On March 5, 2021 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that the Company’s management will participate in two upcoming investor conferences in March (Press release, Corvus Pharmaceuticals, MAR 5, 2021, View Source [SID1234576185]):

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The first conference will be the H.C. Wainwright Global Life Sciences Conference, which is taking place March 9-10, 2021. The Company will conduct one-on-one meetings with institutional investors at this conference and a pre-recorded corporate overview presentation by Richard A. Miller, M.D., president and chief executive officer of Corvus, will be available to play on-demand starting at 7:00 am ET on Tuesday, March 9.

The second conference will be the 33rd Annual Roth Virtual Conference, which is taking place March 15-17, 2021. Dr. Miller will participate in a fireside chat at 2:30 pm ET / 11:30 am PT on Tuesday, March 16 and the Company will conduct one-on-one meetings with institutional investors at the conference. In addition, a pre-recorded corporate overview presentation by Dr. Miller will be made available beginning on Monday, March 8, 2021.
A webcast of the presentations and the fireside chat noted above will be available via the investor relations section of the Corvus website and replays will be available for 90 days following the events.

On March 5, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the H.C. Wainwright Global Life Sciences Conference being held virtually on March 9-10, 2021 (Press release, Regulus, MAR 5, 2021, View Source [SID1234576148]).

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A webcast of the on-demand presentation will be available beginning Tuesday, March 9, 2021 through the investor relations section of the Company’s website at www.regulusrx.com. A replay of the webcast will be archived for 30 days following the presentation date.

On March 5, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has decided to expand Part B of its TACTI-002 Phase II trial, under the study’s Simon’s two- stage clinical trial design (Press release, Immutep, MAR 5, 2021, View Source [SID1234576149]). Immutep has commenced recruitment of an additional 13 second line Non-Small Cell Lung Cancer (NSCLC) patients, forming Stage 2 of Part B.

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The decision follows a preliminary safety and efficacy review by the Data Monitoring Committee and its recommendation, based on the patients recruited in Stage 1 of Part B.

About the TACTI-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across Australia, Europe, the UK and US.

Patients participating in three parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³ 50% (Tumour Proportion Score or TPS) and in HNSCC: < 1%, 1- 19% and ³ 20% (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first line NSCLC patients with a TPS score ³ 1% (US) and ³ 50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively. Pembrolizumab monotherapy is registered in the US (regardless of PD-L1 expression) and EU (³ 50% TPS score) for second line HNSCC patients.

On March 5, 2021 Orphagen Pharmaceuticals, an early-stage biopharmaceutical company focused on developing and commercializing novel therapies for cancer and other serious diseases with significant unmet need, reported that data from its preclinical program to develop OR-449 for the treatment of adrenocortical cancer will be shared at the Endocrine Society’s 2021 Annual Meeting (ENDO 2021) taking place virtually from Saturday, March 20 to Tuesday, March 23 (Press release, Orphagen, MAR 5, 2021, View Source [SID1234576150]).

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OR-449 is an antagonist to the orphan nuclear receptor steroidogenic factor-1 (SF-1) and the product of a dedicated medicinal chemistry and drug development campaign carried out at Orphagen.

Adrenocortical cancer (ACC) is a rare cancer of the adrenal gland. According to clinical experts, the response rates for the most common treatments are <30% for patients with metastatic disease. The preclinical findings presented demonstrate that OR-449 can be dosed orally and can block tumor growth in a mouse xenograft derived from a pediatric ACC tumor.

Orphagen has set a goal of initiating first-in-human trials for OR-449 in 2022.

Full virtual presentation details are listed below, and the full preliminary program is available online at the ENDO 2021 website. The presentations will be on display in ENDO 2021’s virtual poster hall beginning on Saturday, March 20 at 8:00am PST / 11:00am EST. The poster will also be available for download on Orphagen’s web site after the meeting.

A Novel Steroidogenic Factor-1 Antagonist, OR-449, as a Targeted Therapy for Adrenocortical Cancer
Presenter: Paul D Crowe, PhD
Co-Authors: Ray Fox, PhD, Haiyan Tao, PhD, Emily Eastwood, PhD, Neil Raheja, PhD, Raul Ribeiro, MD, Scott Thacher, PhD.
Poster Session: P54, Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications

On March 5, 2021 Lepu Biopharma reported the application for clinical trial of "CG0070 Injection" by Lepu Biopharma Co., Ltd. (hereinafter referred to as"Lepu Biopharma") has been accepted by Center for Drug Evaluation (CDE), NMPA (Acceptance No.: JXSL2100029) and publicized on March 4, 2021 (Press release, CG Oncology, MAR 5, 2021, View Source [SID1234608843]). CG0070 oncolytic virus antineoplastic drug is brought in by Lepu Biopharma fron CG Oncology, Inc., USA., obtaining its product development rights and global supply rights in China.
Oncolytic viruses can selectively replicate in tumor cells and then lyse tumor cells, and could meanwhile try to avoid affecting the growth of normal cells; with the development of cancer immunotherapy, the therapeutic potential of oncolytic viruses in various diseases such as malignant tumors has received more and more attention. Since the US FDA approved Amgen’s T-VEC oncolytic virus antineoplastic drugs in 2015, a number of oncolytic virus antineoplastic drugs have entered clinical studies worldwide. At the same time, a number of clinical studies have also been carried out on the synergistic effect of the combination of oncolytic viruses and other anti-tumor drugs.
CG0070, an oncolytic virus antitumor agent, is a genetically modified adenovirus type 5 (Ad5) that is modified to contain the cancer-selective promoter E2F-1 and the human granulocyte macrophage-colony stimulating factor GM-CSF gene to selectively replicate and lyse tumor cells in tumor cells with defective Rb regulation. Lysis of cancer cells releases tumor-specific antigens and GM-CSF expressed with the virus, which stimulates a systemic anti-tumor immune response.
In recent years, Lepu Biopharma has actively step into the field of oncolytic viruses. In addition to introducing the CG0070 project of CG Oncology, Inc., Lepu Biopharma has also taken a stake in Wuhan Binhui Biopharm Co., Ltd., and has initiated a clinical trial of the combination of immune checkpoint inhibitors and oncolysis virus (OH2).

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