On November 29, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it has signed a Clinical Trial Collaboration and Supply Agreement ("Agreement") with Merck KGaA, Darmstadt, Germany and Pfizer for a new Phase I clinical study in patients with urothelial cancer, called INSIGHT-005 (Press release, Immutep, NOV 29, 2022, View Source [SID1234624573]).

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"We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options," said Immutep CEO, Marc Voigt. "INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of efti and avelumab in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy."

INSIGHT-005 will be an investigator-initiated explorative, open-label study evaluating the safety and efficacy of Immutep’s lead product candidate, efti, in combination with avelumab (BAVENCIO) in up to 30 patients with metastatic urothelial cancer. The study will take place in Germany. The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.

Urothelial cancer is a type of cancer in the bladder or urinary tract. In the US alone, it is estimated there will be 81,180 new cases of bladder cancer in 2022 and an estimated 17,100 people will die of this disease.1 Avelumab is a checkpoint inhibitor that works by targeting and blocking a protein called PD-L1 on the surface of certain immune cells, activating the cells to find and kill cancer cells. It is approved in more than 60 countries around the world as a monotherapy for first-line maintenance treatment for adult patients with advanced urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer.

US National Cancer Institute: View Source

Efti was previously evaluated in combination with avelumab via the INSIGHT-004 study in patients with advanced solid cancers, including colorectal, pleural mesothelioma, squamous anal cell, cervical, and gastroesophageal carcinomas. Immutep announced final data from INSIGHT-004 in June 2021, reporting encouraging efficacy signals from the combination with a response rate of 41.7% according to RECIST 1.1.

Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study. It will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration. INSIGHT consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).

For more information on INSIGHT, visit clinicaltrials.gov (INSIGHT identifier NCT03252938).

The study announced today modifies the previously announced protocol for INSIGHT-005 evaluating efti in combination with bintrafusp alfa. The former INSIGHT-005 study did not advance based on previously generated results for bintrafusp alfa in other studies.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s unique characteristics to stimulate both innate and adaptive immunity. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

On November 29, 2022 COLOTECT 3.0 is a non-invasive colorectal cancer screening test developed by BGI, and will be launched in early 2023 (Press release, BGI, NOV 29, 2022, View Source [SID1234624572]). BGI plans to release pre-clinical case-control data for COLOTECT 3.0 at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. The sensitivity for detecting CRC is 96.08%. The sensitivity for detecting advanced precancerous lesions (APL) is 52.5%, which is better than FIT products.

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COLOTECT 3.0 is a non-invasive colorectal cancer (CRC) self-sampling test that can detect the methylation status of exfoliated cell genes and the Fecal Occult Blood in the stool. It can help screen for colorectal cancer and advanced precancerous lesions (APL) even in the absence of active bleeding lesions.

Colorectal cancer is the third most common cancer and the second deadly cancer worldwide. There were more than 1.9 million new cases of colorectal cancer in 2020. Older age, a history of bowel disease, a family history of related diseases, having type 2 diabetes, overweight or obesity, certain types of diet, smoking, and drinking are all risk factors that can lead to colorectal cancer. In recent years, the incidence rate of colorectal cancer among people younger than 50 has been increasing significantly.

As the tumor grows, patients may experience one or multiple symptoms, including blood in the stool, abdominal pain, and bloating. However, colorectal cancer usually does not produce symptoms in the early stages, which makes some patients undiagnosed until they are at the third or fourth stage and miss the best time for treatment. If colorectal cancer is diagnosed at early stages, the 5-year relative survival rate can be as high as 90%. Conversely, if it is diagnosed at stage IV, the 5-year survival rate will be only about 10%.

On November 29, 2022 The Follicular Lymphoma Foundation (FLF) reported it has awarded four research grants of up to $500 thousand each, a total of $2 million over the next two years, to support targeted and innovative research projects into Follicular Lymphoma (FL) – an incurable form of blood cancer and the second most common type of Non-Hodgkin Lymphoma (Press release, The Follicular Lymphoma Foundation, NOV 29, 2022, View Source [SID1234624571]).

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The grants have been made through the Foundation’s "CURE FL Awards" programme to support targeted and innovative research projects. Each offers a clear path to clinical trial to immediately benefit the more than one 1 million FL patients living with Follicular Lymphoma around the globe, and which will deliver on the Foundation’s mission of finding a cure and finding it fast.

In January 2022 the CURE FL Awards programme issued a call for transformative projects in areas of treatment that the Foundation’s team has identified as being the most likely to deliver rapid progress towards a cure to be made available to patients as soon as possible.

The recipients of the 2022 CURE FL Awards research grants are:

Hans-Guido Wendel, MD, PhD, Memorial Sloan Kettering Cancer Center
Joshua Brody, MD, Icahn School of Medicine at Mount Sinai
Wendy Béguelin, PhD, Weill Cornell Medicine
Patricia Pérez-Galán, PhD, Institut d’Investigacions Biomèdiques August Pi I Sunyer
Commenting on the awarding of the grants, Dr Mitchell Smith, Chief Medical Officer of the Follicular Lymphoma Foundation (FLF) said: "Previously, Follicular Lymphoma has rarely been a central focus for drug development, and we want to change this. With this funding programme, we are putting this disease front and centre in Lymphoma research, and catalysing the development of therapies for the underserved patient populations. By awarding $2 million of funding over the next two years to these four highly skilled investigator teams, we believe we will rapidly move one step closer to finding better treatments."

Nicky Greenhalgh, Founder of the Living with Follicular Lymphoma community and Patient Representative on the Awards review panel) said: "The CURE FL Awards mean real progress towards a cure. In speaking on behalf of our members; we feel supported – it helps us to worry less and look forward to a positive future. Wheels are in motion to find cures for us all, so thank you."

The FLF worked closely with its partners, the Centre for Strategic Philanthropy (CSP) at the Milken Institute, to develop the CURE FL Awards programme. The recipients of the grants were chosen with the input and support of a wide range of experts in the global FL field together with patients, to ensure their views and experiences are a part of the development process for new treatments.

On November 29, 2022 Genomic Vision (Paris:GV) (FR0011799907 – GV, the "Company"), a Euronext-listed biotechnology company that develops tools and services for the highly accurate characterization of DNA sequences, reported a collaboration with the Centre National de la Recherche Scientifique (CNRS), the French state research organization, to launch a four-year core scientific program with the Cancer Research Center of Marseille (CRCM) for the development of companion diagnostic tests using Genomic Vision’s TeloSizer application (Press release, Genomic Vision, NOV 29, 2022, View Source [SID1234624570]).

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Telomeres are repetitive nucleotide sequences that form the ends of linear chromosomes. TeloSizer allows for high precision measurement of telomere length and distribution to uncover links between telomere length and the onset and severity of diseases such as cancer and age-associated diseases.

Learn more about TeloSizer by visualizing the video: View Source
"Genomic Vision continues to apply its innovative technologies for the benefit of patients and this collaboration with CNRS is an important milestone. We are pioneering the use of telomere length as a disease biomarker and this will contribute to cancer research." said Thierry Huet, Ph.D., Research and Development Director of Genomic Vision. "Telomere instability is a well-known hallmark of cancer. With TeloSizer, we can accurately visualize and measure telomeres length."

Christophe Lachaud, Group Leader at CRCM, commented: "We are very excited to utilize Genomic Vision’s TeloSizer application to develop highly accurate companion tests that will benefit patients. TeloSizer offers greater accuracy and more information compared to other telomere measurement methods."

Vincent Geli, Deputy Director of CRCM expert in telomeres added: "TeloSizer will provide new information on individual telomere length and their distribution."

New tests will be developed as part of a four-year core scientific program collaboration set up between Genomic Vision and the CRCM and will utilize Genomic Vision’s DNA combing technology and TeloSizer application. The program will employ scientific teams across the institute and will examine telomere length heterogeneity across different samples to uncover novel leukemia-specific telomere characteristics. Actionable insights from the project will be used for the development of personalize medicine approaches based on telomere morphology.

This project is part of the CRCM/IPC project supported by the OPALE Carnot Institute, a preferred partner to the healthcare Industry for research and development of innovative solutions aimed at diagnostic, treatment and follow-up of patients with leukemia, the blood cancer with the highest mortality rate, but also the leading cancer in children.

On November 29, 2022 Quotient Sciences, a global drug development and manufacturing accelerator, reported a partnership with Emplicure, a Swedish pharmaceutical company focused on chronic pain and abuse-deterrent formulations (Press release, Quotient Sciences, NOV 29, 2022, View Source [SID1234624569]).

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The partnership will see Quotient Sciences support the GMP manufacture and first clinical pharmacokinetic (PK) study for EMPLI03 using its unique Translational Pharmaceutics platform.

Emplicure is developing EMPLI03 as an oral buccal tablet with extended-release properties intended for the treatment of moderate to severe pain. The formulation is also designed to limit the potential for manipulation of the tablet for abuse.

Quotient Sciences’ integrated Translational Pharmaceutics platform has been used to establish the GMP manufacturing process for EMPLI03 and to perform the first clinical PK study. Dosing in the PK study has been successfully completed, and top-line data will be available at the beginning of 2023.

"We have achieved one of our milestones in the development of a Buprenorphine product for the treatment of moderate to severe pain. With properties that limit abuse, EMPLI03 may contribute to a safer medical treatment", said Håkan Engqvist, CEO of Emplicure.

Mark Egerton, PhD, CEO of Quotient Sciences, added, "We are delighted to partner with Emplicure on the development of a potential treatment for moderate to severe pain. Using our unique Translational Pharmaceutics platform, the GMP manufacturing and first PK study for EMPLI03 has been fully integrated, which is a proven approach to accelerate development timelines."

Quotient Sciences introduced its Translational Pharmaceutics platform in 2008 as a fully integrated drug development and clinical testing platform.

The platform integrates drug substance, drug product, and clinical testing activities under one organization to break down industry silos and accelerate molecules through development.