On December 6, 2021 Akeso, Inc. (9926.HK) reported that the company will support an investigator-initiated study (IIS) to evaluate the efficacy and safety of Akeso’s novel, first-in-class anti-PD-1/CTLA-4 bispecific antibody, cadonilimab, for the treatment of neuroendocrine cervical carcinoma in the United States (Press release, Akeso Biopharma, DEC 6, 2021, View Source [SID1234596523]).

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Following a review of the efficacy data from the Akeso-sponsored Phase 2 clinical trial of Cadonilimab in recurrent or metastatic cervical cancer, this study was initiated and will be led by Michael Frumovitz, M.D., M.P.H., FACOG, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center.

INFORMATION ABOUT CADONILIMAB

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bispecific PD-1/ CTLA-4 immunooncology backbone drug developed by Akeso Biopharma. It is one of Akeso’s core assets within the company’s broad pipeline of therapeutic monoclonal antibodies. It is being developed for various indications such as lung cancer, gastric cancer, hepatocellular carcinoma, cervical cancer, esophageal squamous carcinoma, and nasopharyngeal carcinoma. Clinical data from ongoing studies demonstrate that Cadonilimab has promising efficacy against a wide variety of tumor types while exhibiting lower toxicity and a more favorable safety profile when compared to the co-administration of anti-PD-1 plus anti-CTLA-4 therapies.

On December 6, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that it will host a virtual research and development day on Wednesday, December 15, 2021 at 12pm Eastern Time (Press release, Y-mAbs Therapeutics, DEC 6, 2021, View Source [SID1234596559]).

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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 Y-mAbs research and development day will feature presentations from oncology key opinion leaders ("KOLs") Javier E. Oesterheld, M.D. (Atrium Health) and Jaume Mora, M.D., Ph.D. (SJD Barcelona Children’s Hospital).

Dr. Oesterheld will present on the current treatment landscape in the U.S. with DANYELZA (naxitamab-gqgk); and Dr. Mora will present dosing experience with naxitamab for patients with pediatric high-risk neuroblastoma and other solid tumors from compassionate use.

An update on Y-mAbs Therapeutics’ broad and advanced product pipeline, including the SADA technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK) MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).

A question and answer session will follow the formal presentations. To register for the event, please click here.

Featured KOLs:

Jaume Mora, M.D., Ph.D. is the scientific director of Oncology and Hematology at SJD Barcelona Children’s Hospital, as well as the director of its Developmental Tumours Laboratory. He is a member of several national and international scientific societies, including the International Pediatric Oncology Society, which awarded him the Schweisguth Prize, and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which in 2000 honored him with the young investigator award (YIA), as well as the Career Development Award (CDA). In 2011, Dr. Mora was the recipient of the annual BBVA Foundation Award and in 2006 he was awarded first prize of the Spanish Association Against Cancer (AECC) award for the study of child cancer.

Javier E. Oesterheld, M.D., is board certified in pediatric hematology-oncology and is helping to lead the ongoing pursuit of better treatments for childhood cancer. In 2017, he was named the first Jeff Gordon Children’s Foundation Endowment Chair – Levine Children’s Cancer and Blood Disorders Program, a role that supports his mission to improve lives and outcomes of pediatric cancer patients. He’s also the principal investigator for Carolinas Kids Cancer Research Coalition, in conjunction with the developmental therapeutics program at Levine Children’s Hospital. Additionally, Dr. Oesterheld is the study chair and/or site principal investigator for multiple clinical research studies into acute leukemia, refractory pediatric acute lymphoblastic leukemia, relapsed and refractory Neuroblastoma, and relapsed sarcomas. His research has been published in top journals and has led to numerous lecture invitations.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 6, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it will host a key opinion leader (KOL) webinar to discuss the data presented on the Company’s lead asset, VIP152, in chronic lymphocytic leukemia (CLL) and diffuse large B-Cell lymphoma (DLBCL) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Saturday, December 11, 2021 at 7:30pm Eastern Standard Time (Press release, Vincerx Pharma, DEC 6, 2021, View Source [SID1234596473]).

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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 webinar will feature presentations from KOLs John C. Byrd, M.D. (University of Cincinnati) and Rosa Lapalombella, Ph.D. (The Ohio State University) who will discuss the current treatment landscape and unmet medical need in treating patients suffering from chronic lymphocytic leukemia (CLL) and the VIP152 data presented earlier that day at the ASH (Free ASH Whitepaper) Annual Meeting.

Vincerx Pharma’s Vice President of Translational Medicine, Melanie Frigault, Ph.D., will also discuss the VIP152 mechanism of action in lymphoma poster presented at ASH (Free ASH Whitepaper). VIP152 is a potent and highly selective CDK9 inhibitor optimized for intermittent intravenous treatment. VIP152’s differentiated profile for selectivity, potency, and durability has translated to early signals of clinical activity in Phase 1, notably in patient populations with high unmet medical needs including double-hit DLBCL. In addition, VIP152 has demonstrated on-target disruption of PTEFb function with durable reductions in kinase activity, mRNA and protein levels of key oncogenes including MYC and MCL-1.

A live Q&A session will follow the formal presentations. To register for the webinar, please click here.

John C Byrd, M.D. is the Chairman of the Scientific Advisory Board of Vincerx and an internationally known researcher and clinical specialist in leukemia and other hematologic malignancies. Dr. Byrd is currently the Department Chair, The Gordon and Helen Hughes Taylor Professor, University of Cincinnati. Previously, he was the D Warren Brown Chair of Leukemia Research at the Ohio State University College of Medicine.

Dr. Byrd’s research has shown that therapeutic agents such as rituximab, idelalisib, ibrutinib and acalabrutinib are effective against chronic lymphocytic leukemia (CLL) and has led efforts to understand how resistance develops to these agents. Dr. Byrd continues to study novel immune-based therapies for CLL. However, five years ago, he transitioned much of his experimental therapeutics effort toward acute myelogenous leukemia (AML); where he has been attempting to identify genomic-specific targeted therapies in the laboratory and translate them to clinical trials. He serves as the chief medical officer for Beat AML, a precision medicine effort.

Dr. Byrd received his medical degree in 1991 from the University of Arkansas for Medical Sciences. He completed his internship and residency in internal medicine at the Walter Reed Army Medical Center in Washington, D.C., and then completed a fellowship at Walter Reed in hematology, oncology and bone marrow transplantation. Dr. Byrd also received a year of translational laboratory training at Johns Hopkins University.

Rosa Lapalombella, Ph.D. is Professor with Tenure at The Ohio State University (OSU) where she also serves as the Associate Director for Basic Research in the Division of Hematology.

Dr. Lapalombella has a strong history of translational medical research. Her research focus is on epigenetic alterations of cancer cells and the development of experimental therapeutics for hematologic disease. Her work has contributed to the translation of five therapeutic agents into clinical trials for CLL and has been reported in more than 60 articles in Cancer Discovery, Cancer Cell, Journal of Clinical Oncology, Leukemia and Blood. Dr. Lapalombella earned her Ph.D. from the University of Bologna, Italy and completed four years of postdoctoral training at the Ohio State University before joining the Faculty at OSU.

Melanie Frigault, Ph.D. is the Vice President of Translational Medicine of Vincerx. In the year before joining Vincerx, Dr. Frigault was the U.S. head of Translational Medicine at AstraZeneca with a strategic focus on precision medicine and accelerating clinical development using novel biomarker-based endpoints in hematologic malignancies and solid tumors. From 2016 to 2020, Dr. Frigault established a translational science department at Acerta Pharma in South San Francisco, CA to support development of CALQUENCE in mantle cell lymphoma (2017) and chronic lymphocytic leukemia (2019) with clinical biomarker data. Dr. Frigault held positions of increasing responsibility at AstraZeneca from 2011 to 2016 where she inserted science into the development of the portfolio ranging from target selection to phase 3 pivotal trials including biomarker discovery and companion diagnostic development. Dr. Frigault began her clinical research career at Novartis Institute of Biomedical Research in Cambridge, MA where she developed biomarkers and drove preclinical collaborations to inform clinical development.

Dr. Frigault obtained her Ph.D. in Biochemistry from McGill University, Québec, Canada.

On December IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the Company will host a conference call and live audio webcast on Saturday, December 11, 2021, at 7:30 p.m. EST (Press release, IGM Biosciences, DEC 6, 2021, https://investor.igmbio.com/news-releases/news-release-details/igm-biosciences-host-conference-call-and-webcast-review-igm-0 [SID1234596489]). The event will take place following an oral presentation featuring clinical data from the Phase 1 dose escalation study evaluating IGM-2323, the Company’s novel CD20 x CD3 T cell engager IgM antibody for the treatment of B cell proliferative diseases, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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IGM’s management team will be joined by Elizabeth Budde, M.D., Ph.D., Assistant Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center.

The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 9695193. A live webcast of the presentation 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.

On December 6, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process. The offering (the "Offering") of new shares (the "New Shares") in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 40 of 6 December 2021 (Press release, Bavarian Nordic, DEC 6, 2021, View Source [SID1234596505]).

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Bavarian Nordic has successfully completed a directed issue and private placement of 6,373,680 new shares at an offer price of DKK 268 per share, raising gross proceeds to Bavarian Nordic of DKK 1,708 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible qualified institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 40 of 6 December 2021.

As the Offering was oversubscribed, an individual allocation of the New Shares was made.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members elected at the general meeting of Bavarian Nordic’s board of directors as well as members of the executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 70,468,393 shares of DKK 10 each, equivalent to a registered share capital of DKK 704,683,930.

The New Shares represent approximately 9.94 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 9.04 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061682721. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S, in the permanent ISIN code for the existing shares, DK0015998017, on or around 10 December 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Thursday 9 December 2021 Settlement and payment for the New Shares
Thursday 9 December 2021 Registration of the capital increase with the Danish Business Authority
Friday 10 December 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Monday 13 December 2021 Merger of the temporary ISIN code with the permanent ISIN code in the system of VP Securities A/S
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS
Citigroup Global Markets Limited and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.