On December 7, 2021 METiS Therapeutics reported the company debut with $86 million Series A financing to harness artificial intelligence (AI) and machine learning to redefine drug discovery and delivery and develop optimal therapies for patients with serious diseases (Press release, METiS Therapeutics, DEC 7, 2021, View Source [SID1234648428]). PICC PE and China Life led the financing and were joined by Sequoia Capital China, Lightspeed, 5Y Capital, FreeS Fund and CMBI Zhaoxin Wuji Fund. The financing will be used to advance the company’s pipeline of novel assets with high therapeutic potential and the continued development of its AI-driven drug discovery and delivery platform.

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"METiS is well-positioned to change the drug discovery and delivery landscape with the creation of a proprietary predictive AI platform. We leverage machine learning, AI and quantum simulation to uncover novel drug candidates and to transform drug discovery and development, ultimately bringing the best therapies to patients in need," said Chris Lai, CEO, and Founder, METiS Therapeutics. "We are fortunate that our world-class roster of investors believes in our vision and today’s news represents the first of many significant milestones that we will be accomplishing throughout the next year."

The METiS platform (AiTEM) combines state-of-the-art AI data-driven algorithms, mechanismdriven quantum mechanics and molecular dynamics simulations to calculate Active Pharmaceutical Ingredient (API) properties, elucidate API-target and API-excipient interactions, and predict chemical, physical and pharmacokinetic properties of small molecule and nucleic acid therapeutics in specific microenvironments. This enables efficient lead optimization, candidate selection and formulation design. Founded by a team of MIT researchers, serial entrepreneurs and biotech industry veterans, METiS develops and in-licenses novel assets with high therapeutic potential that could benefit from its data-driven platform.

On December 7, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the European Commission has granted Orphan Drug Designation to VIP152, the Company’s PTEFb/CDK9 inhibitor, for the treatment of diffuse large B-cell lymphoma (DLBCL) (Press release, Vincerx Pharma, DEC 7, 2021, View Source [SID1234596540]).

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"The granting of Orphan Drug Designation for VIP152 in DLBCL realizes another significant regulatory milestone for Vincerx," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "VIP152 has the potential to be an effective treatment for rare and highly refractory cancers, for which there is an unmet need in the current therapeutic landscape. We look forward to continued momentum with data presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which include complete disease regression in DLBCL mouse models and modulation of key biomarkers in high-grade B-cell lymphoma cell lines and patients. In addition, we are presenting supportive preclinical mechanistic data in chronic lymphocytic leukemia."

The European Commission grants orphan drug designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union and when no satisfactory method of diagnosis, prevention or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

Vincerx is currently advancing Phase 1b studies of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. The ongoing Phase 1b expansion, first-in-human (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

On December 7, 2021 Arbutus Biopharma Corporation (NASDAQ: ABUS), X-Chem, Inc. (X-Chem) and Proteros biostructures GmbH (Proteros) reported that Arbutus Biopharma has identified several molecules that inhibit the SARS-CoV-2 nsp5 main protease (Mpro), a validated target for the treatment of COVID-19 and potential future coronavirus outbreaks (Press release, Arbutus Biopharma, DEC 7, 2021, View Source [SID1234596557]). Upon achievement of this milestone, as part of their discovery and research agreement, Arbutus has obtained a worldwide exclusive license to the identified molecules. The parties will continue to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks.

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"Our goal with this collaboration was to identify unique and differentiated pan-coronavirus assets targeting the main coronavirus protease which could deliver a much-needed oral antiviral treatment for SARS-CoV-2 and any potential future coronavirus outbreaks," stated Dr. Michael Sofia, Arbutus’s Chief Scientific Officer. "To have identified small molecule inhibitors that are potent and selective against Mpro just six months after commencing this collaboration demonstrates the importance Arbutus, Proteros and X-Chem are placing on quickly developing effective and safe therapies to successfully combat the COVID-19 pandemic. We are excited to have achieved this important milestone and to move this program forward into the lead optimization stage."

In connection with achievement of this development milestone, Arbutus obtained a worldwide exclusive license to the identified small molecule inhibitors. In exchange for that license, Arbutus shall make a milestone payment to X-Chem and Proteros.

In April 2021, Arbutus, X-Chem and Proteros entered into a discovery research and license agreement focused on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease. 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.

On December 7, 2021 LiquidLung, Inc., a biotechnology company dedicated to radically improving the detection, diagnosis and treatment of pulmonary disease, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application No. 17/003,775 for claims related to the non-invasive diagnosis of lung cancer (Press release, LiquidLung, DEC 7, 2021, View Source [SID1234596578]).

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The technology, which is centered around a comprehensive portfolio of novel RNA biomarkers, developed in concert with Liquid Biosciences, a leading bio-analytics provider and dedicated partner to LiquidLung. The technology utilizes various mathematical gene expression signatures that uniquely span early detection and confirmatory diagnosis of lung cancer, both pre- and post-imaging, as well as the diagnostic classification of several prevalent histological subtypes of the disease.

In an independent validation study the lung cancer technology was applied to a blood-based dataset comprised of fully adjudicated in vivo patient samples consisting of patients with confirmed lung cancer and those without lung cancer, the technology achieved 97% sensitivity and 85% specificity for lung cancer detection.

Further, the technology correctly detected 100% of patients with stage I, 89.9% with stage II, 100% with stage III and 100% with stage IV. In addition to detecting lung cancer generally across all stages of disease, the technology also achieved strong sensitivity and specificity for distinguishing between small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), adenocarcinoma, squamous cell carcinoma and large cell carcinoma. Notably, all cited performance was derived from the biomarkers alone, with absolutely no mathematical or scientific value being derived from patient demographics, nodule information, smoking history or any other clinical risk factors, which introduces a defined opportunity to improve upon the already impressive early data with little investment in R&D.

"Imagine a non-invasive testing platform that can rule more high-risk patients with lung cancer into LDCT imaging for further evaluation earlier, reduce negative biopsy procedures for patients with suspicious pulmonary nodules discovered incidentally or through routine screening, and also accelerate the time to life-saving interventions and personalized treatments," stated Founder and Chairman, Marty Keiser. "The comprehensive nature of our to-be patented technology enables us to accurately and efficiently unlock value for patients across the entire care continuum for lung cancer, all while fitting nicely into existing workflows and standards of care."

LiquidLung is one of three companies created out of IV BioHoldings (IVBH), a bio innovation studio known for its progressive approach to R&D, company creation, productization and commercialization. IVBH made headlines in October when it aligned the public debut of its first-in-category pipeline of RNA technologies with the announcement of a strategic lab partnership with P4 Diagnostix, intended to accelerate clinical development and validation of the IVBH assets within lung cancer, non-alcoholic fatty liver disease (NAFLD) and breast cancer.

"The recent worldwide recognition and appreciation for the clinical utility of RNA, from prevention to detection to treatment, has created a timely tailwind for IVBH as we begin to publicly unveil the vast intellectual property portfolio that we have been quietly and strategically amassing since 2018," stated IVBH Chief Commercial Officer, Elizabeth Cormier-May, who also leads the studio’s women’s health company, Mammogen. "The USPTO decision is a significant milestone for LiquidLung and further establishes IVBH’s position as a leader in the rapidly accelerating RNA revolution," Cormier-May continued.

IVBH is currently scaling operationally to support the lung cancer, NAFLD and breast cancer programs through near-term clinical milestones with multiple phases of clinical data generation expected throughout 2022 across all programs.

On December 7, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer, Robert E. Hoffman, will present a corporate overview at the MedInvest Oncology Investor Conference, which is being held virtually on December 7 – 10, 2021 (Press release, Kintara Therapeutics, DEC 7, 2021, View Source [SID1234596541]).

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Mr. Hoffman will deliver his corporate presentation on Thursday, December 9, 2021 at 2:50 p.m. EST.

Mr. Hoffman will be available for one-on-one meetings throughout the conference.