Volastra Therapeutics Partners with Microsoft to Advance Metastatic Cancer Research

On April 6, 2021 Volastra Therapeutics reported it will collaborate with Microsoft to develop tools that help detect drivers of cancer metastasis (Press release, Volastra Therapeutics, APR 6, 2021, View Source [SID1234577634]). These unique digital pathology tools will accelerate the development of promising new therapies for cancer and help identify the patients most likely to benefit.

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"Metastasis is one of the biggest unsolved challenges in cancer treatment, but new insights into tumor biology from our founders have laid the groundwork for major advancements in this field," said Charles Hugh-Jones, M.D., Chief Executive Officer at Volastra. "We are excited to work with Microsoft to apply data science to the challenges of cancer research. The digital tools we develop will fuel our drug discovery efforts and bring new hope to people living with cancer."

"We have seen the tremendous promise of advanced computation in the fields of medical diagnostics and drug discovery," said Desney Tan, Ph.D., Managing Director, Microsoft Health Futures. "The collaboration with Volastra will lead to potential advances in the development of therapies to prevent and treat cancer metastasis. We look forward to continued collaboration with Volastra to deliver solutions for the computational life sciences community."

The teams will work together on algorithms to identify markers that correlate with tumor metastatic behaviors. The collaboration will develop automated machine learning tools capable of rapidly and accurately integrating insights across multiple datasets, including pathology slides and three-dimensional tumor-derived organoids.

Hadassah and MyBiotics to Collaborate for the Discovery of Microbiome-Based Therapy for Improving Cancer Immunotherapy

On April 6, 2021 MyBiotics Pharma Ltd., a microbiome therapeutics company, and Hadasit Medical Research Services and Development Ltd., the technology transfer office of Hadassah Medical Center, reported that they have entered into a research collaboration and licensing agreement for the identification of microbiome-based therapeutics that will enhance the response to and reduce adverse effects of anti-PD-1 and anti-PD-L1 in melanoma patients (Press release, MyBiotics, APR 6, 2021, View Source [SID1234577652]).

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The collaboration will combine Hadassah’s knowhow and expertise in immunotherapy treatment of melanoma patients with MyBiotics’ proprietary microbiome technologies enabling development of novel therapeutics. The two-year joint research project will be conducted by researchers from MyBiotics together with a team of researchers at Hadassah Cancer Research Institute headed by Prof. Michal Lotem, MD., Head of the Center for Melanoma and Cancer Immunotherapy, Department of Oncology at Hadassah Medical Center. It will be funded by MyBiotics, which has an exclusive license for all data and inventions stemming from the collaboration.

The research is aimed at assessing the composition of the gut microbiome and secondary metabolites (organic compounds produced by the gut bacteria) in up to 100 melanoma patients treated with PD-1/PD-L1 checkpoint inhibitors, some of which already exhibited long-term response to the treatment. Stool and blood samples will be collected at various time points along the treatment, for the purpose of identifying microbiome components that promote treatment success.

"Recent research supports the important role played by the microbiome in promoting the success of cancer immunotherapies, and points to the possibility of influencing the composition of the microbiome as an adjunct treatment," stated David Daboush, CEO of MyBiotics Pharma. "In this collaboration with Hadassah we will leverage Mybiotics’ SuperDonor whole microbiome recovery technology in combination with the MyLiveIn computational and predictive tools to advance research in order to unravel new layers of understanding and findings that will enable the design of effective microbiome-based therapeutics."

"We look forward to the joint research with the team at Hadassah Cancer Research Institute, who bring excellent clinical capabilities combined with innovative thinking and expect this will be a significant partnership that will lead to better treatment options for oncology patients within the next few years," Daboush added.

"For years I have strived to study what was driving long-term survival of melanoma patients who did well beyond expectations," stated Prof Michal Lotem, and added, "This collaboration gives us advanced molecular and genomic tools to analyze treatment success. After years of studying how cancer deceives us, I cannot wait to translate lessons of the past to therapies of the future."

"This collaboration is an excellent example of the kind of partnerships we strive to create between medical companies and hospital-based research centers. I trust that the unique combination of scientific excellence and clinical expertise will work for the benefit of patients in Israel and worldwide", stated Dr. Tamar Raz, the CEO of Hadasit.

MyBiotics has developed breakthrough and robust culturing, fermentation and delivery technologies for generating a highly stable and diverse bacterial community that can be efficiently delivered to the gut and can reliably restore microbiome equilibrium. These technologies are effective for single microbes, complex microbial consortia and whole microbiome products, and are integrated with a computational AI platform which enables the design of unique microbial consortia and whole microbiome profiles. The technologies are highly potent and suitable for patients with microbiome-related medical conditions or for those who use antibiotics. Preclinical studies have shown that MyBiotics’ products deliver enhanced durability in various gastrointestinal and manufacturing conditions, enable targeted release in different gastrointestinal locations and exhibit robust colonization in the gut.

About the Microbiome and Cancer Immunotherapy

In the last 5 years, studies elucidating the possible contribution of the microbiome to cancer development and response to treatments has been at the forefront of scientific research. Findings have shown, for example, that broad-spectrum antibiotics can reduce the efficiency of checkpoint inhibitors. In addition, studies have pointed to differences between microbiomes of patients responding to immunotherapy and those who do not respond to treatment. In animal models, tweaking the microbiome or adding secondary metabolites thereof, influenced the efficiency of cancer immunotherapy. These findings and others support the potential of changing the microbiome composition as a tool for improving the efficacy and reducing the toxicity of checkpoint inhibitor immunotherapy in cancer patients.

PCI Biotech to present at European Biotech Investor Days 2021

On April 6, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the European Biotech Investor Days 2021, a US based online event taking place April 7-8, 2021 and hosted by Goodwin, Solebury Trout, Deutsche Bank and Nasdaq (Press release, PCI Biotech, APR 6, 2021, View Source [SID1234585154]).

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On Thursday, April 8, 2021 at 15:00 (CEST), Dr. Per Walday, CEO, will present an overview of PCI Biotech’s proprietary platform technology via a general company presentation.

The presentation can be accessed live through this link View Source

The presentation slides will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Other presentations" after the event.

License agreement for the distribution of Kigabeq® in 14 european countries

On April 6, 2021 ORPHELIA Pharma and Biocodex reported the execution of an exclusive distribution and marketing agreement for Kigabeq (vigabatrin) for most of the European Union territory, including France (Press release, ORPHELIA Pharma, APR 6, 2021, View Source [SID1234577603]).

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Kigabeq, the first pediatric form of vigabatrin developed by ORPHELIA Pharma, is notably indicated in the treatment of infantile spasms (West syndrome). Kigabeq is approved in Europe, where this medicine, intended exclusively for children, benefits from a centralized marketing authorization (Pediatric Use Marketing authorization, PUMA).

"We are very pleased to release this collaboration agreement with Biocodex", says Hugues BIENAYME, Founder and CEO of ORPHELIA Pharma, "With their long-standing experience in the field of pediatric epilepsy, Biocodex is certainly the best partner for Kigabeq distribution in Europe".

"With Kigabeq, the only pediatric presentation of vigabatrin, Biocodex is expanding its portfolio of drugs intended for rare and serious pathologies in children" adds Nicolas Coudurier, CEO of Biocodex, " Kigabeq and Diacomit (stiripentol, developed and marketed by Biocodex) are two drugs which address unmet medical needs for young patients affected by severe and resistant to treatment epilepsies".

"Our objective is to make Kigabeq available to all European clinicians, so that children affected by West syndrome can benefit." concludes Gilles ALBERICI, President of ORPHELIA Pharma, "Thanks to this agreement with Biocodex, Kigabeq will soon be prescribed in most of the European territory."

About Kigabeq

Kigabeq is the first pediatric formulation of vigabatrin, an essential anti-epileptic drug. Presented as soluble and scored tablets of 100 mg and 500 mg for oral or nasogastric administration, Kigabeq is notably indicated for the treatment of infantile spasms (West syndrome), an extremely serious epileptic encephalopathy of the infant. Kigabeq was developed exclusively for children and has been granted European Pediatric Marketing Authorization (PUMA).

About infantile spasms

West syndrome, or infantile spasms, is an extremely serious epileptic encephalopathy in infants that combines epileptic spasms, psychomotor deterioration and a hypsarrhythmic type electroencephalogram. It is a rare disease, with an estimated incidence of 5 per 10,000 births. It can occur in an infant with previously normal development or with a pre-existing delay; in all cases, infantile spasms severely hamper the psychomotor development. Pharmacological treatment should be started quickly to allow the spasms to stop and to improve the prognosis.

Overland ADCT BioPharma Appoints Eric Koo as Chief Executive Officer

On April 6, 2021 Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), reported the appointment of Eric Koo, BSc, MBA, as Chief Executive Officer (Press release, ADC Therapeutics, APR 6, 2021, View Source [SID1234577619]). Mr. Koo brings more than 25 years of pharmaceutical industry and business management experience to Overland ADCT BioPharma with a proven track record of executing successful drug approvals and launches across Asia.

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"Overland ADCT BioPharma has a tremendous opportunity to bridge the clinical gap between the U.S., Europe and Asia through the expanded reach of innovative cancer medicines like antibody drug conjugates," said Eric Koo, BSc, MBA. "It is an honor to assume the role of Chief Executive Officer and I look forward to working closely with both teams at Overland Pharmaceuticals and ADC Therapeutics to develop and commercialize the pipeline in greater China and Singapore."

Mr. Koo most recently served as Vice President, Head of Oncology Business Unit at Takeda China focusing on multiple myeloma and lymphoma. Prior to Takeda China, Mr. Koo served as Director, Oncology Business Unit and Director, Market Access, External Affairs & Key Account Management at Merck, Sharp and Dome (MSD) Taiwan. Prior to MSD, he served as Regional Marketing Director for APAC & Specialty Care BU Head, Malaysia/Singapore at Bayer APAC. Mr. Koo started his pharmaceutical career at Pfizer, spending 16 years in various sales, product management and marketing positions at both Pfizer Taiwan and Pfizer Emerging Market Asia & China, including six years as the China/APAC Regional Marketing Director for Oncology.

Mr. Koo earned his BSc in Pharmacy from Taipei Medical University and his MBA from the University of North Carolina at Charlotte, Belk College of Business.

"Eric joins Overland ADCT BioPharma at an important time in the joint venture’s evolution as the U.S. PDUFA date for Lonca quickly approaches this May," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We are thrilled to welcome a highly qualified, respected and visionary leader like Eric to lead Overland ADCT BioPharma in its quest to develop and commercialize Lonca and other ADCs for difficult-to-treat hematologic and solid tumor indications in greater China and Singapore."

"Eric’s deep expertise and history of expanding access to life-changing cancer therapies in greater China and beyond gives me great confidence in Overland ADCT Biopharma’s ability to fulfill its mission of bringing innovative ADC medicines to patients in Asia and around the world," said Ed Zhang, MBA, Co-founder of Overland Pharmaceuticals. "Since its launch in December 2020, Overland

ADCT BioPharma has submitted two clinical trial applications to evaluate Lonca, underscoring the differentiated scale, speed and execution of this strategic business model. We look forward to supporting the advancement of Overland ADCT BioPharma’s pipeline under Eric’s leadership."

The lead program in the Overland ADCT BioPharma pipeline is Lonca, an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Lonca has been evaluated by ADC Therapeutics in a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL and is in two ongoing trials – a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a Phase 3 confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL. The Overland ADCT BioPharma portfolio also includes the clinical-stage candidates ADCT-602 targeting CD22, which is currently in a Phase 1/2 clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia, and ADCT-601 targeting AXL, which is currently in a Phase 1 clinical trial in patients with selected advanced solid tumors. ADCT-901 targeting KAAG1 is in preclinical development for the treatment of advanced solid tumors with high unmet medical needs.