On September 16, 2020 OCTIMET Oncology NV, a clinical-stage Belgian life science company with a focus on the development of highly selective, differentiated MET kinase inhibitors, reported the licensing of the Greater China rights for its lead clinical compound OMO-1 and a second preclinical asset exclusively to Shanghai Allist Pharmaceuticals Co., Ltd (Press release, Octimet Oncology, SEP 16, 2020, View Source [SID1234565266]).

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OMO-1 is an oral, highly selective small molecule MET kinase inhibitor, that has demonstrated potent single agent and combination activity in a range of preclinical cancer models.

OMO-1 has been evaluated in a monotherapy setting as well as in combination with small molecule EGFR tyrosine kinase inhibitors (TKIs) in Europe, showing a favorable safety profile and early signs of efficacy in MET-selected cancer patients. Allist will drive the clinical development of this compound in China, initially focusing on expanding the combination data with Allist’s third generation EGFR TKI Furmonertinib (AST2818). In China, more than 38% of NSCLC patients harbor activating EGFR mutations, making the region ideal for completing expanded clinical efficacy studies more rapidly whilst addressing a large potential market.

"We are proud to have Shanghai Allist Pharmaceuticals Co., Ltd. as a partner in developing this exciting therapeutic agent," said Shelley Margetson, Chief Executive Officer of OCTIMET. "Development in China is strategically important for OMO-1 and we look forward to seeing the results of the combination studies with Allist’s EGFR TKI compound, thereby making a difference for cancer patients in need of efficacious targeted therapies."

"MET amplification is known to be a key driver of resistance to EGFR TKIs. We are excited to explore further the combination of OMO-1, a differentiated selective MET kinase inhibitor, with our innovative third generation EGFR TKI Furmonertinib and look forward to generating significant efficacy data that will aim to meet clinical unmet need in providing further treatment for seriously ill cancer patients who have few other therapy options," said Ms. Sandy Mou, the CEO from Allist Pharmaceuticals.

About OMO-1

OMO-1 is a small molecule inhibitor of the enzymatic activity of the MET receptor tyrosine kinase (RTK). The MET gene has been shown to be responsible for some hereditary types of cancer. In addition, inappropriate MET activation has been shown in most types of solid tumors, often correlating with poor prognosis (Trusolino et al 2010, Gheradi et al 2012).

About EGFR Tyrosine Kinase Inhibitors

Lung cancer is the leading cause of cancer-related mortality worldwide. Of all lung cancer cases, 80–85% are non-small-cell lung cancers (NSCLC), and the majority of these cases are in advanced or metastatic stage (III or IV) at the time of diagnosis. Among these patients with NSCLC, a substantial number are harboring activating EGFR mutations, ranging from 10% in Europe to 38.4% in Asia. During the past years, EGFR tyrosine kinase inhibitors (TKIs) have been developed and have become standard first-line treatment for patients with EGFR mutation-positive NSCLC. Various trials showed higher response rates and improved progression-free survival (PFS) for first-line treatment with the EGFR TKIs afatinib, erlotinib, and gefitinib compared to platinum-based doublet therapy in patients with activating EGFR-mutated NSCLC.

On September 16, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported a publication in the peer reviewed, open access journal OncoImmunology of a paper on HB-201, an arenavirus vector-based immunotherapy for Human Papillomavirus 16-positive (HPV16+) cancers currently in clinical trials (Press release, Hookipa Pharma, SEP 16, 2020, View Source [SID1234565233]).

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The paper shows that systemically administered HB-201 leads to:

Dose-dependent induction of a robust, systemic cytotoxic T cell response directed against HPV16 proteins;
Tumor infiltration of HPV16 specific cytotoxic T cells; and
Significantly delayed tumor growth or complete tumor clearance accompanied with prolonged survival.
Mice that have cleared tumors post-HB-201 administration developed long-term protection, as demonstrated by the rejection of re-administered tumors. Furthermore, the combination of HB-201 with a checkpoint inhibitor (a-PD-1) increased the anti-tumor efficacy, with more than 77% of treated mice clearing established tumors.

HB-201 is one of HOOKIPA’s lead oncology candidates. It targets HPV16 E6/E7 and is based on the Company’s replicating LCMV (TheraT) arenaviral vector platform. It is currently in Phase 1/2 clinical trials (NCT04180215) for HPV16+ cancers alone and in combination with an approved checkpoint inhibitor.

"HPV-associated cancers, especially head and neck cancers, remain a significant health concern, as no curative therapies are currently available. We are very pleased that these results suggest that the HB-201 program can be a promising therapy for HPV+ cancers," said Igor Matushansky, MD, PhD, HOOKIPA’s Chief Medical Officer and Global Head of Research and Development.

Human Papillomavirus, or HPV, is estimated to cause about 5% of the worldwide burden of cancers. This includes approximately 99% of cases in cervical, up to 60% of head and neck, 70% of vaginal and 88% of anal cancers.

The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous. The publication, "Live-attenuated lymphocytic choriomeningitis virus-based vaccines for active immunotherapy of HPV16-positive cancer", is available online in OncoImmunology.

On September 16, 2020 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a cancer immunotherapy company focused on developing first-in-class biotherapeutics that target novel immunosuppressive myeloid checkpoints, reported that the first patient has been dosed in its Phase I study evaluating IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) (Press release, Immune-Onc Therapeutics, SEP 16, 2020, View Source [SID1234565250]). The Phase I dose escalation and expansion trial will evaluate IO-202 in patients with acute myeloid leukemia (AML) with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).

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IO-202 is the first T-cell activator for AML. In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking leukemia infiltration.

"I am thrilled that we’ve met this important goal and with the support of our investigators are one step closer to bringing a new approach to the treatment of blood cancers, AML and CMML," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "As we learn more about myeloid cell biology and its role in cancer, we see opportunities to explore the potential of IO-202 and other novel antibodies in other types of cancer, including solid tumors, in the near future."

The dose-escalation phase of the trial will identify the optimal dose of IO-202. Once the recommended dose of IO-202 is selected, the trial will enroll patients in an expansion cohort to evaluate IO-202 as monotherapy. There is potential to evaluate IO-202 in combination with other agents with a protocol amendment. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. In August, the company announced it had been awarded a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support development of IO-202.

ABOUT AML and CMML

AML, the most common acute leukemia (blood and bone marrow cancer) in adults, is characterized by the proliferation of abnormal myeloblasts (a type of white blood cell) in the bone marrow. Nearly 20,000 new cases are expected in the U.S. in 2020. Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.

CMML is a cancer that starts in blood-forming cells in the bone marrow and invades the blood. The condition is rare, with about 1,100 cases in the U.S. each year.

ABOUT IO-202

IO-202 is a first-in-class monoclonal antibody that blocks signaling of leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), an immune inhibitory receptor, with high binding affinity and specificity. In October 2018, Immune-Onc and The University of Texas published pioneering research in Nature (DOI: 10.1038/s41586-018-0615-z) illuminating the roles of LILRB4 in immune suppression and tumor infiltration in AML. IO-202 is the first T-cell activator for AML. Preclinical studies showed that IO-202 can convert a "don’t kill me" to "kill me" signal by activating T cell killing of AML cells and a "don’t find me" to "find me" signal by inhibiting leukemia infiltration.

On September 16, 2020 Yufan Biotechnologies reported that Exhaustion of T-cells is a key reason why CAR T-cell therapy may fail to control cancer (Press release, Yufan Biotechnologies, SEP 16, 2020, View Source [SID1234565268]). Recent work led by Xuebin Liao, PhD, Professor of Pharmaceutical Science at Tsinghua University (Si et al., Cancer Cell 2020) shows that HPK1 (hematopoietic progenitor kinase 1) promotes T cell exhaustion via NFkB-Blimp1 activation and that blocking HPK1, either by gene knockout or by small-molecule inhibitors, is an attractive strategy to improve CAR T-cell immunotherapy . These innovative approaches are being evaluated clinically by Yufan Biotechnologies, co-founded by Professor Liao and Yan Zhang, CEO.

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Yufan Biotechnologies has now partnered with Abound Bio, Inc, a life sciences company with world-renowned expertise in finding antibodies to direct CAR T-cells against cancer targets. Abound Bio was co-founded by Dimiter Dimitrov, PhD, and John Mellors, MD, CEO. The three-year partnership covers the incorporation of antibodies to novel cancer targets into the enhanced, HPK1-inhibited CAR T-cell platform.

"We are very excited by the potential to improve cancer therapy through the combination of Yufan’s enhanced CAR T-cell technology and Abound’s highly-specific antibodies," said John Mellors, CEO of Abound Bio.

"Dr. Dimitrov and Dr. Mellors are leading scientists. Our partnership with Abound Bio has the potential to improve CAR T-cell products for cancer therapy," said Yan Zhang, CEO of Yufan Biotechnologies.

The agreement covers 10 cancer targets over multiple years with shared inventorship and development rights for the new technologies.

On September 16, 2020 Pascal Biosciences Inc. (TSX.V:PAS) ("Pascal") reported that has been invited to present at the International Cannabinoid Derived Pharmaceutical (ICDP) Summit (Press release, Pascal Biosciences, SEP 16, 2020, View Source [SID1234565234]). Today Dr. Patrick Gray, CEO of Pascal Biosciences, will present advancements in each of Pascal’s three cannabinoid programs. The title of his presentation is "Identifying and Validating Mechanism of Action In Vivo and In Vitro".

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The Third Annual ICDP conference is the premier format for presentation of ground-breaking discoveries in cannabinoid drug development. As in past years, this conference is hosting top cannabinoid pharmaceutical experts developing therapeutics derived from cannabis. In addition to describing progress for Pascal’s programs in glioblastoma and coronavirus, Dr. Gray will also discuss plans for developing PAS-393 for treatment of cancer in combination with checkpoint inhibitors. This will be a collaborative effort with SōRSE Technology and aims to characterize the safety, pharmacology, and pharmacokinetics of PAS-393 in a Phase 1a clinical trial.

"I am very pleased for the invitation to present Pascal’s work at this impressive conference," commented Dr. Gray. "This validates the importance of our efforts, and we will be featured with other companies making significant advancements in developing cannabis-based medicines."

The session featuring Pascal’s presentation is focused on preclinical testing of cannabinoid therapeutics. Dr. Gray will also participate in a panel discussion titled "Achieving the Ideal Pharmacokinetic and Pharmacodynamic Profiles in Drug Formulation".