On April 13, 2022 Texas Oncology reported that it has entered into an agreement with Foundation Medicine, a pioneer in molecular profiling for cancer, to provide Texas Oncology care teams with access to its Food and Drug Administration (FDA)-approved blood-based comprehensive genomic profiling (CGP) test, FoundationOneLiquid CDx (Press release, Foundation Medicine, APR 13, 2022, View Source [SID1234612168]). From a simple blood draw, the test provides comprehensive biomarker testing for all solid tumors to support oncology providers with targeted treatment planning for their patients. With this agreement in place, Foundation Medicine’s liquid biopsy and solid tumor molecular profile tests are now available for order through Texas Oncology’s precision oncology clinical pathways tool.

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"Many patients with the most common form of lung cancer, known as non-small cell lung cancer (NSCLC), do not have adequate tissue available for the recommended biomarker testing," said Lori Brisbin, vice president for Texas Oncology’s Precision Medicine Program. "Liquid biopsies are an increasingly important option for those patients for whom tissue is not available for complete genomic profiling. For some patients, getting a tissue biopsy is not an option due to tumor location or the patient’s health status, or a patient may simply prefer not to have an additional invasive procedure. Even when the tissue biopsy is available, it may not be accessible for testing. Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer."

"At Foundation Medicine, we recognize the critical need for genomic testing options to support treatment planning in each patient’s unique circumstance. When tumor tissue is not available or adequate, our liquid biopsy test can provide oncologists with the insights needed to implement precision treatment strategies across all cancer types," said Geoff Oxnard, M.D., thoracic oncologist and vice president, head of Clinical Development at Foundation Medicine. "We are committed to expanding precision medicine to cancer patients in the community and are proud to collaborate with Texas Oncology as it works to set the standard around the pathways needed to enable informed decisions about biomarker-driven care."

"Texas Oncology is committed to delivering leading-edge cancer care to patients no matter where they live. That commitment includes access to sophisticated testing that helps guide our providers in making important treatment decisions. This agreement with Foundation Medicine furthers that commitment and makes this testing available and accessible to more cancer patients," said Steven Paulson, M.D., president and chairman of Texas Oncology.

On April 13, 2022 NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, reported the broad combination potential of its long-acting IL-7 candidate – NT-I7 (efineptakin alfa) (rhIL-7-hyFc) – at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in New Orleans, Louisiana, United States, April 8-13 2022 (Press release, NeoImmuneTech, APR 13, 2022, View Source [SID1234612167]).

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In the two pre-clinical studies presented as posters, NT-I7, a novel long-acting human IL-7, was evaluated in combination with IL-2 (hIL-2/TCB2c), and in combination with anti-TIGIT or anti-VEGF therapies. 1,2

NT-I7 has demonstrated in previous studies that it can increase the number of memory T cells with prolonged effect, whereas IL-2 activates the effector T cell for a limited period. The results of the pre-clinical study showed that the combination of their different mechanisms of action (MoAs) created a heightened anti-tumor response.

Additionally, data from the second pre-clinical study showed that NT-I7, in combination with anti-TIGIT or anti-VEGF, enhanced the anti-tumor responses and this effect was further increased when NT-I7 was combined with anti-TIGIT and anti-PD-1 in triple combination.1,2

"Immune checkpoint inhibitor combinations have become the standard of care for many tumor types, however there is still an unmet need to enhance the efficacy," said Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT. "The pre-clinical results we presented at AACR (Free AACR Whitepaper) 2022, which are supported by NT-I7’s safety profile and T cell amplifying mechanism, showed the potential for NT-I7 as part of a double or triple-regimen therapy. We are encouraged by these results, which pave the way to advance these combinations in clinical trials, further enhancing NT-I7 clinical value."

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.

On April 13, 2022 EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, reported it has entered into a research collaboration with Peking University Cancer Hospital to understand gene mutation frequency and clinicopathologic features of patients with advanced colorectal cancer in China, and to advance the study of gene mutations relating to varying response rates to specific targeted therapies (Press release, EdiGene, APR 13, 2022, View Source [SID1234612166]). The research result is expected to enable the development of precision medicine for patients pre-screened by specific mutation patterns.

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"Patients with advanced colorectal cancer have great unmet medical needs in light of the current low long-term survival rates," said Professor Lin Shen, Director of the Department of Gastrointestinal Oncology and Vice President of Peking University Cancer Hospital, and Deputy Director of Beijing Institute for Cancer Research, "The gene mutation spectrum of advanced colorectal cancer is complicated, and targeted therapies need to be precisely applied to appropriate patient populations. By leveraging EdiGene’s systematic research on related genes responding to specific targeted therapy for advanced colorectal cancer, and our extensive research and practical experience, we will support the development of innovative therapies for patients with advanced colorectal cancer."

EdiGene’s high-throughput genome-editing screening platform uses high-throughput screening and bioinformatics analysis to develop new biomarkers and potential targeted therapies.

"Professor Lin Shen’s team is leading the field of gastrointestinal oncology in China with extensive expertise in colorectal cancer," said Dong Wei, Ph.D., CEO of EdiGene, "We have studied and verified the correlations of 1,300 genes with high mutation rates in colorectal cancer and specific response to targeted therapies using our proprietary high-throughput genome-editing screening technology. This collaboration will explore biomarkers that are applicable to patients in China with advanced colorectal cancer to identify targeted therapies best suited to treat their particular cancer."

The number of new colorectal cancer cases in China in 2020 is about 555,000, the second most commonly diagnosed cancer after lung cancer, and the highest number of new cases among gastrointestinal tumors, according to the World Health Organization.1 Early diagnosis is critical. The five-year survival rate is 90 percent for colorectal cancers diagnosed at an early stage compared to just 13 percent for those diagnosed at a late stage, according to the World Cancer Research Fund (WCRF) International.2

With four gene editing based therapeutic platforms, EdiGene has been developing ex vivo therapies, in vivo therapies, and targeted therapies.

On April 13, 2022 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported that interim results from the global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, APR 13, 2022, View Source [SID1234612165]).

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The interim Phase 2 results showed that the combination of CG0070 and pembrolizumab was well tolerated with encouraging early efficacy data in 18 patients. The results (Session CT036) were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.

"These interim results continue to support CG0070’s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population," said Arthur Kuan, Chief Executive Officer, CG Oncology. "As the study nears conclusion, we hope to see continued positive results for CG0070 in combination with pembrolizumab as well as durability in patients who have limited treatment options."

Summary of Interim Clinical Results

As of the interim analysis, based on a data cutoff on April 7, 2022, 18 patients were evaluable for efficacy.
89% of patients evaluable for efficacy (n=18) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 85% (n=13) have also maintained a CR through 6 months, 78% (n=9) through 9 months and 75% (n=8) at the 12-month assessment.
Treatment related adverse events (AEs) were generally limited to transient grade 1-2 local genitourinary symptoms and immune-related adverse events including pollakiuria, bladder spasm, dysuria, fatigue, nocturia, hematuria, chills, autoimmune thyroiditis and hypothyroidism. No treatment-related grade 3 or higher AEs or severe adverse events (SAEs) have been observed.
"These interim results continue to be potentially game changing in patients who are often reluctant to undergo radical surgery for non-invasive bladder cancer," said Dr. Edward Uchio, M.D., study investigator and Urologic Oncologist at UCI Medical Center. "CG0070, which has been administered in over 150 patients to date, exhibits a dual mechanism of action shown to be highly clinically meaningful in bladder cancer."

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 April 13, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Molecular Targeting Technologies Inc. (MTTI), a clinical stage biotech company focused on developing innovative therapies for rare cancers, reported the signing of a global clinical supply agreement that provides MTTI with ITM’s medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu / EndolucinBeta) for the preclinical and clinical development as well as potential commercial production of MTTI’s radiopharmaceutical candidate n.c.a. 177Lu-EBTATE to treat a range of cancers (Press release, ITM Isotopen Technologien Munchen, APR 13, 2022, View Source [SID1234612164]).

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N.c.a. 177Lu-EBTATE is currently in the clinical development for the treatment of neuroendocrine tumors, a special form of thyroid cancer (Hürthle cell) and a rare type of head and neck cancer (nasopharyngeal cancer). The radiopharmaceutical is designed to be used in Targeted Radionuclide Therapy, a highly precise approach to directly target and destroy tumor tissue with minimal impact to surrounding healthy tissue. N.c.a. 177Lu-EBTATE consists of a tumor-targeting molecule and ITM’s medical radioisotope n.c.a. 177Lu, a market-approved, highly pure form of the beta-emitting radioisotope lutetium-177. N.c.a. 177Lu can be linked to a variety of tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments.

"This agreement underscores the potential of our n.c.a. lutetium-177 to provide therapeutic value to patients with hard-to-treat tumors and we are pleased to contribute to MTTI’s exciting program," comments Steffen Schuster, CEO of ITM. "Through our long-term experience in radioisotope technologies, our proprietary pipeline of targeted radiopharmaceuticals and our supply agreements with pharmaceutical companies, we aim to further expand and support the development of Targeted Radionuclide Therapies to improve clinical outcomes and quality of life for patients worldwide."

MTTI CEO, Chris Pak, said, "We’ve identified a timely and sustainable supply of a key therapeutic ingredient needed for the development and launch of our lead asset 177Lu-EBTATE and other EB (Evans blue) platform technologies. We are excited to start this collaboration and build what promises to be a great relationship with a reliable and trusted radioisotope supply partner like ITM for the supply of n.c.a. 177Lu."

The agreement was executed between MTTI and ITM’s wholly-owned subsidiary ITM Medical Isotopes GmbH.

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.