On September 27, 2023 Akeso, Inc. (the Company, Akeso, 9926.HK) reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for AK117, a next generation CD47 monoclonal antibody in combination with azacitidine for treatment of patients with newly diagnosed higher-risk myelodysplastic syndromes (MDS) (Press release, Akeso Biopharma, SEP 27, 2023, View Source;combination-with-azacitidine-in-myelodysplastic-syndromes-301941140.html [SID1234635485]). The upcoming study, known as a randomized, double-blind, global multi-center Phase II study, is set to be conducted in the United States.

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Based on the favorable safety profile and remarkable efficacy of AK117 in combination with azacitidine for the treatment of newly diagnosed higher-risk MDS patients, as showcased in previous studies, and the strong demand from MDS patients worldwide, Akeso has conducted comprehensive scientific communication and discussions with the FDA. Akeso believes that this study will facilitate the global development process for AK117.

"With more time and space, we will consistently implement a comprehensive international strategy to explore and advance our innovative therapies. For the benefit of more patients, we will leverage global resources to improve the success rate of AK117." Said Dr. Michelle Xia, the founder, Chairwoman, CEO, and President of Akeso.

Anemia is a significant symptom of MDS, and effectively managing anemia and minimizing blood transfusion are crucial aspects of disease control. In contrast to other anti-CD47 antibody drugs, which have been reported to worsen anemia in MDS patients by causing RBC hemagglutination, AK117 eliminated RBC hemagglutination and also enabled to maintain full effectiveness of CD47 blockade on tumor cells, which resulted in excellent antitumor efficacy and favorable safety profile of AK117.

The previous studies of AK117 in combination with azacitidine showed positive results in patients with newly diagnosed higher-risk MDS. AK117 reduced anemia and transfusion requirements among MDS patients, and demonstrated a favorable safety profile and remarkable efficacy. These findings position AK117 as a promising therapeutic option for MDS patients worldwide.

Notably, Akeso is consistently advancing the development of AK117 as a therapeutic agent in combination with various agents such as PD-1/CTLA-4 and PD-1/VEGF, for treatment of multiple hematologic malignancies and solid tumors.

About Ligufalimab (AK117)

AK117, independently developed by Akeso, is a next generation of humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors.

On September 27, 2023 XNK Therapeutics AB reported that two posters, regarding bladder cancer (BC) and acute myeloid leukemia (AML) respectively, was presented at the 20th Meeting of the Society for Natural Immunity (NK2023) in Oslo, Norway, in September (Press release, XNK Therapeutics, SEP 27, 2023, View Source [SID1234635483]).

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XNK Therapeutics participate at NK2023 in Oslo and present the latest research relating to the company’s leading natural killer (NK) cell therapies. Two abstracts have been accepted for presentation at the meeting.

The poster on BC shows the feasibility of expanding autologous NK cells from peripheral blood mononuclear cells (PBMCs) from BC patients. Cells were collected from patients both before and after chemotherapy treatment and the expansion and activation process was successful at both collection points demonstrating flexibility in timing for manufacturing. There were no significant differences in total cell yield, NK fraction or NK cell cytotoxicity against tumor cells between cultures started with PBMCs collected before or after chemotherapy treatment.

In AML, the study demonstrated that it was possible to expand and activate NK cells from PBMCs of AML patients of diverse cohorts (remission, newly diagnosed, relapsed/refractory). These NK cells expressed activating receptors and were able to degranulate in response to – and kill- two different leukemic cell lines.

The data have been generated in collaboration with XNK’s external partners, Anders Ullén and Fernanda Costa Svedman at the Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden, for the BC study, and Abhishek Maiti and Naval Daver at The University of Texas MD Anderson Cancer Center in Houston, Texas, USA, for the AML abstract.

NK2023 is the 20th annual meeting arranged by the Society of Natural Immunity and takes place in Oslo, Norway, on September 26-29, 2023. The meeting will attract more than 450 participants and is focused entirely on NK cells, with a preceding day entirely focused on the development of NK cell-based immunotherapies.

"Discussing our pipeline with the leading NK cell experts at NK2023 will help us refine our path forward, and as one of the leading companies in the field we are pleased to contribute to this important meeting" said Anna-Karin Maltais, CSO of XNK Therapeutics.

On September 27, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA’s development program investigating IDE161, a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of adult patients having advanced or metastatic hormone receptor positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations who have progressed following treatment with at least one line of a hormonal therapy, a CDK4/6 inhibitor therapy and a poly (ADP-ribose) polymerase (PARP) inhibitor therapy (Press release, Ideaya Biosciences, SEP 27, 2023, View Source;brca12-mutant-breast-cancer-301939791.html [SID1234635482]).

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"The U.S. FDA Fast Track designations for our potential first-in-class PARG inhibitor, IDE161, in both BRCA1/2-mutant breast and ovarian cancers reflect the potential for IDE161 to address the significant unmet medical need in these indications," said Dr. Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences. "We are excited that IDE161 has been granted Fast Track status in two separate indications, and we look forward to providing further program updates for IDE161 in the fourth quarter of this year," continued Dr. Beaupre.

Fast Track is a U.S. FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Under the Fast Track designation, the IDE161 development program in BRCA1/2 mutant (m) breast cancer, as specified in the Fast Track designation, is eligible for various expedited regulatory review processes, including generally more frequent FDA interactions (e.g., meetings, written communications), potential eligibility for rolling review of a New Drug Application (NDA) and potential accelerated approval and priority review of an NDA.

IDEAYA’s Phase 1 first-in-human clinical trial is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having solid tumors with homologous recombination deficiency (HRD). Early clinical data from the dose escalation cohorts showed preliminary tumor shrinkage in multiple patients having solid tumors with HRD, including in subjects with BRCA 1/2m endometrial cancer and colon cancer. These data supported expansion into priority tumor indications in parallel with continuing evaluation of the optimal move-forward dose for Phase 2 expansion.

The expansion portion of the Phase 1 trial will include patients having HRD+ associated breast cancer and ovarian cancer, as well as a basket of other selected solid tumors. The breast cancer focus is on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (Her2-), HRD+ tumors, which represent approximately 10% to 14% of breast cancer patients. HRD+ ovarian cancer represents approximately 50% of ovarian cancer patients.

IDEAYA is targeting program updates for IDE161 in the fourth quarter of 2023. IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations under its exclusive, worldwide license with Cancer Research UK and University of Manchester.

On September 27, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that Colleen Delaney, MD, MSc, Chief Scientific and Medical Officer, will present at the 2023 Cell & Gene Meeting on the Mesa being held October 10-12, 2023 in Carlsbad, CA at the Park Hyatt Aviara Resort (Press release, Coeptis Therapeutics, SEP 27, 2023, View Source;gene-meeting-on-the-mesa-301939827.html [SID1234635481]).

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Dr. Delaney will provide an overview of Coeptis’ clinical development programs including the recent Phase 1 safety and dosing update for DVX201 in relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection. During the conference Dr. Delaney and Dave Mehalick, President and CEO of Coeptis Therapeutics, will be conducting one-on-one investor and strategic partnering meetings.

Details of the presentation are as follows:

Event:

2023 Cell & Gene Meeting on the Mesa

Date & Time:

October 11, 2023 at 4:30 PM, PDT

Location:

Park Hyatt Aviara Resort, Carlsbad, CA, Rentschler ATMP Ballroom

"The Cell & Gene Meeting on the Mesa is a vital annual event bringing together leaders who are tackling the major scientific, logistic, policy, and economic questions confronting the cell therapy industry," said Dr. Delaney. "Coeptis recently announced excellent interim safety results for DVX201 across two trials with distinct patient populations. These early results are extremely encouraging and represents a major step for this first in-human use of an allogeneic NK cell therapy derived from pooled donor CD34+ HSPCs. I look forward to discussing these results with colleagues as well as the innovative and complementary platforms that Coeptis is assembling to develop powerful cell-based treatments to improve outcomes for patients with cancer, while we also strive to universalize cell therapy to enable greater access to these medical breakthroughs."

Virtual attendance is available which includes a livestream of Coeptis’ presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.

Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Savannah Bryant at [email protected] and interested media should contact Stephen Majors at [email protected].

On September 27, 2023 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported that it will present additional preclinical data from the Company’s CBL-B program in a poster presentation at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 1-5, 2023, in San Diego, CA (Press release, HotSpot Therapeutics, SEP 27, 2023, View Source [SID1234635480]).

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Presentation details are as follows:

Title: Exploring Proximal Biomarkers of CBL-B Inhibition in Human Peripheral Blood Mononuclear Cells
Session Date and Time: Fri., Nov. 3, 9:00 AM-7:00 PM PT
Location: Exhibit Halls A and B1, San Diego Convention Center

Abstract Number: 55

About HST-1011
HST-1011 is an investigational orally bioavailable, selective, small molecule allosteric inhibitor of CBL-B, an E3 ubiquitin protein ligase critically involved in immune cell response. Because CBL-B functions as a master regulator of effector cell (T cell and natural killer cell) immunity, its inactivation removes its endogenous negative regulatory functions to substantially enhance anti-tumor immunity. Preclinical data has demonstrated HST-1011’s ability to bind to and inhibit a natural hotspot on CBL-B, yielding the activation and propagation of a targeted anti-tumor immune response. Enabled by HotSpot’s proprietary Smart Allostery platform, HST-1011 is designed with tight binding, low nanomolar potency, a slow dissociation rate from the target to enable sustained pharmacology, and greater selectivity for CBL-B relative to C-CBL.