On July 12, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that clinicians at University of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML). Brian A. Jonas, MD, PhD, FACP, UC Davis Division of Hematology/Oncology, is the clinical trial’s principal investigator (Press release, GlycoMimetics, JUL 12, 2021, View Source [SID1234584780]).

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According to Eric Feldman, MD, GlycoMimetics’ Chief Medical Officer, "While the field has seen strong uptake on venetoclax paired with a hypomethylating agent (HMA) in the frontline unfit AML setting, the depth and durability of responses, particularly in patients with adverse risk biology, has been somewhat less than optimal. In this setting, there remains a significant unmet need, and we know that environment-mediated drug resistance (EMDR), driven by E-selectin, contributes to HMA/venetoclax resistance. If the study shows that E-selectin antagonism with uproleselan improves minimal residual disease (MRD) negative response rates, this would be an important step forward that underscores the foundational opportunities for uproleselan across the broad spectrum of patients treated for AML."

The UC Davis Comprehensive Cancer Center study is an investigator-sponsored trial (IST) for which GlycoMimetics is providing uproleselan. Designed to evaluate the safety and efficacy of the triple combination, the study is non-randomized, open label and multi-center. The goal of the two-part trial is first to determine a recommended Phase 2 dose, and then to explore efficacy in a dose expansion cohort. Up to 31 patients will be enrolled, and a preliminary/interim readout is expected in 2022.

At the 2020 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), a preclinical study of uproleselan in combination with venetoclax and the HMA azacitidine demonstrated the triple combination’s potential in overcoming some of the limitations related to depth and durability of response with venetoclax/HMA alone. An oral presentation highlighted how antagonizing E-selectin with uproleselan can overcome microenvironment-mediated resistance to venetoclax/HMA therapy. In the study, the addition of uproleselan both prolonged survival of the murine model, and also promoted normal hematopeoic stem cell pro-survival signaling.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. FDA and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

On July 12, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the appointment of Octávio Costa, MD, as Chief Medical Officer (Press release, Monopar Therapeutics, JUL 12, 2021, View Source [SID1234584778]). In this role, Dr. Costa will oversee global clinical development and regulatory affairs, and will provide strategic direction for Monopar’s pipeline.

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Dr. Costa joins Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through 4 clinical development expertise as well as regulatory experience. Dr. Costa’s previous roles include positions of increasing responsibility in clinical development at Merck, Celgene, Novartis and most recently as Chief Medical Officer at Rafael Pharmaceuticals. He has played an important role in the development and life-cycle management of significant products, including the blockbuster product REVLIMID (lenalidomide). Dr. Costa earned his Doctor of Medicine from The Medical College of Sorocaba, São Paulo.

"We are excited to welcome Octávio, especially as our lead program enters late-stage clinical studies," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "Octávio’s track record of navigating all stages of clinical development will aid Monopar in executing our growing clinical development pipeline."

"I am thrilled to be joining this accomplished management team, as Monopar’s Chief Medical Officer," said Dr. Costa. "My industry knowledge and expertise in moving cancer therapies through all stages of clinical testing is well suited to help accelerate Monopar’s pipeline of innovative mid- and late-stage clinical programs and early drug development candidates."

On July 12, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor (Press release, Halozyme, JUL 12, 2021, View Source [SID1234584777]). The approval marks Janssen’s sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

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"We are delighted that Janssen received this FDA approval for DARZALEX FASPRO, making it the first and only FDA-approved subcutaneous anti-CD38 monoclonal antibody therapy available in this combination," said Helen Torley, president and chief executive officer at Halozyme. "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."

DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

This FDA approval for DARZALEX FASPRO in combination with Pd for patients with multiple myeloma after first or subsequent relapse is supported by data from the Phase 3 APOLLO study, which met its primary endpoint of improved progression-free survival (PFS). For more information related the Phase 3 APOLLO study findings, please view Janssen’s press release.

On July 12, 2021 ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, reported that the first patient was dosed in a Phase 1/2 clinical trial (‘SIDNEY’) with EO2463, its second OncoMimicsTM vaccine for the treatment of indolent non-Hodgkin lymphomas (iNHL) (Press release, Enterome, JUL 12, 2021, View Source;utm_medium=rss&utm_campaign=enterome-announces-first-patient-dosed-in-a-phase-1-2-trial-with-second-oncomimicstm-vaccine-eo2463-in-non-hodgkin-lymphoma [SID1234584776]). Initial clinical data from the trial are expected in 2022.

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EO2463 is an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers. EO2463 is designed to trigger the immune system into recognizing B cells as bacterial (i.e. non-self) and eliciting a targeted cell-killing response. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes that cause NHL.

The SIDNEY trial (EONHL1-20; NCT04669171) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination with standard-of-care lenalidomide and/or rituximab in patients with follicular and marginal zone lymphoma. A total of 60 patients are expected to be enrolled in Europe and the US.

This is the third clinical trial investigating OncoMimicsTM cancer vaccine candidates in solid and liquid malignancies to be launched by Enterome in the last 12 months.

Professor Pier Luigi Zinzani, MD, PhD, from the University of Bologna (Italy), is SIDNEY’s Global Coordinating Investigator. Prof. Zinzani is a renowned hematologist with extensive clinical research and drug development experience in the field of NHL, Hodgkin’s disease and chronic lymphocytic leukemia.

Prof. Zinzani, said: "Targeting B-cell specific antigens with a therapeutic non-self, off-the-shelf, vaccine is a very interesting approach to treating NHL. We are excited to begin clinical studies to investigate whether EO2463 can impact not only relapsed disease in combination with established standard-of-care options, but also very early stages of iNHL when used as monotherapy. We look forward to seeing the immunological and clinical impact of the vaccine and providing updates on the progress of this study."

Dr. Jan Fagerberg, Chief Medical Officer of Enterome, said: "EO2463 is Enterome’s second microbiome-peptide based cancer vaccine generated from our unique drug discovery platform. This clinical trial is another significant step in our strategy to deliver proof of concept data for our OncoMimicsTM vaccines, which we believe can target both solid and liquid malignancies. We are delighted to initiate this trial and believe that the data we expect to generate from clinical trials with EO2401 and EO2463 will position Enterome as a clear leader of next-generation cancer vaccines."

On July 12, 2021 Vaccibody AS (Euronext Growth (Oslo): VACC), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that it has entered into an exclusive license agreement with Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, to use a broad selection of virus-specific T cell epitopes identified by Adaptive for Vaccibody to design and develop novel SARS-CoV-2 vaccines (Press release, Vaccibody, JUL 12, 2021, View Source [SID1234584775]).

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Vaccibody’s development strategy for its second-generation SARS-CoV-2 vaccine is designed to respond to the emerging threats of evolving variants with reduced sensitivity to first generation vaccines that were developed using the 2020 prototype spike protein. The 2-armed strategy aims to develop two candidates for the broad population. First, a vaccine candidate encoding the receptor binding domain (RBD) derived from the South African beta variant of concern. And second, a T cell based vaccine candidate, encoding multiple validated immunodominant, conserved Adaptive-identified T-cell epitopes spanning multiple antigens across the SARS-CoV-2 genome. 2

"To date, SARS-CoV-2 has resulted in the death of over 4 million people globally and we are facing a tremendous threat from emerging variants of concern. We are very excited to have access to Adaptive’s T cell epitopes for our use in developing second-generation SARS-CoV-2 vaccines to specifically address current and future variants of concern. Vaccibody has exclusively licensed validated SARS-CoV-2 T-cell epitopes for use in the design and development of our T-cell vaccine candidates, including the candidate in our previously announced clinical trial" said Agnete B. Fredriksen, Chief Innovation and Strategy Officer of Vaccibody.

Adaptive has mapped the T cell immune response using more than 6,500 samples from patients impacted by COVID-19. Adaptive used its immune medicine platform, leveraging its proprietary antigen mapping and deep sequencing capabilities, to identify naturally processed and presented T-cell epitopes to SARS-CoV-2 antigens. Adaptive’s T-cell epitopes will be used by Vaccibody in its modular vaccine technology platform to target specific SARS-CoV-2 antigens to antigen presenting cells.

Michael Engsig, Chief Executive Officer of Vaccibody continued, "Our aim is to design and develop novel second-generation COVID-19 vaccines using Vaccibody’s unique modular vaccine technology platform and Adaptive’s functionally validated, immunodominant T-cell epitopes."

"The SARS-COV-2 virus’ ability to rapidly mutate can impact the efficacy of many firstgeneration vaccines. Adaptive’s unique ability to read and access the immune system enables us to identify and validate SARS-COV-2 T-cell epitopes from convalescent COVID-19 individuals. We are excited to combine the strength of validated T-cell epitopes, identified using our immune medicine platform, with Vaccibody’s innovative vaccine technology in fighting the pandemic," added Harlan Robins, Chief Scientific Officer and co-founder of Adaptive Biotechnologies.

Mikkel W. Pedersen, Ph.D., Chief Scientific Officer of Vaccibody continued, "We are thrilled to work with Adaptive Biotechnologies to accurately identify immunogenic and conserved T-cell epitopes. Adaptive’s epitopes have enabled us to create a multivalent SARS-CoV-2 T-cell vaccine that may provide more complete viral protection, long-term immunity and viral clearance compared to first generation vaccines. Our T-cell candidate may have both prophylactic and therapeutic potential and may also fit the profile of a universal SARS-CoV-2 vaccine booster for individuals previously vaccinated with Spike based vaccines."

Vaccibody has demonstrated that the SARS-CoV-2 vaccine candidate that incorporates Adaptive’s T-cell epitopes induces a rapid, strong and broad T-cell response after administration of a single dose in a humanized preclinical model.

Under the terms of the license agreement, Adaptive has provided certain selected T-cell epitopesfor exclusive use in Vaccibody’s next-generation SARS-CoV-2 vaccines. Vaccibody will 3 be responsible for further development of the potential T-cell SARS-CoV-2 vaccine candidates. Financial terms of this agreement will not be disclosed.

The phase 1/2 trial is currently in the planning phase. The CTA (Clinical Trial Application) is expected to be submitted in Q3 2021 and initiation is planned for Q4 2021. The clinical trial will be conducted in Norway. Please also referto Vaccibody’s announcement on June 29, 2021 about the clinical trial.

Webcast
Michael Engsig, Chief Executive Officer of Vaccibody, and other members of Vaccibody’s management team will host a webcast on July 12, 2021 at 4 p.m. CET / 10 a.m. EDT. Harlan Robins, Chief Scientific Officer of Adaptive Biotechnologies, will also join them to discuss how Adaptive identified the T cell epitopes that Vaccibody will use in its second generation COVID19 vaccine using its proprietary immune medicine platform. A presentation will be available on Vaccibody’s website, www.vaccibody.com/financial-reports-and-presentations, before the webcast.