On April 28, 2021 Medivir AB reported that Interim Report January – March 2021 (Press release, Medivir, APR 28, 2021, View Source;interim-report-january–march-2021-301278700.html [SID1234578697]).

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Financing secured to bring the MIV-818 study into the next phase

January – March

Financial summary for the quarter

Net turnover amounted to SEK 9.9 (7.3) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -7.2 (-20.7) million. Basic and diluted earnings per share amounted to SEK -0.18 (-0.96) and SEK -0.18 (-0.96) respectively.
Cash flow from operating activities amounted to SEK -1.5 (-16.6) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 269.3 (116.6) million.
Significant events during the quarter

In January the company signed an exclusive license agreement with IGM Biosciences, Inc. for birinapant. Medivir received a payment of USD 1 million after signing, which is to be followed by an additional USD 1.5 million when IGM includes birinapant in phase I clinical trials. In addition, the agreement entitles Medivir to milestone payments and royalties.
A rights issue of class B shares with preferential rights for existing shareholders was completed in early February. Through the rights issue, which was oversubscribed to 93.5 percent, Medivir received approximately SEK 170 million before transaction costs.
The Board of Directors decided to exercise the over-allotment option of SEK 25 million, directed to the specialist investor HealthInvest.
An Extraordinary General Meeting on March 11, 2021, decided on a directed new share issue of approximately SEK 28 million to Linc AB.
In February 2021 a licensing agreement with Ubiquigent was signed for the preclinical research program USP7.
In March, the last patient was included in the first part of the phase Ib study with MIV-818.
In March 2021, it was announced that Yilmaz Mahshid will leave his position as CEO of Medivir at the Annual General Meeting on May 5, for personal reasons. The recruitment process for a new CEO has begun.
Medivir’s Nomination Committee proposes the re-election of Uli Hacksell, Lennart Hansson, An van Es Johansson and Bengt Westermark as board members. The Nomination Committee proposes the election of Yilmaz Mahshid as new board member and that Uli Hacksell is elected Chairman of the Board.
Bengt Julander and Helena Levander have declined re-election.
Significant events after the end of the quarter

On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He will take up his new role in connection with Medivir’s Annual General Meeting on May 5, 2021.
On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.

Conference call for investors, analysts and the media
The Interim Report January – March 2021 will be presented by Medivir’s President & CEO, Yilmaz Mahshid.

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

On April 28, 2021 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it will host an investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo and data from its Phase 1 study of RP2 alone and in combination with Opdivo (Press release, Replimune, APR 28, 2021, View Source [SID1234578745]). The event will include presentations by Philip Astley-Sparke, Chief Executive Officer of Replimune, Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford.

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The event will begin at 8:00 a.m. Eastern Time on Thursday, June 3, 2021. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

Opdivo (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.

On April 28, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the company’s selection for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually June 4-8, 2021 (Press release, Merus, APR 28, 2021, View Source [SID1234578824]).

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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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The presentation highlights updated interim clinical data for the targeted bispecific antibody, zenocutuzumab (Zeno), in NRG1 fusion positive (NRG1+) cancers. Merus is currently recruiting patients into the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers.

Oral Presentation:

Title: Efficacy and safety of zenocutuzumab in advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Lead Author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Abstract #: 3003
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 4, 2021, 11:00 AM-2:00 PM EDT

The abstract will be available on May 19 at 5:00 pm. ET and the presentation, with an updated interim analysis of the currently enrolled population, will be broadcasted during the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session on June 4 from 11:00-2:00 ET, both on the ASCO (Free ASCO Whitepaper) Meeting Library. It will also be available on the Merus website shortly after the live presentation.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.

Learn more about Zeno Dock & Block at View Source

On April 28, 2021, Akeso, Inc. reported that, the Center for Drug Evaluation ("CDE") of the National Medical Products Administration (NMPA) of the People’s Republic of China (the "PRC") agreed to start the evaluation of the first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104), which is an immuno-oncology therapy independently developed by the Company, plus platinum-based chemotherapy in combination with/without bevacizumab for a randomized, double-blind, placebo-controlled phase III clinical trial for first-line treatment of persistent, recurrent or metastatic cervical cancer (Press release, Akeso Biopharma, APR 28, 2021, View Source [SID1234633507]). This is the first phase III clinical trial of dual immunotherapy for first-line treatment of cervical cancer in the PRC.

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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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Recently, the Company successfully held a seminar of this global phase III clinical trial attended by experts and scholars of world-renowned gynecological oncology research institutions from China, the United States, Europe and Australia. The seminar reviewed the current status of cervical cancer treatment in the world, summarized the results of early stage clinical trials of Cadonilimab on several tumor indications, and discussed in detail the framework proposal of the global phase III clinical trial of Cadonilimab.

President & CEO of Akesobio, Michelle Xia, PhD, said, "Cadonilimab has demonstrated exceptional clinical efficacy in early stage clinical trials on cervical cancer. Based on this, the Company will further carry out the global phase III clinical trial for the first-line treatment of cervical cancer, which shows the excellent clinical operation efficiency of the company and will be beneficial to more patients suffering from cervical cancer around the world. The Company believes that Cadonilimab will become the first PD-1/CTLA-4 bi-specific antibody novel drug approved for market launch in the world."

Because of its satisfactory clinical data, Cadonilimab obtained fast track designation from the Food and Drug Administration of the United States (FDA) for treating patients with recurrent or metastatic cervical cancer after standard therapies in August 2020. Cadonilimab was also approved by the CDE for the inclusion in the "Breakthrough Therapy Designation" list for treating patients with recurrent or metastatic cervical cancer after standard therapies in October 2020. Patient enrollment of the registrational phase II clinical trial of Cadonilimab for the treatment of recurrent or metastatic cervical cancer was completed in January 2021 in the PRC.

INFORMATION ABOUT CADONILIMAB (PD-1/CTLA-4 BI-SPECIFIC ANTIBODY)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/ CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.Our AK104 project has been incorporated in the Major New Drug Innovation Program under the 13th Five-year Plan for Major Technology Project (The 13th Five-Year Plan for Major Technology Project) issued by National Health Commission and Ministry of Science and Technology in 2017 and has been enlisted in the 2017 Pearl River Talent Program of Guangdong Province — Introduction of Innovation and Entrepreneurship Team Support Program (2017 Guangdong Province "Pearl River Talent Program" Introduction of Innovation and Entrepreneurship Team Support Project). It was also jointly rated by China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017 Top Ten Medicinal Biotechnology Advancements in China).It was also jointly rated by China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017 Top Ten Medicinal Biotechnology Advancements in China).It was also jointly rated by China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017 Top Ten Medicinal Biotechnology Advancements in China).

On April 28, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) reported that Steve Hoerter, President and Chief Executive Officer, will participate in a fireside chat at the Truist Securities Life Sciences Summit on May 5, 2021 at 9:40 AM ET (Press release, Deciphera Pharmaceuticals, APR 28, 2021, View Source [SID1234578616]). The conference will be held in a virtual meeting format.

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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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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.