On October 31, 2022 Turnstone Biologics Corp, a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) for Turnstone’s lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01 (Press release, Turnstone Biologics, OCT 31, 2022, View Source [SID1234622644]). Turnstone is expected to commence a multi-site Phase 1 clinical trial later this year that will evaluate its safety and anti-tumor activity. This trial represents the second Phase 1 clinical study of TIDAL-01, which separately is being evaluated in collaboration with Moffitt Cancer Center.

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"Clearance of our IND is a critical milestone for Turnstone in the advancement of our novel TIL therapy pipeline," said Sammy Farah, Ph.D., M.B.A., President and Chief Executive Officer, Turnstone Biologics. "TIDAL-01 is a potentially transformative approach to improving the potency of TILs and bringing the clinical benefit of Selected TILs to patients with solid tumor cancers where the unmet medical need is high. We are eager to commence the clinical study for TIDAL-01 and to progress this candidate through the clinic."

Selected TILs represent the foundational therapeutic modality driving Turnstone’s cancer immunotherapy pipeline and leverage decades of work anchored in academic research that has demonstrated the promise of this approach. By identifying, selecting, and expanding the most potent subsets of patient specific tumor-reactive T-cells, Turnstone aims to improve and broaden the clinical efficacy of TILs, and to overcome the limitations of current TIL-based therapies to achieve positive outcomes in harder to treat, lower mutational burden cancers. The STARLING trial, Turnstone’s multi-site Phase 1 clinical trial of TIDAL-01, will enroll patients with advanced solid tumors including breast cancer and colorectal cancer. Additionally, TIDAL-01 is being evaluated in a Moffitt Cancer Center-sponsored Phase 1 clinical study in additional solid tumors, including cutaneous and non-cutaneous melanoma.

"To achieve success against solid tumors, we are applying a differentiated approach with TILs to overcome what we believe to be the greatest barrier to more effective cell therapies: the low amount of T-cells that recognize and attack the tumor," said Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics. "In identifying, selecting and expanding these tumor-reactive T-cells, we aim to drive more potent solid tumor killing and improved clinical outcomes in multiple different cancer indications."

On October 31, 2022 Thermo Fisher Scientific, the world leader in serving science, reported that it is showcasing its latest innovative research and diagnostic technologies at the 2022 annual meeting and expo of the Association for Molecular Pathology (AMP) taking place at the Phoenix Convention Center from Nov. 1-5 (Press release, Thermo Fisher Scientific, OCT 31, 2022, View Source [SID1234622643]). The solutions on display are designed to address a broad range of disease states and include assays and instruments that leverage real-time and digital PCR, as well as next generation sequencing (NGS) platforms.

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"Diagnostic tools and access to the most advanced platforms are critical pieces of an effective health care infrastructure because they help clinical laboratories successfully address the challenges they face in assessing health," said Mark Smedley, Senior Vice President and President, Genetic Sciences Group of Thermo Fisher Scientific. "We are committed to continually developing both research and diagnostic innovative solutions to drive toward bettering human health, and we look forward to sharing our latest molecular diagnostic tools that support this endeavor."

Genetic Testing Solutions

As laboratories continue to seek ways to leverage their increased testing capacity following the peak of the COVID-19 pandemic, Thermo Fisher has developed new solutions for other disease research areas, such as respiratory illness, gastrointestinal and urinary tract infections, sexually transmitted diseases, HIV drug resistance, and pharmacogenomics. Some of the research products highlighted at AMP include:

An update to its infectious disease testing portfolio, which now includes the Applied Biosystems TrueMark Respiratory Panels* for viral, bacterial and syndromic testing for research.
The Applied Biosystems QuantStudio Absolute Q Digital PCR System* – a plate-based digital PCR (dPCR) research platform powered by proprietary microfluidic array plate (MAP) technology that enables all necessary steps for dPCR—compartmentalizing, thermal cycling and data acquisition—to be conducted on a single instrument.
Thermo Fisher’s newly expanded Absolute Q Liquid Biopsy dPCR Assays* include products that enable reproducible, specific detection of known somatic mutations for cancer research. Each predesigned assay has been validated using controls to detect down to 0.1% variant allele frequency and can provide results to researchers in less than two hours.
The Applied Biosystems Absolute Q SARS-CoV-2 Wastewater Surveillance Kit*, designed to provide simple, rapid, and consistent absolute quantitation of relevant SARS-CoV-2 targets from wastewater samples by dPCR.
The Applied Biosystems HIV-1 Genotyping Kit with Integrase*, which examines positive samples of human immunodeficiency virus (HIV) to identify genetic variants that resist common antiretroviral therapeutics.
Some of the diagnostic products highlighted at AMP include:

The TaqPath COVID-19, Flu A, Flu B Combo Kit* – an Emergency Use Authorized molecular diagnostic test to detect and differentiate between COVID-19, Influenza A, and Influenza B.
Thermo Fisher’s newest CE-IVD- and IVDR-compliant real-time PCR instruments, the Applied Biosystems QuantStudio 5 DX Real-Time PCR System** and Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System**. Both instruments are designed to provide expandable and streamlined solutions to support in vitro diagnostic (IVD) applications. They provide quick- and easy-to-interpret results and minimize the amount of training needed to get the systems integrated in the lab.
Next Generation Sequencing

To support laboratory needs for fast, comprehensive genomic profiling (CGP), Thermo Fisher is introducing the Genomic Instability Metric (GIM)* as an approach to measure genomic scarring related to homologous recombination deficiency (HRD)*. Details will be presented during one of several company-sponsored workshops at AMP. Thermo Fisher will also feature the Ion Torrent Genexus System*, a true end-to-end NGS workflow designed to provide genomic profiling results in as little as one day.

The company’s booth will also feature the Thermo Scientific AcroMetrix Oncology Hotspot Control***, a highly multiplexed quality control solution that can help assess the performance of NGS assays that detect somatic mutations. It is also intended to provide a means for assessing day-to-day test variation and can help identify increases in random or systematic error.

Thermo Fisher is launching the Molecular Diagnostics Assay Developer Program for OEM partners. This free plan helps companies pursue the development of assays using PCR products, isothermal amplification and NGS workflows. The program also provides access to discounts and commercial rights as companies develop molecular tests.

Workshops and Posters

Thermo Fisher is sponsoring eleven workshops, many of which will highlight the company’s latest platforms and assays, and 19 posters with topics ranging from infectious disease, hematopathology, and solid tumor research, among others. For more information on the workshops, posters and products, we invite you to stop by at Thermo Fisher’s booth (#1308) at AMP or visit: View Source

On October 31, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first adolescent patient has been dosed in clinical trial with its second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer Center (Press release, InnoCare Pharma, OCT 31, 2022, View Source [SID1234622642]). This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent (12 to 18 years old) patients after showing good safety and efficacy in adult patients.

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ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma, etc., and for patients resistant to the first generation of TRK inhibitors.

Among the adult patients with NTRK fusion treated at the recommended Phase II dose (RP2D), ICP-723 showed good efficacy and safety. After the clinical study performed in adolescent patients for the first time, InnoCare will also expand ICP-723 to treat pediatric patients (2 to 12 years old).

Based on the Proof-of-Concept (POC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China. The Company has also conducted a clinical study of ICP-723 in the United States. Currently there was no dose-limiting toxicities (DLTs) observed at the first dose group.

Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, "NTRK gene fusion occurs in adult, adolescent and pediatric cancers, especially among adolescent and pediatric patients. InnoCare will accelerate the clinical trials to meet their unmet clinical needs."

On October 31, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that Rick Pauls, its President and CEO, will present a corporate overview at the Credit Suisse 31st Annual Healthcare Conference, which will take place November 8 – 10, 2022 in Rancho Palos Verdes, California (Press release, DiaMedica, OCT 31, 2022, View Source(Nasdaq%3A%20DMAC)%2C%20a,Conference%2C%20which%20will%20take%20place [SID1234622641]).

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Mr. Pauls is scheduled to present at 8:35 a.m. Eastern Time on November 9, 2022. In addition to the presentation, Mr. Pauls will be available for one-on-one investor meetings throughout the conference. Investors that are interested in arranging a meeting should contact their Credit Suisse representative.

On October 31, 2022 Theriva Biologics, Inc. (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that it will host a key opinion leader (KOL) webinar on Monday, November 7, 2022 at 11:00 a.m. ET to discuss the oncolytic virus landscape and the encouraging data that positions the Company’s novel oncolytic adenovirus (OV) platform at the forefront of development to address devastating cancers with high unmet need (Press release, Theriva Biologics, OCT 31, 2022, View Source [SID1234622640]). The discussion will also include recent findings from independent research highlighting the market opportunities for pancreatic ductal adenocarcinoma (PDAC).

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VCN-01, Theriva Biologic’s lead clinical-stage drug candidate, is an intravenous, oncolytic adenovirus designed to break down the tumor stroma. Theriva’s upcoming Phase 2 clinical trial, VIRAGE, will evaluate VCN-01 in combination with standard-of-care chemotherapy gemcitabine/nab-paclitaxel in patients with PDAC.

The webinar will feature the KOLs Michael Aaron Morse, M.D., Professor of Medicine and Professor in the Department of Surgery in Medical Oncology at the Duke University School of Medicine, as well as Arsen Osipov, M.D., medical oncologist and clinical-translational investigator in the Gastrointestinal Disease Research Group and Pancreas Cancer Research Group of the Samuel Oschin Cancer Center at Cedars-Sinai. Dr. Morse is a pioneer in the use of immune therapies to treat various cancers, including gastrointestinal, breast, lung cancers and melanoma. Dr. Osipov focuses on the development of novel immunotherapy-based treatment strategies for gastrointestinal malignancies, with a focus on pancreatic cancer.

A live Q&A session will follow the formal discussion. To register for the event, please click here. An archived webcast will also be accessible in the "Events" section of the company’s website at www.therivabio.com.