On March 5, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its 2020 annual report on Friday, March 12, 2021 (Press release, Bavarian Nordic, MAR 5, 2021, View Source,-Email%20Print%20Friendly&text=COPENHAGEN%2C%20Denmark%20%E2%80%93%20March%205%2C,Friday%2C%20March%2012%2C%202021. [SID1234576156]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CET (8:00 am EST) on the same day to present the full-year results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at http://bit.ly/3rkKNed.

On March 5, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it has entered into an at-the-market (ATM) equity offering sales agreement with Canaccord Genuity LLC (Press release, Oncolytics Biotech, MAR 5, 2021, View Source [SID1234576151]). The ATM allows the Company, at its sole discretion, to issue common shares from treasury, at prevailing market prices, with an aggregate gross sales amount of up to US$80 million. The company has no obligation to sell any shares pursuant to the ATM. The ATM provides Oncolytics the option to efficiently tap into the financial markets as needed to support ongoing business development activities and clinical trials, while bolstering management’s ability to negotiate potential business development agreements from a position of financial strength.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In connection with the ATM, Oncolytics has filed a Prospectus Supplement with the Alberta Securities Commission and with the United States Securities and Exchange Commission, which supplements Oncolytics’ Canadian short form base shelf prospectus dated June 12, 2020, and Oncolytics’ shelf registration statement on Form F-10 declared effective on June 15, 2020 by the United States Securities and Exchange Commission. Sales of the ATM offering will only be conducted in the United States through NASDAQ or another exchange at market prices. No sales will be conducted in Canada or through the Toronto Stock Exchange.

A copy of the Prospectus Supplement is available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov or may be obtained upon request to Oncolytics’ Investor Relations Department using the contact information set out below. Before you invest, you should read the Prospectus Supplement and accompanying base shelf prospectus and the other documents the Company has filed with the SEC for more complete information about the Company and the ATM offering. Alternatively, a copy of the Prospectus Supplement and accompanying base shelf prospectus are available upon request by contacting Canaccord Genuity LLC Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, Attn: Equity Syndicate Department, by telephone at (617) 371-3900 or by e-mail at [email protected].

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 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 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.