On April 1, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, and other members of the executive team will present at the following virtual banking and industry conferences (Press release, Synlogic, APR 1, 2021, View Source [SID1234577534]):

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20th Annual Needham Virtual Healthcare Conference: Dr. Brennan and Daniel Rosan, SVP & Head of Finance, will present at 3:00 pm on Monday, April 12, 2021.
Jefferies Microbiome-based Therapeutics Summit: Dr. Brennan will participate in a Fireside Chat that will become available on Thursday, April 22, 2021.
These are virtual events. A live webcast of the presentations, if available, can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

On April 1, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported the sale of its minority share in Q2 Solutions to IQVIA (NYSE: IQV), a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, for $760 million in an all-cash transaction (Press release, Quest Diagnostics, APR 1, 2021, View Source [SID1234577533]).

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Q2 Solutions is a leading global clinical laboratory services organization that provides comprehensive testing, project management, supply chain, biorepository, biospecimen and consent tracking solutions for clinical trials. IQVIA and Quest established Q2 Solutions as a joint venture in 2015. IQVIA previously owned a 60 percent majority share and Quest Diagnostics owned a 40 percent minority share.

"Divesting from Q2 Solutions supports our vision to be focused on empowering better health with diagnostic information services," said Steve Rusckowski, Quest Diagnostics Chairman, CEO and President. "We are proud of our contributions to the growth of Q2 Solutions, and are confident that IQVIA has the strategic vision and agility to lead Q2 Solutions on the next phase of its journey as a global leader in central lab services."

Under a multi-year agreement, Quest will remain the strategic preferred laboratory provider for Q2 Solutions’ clients, providing a range of complementary lab testing capabilities to augment Q2 Solutions’ core offerings and extend its industry leading suite of services.

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 [SID1234577530]). 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 KAHR, a cancer immunotherapy company developing novel multifunctional immuno-recruitment proteins, reported that it has entered into a licensing agreement with Thomas Jefferson University — a national doctoral research university — and its clinical enterprise, Jefferson Health, located in Philadelphia, PA (Press release, KAHR Medical, APR 1, 2021, View Source;and-tri-specific-fusion-proteins-for-cancer-immunotherapy-301260406.html [SID1234577526]). Under the agreement, Thomas Jefferson University is granting KAHR an exclusive license to develop and commercialize multiple new drug candidates including DSP502, a TIGITxPD1 fusion protein, and DSP216, a LILRB2xSIRPa fusion protein for immuno-oncology.

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"With this agreement we are adding a second fusion protein platform to our portfolio, enabling us to broaden our immuno-oncology target pipeline and positioning KAHR as a world leader in the fusion protein space," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. "Both DSP502 and DSP216 focus on promising checkpoint pathways, unleashing the potential of innate and adaptive immune cells and enhancing anti-tumor immunoactivity through dual checkpoint inhibition. These products are differentiated from current drug candidates targeting the same pathways as they target the ligands, not the receptors, thus increasing tumor selectivity by dual binding and avoiding potential redundancy compensation by other receptors of the same ligands."

"Expanding our collaboration with the outstanding team at KAHR provides the opportunity to expand this new platform into novel targets and to unleash the activity of other immune cell types of the innate and adaptive immune systems," said Mark Tykocinski, MD, Provost of Thomas Jefferson University and Dean of its Sidney Kimmel Medical College.

"The synergy between Dr. Tykocinski’s innovative work on activation of anti-cancer immunity using multifunctional recombinant proteins and KAHR’s dedication to the development of cutting-edge immuno-recruitment cancer drugs is the next step to accelerate the translation of this technology to the clinic," said Dr. Heather Rose, Jefferson’s Innovation Vice President, who led the negotiations. "KAHR is a perfect partner for Jefferson to advance this compelling and important work," added Dr. Rose Ritts, Jefferson’s Innovation Executive Vice President, who oversees out-licensing of Jefferson-owned intellectual property.

KAHR’s current technology is based on multi-functional immuno-recruitment proteins (MIRP) that take advantage of the overexpression of checkpoint antigens on cancer cells in order to selectively target the tumor. Its lead asset, DSP107, is a bi-functional fusion protein that targets CD47 and 4-1BB. It triggers a local, synergistic immune response by binding both CD47, over-expressed on cancer cells, thereby disabling its "don’t eat me" signal, and 4-1BB receptors expressed on activated, tumor-reactive T-cells, stimulating their proliferation and activation. The trimeric structure of DSP107 and its binding to CD47 enables cross-presentation of 4-1BBL for conditional, tumor-localized 4-1BB receptor activation on tumor reactive T-cells.

DSP107 is currently being evaluated in a Phase 1/2 multicenter, open-label, dose-escalation and expansion study (NCT04440735). The study is evaluating the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 as a monotherapy and in combination with Roche’s PD-L1-blocking checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced solid tumors.

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.