On October 31, 2022 OncoPrecision reported $3.3 million in Seed Funding to further develop its Patient Micro Avatar technology which seeks to recreate cancer patients’ disease ex-vivo to precisely evaluate the response of these avatars to a wide range of both Standard of Care and explorational treatments within a week (Press release, OncoPrecision, OCT 31, 2022, View Source [SID1234622659]). The company’s goal is to unlock precise patient-specific insights that may help oncologists determine the best course of treatment, as well as to collaborate with the biopharmaceutical industry to optimize the development of transformational therapeutics.

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The funding was closed in April with the participation of SOSV’s IndieBio, GRIDX, New York Ventures (the venture capital arm of the State of New York), Creative Ventures, Fundación Para el Progreso de la Medicina (a high-complexity diagnostics lab where the company’s Argentine lab is based), exited biotech and non-biotech founders, as well as strategic angel investors and family offices. OncoPrecision has raised a total of $4.2 million to date.

The company’s high-throughput platform focuses on obtaining patient-derived cells from biopsies and recreating the tumor microenvironment by combining them with proprietary engineered cells that seek to "trick" the cancer cells to act as though they were still in the patient’s body. With this combination of patient-derived cells and engineered cells, OncoPrecision creates highly-miniaturized Patient Micro Avatars which are then dosed with single and combinatory drugs simultaneously. Each Avatar’s response to treatment is then analyzed at a high resolution using flow cytometry and machine learning models that accurately track the response of the distinct cell populations within each Avatar. With these insights, OncoPrecision is hoping to offer its Drug Activity and Resistance Test (DART) as a service to assist clinicians to prescribe the most appropriate treatment, as well as collaborate with the pharmaceutical industry to increase the success rate of oncology drug development.

OncoPrecision is currently performing clinical validation studies with multiple cancer centers for its Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia models and is advancing in the development of its technology for additional hematologic and solid cancers. The company is also in active drug development collaborations.

The company was founded in late 2020 by Dr. Gastón Soria, Dr. Candelaria Llorens, Dr. Gerardo Gatti and repeat founder Tarek Zaki. OncoPrecision was born as an idea that originated while Dr. Soria was leading his Synthetic Lethality Lab at the National University of Córdoba after returning from his Postdoctoral Studies in Epigenetics at Institut Curie and the Erasmus Medical Center. Dr. Soria’s Lab was focused on the development of high-throughput screening technologies for target identification and drug discovery in collaboration with some of the largest pharmaceutical companies in the world when he realized that patient-derived models had the potential to create a paradigm shift in cancer treatment.

"The heterogeneous nature of cancer and its devastating impact on patients truly requires each case to be treated as a unique disease. Precision Oncology holds great promise, but it has historically been synonymous with Genetics, which unfortunately play a limited role in true response prediction," said Kulika Weizman, Principal at Creative Ventures. "We believe in OncoPrecision’s radically different approach and are thrilled to join them on their journey to improve patient outcomes through truly personalized cancer treatment from bench to bedside."

"During my academic career, I first fell in love with Genetics as potentially holding some of the elusive answers we’ve been searching for during decades of cancer research. Once I realized Genetics wouldn’t entirely answer them, I shifted my focus towards Epigenetics as the potential path forward until I realized that they wouldn’t give us all the answers either," said Dr. Gastón Soria, Co-Founder & Chief Scientific Officer. "At OncoPrecision, we have the humbling view that while we are not capable yet to understand the complex mechanisms behind cancer therapy outcomes, cancer cells hold the answer, by integrating not only Genetics and Epigenetics, but also the plethora of layers that ultimately drive response or non-response to treatment."

"We’re at a pivotal moment in cancer care when shifting away from the historic one-size-fit-all approach towards bespoke treatments that are tailored to each patient is a possibility," said Tarek Zaki, Co-Founder & CEO. "We founded OncoPrecision to make that a reality."

On October 31, 2022 Theravance Biopharma, Inc. (NASDAQ: TBPH) reported that it will report its third quarter 2022 financial results and provide a business update after market close on Monday, November 7, 2022 (Press release, Theravance, OCT 31, 2022, View Source [SID1234622658]). An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm ET (2:00 pm PT/10:00 pm GMT) that day.

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Conference Call Information

To participate in the live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investors section, Presentations and Events.

A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through December 7, 2022.

On October 31, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Company will release its third quarter 2022 financial results on Monday, November 14, 2022, before the U.S. financial markets open (Press release, Compugen, OCT 31, 2022, View Source [SID1234622657]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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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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As part of the update, management will discuss Compugen’s data to be presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held on November 8-12, 2022.

To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S.,
or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link

Following the live webcast, a replay will be available on the Company’s website.

On October 31, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that their first patient has been successfully dosed, in a phase I clinical study evaluating the combined treatment with Senhwa’s Pidnarulex, the 2019 PCF-Pfizer Global Challenge Awards winner and Pfizer’s PARP inhibitor, Talazoparib (Talzenna), in patients with metastatic castration-resistant prostate cancer(mCRPC) (Press release, Senhwa Biosciences, OCT 31, 2022, View Source [SID1234622656]). The study will be conducted by Peter MacCallum Cancer Centre (PMCC), Senhwa’s clinical partner in Melbourne, Australia.

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This Phase I trial of Pidnarulex and Talazoparib will be mainly funded by the US Prostate Cancer Foundation (PCF) and Pfizer. Senhwa will provide supplies of their study drug, Pidnarulex, in addition to specific funding for the study.

In 2020, US FDA granted approval of the use of PARP inhibitors (PARPi), such as olaparib (Lynparza) and rucaparib (Rubraca), to treat prostate cancer patients, whose tumors have specific genetic alterations. The most common gene alterations in this population were BCRA1/2. While BRCA1/2 deficient tumor cells are responsive to PARPi treatments, the development of PARPi resistance is common.

In a previous Phase I trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2 and PALB2 mutations and that were also resistant to PARP inhibitors, platinum-based drugs and other chemotherapeutics.

"Pidnarulex, alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. Therefore, we think Pidnarulex demonstrates great potential as an alternative treatment for prostate cancer patients who have acquired resistance to PARPi or other chemotherapies," said Dr. Jin-Ding Huang, Chief Executive Officer of Senhwa Biosciences.

Prostate Cancer is the second most lethal cancer for men in the United States. Although nearly 70% of patients can be cured with surgery, once the cancer has metastasized, almost all patients develop into castration-resistance (a form of advanced prostate cancer in which the cancer no longer completely responds to treatments that lower testosterone), with a median survival time of less than two years.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On October 31, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Investigational New Drug (IND) application for ATG-017 has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, Antengene, OCT 31, 2022, View Source [SID1234622654]). The IND clearance enables Antengene to initiate the combination portion of the Phase I "ERASER" clinical trial in the United States (U.S.) to evaluate the safety, pharmacokinetics, and preliminary efficacy of ATG-017 combination therapy with nivolumab in patients with advanced solid tumors.

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ATG-017 is an oral, potent, and selective inhibitor of extracellular signal-regulated protein kinase 1 and 2 (ERK1/2). Nivolumab is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. The clinical collaboration between Antengene and Bristol Myers Squibb to evaluate ATG-017 in combination with nivolumab builds on Antengene’s preclinical data. The data, including studies presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-conference Programs in November 2021, has demonstrated that the combination of an ERK1/2 inhibitor and an immune checkpoint inhibitor (ICI) worked synergistically to produce improved efficacy in preclinical ICI-resistant in vivo mice models.

"We are excited to have received IND clearance for activation of the ERASER study in the U.S. Preclinical results with ATG-017 have been very promising both as a monotherapy and in combination with ICIs in aggressive and resistant malignancies. We are very pleased that the further clinical exploration will involve multiple geographies as we attempt to define the potential role of ATG-017 as a novel cancer treatment," said Dr. Kevin Lynch, Antengene’s Chief Medical Officer."Every day, we see advanced cancer patients with limited treatment options. We intend to initiate the study in the U.S. soon, and hope that ATG-017 will eventually offer a safe and effective new treatment option to those patients in need."

"The development of new therapies for cancer patients with refractory, relapsed, or advanced diseases is a cornerstone of Antengene’s work. ATG-017 is an exciting compound because of its attractive pharmacology, impressive preclinical activity on the RAS-MAPK pathway and the potential ability to synergize with ICIs. These attributes provide the rationale for evaluating ATG-017 as a monotherapy and in combination with ICIs such as nivolumab in patients with resistant or relapsed disease," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "We are very encouraged by this IND clearance from the U.S. FDA as it paves the way for one of Antengene’s first studies in the U.S. and marks an important milestone in the global clinical development of ATG-017. We look forward to initiating patient enrollment of the ERASER trial in the U.S."

About ATG-017

ATG-017 is an oral, potent, and selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor. ERK1/2 are related protein-serine/threonine kinases that function as terminal kinases in the RAS-MAPK signal transduction cascade. This cascade regulates a large variety of cellular processes, including proliferation. The RAS-MAPK pathway is dysregulated in more than 30% of human cancers with the most frequent alterations being observed in RAS or BRAF genes across multiple tumor types. An ERK inhibitor enables the targeting of both RAS and BRAF mutant diseases.

Antengene presented data at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-conference Programs in November 2021 detailing compelling preclinical results showing the combination of ATG-017 and an anti-PD-L1 monoclonal antibody (atezolizumab) in an aggressive immune checkpoint resistant murine cancer model rendered "cold" tumors "hot". To date, ATG-017 has been approved in Australia and the United States to enter clinical studies in patients with advanced solid tumors or hematologic malignancies.