On May 22, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported the upcoming presentation of clinical data from the First-In-Human C101 phase Ia/Ib study of its GM102 antibody during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 4 in Chicago, USA (Press release, GamaMabs Pharma, MAY 22, 2018, View Source [SID1234527257]).

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Data will be reported on 27 patients with advanced or recurrent AMHRII-positive epithelial ovarian (EOC), granulosa ovarian (GCT), cervical and endometrial cancers, treated with GM102 monotherapy in eight successive escalation cohorts at five major European cancer centers.

No safety signal was reported at all doses tested. Two clinical objective partial responses according to RECIST criteria were observed among four GCT patients. Peripheral blood pharmacodynamic changes observed under GM102 treatment suggested an immune cell recruitment to the tumor site. In paired tumor biopsies before and under GM102 treatment, enhanced CD16 and Granzyme B biomarker expression was observed in the tumor micro-environment, suggesting GM102-induced cellular cytotoxicity or phagocytosis.

Expansion cohorts in EOC and GCT at the recommended GM102 dose are currently ongoing, with first results anticipated early 2019.

GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa tumors (GCT) and re-expressed in approximately 70% of gynecological tumors. GM102 exerts its anti-tumor activity through NK cell and macrophage engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and ADCC (Antibody Dependent Cell Cytotoxicity).

"These first results are really encouraging, especially for patients with granulosa ovarian cancers who do not have therapeutic alternatives at this stage," said Pr. Alexandra Leary, Gustave Roussy Institute (France), principal investigator of the study. "We are gathering experience with additional patients in the expansion part of the study; should these first results be confirmed, we will move forward with a larger phase 2 study in this indication with great enthusiasm, given the unmet medical need."

"We are happy to share such exciting data with the medical community, which confirm the unique immunological mode of action of GM102 and shows its translation into clinical activity," said Stéphane Degove, CEO at GamaMabs Pharma. "We are expanding our GM102 clinical development program beyond the field of gynecological cancers in other tumor types that also express AMHRII," he added.

Results will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, during the Gynecologic Cancer session, on June 4, 2018, 1:15 PM-4:45 PM.
Abstract #5542; Poster ID 214461, ‘A first-in-human study of monoclonal antibody GM102 in patients with Anti-Mullerian-Hormone-Receptor II (AMHRII) positive gynecological cancers’ by A Leary and co-authors.
Following the presentation, the poster will be available on the Publication page of GamaMabs’ website1.

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 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.