On April 19, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported the Company will present at the virtual LILRB/ILT Symposium: A Deep Dive into Myeloid Checkpoint Therapeutics in Cancer on Tuesday, April 26, 2022, at 2:00 PM EDT, hosted by Raymond James biotech analysts (Press release, Immune-Onc Therapeutics, APR 19, 2022, View Source [SID1234612509]). Charlene Liao, Ph.D., chief executive officer of Immune-Onc and Paul Woodard, M.D., chief medical officer, will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond. Dr. Chengcheng (Alec) Zhang, Professor of Physiology at UT Southwestern Medical Center and Scientific Founder of Immune-Onc, will give an expert presentation on the LILRB/ILT family of receptors as myeloid checkpoint targets in immuno-oncology at 2:30 PM EDT.

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"As a private company and a leader in LILRB/ILT family of myeloid checkpoint target validation and therapeutics development, we are pleased to be invited to the Raymond James LILRB/ILT Symposium," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "Immune-Onc was founded on groundbreaking science that first illuminated the role of the previously unexplored LILRB family of myeloid checkpoints in cancer. This research has rapidly advanced a completely new field of study and class of cancer immunotherapy that goes beyond T cells to overcome immune resistance and the limitations of current treatment options. We look forward to sharing our pipeline progress on the same stage with our Scientific Founder Dr. Alec Zhang."

On April 19, 2022 Oncomatryx reported that it is embarking on a new phase in the development of its tumor microenvironment – targeted ADCs (Press release, Oncomatryx, APR 19, 2022, View Source [SID1234612508]).

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OMTX705, the Crown Jewel, has already proven high antitumor efficacy and unbeatable ADC safety in murine and non-human primate models. Phase I clinical trials in patients suffering metastatic solid tumors will be launched in Europe and USA in Q2 2022.

In order to fund OMTX705 Phase I clinical trials, Oncomatryx has raised 15 million euros. The capital increase was funded by current shareholders and by national and international family offices. These funds, together with Oncomatryx recurring revenues from its licensing agreements with international biopharmaceutical companies, will be used for the clinical development of additional ADCs of Oncomatryx tumour-microenvironment pipeline. The total investment for the three-year period 2022-2024 will be 50 million Euros.

In addition, Dr. Ignacio Garcia-Ribas has been appointed as Medical Director of Oncomatryx. Dr. Garcia-Ribas will lead the clinical development of OMTX705 and oversee the transition of molecules in the Oncomatryx pipeline from preclinical to clinical studies.

Dr. Garcia-Ribas is a medical oncologist with 17 years of experience in early-stage oncology drug development. Most recently he was Chief Medical Officer of the Swedish company Cantargia where he created and implemented the initial development plan for Nadunolimab in both Europe and USA. He previously worked at Takeda as global clinical lead on several Phase 1/2 programmes with a specific focus on immuno-oncology, and before that he was Senior Medical Director and a member of the Early Development Group of Sanofi’s Oncology Division where he was involved in the clinical development of small molecules and ADCs. Prior to that, he was part of the Early Development Unit at Eli Lilly, where he contributed to the development of several small molecules and antisense oligonucleotides. Dr. Garcia Ribas received his PhD in Medicine from the Richard Dimbleby Cancer Research Department/ICRF Unit at St. Thomas’ Hospital in London, which focused on cancer gene therapy.

On April 19, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program ADI-001, an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL) (Press release, Adicet Bio, APR 19, 2022, View Source [SID1234612507]).

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ADI-001 is currently being evaluated in an ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001 for the potential treatment of NHL. The Fast Track Designation was granted based on ADI-001’s potential to address an unmet need within the adult NHL patient population.

"Fast Track Designation represents an important milestone in the clinical development of ADI-001," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We believe ADI-001 is unique in that it is designed to target malignant B cells by leveraging the innate and adaptive receptors found naturally on gamma delta T cells with the added benefit of an engineered anti CD20 CAR. We remain optimistic about the potential of our program and look forward to reporting additional data from the Phase 1 trial of ADI-001 in the first half of 2022."

Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

On April 19, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ reported a peer-reviewed publication in ClinicoEconomics and Outcomes Research outlining the potential clinical and health economic benefits of lenzilumab, if authorized or approved for use in the United Kingdom (Press release, Humanigen, APR 19, 2022, View Source [SID1234612506]).

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"As COVID-19 continues to place significant burden on the National Health Service ("NHS"), this paper demonstrates there is an opportunity to realize significant cost savings for healthcare systems of the UK while improving outcomes for patients. As a variant-agnostic treatment, lenzilumab may offer both a clinically effective and cost-effective option against current and emerging variants," said Adrian Kilcoyne, M.D., Chief Medical Officer, Humanigen, the lead author of the publication.

The publication demonstrated, in all cases, lenzilumab plus SOC improved all specified clinical outcomes compared with SOC alone. Additionally, patient selection, utilizing CRP<150 mg/L as a biomarker, optimized both clinical and economic outcomes. The observed cost savings are mainly driven by fewer bed days, days on invasive mechanical ventilation and ICU days.

The greatest per-patient cost savings were for patients aged <85 years, CRP <150 mg/L, and receiving remdesivir of £10,427 (net savings of £3,127 after expected lenzilumab acquisition costs); and for Black patients with CRP <150 mg/L of £17,277 (net savings of £9,977).

"During these unprecedented and challenging times, we are preparing to commercialize lenzilumab, if authorized or approved, as a single day treatment and a potential driver of clinical and economic value to patients and the healthcare system," said Edward Jordan, Chief Commercial Officer, Humanigen.

This peer-reviewed publication highlights the significant costs of treating hospitalized COVID-19 patients and the economic benefits of potentially improving survival without ventilation, reducing ventilator use, hospital days and ICU days which may be associated with adding lenzilumab to standard of care.

Lenzilumab is an investigational product and is not approved or authorized in any country.

About Lenzilumab

Lenzilumab is a proprietary Humaneered first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19. Humanigen believes that GM-CSF neutralization with lenzilumab also has the potential to reduce the hyper-inflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor T-cell (CAR-T) therapy and acute Graft versus Host Disease (aGvHD).

In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta in which the overall response rate was 100% and no patient experienced severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 3 study ("SHIELD") to evaluate its efficacy and safety when combined with Yescarta and Tecartus CAR-T therapies in non-Hodgkin lymphoma. Lenzilumab will also be tested to assess its ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, that showed RAS mutations are associated with hyper-proliferative features, which may be sensitive to GM-CSF neutralization.

On April 19, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that dosing of the first patient in the Company’s streamlined, multi-cohort Phase 1/2 study of oral CYC140 in patients with advanced solid tumors and lymphomas (Press release, Cyclacel, APR 19, 2022, View Source [SID1234612505]).

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"With the start of this trial, Cyclacel is now enrolling patients across three registration-directed studies to evaluate safety and efficacy of our two lead drug candidates, fadraciclib and CYC140, for the treatment of various solid tumors, lymphomas and leukemias," said Spiro Rombotis, Cyclacel’s President and Chief Executive Officer. "As with the fadraciclib studies, the Phase 1 stage of this trial will determine an optimal dosing regimen of oral CYC140 and provide insights with respect to safety, tolerability and clinical activity. The Phase 2 stage will enroll up to seven cohorts by histology and also a basket cohort. We expect initial data from this trial during the first half of 2023. We also look forward to reporting initial data from the fadraciclib clinical study in advanced solid tumors during the first half of 2022."

"Overexpression of PLK1 is known to be important in many types of cancer," said Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer. "We have optimized the properties of CYC140 to fit its apoptosis-driven mechanism, including a short half-life and differentiated structural and biological properties, compared to other PLK1 inhibitors in development. In preclinical studies CYC140 has demonstrated promising activity in multiple solid tumors and leukemias. The study has initially opened at City of Hope and MD Anderson Cancer Center with more sites to join later on. In addition to patients with certain PLK1 over-expressing tumors, the study will enroll patients with MYC amplified and KRAS-mutated cancers in which PLK1 inhibition may be effective. If successful, CYC140 may provide new treatment options for patients with advanced solid tumors or lymphomas."

"As a key regulator of cell mitosis, PLK1 plays an integral role in prolonged survival of many cancer cells, including p53(-) and KRAS mutant genotypes," said Miguel Villalona-Calero, M.D., co-leader of the Development Cancer Therapeutics Program and Professor, Department of Medical Oncology & Therapeutics Research at City of Hope, one of the largest cancer research and treatment organizations in the United States. "The totality of preclinical evidence suggests that CYC140 has significant potency and single-agent activity. This novel agent warrants clinical investigation across multiple solid tumors and lymphomas."

The Phase 1/2 registration-directed trial, designated CYC140-101, uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to 7 mechanistically-relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for CYC140.

About Polo-like kinase 1 (PLK1) and CYC140

Polo-like kinase 1 (PLK1) is a serine/threonine kinase that plays a central role in cell division or mitosis. PLK1 is an important regulator of the DNA damage cell cycle checkpoint, mitotic entry and exit, spindle formation and cytokinesis, or cell separation into daughter cells. Cancer cells in general, and in particular KRAS mutated and p53(-) cells, are very sensitive to PLK1 depletion. In contrast normal cells with intact cell cycle checkpoints are less sensitive. Pharmacological inhibition of PLK1 in cancer cells blocks proliferation by prolonged mitotic arrest and induces onset of apoptotic death of such cells.

CYC140 is a novel, small molecule, selective and potent PLK1 inhibitor. It has demonstrated impressive efficacy in human tumor xenografts at nontoxic doses. Cyclacel’s translational biology program supports the development of CYC140 in solid tumors and leukemias. CYC140 was designed with improved pharmaceutical properties over earlier clinical-stage PLK inhibitors. Recent data suggest that PLK1 inhibition may be effective in KRAS-mutated metastatic colorectal cancer. PLK1 overexpression correlates with poor patient prognosis in several tumors, including esophageal, gastric, leukemia, lung, ovarian, and squamous cell cancers, as well as MYC-amplified cancers.