Cellectis Announces Oral Presentation on AMELI-01 and Poster Presentation on Multiplex Engineering for Superior Generation of CAR T-cells at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

On May 2, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that it will present clinical data on its Phase 1 AMELI-01 clinical trial (evaluating UCART123) that were presented in an oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, as well as preclinical data on multiplex engineering for superior generation of CAR T-cells, at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting taking place May 16-20, 2023 in Los Angeles, CA (Press release, Cellectis, MAY 2, 2023, View Source [SID1234630832]).

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Oral presentation:

AMELI-01, a study evaluating UCART123, an allogeneic CAR T-cell product candidate, in relapsed/refractory acute myeloid leukemia (r/r AML)

The presentation includes preliminary clinical data from the Phase 1, open-label, dose-escalation trial, AMELI-01, in patients with r/r AML administered UCART123 following lymphodepletion (LD) with either fludarabine and cyclophosphamide (FC) or FC with alemtuzumab (FCA).

The data show that adding alemtuzumab to the FC regimen was associated with improved LD and significantly higher UCART123 cell expansion, which correlated with improved activity.

UCART123 is a novel and genetically modified allogeneic T-cell product manufactured from healthy donor cells. Donor-derived T-cells are transduced using a lentiviral vector to express the anti-CD123 chimeric antigen receptor (CAR) and are further modified using Cellectis’ TALEN technology to disrupt the T-cell receptor alpha constant (TRAC) and CD52 genes to minimize risk of graft-vs-host disease (GvHD) and allow use of anti-CD52–directed therapy as a component of the LD regimen, respectively.

Title: AMELI-01: A Phase I Trial of UCART123v1.2, an Anti-CD123 Allogeneic CAR-T Cell Product, in Adult Patients with Relapsed or Refractory (R/R) CD123+ Acute Myeloid Leukemia (AML)

Session Date/Time: 5/17/2023 – 3:45 PM – 5:30PM PDT

Session Title: CAR Engineering and Production Advances for Targeting Hematologic and Solid Tumor Malignancies

Session Room: 502 AB

Final Abstract Number: 94

Poster presentation: Expanding the scope of multiplex engineering for superior generation of efficient CAR T-cells

CAR T-cell therapies have revolutionized the way we can treat hematological malignancies. However, additional physiological and biological barriers imposed by the hostile tumor microenvironment has limited the ability to target solid tumors. In recent years, advances in genomic-based cellular engineering are bringing us a step closer to conquer solid tumors. This glimpse of success also demonstrated that we need to be able to creatively customize and equip CAR T-cells to target these tumors.

In this presentation, Cellectis shows how we can use its state-of-the-art TALEN technology to precisely edit up to four loci simultaneously while delivering several additional payloads to increase the efficacy and persistence of CAR T-cells.

Cellectis takes it a step further and uses a curated combination of genome engineering technologies including TALE base editors to leverage the efficiency of multiplexed gene editing while safeguarding genomic integrity. By carefully choosing a range of gene and cell engineering approaches, Cellectis can develop CAR T-cells focused on unmet medical needs with a high level of efficiency for gene editing and targeted-integration.

Title: Expanding the Scope of Multiplex Engineering for Superior Generation of Efficient CAR T-cells

Session Date/Time: 5/17/2023 12:00 PM PDT
Session Title: Wednesday Poster Session
Poster Board Number: 604

Final Abstract Number: 604

Details from the presentations will be available following the event on the Cellectis website at: View Source

PRESS RELEASE: Carina Biotech to Present Details of Planned Phase 1/2a Clinical Trial at 2023 ASCO Annual Meeting

On May 2, 2023 Carina Biotech (Carina), a cell therapy immuno-oncology company, reported a poster presentation showcasing its planned Phase 1/2a clinical trial of its LGR5-targeted CAR-T cell therapy candidate CNA3103 in patients with metastatic colorectal cancer (mCRC) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that will take place in Chicago, Illinois on June 2-6 (Press release, Carina Biotech, MAY 2, 2023, View Source [SID1234630831]).

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"We look forward to sharing the innovative design of our planned Phase 1/2a trial with the oncology community at the upcoming 2023 ASCO (Free ASCO Whitepaper)," remarked Deborah Rathjen, Carina’s Chief Executive Officer. "We are currently activating sites in Australia and anticipate commencing patient dosing before the end of the second quarter."

The Phase 1/2a clinical trial is designed to enrol up to 44 patients with metastatic disease failing prior lines of chemotherapy and who express LGR5 on their cancer cells. The Phase 1 segment of up to 24 patients will follow a BOIN (Bayesian Optimal Interval) design and ascending CAR-T cell doses will be administered to cohorts of three patients each, to assess the safety and tolerability of CNA3103, and to determine its optimal dose. The subsequent Phase 2 segment will enrol 20 patients at the optimal dose, in both Australia and the U.S., to characterize the activity of CNA3103, in terms of anti-tumor response, duration of response and time to disease progression.

Further details about the Phase 1/2a trial (NCT05759728) can be found at clinicaltrials.gov.

Poster Presentation Details
Title: A phase 1/2a, multicenter, open-label study of CNA3103 (LGR5-targeted, autologous CAR-T cells) in patients with metastatic colorectal cancer (mCRC)
Lead Author: José Iglesias, MD, Carina’s Chief Medical Officer
Session Type/Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Session Date and Time: Monday June 5, 2023 from 8:00 AM CDT – 11:00 AM CDT
Published Abstract Number: TPS3632

About CNA3103
Carina’s proprietary CNA3103 CAR-T cell targets LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5 expression has been correlated with poor prognosis. Cancer stem cells are a small sub-population of cells within a tumor with the ability to self-renew, differentiate into the many cell types of a tumor, initiate new tumors, and resist chemotherapy and radiotherapy (leading to relapses). By targeting cancer stem cells, it is hoped that this therapy will reduce the tumor’s ability to generate new cancer cells, resulting in durable tumor suppression and preventing the relapses that are very common in patients with colorectal cancer. Carina’s pre-clinical studies of CNA3103 have shown promising results with complete tumor regression and no tumor recurrence following a single administration. CNA3103 has also demonstrated impressive tumor access, prolonged survival, and rejection of tumor rechallenge.

Inhibition of Pancreatic Cancer by Namodenoson: Molecular Mechanism of Action Discovered by Can-Fite Scientists

On May 2, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that it discovered the mechanism of action (MOA) involved with the significant anti-cancer effect of Namodenoson in pancreatic carcinoma (Press release, Can-Fite BioPharma, MAY 2, 2023, View Source [SID1234630830]). Namodenoson de-regulates the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.

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The discovery was made when analyzing results from pre-clinical studies conducted on advanced pancreatic carcinoma patient cells exposed to Namodenoson, which had a significant anti-cancer effect. This is the same MOA at work for Namodenoson in liver cancer.

Namodenoson is currently under a pivotal Phase III study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment.

"Knowing Namodenoson’s mechanism of action in pancreatic cancer is an important step in moving this indication toward potential partnerships. Our findings inform potential dosage and study design and increase the probability of success in human trials," stated Can-Fite CEO Dr. Pnina Fishman.

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Bristol Myers Squibb to Participate in Bank of America Securities 2023 Healthcare Conference

On May 2, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in the Bank of America Securities 2023 Healthcare Conference in Las Vegas, Nevada on Tuesday, May 9, 2023 (Press release, Bristol-Myers Squibb, MAY 2, 2023, View Source [SID1234630828]). Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer, will answer questions about the company at 8:40 a.m. PT/11:40 a.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

BIO-TECHNE TO PRESENT AT THE BofA SECURITIES 2023 HEALTH CARE CONFERENCE

On May 2, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the BofA Securities 2023 Health Care Conference on Wednesday, May 10, 2023, at 1:40 p.m. PDT (Press release, Bio-Techne, MAY 2, 2023, View Source [SID1234630827]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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