Lyell Immunopharma to Present Preclinical Data for Two Product Candidates in Clinical Development at ASGCT Annual Meeting

On May 2, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that two abstracts have been accepted for poster presentations at the 25th Annual Meeting of the American Society of Gene & Cell Therapy, scheduled for May 16 – May 19, 2022, in Washington, DC (Press release, Lyell Immunopharma, MAY 2, 2022, View Source [SID1234613292]).

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The presentations will highlight preclinical data characterizing two investigational products in Phase 1 clinical development that incorporate Lyell technologies designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality.

The first abstract presents preclinical data for LYL797 demonstrating that Gen-R and Epi-R can enhance and prolong anti-tumor functions of ROR1-targeting CAR T-cell therapy in solid tumor model systems. The second abstract presents preclinical data for LYL132 demonstrating that Epi-R creates populations of stemlike NY-ESO-1-targeting TCR T cells that lead to products with increased proliferative capacity and prolonged functional activity in the presence of persistent antigen exposure.

Details on the presentations are below:

Preclinical Development of LYL797, a ROR1-Targeted CAR T-Cell Therapy Enhanced with Genetic and Epigenetic Reprogramming for Solid Tumors

Session: Cancer – Immunotherapy, Cancer Vaccines II
Presentation Date, Time & Location: May 17, 5:30 – 6:30 PM, Hall D, Tu-166
Abstract number: 661
Epigenetic Reprogramming (Epi-R) Yields T-Cell Receptor Products with Improved Stemness, Metabolic Fitness, and Functional Activity in the Presence of Persistent Antigen Exposure

Session: Cancer – Targeted Gene and Cell Therapy II
Presentation Date, Time & Location: May 18, 5:30 – 6:30 PM, Hall D, W-241
Abstract: 1115
About LYL797 and LYL132

LYL797 is an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors. LYL797 incorporates Lyell’s novel Gen-R and Epi-R reprogramming technologies. The Phase 1 trial will assess LYL797 in patients with relapsed/refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). More information can be found on ClinicalTrials.gov by searching NCT05274451.

LYL132 (GSK4427296) is an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) being developed in collaboration with GSK. LYL132 incorporates Epi-R reprogramming technology and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development. The Phase 1 trial will assess LYL132 in patients with NY-ESO-1+ advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS). Lyell will manufacture LYL132 in its LyFE Manufacturing Center and GSK will conduct the Phase 1 trial. More information can be found on ClinicalTrials.gov by searching NCT04526509.

NeuBase Therapeutics Announces Presentations at the American Society of Gene & Cell Therapy (ASGCT) 2022 Annual Meeting

On May 2, 2022 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology platform company Drugging the Genome to address disease at the base level using a new class of precision genetic medicines, reported two abstracts have been accepted for presentation at the American Society of Gene and Cell Therapy ("ASGCT") 25th Annual Meeting, taking place virtually and in person in Washington, D.C., May 16-19, 2022 (Press release, NeuBase Therapeutics, MAY 2, 2022, View Source [SID1234613291]).

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NeuBase will present new preclinical data on the biodistribution in key tissues of the company’s lead candidate, NT-0231.F, a precision genetic medicine in development to treat myotonic dystrophy, type 1 ("DM1"). NeuBase recently presented data at the 2022 MDA Clinical & Scientific Conference demonstrating that systemic administration of NT-0231.F in the HSALR model achieves clinically relevant molecular and functional rescue, including rescue of the spliceopathy, resolution of nuclear aggregates, and reversal of myotonia (delayed muscle relaxation after contraction). Pharmacokinetic studies of NT-0231.F in wild-type BALB/C mice showed a single IV or SC dose achieved high volume of distribution.

The presentations are listed below, and the full abstracts are available on the ASGCT (Free ASGCT Whitepaper) meeting website. All times are listed in Eastern Time (ET).

Title: Pharmacokinetics, Biodistribution, and CNS Penetration of a PATrOL-Enabled Investigational Genetic Therapy for Myotonic Dystrophy-Type 1 Following Systemic Administration Systemic Administration in Mice
Presenter: Noel Monks, Ph.D.
Session Date/Time: Tuesday, May 17, 5:30 PM – 6:30 PM
Poster Board Number: Tu-90
Session Title: Oligonucleotide Therapeutics II
Room: Hall D
Abstract Number: 585

Title: Pharmacology, Biodistribution and Tolerability of a PATrOL-Enabled Investigational Genetic Therapy for Myotonic Dystrophy, Type 1
Presenter: Sandra Rojas-Caro, M.D.
Session Date/Time: Wednesday, May 18, 5:30 PM – 6:30 PM
Poster Board Number: W-175
Session Title: Musculo-skeletal Diseases
Room: Hall D
Abstract Number: 1049

About NeuBase’s DM1 Program
Patients with DM1 suffer from cognitive deficits and muscle pathology caused by a trinucleotide expansion in the DMPK gene which, when transcribed, results in an RNA hairpin structure that sequesters RNA splice proteins. NeuBase’s DM1 investigational genetic therapy, NT-0231.F, targets mutant DMPK pre-mRNA with a novel peptide-nucleic acid ("PNA") pharmacophore and is designed to selectively engage with the toxic RNA hairpin structure, release the splicing proteins, and restore RNA splicing and downstream protein production. The PNA pharmacophore is conjugated to NeuBase’s novel delivery technology that is designed for broad distribution, including into the deep brain, with the potential for a whole body, disease-modifying solution for DM1. For more information, visit www.neubasetherapeutics.com/pipeline/.

Umoja Biopharma to Present at the American Society of Gene and Cell Therapy 25th Annual Meeting

On May 2, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, reported that it will have an oral presentation and two posters at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, to be held May 16-19, 2022 (Press release, Umoja Biopharma, MAY 2, 2022, View Source [SID1234613290]).

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The oral presentation will include preliminary safety data of UB-VV100, a combination of VivoVec and RACR technology platforms. VivoVec is an in vivo lentiviral vector-based CAR T-cell platform developed for off-the-shelf use, while RACR is a rapamycin-activated cytokine receptor designed to drive in vivo CAR T-cell survival without the requirement for lymphodepletion through administration of rapamycin. The poster presentations will include descriptions of VivoVec platform advancements that expand particle mechanisms of action and enhance particle manufacturing processes.

Presentation details:

Oral Presentation Title: Preclinical Activity and Safety of UB-VV100, A Novel Lentiviral Vector Product Designed for Selective and Effective In Vivo Engineering of Therapeutic Anti-CD19 CAR T Cells for B cell Malignancies
Abstract Number: 1242
Session: Cell-Based Cancer Immunotherapies III
Presenting Author: Alissa Brandes, Ph.D., Principal Scientist, Umoja Biopharma
Presentation Date, Time: Thursday May 19, 2022; 10:15 AM – 12:00 PM ET

Poster Presentation Title: A Lentiviral-Based In Vivo CAR T Cell Generation Platform with Viral Particle Surface Engineering Incorporating Anti-CD3 Single Chain Variable Fragment and T Cell Costimulatory Molecules
Abstract Number: 879
Session: RNA Virus Vectors
Presenting Author: Christopher Nicolai, Ph.D., Senior Scientist, Umoja Biopharma
Presentation Date, Time: Wednesday May 18, 2022; 5:30 – 6:30 PM ET

Poster Presentation Title: Development of a Scalable, Suspension Cell Culture-Based Manufacturing Process for VivoVec, a Lentiviral Vector Platform for In Vivo CAR-T Cell Generation
Abstract Number: 1166
Session: Vector Product Engineering, Development or Manufacturing III
Presenting Author: Jeff Plomer, Senior Director Process Development, Umoja Biopharma
Presentation Date, Time: Wednesday May 18, 2022; 5:30 PM – 6:30 PM ET

Presentations can be accessed from the ASGCT (Free ASGCT Whitepaper) website at View Source

Geron to Announce First Quarter 2022 Financial Results on May 9, 2022

On May 2, 2022 Geron Corporation (Nasdaq: GERN) reported that it will release its first quarter 2022 financial results after the market closes on Monday, May 9, 2022 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAY 2, 2022, View Source [SID1234613289]). Geron will host a conference call to discuss the financial results as well as recent highlights at 4:30 p.m. ET the same day.

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A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source Participants that are unable to register online can access the conference call via telephone by dialing domestically +1 (888) 330-2434 or internationally +1 (240) 789-2725. The conference ID is 67335.

Zymeworks Announces Participation in Upcoming Investor Conferences

On May 2, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, MAY 2, 2022, View Source [SID1234613288]):

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H.C. Wainwright Global Investment Conference. Zymeworks will participate virtually in one-on-one meetings on May 24th – 26th and a corporate presentation will be available virtually on May 24th at 7 a.m. ET.

The presentation will be available on Zymeworks’ website at View Source