On October 27, 2022 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage mRNA-immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MT-101 in patients with refractory or relapsed CD5+ peripheral T cell lymphoma (PTCL) (Press release, Myeloid Therapeutics, OCT 27, 2022, View Source [SID1234622532]). MT-101 is the first mRNA engineered CAR monocyte derived from the Company’s proprietary ATAK platform delivered with a vein-to-vein time of only 8 days. MT-101 targets CD5, a surface receptor present on greater than 75% of PTCL. The ATAK CAR is proprietary to Myeloid and manufactured using the company’s patented process. MT-101 has been specifically designed to harness the ability of myeloid cells to penetrate into tumors and promote broad anti-tumor activity.

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"We are pleased that MT-101 has received Fast Track designation from the FDA," said Michele Gerber, MD, MPH, Chief Medical Officer of Myeloid. "The designation speaks to the serious nature of CD5+ relapsed/refractory PTCL, an aggressive form of non-Hodgkin lymphoma, and the potential MT-101 has to transform the treatment paradigm of this disease. IMAGINE, a Phase 1/2 trial assessing safety, tolerability, and efficacy of MT-101 in this indication is open for enrollment and the initial data is very encouraging."

"MT-101 is the first mRNA engineered monocyte cell product to receive Fast Track designation from the FDA, representing a tremendous milestone for Myeloid and the broader field of cell therapy," said Daniel Getts, PhD, CEO of Myeloid. "We continue to demonstrate our ability to manufacture scalable and cost-effective cell therapy products and deliver them expeditiously to the clinic. We remain optimistic on the future of MT-101 and its ability to provide PTCL patients with improved outcomes."

Fast Track designation is designed to facilitate development and expedite the review of therapies with the potential to treat serious or life-threatening conditions and fill an unmet medical need. Investigational products that receive Fast Track designation may benefit from early and frequent communication with the FDA and are eligible for rolling submission and review of the marketing application. Additionally, this designation provides potential pathways for accelerated regulatory approval.

About the IMAGINE Study
IMAGINE is a Phase 1/2, multicenter, open-label, first-in-human, multiple ascending dose study evaluating MT-101 in patients with refractory or relapsed PTCL. The dose-escalation portion of this Phase 1 study, with and without conditioning therapy, is open and enrolling patients. Once Myeloid establishes the recommended Phase 2 dose, a Phase 2 trial will be initiated to support registration in this patient population.

Please visit www.clinicaltrials.gov (NCT05138458) for additional information.

About the ATAK Immunotherapy Platform
Myeloid’s proprietary ATAK platform is designed to harness the innate abilities of myeloid cells. When applied to a therapeutic candidate, the immunotherapy recognizes cancer cells, alters the tumor microenvironment, produces anti-tumor cytokines, promotes anti-tumor adaptive immunity, and ultimately, kills cancer. The natural immune surveillance and trafficking ability of myeloid cells makes them particularly advantaged for finding cancers metastases, an especially relevant consideration for many advanced-stage patients. Myeloid’s initial products are based on ATAK CAR monocytes, which are myeloid cells with innate immune receptor-inspired CARs to recognize and kill cancer. In addition, Myeloid developed a proprietary, streamlined manufacturing process for its ATAK cell therapy candidates, with a rapid, single-day cell process. This process provides significant advantages to the patient and contract development and manufacturing organizations (CDMO) over allogenic approaches.

On October 27, 2022 Ipsen reported sales growth in the first nine months of 2022 (Press release, Ipsen, OCT 27, 2022, View Source [SID1234622531]).

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On October 27, 2022 XtalPi, Inc., a privately-held solution provider accelerating biopharmaceutical research via its integrated technology platform, reported a research collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen") to deliver chemical matter with validated binding affinities and desirable property profiles (Press release, Janssen Pharmaceutica, OCT 27, 2022, View Source [SID1234622530]). The collaboration was facilitated by Johnson & Johnson Innovation LLC.

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Under the agreement, XtalPi will deliver validated small molecule hits that possess defined properties for a given target nominated by Janssen. XtalPi will deploy its comprehensive, end-to-end platform – Inclusive Digital Drug Discovery & Development (ID4), which includes proprietary cloud-based computations and state-of-the-art wet lab capabilities with the aim to shorten the "Design-Make-Test-Analyze" (DMTA) cycle.

XtalPi has long enjoyed unparalleled success in prediction accuracy of solid-state polymorphism through numerous collaboration projects with pharmaceutical partners but noting that many additional bottlenecks exist in the drug discovery process, the company undertook ambitious plans to expand its capabilities during the last few years. With significant investments in automation, personnel growth in all relevant disciplines of medicinal chemistry, synthetic chemistry, and biology, as well as the deployment of AI to seamlessly improve computational algorithms’ prediction accuracy through rapid validation and refinement against experiments, XtalPi can now offer the full spectrum of research support leading right up to a development candidate.

"I’m excited that we will work together and put our ID4 platform to the test and showcase what it can do," says Dr. Ma Jian, XtalPi’s CEO.

On October 27, 2022 Simcere Pharmaceutical Group (2096.HK), an innovative global pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for SIM0237, an anti-PD-L1/IL-15 bi-functional fusion protein, for the treatment of adult patients with advanced solid tumors (Press release, Jiangsu Simcere Pharmaceutical Company, OCT 27, 2022, View Source [SID1234622529]). It is the second IND approval Simcere obtained in the US this year. In addition, the IND application of SIM0237 in China was accepted by the National Medical Products Administration on October 10, 2022.

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"There is demonstrated history of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) showcasing strong efficacy in a variety of cancers, but there is a large percentage of oncology patients who are either refractory these therapeutics or develop resistance," said Dr. Bijoyesh Mookerjee, M.D., Chief Medical Officer, Oncology of Simcere. "By developing this compound as a bi-functional fusion protein, that combines an anti-PD-L1 antibody with an IL-15 cytokine, we can direct therapeutic activity to the tumor microenvironment, enabling us to potentially limit toxicity while improving tolerability and enhancing efficacy in patients with metastatic or locally advanced solid tumors."

IL-15 is an immune-activating cytokine that promotes the expansion and activation of NK cells and CD8 + T cells. Previous research has revealed that IL-15 when combined with anti-PD-L1/PD-1 antibodies showed good clinical benefits in patients with advanced malignancies including patients who have either not responded to or have relapsed after immune checkpoint inhibitor treatment. Therefore, bi-functional fusion protein, targeting both IL-15 and PD-1/PD-L1 may have the potential for antitumor efficacy in relapsed/refractory patients after immunotherapy.

About the SIM0237-101 Clinical Trial

SIM0237-101 is a phase 1, first-in-human, open-label, multicenter study to investigate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SIM0237 in adult participants with advanced solid tumors. The dose escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) or the recommended dose for expansion (RDE) of SIM0237. The dose expansion phase of the study assess safety, and activity of SIM0237 at the RDE.

About SIM0237

SIM0237 is an anti-PD-L1 monoclonal antibody fused with potency reduced IL-15/IL-15Rα sushi domain developed in-house by utilizing the Simcere’s protein engineering platform. It can block the PD-1/PD-L1 immunosuppressive pathway via binding to PD-L1 and activate the immune system through its IL-15 part, thus playing a synergistic role of relieving immunosuppression and boosting the immune activation to exhibit antitumor effect. The attenuated IL-15 part of SIM0237 prolongs its PK, increases MTD and avoids overstimulation and accompanied anergy of NK and CD8+ T cells. In the meantime, fusion of attenuated IL-15 to full anti-PD-L1 mAb further enhances the half-life of attenuated IL-15 and delivers IL-15 directly to the tumor microenvironment avoiding notorious CRS toxicity induced by systemic IL-15 exposure. Moreover, SIM0237 is able to bridge CD8+ T and NK cells to PD-L1+ APC/tumor cells, which fosters immune synapse formation to further boost the activation of effective cells and promote tumor cell lysis. Preclinical studies showed that SIM0237 is more effective than PD-L1 or IL-15 mono treatment in mouse tumor models, suggesting a high potential for clinical development.

On October 27, 2022 Cytovia Therapeutics, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multispecific antibodies, reported that it will be presenting new preclinical data for its CD38-targeted Flex-NK cell engager antibodies at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 64th Annual Meeting (ASH 2022) taking place in New Orleans, LA, and virtually December 10-13th, 2022 (Press release, Cytovia Therapeutics, OCT 27, 2022, View Source [SID1234622528]).

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Details about the ASH (Free ASH Whitepaper) poster presentation are as follows:

Title: Biological Characterization and Differential Gene Expression Analysis of CYT-338 NK Cell Engager (NKE) Against Multiple Myeloma (MM) Tumors
Abstract Number: 3142
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster II
Date and Time: Sunday, December 11th, 2022 (6-8PM CST)
Location: Ernest N. Morial Convention Center, Hall D, New Orleans, LA
Abstracts available online: November 3, 2022, 9:00 a.m. Eastern time

About Multiple Myeloma
Multiple Myeloma is a currently incurable cancer, affecting a type of white blood cell known as plasma cells. It leads to an accumulation of tumor cells in the bone marrow, rapidly outnumbering healthy blood cells. Instead of producing beneficial antibodies, cancerous cells release abnormal proteins causing several complications. According to the World Cancer Research Fund, Multiple Myeloma is the 3rd most common blood cancer, with 176,404 new cases worldwide in 2020 including more than 50,000 cases in Europe, 35,318 in the US, and 31,890 in Eastern Asia. There have been more than 117,000 deaths worldwide in 2020 with a median overall survival of less than 12 month in patients refractory to standard of care.
Initial treatment comprises of a combination of different biological and targeted chemotherapies, and bone marrow transplants for eligible patients. Immunotherapy with monoclonal antibodies against CD38 such as daratumumab and isatuximab are the most rapidly growing treatment option. Antibody-drug conjugates and Chimeric antigen receptor (CAR) T-cell therapy targeting BCMA and T-Cell Engager Bispecific Antibodies have recently been approved for Multiple Myeloma but high cost, limited product supply and the need for strict safety monitoring may limit their use.