strong commercial capability and network, Huadong Medicine is granted the exclusive right to commercialize zevor-cel in mainland China.

"Huadong’s extensive commercialization experience in mainland China along with their strategic goal of being a leader in the oncology therapeutic area created the opportunity for a strong, strategic and mutually beneficial partnership between our two companies," said Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, "Despite advancements in recent years, there are still significant unmet medical needs for the treatment of multiple myeloma. Zevor-cel, a differentiated BCMA CAR T cell therapy, has shown promising data in clinical programs and is now under NDA priority review by NMPA. We believe this collaboration with Huadong Medicine will enhance the successful commercialization of zevor-cel in mainland China."

"CARsgen is a leading biotech company in the development of innovative cell therapies for cancer patients and has built integrated R&D and manufacturing capabilities," added Liang Lv, Chairman of Huadong Medicine. "We are excited to collaborate with CARsgen to commercialize CT053. Leveraging Huadong’s strong commercial presence in hematology, Huadong is committed to bringing CT053, an innovative and highly effective new treatment, to more R/R MM patients in China, and improve their survival and quality of life."

Under the terms of the agreement, CARsgen will receive an upfront payment of RMB200 million and is eligible to receive regulatory and commercial milestone payments up to RMB1,025 million. CARsgen will continue to be responsible for the development, regulatory approval, and manufacturing of CT053 in mainland China.

About CT053

CT053, zevorcabtagene autoleucel ("zevor-cel"), is a fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. The New Drug Application (NDA) based on the phase I/II data from LUMMICAR STUDY 1 in China has been accepted by NMPA. CARsgen is conducting the phase 1b/2 LUMMICAR STUDY 2 in North America to evaluate the safety and efficacy of CT053 for R/R MM in that population. The Company also plans additional clinical trials for earlier line multiple myeloma treatment.

CT053 received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, as well as the Priority Medicines (PRIME) and Orphan Medicinal Product designations from the European Medicines Agency (EMA) in 2019 and 2020, respectively. CT053 also received Breakthrough Therapy designation from the NMPA in 2020.