On May 20, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of precision genetic medicines, reported the appointment of Sandra Rojas-Caro, M.D., as Chief Medical Officer, effective May 24, 2021 (Press release, NeuBase Therapeutics, MAY 20, 2021, View Source [SID1234580377]). With more than 20 years of drug development experience across all phases of drug development, Dr. Rojas-Caro will oversee the preclinical and clinical development, medical, and regulatory strategy of NeuBase’s pipeline to address disease at its base cause.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Sandra is a dynamic and experienced R&D leader, whose expertise covers all aspects of clinical development, including the successful advancement of a novel therapeutic from IND to FDA approval," said Dietrich A. Stephan, Ph.D., Founder, CEO and Chairman of NeuBase. "Furthermore, she’s been responsible for dozens of clinical studies in multiple therapeutic modalities and indications from rare to common diseases. Now is an important time to welcome Sandra to the executive leadership team as we look to advance our first drug candidate into clinical trials next year and expand our pipeline to address historically undruggable oncogenic driver mutations."

"I’m impressed by NeuBase’s unique, targeted therapeutic approach to precision genetic medicines, which is designed to fundamentally address disease-causing mutations at the DNA or RNA level," said Dr. Rojas-Caro. "I am excited to join NeuBase’s exceptional leadership and scientific team, which is comprised of a number of founders and leading innovators in precision medicine. I look forward to applying NeuBase’s PATrOLTM platform, which has broad potential to address a wide range of rare and common genetically defined diseases."

Dr. Rojas-Caro has broad R&D leadership, executive management and team-building experience in private and public biotech companies and large pharma. She has been directly involved in successful global regulatory submissions, including an FDA and EMA approval and more than 10 investigational new drug (IND) applications. Most recently, she was Chief Medical Officer for Gemini Therapeutics, a company focused on redefining age-related macular degeneration (AMD) and linked disorders with precision medicine. At Gemini, she led development through several milestones, including the company’s first IND and the first cohorts of genetically selected patients dosed with the company’s leading biologic therapeutic. Prior to Gemini, Sandra served as Chief Medical Officer for Aeglea BioTherapeutics, a biotechnology company developing a new generation of enzyme-based therapeutics to treat inborn errors of metabolism (IEM). Prior to Aeglea, she served as Group Vice President of Clinical Research and Development at Synageva BioPharma where she was instrumental in leading the clinical development team that secured the FDA and EMA approval of Kanuma (sebelipase alfa) for the treatment of lysosomal acid lipase deficiency, as well as advancing the clinical development of other IEM programs. Following the acquisition of Synageva by Alexion, Dr. Rojas-Caro served as Vice President and R&D Project Team Leader for the Metabolic Rare Diseases Unit, and she supported the post-merger integration. Earlier in her career, she held roles in clinical and translational research with increasing levels of responsibility at Roche, Array BioPharma and Pfizer, where she was responsible for the design and implementation of early development clinical strategy across a broad range of indications.

On May 20, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating virtually in the following investor conferences (Press release, Guardant Health, MAY 20, 2021, View Source [SID1234580394]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

William Blair 41st Annual Growth Stock Conference
Fireside Chat on Tuesday, June 1st at 12:00 p.m. Pacific Time / 3:00 p.m. Eastern Time
Goldman Sachs 42nd Annual Global Healthcare Conference
Fireside Chat on Tuesday, June 8th at 12:00 p.m. Pacific Time / 3:00 p.m. Eastern Time
Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

On May 20, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that it will publish its report for the first quarter 2021 on May 26. Investors, financial analysts and media are invited to participate in a webcast with a QnA session on the same day at 12:00 CEST (Press release, Oncopeptides, MAY 20, 2021, View Source [SID1234580410]). The event will be hosted by CEO, Marty J Duvall and members of the Oncopeptides’ Leadership team. The presentation will be held in English.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.

On May 20, 2021 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, reported the pricing of an underwritten public offering of 19,354,840 shares of its common stock, at a price to the public of $3.10 per share (Press release, Apricus Biosciences, MAY 20, 2021, View Source [SID1234580445]). In addition, the Company granted the underwriters a 30-day option to purchase up to 2,903,226 additional shares of its common stock. All of the shares of common stock in the offering are being sold by Seelos.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Guggenheim Securities and Cantor are serving as joint book-running managers for the offering. BTIG is serving as lead manager for the offering. The Benchmark Company acted as a financial advisor for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $56.1 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use an aggregate of $6.3 million of the net proceeds from the offering for the partial repayment of certain outstanding convertible promissory notes and the remainder for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about May 24, 2021, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-251356) previously filed with the Securities and Exchange Commission (the "SEC") on December 15, 2020, amended on December 22, 2020 and declared effective by the SEC on December 23, 2020. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by calling (212) 518-9544 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On May 19, 2021 MorphoSys AG (FSE:MOR; NASDAQ:MOR) reported that new data from the tafasitamab (Monjuvi(R)) development program will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, MorphoSys, MAY 20, 2021, View Source [SID1234580345]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which was approved as Monjuvi(R) (tafasitamab-cxix) in July 2020 by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"We are proud to present important findings from our comprehensive development program for tafasitamab at the ASCO (Free ASCO Whitepaper) Annual Meeting, including three-year follow-up data from the Phase 2 L-MIND study showing a long durability of responses and overall survival in patients with R/R DLBCL," commented Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "In addition, we will show details from our First-MIND study in front-line DLBCL, indicating our ambition to position Monjuvi as a back-bone strategy in DLBCL and to increase cure rates or duration of remission in DLBCL across all lines of therapy."

Abstracts accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting include:

Poster Discussion

LONG-TERM ANALYSES FROM L-MIND, A PHASE 2 STUDY OF TAFASITAMAB (MOR208) COMBINED WITH LENALIDOMIDE (LEN) IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (R/R DLBCL)

Abstract Number: 7513
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

ePosters

First-MIND: A PHASE 1B, OPEN-LABEL, RANDOMIZED STUDY TO ASSESS SAFETY OF TAFASITAMAB (TAFA) OR TAFA + LENALIDOMIDE (LEN) IN ADDITION TO R‑CHOP IN PATIENTS WITH NEWLY DIAGNOSED DLBCL

Abstract Number: 7540
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAFASITAMAB PLUS LENALIDOMIDE AND RITUXIMAB VERSUS PLACEBO PLUS LENALIDOMIDE AND RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) OR MARGINAL ZONE LYMPHOMA (MZL)[1]

Abstract Number: TPS7568
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Please refer to the ASCO (Free ASCO Whitepaper) online program for full session details and data presentation listings: View Source All presentations will be available on demand starting June 4, 2021.

MorphoSys is looking forward to meeting registered ASCO (Free ASCO Whitepaper)21 Virtual attendees at its virtual booth accessible through the conference website and through the company’s ASCO (Free ASCO Whitepaper) microsite at www.morphosysevents.com.

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

– Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

– Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

– Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

– Feeling tired or weak

– Diarrhea

– Cough

– Fever

– Swelling of lower legs or hands

– Respiratory tract infection

– Decreased appetite

These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

– Have an active infection or have had one recently.

– Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

– You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

– Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

– Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.