On July 15, 2021 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA (capmatinib) may be appropriate (Press release, Foundation Medicine, JUL 15, 2021, View Source [SID1234584892]). TABRECTA is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.

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NSCLC accounts for approximately 85% of lung cancer diagnoses,[1] 3 to 4% of which are associated with METex14.[2] Today’s approval adds to the number of therapies for which both of Foundation Medicine’s FDA-approved comprehensive genomic tests are listed as companion diagnostics. FoundationOneCDx, Foundation Medicine’s tissue test, was approved as a companion diagnostic for TABRECTA in May 2020.

"For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for TABRECTA and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient."

Using a simple blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The test is now approved as a companion diagnostic for nine targeted therapies across four cancer types. TABRECTA is the second therapy for which both of Foundation Medicine’s FDA-approved tests, FoundationOne CDx and FoundationOne Liquid CDx, are listed as companion diagnostics.

Additionally, as a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

Foundation Medicine’s strategic collaboration with Novartis now includes four companion diagnostics for the Novartis portfolio of targeted oncology therapeutics.

On July 15, 2021 PharmEnable, an AI drug discovery company unlocking challenging biological targets, reported that it has entered into a drug discovery collaboration with LifeArc, an independent UK medical research charity, to apply their respective technologies and expertise to discover novel oral antiviral drugs with activity against coronaviruses (Press release, LifeArc, JUL 15, 2021, View Source [SID1234585348]).

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The COVID-19 pandemic has not only demonstrated the threat that novel and variant viruses pose, but also the vital role of innovative science to develop vaccines and drugs to combat infection, improving patient health while minimising economic impact. Although vaccines will be invaluable in controlling the pandemic, they are rarely 100% effective. The impact of COVID-19 is showing no signs of abating with the risk of new variants and novel coronaviruses remaining an ever-present threat.

The aim of the risk-sharing collaboration is to produce an oral therapeutic that has broad applicability across SARS-CoV-2 variants and emerging coronaviruses.

PharmEnable’s approach identifies three-dimensional (3D) small molecule drug candidates with improved specificity compared with traditional screening methods. Its proprietary advanced artificial intelligence (AI)-enabled and medicinal chemistry platform allows the company to mine unexplored chemical space to deliver innovative medicines, and has been used to identify and develop novel, highly specific drug leads.

LifeArc plays a vital role in advancing medical research through funding, advice and scientific expertise to translate early discoveries into patient benefit. Since the beginning of the pandemic, LifeArc has contributed £27m to research projects to address the healthcare challenges of COVID-19. Within this collaboration, it will provide resources for the synthesis, optimisation and biological validation of molecules and contribute its expertise in the translation of early-stage science into healthcare treatments.

Dr Hannah Sore, Chief Executive Officer of PharmEnable, said: "We are delighted that PharmEnable was chosen by LifeArc as part of its highly competitive coronavirus initiative. Our platform is proven in its ability to tap unexplored parts of the chemical universe to find novel and specific small molecule candidates for important and challenging targets. Combining our platform with the expertise and experience of LifeArc should enable us to generate several powerful oral drug candidate molecules against SARS-CoV-2 variants and similar viruses.

"We are excited that by working with LifeArc our technology platforms might play a role in expanding the arsenal of treatments available to manage coronavirus-related diseases and save lives."

Dr Justin Bryans, Executive Director, Drug Discovery and Diagnostics at LifeArc added: "We have been actively mobilising our resources and have forged new partnerships to enable us to find ways in which to address the ongoing challenges of COVID-19. This promising new collaboration combines our drug discovery expertise and translational science skills with PharmEnable’s technology to discover novel, anti-viral drug therapies that may be highly effective against evolving coronaviruses."

On July 15, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ:IPA) (TSX VENTURE:IPA) a leader in full-service, therapeutic antibody discovery and development, reported the Company will host a conference call to discuss its financial results and business highlights for the full fiscal year 2021, on Wednesday, July 28, 2021, after the close of market (Press release, ImmunoPrecise Antibodies, JUL 15, 2021, View Source [SID1234584877]). The financial results will be issued in a press release prior to the call. ImmunoPrecise management will host the conference call followed by a question-and-answer period. Investors interested in submitting questions must do so in advance of the call and are encouraged to email questions to the Company’s investor relations representative.

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The conference call will be webcast live and available for replay via a link on the main page of the Company’s Investors section at: View Source

If you are dialing into the call, please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Toronto Stock Exchange and Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 15, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported that the first patient has been dosed in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific antibody (Press release, Innovent Biologics, JUL 15, 2021, View Source [SID1234584893]).

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The objective of this open-label, multi-center Phase 1a/1b dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI319 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.

In preclinical studies, IBI319 has demonstrated synergistically targeting both PD-1 and CD137 to simultaneously achieve anti-tumor activity and enhance efficacy.

Professor Yilong Wu, Tenured Professor of Guangdong Provincial People’s Hospital and Honorary Director of Guangdong Lung Cancer Research Institute, stated, "While immune checkpoint inhibitors have shown efficacy in treating a variety of tumor types, we still face challenges of primary and secondary drug resistance. The development of next-generation bispecific antibodies can have important clinical value implications. CD137 is a key co-stimulatory immune checkpoint molecule that plays a role in maintaining immune homeostasis and enhancing anti-tumor immune memory. With the innovative mechanism of a bispecific antibody that provides additional immune activation through CD137 axis in the suppressed tumor microenvironment, the preclinical research results of IBI319 are very promising."

Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, stated: "Currently, there is no other bispecific antibody with the same target in clinical development in the world. Preclinical results have shown that IBI319 can further enhance the immune activation with improved convenience of administration, compared to the combination of two monoclonal antibodies. "

About IBI319 (anti-PD-1/CD137 bispecific antibody)

IBI319 was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. The IND for IBI319 has been approved by the NMPA in China, and clinical trial in China are actively being conducted.

About the Phase 1 Study of IBI319 (CIBI319A101)

Conducted by Innovent in China, this Phase 1a/1b study (CIBI319A101) will assess the efficacy and safety of IBI319 in patients with advanced malignant tumors. Phase 1a of the study will evaluate dosing and Phase 1b will further explore the efficacy of IBI319 in a variety of solid and hematological tumors (ClinicalTrials.gov, NCT04708210).

On July 15, 2021 Incyte (Nasdaq:INCY) reported that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, August 3, 2021 (Press release, Incyte, JUL 15, 2021, View Source [SID1234584878]).

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The schedule for the press release and conference call/webcast is as follows:

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international caller is 201-612-7415. To access the replay you will need the conference ID number 13721454.

The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 90 days.