On December 9, 2021 Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, reported the initiation of a Phase 1 clinical trial to investigate tegavivint in a first-line combination study with osimertinib in previously untreated patients with metastatic epidermal growth factor receptor (EGFR)-positive Non-Small Cell Lung Cancer (NSCLC) (Press release, Iterion Therapeutics, DEC 9, 2021, View Source [SID1234596719]). Tegavivint is a potent and selective first-in-class small molecule inhibitor of Transducin beta-like Protein One (TBL1), a novel downstream target in the Wnt/beta-catenin signaling pathway. The trial (NCT04780568) is sponsored by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), and led by Regan M. Memmott, M.D., Ph.D., an OSUCCC – James oncologist.

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An important clinical challenge with EGFR-TKIs (tyrosine kinase inhibitors), including osimertinib, is that while such drugs are recommended as first line therapy in metastatic EGFR-positive NSCLC, this class of drugs enriches for "drug-tolerant persister cells" (DPCs), resulting in the eventual development of resistance. Researchers at OSUCCC – James determined that enrichment of DPC’s by osimertinib is driven by activation of beta-catenin, and further demonstrated that administration of tegavivint in combination with osimertinib prevented osimertinib-induced enrichment of DPCs. Use of this combination also showed deeper anti-tumor responses and prolonged overall survival in mouse models of EGFR-mutant NSCLC.1

"For the estimated 15-30% of patients in the U.S. who have EGFR-positive NSCLC, treatment with EGFR-TKIs, such as osimertinib, has been shown to be very effective, but unfortunately patients will relapse as a result of their tumors eventually developing resistance," said Dr. Memmott, principal investigator for the study. "Research conducted at OSUCCC – James suggests that combining tegavivint with osimertinib could curtail the osimertinib-induced drug-tolerant persister cells from developing due to tegavivint’s ability to act as a beta-catenin inhibitor via TBL1 inhibition. This new Phase 1 clinical trial evaluates osimertinib in combination with tegavivint as a potential first-line treatment for EGFR-positive NSCLC, which is exciting in a disease that is the No. 1 cause of cancer-related death in the United States."

"We are excited to collaborate with OSUCCC and the National Cancer Institute to initiate this Phase 1 first-line study of tegavivint in combination with osimertinib in previously untreated patients with metastatic EGFR-mutant NSCLC," said Rahul Aras, Ph.D., CEO of Iterion. "NSCLC is the most common type of lung cancer, accounting for 85% of all lung cancer diagnoses, according to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). This trial has the potential to help this enormous patient population and to further demonstrate tegavivint’s unique mechanism of action of TBL1 inhibition, thereby disrupting the oncogenic activity of beta-catenin. Tegavivint has already demonstrated safety in desmoid tumor patients and is currently being investigated in additional clinical trials as a potential treatment for acute myeloid leukemia and solid and hematologic pediatric tumors."

This Phase 1 clinical trial is funded by Pelotonia, a Columbus-based organization that has raised more than $236 million for cancer research conducted at the OSUCCC – James, and the V Foundation.

About Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James)
OSUCCC is one of 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only a few centers funded by the NCI to conduct both Phase 1 and Phase 2 clinical trials on novel anticancer drugs sponsored by the NCI. The James at Brain and Spine Hospital has been ranked one of the top cancer hospitals in the nation by U.S. News & World Report and has achieved Magnet designation, the highest honor an organization can receive for quality patient care and professional nursing practice.

On December 9, 2021 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted premarket approval to it’s Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT (amivantamab-vmjw)*, Janssen Biotech, Inc.’s (Janssen’s) targeted therapy (Press release, Thermo Fisher Scientific, DEC 9, 2021, View Source [SID1234596718]).

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"The FDA’s approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the U.S. who may benefit from this important new therapy," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "In situations where conventional testing may miss key mutations that could match patients with targeted therapies, NGS technology is vital to make these connections and advance precision medicine. We look forward to expanding registration of the test as a companion diagnostic for RYBREVANT globally to help improve outcomes for more patients."

This is the second approval for Oncomine Dx Target Test as a CDx for EGFR Exon20 insertion mutant patients and the 12th NSCLC global approval overall. The test is the first and only FDA-approved next-generation sequencing (NGS) CDx on formalin-fixed, paraffin-embedded (FFPE) tissue for determining RYBREVANT eligibility in patients whose disease has progressed on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer deaths worldwide.1 EGFR mutations are an important therapeutic target in NSCLC; EGFR Exon20 insertion mutations, specifically, are associated with resistance to immune checkpoint inhibitor therapies and poor patient prognosis.2 Further, EGFR Exon20 insertion mutations are often under-detected by conventional, single-gene testing methods.4,5 This is driving the need for more comprehensive biomarker testing with NGS technology, which simultaneously interrogates multiple biomarkers for early identification and appropriate characterization of cancer patient samples.

Thermo Fisher’s Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC. The FDA first approved the test as a CDx in 2017, and it is now approved in the U.S. for six targeted therapies for NSCLC and one for cholangiocarcinoma. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers – EGFR, ALK, ROS1, BRAF, and RET – associated with 10 targeted therapies for NSCLC. The test is the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries. This includes the U.S., multiple European nations, Japan, South Korea and the Middle East, covering more than 550 million lives globally.

On December 9, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (the "Company" or "IceCure"), developer of minimally-invasive cryoablation technology, the ProSense System, reported that destroys tumors by freezing as an alternative to surgical tumor removal, reported the pricing of an underwritten public offering of 3,313,827 shares of the Company’s ordinary shares (the "Ordinary Shares") at a price to the public of $3.45 per share, before underwriting discounts and commissions, and to certain investors in lieu of Ordinary Shares, pre-funded warrants to purchase up to an aggregate of 1,034,000 Ordinary Shares at a price to the public of $3.449 per pre-funded warrant, which represents the per share public offering price for the Ordinary Shares less the $0.001 per share exercise price for each such pre-funded warrant (Press release, IceCure Medical, DEC 9, 2021, View Source [SID1234596717]). The gross proceeds of the offering to the Company are expected to be approximately $15 million, before deducting underwriting discounts, commissions, and other estimated offering expenses. The Company has granted the underwriters a 45-day option to purchase up to an additional 652,173 Ordinary Shares at the public offering price to cover over-allotments, if any. The offering is expected to close on or about December 13, 2021, subject to satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-manager for the offering.

The Company intends to use the net proceeds from the offering for next generation product development, business development, working capital and general corporate purposes.

The offering is being conducted pursuant to IceCure Medical Ltd. registration statement on Form F-1 (File No. 333-261487) previously filed with the Securities and Exchange Commission ("SEC") and declared effective on December 8, 2021. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the prospectus relating to this offering, when available, may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 at (212) 624-2060.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 9, 2021 OncoPep, Inc., a developer of transformative immunotherapeutics, reported $11 million in Series D funding (Press release, OncoPep, DEC 9, 2021, View Source [SID1234596716]). The Series D was led by Tera Science and Kukje Pharma with participation from SX Company and CrystalBioScience.

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The Series D funding will enable OncoPep to continue its clinical trials and advance preclinical development of novel pipeline agents. OncoPep’s lead investigational candidate, PVX-410, is a cancer vaccine in clinical development for smoldering multiple myeloma (SMM) and triple negative breast cancer (TNBC).

"The financial support provided by these global investors is a crucial step in our journey to transform cancer care," said Michael Krepps, SVP of OncoPep. "This funding will allow us to continue clinical exploration of our cancer vaccine in combination with proven cancer therapeutics such as pembrolizumab and lenalidomide, and also accelerate preclinical studies for our novel cell therapies and immunotherapeutics," he added.

In anticipation of expanding its discovery pipeline and clinical development programs, the Massachusetts-based OncoPep has secured new laboratory space in Waltham, MA and office space in Boston’s Kendall Square. OncoPep is also growing its advisory team with the addition of Dr. Dennis Klinman, MD, PhD and Dr. Christopher Bahl, PhD to the Scientific Advisory Board.

Dr. Klinman has given pivotal contributions to the field of immuno-oncology and vaccinology by being the first to discover CpG oligonucleotides (TLR9 agonists), which are used as immune modifiers in FDA-approved vaccines and for cancer therapy. He spent 15 years at the National Cancer Institute as a Senior Investigator and served as the head of the NCI Cancer and Inflammation Program’s Immune Modulation Section. Dr. Klinman earned his MD and PhD in Medicine from the University of Pennsylvania. His extensive experience in pre-clinical and clinical trial development of novel immunotherapeutics will be a valuable contribution to OncoPep’s efforts to improve cancer patient outcomes.

Dr. Bahl is fusing cutting-edge computer science with synthetic protein biology to develop a new class of therapeutics. In 2019, Dr. Bahl was selected as a TED Fellow for his pioneering work on the de novo design of novel mini-proteins and constrained peptides, an innovative approach for creating therapeutics with potential to tackle long-standing challenges in medicine. In his postdoctoral studies, he successfully developed computational design methods to create constrained peptides, molecules that meld the best attributes of antibodies and small molecules into promising biologic drugs. He is the former Head of Protein Design at the Institute for Protein Innovation and his experience in advancing the protein design field will contribute immensely to OncoPep’s efforts to develop transformative immunotherapeutics. He earned his PhD in Biochemistry from Dartmouth University and holds a BS and MS from the University of Maine.

On December 9, 2021 Eucure Biopharma, a wholly owned subsidiary of Biocytogen, reported the first patient dosing for a phase I clinical trial of YH004 (anti-4-1BB monoclonal antibody, mAb) (No. YH004002) in Australia (Press release, Biocytogen, DEC 9, 2021, View Source [SID1234596714]).

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The study is an open-label, multi-center, classical dose-escalation phase I study of YH004 monotherapy or YH004 in combination with anti-PD-1 mAb. Subjects are patients with advanced solid tumors or relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL). The objective of the study is to evaluate the safety, tolerability and efficacy of YH004 alone or in combination with anti-PD-1 mAb in patients with advanced solid tumors or R/R NHL. Pharmacokinetics and immunogenicity of YH004 will also be evaluated.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that Eucure Biopharma plans to continue making rapid progress in clinical studies of YH004, so that patients around the world may be able to access the therapy as soon as possible.

About YH004
YH004 is a humanized IgG1 agonistic monoclonal antibody (mAb) targeting 4-1BB with high affinity and specificity. YH004 can enhance the immune response against tumors through multiple mechanisms. Antibody-mediated activation of 4-1BB can enhance the co-activation of T cells, enhance NK cell cytotoxicity, promote the maturation of antigen presenting cells (APCs) and inhibit regulatory T cells (Tregs). Both in vitro and in vivo data indicates that YH004, whether alone or in combination with anti-PD-1 antibody, exhibits significant anti-tumor activities with good safety and tolerability.