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 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 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 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 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).