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 Verastem, Inc. (NASDAQ: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that Jonathan Pachter, PhD, the Company’s Chief Scientific Officer, will give an oral presentation and moderate a roundtable discussion at the 3rd Annual Advances in Immuno-Oncology Congress being held May 24-25, 2018 in London, UK (Press release, Verastem, MAY 21, 2018, View Source;p=RssLanding&cat=news&id=2350086 [SID1234526826]).

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"The data that will be presented at the Immuno-Oncology Congress demonstrate the unique potential of duvelisib, as a dual inhibitor of PI3K-delta and PI3K-gamma, to enhance the efficacy of immune checkpoint and co-stimulatory antibodies in preclinical models of both hematological malignancies and solid tumors," said Dr. Pachter. "These results support continued research and lend particular importance as we move toward the commercialization of duvelisib, Verastem’s lead candidate an oral, dual inhibitor of PI3K-delta and PI3K-gamma. The duvelisib New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma. I will also give an update on the scientific rationale and clinical progress of our FAK inhibitor defactinib in combination with PD-1 and PD-L1 inhibitors in solid tumors."

Details for the presentation and round table discussion at the Congress are as follows:

Oral Presentation Title: Immunological Effects of Clinical Stage FAK & PI3K-Delta/Gamma Inhibitors
Session: Translational Immuno-Oncology
Date and time: Thursday, May 24, 2018 at 5:40 – 6:10 PM BST

Round Table Discussion Title: Novel Checkpoint Pathways & Strategies for Combined Modality Treatment
Date and time: Friday, May 25, 2018 at 7:30 – 8:00 AM BST

A copy of the oral presentation will be available following the presentation.

About Duvelisib
Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib
Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.

On May 21, 2018 F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies, reported successful dosing of the first patient with FS118 in a Phase I clinical trial (Press release, f-star, MAY 21, 2018, View Source [SID1234526829]).

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FS118 is a first-in-class bispecific antagonist simultaneously targeting LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1), two immune checkpoint molecules involved in tumour growth through attenuation of immune surveillance. In preclinical models, FS118 has demonstrated potent anti-cancer activity, as recently presented by F-star at the 2018 AACR (Free AACR Whitepaper) meeting.

"The initiation of a Phase I clinical study of FS118 is a pivotal milestone for F-star and validation of our unique bispecific technology and approach to improving cancer care" said John Haurum, CEO of F-star. "FS118 leverages novel biology that cannot be attained through combination approaches, we believe this is an important step forward in providing improved therapies for patients with advanced cancer."

The first-in-human study is designed to assess the safety, tolerability and pharmacokinetic profile of FS118 in patients with advanced malignancies that have progressed while on PD-1/PD-L1 therapy. The trial is being conducted at clinical centres in the US.

"FS118 is positioned to address a clear unmet medical need as only approximately one in five patients treated with checkpoint inhibition monotherapy reach durable and clinically meaningful responses" according to F-star’s CSO, Neil Brewis. "FS118 has the potential to increase this response rate by overcoming tumour resistance and restoring anti-cancer immunity and responsiveness."

FS118 was generated using F-star’s proprietary Modular Antibody Technology by incorporating an anti-LAG-3 Fcab (Fc-region with antigen binding) into a PD-L1-specific antibody. The mAb² is under option to Merck KGaA, Darmstadt, Germany as part of a collaboration announced in June 2017.

Further information about the trial is available on clinicaltrials.gov NCT03440437.

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 Bioasis Technologies, Inc. (TSX.V:BTI; OTCQB:BIOAF) and WUXI BIOLOGICS (2269.HK) reported an initial strategic collaboration for the development and manufacturing of xB3-001, Bioasis’ lead investigational biological candidate to treat brain cancer (Press release, biOasis, MAY 21, 2018, View Source [SID1234526832]).

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Bioasis is a biopharmaceutical company developing xB3, a proprietary platform technology for the delivery of therapeutics across the blood-brain barrier (BBB) and the treatment of CNS disorders in areas of high unmet medical-need, including brain cancers and neurodegenerative diseases.

Headquartered in Wuxi city, Jiangsu province, China, WuXi Biologics is a leading global platform company providing end-to-end solutions for biologics with a mission to accelerate and transform biologics discovery, development and manufacturing to benefit patients around the world.

"The initiation of manufacturing for xB3-001 is a pivotal milestone for Bioasis as we look to advance our lead program in HER2+ breast cancer brain metastases," said Mark Day, Ph.D., president and chief executive officer, Bioasis. "WuXi Biologics’ expertise and experience in manufacturing biologics is instrumental to Bioasis in developing our pipeline."

The delivery of most biologics across the BBB and into the brain has been the single greatest challenge to treating brain diseases. Bioasis is engineering its first biologic product candidate, xB3-001, to overcome this obstacle in brain cancer. Manufacturing these sophisticated therapies requires a tailor-made approach, with expertise and agility in cell line, process and formulation development.

"We are excited to take on this work with Bioasis to enable them bringing innovative therapies to patients suffering from brain cancer," said Dr. Chris Chen, chief executive officer, WuXi Biologics. "This collaboration allows us to leverage our expertise across biological drug development and anticipate Bioasis’ needs as they move from pre-clinical to clinical and beyond."

Through this partnership Bioasis will have access to WuXi Biologics’ extensive expertise and technologies from cell line construction and development, cell culture process development, purification process development and formulation development. WuXi Biologics will focus on ensuring that Bioasis’ drug product candidates are manufactured with optimal formulation, stability and exceptional quality for the clinic.