On February 1, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported plans to participate in the virtual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference (Press release, Pulse Biosciences, FEB 1, 2022, View Source [SID1234607633]).

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Management is scheduled to conduct meetings with investors during the conference on Tuesday, February 15th and Wednesday, February 16th, 2022.

On February 2, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that it has completed the acquisition of Virex Health, Inc., a Boston, MA based company ("Virex"), spun out of the labs of Professors Mark Grinstaff and Scott Schaus at BU, on February 1, 2022 (Press release, Sorrento Therapeutics, FEB 1, 2022, View Source [SID1234607603]). The proprietary Virex Technology utilizes enzymatic and electrochemical amplification to detect picogram level biological analytes, such as SARS-CoV-2 and its variants, Flu A/B, as well as markers for liver cancer, inflammation and hormone monitoring.

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"One of the most exciting things about this Virex platform is the potential to finally provide an extremely sensitive and affordable detection test which is simple enough to use at home. Similar to a glucose meter, the amplified electrochemistry signal is converted to an electrical current and read in a reusable glucometer," said Dr. Scott Schaus, Co-Founder and Professor of Chemistry at BU. "Today there are glucose meters in nearly 1 in 10 households in the world. We know the chemistry is broadly adaptable and the supply chain highly scalable."

The Virex and Sorrento teams have been working together to define the first test with which to pursue commercialization. Key personnel, including Drs. Mark Grinstaff and Scott Schaus and Virex scientists, will assist with further development and commercialization.

"The current sensitivity for at-home testing is just too low, and the price per test is still too high for daily testing. With capabilities both in therapeutics and in diagnostics, Sorrento is an ideal company to take this next-generation Virex platform to the world across a wide range of analytes, including viruses, nucleic acids, proteins, hormones and other biomarkers," said Dr. Grinstaff, Co-Founder and a Distinguished Professor of Translational Research. Dr. Grinstaff is a Professor of Biomedical Engineering, Chemistry, Materials Sciences, Engineering and Medicine at BU. Dr. Grinstaff is an inventor of Abraxane and Adherus Surgical Sealants, and he has over 200 patents and patent applications to his name. "Virex seeks to leverage Sorrento’s extensive expertise in producing highly selective and specific monoclonal antibodies for use in at-home diagnostic tests, including tests capable of detecting SARS-CoV-2 nucleocapsid proteins and whole viruses."

"Sorrento has remarkable vision for impacting diagnostics and other sectors of healthcare," said Virex co-founder Keith Hearon, a former postdoctoral fellow in Professor Robert Langer’s Group at MIT. "Sorrento’s acquisition of Virex is particularly strategic because of Sorrento’s robust antibody library, which is highly complementary to Virex’s enzymatic amplification diagnostic assay platform. The puzzle pieces fit very nicely together."

"As Keith’s former postdoctoral advisor at MIT, I’ve continued to follow his career and I’m very proud of what a terrific entrepreneur he has become. He did a great job with his vision for Virex and found a wonderful home for it with Sorrento under the outstanding leadership of Henry Ji," said Professor Langer, David H. Koch Institute Professor at Massachusetts Institute of Technology.

"We at Sorrento are amazed by the unmatched sensitivity of the Virex tests for detecting the virus that causes COVID-19 and are excited to mass produce and commercialize the rapid at-home tests for daily COVID-19 testing and frequent early cancer detection," said Dr. Henry Ji, Chairman and CEO of Sorrento.

Virex received funding support in 2021 from the Massachusetts Life Sciences Center under its Accelerating Coronavirus Testing Solutions program.

On February 1, 2022 Glycotope GmbH, a biotechnology company developing antibodies against proteins carrying tumor-specific carbohydrate structures, and CantonBio Deutschland GmbH, a subsidiary of Canton Biologics Co. Ltd., a leading Chinese CDMO, reported the successful completion of CantonBio’s acquisition of Glycotope’s service business under the newly formed FyoniBio GmbH (Press release, Glycotope, FEB 1, 2022, View Source [SID1234607597]).

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The spin-out completes Glycotope’s refocus solely towards drug discovery and development, utilizing its proprietary technology platform to develop uniquely tumor-specific monoclonal antibodies. FyoniBio, now as part of Canton Biologics Group, will continue the contract development service business and offer a broad range of ISO-9001 compliant services from cell line development to clinical bioanalysis.

Henner Kollenberg, Glycotope’s Chief Executive Officer, said "We look forward to collaborating with FyoniBio for our development needs, while Glycotope’s renewed focus solely on drug discovery and development sharpens our profile as a platform company for tumor targeting antibodies with unique specificity."

Dr. Lars Stöckl, Managing Director of FyoniBio said "We are also looking forward to continuing the service business with a great team of long-term colleagues and long-standing existing partners as well as potential new collaborators."

Dr. Hans Baumeister, Managing Director of FyoniBio added; "We are so happy to be able to offer extended one-stop service packages from clone and cell line development all the way to GMP manufacturing. Our portfolio in clinical bioassay services performed under GCLP quality regulations is surely an add-on for the CDMO service offered by FyoniBio and Canton Biologics."

Dr. Xiao Shen, Founder and Chief Executive Officer of Canton Biologics said, "The acquisition of FyoniBio not only supports the international growth strategy of Canton Biologics, more importantly, through FyoniBio, Canton Biologics can significantly extend our technology platforms and service scope to better support international clients in Europe and worldwide."

On February 1, 2022 DiscoveryBioMed, Inc. and collaborators reported that they are humbled and honored to receive a 2-year grant from the Michael J. Fox Foundation for Parkinson’s Research (MJFF) (Press release, DiscoveryBioMed, FEB 1, 2022, View Source [SID1234607596]). MJFF is a premier private foundation driving cutting-edge research that will yield viable therapeutics for Parkinson’s disease.

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The monies are awarded to develop, validate, select and progress hit-to-lead Stimulator of Interferon Genes (STING) inhibitors for Parkinson’s disease. DiscoveryBioMed, Inc. and our collaborator, Nitor Therapeutics led by Dr. Shanta Bantia, are performing in vitro assays currently to determine which hit-to-lead STING inhibitors bind STING directly and which inhibit the STING-associated signal transduction pathway in human immune-relevant cells. Then, we will identify STING inhibitors that are both blood-brain barrier permeant and that are also potent and effective at inhibiting STING and the STING-based signaling pathway in innate immunity-relevant human cells in vitro. This therapeutic approach may quell chronic neuroinflammation in Parkinson’s disease. MJFF funded the program and has already provided sage advice in the beginnings of the project. Later term, bioavailability of our lead STING inhibitors in the central nervous system (CNS) will be determined, and critical proof-of-concept efficacy testing in a mutant alpha-synuclein over-expression model of Parkinson’s disease in the brain of mice will be performed with a lead STING inhibitor. In addition to Dr. Bantia as a paid consultant, Dr. David G. Standaert, MD, PhD, John N. Whitaker Professor and Chair of the Department of Neurology at the UAB Heersink School of Medicine is also advising DBM on this project as a world expert on Parkinson’s disease and other neurological disorders that affect movement.

"We are honored to be funded and working with MJFF. The experience working with MJFF has already been helpful, and we are excited to identify a lead STING inhibitor as a potential Parkinson’s disease therapeutic," declared Dr. Erik Schwiebert, DBM’s CEO and Chief Scientific Officer, and Dr. John Streiff, DBM’s Chief Chemistry Officer. "Our chemical series are distinct from nucleosides and nucleotides that have been classical STING ligands in past efforts."

The discovery of multiple hit-to-lead chemical classes of STING inhibitors was funded by a successful Phase 1 SBIR award from the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Disease (NIAID). A potential Phase 2 SBIR award is pending possible funding.

On February 1, 2022 Oak Hill Bio ("Oak Hill"), a clinical-stage rare disease therapeutics company developing life-changing medicines for extremely preterm infants and patients suffering from rare autoimmune diseases, reported the Company’s launch and plans to advance a pipeline of promising clinical and preclinical investigational therapeutics acquired and licensed from Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Takeda, FEB 1, 2022, View Source [SID1234607592]).

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Under the terms of the agreements, Takeda will receive an upfront payment, an ownership stake in Oak Hill and potential milestones and royalty payments in exchange for the acquired and licensed programs. Takeda will also support the transition for continued research and development of the acquired programs. The pipeline includes two clinical-stage and four preclinical-stage programs.

Two Takeda executives with direct experience working on the acquired programs will join Oak Hill, including Victoria Niklas, M.D., as Chief Medical Officer, and Norman Barton, M.D., as a senior scientific advisor. Daniel Curran, M.D., Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda, will join the Oak Hill board of directors.

"Oak Hill has a significant opportunity to take these promising programs and advance them through clinical development to bring life-altering new medicines to patients in need," said Josh Distler, J.D., President and Chief Financial Officer of Oak Hill Bio. "We are confident not only in these potentially transformative compounds, but also in the extraordinary team that has come together to deliver these innovative therapies."

Oak Hill’s lead therapeutic candidate, OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), the natural version of which is a key driver of fetal growth and development in utero, and its binding protein, IGFBP-3.

Mothers are the primary source of IGF-1 for the developing fetus, with the fetus producing very little of its own until reaching 30 weeks of gestational age. At birth, extremely premature infants, born at less than 28 weeks of gestational age, have low levels of IGF-1 which are associated with greater complication rates. OHB-607, as a human IGF-1 replacement, is designed to help promote continued development and maturation of vital organs and the vasculature that supports them.

OHB-607 has been evaluated in both preclinical and clinical studies. A Phase 2 clinical trial showed a statistically significant shift towards milder bronchopulmonary dysplasia and a positive trend in reducing intraventricular hemorrhage (pre-specified secondary endpoints), with no significant safety signal observed.

"Every year, hundreds of thousands of infants worldwide are born extremely prematurely and, as a result, suffer from severe complications in their lungs, brain, and eyes that hinder their long-term development and quality of life. While prenatal steroids, surfactants, ventilators and improved resuscitation protocols have increased the survival rate of premature infants, there has been little progress in protecting their not fully developed organs from the trauma of life-saving measures at birth, including supplemental oxygen and breathing machines," said Victoria Niklas, M.D., Chief Medical Officer at Oak Hill Bio and former Global Program Lead for OHB-607 at Takeda. "We are committed to delivering innovation into this area of high unmet medical need for infants born extremely premature. OHB-607 has the potential to be the first breakthrough in more than 30 years to improve outcomes for these infants and their families."

OHB-101 (Formerly TAK-752), a Phase 2a program, is currently being investigated for the treatment of a wide array of rare autoimmune diseases. It is a soluble recombinant version of the FcγR2B receptor that is designed to bind to immune complexes to prevent them from interacting with the fc gamma receptors that drive inflammation and autoimmune cascades. Preliminary clinical studies have been conducted in multiple autoimmune indications, including systemic lupus erythematosus, a rare autoimmune primary glomerular disease, and immune thrombocytopenia, a rare autoimmune blood disorder.

Oak Hill intends to advance the ongoing Phase 2b clinical study of OHB-607 for complications of premature birth in 2022 and initiate two Phase 2b clinical studies of OHB-101 in rare autoimmune diseases. The company also anticipates commencing IND-enabling activities for certain of its four preclinical programs, which include three novel anti-FCγR2B receptor monoclonal antibodies for autoimmune disease and an oral pKAL inhibitor for diabetic macular edema.

"There is a tremendous need for new therapies to prevent the complications of prematurity and for those suffering from rare autoimmune disorders," said Dr. Curran. "Making a strategic investment in Oak Hill Bio and their strong leadership team is an ideal path to continue the development of these promising programs."

Executive Team

Oak Hill’s executive team includes experienced biopharma executives, biotech entrepreneurs and financial operations and capital markets experts as well as rare disease and neonatology experts from Takeda:

Josh Distler, J.D., President and Chief Financial Officer, has extensive experience building and investing in biotechnology companies, having served as Head of Crossover and Quantitative Equity at Athanor Capital, COO of Global Private Investing for D. E. Shaw & Co., Chief Operating Officer at Attenuon, a cancer drug development firm and as a Director of Schrödinger, Inc.
Mark McHale, Ph.D., Chief Scientific Officer, most recently helped found Aslan Pharmaceuticals and served as its Chief Development Officer and Head of R&D. He has also held leadership positions with AstraZeneca and SmithKline Beecham (now GlaxoSmithKline Plc.).
Victoria Niklas, M.D., Chief Medical Officer, has served in several roles at Takeda, including Global Program Leader of the OHB-607 program. She has extensive experience as a translational scientist and academic neonatologist including serving as Chief of the Division of Neonatology for Nemours Children’s Hospital and Professor of Pediatrics, Division Chief and Medical Director, at UCLA’s Olive View Medical Center.