On May 22, 2018 CoBioRes NV, an early stage biotech company that valorises promising academic research in the field of medicine by translating it into innovative therapeutic approaches, reported that it has received a € 1.7 million R&D grant from Flanders Innovation and Entrepreneurship (VLAIO) (Press release, Collaborative Biotech Research, MAY 22, 2018, View Source [SID1234526842]). This grant will allow CoBioRes to further develop and to select a lead Tetra-doxo candidate (doxorubicin prodrug) for treatment of Triple Negative Breast Cancer (TNBC) based on in vivo efficacy and toxicity testing. Furthermore, potential new biomarkers will be investigated.

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Approximately 12% of all breast cancers are triple negative. In TNBC the growth of the cancer is not supported by the hormones estrogen and progesterone, nor characterised by the presence of many HER2 receptors. Therefore, TNBC does not respond to hormonal therapy or therapies that target HER2 receptors, such as trastuzumab (Herceptin). There’s a clear need for new effective treatments in this large patient population.

"We are very pleased to receive this support from VLAIO. This will enable the company to obtain in vivo proof-of-concept of its Tetra-doxo prodrugs and to identify new biomarkers for patient selection. This will pave the way for initiation of further preclinical and clinical development," said dr. Nele Kindt, CEO at CoBioRes.

About Tetra-prodrugs technology
Use of traditional chemotherapeutic drugs is restricted by severe side effects and lack of tumour specificity. CoBioRes has designed a tumour-specific activation system by chemically linking a cap and a specific oligopeptide to a chemotherapeutic drug, rendering the modified drug inactive and blocking systemic toxic side effects of the drug. The chemotherapeutic prodrugs are activated by selective proteases available in the tumour microenvironment. This leads to a precise control of drug activation and release, circumventing distribution of native active drugs in other tissues. This finally leads to a combination of selective efficacy and reduced systemic toxicity, resulting in an improved therapeutic index.

On May 22, 2018 Immunocore Limited, a leading T cell receptor (TCR) company focused on delivering first-in-class biological therapies that have the potential to transform lives, reported that new data from its phase I/II dose escalation trial of its wholly-owned, lead programme, IMCgp100, in metastatic uveal melanoma (mUM) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on 4 June 2018 (Press release, Immunocore, MAY 22, 2018, View Source [SID1234526841]).

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Redirected T cell lysis in patients with metastatic uveal melanoma with gp100-directed TCR IMCgp100: Overall survival findings (abstract 9521, poster #348) will be presented by Takami Sato, MD, PhD, Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, in the melanoma/skin cancers poster session on Monday 4 June, 13:15-16:45 CDT. The poster presentation will include updated data and additional findings from the IMCgp100-102 clinical trial.

"Patients with metastatic uveal melanoma have an extremely rare form of eye cancer and there are currently few treatment options that can address their needs," said Dr. Chris Coughlin, Chief Medical Officer at Immunocore. "We are actively recruiting for our pivotal trials in metastatic uveal melanoma, and are looking forward to sharing updated overall survival data from our IMCgp100-102 study at this year’s ASCO (Free ASCO Whitepaper) meeting."

On May 21, 2018 Immedica Group reported that it has entered into an exclusive supply and distribution agreement with German based Oncoscience GmbH regarding the distribution, marketing and sale of CIMAher (Nimotuzumab) in the Nordics (Press release, Immedica Pharma, MAY 21, 2018, View Source [SID1234555254]). Under the agreement, Medical Need AB gains the rights to distribute CIMAher in Denmark, Finland, Iceland, Norway and Sweden, and will initially do so on a named patient basis in the territories.

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Tomas Gloveus, the Head of Marketing and Sales at Medical Need AB said, "CIMAher addresses a significant unmet medical need for many patients with severe cancers, who are currently left to treatment alternatives with severe side-effects and we look forward to making CIMAher available in the Nordic countries."

Dr. Dirk Reuter, the Managing Director of Oncoscience GmbH added, "The niche focus combined with their capabilities within oncology, makes Medical Need a very suitable partner for us in the Nordics, and we look forward to working together to improve the access of CIMAher in the Nordic region."

Nimotuzumab is a well-established monoclonal antibody within oncology that targets the epidermal growth factor receptor (EGFR) on cancer cells and inhibits their signalling pathway which stops cancer cells from growing and proliferating. To date, Nimotuzumab has been administered to more than 65,000 patients globally and has undergone 82 clinical studies. Nimotuzumab is already approved in 25 countries around the world for a variety of cancers, such as head & neck cancer, oesophageal cancer, highly malignant brain tumours and pancreatic cancer.

Nimotuzumab has an EU orphan designation for the treatment of pancreatic cancer and glioma and has been used in EU under named patient basis, following special individual approvals from a national regulatory authority as it does not yet hold a EU marketing authorization.

About CIMAher (Nimotuzumab)
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Nimotuzumab’s capacity to bind to EGFR is strongly dependant on cell receptor density and it’s bivalent binding mechanism. EGRF is overexpressed in many cancer cells as compared to normal tissue and nimotuzumabs bivalent binding mechanism results in more specific bonds and therefore, potentially increases anti-tumor activity with decreased toxicity in normal tissue (i.e. skin and healthy organ toxicity).

Nimotuzumab is currently available as a registered treatment in 25 countries around the world for a variety of cancers, including head & neck cancers in advanced stages, nasopharyngeal carcinoma, oesophageal cancer, high-malignant glial cancers (glioblastoma multiforme and anaplastic astrocytoma), and locally advanced or metastatic pancreatic cancer (adenocarcinoma). Nimotuzumab has also been approved in a number of countries for high-grade gliomas in children and adolescents (newly diagnosed, recurrent and refractory).

On May 21, 2018 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported it has raised USD$300 million in an oversubscribed Series C financing (Press release, Grail, MAY 21, 2018, View Source [SID1234526850]). The financing is led by Ally Bridge Group, co-led by Hillhouse Capital Group and 6 Dimensions Capital, and includes Blue Pool Capital, China Merchant Securities International, CRF Investment, HuangPu River Capital (HPR), ICBC International, Sequoia Capital China, and WuXi NextCODE.

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Since early 2016, GRAIL has raised more than $1.5 billion in three rounds of equity financing to pursue its vision of transforming the way cancer is diagnosed and reducing global cancer mortality. The Series C funding will add to the company’s balance sheet and support ongoing development and validation of products for the early detection of cancer in GRAIL’s clinical research program.

"GRAIL has continued to execute at a rapid pace towards its goal of saving lives through early detection of cancer. We have enrolled more than 73,000 participants in our population-scale clinical studies, CCGA and STRIVE, and are on-track to complete enrollment in both studies this year," said Jennifer Cook, Chief Executive Officer of GRAIL. "We recently reported data supporting the potential for development of a highly specific and sensitive blood test, and are now continuing our development programs to optimize and validate a product for early detection of multiple cancer types."

"We are fortunate to partner with new international investors who share our vision of delivering early detection products to people globally," said Ken Drazan, President of GRAIL. "Many of our new investors have a focus in Asia, which we believe is a natural fit as we plan to grow our capabilities and operations in the region, following the planned launch of our first product for early detection of nasopharyngeal cancer in Hong Kong this year."

"We are very impressed with the scientific, clinical, and software engineering achievements the team at GRAIL has made in just over two years. Our significant investment in GRAIL aligns well with Ally Bridge’s strong focus on investing in some of the world’s most innovative life science technologies and enhancing value-creation across geographies," said Frank Yu, Founder and Chief Executive Officer, Ally Bridge Group.

On May 21, 2018 Rain Therapeutics Inc., a privately-held, clinical stage biotechnology company focused on biomarker-driven, small molecule therapeutics for patients with cancer, reported the closing of a tranched Series A financing of $18.4 million (Press release, Rain Therapeutics, MAY 21, 2018, View Source [SID1234526835]). The financing was led by San Francisco-based, Biotechnology Value Fund (BVF) and followed by Perceptive Advisors, Auckland UniServices Limited’s Inventors Fund and other private investors. BVF’s Gorjan Hrustanovic, Ph.D., will join the Rain Board of Directors in conjunction with the financing. The Series A round follows a $1 million convertible note financing completed in late-2017.

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Rain plans to use the proceeds to advance the clinical development of its lead program, Tarloxotinib (Tarlox), in patients with EGFR and ErbB Exon 20 insertion mutations in non-small cell lung cancer (NSCLC). The company intends to commence a Phase 2 study in patients with EGFR and ErbB Exon 20 insertion mutations in NSCLC in the first half of 2019.

"With the proceeds from recent financings we can complete a Phase 2, proof-of-concept study and continue to advance Tarloxotinib," said Avanish Vellanki, Rain’s co-founder and chief executive officer. "Our goal is to provide Exon 20 patients with a novel treatment option that results in strong anti-tumor responses while avoiding the debilitating, dose-limiting EGFR toxicities in the gut and skin that are associated with conventional small molecule inhibitors."

"Targeting wildtype EGFR, or wildtype EGFR-like tumors has always been very challenging with conventional small molecule inhibitors because of the abundance of EGFR in healthy tissues," said Robert Doebele, M.D., Ph.D., co-founder of Rain Therapeutics, and associate professor of medicine and director of the Thoracic Oncology Research Initiative at the University of Colorado. "Patients with Exon 20 lung cancer show an addiction to EGFR, however the resemblance of EGFR Exon 20 to EGFR wildtype suggests most conventional strategies will be limited by toxicity. With its novel mechanism of action, Tarlox has the potential to address this inherent, unmet challenge in Exon 20 patients."

Rain has worldwide development and commercialization rights for Tarlox through an exclusive license to technology developed at the University of Auckland.