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.

On December 7, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that priced an $8.0 billion public offering of five series of senior unsecured notes (collectively, the "notes") (Press release, Merck & Co, DEC 7, 2021, View Source [SID1234596558]). The notes include:

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$1.5 billion of 1.700% notes due 2027 (the "2027 notes")

$1.0 billion of 1.900% notes due 2028 (the "sustainability notes")

$2.0 billion of 2.150% notes due 2031 (the "2031 notes")

$2.0 billion of 2.750% notes due 2051 (the "2051 notes")

$1.5 billion of 2.900% notes due 2061 (the "2061 notes")

Merck intends to use the net proceeds from the offering of the 2027 notes, the 2031 notes, the 2051 notes and the 2061 notes for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings (including commercial paper borrowings in connection with Merck’s acquisition of Acceleron), and other indebtedness with upcoming maturities. Merck intends to allocate an amount equal to the net proceeds of the offering of the sustainability notes to finance or refinance, in whole or in part, eligible projects. The offering is expected to close on Dec. 10, 2021, subject to customary closing conditions. BofA Securities, Inc., Barclays Capital Inc., Credit Suisse Securities (USA) LLC, Deutsche Bank Securities Inc. and Goldman Sachs & Co. LLC are acting as the joint book-running managers for the offering.

The offering of the notes is being made pursuant to an effective shelf registration statement (including a base prospectus) filed with the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus and related prospectus supplement, copies of which may be obtained by calling BofA Securities, Inc. toll-free at 1-800-294-1322, Barclays Capital Inc. toll-free at 1-888-603-5847, Credit Suisse Securities (USA) LLC toll-free at 1-800-221-1037, Deutsche Bank Securities Inc. toll-free at 1-800-503-4611 or Goldman Sachs & Co. LLC toll-free at 1-866-471-2526. An electronic copy of the registration statement and prospectus supplement, together with the base prospectus, is available on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On December 7, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the first interim analysis met the primary study endpoint of the overall survival (OS) of the Phase 3 clinical study (NCT04063163) of its innovative PD-1 inhibitor serplulimab in combination with chemotherapy in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Shanghai Henlius Biotech, DEC 7, 2021, View Source [SID1234596579]). There is no anti-PD-1 mAb approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) worldwide.

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The study’s main purpose is to explore the efficacy and safety of serplulimab in combination with chemotherapy in previously untreated patients with ES-SCLC. Based on the results of a pre-defined interim analysis conducted by the Independent Data Monitoring Committee (IDMC), serplulimab in combination with chemotherapy showed a significant improvement in OS against chemotherapy, which met the pre-defined efficacy criteria, with good safety and no detection of a new safety signal. IDMC suggested that the company can hence communicate with healthy authority.

Professor Ying Cheng, the principal investigator of NCT04063163, Director of Jilin Department of Medical Oncology Cancer Center, Jilin Province Lung Cancer Diagnosis and Treatment Center, and Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center, said, "I’m very excited to see that the Phase 3 study of serplulimab in ES-SCLC has met its primary endpoint OS, and its efficacy and safety have been fully validated. This study is the first and largest ES-SCLC international multi-center clinical study led by Chinese researchers for anti-PD-1 mAb. The favorable clinical results show China’s ability to innovate with a high clinical trial level. We are looking forward to serplulimab launching as soon as possible, which brings a drug with Chinese independent intellectual property to patients with small cell lung cancer all over the world."

IDMC Chairman of NCT04063163, and Cancer Hospital Chinese Academy of Medical Sciences, Professor Jie Wang, said, "SCLC is a type of lung cancer with strong invasion and poor prognosis, among which ES-SCLC cancer cells are prone to metastasis. At present, ES-SCLC is still mainly treated with chemotherapy or chemotherapy combined with PD-L1 inhibitors. It is easy to progress after chemotherapy, and the 5-year survival rate is generally less than 5%. The prognosis has not been improved for a long time. The results of the Phase 3 trial of serplulimab bring a new option for anti-PD-1 mAb as a first-line ES-SCLC therapy."

Professor Giorgio Scagliotti from the Medical Oncology, University of Turin in Italy, one of IDMC members, said, "There are limited choices for SCLC clinical treatment, especially in anti-PD-1 mAb. Currently, the first-line treatment is chemotherapy or anti-PD-L1 mAb combined with chemotherapy according to the NCCN guidelines. This international multi-center Phase 3 clinical study on ES-SCLC has been carried out in many countries in Asia and Europe, witmore than 580 subjects worldwide. It is believed that by means of international multi-center clinical data, serplulimab will enter the international market and benefit more patients worldwide."

Mr. Jason Zhu, President of Henlius, said, "Serplulimab is an innovative mAb independently developed by Henlius, and the company has carried out a comprehensive first-line treatment layout for lung cancer. Based on the large number of unmet clinical needs, the company has invested in SCLC. The excellent results of this Phase 3 study are expected to contribute serplulimab in becoming the first anti-PD-1 mAb for the first-line treatment of SCLC, which will significantly improve the overall prognosis. Henlius focuses on high-incidence cancers both globally and in China. In the future, we will proactively promote the combination immunotherapy of serplulimab and international clinical research, benefiting more patients around the world."

SCLC is highly malignant, and the available treatment is limited

According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally and accounts for 11.4% of the global cancer incidence in 2020. It is estimated that there are 810,000 new cases with LC in China in 2020, and LC is the leading cause of cancer incidence and mortality. SCLC accounts for 15%-20% among LC, and is the most aggressive subtype of LC, which is divided into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Most patients are already in extensive stage when diagnosed. Patients with ES-SCLC always have rapid tumour growth and poor prognosis. Some of them have shorter survival due to extensive tumor metastasis and poor physical status only with supportive care.

Over 20 years, etoposide plus carboplatin/cisplatin is still the standard of care for ES-SCLC, but 80% of patients with limited stage disease and almost all patients with extensive stage disease relapse within one year, with a median survival of only 4 to 5 months after relapse. The emergence of immune checkpoint inhibitors provides a new option. At present, anti-PD-L1 mAb combined with chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for ES-SCLC. However, the application of immunotherapy in ES-SCLC still faces challenges. In recent years, a number of PD-1 mAbs have failed in the area. Therefore, more effective first-line treatment of PD-1 inhibitors is urgently needed.

Centering on the unmet needs of patients, covering the first-line treatment of all types of lung cancer

Henlius has adopted a differentiated "Combo+Global" strategy on serplulimab. Currently, serplulimab has been approved for clinical trials in China, the United States, the European Union and other countries and regions. A total of 10 immuo-oncology therapies clinical trials of serplulimab are ongoing to evaluate its safety and efficacy in a wide variety of solid tumors that cover LC, hepatocellular carcinoma, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer etc. Up to date, about 2300 patients have been enrolled worldwide, proving that the quality of serplulimab has built trust in foreign markets. In April, the New Drug Application (NDA) of serplulimab for the treatment of MSI-H solid tumours was accepted by the National Medical Products Administration (NMPA) and granted priority review, which is expected to be approved in the first half of 2022.

According to the characteristics of cancer patients both globally and in China, the company focus on lung cancer and gastrointestinal cancer with serplulimab as the backbone. Henlius has achieved a comprehensive first-line clinical layout of LC, and has carried out trials on serplulimab in sqNSCLC, non-squamous non-small cell lung cancer and SCLC, covering more than 90% of lung cancer patients. Based on a randomized, double-blind, international multi-center Phase 3 clinical trials conducted in previously untreated patients with locally advanced or metastatic sqNSCLC, the NDA of serplulimab for first-line treatment of locally advanced or metastatic sqNSCLC has been accepted by the NMPA. In the future, with abundant international clinical research data, Henlius will continue expanding the international distribution of serplulimab and benefit more patients around the world.