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Orphagen Pharmaceuticals to present preclinical data for OR-449 at the Endocrine Society’s 2021 Annual Meeting

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

IMMUTEP EXPANDS PART B OF TACTI-002 STUDY

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.

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.

Regulus Therapeutics to Present at the H.C. Wainwright Global Life Sciences Conference

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]).

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.

Cellectar to Participate at Upcoming Institutional Investor Conferences

On March 5, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported that the company will be available for 1×1 meetings at the following upcoming conferences (Press release, Cellectar Biosciences, MAR 5, 2021, View Source [SID1234576146]):

H.C. Wainwright Global Life Sciences Conference
Date: March 9-10, 2021
Time: Available for 1×1 meetings
To schedule, click on the link HERE

Roth Capital Partners 33rd Annual Conference
Date: March 15-17, 2021
Time: Available for 1×1 meetings
To schedule, click on the link HERE
The company’s presentation is available for on-demand viewing in the link HERE.

Seagen Recommends Rejection Of ‘Mini-Tender’ Offer from TRC Capital Investment Corporation

On March 5, 2021 Seagen Inc. (Nasdaq:SGEN) reported that it has been notified of an unsolicited "mini-tender" offer dated February 22, 2021, made by TRC Capital Investment Corporation, an Ontario, Canada corporation, to purchase up to 1,000,000 shares of Seagen’s common stock (Press release, Seagen, MAR 5, 2021, View Source [SID1234576145]). According to TRC, its "mini-tender" offer price of $151.00 per share was approximately 4.28% below the closing price of Seagen’s common stock on February 19, 2021, the last trading day prior to the date of its offer.

Seagen does not endorse TRC Capital’s unsolicited "mini-tender" offer and is not associated in any way with TRC Capital, its "mini-tender" offer, or its "mini-tender" offer documents. Seagen recommends that Seagen shareholders reject the offer and not tender their shares in response to this unsolicited offer, for the reasons described below.

TRC has made many similar "mini-tender" offers for the shares of other companies. "Mini-tender" offers are designed to seek less than five percent of a company’s outstanding shares, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (SEC) because they are below the SEC’s threshold to provide such disclosure and procedural protections for investors.

The SEC has cautioned investors about "mini-tender" offers in an investor alert. The SEC noted that these offers "have been increasingly used to catch investors off guard" and that many investors who hear about "mini-tender" offers "surrender their securities without investigating the offer, assuming that the price offered includes the premium usually present in larger, traditional tender offers."

To read more about the risks of "mini-tender" offers, please review the alert on the SEC’s website at View Source

TRC’s "mini-tender" offer is subject to numerous conditions, including TRC obtaining sufficient financing available to consummate the offer on terms satisfactory to TRC in its reasonable discretion. Seagen urges shareholders to obtain current stock quotes for their shares of Seagen common stock, review the terms and conditions to the offer, consult with their broker or financial adviser and exercise caution with respect to TRC Capital’s "mini-tender" offer. Shareholders who have already tendered shares should consider the advisability of withdrawing their shares as permitted under TRC’s Offer to Purchase documents.

According to the offer documents, the offer is currently scheduled to expire at 12:01 a.m., Eastern time, on March 23, 2021.

Seagen requests that a copy of this news release be included with all distributions of materials relating to TRC’s "mini-tender" offer related to shares of Seagen’s common stock.