On March 9, 2022 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, La., from April 8-13, 2022 (Press release, Imvax, MAR 9, 2022, View Source;utm_medium=rss&utm_campaign=imvax-to-present-new-data-on-tumor-derived-immunotherapy-platform-at-aacr-annual-meeting-2022 [SID1234609745]).

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At the meeting, Imvax will present data that support the applicability of its platform to solid tumor types beyond glioblastoma. Using murine models of hepatocellular carcinoma and ovarian cancer, Imvax found that treatment with IHV-001 hepatocellular and IOV-001 ovarian immunotherapeutic products led to a significant improvement in survival and reduction in tumor burden of mice treated.

The company will also present analyses of new laboratory data from a Phase 1b clinical study using IGV-001 product candidate in newly diagnosed glioblastoma. That study had previously reported a median progression-free survival of 38.4 months in a subgroup of patients treated with IGV-001, compared with 8.3 months in historical standard-of-care-treated patients (P=0.0008) (Andrews et al., Clin. Canc. Res. 2021). In the new analysis, the company used serum profiling and machine learning classification to identify key cytokines that may be associated with patient outcome.

Details of the poster presentations are as follows:

Title: Personalized immunotherapeutic platform with evidence of clinical activity in glioblastoma (IGV-001) protects mice against other lethal solid tumor challenges
Number: 626
Timing: April 10, 2022, 1:30 p.m. – 5:00 p.m. CDT
Presenter: Mark Exley, Ph.D., Chief Scientific Officer

Title: Machine learning algorithm identifies key serum cytokines associated with evidence of clinical activity in patients treated with personalized immunotherapeutic platform (IGV-001)
Number: 2782
Timing: April 12, 2022, 9:00 a.m. – 12:30 p.m. CDT
Presenter: Mark Exley, Ph.D., Chief Scientific Officer

On March 8, 2022 Cothera Bioscience, the parent company of Percans Oncology, reported that it received approval from the National Medical Products Administration (NMPA) to conduct a Phase 2 clinical trial to test its targeted MYC mutation inhibitor PC-002 as a first-line or second-line treatment for drug-resistant or relapsed high-grade B-cell lymphoma (HGBCL) (Press release, Cothera Bioscience, MAR 8, 2022, View Source [SID1234618849]). The NMPA completed its review of the project in just 45 working days, demonstrating the strong support of regulatory authorities for innovative drugs.

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PC-002, the core product of Cothera Bioscience, is a first-in-class small molecule drug targeting MYC-mutated tumors. With a unique mechanism of action (MOA), PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. Via its unique mechanism, PC-002 selectively kills tumor cells with MYC mutation and may potentially target multiple indications in cancers.

On March 8, 2022 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology therapeutics that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that it will present posters for three of the company’s preclinical pipeline programs at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held in-person and virtually at the Ernest N. Morial Convention Center in New Orleans, LA from April 8-13, 2022 (Press release, Bolt Biotherapeutics, MAR 8, 2022, View Source [SID1234618689]).

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"We are pleased to present three poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting that highlight the significant progress made by our research team and the depth of our expertise in myeloid biology. We are continuing to expand our Boltbody ISAC platform with advanced CEA- and PD-L1-targeting ISACs, both of which have the potential to provide cancer patients with new options where few treatments are currently available. We are expanding our pipeline beyond ISACs through the development of our novel myeloid modulating antibody, BDC-3042, which repolarizes tumor-associated macrophages, or TAMs, into tumor destructive macrophages via agonism of Dectin-2," said Randall Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics.

Three of Bolt Biotherapeutics’ preclinical programs will be featured in poster presentations: (1) BDC-2034, a CEA-targeting immune-stimulating antibody conjugate (ISAC) expected to enter clinical development in the second half of 2022, (2) BDC-3042, a Dectin-2-targeting, myeloid-modulating antibody anticipated to enter clinical development in 2023, and (3) a PD-L1-targeting ISAC. These posters will highlight updates on preclinical research for each of the programs, demonstrating anti-tumor activity and supporting future clinical development for all three programs.

Poster presentation sessions will be conducted in-person and available electronically on April 12 and 13 and will be published in Proceedings of the AACR (Free AACR Whitepaper). Details for each presentation can be seen below and on the AACR (Free AACR Whitepaper) website.

Title: The CEA-targeted ISAC, BDC-2034, shows preclinical efficacy associated with innate immune activation, phagocytosis, and myeloid reprogramming
Presenter: William G. Mallet, Ph.D.
Session Date and Time: Tuesday Apr 12, 2022, 9:00 a.m. – 12:30 p.m. CST
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38
Poster Board Number: 26
Abstract Number: 2911

Title: Dectin-2 agonist antibodies reprogram tumor-associated macrophages to drive anti-tumor immunity
Presenter: Shelley Ackerman, Ph.D.
Session Date and Time: Tuesday Apr 12, 2022, 9:00 a.m. – 12:30 p.m. CST
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Poster Board Number: 26
Abstract Number: 2883

Title: PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models
Presenter: Justin Kenkel, Ph.D.
Session Date and Time: Wednesday Apr 13, 2022, 9:00 a.m. – 12:30 p.m. CST
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 39
Poster Board Number: 11
Abstract Number: 4252

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, which can lead to the conversion of immunologically "cold" tumors to "hot" tumors with the goal of durable responses for patients with cancer.

On March 8, 2022 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that an abstract has been accepted for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, scheduled for April 8-13 in New Orleans (Press release, Lyell Immunopharma, MAR 8, 2022, View Source [SID1234609998]).

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The poster presentation being presented at AACR (Free AACR Whitepaper) will highlight the preclinical data characterizing LYL797, Lyell’s first therapeutic candidate incorporating T-cell reprogramming technologies for the treatment of solid tumors. 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 two 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 the properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist, and self-renew with anti-tumor functionality.

"With LYL797 entering clinical development, we are excited to present the preclinical data evaluating our two T-cell reprogramming technologies which are designed to overcome the barriers we believe have impeded the development of more effective cell therapies for patients with solid tumor cancers," said Tina Albertson, MD, PhD, Chief Medical Officer and Head of Development of Lyell. "Reprogramming T cells to be able to resist exhaustion and demonstrate properties of durable stemness is key to our mission to develop cell therapies that can outlast and eradicate hard-to-kill solid tumors."

Details on the poster presentation are below:

Poster Title: LYL797, a ROR1 CAR T-cell therapy with genetic and epigenetic reprogramming for solid tumors
Session: Adoptive Cell Therapy
Abstract Number: 3808
Presentation Date, Time & Location: Tuesday, April 12, 9:00am – 12:30pm, Section 30
Presenter: Spencer Park, PhD, Lyell Immunopharma

The abstract has been posted to the AACR (Free AACR Whitepaper) online itinerary planner. Following the meeting, the abstract will be published in an online-only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research.

Lyell announced U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for LYL797 in December 2021.

On March 8, 2022 Eucure Biopharma, a wholly owned subsidiary of Biocytogen, reported the first patient dosing for a phase I multi-regional clinical trial (MRCT) of YH002 (anti-OX40 monoclonal antibody, mAb) in combination with YH001 (anti-CTLA-4 mAb) (No. YH002004) in Australia (Press release, Biocytogen, MAR 8, 2022, View Source [SID1234609975]). This phase I MRCT will be conducted in Australia and China.

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The clinical trial is an open-label, dose-escalation phase I study designed to evaluate the safety, tolerability and preliminary efficacy of YH002 in combination with YH001 in patients with advanced solid tumors. Pharmacokinetics and immunogenicity of YH001 and YH002 will also be evaluated.

Eucure Biopharma has previously completed mono-dose-escalation studies for YH001 and YH002. The results show that both YH001 and YH002 have good tolerance and safety.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said, "Both YH001 and YH002 are developed from Biocytogen’s evidence-based in vivo efficacy screening platform. Using animal models, we found for the first time, that combination of YH002 and YH001 has very good antitumor activity. We expect the results from animal models can be verified in patients. We are hopeful that these platforms will continue to drive the discovery and development of novel therapeutic antibodies, ADCs and bispecific ADCs for future clinical benefit."

About YH002

YH002 is a recombinant anti-OX40 humanized IgG1 antibody. Targeting OX40 enhances anti-tumor responses both by activating effector T cells and inhibiting or exhausting regulatory T cells (Treg). In preclinical studies, YH002 demonstrated excellent specificity, affinity and safety. In vivo studies using Biocytogen’s humanized mouse models demonstrated improved therapeutic potential of YH002 compared to benchmark antibodies, and indicated promising potential for combination therapy.

About YH001

YH001 is an anti-CTLA-4 monoclonal antibody that aims to enhance the anti-tumor immune response through removal of Treg from the tumor microenvironment. Combination therapies that block multiple inhibitory immune checkpoints (including CTLA-4 and PD-1) are currently considered to be promising treatments for multiple types of tumors, due to their potential to influence the activity of multiple populations of T cells.