On April 1, 2021 Arbutus Biopharma Corporation (NASDAQ: ABUS), X-Chem, Inc. (X-Chem) and Proteros biostructures GmbH (Proteros) reported that they have entered into a discovery research and license agreement focused on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease (Mpro) (Press release, X-Chem, APR 1, 2021, View Source [SID1234577492]). The agreement is designed to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks.

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This collaboration brings together Arbutus’ expertise in the discovery and development of antiviral agents with X-Chem’s industry leading DNA-encoded library (DEL) technology and Proteros’ protein sciences, biophysics and structural biology capabilities and provides important synergies to potentially identify safe and effective therapies against coronaviruses including SARS-CoV-2. The collaboration will allow for the rapid screening of one of the largest small molecule libraries against Mpro (an essential protein required for the virus to replicate itself) and the use of state-of-the-art structure guided methods to rapidly optimize Mpro inhibitors, which Arbutus could potentially progress to clinical candidates. Financial terms of the transaction were not disclosed.

"It is well accepted that in addition to the availability of vaccines, effective and safe therapies are needed to successfully combat the COVID-19 pandemic and any future coronavirus outbreaks," stated Dr. Michael Sofia, Arbutus’s Chief Scientific Officer. "Arbutus, X-Chem and Proteros have complementary and valuable expertise that makes this collaboration particularly well-suited for small molecule drug discovery targeting coronaviruses. Our goal is to identify unique and differentiated pan-coronavirus assets targeting the main coronavirus protease which, when combined with assets arising from our internal nucleoside program targeting the SARS-CoV-2 nsp12 viral polymerase, could deliver a much-needed all-oral antiviral treatment for SARS-CoV-2 and any potential future coronavirus outbreaks."

"We are delighted of this joint discovery research collaboration with Arbutus and X-Chem, which has the potential to identify unique small molecule treatment options for COVID-19 and other possible coronavirus related respiratory diseases" said Dr. Torsten Neuefeind, Proteros’ CEO. "The complementary strengths of all parties gives us a strong position to potentially inhibit a key enzyme with a central role in the viral life cycle in a specific and effective manner."

"The discovery and development of novel drugs to combat infections caused by coronavirus is an incredibly important and challenging task", added Matt Clark, PhD, Chief Executive Officer of X-Chem. "We are exhilarated to join forces with industry leaders Arbutus and Proteros in this effort and bring our drug discovery expertise to this important area of antiviral research."

On April 1, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced today that it has successfully completed the twelve-months product stability testing required by the U.S. Food and Drug Administration (FDA) for its CypCaps final clinical trial product (Press release, PharmaCyte Biotech, APR 1, 2021, View Source [SID1234577508]). This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer upon the FDA lifting the clinical hold on PharmaCyte’s Investigational New Drug Application (IND).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed twelve-month stability study, "We are pleased that our CypCaps product successfully completed all of the required stability tests and that the product has now shown itself to be stable and active after being stored for 1 year at -80oC. The study will continue in order to determine the maximum shelf life of the CypCaps product. It should be noted that this data is exceptional for a product of this kind."

As reported previously, the ongoing stability study is designed to determine the shelf life of the Cell-in-a-Box encapsulated cell product, CypCaps, stored frozen at -80oC. Upon analysis after 12 months in storage at -80oC, the unfrozen CypCaps product passed all of the specified tests, including cell viability, enzyme activity and cell potency as well as pH, label check, capsule appearance, and integrity. This twelve-month data, as well as all future longer-term time points of the shelf life analyses, such as the next time point to be evaluated after 18-months of storage at -80oC, will be reported to the FDA. This ongoing stability study was initiated prior to the submission of the company’s IND to the FDA, and the information and data will form part of the package of information together with data from additional studies requested by the FDA.

In a survey of European biotech/biomedical companies developing advanced therapeutic medicinal products (i.e., products containing living cells like CypCaps), shelf life issues were reported to be one of the major challenges that such products face (ten Ham et al., 2018, Molecular Therapy: Methods & Clinical Development vol. 11, pp121-130). Laboratory data on non-GMP produced encapsulated cells have suggested that the shelf life of Cell-in-a-Box products stored at -80oC is even longer than 1 year.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On April 1, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease (PD) and related disorders inside and outside of the brain, reported financial results for the fourth quarter and full year ended December 31, 2020 and highlighted recent developments (Press release, Inhibikase Therapeutics, APR 1, 2021, View Source [SID1234577525]).

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Key Business and Clinical Highlights

Completed Initial Public Offering: In December 2020, Inhibikase successfully completed its initial public offering (IPO) of 1,800,000 shares of common stock at a public offering price of $10.00 per share. The Company received aggregate net proceeds of approximately $14.60 million after deducting offering costs, underwriting discounts and commissions.

Commenced Dosing of Patients in Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February 2021, Inhibikase commenced patient dosing in older and elderly healthy volunteers in a Phase 1 randomized single ascending dose and multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of IkT-148009. IkT-148009 is a novel brain penetrant Abelson tyrosine kinase, or c-Abl, inhibitor intended to be used to modify Parkinson’s disease and its gastrointestinal complications.

Accelerated timelines for completion of the Phase 1 trial and initiation of dosing in PD patients. Early data from this study have led to a reduction in the timelines for completion of the study by 6 or more months, providing the opportunity to obtain regulatory approval to commence dosing of PD patients much earlier than previously anticipated.

Commenced chronic toxicology studies of IkT-148009 to permit long-term dosing in patients. In January, 2021 Inhibikase commenced 3 month and 6 month long-term toxicology studies of IkT-148009 in rats and 3 month and 9 month long-term toxicology studies of IkT-148009 in monkeys as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. These studies are expected to be completed in the fourth quarter of 2021.

Commenced clinical batch manufacturing and pill formulation of IkT-001Pro in preparation for an Investigational New Drug application filing in the second quarter of 2021. In February, 2021 Inhibikase commenced clinical batch manufacturing and final product formulation of IkT-001Pro as a film-coated tablet in preparation for regulatory filing with the Food and Drug Administration to initiate clinical development. This regulatory filing is anticipated to be completed near the end of the second quarter of 2021, with initiation of clinical development 30 days after the filing, subject to FDA agreement and issuance of a Study May Proceed notification.
"2020 was a transformative year for Inhibikase, as we successfully completed our IPO and worked diligently to advance our novel programs to treat neurodegenerative diseases towards the clinic," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "Just recently, we were pleased to announce the advancement of our lead candidate, IkT-148009, into a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics in elderly volunteers. Early data from this study has been encouraging and we are shortening the timeline to completion by six or more months, with an expectation to move into early patient studies this year. We believe that IKT-148009 could be a transformative therapy for millions of Parkinson’s patients worldwide. Simultaneously, we have advanced our oncology clinical candidate, IkT-001Pro, into manufacturing and expect to initiate clinical development early in the third quarter. Our highly dedicated team has exceeded all of our internal expectations to move these clinical programs forward for the benefit of patients."

Fourth Quarter and Full Year 2020 Financial Review

Net Loss: Net loss for the fourth quarter ended December 31, 2020, was $1.21 million, or $0.15 per share, compared to a net loss of $0.43 million, or $0.05 per share for the fourth quarter 2019. For the full year ended December 31, 2020, net loss was $2.85 million, or $0.35 per share, compared to a net loss of $5.72 million, or $0.70 per share, for the same period in 2019.

R&D Expenses: Research and development expenses were $0.23 million for the fourth quarter 2020, compared to $0.27 million for the same period in 2019. For the full year 2020, research and development expenses were $0.89 million, compared to $2.55 million for the same period in 2019. The decrease was primarily driven by a decline in grant related research expenditures and non-grant related research.

SG&A Expenses: Selling, general and administrative expenses for the fourth quarter 2020 were $1.14 million compared to $0.39 million for the fourth quarter 2019. For the full year 2020, selling, general and administrative expenses were $2.62 million, compared to $4.27 million for the same period in 2019. The decrease was primarily related to a non-recurring 2019 charge of $1.59 million of deferred IPO costs in connection with the 2018 abandoned IPO effort plus net decrease in all other selling, general and administrative expenses of $0.06 million.

Cash Position: Cash and cash equivalents were $13.95 million as of December 31, 2020.

On April 1, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the appointment of health innovation expert and executive Linda Maxwell, M.D., MBA, as an independent member of the company’s board of directors (Press release, NantKwest, APR 1, 2021, View Source [SID1234577493]). The company also appointed CEO Richard Adcock to the board; he was named CEO of NantKwest in October and remains the CEO of the company after the merger of NantKwest with ImmunityBio in March. Both appointments are effective March 29, 2021.

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The nine-member ImmunityBio board is led by Founder and Executive Chairman Patrick Soon-Shiong, M.D. The board includes two other recently appointed outside members, former CIA director John Brennan and retired U.S. Army General Wesley Clark, along with current board members Michael Blaszyk, Cheryl Cohen, Christobel Selecky, and Barry Simon, M.D.

"Linda’s background as a physician and surgeon combined with her extensive global healthcare industry and business experience will enable us to build on ImmunityBio’s strong foundation and help us take the company to the next level," said Soon-Shiong. "As a company working to bring novel therapeutic approaches to treating cancer and other serious conditions, we will benefit greatly from Linda’s insights on innovation."

The company also announced that two current directors—Fred Driscoll and John D. Thomas—will conclude their service on the board effective with the new appointments.

"We are grateful to Fred and John for their many years of service and the value they brought to our shareholders and employees," said Soon-Shiong. "During their tenure, we have expanded our pipeline and grown our portfolio of immunotherapy agents. Their contributions during that time were important to establishing this strong foundation and baseline for the growth we anticipate."

About Dr. Linda Maxwell

Dr. Maxwell is a medical educator, surgeon, and health technology entrepreneur and innovator. She has guided a wide variety of startup companies through clinical development capitalization and commercialization as Founder and Executive Director of the Biomedical Zone, Canada’s first and only hospital-embedded, physician-led business incubator for emerging health technology companies. Dr. Maxwell also managed a life sciences tech transfer portfolio at the University of Oxford and the UK national Health Service, executing patent strategy, spin-out company formation, and early stage capital raising. She has also served as a healthcare innovation expert in various Canadian federal, provincial, and local government entities, as a member of the Department Audit Committee and the Public Health Agency of Canada, as an advisor to the Canadian Medial Association and the Canadian Space Agency. Dr. Maxwell earned an A.B. with honors from Harvard University, an M.D. from Yale University and an M.B.A. from the University of Oxford. She serves as an independent member of the Board of Directors of United Therapeutics, Inc.

"I’m honored to join the ImmunityBio board at such an important time of growth and opportunity for the company," she said. "I’m impressed with both the science and the leadership that I believe will take the company on an upward trajectory as it makes innovative contributions to medicine."

On April 1, 2021 McKesson Corporation (NYSE: MCK) reported that it will release its fourth quarter fiscal 2021 financial results after market close on Thursday, May 6, 2021 (Press release, McKesson, APR 1, 2021, View Source [SID1234577509]). The company will host a live webcast of the earnings conference call for investors at 4:30 PM Eastern Time to review its financial results.

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The live webcast will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation.