On April 8, 2022 Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that study findings accepted for presentation at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in New Orleans, LA, Friday, April 8 – Wednesday, April 13 (Press release, Carisma Therapeutics, APR 8, 2022, View Source [SID1234611777]). The accepted data reinforce the potential of Carisma’s differentiated and proprietary cell therapy platform focused on engineered macrophages as a novel treatment pathway for hard-to-treat cancers and other serious illnesses and provides information on the feasibility of a shortened manufacturing process for chimeric antigen receptor (CAR) monocytes.

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Carisma will share key findings from recent studies including, "Chimeric antigen receptor macrophages (CAR-M) sensitize solid tumors to anti-PD1 immunotherapy," presented by Stefano Pierini, PhD, Principal Scientist at Carisma. Findings demonstrate robust synergy between the CAR-Macrophage platform and T cell checkpoint inhibitor therapy. Using pre-clinical solid tumor animal models that are resistant to PD1 blockade, Carisma demonstrated that adding CAR-Macrophages to the treatment regimen significantly enhanced tumor control, overall survival, and tumor microenvironment (TME) activation. Notably, while CAR-Macrophage monotherapy led to TME remodeling, the combination with anti-PD1 led to an increased infiltration of T cells, dendritic cells, and other inflammatory immune cells. Carisma will seek to further evaluate CT-0508, the anti-human epidermal growth factor receptor 2 (HER2) CAR-Macrophage, in a combination study with pembrolizumab in patients with HER2 overexpressing tumors.

"Pre-clinical development of CAR Monocytes (CAR-Mono) for solid tumor immunotherapy," presented by Carisma Principal Scientist, Daniel Blumenthal, PhD, demonstrated that CAR-Monocytes can be produced in a single day, induce robust and targeted anti-tumor activity in vitro and in vivo, differentiate into M1 polarized CAR-Macrophage within tumors, and persist for over six months in animal models. In this study, Carisma established an ultra-rapid, same-day CAR-Monocyte manufacturing process, which holds the potential to significantly reduce the future cost of goods and manufacturing turnaround time associated with the autologous cell therapy.

Also accepted for AACR (Free AACR Whitepaper) presentation is the clinical trial design and foundational details regarding Carisma’s lead candidate, CT-0508, a HER2-targeted CAR-Macrophage, "A phase 1, first in human (FIH) study of autologous anti-HER2 chimeric antigen receptor macrophages (CAR-M) in HER2-overexpressing solid tumors (ST)," presented by Kim A. Reiss, MD, Assistant Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania (Penn) and the principal investigator for Carisma’s clinical trial of CT-0508. This first-of-its kind Phase 1 clinical trial is actively enrolling patients at five sites, including Penn; the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill; City of Hope in Duarte, California; University of Texas MD Anderson Cancer Center in Houston, Texas; and Sarah Cannon Research Institute at Tennessee Oncology – Nashville.

"The preclinical data presented at the AACR (Free AACR Whitepaper) Annual Meeting reinforces the exciting potential of Carisma’s engineered macrophage and monocyte platforms," shared Debora Barton, MD, Chief Medical Officer at Carisma Therapeutics. "Our commitment remains steadfast to providing new solutions to patients and their providers, as we continue our first-of-its-kind clinical trial of CT-0508 and look to expand utilization of this technology."

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

Sunday, April 10 at 1:30 pm ET:
Pre-clinical development of CAR Monocytes (CAR-Mono) for solid tumor immunotherapy
Monday, April 11 at 1:30 pm ET:
Chimeric antigen receptor macrophages (CAR-M) sensitize solid tumors to anti-PD1 immunotherapy
Tuesday, April 12 at 9:00 am ET:
A phase 1, first in human (FIH) study of autologous anti-HER2 chimeric antigen receptor macrophages (CAR-M) in HER2-overexpressing solid tumors (ST)
Editor’s Note: Carisma has licensed certain Penn-owned intellectual property from the University of Pennsylvania, and Penn’s Perelman School of Medicine receives sponsored research and clinical trial funding from the company. Penn may also be entitled to receive additional financial benefits from technologies licensed and optioned to Carisma in the future. In addition, Penn is a co-founder of the company and holds equity interests in Carisma.

On April 8, 2022 Cytovia Therapeutics, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multispecific antibodies, reported that the novel data it is presenting at the American Association of Cancer Research’s annual meeting in New Orleans on April 12th, 2022 is now available on both the AACR (Free AACR Whitepaper) and Cytovia websites (Press release, Cytovia Therapeutics, APR 8, 2022, View Source [SID1234611775]).

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"We are very pleased with the decisive progress of Cytovia’s R&D team towards the manufacturing and preclinical validation of its two synergistic platforms," commented Dr. Daniel Teper, CEO and Chairman of Cytovia Therapeutics. "The data presented at AACR (Free AACR Whitepaper) supports the advancement of our lead GPC3-targeting hepatocellular carcinoma (HCC) program towards clinical trials and our differentiated CD38-targeting multiple myeloma program to IND-enabling studies. Cytovia is the first company to combine its own iPSC-derived natural killer (iNK) cells and multispecific, NK cell-engaging antibodies and is building a pipeline that encompasses both hematological malignancies and solid tumors."

"Cytovia’s GPC3-directed NK-engager in combination with iPSC-derived NK cells demonstrated impressive anti-tumor activity in mice that merits clinical development," added Dr. Michael Friedman, a member of Cytovia’s Board of Directors. "For the large number of hepatocellular cancer patients who currently have such limited, poor clinical options, a novel tumor antigen-directed NK engager is needed. It would be a welcome addition to a physician’s armament, with high potential for numerous combinations. The early CYT-338 data, showing superiority over daratumumab in several in vitro assays, is similarly impressive and warrants further preclinical development in my opinion."

Highlights from Posters Presented at the AACR (Free AACR Whitepaper) Annual Meeting

CYT-303

The FLEX-NKTM tetravalent, multifunctional antibody CYT-303 directed against NKp46 and GPC3 demonstrated in vitro and in vivo activity against HCC tumor targets.
iNK cells expressed a favorable combination of multiple activation and few inhibitory receptors that corresponded to more potent cytolytic activity against HCC targets.
The combination of the FLEX-NKTM and iNK platforms demonstrated greater in vitro and in vivo anti-tumor activity in HCC models than iNK cells alone, with a favorable in vitro cytokine release and immune cell subset safety profile.
These preclinical proof of concept studies with CYT-303 alone or in combination with iNK cells in HCC warrant clinical development.
CYT-338

The FLEX-NKTM multifunctional engager antibody CYT-338 directed against NKp46 and CD38 demonstrated in vitro activity against multiple myeloma tumor targets.
An analysis of binding sites on CD38 indicates CYT-338 binds an epitope that is distinct from daratumumab.
The binding, cytokine release, cytotoxicity, and fratricide profiles of CYT-338 were superior to daratumumab.
These data support further development of CYT-338 as a therapeutic for targeting CD38 expressing multiple myeloma cells.
For details on in-person poster presentations, please see the following:

Title: Preclinical characterization of FLEX-NKTM tetravalent NKp46 engager directed against GPC3 (CYT-303) alone or in combination with iPSC derived Natural Killer cells (iNKs) against hepatocellular carcinoma (HCC)
Presenter: Antonio Arulanandam
Session Title: Adoptive Cell Therapy
Session Date and Time: Tuesday, Apr 12, 2022, 9:00 AM – 12:30 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 30
Poster Board Number: 8
Permanent Abstract Number: 2752
Abstract Link

Title: Novel multifunctional tetravalent CD38 NKp46 FLEX NKTM engagers actively target and kill multiple myeloma cells
Presenter: Liang Lin
Session Title: Combination Immunotherapies / Therapeutic Antibodies
Session Date and Time: Tuesday, Apr 12, 2022, 1:30 PM – 5:00 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 32
Poster Board Number: 17
Permanent Abstract Number: 3436
Abstract Link

On April 8, 2022 Sumitomo Pharma Oncology, Inc., (SMP Oncology) a clinical-stage company focused on research and development for novel cancer therapeutics, reported it will present new clinical and preclinical data on a range of investigational agents from the company’s pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 8-13, 2022, in New Orleans, LA (Press release, Sumitomo Pharmaceuticals, APR 8, 2022, View Source [SID1234611774]).

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The data that will be presented at the meeting includes Phase 1 clinical data evaluating the potential anti-cancer activity of the cyclin dependent kinase 9 (CDK9) inhibitor oral TP-1287, the WT1 immunotherapeutic cancer vaccine DSP-7888 plus nivolumab (NIV) or pembrolizumab (PEM), and the activin receptor-like kinase-2 (ALK2) inhibitor oral TP-0184.

"The data emphasize our commitment to, and the progress being made in advancing our pipeline to discover novel approaches to address unmet needs in the oncology space," said Patricia S. Andrews, CEO and Global Head of Oncology, SMP Oncology. "These trials represent a significant step forward for patients as we continue toward advancing purposeful research and drug development in oncology."

Below are the details for the presentations:

Abstract Title

Details

Presenter/Authors

CT191 / 16 – Phase 1, first-in-human, dose-escalation study of oral TP-1287, a cyclin dependent kinase 9 (CDK9) inhibitor, in patients (pts) with advanced solid tumors (ASTs)

Abstract

Wednesday April 12, 2022, 9:00AM – 12:30PM

Session PO.CT01.02 – Phase I Clinical Trials 2

Nicholas J. Vogelzang, Ben George, Nissa Ashenbramer, William J. Edenfield, Donald Richards, Mitchell E. Gross, Gil D. Fine, Pablo Martinez. Comprehensive Cancer Centers of Nevada, Las Vegas, NV, LaBahn Pancreatic Cancer Program, Departments of Medicine-Hematology/ Oncology, Medical College of Wisconsin, Milwaukee, WI, Sumitomo Pharma Oncology, Inc., Cambridge, MA, Greenville Health System Cancer Institute, Greenville, SC, Department of Oncology, US Oncology Research, Texas Oncology-Tyler, Tyler, TX, University of Southern California, Keck School of Medicine, Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, CA

Preliminary safety and efficacy of DSP-7888 plus nivolumab (NIV) or pembrolizumab (PEM) in patients (pts) with advanced solid tumors (ASTs): a phase (Ph) 1b/2 open-label study

Abstract

Monday, April 11, 2022, 1:30PM – 5:00PM

Session PO.CT01.01 – Phase I Clinical Trials 1

Wael A. Harb, Makoto Origuchi, Patrick W. Cobb, Trisha Wise-Draper, Natsuko Suginobe, Megumi Nakamura, Masashi Goto, Aaron Chen, Jian Li, James L. Wade III. Syneos Health, Morrisville, NC, Horizon Oncology Center, Lafayette, IN, Sumitomo Pharma Oncology, Inc., Cambridge, MA, St. Vincent Frontier Cancer Center, Billings, MT, Department of Internal Medicine, Division of Hematology/Oncology, University of Cincinnati, Cincinnati, OH, Sumitomo Pharma Co., Ltd., Osaka, Japan, Cancer Care Specialists of Illinois, Decatur, IL

CT134 / 1 – Phase 1, first-in-human, dose-escalation, safety, pharmacokinetic (PK), and pharmacodynamic study of oral TP-0184, an activin receptor-like kinase-2 (ALK2) inhibitor, in patients (pts) with advanced solid tumors (ASTs)

Abstract

Tuesday April 11, 2022, 1:30PM – 5:00PM

Session PO.CT01.01 – Phase I Clinical Trials 1

Joaquina Baranda, Michael S. Gordon, Aparna R. Parikh, Huyuan Yang, Gregory K. Pennock, Philip Komarnitsky, Muhammad S. Beg. Division of Medical Oncology, Department of Medicine, University of Kansas Cancer Center, Westwood, KS, HonorHealth Research Institute, Scottsdale, AZ, Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, MA, Sumitomo Pharma Oncology, Inc., Cambridge, MA, The University of Texas Southwestern Medical Center, Dallas, TX

Additionally, at AACR (Free AACR Whitepaper) SMP Oncology will present preclinical data on TP-1287 in sarcomas in a poster.

Below are the details for the poster:

Poster Title

Details

Presenter/Authors

CDK9 as a potential therapeutic target in sarcomas

Poster:

Wednesday April 12, 2022, 9:00AM – 12:30PM

Session PO.MCB06.01 – Cell Cycle Control and Cell Cycle Regulators as Therapeutic Targets

Yuta Matsumura, Hiroki Umehara, Jun Oishi, Adam Siddiqui, Jason M. Foulks, Setsuko Yamamoto, Steven L. Warner. Sumitomo Pharma Oncology, Inc., Lehi, UT, Sumitomo Pharma Co., Ltd., Osaka, Japan

About TP-1287
TP-1287 is an investigational oral CDK9 inhibitor that has shown favorable oral bioavailability in preclinical models. TP-1287 is enzymatically cleaved, yielding the active moiety, a potent inhibitor of CDK9.1 Inhibiting CDK9 is thought to downregulate the transcription of target genes, including MCL-1, reducing leukemic blast viability in MCL-1–dependent hematologic malignancies, and c-MYC, an important oncogene across multiple tumor types.2, 3, 4 TP-1287 is in a Phase 1 first-in-human study of oral TP-1287 in patients with advanced solid tumors (NCT03604783).

About DSP-7888
Ombipepimut-S Emulsion (DSP-7888) is an investigational immunotherapeutic cancer vaccine containing 2 peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTLs) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic malignancies and solid tumors.5, 6 Researchers have identified that adding helper T-cell–inducing peptides improved WT1-specific CTL induction, which may contribute to tumor cytotoxicity.5 Ombipepimut-S Emulsion is in a Phase 1/2 study with immune checkpoint inhibitors in adult patients with advanced solid tumors (NCT03311334).

About TP-0184
TP-0184 is an investigational inhibitor of activin receptor-like kinase 2 (ALK2) and ALK5 (also known as TGFβR1). This bimodal inhibitor is believed to downregulate multiple TGF-β superfamily signaling pathways, enabling hematopoietic regulation in myelodysplastic syndrome (MDS) through hepcidin decreases, bioavailable iron increases, and hemoglobin restoration, as well as antitumor activity in several cancers.7, 8, 9 TP-0184 is in two clinical trials; A Phase 1/2 study to treat anemia in adults with IPSS-R low or intermediate risk MDS (NCT04623996); A first-in-human study of oral TP-0184 in patients with advanced solid tumors (NCT03429218).

On April 8, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported the early results of a first-in-human clinical study of GC502, an allogeneic CD19/CD7 dual-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) (Press release, Gracell Biotechnologies, APR 8, 2022, View Source [SID1234611773]). Gracell will share the data in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 on April 12.

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GC502 leverages the novel dual-directed CAR design of Gracell’s proprietary TruUCAR platform, designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with faster patient’s access. TruUCAR-enabled GC502 utilizes the dual-directed CAR design with one CAR targeting CD19 on malignant cells and a second CAR targeting CD7 to suppress host-versus-graft rejection. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells.

"We are very excited to present our data on GC502 at this year’s AACR (Free AACR Whitepaper) annual meeting. CD19 is a validated target in the treatment of r/r B-ALL," said Dr. Martina Sersch, Chief Medical Officer of Gracell. "As an allogeneic, off-the-shelf CAR-T therapy, GC502 has the potential to provide patients who may not be eligible for autologous CAR-T therapy with hope to achieve a deep response. The early results show the potential of GC502 and warrant further evaluation in the ongoing clinical investigator-initiated-trial (IIT). Being the second product candidate from our allogeneic TruUCAR platform, GC502 further validates TruUCAR’s platform approach and potential wide applicability."

Between September 2021 and January 2022, four r/r B-ALL patients were enrolled and treated in an open-label, non-randomized, prospective IIT study in China in two different dose levels and with two different formulations. Patients were heavily pretreated, and all had previously received either autologous or donor derived CD19 or CD19/CD22 targeted CAR-T therapy. As of the January 28, 2022 data cutoff date, all four patients had received a single dose of GC502, including one patient at dose level 1 (DL1) 1.0×107 cells/kg and three patients at dose level 2 (DL2) 1.5×107 cells/kg. Patients received a Flu/Cy based lymphodepletion regimen prior to treatment with GC502.

As highlighted in the AACR (Free AACR Whitepaper) poster, three out of four patients achieved minimal residual disease negative complete response or complete response with incomplete count recovery (MRD- CR/CRi), and one patient achieved a partial response at month one and subsequently received allogeneic hematopoietic stem-cell transplantation (allo-HSCT) on day 39.

Cytokine release syndrome (CRS) presented as Grade 2 and Grade 3 with no Grade 4 or 5 events. No immune effector cell-associated neurotoxicity syndrome (ICANS) or acute graft-versus-host disease (aGvHD) were observed.

For more information on the ongoing trial, refer to the ClinicalTrials.gov Identifier: NCT05105867.

Details of the presentation are as follows:

Presentation Title: Early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
Session Title: Phase I Clinical Trials 2
Session Date and Time: Tuesday, April 12, from 9:00AM – 12:30PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33
Poster Board Number: 21
Permanent Abstract Number: CT196
Additional meeting information is available on the AACR (Free AACR Whitepaper) website. The full text of the abstract is available on the AACR (Free AACR Whitepaper) Online Itinerary Planner and the e-poster is viewable to registered attendees on the AACR (Free AACR Whitepaper)’s e-poster website through Wednesday, July 13, 2022.

About GC502

GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied in an ongoing Phase 1 IIT in China for the treatment of B-cell malignancies. GC502 is manufactured using T cells from non-human leukocyte antigen (HLA) matched healthy donors. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells. Optimized for CD19/CD7 dual-CAR functionality and in vivo durability, GC502 has demonstrated robust anti-tumor effects with potential to suppress host versus graft (HvG) rejection in preclinical models.

About B-ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in the United States in 2022[1]. B-ALL accounts for 75% of ALL diagnoses in adults.

About TruUCAR

TruUCAR is Gracell’s proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host versus graft rejection (HvG) as well as graft versus host disease (GvHD) without the need for being co-administered with additional immunosuppressive drugs after standard lymphodepletion. The novel dual-CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress HvG response.

On April 8, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported safety and preliminary efficacy data of the combination of the Company’s lead immunotherapy candidate, maveropepimut-S (MVP-S), with pembrolizumab from a Phase 2 basket study of patients with advanced, metastatic bladder cancer (Press release, IMV, APR 8, 2022, View Source [SID1234611771]). Data will be presented at a mini-symposium on Immunotherapy Combination Strategies in Clinical Trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 8-13, 2022, in New Orleans, Louisiana.

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Seventeen subjects with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy, were enrolled in this arm of the Phase 2 basket study (NCT03836352) and treated with the combination of MVP-S/CPA and pembrolizumab. The preliminary results, described below, suggest that IMV’s therapy may provide a well-tolerated therapeutic alternative for advanced, metastatic bladder cancer patients in need of new treatment options.

"The basket trial was designed to identify signals of clinical benefit for the combination of MVP-S/ CPA and pembrolizumab," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc. "We are very encouraged to see such positive clinical results, particularly in advanced, metastatic bladder cancer patients that had already been treated with immune checkpoint inhibitors. We are now meeting with top key opinion leaders in the field to design follow-on trials to deepen our understanding of this clinical benefit."

Key Findings

Five out of 17 subjects showed response (2 confirmed complete responses (CRs) and 3 additional partial responses);
Three of these, including both confirmed CRs, had progressed on prior anti-PD-1/L1 therapy;
Long-term clinical benefit was observed in several subjects as was an increase in detectable survivin-specific T cells in peripheral blood; one patient remains on treatment after 18 months;
The combination treatment was well-tolerated, with the majority of adverse events being grade 1 or grade 2.
This presentation will be available on the conference platform and on the IMV website under the Scientific Publications & Posters section following the meeting.

Presentation details:

Safety, preliminary efficacy and pharmacodynamic (PD) analysis of maveropepimut-S, intermittent low-dose cyclophosphamide and pembrolizumab in patients with advanced, metastatic bladder cancer

Presenter: Jeremy R. Graff, Ph.D., Chief Scientific Officer at IMV
Session Title: Immunotherapy Combination Strategies in Clinical Trials
Presentation Number: CT035
Session Date and Time: Tuesday, Apr. 12, 2022, 2:30 p.m. – 4:30 p.m. CST