On March 30, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its first quarter of 2021 financial results before the market opens on Thursday, April 29, 2021, and then will host a conference call and webcast beginning at 9:00 a.m. ET to discuss the results (Press release, LabCorp, MAR 30, 2021, View Source [SID1234577355]). The earnings release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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Interested parties can access the conference call by dialing 1-877-898-8036 within the U.S. and Canada, or 1-720-634-2811 internationally, using the conference ID 6566853. In addition, a real-time webcast of the conference call will be available on the Labcorp Investor Relations website.

An audio replay of the conference call will be available from 1:00 p.m. ET on April 29, 2021, until 11:30 p.m. ET on May 13, 2021, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the conference ID 6566853. The webcast of the conference call will be archived and accessible through April 15, 2022, on the Labcorp Investor Relations website.

On March 30, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that preclinical data of its TUSC2 immunogene therapy (REQORSA) in combination with chemotherapy and immunotherapies, as well as in combination with targeted therapies to overcome resistance to osimertinib, for the treatment of non-small cell lung cancer (NSCLC), will be featured in two presentations at the upcoming annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 21) taking place virtually from April 9-14, 2021 (Press release, Genprex, MAR 30, 2021, View Source [SID1234577371]).

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"We look forward to the presentation of these data that highlight the potential of TUSC2 immunogene therapy to enhance chemo-immune combination treatments and overcome resistance to osimertinib in lung cancer, to an audience of the world’s leading cancer researchers," said Rodney Varner, President and Chief Executive Officer of Genprex. "As lung cancer is the leading cause of cancer deaths worldwide, we remain keenly focused on initiating our Acclaim-1 and Acclaim-2 clinical trials to evaluate REQORSA, our proprietary TUSC2 immunogene therapy, in non-small cell lung cancer."

Acclaim-1 is a Phase 1/2 combination clinical trial using REQORSA combined with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC whose disease progressed after treatment with Tagrisso. Acclaim-2 is a Phase 1/2 combination clinical trial using REQORSA combined with Merck & Co’s Keytruda (pembrolizumab) in NSCLC patients who are low expressors of PD-L1.

Featured Genprex-supported abstracts to be presented at AACR (Free AACR Whitepaper) 21 include:

Oral Presentation

Session: MS.IM02.02 – Overcoming Resistance in the Tumor Microenvironment: Novel Immunomodulatory Agents

Title: "TUSC2 immunogene therapy enhances efficacy of chemo-immune combination therapy and induces robus antitumor immunity in KRAS-LKB1 mutant NSCLC in humanized mice"

Poster Number/Channel: #76/Channel 03

Presentation Date/Time: April 10, 2021 from 2:50-3:00 p.m. ET

Presenters: Ismail M. Meraz, Mourad Majidi, RuPing Shao, Feng Meng, Min Jin Ha, Elizabeth Shpall, Jack A. Roth. University of Texas MD Anderson Cancer Center, Houston, TX

Poster Presentation

Session: PO.ET03.01 – Drug Resistance in Molecular Targeted Therapies

Title: "Overcoming resistance to osimertinib by TUSC2 gene therapy in EGFR mutant NSCLC"

Poster Number: #1105

Presentation Date/Time: April 10, 2021 from 8:30 a.m. – 11:59 p.m. ET

Presenters: Ismail M. Meraz, Mourad Majidi, RuPing Shao, Lihui Gao, Meng Feng, Huiqin Chen, Min Jin Ha, Jack A. Roth. University of Texas MD Anderson Cancer Center, Houston, TX

On March 30, 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 Center for Drug Evaluation (CDE) of China’s Nation Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Parsaclisib (IBI376) for the treatment of patients with relapsed/refractory follicular lymphoma (FL) (Press release, Innovent Biologics, MAR 30, 2021, View Source [SID1234577387]). IBI376 is a phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor originally discovered by Incyte. Innovent owns the rights to develop and commercialize Parsaclisib in greater China.

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NMPA grants Breakthrough Therapy Designation to new medicines that are intended to treat serious conditions and where clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The BTD designation for Parsaclisib is based on the results observed in an ongoing Phase 2 study for the treatment of adults with relapsed or refractory FL being conducted in China (CTR2019239). Parsaclisib is currently in Phase 2 pivotal trials for the treatment of adults with relapsed or refractory follicular or with marginal zone lymphoma.

In clinical studies, Parsaclisib has demonstrated potent and rapid anti-lymphoma activity with promising safety, efficacy, and persistence. Preliminary clinical results of the CITADEL-203 study in relapsed or refractory FL presented at the 62st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) held in 2020 highlighted the safety profile, efficacy, and the durability of response of Parsaclisib (Abstract 2935). Study results showed that in the dosing group (N=95), Parsaclisib monotherapy achieved an objective response rate of 75%, with median PFS of 15.8 months in relapsed or refractory FL patients.

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The breakthrough therapy designation from NMPA indicated that Parsaclisib possesses great potential in treating relapsed or refractory follicular lymphoma and we are hopeful that this product can help benefit more patients in the future."

About Parsaclisib (IBI376)

Parsaclisib is an investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) isoforms. PI3Kδ is an important anticancer target implicated in malignant B-cell growth, survival and proliferation which has demonstrated potency and selectivity in preclinical studies and has potential therapeutic utility in the treatment of patients with hematologic malignancies such as lymphoma. Parsaclisib is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of Parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are also underway; and there are plans to initiate a trial to evaluate Parsaclisib in combination with tafasitamab for non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including Parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize Parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

About Follicular Lymphoma

Follicular lymphoma (FL) is a B-cell cancer that originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. Although it is classified as indolent lymphoma, and the current immunochemotherapy has achieved good efficacy, it still often relapses following by aggressive diseases, which may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent or refractory follicular lymphoma.

About Breakthrough Therapy Designation

In recent years, in order to encourage innovation to address unmet clinical needs, China has established a rapid drug review and approval pathway. A Breakthrough Therapy Designation (BTD) is intended to facilitate and expedite development and review of an investigational drug to treat serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but also allow the sponsor to obtain timely advice and communications from the CDE to accelerate the approval and launch in order to address the unmet clinical needs of patients at an accelerated pace.

On March 30, 2021 Race Oncology Limited ("Race") reported that it has entered into a new collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, MAR 30, 2021, View Source [SID1234577414]). This work will be led by the eminent cancer researcher, Associate Professor Nikki Verrills, who successfully ran Race’s preclinical breast and ovarian program (ASX announcements: 24 November 2020, 23 February 2021, 9 March 2021).

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The aim of this project is to support the clinical use of Bisantrene as a novel treatment for extramedullary AML, a difficult to treat form of AML, using an extramedullary mouse model developed by A/Prof Verrills’ team. Extramedullary AML occurs when the leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain, or other organs1. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have extramedullary AML2.

In a recent Sheba Medical Centre Phase II clinical trial conducted in relapsed and refractory (R/R) AML patients (ASX announcement: 16 June 2020), Bisantrene was observed to be highly effective in patients with extramedullary AML, with all patients with this subtype (4/4) showing a clinical response3. Patients with extramedullary AML currently have limited treatment choices with no approved, and very limited experimental treatment options4.
Race is pursuing Bisantrene therapies targeting AML, as part of its Three Pillar strategy (ASX announcement: 30 Nov 2020). This new program could lead to AML treatments with improved safety and efficacy for patients with extramedullary AML.

In addition, this study will be used to provide supportive data for a pivotal (Phase II/III) trial of Bisantrene in extramedullary AML patients with the aim of providing a rapid path to FDA approval for Bisantrene as an orphan drug under the 505(b)(2) track. Orphan drug designation provides for seven years post approval marketing exclusivity in the USA and 10 years in the EU/UK, as well as other tax and regulatory benefits.

"This is a key project for Race using Associate Professor Verrills’ extramedullary AML mouse model. Recent clinical evidence has identified Bisantrene as an effective treatment option for patients with the difficult-to-treat extramedullary form of AML. We believe that we have identified a low-risk pathway to rapid approval of Bisantrene via this indication that offers significant upside for Race in a crowded clinical space."

Chief Scientific Officer, Dr Daniel Tillett
This project is to start immediately with the pre-clinical results expected to be reported over the coming 12 months.

About Associate Professor Verrills
Since completing her PhD in 2005 on chemotherapy resistance in childhood leukaemia, Associate Professor Verrills was awarded a Peter Doherty Postdoctoral Fellowship from the National Health and Medical Research Council in 2006. In the same year she was the inaugural recipient of a Hunter Medical Research Foundation grant for young cancer researchers. Since then she has established an innovative research lab at the University of Newcastle studying the differences between cancer cells that respond well to drug treatments and those that do not.

Prof Verrills is currently supported by a fellowship from the Australian Research Council and project funding from the National Health and Medical Research Council. She has published over 60 journal articles with an H-index of 24.

On March 30, 2021 InDex Pharmaceuticals Holding AB (publ) reported that the company has entered an agreement for services with global clinical research organization (CRO) Parexel Biotech for the phase III study CONCLUDE(Press release, InDex Pharmaceuticals, MAR 30, 2021, View Source [SID1234584071]). The study will evaluate the efficacy and safety of the drug candidate cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.

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"We are excited to advance cobitolimod into phase III, which is the final stage of development before application for market approval. After the successful collaboration in our recent phase IIb study CONDUCT, we are very pleased to collaborate once again with Parexel Biotech as our clinical development partner", says Peter Zerhouni, CEO of InDex Pharmaceuticals. "Parexel Biotech is a leading global CRO with considerable experience managing phase III studies in inflammatory bowel disease, which will ensure an efficient execution of the study."

CONCLUDE is a randomised, double-blind, placebo-controlled, global phase III study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. The induction study will include approximately 400 patients, and the primary endpoint will be clinical remission at week 6. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo.

Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, the phase III study will also evaluate a higher dose, 500 mg x 2, in an adaptive study design. This higher dose has the potential to provide an even better efficacy than what was observed in the phase IIb study.

"We are pleased to partner with InDex Pharmaceuticals on the phase III clinical trial CONCLUDE to evaluate a potential new therapy for patients with moderate to severe ulcerative colitis," said Jim Anthony, Senior Vice President and Global Head, Parexel Biotech. "Our collaboration with InDex Pharmaceuticals demonstrates our commitment to designing innovative solutions that draw from our global clinical experience and therapeutic expertise to fulfill unmet medical needs on behalf of patients worldwide."

For more information:
Peter Zerhouni, CEO
Phone: +46 8 122 038 50
E-mail: [email protected]

Publication
The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on March 30, 2021.

Cobitolimod in brief
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results were recently published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.