On April 9, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported two upcoming poster presentations accepted as late breaking abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, to be held virtually April 10-15, 2021 (Press release, Apexigen, APR 9, 2021, View Source [SID1234577808]). Details are as follows:

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Title of Presentation: APX601, a Potent TNFR2 Antagonist as a Novel and Promising Approach to Reverse Tumor Immune Suppression (Abstract ID LB175)
AUTHORS: Sushma Krishnan, Ryan Alvarado, George Huang, Xiaodong Yang and Erin L Filbert
PRESENTER: Erin L. Filbert, Ph.D.

Title of Presentation: Targeting SIRPα with APX701, a Novel Myeloid Checkpoint Inhibitor (Abstract ID LB177)
AUTHORS: Ryan Alvarado, Sushma Krishnan, Minu K. Srivastava, Christine Tan, George Huang, Swati Jalgaonkar, Frances R. Bahjat, Erin Filbert and Xiaodong Yang
PRESENTER: Ryan Alvarado

The posters will be available on the e-poster website from at 8:30 am EDT on April 10, 2021, through June 21, 2021.

On April 9, 2021 CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported study findings accepted for virtual presentation at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on Saturday, April 10 – Thursday, April 15 (Press release, Carisma Therapeutics, APR 9, 2021, View Source [SID1234577807]). The accepted data reinforces the potential of CARISMA’s proprietary chimeric antigen receptor macrophage (CAR-M) platform, as well as the importance of evaluating CAR-monocytes (CAR-Mono) as a novel and expedited immunotherapeutic pathway.

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CARISMA will share key findings from recent studies including, "Chimeric antigen receptor macrophages (CAR-M) induce anti-tumor immunity and synergize with T cell checkpoint inhibitors in pre-clinical solid tumor models," presented by Dr. Stefano Pierini, Senior Scientist at CARISMA, which established a fully immunocompetent solid tumor mouse model and evaluated the interaction of CAR-M with the tumor microenvironment and the endogenous adaptive immune system. This study marks the first time CAR-Ms have been assessed in a fully immunocompetent animal model. The findings demonstrate that CAR-M therapy showed significant tumor control, increased overall survival, remodeled the tumor microenvironment, and protected mice from antigen negative tumor recurrence. Additionally, the studies demonstrate that CAR-M synergize with T cell checkpoint inhibitors against PD1 resistant solid tumors. The data build on findings from CARISMA’s foundational CAR-M platform that were published in Nature Biotechnology in March 2020.

Also accepted for AACR (Free AACR Whitepaper) presentation is the clinical trial design and foundational details regarding CARISMA’s lead candidate, CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted CAR-M, "A phase 1, first in human (FIH) study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor (CAR) in subjects with HER2 overexpressing solid tumors," presented by Joshua Bauml, MD, an Assistant Professor of Medicine in the division of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania (Penn). This first-of-its kind Phase 1 clinical trial is actively enrolling patients at two sites, Penn and the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill. Dr. Bauml is the principal investigator for the trial at Penn.

In "Anti-HER2 CAR monocytes demonstrate targeted anti-tumor activity and enable a single day cell manufacturing process," presented by CARISMA Scientist Dr. Linara Gabitova, new data shows the successful development of CAR-Mono with direct anti-tumor activity and capacity to differentiate into M1-polarized CAR-M. In addition, CARISMA established an ultra-rapid, same-day CAR-Mono manufacturing process for this study, which has the potential to significantly reduce the future cost of goods and manufacturing turn-around-time associated with the autologous cell therapy.

"The data presented at the AACR (Free AACR Whitepaper) Annual Meeting build upon the broad engineered monocyte and macrophage platform established by CARISMA Therapeutics," shared Michael Klichinsky, PharmD, PhD, Scientific Co-founder, and Senior Vice President of Research at CARISMA Therapeutics. "These critical pre-clinical data demonstrate that CAR-M not only directly shrink tumors but instill long-term anti-tumor immunity via antigen presentation to T cells, protecting from relapse in the future."

The following presentation and posters will be published on the AACR (Free AACR Whitepaper) Annual Meeting website and available for registered attendees during the dates/times indicated below:

Saturday, April 10 at 8:30 am ET:
A phase 1, first in human (FIH) study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor (CAR) in subjects with HER2 overexpressing solid tumors
Anti-HER2 CAR monocytes demonstrate targeted anti-tumor activity and enable a single day cell manufacturing process
Monday, April 12 at 3:05 pm ET:
Chimeric antigen receptor macrophages (CAR-M) induce anti-tumor immunity and synergize with T cell checkpoint inhibitors in pre-clinical solid tumor models

On April 9, 2021 Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, reported its first two cancer drug candidates, one from each of Nammi’s distinctive drug development platforms, Nammisomes and Masked ImmunoCytokines (MIC) (Press release, Nammi Therapeutics, APR 9, 2021, View Source [SID1234577806]). Nammi is presenting the lead products for each platform in two posters at the 2021 annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference. The posters will be available on the conference website April 10-June 21, 2021. The therapies being presented are selected products initiating GMP manufacturing and IND-enabling studies. Both of Nammi’s platforms embody our 3 core principles:

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The redundancy of immune regulatory pathways requires synergistic combinations for robust and broad efficacy of immuno-therapies in cancer;
Potent immune stimulators must be dampened while in circulation to avoid systemic toxicities; and
Optimal therapies will employ mechanisms to selectively deliver and activate immune cells within tumors to focus on killing the tumor rather than healthy tissue.
Nammi’s Nammisome platform combines immune modulating prodrugs into lipid nanoparticles enabling selective delivery to tumors. A second immunotherapy platform called Masked ImmunoCytokines (MICs) was acquired by a recent merger with Qwixel Therapeutics. MICs employ interferons, that have both direct anti-tumor cytotoxic activity as well as broad immune stimulating activity, and focus the potent effects by fusion to an anti-tumor targeting antibody and masking of the interferon so that it is only activated in the tumor microenvironment

QXL138AM: Poster #1726 highlights preclinical validation of our first in class MIC comprised of a CD138-targeted antibody fused with Interferon alpha (IFNα) that is masked with a tumor-selectively releasable peptide. CD138 is expressed in multiple myeloma as well as many different solid tumor indications including breast, colon, hepatic, ovarian, urothelial, and head and neck cancers.

NTI-55: Poster #1581 highlights preclinical validation of NTI-55, a novel combination of validated immune modulator lipid prodrugs, including a TLR7 agonist and an A2AR inhibitor, that stimulates an immune response and blocks an important tumor-derived immune checkpoint. These are broad based mechanisms that provide potential for NTI-55 in all solid tumor indications. These lipid prodrugs are assembled into lipid nanoparticles called Nammisomes that reduce systemic exposure to the immunotherapies while synchronizing delivery to, and activation at, the tumor sites.

"While strikingly distinct in design, the two approaches elegantly exemplify the vision of Nammi to develop immunotherapies that focus the immune system on anti-tumor activity while sparing patients from toxicities associated with systemic immune activation. We also believe there is a strong potential for synergy in combining the drugs to triangulate their immune activation for even more robust efficacy", said David Stover, Ph.D., President and CEO of Nammi.

Nammi has raised over $10M to date from Founders and Angel investors to drive preclinical development of both platforms. Nammi foresees filing INDs for both lead programs in mid-2022. Additional pipeline products, stemming from both the Nammisome and the MIC platforms, are in lead selection stage.

On April 9, 2021 Repertoire Immune Medicines, a clinical-stage biotech company decoding the immune synapse to create novel immune therapies for cancer, immune disorders, infectious disease, and other serious diseases, reported the presentation of translational data obtained from applying its proprietary antigen-specific TCR-MHC DECODE platform in its Phase 1 trial evaluating PRIME IL-15 (RPTR-147) in patients with advanced or metastatic solid tumor cancers (Press release, Repertoire, APR 9, 2021, View Source;-PRIME-IL-15-RPTR-147—-in-Advanced-or-Metastatic-Solid-Tumor-Cancers [SID1234577805]). The data will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting Week 1, taking place April 10-15, 2021. PRIME IL-15, the company’s lead investigational therapy, is a novel non-genetically modified, autologous, multiclonal T cell product derived from the patient’s T cell repertoire in the peripheral blood, activated against a curated set of tumor antigens, and armored with an IL-15Fc nanogel. It is being evaluated for a variety of solid tumors.

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In this study, Repertoire Immune Medicines’ applied its proprietary DNA-barcoded pMHC tetramer technology (CIPHERTM) to determine the specificity of its multiclonal T cell product. In addition, bulk sequencing of TCRVβ was performed on tumors pre- and post-treatment and identified product derived CD8+ T cell clonotypes in the post-, but not pre-treatment biopsies. The presentation also details the use of the company’s platform to de-orphan these tumor infiltrating lymphocytes (TIL) of interest, and clone selected TIL TCRs to determine their exact specificities by epitope and HLA.

These translational data demonstrate that rare T cell clones — derived from the peripheral blood — can be amplified and directed to tumor antigens in humans. Further, these findings highlight the unique capability of the company’s DECODE platform to fully decipher the immune synapse by identifying the T cell clones and their cognate antigens by HLA that matter in patients.

Details:

Abstract title: Tracking and Decoding the Antigen Specificity of Peripherally Derived T Cells that Infiltrate into Solid Tumors in patients treated with PRIME IL-15 (RPTR-147)
Session category: Adoptive Cell Therapy (PO.CL06.01)
Date & time: April 10, 2021 from 8:30 a.m. – 12:00 p.m. EDT

On April 9, 2021 Humanigen, Inc. (Nasdaq:HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported positive results from the Phase 1 safety and bioimaging trial of its second Humaneered antibody, ifabotuzumab, in patients with glioblastoma multiforme (GBM) (Press release, Humanigen, APR 9, 2021, View Source [SID1234577804]). In the study, ifabotuzumab demonstrated highly sensitive, specific, and reproducible targeting of the tumor and tumor microenvironment in all patients. The results will be presented as a poster at the AACR (Free AACR Whitepaper) Annual Meeting 2021, held virtually from April 10-15, 2021, and remain available until June 21, 2021.

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The Phase 1 study primarily sought to determine the safety and recommended Phase 2 dose of ifabotuzumab in patients with GBM, the most frequent and lethal primary brain neoplasm, with 5-year survival rates of 10%. It is estimated there are more than 18,000 deaths from brain cancer annually in the United States.1 Ifabotuzumab is a non-fucosylated IgG1κ antibody targeting the EphA3 receptor. EphA3 is a tumor-restricted antigen expressed in the tumor vasculature and tumor stroma of various solid tumors including breast, colon, lung, prostate, melanoma, and GBM. The study showed that, at both doses, ifabotuzumab demonstrated highly sensitive, specific, and reproducible targeting of the tumor and tumor microenvironment in all patients. There were no dose-limiting toxicities observed and all adverse events were readily manageable. Additional studies are planned to evaluate ifabotuzumab as an antibody-drug conjugate in solid tumor patients.

"GBM represents an extremely aggressive form of cancer that has historically eluded effective treatment, and we remain committed to investigating ifabotuzumab as a potential new approach to treat this devastating disease as well as other solid tumors," said Prof. Andrew Scott, Head, Tumor Targeting Laboratory, Olivia Newton-John Cancer Research Institute, Professor, School of Cancer Medicine, La Trobe University, member of the Australian Brain Cancer Mission Strategic Advisory Group, and Principal Investigator of the Phase 1 study. "The positive results of the Phase 1 study, which show ifabotuzumab to be well-tolerated and effective at targeting the EphA3 receptor, support further investigation into ifabotuzumab’s effect on other solid tumors in a Phase 2 study."

The poster, titled "A phase 1 safety and bioimaging trial of ifabotuzumab (KB004) in patients with glioblastoma," will be presented virtually at the AACR (Free AACR Whitepaper) Annual Meeting during the Phase 1 Clinical Trials Session on Saturday, April 10, 2021. The study was led by Principal Investigator Andrew Scott from the Olivia Newton-John Cancer Research Institute in Australia. Funding was provided by Cure Brain Cancer Foundation, the Queensland Government, Austin Health, and Humanigen.

"We are pleased to announce the positive Phase 1 results of ifabotuzumab in patients with gliobastoma multiforme," said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. "There is a tremendous need to advance new therapies for solid tumors, and this trial shows that ifabotuzumab demonstrates great potential. Ifabotuzumab represents an important part of Humanigen’s immuno-oncology arsenal as we advance our pipeline to target a wide-range of cancers, and we are proud to present our findings at this year’s AACR (Free AACR Whitepaper) Annual Meeting."

Details for the upcoming event are below:

AACR Annual Meeting 2021

Virtual abstract presentation viewable starting on Friday, April 9, 2021
Register here: View Sourceregistration/" target="_blank" title="View Sourceregistration/" rel="nofollow">View Source

E-poster presentation
Date: Saturday, April 10, 2021
Link: View Source