On May 21, 2018 Splash Pharmaceuticals, Inc. ("Splash"), a private biopharmaceutical company that develops novel cancer therapies, reported completion of a financing round to support the ongoing clinical trial of SPL-108 (Press release, Splash Pharmaceuticals, MAY 21, 2018, View Source [SID1234526834]). The round was oversubscribed and was led by existing investors Hamilton BioVentures ("Hamilton") and Solstice Capital. The proceeds will support Splash’s clinical trial in platinum-resistant ovarian cancer patients.

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Splash is developing a pipeline of novel therapeutics that target CD44 with the goal to achieve dramatic and durable responses in cancer patients. The first of these therapies, SPL-108, has demonstrated significant activity in animal models including ovarian, breast, endometrial, prostate, liver and brain cancers. SPL-108 has also demonstrated activity in multiple Phase I and II clinical trials in gynecological cancers with an excellent safety profile. Splash believes that combining SPL-108 with other therapies will provide even greater activity which is the basis for the current clinical trial.

"We are very pleased to close this financing round and are particularly gratified by the strong support from our existing investors who know the story best," said Dr. David Nelson, President and CEO of Splash Pharmaceuticals. "We are excited by the breadth and depth of preclinical and clinical data that we have generated in support of our latest clinical trial in ovarian cancer. SPL-108 holds great promise for many types of cancer and we look forward to testing this clinical hypothesis with our latest trial."

"Hamilton is excited to participate in this financing round," said Dr. Kerry Dance, Chairman of Hamilton BioVentures. "The unique mechanism of action of SPL-108 provides a compelling possibility of achieving durable responses, which is something that has remained elusive in many recent breakthrough cancer therapies."

On May 21, 2018 NantOmics, LLC, the leader in molecular analyses and a member of the NantWorks ecosystem of companies, reported the publication of peer-reviewed research defining for the first time three distinct classifications of sebaceous carcinoma, a rare and sometimes deadly former of skin cancer (Press release, NantOmics, MAY 21, 2018, View Source [SID1234526833]).

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A study published on May 14 in the journal Nature Communications shows that a signature analysis reveals three clinically distinct classes of sebaceous carcinoma. The research offers fresh insights into how to treat the disease and adds more data to the concept that different mutational processes drive cancers that originate in the same location but are clinically distinct.

Using the technology that drives NantHealth Inc’s (NASDAQ: NH) GPS Cancer platform, NantOmics scientists performed tumor-normal DNA sequencing and RNA sequencing on tissue samples from 32 patients with sebaceous carcinoma, revealing that the cell of origin and mutation patterns defined three clinically distinct classes. These explain both cancer ontogeny and clinical course.

"This is the first time that we have been able to define sebaceous carcinoma into distinct molecular classifications with defined mutational signature profiles," said Dr. Shahrooz Rabizadeh, Chief Scientific Officer at NantOmics. "We believe that our findings and the classifications have significant implications on patient treatment."

Dr. Patrick Soon-Shiong, CEO and founder of NantOmics said the research reiterated the importance of no longer treating cancer by anatomy, but based on biology.

"This research has helped to decode signatures that are based on the diseases molecular profile," Soon-Shiong said. "Beyond treatment implications, this shows the absolute importance of looking at cancer treatment from a biological perspective."

Nature Communications is a peer-reviewed, open-access journal that publishes research on all areas of natural sciences. Papers published by the journal are considered to represent important advances in their fields of research.

Other highlights from the paper:

A UV-damage signature classification predominates in ten of the 32 samples.
Nine of the samples are classified by microsatellite instability (MSI) profiles, which has been shown to be responsive to and is approved for pembrolizumab (Keytruda) use.
The third classification, pauci-mutational sebaceous carcinoma has a more varied signature, but half of which shared a similar mutation pattern in ZNF750 transcription factor in this study.
Neoepitope analysis identified a subset of patients with highly clonal mutation burden that may be most responsive to immunotherapy, and may potentially be strong candidates for treatment with neoepitope vaccines.

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.

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 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.