On April 27, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported that updated safety and efficacy data from the Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s Lymphoma (NHL) will be delivered as an oral presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago and online June 3-7, 2022 (Press release, Adicet Bio, APR 27, 2022, View Source [SID1234613073]).

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Details of the oral presentation are as follows:
Abstract Number: 7509
Abstract Title: A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta (γδ) t cells in adults with B-cell malignancies
Presenting Author: Sattva Neelapu, MD, MD Anderson Cancer Center
Session Type/Title: Clinical Science Symposium/ Beating Bad Blood: The Power of Immunotherapy in Hematologic Malignancies
Date: June 6, 2022
Time: 8:00 AM-9:30 AM CDT

The abstract will be available on Thursday, May 26 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.

On April 27, 2022 Repertoire Immune Medicines announced today that Science Advances published preclinical research demonstrating the company’s cell-tethering technology can deliver the potent cytokine interleukin-12 (IL-12) to solid tumors without eliciting the severe systemic toxicities typically associated with the use of this cytokine (Press release, Repertoire, APR 27, 2022, View Source [SID1234613072]). The research, conducted in mouse models, found that the use of cell-tethered IL-12 elevated anti-tumor activity in the immunosuppressive tumor microenvironment (TME).

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"A tumor has multiple mechanisms that help it avoid recognition and elimination by the immune system. These defense mechanisms remain a major challenge for cellular immunotherapies to achieve a durable clinical response," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire Immune Medicines. "In this preclinical research, Repertoire’s cell-tethering technology delivered dose-controlled amounts of IL-12 onto the surface of tumor-targeted T cells. These IL-12-tethered T cells were associated with pronounced repolarization of the tumor microenvironment, ultimately resulting in enhanced T cell response, which has the potential to improve the efficacy of the cellular immunotherapies."

Tumors have immunosuppressive microenvironments that can limit the efficacy of cellular immunotherapies used in cancer treatment. Immune-stimulating cytokines such as IL-12 have been shown to counter the immunosuppressive conditions within the tumor. However, the dose of IL-12 required to achieve these beneficial effects has been associated with severe systemic toxicities.

In the publication, "Cell-surface tethered IL-12 repolarizes the tumor immune microenvironment to enhance the efficacy of adoptive T cell therapy," Repertoire’s tethering technology achieved direct and localized delivery of IL-12 to tumors without systemic toxicities. The use of tethered IL-12 was also associated with repolarization of myeloid-derived suppressor cells into activated inflammatory monocytes that support anti-tumor activity in the TME.

Repertoire is currently investigating the use of cell-tethered IL-12 in an ongoing Phase 1 study of its investigational candidate RPTR-168 for human papillomavirus-positive tumors.

About RPTR-168

RPTR-168 is an autologous multi-targeted T cell (MTC) therapeutic candidate derived from rare peripheral blood T cells. The T cells are collected from each patient through apheresis and are primed and expanded by a set of five tumor-associated antigens known to be expressed on human papillomavirus (HPV)-16-positive tumors. RPTR-168 is designed to deliver interleukin-12 (IL-12), a potent immunomodulatory agent that has been shown to improve anti-tumor activity by promoting T cell function inside the tumor microenvironment.

On April 27, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the release of titles of abstracts on neratinib to be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, APR 27, 2022, View Source [SID1234613071]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held at McCormick Place in Chicago and online from June 3-7. Posters will be available on Puma’s website following presentation.

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Full abstracts of the following posters will be available online at View Source on May 26.

Abstract 1028: Neratinib + fulvestrant + trastzuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): Outcomes and biomarker analysis from the SUMMIT trial
Presenter: Komal L. Jhaveri, FACP, MD | Memorial Sloan Kettering Cancer Center
Abstract 4079: Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT ‘basket’ trial
Presenter: James J. Harding, MD | Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College

On April 27, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors (Press release, SQZ Biotech, APR 27, 2022, View Source [SID1234613070]).

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Fast Track Designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment currently exists or where the treatment in discovery may be better than what is currently available.

"We are thrilled to receive FDA Fast Track Designation for our SQZ Antigen Presenting Cells product candidate," said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies. "This designation adds to our exciting clinical data presented at ESMO (Free ESMO Whitepaper)-IO last year where we first demonstrated the potential of our Cell Squeeze technology to drive clinical benefit while maintaining favorable tolerability. The FDA Fast Track program can potentially expedite future review processes and accelerate the registrational path for SQZ-PBMC-HPV."

Data presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 has shown that the company’s lead APC cell therapy candidate induced radiographic, symptomatic and immune response as monotherapy in a post-checkpoint HPV16+ solid tumor patient. The company continues to enroll patients in its highest dose monotherapy cohort and is simultaneously enrolling patients for combination therapy in the company’s Phase 1/2 SQZ-PBMC-HPV-101 clinical trial.

SQZ-PBMC-HPV-101 Trial Design

SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On April 27, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, reported it will present new clinical data for its lead asset NT-I7 (efineptakin alfa) across three presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held in Chicago, June 3-7, 2022 (Press release, NeoImmuneTech, APR 27, 2022, View Source [SID1234613069]). These include one poster discussion and two poster displays.

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Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said: "We are pleased that the ASCO (Free ASCO Whitepaper) Scientific Program Committee selected our abstract on the efficacy and safety of NT-I7 in combination with pembrolizumab for a poster discussion. While the abstract was based on data cutoff as of January 14, 2022, the actual Phase 2a data presented and discussed at the congress will have a few additional months of follow-up. They will shed new light on the benefit of combining NT-I7 with a checkpoint inhibitor (CPI) in patients with immune-cold microsatellite stable colorectal cancer or pancreatic cancer and in those who progressed on previous CPI treatment. We are also excited to report progress made with NT-I7 administration after CAR-T infusion, another important area of potential NT-I7 use."

NIT presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting:

Primary
Author

Abstract Title

Presentation details

Naing, A

Efficacy and Safety of NT-I7, Long-Acting
Interleukin-7, plus Pembrolizumab in
patients with advanced solid tumors: results
from the Phase 2a study

Abstract #2514
Poster discussion Session: Developmental Therapeutics
-Immunotherapy
June 5, 2022
11:30 AM-1:00 PM;
8:00 AM-11:00 AM CDT
Gastman, B

A phase 1b/2a study of safety and efficacy of
NT-I7 in combination with anti-PD-L1
(atezolizumab) in patients with anti-PD-
1/PD-L1 naïve or relapsed/refractory (R/R)
high-risk skin cancers: The phase 1b report.

Abstract #9561
Poster display Session:
Melanoma/Skin Cancers
June 6, 2022
1:15 PM-4:15 PM CDT
Ghobadi, A

Trial in Progress: A phase 1b study evaluating
the safety, tolerability and preliminary anti-
tumor activity of NT-I7 (efineptakin alfa), a
long-acting human IL-7, post-tisagenlecleucel
in subjects with relapsed/refractory large B-
cell lymphoma

Abstract # TPS7596
Poster display – Trial in
progress (TiP) Poster Session:
Hematologic Malignancies
– Lymphoma and Chronic Lymphocytic Leukemia
June 4, 2022
8:00 AM- 11:00 AM CDT
About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.