On April 9, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its first-quarter 2021 financial results on Tuesday, May 4, 2021 (Press release, Bausch Health, APR 9, 2021, View Source [SID1234577810]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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On April 9, 2021 Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, a first-in-class anti-cancer agent, reported that Sandra Van Schaeybroeck, PhD (Queen’s University Belfast) will be presenting research supporting BOLD-100 as a potential anti-resistance therapy for difficult-to-treat cancers, specifically BRAF-mutant colorectal cancer (Press release, Bold Therapeutics, APR 9, 2021, View Source [SID1234577809]).

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Van Schaeybroeck’s AACR (Free AACR Whitepaper) poster presentation "Targeting the DNA repair pathway with BOLD-100 in BRAF-mutant colorectal cancer" (Poster# 1183, Session PO.ET04.03 on April 10) highlights the promising research conducted by the Drug Resistance Group at the Patrick G. Johnston Centre for Cancer Research at Queen’s University Belfast, which investigated BOLD-100’s mechanism-of-action and identified promising treatment combinations in difficult-to-treat BRAF-mutant colorectal cancers.

Colon cancer is one of the most frequently diagnosed malignancies in adults, responsible for approximately 11% of all new cases of cancers worldwide and one-third of cancer deaths. BRAF-mutant colorectal cancers comprise 10% of those patients, and this subgroup has morphological, clinical, and therapeutic characteristics that differ substantially from patients without this genetic alteration. Importantly, there is no established standard of care for BRAF-mutant colorectal cancer, which is associated with a particularly poor prognosis and a median OS of less than 12 months versus more than 30 months for BRAF wild type metastatic colorectal cancer (mCRC), with V600E BRAF-mutated colorectal cancer being the most challenging subtype.

"BOLD-100 has a unique and complex mechanism-of-action and has potential in various challenging cancer subtypes, such as V600E BRAF-mutated colorectal cancer," stated Van Schaeybroeck. "This study further elucidated the mechanism-of-action for BOLD-100 and identified potentially synergistic drug-drug combinations for future investigation."

The AACR (Free AACR Whitepaper) Annual Meeting provides an opportunity to discuss the latest discoveries in cancer research and highlights the work being done by institutions around the world. This year’s virtual conference is taking place April 10-15 and May 17-21.

"Bold Therapeutics has developed a global consortium of world-class academic collaborators to investigate the potential of BOLD-100 as a revolutionary first-in-class anti-cancer agent that targets both ER stress and DNA repair pathways," said Mark Bazett, PhD, Director of Preclinical Development at Bold Therapeutics. "We look forward to connecting with interested researchers at AACR (Free AACR Whitepaper) 2021 to further develop this novel therapy."

Bold Therapeutics is headquartered in Vancouver, British Columbia, Canada. BOLD-100 is currently being investigated in a Phase 1b/2 study in combination with FOLFOX in the treatment of advanced gastrointestinal cancers at six sites in Canada, with additional sites opening in the United States and South Korea in late 2021.

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.