On November 13, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from three posters were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, highlighting the company’s immuno-oncology offerings for biopharmaceutical and academic researchers (Press release, Veracyte, NOV 13, 2021, View Source [SID1234595522]).

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The data demonstrate the ability of Brightplex to assess the spatial distribution of targeted immune cell subpopulations in tumors, which could potentially help clinical researchers design more effective immunotherapies in cancer treatment. Veracyte acquired the novel Brightplex technology – which combines information from multiplex immunohistochemistry (IHC) and advanced digital pathology analysis to provide a comprehensive picture of the tumor micro-environment – through its acquisition of HalioDx in August 2021.

The posters include new data regarding the use of Brightplex TCE (for T Cells Exhaustion) to stratify non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors in the "Biomarker analysis" part of the PIONeeR project1,2. This research program, promoted by the French government, is designed to better understand, predict and overcome anti-PD-1/PD-L1 resistance in advanced lung cancer patients and includes the analysis of hundreds of circulating and tumor biomarkers. The new findings on a preliminary PIONeeR patient data set suggest that one of those tests, the Brightplex TCE assay, can stratify NSCLC patients eligible for anti-PD-1/PD-L1 therapy into four Spatial Tumor-infiltrating lymphocyte (TILs) subtypes – Cold, Stroma-infiltrated, Parenchyma Hot and Hot – which may predict their outcomes. In the Hot subtype, for example, long-term progression-free survival (PFS) is observed for more than 40% of patients, regardless of PD-L1 status. In this Hot subtype, activated T-cell densities seem higher in tumors of patients with longer PFS, suggesting that immune-response evaluation with the Brightplex TCE assay could refine the stratification of patients, enriching responders to immune checkpoint inhibitor therapy.

"We are delighted to highlight these new data on our Brightplex assays from the PIONeeR project, which help confirm its potential role in patient stratification for anti-PD-1/PD-L1 therapeutics," said Corinne Danan, Veracyte’s general manager, Biopharma. "Our Brightplex assays are a key technology for a growing number of biopharmaceutical researchers as we can develop multiplex, customized panels using more than 80 distinct, validated biomarkers to decipher the tumor micro-environment, to help meet our partners’ needs."

The following posters can be accessed here:

"Spatial distribution of infiltrating T lymphocytes with Immunoscore CR T Cells Exhaustion test helps stratification of NSCLC patients treated with PD1/L1 inhibitors in the PIONeeR project" (poster #460)
"Assessment of the spatial distribution of B cells subpopulations in the tumor microenvironment and tertiary lymphoid structures by Brightplex, a sequential chromogenic multiplex assay" (Poster #57)
Assessment of the spatial distribution of CD4+ T cells subpopulations in the tumor microenvironment by Brightplex, a sequential chromogenic multiplex assay" (Poster #41)

On November 13, 2021 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported preliminary Phase 2 study (CORE1) results for CG0070 in combination with KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, NOV 13, 2021, View Source [SID1234595526]).

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The preliminary Phase 2 results showed that a combination of CG0070 and pembrolizumab was well tolerated with encouraging early efficacy data in 9 patients. The results (Abstract #955) were presented as a late-breaking oral presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting.

"We are excited to announce these preliminary results toward CG0070’s safety, tolerability and clinical efficacy in patients with bladder cancer unresponsive to BCG who have limited treatment options," said Arthur Kuan, Chief Executive Officer, CG Oncology. "We hope to see continued responses as the study progresses, as CG0070’s dual mechanism of action has shown to be highly effective in this difficult-to-treat patient population."

Summary of Preliminary Clinical Results

The analysis, based on a data cutoff on November 8, 2021, reported that 100% of patients evaluable for efficacy (n=9) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients that have reached additional timepoints, 100% (n=6) have also maintained a CR through 6 months and 100% (n=3) at the 9-month assessment.
Treatment related adverse events (AEs) were limited to transient grade 1-2 local genitourinary symptoms and immune-related adverse events including urinary frequency, bladder spasm, fatigue, chills, autoimmune thyroiditis, blood discharge, dysuria, and flu-like symptoms. No treatment-related grade 3 or higher AEs or severe adverse events (SAEs) have been observed.
"These preliminary results are exciting," said Dr. Roger Li, M.D., lead study investigator and Urologic Oncologist at Moffitt Cancer Center. "If similar trends hold moving forward, we may have a game changer to combat BCG-unresponsive bladder cancer for patients with significant unmet medical need."

About the CORE1 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CG0700

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in NMIBC following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.

On November 13, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported the Company made two presentations on novel lead asset, INT230-6, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC) (Free SITC Whitepaper) in Washington, D.C (Press release, Intensity Therapeutics, NOV 13, 2021, View Source [SID1234595530]).

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"Patients with metastatic and refractory cancers continue to have poor survival. Response rates remain low in most tumor types even with the use of immunotherapies such as checkpoint inhibitors," said Jacob S. Thomas, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine at the University of Southern California (USC) and oncologist at USC’s Norris Comprehensive Cancer Center, part of Keck Medicine of USC. "INT230-6 demonstrates direct tumor killing in injected lesions. In addition, analysis shows increases of immune cells in tumors and the shrinkage of uninjected tumors or abscopal results. These data suggest dosing INT230-6 may activate a T-cell mediated immune response. Results presented at SITC (Free SITC Whitepaper) indicate that use of intratumoral INT230-6 appears to be a viable approach in treating metastatic disease alone or in combination with immunotherapies."

"Sarcoma continues to be a very challenging cancer to treat and has proven resistant to checkpoint blockade. Novel immunotherapy-based approaches are still needed, and sarcoma is an attractive cancer for intratumoral injection of INT230-6, which is a direct tumor killing agent," said Matthew Ingham, M.D., Assistant Professor of Medicine in the Division of Hematology and Oncology, Columbia University Irving Medical Center. "Biopsies from tumors treated using INT230-6 showed substantial tumor necrosis, reduction of viable cancer, a decreased cancer proliferation as measured by Ki67, and increased tumor infiltrating lymphocytes such as CD4 and CD8 T-cells. An exploratory analysis suggests promising survival for subjects receiving INT230-6 compared to historical standards."

"Our Phase 1/2 data show INT230-6 alone or in combination with checkpoint inhibitors was well tolerated with no severe toxicities," remarked Dr. Ian Walters, Intensity’s Chief Medical Officer. "We now have promising early results from 115 patients with this drug, and the safety remains favorable even with injections into multiple deep tumors. The most common adverse event related to the drug is pain at the injection site. We have also demonstrated rapid tumor necrosis and promotion of systemic immune responses."

These presentations illustrate three different treatment regimens of INT230-6; as monotherapy, with pembrolizumab, or with ipilimumab. The results showcase the broad treatment potential of our locally-delivered anti-cancer product candidate in a variety of tumor types," stated Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Extended survival is the goal of any new cancer treatment, and these data show the potential for longer survival using INT230-6 when compared to historical results. Survival also appears to be improved with higher INT230-6 loading into tumors and treating more tumors over the course of therapy. Based on these encouraging early results, we are planning to initiate a randomized Phase 3 study with INT230-6 in patients with advanced soft tissue sarcomas next year."

The posters are accessible on the "Publications, Papers and Posters" section of Intensity’s website at: View Source

Highlights from the presentations are as follows:

Abstract Number: 501 "Survival and Immune Response Data from Intratumoral INT230-6 Alone (IT-01) and with Pembrolizumab [KEYNOTE-A10] in Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors"

Authors: Jacob Thomas, MD; Anthony El-Khoueiry, MD; Anthony J. Olszanski, MD, RPh; Nilofer Azad, MD; Giles F. Whalen, MD; Diana Hanna, MD; Matthew Ingham, MD; Syed Mahmood, MD; Lewis H. Bender, MS, MA, MBA; Ian B. Walters, MD, MBA; Lilian L. Siu, MD

This presentation reports results from 78 subjects summarizing the preliminary efficacy and safety of either INT230-6 alone (n=60) or in combination with the anti-PD-1 therapy, pembrolizumab (n=18) from an ongoing open-label, multi-arm Phase 1/2 clinical trial. Patients had a variety of relapsed, refractory metastatic solid tumors and progressed following a median of four prior therapies. INT230-6 was administered at doses of 0.3 to 175mL (86 mg CIS, 17.2 mg VIN) in a single session, which are higher amounts than typical IV doses, with repeated intratumoral injections in multiple tumors.
The median overall survival (mOS) of 373 days for all monotherapy (n=53) patients compares favorably to results seen in studies with similar Phase 1 solid tumor populations. An exploratory analysis of dose relative to total tumor burden (TTB) showed that subjects receiving a dose of INT230-6 to <40% of their reported TTB had a mOS of 96 days, while in subjects receiving a dose of INT230-6 to ≥40% of TTB, had a mOS of 570 days (HR=0.104, 95% CI(0.038, 0.29)). Patients receiving the pembrolizumab combination had a mOS of 376 days (n=16). Comparison of the survival data of INT230-6 monotherapy to the pembrolizumab combo was not made due to different cancer types in the two cohort populations.
As of July 31, 2021, six patients in the monotherapy arm who received an INT230-6 dose of ≥40% of the TTB demonstrated abscopal effects (i.e., shrinkage of multiple non-injected tumors), further emphasizing the importance of dosing sufficient amounts to cause substantial tumor necrosis. Together with the immunohistochemistry biomarker findings, the results suggest a systemic immune system activation.
INT230-6, either as monotherapy or in combination with pembrolizumab, was well tolerated. The most common adverse events (AEs) were localized tumor-related pain, nausea, fatigue and vomiting. AEs were mainly mild to moderate with no Grade 4 or 5 AEs.
Abstract Number: 16284 "Intratumoral INT230-6 Shows a Favorable Safety Profile and Early Signs of Efficacy in Advanced Soft Tissue Sarcoma with Monotherapy and in Combination with Ipilimumab [Intensity IT-01; BMS#CA184-592]"

Authors: Matthew Ingham, MD; James Hu, MD; Giles F. Whalen, MD; Jacob Thomas, MD; Anthony El-Khoueiry, MD; Diana Hanna, MD; Anthony J. Olszanski, MD, RPh; Christian F. Meyer; Nilofer Azad, MD; Syed Mahmood, MD; Lewis H. Bender, MS, MA, MBA; Ian B. Walters, MD, MBA; Lilian L. Siu, MD; Albiruni R. Razak

The poster reports preliminary efficacy and safety results from 19 subjects treated with either INT230-6 alone (n=10) or in combination with checkpoint inhibitors primarily ipilimumab from an ongoing Phase 1/2 clinical trial. Patients had a variety of relapsed, refractory sarcoma types and progressed following a median of three prior therapies. Demographics were similar in subjects enrolled in monotherapy and checkpoint inhibitor combination arm. The cumulative dose of INT230-6 injections given every 2 weeks over 56 days ranged from 20 to 530mL with repeated intratumoral injections in multiple tumors. Pharmacokinetic (PK) profile analysis from 18 sarcoma subjects were analyzed for cisplatin, SHAO and vinblastine and showed that greater than 95% of the active drugs remains in the tumor.
Kaplan Meier estimates that approximately 60% of those of sarcoma subjects receiving INT230-6 monotherapy a dose volume greater than 40% of their total tumor burden will be alive at 1 year. These results compare favorable to results of survival data in studies of mixed refractory sarcoma patients with similar prognostic factors scores (ECOG, LDH, # of metastatic sites) where the median survival is estimated to be 3 to 8 months
Biopsies showed substantial tumor necrosis, reduction of viable cancer, a decreased cancer proliferation as measured by Ki67, and increased Tumor Infiltrating Lymphocytes (CD4 and CD8 T-cells). Monotherapy patients had abscopal effects (i.e., shrinkage of multiple non-injected tumors).
INT230-6 safety data showed that INT230-6 is well tolerated as monotherapy and preliminary data suggests that INT230-6 is well tolerated in combination with ipilimumab in sarcoma subjects. Most adverse events were low grade and transient. There were no grade 4 or 5 treatment emergent AEs and no events that were dose limiting.
About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In addition to local disease control, direct killing of the tumor by INT230-6 creates neoantigens leading to engagement of the immune system and systemic anti-tumor effects in the tumor. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

INT230-6 is currently being evaluated in several Phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant Phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

On November 13, 2021 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate accomplishments (Press release, Compass Therapeutics, NOV 13, 2021, View Source [SID1234595476]).

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"We have made major progress on reaching our corporate goals, highlighted by achieving significant advancements for both of our clinical stage programs and raising capital to support our objectives," said Thomas J. Schuetz, MD, PhD, Co-founder and Chief Executive Officer. "We released promising interim Phase 2a data on our lead program, CTX-009, which support our conviction that CTX-009 is a promising novel bispecific antibody therapy with activity across a broad range of solid tumors. Additionally, CTX-471 continues to advance well in development, and has demonstrated encouraging activity as a monotherapy in the post anti-PD-1/PD-L1 patient population, an area of a particularly high unmet medical need."

"On the financing side, we completed a $125 million public offering and concurrently uplisted to Nasdaq," added Vered Bisker-Leib, PhD, MBA, President and Chief Operating Officer. "We expect this offering will extend our cash runway into the fourth quarter of 2024, which will support the advancement of our pipeline. These are significant achievements for Compass and position us well to grow and fund key milestones throughout the next several years."

Third Quarter Development Highlights:

CTX-009 (DLL4 and VEGF-A bispecific antibody):

A Phase 2a study was initiated in Q1 2021 testing CTX-009 in combination with paclitaxel in patients with Biliary Tract Cancers (cholangiocarcinoma). Enrollment in the first part of the study has been completed and the criteria to advance to the second part of the study have been met. Notably, five partial responses (PRs) have already been observed among the first 17 patients evaluated leading to a preliminary overall response rate (ORR) of 29%, and all patients evaluated have had stable disease or better with a decline in tumor burden observed in 16 of the 17 patients leading to a Clinical Benefit Rate (CBR) of 100%. The study is being conducted in South Korea by Handok Pharmaceuticals and the clinicaltrials.gov identifier for the study is NCT04492033. Compass plans to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the fourth quarter of 2021 and subject to the IND clearance with the FDA, to initiate a Phase 2 study in 2022 in the United States.
CTX-471 (monoclonal antibody agonist of CD137, a key co-stimulatory receptor on immune cells):

We initiated a Phase 1b dose expansion study for CTX-471 in 2019 and treated 36 patients with 13 different tumor types in the study as of October 21, 2021. Of the 25 evaluable patients in the dose expansion part of the study, two patients had a PR, one of which has been confirmed by RECIST 1.1 and the other PR has been seen at the first tumor evaluation at Week 9. 11 patients have reached stable disease, leading to a preliminary ORR of 8% and a CBR of 52%. The first PR observed in the study was in a patient with advanced small cell lung cancer who had a PR at Week 17 and this response was confirmed at Week 25. This patient has now been treated with CTX-471 for more than one year with a durable PR. In October 2021, a second PR was observed in a patient with metastatic melanoma who was previously treated with and progressed on nivolumab. We expect to complete the Phase 1b stage of this study during the first half of 2022.
CTX-8371 (bispecific antibody that simultaneously targets both PD-1 and PD-L1):

We initiated IND-enabling studies and the GMP manufacturing campaign for CTX-8371. Due in part to delays at our contract development manufacturing organization, we are currently targeting an IND submission in the second half of 2022.
Third Quarter Corporate Highlights:

In November 2021, Compass closed an underwritten public offering to sell 35,715,000 shares of common stock at a public offering price of $3.50 per share. The gross proceeds to Compass from the offering, before deducting the underwriting discounts and commission, were approximately $125 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 5,357,250 shares of common stock.
In connection with the public offering, Compass also uplisted its common stock to Nasdaq and its shares began trading on the Nasdaq Capital Market under the symbol "CMPX" on November 2, 2021.
Third Quarter 2021 Financial Results

Cash Position: As of September 30, 2021, cash and cash equivalents were $25.5 million as compared to $47.1 million as of December 31, 2020. The Company believes that our existing cash and cash equivalents, together with the proceeds of our November 2021 public offering, will allow us to fund our operating expenses and capital expenditures into the fourth quarter of 2024.
Research and development (R&D) Expenses: R&D expenses were $3.2 million for the third quarter of 2021, as compared to $3.7 million for the same period in 2020, a decrease of $0.5 million or 14%. The lower costs were principally driven by less depreciation expense of $0.3 million and program related expenses of $0.2 million.
General and Administrative (G&A) Expenses: G&A expenses were $2.7 million during the third quarter of 2021, as compared to $5.3 million for the same period in 2020, a decrease of $2.6 million or 49%. The lower costs were driven primarily by lower stock compensation expense of $1.4 million due to an accelerated vesting of shares and $0.5 million of professional fees related to the reverse merger in the third quarter of 2020. In addition, facilities expense decreased by $0.3 million.
Net Loss: Net loss for the third quarter was $6.0 million or $0.10 per diluted common share, compared to $9.2 million or $0.18 per diluted common share for the third quarter of 2020.

On November 13, 2021 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that do not require gene editing and co-opt the natural biology of T cells to treat patients with solid tumors, reported the presentation of preclinical data from its proof-of-concept study in gastric cancer (Press release, Triumvira Immunologics, NOV 13, 2021, View Source [SID1234595519]). These new data demonstrate that Triumvira’s novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) effectively eradicates CLDN18.2-expressing gastric tumor cells in vitro and in vivo. The results will be presented in a poster presentation today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 10-14, 2021, virtually and in-person at the Walter E. Washington Convention Center in Washington, D.C.

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CLDN18.2 is a promising, clinically validated target for cancer drug development as gastrointestinal malignancies, more prominently gastric tumor cells, have been found to selectively express CLDN18.2 on their surface, making it a preferred antigen for specific targeting of tumor cells using TAC-T cells. A key feature of TAC-T cells is the proprietary TAC receptor, a multi-domain chimeric molecule that works directly with the natural T cell receptor to help a T cell recognize and attack cancer cells. Unlike CAR-T cells, TAC-T cells do not exhibit tonic signaling, do not show premature exhaustion, show long term persistence, and demonstrate deep penetration into and activation in solid tumors in various preclinical models.

"We’re excited about the level of activity we are seeing with our Claudin 18.2-directed TAC-T cells in our preclinical models of gastric cancer," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. "These results confirm the versatility of our TAC platform for difficult-to-treat solid tumors and pave the way for initiating IND-enabling studies in an effort to bring CLDN18.2-TAC T cells to patients as quickly as possible in an area of significantly unmet medical need."

In addition to eradicating CLDN18.2-expressing gastric tumor cells in vitro and in vivo, the study demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. CLDN18.2-TAC T cells did not show signs of auto-activation or elevated exhaustion markers post-manufacturing, which is a key feature of the TAC technology designed to enhance the durability of TAC-T products.

Details of the poster presentation are as follows:

Poster Title: Development of Claudin 18.2 TAC T cells for the treatment of gastric cancer
Poster Number: 118
Category: Cellular Therapies
Date and Time: Saturday, November 13, 2021; 7:00 a.m. – 8:30 p.m. EST
Location: Walter E. Washington Convention Center, Hall E
Presenter: Christopher Helsen, Ph.D. – Executive Director, Research and Development, Triumvira