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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On December 9, 2021 Exai Bio, a next-generation liquid biopsy company, reported it has raised a $67.5 million Series A financing to accelerate development of its non-invasive, RNA-based liquid biopsy platform for early cancer detection (Press release, Exai Bio, DEC 9, 2021, View Source [SID1234596709]). The financing was led by leading life sciences and tech investors Section 32 and Casdin Capital, with participation from Two Sigma Ventures, who have been integral to advancing cancer diagnostics and artificial intelligence/machine learning technologies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Exai Bio’s platform delivers unprecedented clinical insight into cancer biology from non-invasive blood samples enabling early and accurate diagnosis of cancer to inform personalized care treatments. Unlike first generation liquid biopsy tests which measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns), Exai Bio’s proprietary platform measures cell-free RNA profiles, analyzing them using advanced artificial intelligence and machine learning algorithms. Specifically, Exai Bio is focused on orphan non-coding RNA (oncRNA), small RNA sequences not seen in normal tissue but abundant in tumors. In liquid biopsy samples, these tumor-specific oncRNAs translate to higher sensitivity and specificity, ultimately enabling a more accurate diagnosis as compared to ctDNA-based liquid biopsy tests. Exai Bio’s approach is applicable across multiple unmet needs in cancer.

"Exai Bio is the first company founded to explore the important role of oncRNA in early and more accurate cancer detection and its important impact on improved patient outcomes and health economics," said Patrick Arensdorf, chief executive officer, Exai Bio. "Combining oncRNA technology with cutting-edge machine learning and artificial intelligence to decipher tumor signals and understand the active biology of disease, Exai Bio’s next generation liquid biopsy platform provides actionable information to help inform accurate clinical decisions."

Exai Bio’s next generation liquid biopsy platform was developed based on groundbreaking research conducted by Hani Goodarzi, PhD, assistant professor of Biochemistry and Biophysics, a member of the Bakar Computational Health Sciences Institute and the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco (UCSF), and co-founder and scientific advisor for Exai Bio. Dr. Goodarzi’s research, published in Nature, 2018, was the first to identify breast cancer-specific oncRNA and its role as a robust promoter of breast cancer metastasis. The paper also identified the opportunity to utilize oncRNA for early cancer detection via liquid biopsy.

Since 2018, Dr. Goodarzi’s research into oncRNA has continued, and today, Exai Bio’s liquid biopsy platform has been utilized in multiple studies, most notably including the I-SPY 2 study collaboration with UCSF. I-SPY 2 is a neoadjuvant, adaptive clinical trial designed to improve outcomes in individuals with high-risk breast cancer.

Dr. Goodarzi will present data from I-SPY 2 at the San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster, "Tumor-released circulating orphan non-coding RNAs reflect treatment response and survival in breast cancer," demonstrates that the changes in tumor-released oncRNA content of the blood are a significant predictor of clinical outcomes. The study results show that oncRNA "fingerprints" are blood-accessible and enable building predictive models of tumor response. These data will be presented on Thursday, December 9th, 2021 at 7:00 AM Central Time.

Dr. Goodarzi commented, "It’s incredibly rewarding that our early research and the discovery of tumor specific-RNA can have such a meaningful impact on early cancer detection and therapy selection, and potentially improve health outcomes for so many people diagnosed with cancer. The data in the neoadjuvant breast cancer setting is significant, as early stage breast cancer has been a difficult target for ctDNA-based liquid biopsy approaches. I look forward to the continued development of our platform and its exploration in a broad range of cancers."

Exai Bio holds the exclusive license for the development and commercialization of its next generation liquid biopsy platform from the UCSF Innovation Ventures’ Office of Technology Management & Advancement, which leads licensing and business development efforts on behalf of the university.

Exai Bio is led by an experienced founding management team and advisors including:

Patrick Arensdorf, founder and chief executive officer, formerly Chan Zuckerberg Biohub, Bluestar Genomics, ImmuMetrix (acquired by CareDx), Intersect ENT (acquired by Medtronic)
Babak Alipanahi, PhD, founder and chief scientific officer, formerly Google Health, 23andMe, Deep Genomics
Nelson Lee, chief administrative officer, formerly Lawrence J. Ellison Institute for Transformative Medicine (USC), Evidation Health, Crescendo Bio (acquired by Myriad)
Kimberly Chau, vice president clinical operations, formerly CELLective Dx, Kyphon (acquired by Medtronic), Scios (acquired by Johnson & Johnson), Corgentech
Hani Goodarzi, PhD, founder and scientific advisor, UCSF, Rockefeller, Princeton, 2021 Vilcek Prize for Creative Promise in Biomedical Sciences
Robert Warren, MD, clinical advisor, UCSF Surgical Oncology Research Lab
Michael Pellini, MD, managing partner at Section 32, commented, "Exai Bio is delivering clinically meaningful advances in liquid biopsy approaches with the potential to significantly improve cancer care. The ability of Exai Bio’s platform to detect and utilize oncRNA as a cancer signal reveals important insights into cancer biology that can lead to earlier and more accurate cancer detection and diagnosis and better inform personalized treatment options."