Asher Bio to Present New Preclinical Data for CD8+ T Cell Targeted Immunotherapies, AB248 and AB821, at SITC 2022

On October 5, 2022 Asher Biotherapeutics, Inc. (Asher Bio), a biotechnology company focused on developing therapies to precisely engage specific immune cells to fight cancer, chronic viral infections and autoimmune disorders, reported that it will present preclinical data for two of its cis-targeted immunotherapies, AB248 and AB821, at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held in Boston, Massachusetts, on November 8-12, 2022 (Press release, Asher Biotherapeutics, OCT 5, 2022, View Source [SID1234621745]).

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AB248, Asher Bio’s lead cis-targeted immunotherapy, is a novel CD8-targeted IL-2 mutein designed to selectively activate interleukein-2 (IL-2) signaling on CD8+ T cells over natural killer cells and regulatory T (Treg) cells. Asher Bio plans to investigate the use of AB248 in multiple solid tumor indications as monotherapy and in combination with PD(L)-1 checkpoint inhibitors and expects to initiate a Phase 1 clinical trial in the fourth quarter of 2022.

AB821 is a CD8-targeted interleukin 21 (IL-21), designed to selectively activate CD8+ T cells with an attenuated version of IL-21. Asher Bio expects to file an investigational new drug application for AB821 in the second half of 2023.

Details of the poster presentations are as follows:

Title: CD8+ T cell selectivity of AB248 is essential for optimal anti-tumor activity and safety in nonclinical models

Session Date and Time: Friday Nov 11th, 9:00 a.m. – 9:00 p.m. ET
Location: Hall C
Abstract Number: 1092
Title: AB821 is a CD8+ T cell selective IL-21 with enhanced bioavailability that mediates potent anti-tumor activity, cytotoxicity, and expansion of memory CD8+ T cells

Session Date and Time: Thursday, Nov. 10th , 9:00 a.m. – 9:00 p.m. ET
Location: Hall C
Abstract Number: 1083
Both abstracts will become available online on the SITC (Free SITC Whitepaper) conference website beginning at 8:00 a.m. ET on Monday, November 7, 2022.

Catamaran Bio to Present Preclinical Efficacy Data for Allogeneic CAR‑NK Cell Therapies to Treat Solid Tumors at SITC Annual Meeting

On October 5, 2022 Catamaran Bio, Inc., a biotechnology company developing off‑the-shelf NK cell therapies to treat cancer, reported that the company will present preclinical efficacy data for its allogeneic, cryopreserved CAR-NK cell therapies designed to treat solid tumors, engineered using Catamaran’s TAILWINDTM platform (Press release, Catamaran Bio, OCT 5, 2022, View Source [SID1234621744]). The data demonstrate the promise of two of the company’s CAR-NK cell therapies, CAT-248 and CAT-179, for the treatment of solid tumors, and will be presented in two poster presentations at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held in Boston, Massachusetts, November 8-12, 2022.

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Details of the poster presentations are as follows:

Title for CAT-248 poster: Engineering CD70-directed CAR-NK cells for the treatment of hematological and solid malignancies

Lead Authors: Branden Moriarity, PhD, Associate Professor, Division of Hematology/ Oncology and Jae-Woong Chang, PhD, Research Associate, University of Minnesota (research agreement sponsored by Catamaran Bio); Eugene Choi, Principal Scientist, Catamaran Bio
Session Date and Time: November 11, 2022, 9:00 a.m. – 8:30 p.m.
Location: Poster Hall
Abstract Number: 392
Title for CAT-179 poster: Allogeneic natural killer cells engineered to express HER2-directed CAR, interleukin-15 and TGFß dominant negative receptor effectively control HER2+ tumors

Lead Author: Finola Moore, PhD, Director, Catamaran Bio
Session Date and Time: November 11, 2022, 9:00 a.m. – 8:30 p.m.
Location: Poster Hall
Abstract Number: 264
Both abstracts will become available online on the SITC (Free SITC Whitepaper) conference website beginning at 8:00 a.m. ET on Monday, November 7, 2022.

New Data From Repertoire® Immune Medicines Demonstrate Effectiveness of Its DECODE™ Platform to Characterize and Identify New Immunotherapeutic Targets in HPV Positive Cancer

On October 5, 2022 Repertoire Immune Medicines reported that it will present data from its ongoing research to characterize the cellular response and identify novel therapeutic targets with the company’s DECODE platform in human papillomavirus (HPV) 16 and HPV 33 positive tumors (Press release, Repertoire, OCT 5, 2022, View Source [SID1234621743]). This research will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2022) 37th Annual Meeting, November 8-12, in Boston, Massachusetts.

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Repertoire’s DECODE platform is a suite of integrated experimental and computational technologies designed to decipher the immune synapse, the complex interface between T cells and the epitopes they recognize, which are presented on antigen-presenting cells (APC). DECODE is being used to assess the immunogenic profile of HPV 16 and HPV 33 positive tumors in oropharyngeal squamous cell carcinoma. By characterizing the cellular response to these cancers, it is possible to identify the T cell receptors (TCR) and the specific epitopes they recognize that may be ideal targets for immunotherapies.

The company will also present data from early research in delivering interleukin-2 (IL-2) to solid tumors at efficacious levels and with reduced toxicity.

DECODE Discovery: Cellular Response and Antigen Discovery in HPV Positive Cancer

HPV16 E1 and E2 elicit a robust cytotoxic immune response in virally driven Oropharyngeal Squamous Cell Carcinoma
Presenting Author: Christine M. McInnis, Repertoire Immune Medicines, Cambridge, MA
Date/Time: Thursday, November 10 – Friday, November 11, 2022, 9:00 AM – 9:00 PM EST

HPV33-driven Oropharyngeal Squamous Cell Carcinomas are increasing in prevalence and are characterized by low CD8 infiltration and epitope presentation deficiencies
Presenting Author: Shilpa Bhatia, Repertoire Immune Medicines, Cambridge, MA
Date/Time: Thursday, November 10 – Friday, November 11, 2022, 9:00 AM – 9:00 PM EST

Cytokine Delivery Technology
Targeting wildtype IL-2 to CD8 T cells induces potent anti-tumor immune responses and decreases IL-2 mediated toxicity
Presenting Author: Selvi Ramasamy, Repertoire Immune Medicines, Cambridge, MA
Date/Time: Thursday, November 10 – Friday, November 11, 2022, 9:00 AM – 9:00 PM EST

About the DECODE Platform

The DECODE platform is a powerful discovery engine that characterizes essential elements of the immune synapse. In particular, the platform identifies T cell receptor-antigen pairs in the context of other important features of the immune synapse, such as T cell function and how antigens are presented by molecules on antigen-presenting cells, known as major human leukocyte antigen, or HLA, molecules. Repertoire intends to utilize these insights into key drivers that govern immune function to design and develop novel immune product candidates.

Humanetics Receives FDA Clearance to Begin Studies in Second Oncology Indication

On October 5, 2022 Humanetics Corporation (Humanetics) reported that it has received FDA clearance of its Investigational New Drug (IND) application for BIO 300 to mitigate erectile dysfunction in men undergoing radiation treatment for prostate cancer (Press release, Humanetics, OCT 5, 2022, View Source [SID1234621742]). This is the second IND for BIO 300 in oncology patients, and the fourth IND overall for the Company.

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Aside from non-melanoma skin cancer, prostate cancer is the most common cancer in men and is often treated with radiation. Unfortunately, greater than 50 percent of men treated with radiation will experience radiation-induced erectile dysfunction (RiED). RiED greatly affects patient quality of life and, in most cases, is permanent and unresponsive to drugs such as Viagra and Cialis. The chance of developing RiED, especially in younger men, can alter treatment decisions and can push patients toward less effective treatment options. Currently, there are no treatments available to mitigate RiED in these patients.

BIO 300 is an oral drug that is self-administered at home by the patient prior to their radiation treatments. It has shown potential to minimize radiation damage in normal tissues without impacting the effectiveness of the radiation therapy against the tumor. Previously, Humanetics published nonclinical studies demonstrating that BIO 300 can prevent RiED. Additionally, nonclinical research with BIO 300 has shown that it may help improve the effectiveness of radiation against multiple types of tumors. BIO 300 was the recent subject of an early-stage trial in non-small cell lung cancer patients undergoing chemoradiotherapy and was found to be safe, with results pointing to positive clinical outcomes.

Humanetics licensed BIO 300 from the United States Department of Defense (DOD), where it was discovered as a potent radioprotectant for warfighters on the battlefield. Humanetics is continuing the development of BIO 300 on behalf of DOD for use by military personnel, first responders, and civilian populations who may be threatened with radiation exposure. Its use in cancer patients is highly aligned with its military use, as it serves in both cases to protect normal tissues from radiation damage. The drug is also being evaluated in a phase 2 trial of long COVID patients to determine if it can mitigate pulmonary damage.

"Continuing to expand the use of BIO 300 with cancer radiation therapy is one of our major goals," said Ronald J. Zenk, President and CEO of Humanetics. "We believe that BIO 300 may improve treatment

Medikine to Present Preliminary Phase 1 Clinical Trial Results for MDK-703 at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022)

On October 5, 2022 Medikine, Inc., a biopharmaceutical company developing transformative therapeutics for cancer, autoimmune disorders, and infectious diseases using its novel PEPTIKINE technology, reported that it will deliver two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting (SITC 2022), taking place virtually and in Boston on November 8-12 (Press release, Medikine, OCT 5, 2022, View Source [SID1234621741]).

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The first poster presentation will highlight preliminary Phase 1 safety, tolerability, and pharmacokinetic/pharmacodynamic data on Medikine’s lead program, MDK-703, an Fc-peptide fusion protein incorporating an IL-7 PEPTIKINE discovered using Medikine’s innovative platform technology. A second poster will detail preclinical data on MDK-1654, Medikine’s dual-acting agonist that incorporates both IL-7 and non-alpha IL-2/15 PEPTIKINEs.

Details on the poster presentations are as follows:

Title: A Phase 1 Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of MDK-703, an IL-7 Mimetic With Extended Half-life

Abstract #: 625
Presenter: Ron Barrett, PhD, Medikine
Date/Time: Thursday, November 10, 2022, from 9:00 a.m. to 9:00 p.m. EST
Title: MDK1654: A Branched Synthetic Peptide that Activates Both the IL-7 Receptor and the βγc Form of the IL-2/15 Receptor

Abstract #: 1097
Presenter: Angie Park, PhD, Medikine
Date/Time: Thursday, November 10, 2022, from 9:00 a.m. to 9:00 p.m. EST
Full abstracts will be made available online and will be included in the Journal for ImmunoTherapy of Cancer (JITC) supplement on November 7. Posters will also be available on the Medikine website at www.Medikine.com following the poster presentations.