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.

On December 9, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported enrollment of the first patient in its open-label phase 1 trial of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, in metastatic castration-resistant prostate cancer (mCRPC) (Press release, Immunic, DEC 9, 2021, View Source [SID1234596713]).

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The trial’s Principal Investigator is Johann Sebastian de Bono, M.D., Ph.D., Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine, The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London. The trial has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the Research Ethics Committee (REC) and the Health Research Authority (HRA) in the United Kingdom.

"After receiving available established treatments, many of which are being given soon after diagnosis, few effective treatments remain for men suffering from mCRPC with this disease being invariably fatal. There is therefore an urgent need to find alternative therapeutic options," stated Professor de Bono. "Preclinical data indicate that IMU-935 may suppress the expression of the mutated AR-V7 receptor, which is a hallmark and progression driver of CRPC. In addition, by repressing pro-tumorigenic Th17 cells and IL-17 cytokines, IMU-935 may further impact tumor growth. I look forward to exploring the anticancer activity of this agent against mCRPC."

"As one of world’s leading experts on the subject of castration-resistant prostate cancer, Professor de Bono’s expertise and deep understanding of the unique mechanism of action of IMU-935 provides important corroboration of this key pipeline program within the scientific and clinical communities," noted Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Based on the compelling preclinical data highlighting the therapeutic potential of IMU-935 to affect mCRPC, which is the second leading cause of cancer-related death among men, we recognize the potential importance of this program. We are pleased to have enrolled the first patient on plan and look forward to continuing to progress the trial."

The phase 1 trial is structured in two portions: a dose-escalation part and an optional expansion part. A total of between 18 and 24 patients are planned to be enrolled in the dose-escalation part at three dose levels of IMU-935 to be given for three cycles of 28 days each. At each of the three dose levels, a safety analysis after 28 days and an interim analysis after three months of treatment will be performed. The main analysis for this trial is planned after the last patient has received six months of study treatment. The primary objective is to evaluate the safety and tolerability of increasing doses of IMU-935 to establish the maximum tolerated dose and the recommended phase 2 dose. The trial will also evaluate the anti-tumor activity of IMU-935 by means of prostate-specific antigen (PSA) levels, circulating tumor cell (CTC) numbers, and radiographic response assessments of tumor progression. Patients who receive a benefit from IMU-935 will have the option to continue treatment until progression. Following completion of all dose-escalation cohorts, an expansion cohort at one or two therapeutically active dose levels with up to 18 additional patients may be performed to support selection of a recommended phase 2 dose. Initial clinical data is expected to be available in the third quarter of 2022.

The company also re-iterates its prior guidance that data from the multiple ascending dose part of the ongoing phase 1 trial of IMU-935 is expected in the fourth quarter of 2021, with initial clinical data in psoriasis expected in the second quarter of 2022, and that regarding vidofludimus calcium (IMU-838), phase 2 top-line data in ulcerative colitis is expected to be available in the second quarter of 2022.

For more information on the phase 1 clinical trial of IMU-935 in mCRPC, please visit: www.clinicaltrials.gov, NCT05124795.

About Castration-Resistant Prostate Cancer
Castration-resistant prostate cancer (CRPC) is a form of advanced prostate cancer. Approximately 200,000 new cases of prostate cancer are diagnosed each year in the United States, with roughly 40,000 cases progressing to CRPC. Because early stages of prostate cancer rely on testosterone to grow, approaches to lower testosterone can be employed therapeutically. With CRPC, the cancer no longer completely responds to treatments that lower testosterone, significantly limiting available treatment options in these patients. Common sites of metastasis are lymph nodes, bones, bladder, rectum, lung, or liver. Although metastatic CRPC may be asymptomatic, typical signs/symptoms include problems urinating, pain while passing urine or blood in the urine, tiredness, weakness, weight loss, shortness of breath, or bone pain. The main goal in treating metastatic CRPC is to control symptoms and slow progression.

About IMU-935
IMU-935 is a highly potent and selective inverse agonist of RORγt (retinoic acid receptor-related orphan nuclear receptor gamma truncated) with additional activity on DHODH (dihydroorotate dehydrogenase). The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong cytokine inhibition targeting both Th17 and Th1 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and inflammatory bowel disease. Preclinical experiments indicate that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation. IMU-935 is an investigational drug product that has not been approved in any jurisdiction.