On May 2, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, reported the presentation of new preclinical data from its differentiated allogeneic cell engineering platform at Keystone Symposia’s Precision Genome Engineering Conference, taking place April 27 – May 1, 2022, in Keystone, Colorado (Press release, Intellia Therapeutics, MAY 2, 2022, View Source [SID1234613310]). The data presented support the development of NTLA-6001, Intellia’s allogeneic CAR-T development candidate targeting CD30 for the treatment of CD30-expressing hematologic cancers, including relapsed or refractory classical Hodgkin lymphoma (cHL).

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"We are pleased to present promising preclinical data that led to the nomination of Intellia’s wholly owned allogeneic development candidate, NTLA-6001, for CD30-expressing hematologic lymphomas. NTLA-6001 is the first candidate using our differentiated allogeneic platform, which leverages a novel combination of sequential, LNP-delivered gene edits to yield T cells shielded from immune rejection," said Intellia Chief Scientific Officer Laura Sepp-Lorenzino, Ph.D. "Our approach to engineering T cells aims to solve key immunological challenges to allogeneicity, while retaining cell attributes necessary for potent and durable tumor killing. We look forward to advancing NTLA-6001 toward IND-enabling activities."

The data shared at Keystone demonstrated that Intellia’s proprietary allogeneic solution created T cells that not only avoided immune recognition by host CD4 and CD8 T cells, but also were protected from NK cell-mediated killing in in vitro and in vivo mouse models. Furthermore, allogeneic T cells engineered sequentially with LNPs retained high viability, cell expansion, memory phenotype, cytotoxic and cytokine secretion characteristics. Intellia’s allogeneic platform can be deployed for TCR-T and CAR-T cell therapy.

As part of these platform advancement efforts, Intellia evaluated multiple CD30 CAR constructs in a series of in vitro and in vivo experiments. The most potent CAR construct showed complete tumor regression and protection from tumor rechallenge in a T cell lymphoma model. This lead allogeneic CAR-T cell candidate, NTLA-6001, is now in preclinical development for cHL and certain CD30+ T cell lymphomas. CD30, the target for NTLA-6001, is a cell surface protein that is often overexpressed in a variety of hematologic cancers, making it an important candidate for CAR-T cell therapy.

The presentation is available on Intellia’s website at www.intelliatx.com.

On May 2, 2022 HAYA Therapeutics, SA, a company developing precision medicines that target tissue and cell-specific long non-coding RNAs (lncRNAs), reported that Innosuisse, the Swiss Innovation Agency, is supporting two research collaboration projects between HAYA and the University of Bern, University Hospital of Bern and Lausanne University Hospital (Press release, Haya Therapeutics, MAY 2, 2022, View Source [SID1234613326]). Innosuisse is funding 50 percent of the total project costs of approximately CHF 3.1 million (US$3.3 million).

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The first project will advance HAYA’s lead program, an antisense oligonucleotide targeting the lncRNA Wisper, a cardiac tissue-enriched driver of fibrosis in the heart. In collaboration with the Department for BioMedical Research at University of Bern and the Department of Cardiology at University Hospital of Bern (Inselspital), the two-year project will be focused on dosing studies, pharmacodynamics, and pharmacokinetics for this first-in-class therapeutic target for the potential treatment of non-obstructive hypertrophic cardiomyopathy. The study also includes state-of-the-art cardiac MRI read-outs to provide evidence for efficacy and translatability of the therapeutic approach and advancing it towards the clinic and in-need patients.

"The whole team at HAYA is extremely excited to see our lead Wisper-targeting antisense compound being evaluated in a translationally relevant preclinical model of heart failure," said Daniel Blessing, Ph.D., Co-founder and CTO of HAYA Therapeutics. "Support from Innosuisse has been instrumental to enable this study and collaboration with the University and Inselspital Bern."

"As a pioneer in the field of lncRNA, HAYA has made significant progress in developing a novel treatment targeting lncRNA for hard-to-treat cardiac diseases," said Dr. Robert Rieben, Professor at the University of Bern. "With experience in preclinical cardiovascular research, we are excited to work with HAYA and support their efforts of bringing this therapy to patients who desperately need them."

HAYA’s second project will aim to develop a next-generation oncology therapy targeting cancer-associated fibroblasts for the treatment of squamous cell carcinoma. Through a partnership with Lausanne University Hospital (Centre hospitalier universitaire vaudois, CHUV), the collaborators will use HAYA’s proprietary drug discovery engine, DiscoverHAYATM, to identify oncology-associated fibroblast-specific lncRNAs for the development of a precision RNA-targeted therapy.

"Since launch, HAYA has been diligently working on bringing our lead lncRNA-targeting antisense candidate for the treatment of heart failure closer to clinical testing. At the same time, we have been conducting studies using our innovative discovery engine to identify novel lncRNA targets outside of cardiomyopathy," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "With this project funding from Innosuisse, we can continue our efforts in heart disease and use our technology beyond cardiology into cancer. This will open up tremendous opportunities in the discovery of oncology-based lncRNA targets."

On May 2, 2022 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Company will release its first quarter 2022 financial results on Monday, May 16, 2022, before the U.S. financial markets open (Press release, Compugen, MAY 2, 2022, View Source [SID1234613342]). Management will not host a conference call to accompany this release.

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Management plans to provide a corporate update at two global investor healthcare conferences in June 2022. Details of the planned presentations will be provided closer to the events.

On May 2, 2022 NKGen Biotech Inc., a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that three abstracts with clinical information on its NK cell therapy (SNK01) were accepted for presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago, Illinois (Press release, NKMax America, MAY 2, 2022, View Source [SID1234613279]).

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Details of the presentations are as follows:

Poster Discussion

Title: Interim Analysis of a Phase I Study of SNK01 (Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) and Avelumab in Advanced Refractory Sarcoma

Authors: Sant P. Chawla, Victoria S. Chua, Erlinda Maria Gordon, Ted T. Kim, William Feske, Brenda L. Gibson, Paul Y. Chang, Debra Robinson, Paul Y. Song

Session Type: Poster Discussion

Session Title: Sarcoma

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am; Discussion 11:30 am – 1:00 pm CDT

Poster Presentation

Title: Preliminary Analysis of a Phase I Study of SNK01 (Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) Monotherapy in Patients with Advanced Solid Tumors

Authors: Victoria S. Chua, Sant P. Chawla, Erlinda Maria Gordon, Ted T. Kim, Simranjit Sekhon, William Feske, Lucia Hui, Brenda L. Gibson, Paul Y. Chang, Debra Robinson, Paul Y. Song

Session Type: Poster Presentation

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am CDT

Poster Presentation

Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors

Authors: Anthony B. El-Khoueiry, Paul Y. Song, Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada

Session Type: Poster Presentation

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am CDT

Abstracts will be released to the public on Friday, May 26, 2022 at 5:00 pm EDT.

More information on the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting and related posters sessions can be found at www.asco.org

On May 2, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that five abstracts covering preclinical data from its hypoimmune and fusogen platforms were accepted for either oral or poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting taking place May 16-19, 2022 in Washington, D.C (Press release, Sana Biotechnology, MAY 2, 2022, View Source [SID1234613295]).

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"We will have a strong presence at ASGCT (Free ASGCT Whitepaper), with presentations of data from multiple technology platforms, including two oral presentations on our hypoimmune platform and two posters on our fusogen platform," said Steve Harr, MD, Sana’s President and CEO. "We remain excited with the progress we are making with these platforms that are targeted to address some of the major challenges faced in the field of gene and cell therapy. Our goal is to file two INDs this year from two of these platforms, with the aim of translating our exciting scientific progress into beneficial therapeutics for patients."

The ASGCT (Free ASGCT Whitepaper) abstracts are available to the public at View Source

Oral Presentations:
Title: Hypoimmune mouse primary pancreatic islet cells survive and functionally rescue allogeneic diabetic mice
Summary: Hypoimmune islet cells transplanted intramuscularly may be capable of persisting and functioning in diabetic patients without immune suppression
Abstract Number: 1244
Session: Cell Therapies for Hematological Disorders
Date/Time: Thursday, May 19, 2022 from 10:30 a.m. – 10:45 a.m. ET

Title: Generation of off-the-shelf allogeneic hypoimmune Tregs
Summary: A method to genetically engineer immune evasive "hypoimmune" regulatory T cells (Tregs) ex vivo that, in the assays tested, are immune evasive, functional, and protected from innate immune reactivity
Abstract Number: 1254
Session: Cell Therapy Product Engineering, Development or Manufacturing
Date/Time: Thursday, May 19, 2022 from 11:15 a.m. – 11:30 a.m. ET

Poster Presentations:
Title: Retargeted "fusosomes" for in vivo delivery to T cells
Summary: In vivo delivery of a CD19 CAR transgene payload with either CD8- or CD4-targeting vectors in Nalm-6 tumor bearing mouse models demonstrated robust production and persistence of CAR T cells, leading to tumor eradication
Abstract Number: 1081
Session: Cancer – Immunotherapy, Cancer Vaccines III
Date/Time: Wednesday, May 18, 2022 from 5:30 p.m. – 6:30 p.m.

Title: Fusosome-targeted gene transfer to human hepatocytes
Summary: Proof of principle data showing efficient delivery of a reporter transgene to human hepatocytes in vivo using a humanized liver mouse model
Abstract Number: 875
Session: RNA Virus Vectors
Date/Time: Wednesday, May 18, 2022 from 5:30 p.m. – 6:30 p.m. ET

Title: A novel VCN assay that detects lentiviral vector integrations while overcoming limitations caused by plasmid residuals
Summary: Data from a novel assay that relies on a unique amplicon and droplet digital PCR process that is specific to only reverse-transcribed self-inactivating viral vector nucleic acids
Abstract Number: M-305
Session: Pharmacology / Toxicology Studies or Assay Development
Date/Time: Monday, May 16, 2022 from 5:30 p.m. – 6:30 p.m. ET
About Hypoimmune Platform
Sana’s hypoimmune platform is designed to create cells ex vivo that can "hide" from the patient’s immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both pluripotent stem cells, which can then be differentiated into multiple cell types, and to donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale. Preclinical data demonstrates across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers and stem-cell derived pancreatic cells for patients with type 1 diabetes.

About Fusogen Platform
Sana is developing re-targetable fusogens as a platform technology to enable the in vivo delivery of genetic payloads to specific cell types. Fusogens can bind to cell-surface proteins on the target cell type and, when combined with delivery vehicles to form fusosomes, deliver a genetic payload directly to the cell’s cytoplasm. We have shown in preclinical studies that we can engineer fusogens to specifically target diverse cell surface receptors that allow cell-specific delivery across multiple different cell types. Our most advanced programs utilizing this platform include in vivo CAR T cell fusosome product candidates targeting CD19+ cancer cells, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphocytic leukemia.