On March 22, 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 PEPAXTO (melphalan flufenamide) has been included in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN) in Oncology (Press release, Oncopeptides, MAR 22, 2021, View Source [SID1234576981]). PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

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"The NCCN Guidelines are a trusted resource for clinicians in the management of oncology patients," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. "We are grateful that melphalan flufenamide is included in these guidelines and believe that they will facilitate the management of previously treated multiple myeloma patients, who need additional treatment options".

NCCN is an alliance of 30 cancer centers in the United States. Over the past 25 years, NCCN has developed an integrated suite of tools to improve the quality of cancer care. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. To learn more about the NCCN Guidelines and Clinical Resources you may visit www.nccn.org.

About melphalan flufenamide

Melphalan flufenamide, also known as melflufen, is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma. Melphalan flufenamide uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound. Due to its high lipophilicity, melphalan flufenamide is distributed into cells. Melphalan flufenamide is designed to leverage aminopeptidases, which are overexpressed in multiple myeloma cells and cause the release of cytotoxic agents. Melphalan flufenamide is administered once monthly, by a thirty-minute infusion.

In the US, PEPAXTO (melphalan flufenamide) is indicated in combination with dexamethasone for the treatment of adult patients with triple class refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-monoclonal directed antibody. PEPAXTO is a registered trademark in the U.S.

On March 22, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported the appointment of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca, as Head of Clinical Operations, effective March 22, 2021 (Press release, Sonnet BioTherapeutics, MAR 22, 2021, View Source [SID1234576945]).

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"I am pleased to welcome Richard and Manuel to Sonnet at such an exciting time as we prepare to enter SON-1010, our proprietary fully human Interleukin 12 (IL-12) therapeutic candidate configured with our Fully Human Albumin Binding (FHAB) technology, into the clinic," said Pankaj Mohan, Ph.D., Founder and CEO. "Richard is a seasoned industry leader with a demonstrated track record of overseeing clinical development teams and managing regulatory affairs. Manuel will bring to Sonnet his expertise in clinical operations and project management that comes at an opportune time as we continue to prepare our FHAB platform for its first clinical study."

Dr. Kenney has more than 20 years of experience in translational-stage development of biologics, as well as the commercialization strategy and corporate management of preclinical, clinical-stage and commercialized vaccines and immunotherapies. As President of ClinReg Biologics, he has provided strategic consulting in clinical and regulatory affairs of biologics, medical monitoring and pharmacovigilance in several capacities. Dr. Kenney most recently served as Chief Development Officer at X-VAX Technology and previously held Chief Medical Officer roles at Immune Design and Crucell Holland, where he led the clinical development and regulatory affairs groups. Dr. Kenney was a researcher/reviewer for the FDA for over six years and did post-graduate training at Duke and NIH. Dr. Kenney received a B.S. in Chemistry from George Washington University and his M.D. from Harvard Medical School.

"I am thrilled to join Sonnet to continue to build upon the important work of the team," commented Dr. Kenney. "I believe the FHAB platform has the potential to address difficult-to-treat solid tumors in broad cancer populations and at various stages of the disease. I look forward to applying my skillset as we advance our FHAB programs, as well as the low-dose IL-6 programs, through the clinic."

Mr. Dafonseca has over 30 years of experience in pharmaceutical development, ranging from discovery stage programs to post approval activities. Most recently he served as Director of Global Clinical Trial Operations – Oncology at Merck where he was responsible for the successful execution, enrollment and quality of his assigned portfolio within the company’s oncology portfolio. Prior to his time at Merck, Mr. Dafonseca served as the Director of Clinical Operations at Ipsen Biopharmaceuticals, where he led the North America clinical operations group, including the strategic planning, execution and management of Dysport and Somatuline to support global regulatory submissions. Mr. Dafonseca received his B.S in Medical Technology and M.S. in Zoology and Physiology from Rutgers University.

"This is a dynamic time for Sonnet’s FHAB platform, as the Company prepares its lead candidates for the clinic, and I am excited to be joining the team," stated Manuel Dafonseca. "The recent non-human primate (NHP) data is very encouraging and I look forward to applying my experiences in clinical trial management, from early stage to pre-approval activities, to bring Sonnet’s innovative treatments to cancer patients."

On March 22, 2021 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its Board of Directors approved a dividend of $0.71875 per share to holders of XOMA’s Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) (Press release, Xoma, MAR 22, 2021, View Source [SID1234576964]). The cash dividend will be paid on or about April 15, 2021, to XOMAP holders of record at the close of business on April 2, 2021.

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On March 22, 2021 Tavotek Biotherapeutics reported it has raised over $20M in Round A1 and Round A2 financing in the preceding two months (Press release, Tavotek, MAR 22, 2021, View Source [SID1234576982]). YuanBio Venture Capital led the A1 finance round followed by Oriza Holdings, Ming BioVentures, and New Alliance Capital. Series A2 financing was jointly invested by GF Xinde, CTS Capital, and Lanhu Capital. The two rounds of financing will be used to accelerate the CMC production and IND filings of three antibody drugs (Tavo111, Tavo103, and Tavo101) developed by the company based on its TavoPrecise antibody platform. In addition, the funding will also be used to strengthen its bispecific / multispecific antibody pipelines and the development of multicyclic intracellular peptide (MIP) programs.

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Tavotek Biotherapeutics, established in early 2019, received its initial Round A investment from Apricot Capital. Tavotek is committed to using innovation to improve the well-being of patients with unmet medical needs. Presently, the company has two R&D centers: one in Lower Gwynedd, Pennsylvania and another in Suzhou, China. The core team members have decades of successful drug development experiences at multinational pharmaceutical firms (J&J, Abbott, GSK, Eli Lilly) which include many blockbuster drugs with annual sales of more than $1 billion.

Tavotek’s research platforms are built upon three breakthrough technologies: TavoSelect (an innovative Phage Display Library that generates conformational selective human full-length and single domain antibodies); TavoPrecise (a differentiated engineering platform for next generation tissue-specific biologics); and TavoMIP (a multicyclic peptide platform that makes undruggable targets more accessible). With the new infusion of capital, Tavotek is developing novel biologics targeting oncology and autoimmune diseases for patients. The company plans to bring three innovative antibodies into human clinical trials in late 2021 with another three assets to IND in 2022.

On March 22, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the publication of preclinical data in the Journal for ImmunoTherapy of Cancer (JITC) highlighting efficacy of ImmunityBio’s PD-L1 t-haNK natural killer cell-based therapy in combination with T cell-based immunotherapy against heterogeneous tumors (Press release, NantKwest, MAR 22, 2021, View Source [SID1234576948]). ImmunityBio’s novel PD-L1 t-haNKs are derived from a human, allogeneic NK cell line (NK-92) that has been engineered to express IL-2, CD16, and a chimeric antigen receptor (CAR) that recognizes PD-L1.

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Human solid tumors are made of multiple clones of tumor cells, some of which harbor genomic alterations that make them invisible to T cells. These resistant clones accomplish this "cloaking ability" by preventing the presentation of the tumor antigens on MHC-I receptors, thus "hiding" from killer T cells. For these patients, maximum activation of T cells with immunotherapy is unlikely to lead to durable tumor control or a cure. However, when NK cells are activated, tumor recognition and targeting is restored. The study shows that when subpopulations of tumors cells escape T cell detection or killing, they upregulate PD-L1 in the process because of interferon in the tumor microenvironment. This increase in tumor cell PD-L1 expression sensitizes them to killing by PD-L1 t-haNKs.

"Our results suggest that sequential treatment, first with T cell immunotherapy to kill the sensitive tumor cells and upregulate PD-L1 on the remaining cells, followed by PD-L1 t-haNK treatment, may overcome the issue of tumor heterogeneity and enhance rates of durable tumor control in patients with relapsed solid cancers," said Clint T. Allen, M.D., Principal Investigator, Section on Translational Tumor Immunology in the National Institute on Deafness and Other Communication Disorders (NIH) and corresponding author of the publication.

The publication by first author Maxwell Lee et al., "Chimeric antigen receptor engineered NK cellular immunotherapy overcomes the selection of T cell escape variant cancer cells," describes the development of preclinical models with heterogenous cancers containing T cell escape variant tumor cells. T cell-based immunotherapy administered in these preclinical models resulted in IFNγ production that in turn upregulated PD-L1 expression in T cell escape variants. Subsequent administration of irradiated PD-L1 t-haNKs targeted and eliminated the tumor cell populations that had evolved to be resistant to T-cell immunotherapy alone, resulting in synergistic anti-tumor activity.

"We are excited to see this preclinical study that affirms our hypothesis of ‘Quantum Oncotherapeutics,’ which is currently being studied in Phase1/2 QUILT trials across multiple tumor types. The theory we hold is that our treatment itself induces changes in the tumor immune microenvironment. By anticipating these dynamic cellular changes, we can administer and activate NK cells at the optimal time and, ultimately, outsmart the tumor. These spatial-temporal insights informing treatment, have the potential to change the paradigm of cancer care with modernized immunotherapy protocols, beyond the standard-of-care therapy and beyond checkpoint therapy alone. Late-stage, randomized controlled trials in pancreatic and lung cancers that orchestrate NK cells and T cells are underway at ImmunityBio to confirm this hypothesis," said Patrick Soon-Shiong, M.D. Founder and Executive Chairman of ImmunityBio.