On June 23, 2021 Genomic Testing Cooperative, LCA (GTC) reported that the New York State Clinical Evaluation Program (CLEP) has completed their evaluation and approved all GTC’s Next Generation Sequencing (NGS) profiling tests for hematologic neoplasms and solid tumors (Press release, Genomic Testing Cooperative, JUN 23, 2021, View Source [SID1234584269]). This includes:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

-GTC Hematology Profile (177 genes)
-GTC Hematology Fusion/Expression (1408 genes)
-GTC Hematology PLUS (177 DNA + 1408 RNA)
-GTC Liquid Biopsy, Hematology Profile (177 genes)
-GTC Solid Tumor Profile (434 genes)
-GTC Solid Tumor Profile Fusion/Expression (1408 genes)
-GTC Solid Tumor PLUS (434 DNS + 1408 RNA)

These tests are also covered by Medicare Administrative Contractor Palmetto GBA (MolDx). The tests are carefully designed to provide cost-effective comprehensive evaluation of clinically relevant molecular abnormalities and biomarkers.

"At GTC, we believe that all patients with cancer have the right to have their cancer fully molecularly profiled and for their physicians to be able to discuss their treatment options prior to initiating therapy. Medicare coverage combined with NY state approval make this testing easily accessible for cancer patients living in NY. Our cooperative (Co-Op) business model enables other laboratories and large oncology practice groups to obtain similar coverage and approval when they internalize our tests" said Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer. "Our goal is to improve lives of cancer patients by democratizing NGS-based cancer profiling. We continue to collaborate with other Co-Op members to develop and validate new tests to address minimal residual disease, early diagnosis and other specific clinical indications" added Dr. Albitar.

GTC is first-in-class diagnostic company based on a cooperative business model. Using the most recent advances in NGS technology, GTC tests can be performed on minute samples including needle aspiration samples. Analysis of sequencing runs, curating data and interpretation of results is performed using proprietary algorithms/artificial intelligence (AI) software’s specially designed and developed for GTC’s technology. Cancer profiling combining DNA and RNA data is the most thorough approach not only for selecting therapeutic approaches and targeted therapy but also to help in establishing the diagnosis and classification of tumors, prognosis, and determining early relapse risk. GTC Hematology liquid biopsy is especially designed to be comprehensive and to replace the need for performing a bone marrow biopsy, which is a painful procedure and can be associated with complications.

On June 23, 2021 Aleta Biotherapeutics (‘Aleta’) and Cancer Research UK reported a collaboration to advance the early phase clinical development of Aleta’s CAR-T cell engager candidate, ALETA-001 (Press release, Aleta Biotherapeutics, JUN 23, 2021, View Source [SID1234584286]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aleta is a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, and Cancer Research UK is the world’s leading cancer charity dedicated to saving lives.

Under the terms of the clinical development partnership, Cancer Research UK’s Centre for Drug Development will fund, sponsor and conduct the first-in-human Phase 1/2a clinical trial of ALETA-001, which will be led by Dr Amit Patel’s Cellular and CAR-T therapies team at The Christie NHS Foundation Trust in Manchester, UK.

ALETA-001 has been developed to benefit people with B-cell lymphoma and leukemia whose disease has progressed after receiving CD19 CAR-T cell therapy, and it is hoped that ALETA-001 will offer a new therapy for these patients who have limited treatment options.

CAR-T cell therapy works by targeting the T cell response against cancer through the engineering of T cells to recognize CD19 proteins on the surface of lymphoma and leukemia cells*. CAR-T cell therapy is showing promising results in treating people with blood cancers who are no longer responding to current lines of treatment.

However, over half of the patients treated with CD19 CAR-T cell therapy relapse, mostly due to reduction or loss of CD19 expression. Through binding CD20 present on the surface of cancer cells, ALETA-001 reactivates the CD19 CAR-T cells by effectively ‘recoating’ the cancer cell with the target CD19 proteins** and restoring the CAR-T cells ability to recognise and engage the cancer cell.

In the Cancer Research UK-sponsored Phase 1/2a trial, patients with B-cell lymphoma/leukemia who have received CD19 CAR-T cell therapy but did not achieve a complete response or who relapsed from a complete response will be enrolled. After the recommended Phase 2 dose of ALETA-001 has been determined, Aleta will initiate a multi-center, single arm, pivotal Phase 2 trial in the United States focused on diffuse large B-cell lymphoma (DLBCL) patients. This clinical trial will be designed to support potential accelerated approval of ALETA-001.

Aleta retain the rights to further develop and commercialize ALETA-001 and will receive a licence to the results of the clinical trial from Cancer Research UK in return for undisclosed success-based milestone and royalty payments.

Paul Rennert, President, Co-Founder and Chief Scientific Officer, Aleta Biotherapeutics, said: "We are deeply honored to be partnering with Cancer Research UK to rapidly advance our lead drug candidate, ALETA-001, into the clinic. There is an urgent need to develop new therapies that can help people with B-cell cancers, such as lymphoma and leukemia, whose cancer has progressed after treatment with CD19 CAR-T cell therapy. Our collaboration with Cancer Research UK is a strong endorsement of the potential of our scientific platform to address the critical issues of CAR-T cell persistence, tumour antigen loss leading to patient relapse, and tumour antigen heterogeneity. We look forward to working with Cancer Research UK’s exceptional network of experienced clinical trial investigators and researchers to conduct the trial."

Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "CAR-T cell therapy has been transformative in treating patients with hard-to-treat blood cancers, but many will see their cancer return and treatment options begin to run out. ALETA-001 uses a simple yet elegant method to redirect a patient’s circulating CD19 CAR-T cells against cancer cells expressing CD20, and we hope this could be a new treatment avenue for blood cancer. This is a landmark collaboration for Cancer Research UK as it’s the first-in-human trial for a new drug that reboots CAR-T cell therapy, and we look forward to progress its early clinical development with Aleta."

Notes to editor

* CAR T cell therapy consists of T cells that have been taken from a patient and are reprogrammed in the lab to recognize cancer cells so they can target and kill them more effectively. T cells are taken from a patient and are engineered in the lab to carry a specific CD19 receptor on their surface, which will allow them to target and kill the cancer cells through binding the CD19 antigen present on B cell leukemia and lymphoma cells. The CAR-T cells are then given back to the patient to mount an immune response directed at cancer cells. CAR-T therapy is thus a patient specific personalized anti-cancer treatment.

** In order to replace and increase CD19 antigen expression on the cancer cell surface, ALETA-001 binds to CD20 on the tumour cell leading to the presentation of the CD19 extracellular domain which is recognised and engaged by circulating CD19 CAR-T cells leading to cancer cell killing. CD20 is another type of receptor found expressed on cancer cells, but it appears to be more stable than CD19 and its expression is rarely lost.

On June 23, 2021 Certara, a global leader in biosimulation, reported that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp and Phoenix biosimulation software (Press release, Certara, JUN 23, 2021, View Source [SID1234584301]). The PMDA has been using Certara’s biosimulation software since 2014.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Simcyp Physiologically-Based Pharmacokinetic (PBPK) Simulator is used in drug development to determine first-in-human dose, design more efficient and effective clinical studies, and predict drug-drug interactions using virtual populations. The Phoenix Pharmacokinetic and Pharmacodynamic (PK/PD) Platform is used for pharmacokinetic, pharmacodynamic, and toxicokinetic modeling and simulation to help drug developers save time by streamlining data management.

"The continued growth in modeling and simulation approaches for new drug applications in Japan is helping to support the development of medicines for difficult-to-treat diseases and for much needed areas, including pediatrics," said Certara’s CEO William Feehery, Ph.D. "Regulatory guidance and support are critical to expand new use cases for biosimulation to ultimately bring safe and efficacious therapies to patients."

Taking into account the increase in the use of exposure-response and PBPK analyses, two guidelines were issued by Japan’s Ministry of Health, Labour, and Welfare for the use of modeling and simulation in 2020: "Guideline for Drug Exposure‐Response Analysis" and "Guidelines for Analysis Reports Involving Physiologically based Pharmacokinetic Models."

According to a report presented in March 2021 at the PMDA Public Workshop of ‘Role of Model Informed Drug Development’, an increasing number of drug approval applications have used modeling and simulation to optimize dosing regimens and establish precautions in new drug application documents submitted to the PMDA. Certara works with more than 130 biopharmaceutical companies and research institutions in Japan, including all of the top 10 Japanese biopharmaceutical companies by R&D spend.

On June 23, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the U.S. Food and Drug Administration (FDA) has reviewed and confirmed all comments have been addressed regarding the Company’s clinical trial protocol for the Acclaim-1 clinical trial, an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with AstraZeneca’s Tagrisso in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso (Press release, Genprex, JUN 23, 2021, View Source [SID1234584270]). In January 2020, Genprex received FDA Fast Track Designation for the Acclaim-1 patient population.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, the Company has engaged its first clinical site for Acclaim-1, and Genprex is continuing to work with a number of other important cancer research centers and academic institutions to select optimal study sites.

"This feedback from the FDA on our Acclaim-1 clinical trial and the engagement of our first clinical site are key milestones for Genprex," said Rodney Varner, President and Chief Executive Officer of Genprex. "We are now looking forward to opening patient enrollment in this important study of this cutting-edge investigational gene therapy to evaluate the role it can play in the fight against lung cancer, the leading cause of cancer deaths worldwide."

The Company expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients at three clinical sites and for the Phase 2 portion to enroll approximately 74 patients (a 1:1 ratio of REQORSA and Tagrisso combination therapy versus Tagrisso monotherapy) at up to 15 clinical sites. The first part of the Phase 1/2 clinical trial will be a dose escalation study. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization after first progression on Tagrisso, to first event (second progression) or death. An interim analysis will be performed at 51 events.

Genprex recently announced the Centralized Institutional Review Board (IRB) approval for the Acclaim-1 clinical trial in NSCLC. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

On June 23, 2021 Pfizer Inc. (NYSE: PFE) reported that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial (Press release, Pfizer, JUN 23, 2021, View Source [SID1234584287]). The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC). The first patient was dosed at a site in Glendale, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "By combining enzalutamide, which has a proven clinical benefit in men with metastatic castration-sensitive prostate cancer, with talazoparib, our PARP inhibitor that is active in DDR-mutated cancer, we may be able to offer a new treatment option that targets the underlying genetic mechanisms associated with DDR-mutated mCSPC."

The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. The primary endpoint of the study is radiographic progression-free survival (rPFS), and overall survival (OS) is a secondary endpoint. The anticipated primary completion date is late-2024.

"With the introduction of PARP inhibitors in the metastatic castration-resistant prostate cancer setting, it is important to explore how a combination approach may impact outcomes for men with metastatic castration-sensitive disease," said Neeraj Agarwal, M.D., Professor of Oncology at the University of Utah School of Medicine, Senior Director for Clinical Research Innovation at Huntsman Cancer Institute and member of the TALAPRO-3 steering committee. "It’s exciting to be at the forefront of landmark studies like TALAPRO-3, which are helping to further our understanding of how different approaches may advance care for these men."

More information about the TALAPRO-3 trial and participating sites may be found at www.clinicaltrials.gov (NCT04821622).

Talazoparib is currently approved under the brand name TALZENNA for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Selection of patients for therapy is based on an FDA-approved companion diagnostic for TALZENNA. Talazoparib is not approved for the treatment of prostate cancer. Enzalutamide is an androgen receptor inhibitor currently approved under the brand name XTANDI and is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and mCSPC. As part of a global agreement, Pfizer and Astellas jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

In addition to the TALAPRO-3 trial, the combination of enzalutamide plus talazoparib is being investigated in TALAPRO-2 (NCT03395197), a two-part, Phase 3, randomized, double-blind, placebo-controlled study in men with metastatic CRPC (with and without DDR defects).

About TALAPRO-3 Trial

The Phase 3, randomized, double-blind, placebo-controlled, global TALAPRO-3 trial (NCT04821622) will enroll 550 men with DDR-deficient mCSPC across approximately 285 clinical trial sites in 28 countries. In the study, participants will be randomly assigned to one of the two treatment groups and receive either talazoparib (0.50 mg once daily) in combination with enzalutamide (160 mg once daily) or placebo capsules identical to talazoparib in combination with enzalutamide. Men with moderate renal impairment at screening may be enrolled and given a lower dose of either talazoparib (0.35 mg once daily) or the placebo.

The primary endpoint of the study is radiographic progression-free survival (rPFS), which is defined as the time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first.

About Metastatic Castration-Sensitive Prostate Cancer

Prostate cancer is considered metastatic once it has spread outside of the prostate gland to other parts of the body, such as the lymph nodes, bones, lungs, and liver.i Men are considered castration-sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.ii The prevalence of mCSPC in the U.S. in 2020 was estimated to be just over 41,000.iii Studies have shown that DDR defects are found in 23%-27% of metastatic prostate cancers.iv,v

About talazoparib

Talazoparib is an inhibitor of PARP enzymes, which play a role in DNA response. Preclinical studies have demonstrated that talazoparib blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death. Talazoparib is being evaluated in several ongoing clinical trials in prostate cancer, as well as other novel combinations with targeted therapies in various solid tumors.

About XTANDI (enzalutamide)

XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

Prescribing Information for XTANDI and TALZENNA

Please see Full Prescribing Information for XTANDI (enzalutamide) at www.Xtandi.com.

Please see Full Prescribing Information for TALZENNA (talazoparib) at www.Talzenna.com.

About the Pfizer/Astellas Collaboration

In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.