On January 31, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported preliminary unaudited year-end financial results for the twelve months ended December 31, 2021 (Press release, IceCure Medical, JAN 31, 2022, View Source [SID1234607533]).

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Revenues increased to $4.1 million in 2021 compared to $3.9 million in 2020, primarily driven by sales through distribution agreements in Europe and sales of the Company’s ProSense system and probes in the United States.

As of December 31, 2021, the Company’s cash and cash equivalents totaled $25.6 million compared to $3.5 million for the period ending December 31, 2020, as a result of the two equity raises in 2021 totaling $32 million.

"2021 was pivotal for IceCure, beginning with a private placement of $15 million early in the year, listing of our shares on the Nasdaq, followed by an additional $17 million offering at a greater enterprise value. We have expanded the global distribution network for ProSense and increased our sales in the United States and Europe. Furthermore, our U.S. ICE3 trial demonstrated supportive data for our cryoablation technology in combating early-stage breast cancer which we reported at various academic meetings," stated Mr. Eyal Shamir, the Chief Executive Officer of IceCure.

"Notably, we remain focused on expansion on all fronts from both a commercial and product development standpoint, and we have also made important progress on the development of our next-generation cryoablation, single-probe, and multi-probe systems with a European patent-pending for our cryogenic pump which will potentially expand clinical applications with cryoablation for bigger tumors or multiple tumors simultaneously."

"In 2022, we intend to further advance our regulatory and commercial strategies in the United States, China, and Japan. We also plan to engage with new strategic commercial partners. One of our major focuses will be additional regulatory approvals in major countries for our business, namely, the United States and China. In the United States, we’ve already filed a pre-submission package with the Food and Drug Administration (the "FDA") for early-stage breast cancer and high risk to surgery and suggested a De Novo classification based on our ongoing ICE3 clinical trial. We hope that our Breakthrough Device Designation with the FDA will secure priority review," Mr. Shamir concluded.

IceCure plans to report full 2021 audited financial results upon filing its annual report on Form 20-F with the U.S. Securities and Exchange Commission.

The above information reflects preliminary estimates with respect to certain results of IceCure Medical for the full year ended December 31, 2021, based on currently available information. Because the audit for 2021 is not yet complete, IceCure’s final results may vary from the preliminary estimates.

On January 31, 2022 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported the promotion of current CMO, Marcel Rozencweig, M.D., to President and the appointment of Scott Z. Fields, M.D., as the new chief medical officer, effective tomorrow, Feb. 1, 2022 (Press release, NeoTX, JAN 31, 2022, View Source [SID1234607532]). Dr. Fields brings more than 30 years of experience in clinical drug development and has been previously the Senior Vice President and Pharmaceutical Development Head, Oncology at Bayer Pharmaceuticals.

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"We are thrilled that Marcel will be the President to lead NeoTX in its next chapter of growth and success. He has been a key part of NeoTX growth since its inception and, in his new role as President, will help to accelerate growth and expand strategic industry partnerships," said Asher Nathan, Ph.D., chief executive officer of NeoTX.

"I am very pleased and looking forward to leading, as President, in NeoTX’s advancement," said Dr. Rozencweig. "Additionally, as a founding member of NeoTX, it gives me great pleasure to welcome Dr. Fields to our leadership team."

"We, at NeoTX, are delighted that Scott is bringing his strong industry and operational leadership, which will prove valuable for our clinical development and registration strategies. His broad experience in oncology drug development, with over a dozen drug approvals, is an excellent fit with our vision," said Asher Nathan, Ph.D., chief executive officer of NeoTX.

"I’m thrilled to join NeoTX at this time of important growth and evolution of the company," said Dr. Fields. "Together with our experienced leadership team, I look forward to helping the company accelerate the development of our pipeline and bring innovative new medicines to patients."

As Global Head of Development for Oncology at Bayer Pharmaceuticals, Dr. Fields was responsible for early and late-stage development including several novel oncology medicines across the platforms for targeted therapies/precision medicine, antibody drug/alpha radiation conjugates and novel Immuno-Oncology agents. His group was responsible for the development and global registration of Darolutamide – a next generation androgen receptor inhibitor for prostate cancer and with partner Loxo, for Larotrectinb – a tissue agnostic NTRK inhibitor. He was also responsible for the Oncology Operations, Project Management, Regulatory, Biomarkers, Biostatistics and Medical Writing groups. Prior to his position at Bayer, Dr. Fields held senior positions at Vertex Pharmaceuticals, SmithKline Beecham, Amgen, Eisai, and Arno Therapeutics and helped bring over a dozen drugs to market. He also practiced oncology/hematology and transplant medicine in academic settings. Dr. Fields received his medical degree from SUNY Downstate Medical Center in New York, followed by training in internal medicine, hematology and oncology at Columbia University Medical Center.

On January 31, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its third quarter fiscal year 2022, ended December 31, 2021, at 4:15 p.m. EST on Monday, February 14, 2022 (Press release, Aethlon Medical, JAN 31, 2022, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-third-quarter-financial-results-and-host-conference-call-on-february-14-2022-301471097.html [SID1234607531]).

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Management will host a conference call on Monday, February 14, 2022 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 2728183.

On January 31, 2022 Children’s Hospital of Philadelphia (CHOP) reported that Fusion oncogenes, such as RET- and NTRK-gene fusions, are associated with more invasive pediatric thyroid cancers, correlating with the highest risk of metastases and a lower likelihood of achieving remission one year after initial therapy (Press release, CHOP, JAN 31, 2022, View Source [SID1234607530]). The findings, which were published in the Journal of Clinical Oncology, contrast those previously established in adults, for whom BRAF mutations, not fusion oncogenes, are associated with more invasive disease that is less response to therapy.

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"This study shows fusion oncogenes are more prevalent in pediatric thyroid cancer that is likely to spread to the lungs, whereas tumors with RAS-like and BRAF mutations are associated with low- and intermediate risk, respectively," said Andrew J. Bauer, MD, Director of the Pediatric Thyroid Center at Children’s Hospital of Philadelphia and senior author of the study. "This provides an opportunity for increased collaboration among surgeons, endocrinologists, and oncologists to stratify the treatment of tumors, approaching RAS-like mutations with less extensive surgery, while also exploring the new treatment protocols using FDA-approved oncogene specific inhibitors to optimize the treatment of patients with lung metastasis."

The results from the CHOP thyroid team are a pediatric-specific follow-on study to the 2014 Cancer Genome Atlas (TCGA) report that classified adult papillary thyroid cancer (PTC) into two molecular subtypes – RAS-like or BRAF-like – and concluded that molecular classification more accurately reflected tumor behavior, including disease severity and prognosis. To determine whether the adult based TCGA classification predicted the similar clinical behavior and outcomes in pediatric patients with DTC, the CHOP researchers analyzed 131 pediatric thyroid tumors. Of those, 66 were collected and sequenced using the CHOP Division of Genomic Diagnostics platform between 2016 and 2019, with the remaining 65 collected between 1989 and 2012 and sequenced on a commercial platform. In analyzing the sequenced samples, the researchers categorized mutated genes into three categories: RAS-mutant, BRAF-mutant, and RET/NTRK fusions. The researchers evaluated these categories against numerous parameters, including patient demographics, thyroid pathology, and clinical characteristics.

The researchers found that the three-tier classification system more accurately reflected the clinical behavior of DTC in pediatrics. Based on the low prevalence of RAS-mutant tumors among the pediatric samples and their low-risk of metastasis, the CHOP researchers limited their statistical analysis to comparing samples with a BRAF mutation to samples with RET/NTRK fusions. The researchers found no distant metastasis in any patients with BRAF-mutant thyroid tumors, whereas 36% of patients with RET/NTRK fusions had distant metastasis. Persistent disease at one year was also more frequent in the subgroup harboring RET/NTRK fusions: 36% vs. 17% among those with a BRAF mutation.

In line with prior studies, the researchers also found that RET/NTRK fusions are more common in PTC patients under the age of 10. Of the samples in their analysis, 91% of those in patients under the age of 10 harbored fusion events. The prevalence gradually decreased in pediatric patients older than 10 years (27%) and into adulthood (9%). By contrast, only one BRAF mutation (9%) was found among patients under the age of 10, compared with 25 pediatric patients aged 10 years or older (20%) and 58% of adults with PTC.

"Considering the high prevalence of RET/NTRK fusions in pediatric differentiated thyroid cancer, and their association with more metastatic behavior, it will be crucial to generate the transcriptional signatures of RET/NTRK and BRAF-mutant subgroups in the pediatric population to understand the differential impact of these alterations on signaling pathways, differentiation, and clinical outcomes," said first author Aime T. Franco, PhD, investigator in the Center for Childhood Cancer Research and director of the Pediatric Thyroid Cancer Translational Research Laboratory at Children’s Hospital of Philadelphia. "Future research in our Thyroid Center Frontier Program at CHOP will also investigate the underlying reason for the significant differences between children and adults when it comes to invasive disease, as well as the role of BRAF and RET/NTRK in response to radioiodine therapy."

Franco AT, Ricarte-Filho JC, Isaza A, Jones Z, Jain N, Mostoufi-Moab S, Surrey L, Laetsch TW, Li MM, DeHart JC, Reichenberger E, Taylor D, Kazahaya K, Adzick NS, and Bauer AJ. "Fusion Oncogenes Are Associated with Increased Metastatic Capacity and Persistent Disease in Pediatric Thyroid Cancers," Journal of Clinical Oncology, online January 11, 2022, DOI: 10.1200/JCO.21.01861

On January 31, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), for the treatment of solid tumors (Press release, Immune-Onc Therapeutics, JAN 31, 2022, View Source [SID1234607529]).

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Myeloid cells are abundant and often immune suppressive in the solid tumor microenvironment. The LILRB4 receptor is expressed on monocytic myeloid cells, including dendritic cells, and contributes to a tolerogenic myeloid cell phenotype, resulting in decreased tumor immune surveillance. In preclinical data presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, IO-202 was found to enhance dendritic cell function and T cell activation in vitro and promote anti-tumor immunity in a solid tumor model in vivo. These data provided a strong rationale to evaluate the therapeutic potential of IO-202 as a myeloid checkpoint inhibitor in solid tumors.

"The FDA clearance to begin our Phase 1 study for IO-202 in solid tumors is a major milestone for Immune-Onc, which represents the third IND for our pipeline and the second for IO-202," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "We know that high LILRB4 expression on myeloid cells infiltrating solid tumors contributes to tumor immune evasion. IO-202 is a first-in-class myeloid checkpoint inhibitor targeting LILRB4, which may provide therapeutic benefit to multiple solid tumor types where evasion of the immune system allows disease to progress and create resistance to therapy, including to T cell checkpoint inhibitors. We look forward to advancing IO-202 into the clinic to evaluate its potential as a monotherapy and in combination with an anti-PD-1 in patients with solid tumors."

The Phase 1, multicenter, dose-escalation and dose expansion study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1 antibody, followed by indication-specific expansion cohorts to be treated with IO-202 in combination with pembrolizumab at the recommended Phase 2 dose. Various biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including dendritic cells. LILRB4 inhibits antigen-presenting cell activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in acute myeloid leukemia (AML) and presented the rationale for targeting LILRB4 in solid tumors at the AACR (Free AACR Whitepaper) Annual Meeting 2021.

ABOUT IO-202

IO-202 is a first-in-class LILRB4 antagonist antibody with broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In solid tumors, preclinical data showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in a solid tumor model in vivo.

IO-202 is currently in Phase 1 clinical development for the treatment of AML and chronic myelomonocytic leukemia (CMML). The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designations for treatment of AML in 2020. The company has received IND clearance to evaluate IO-202 in solid tumors in January 2022.