On February 26, 2024 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported new data from a preliminary, independent breast cancer study conducted by Principal Investigator and ProSense user, Dr. Federica. di Naro, of Azienda Ospedaliero-Universitaria Careggi, Diagnostic Senology Unit in Florence, Italy (Press release, IceCure Medical, FEB 26, 2024, View Source [SID1234640475]). IceCure previously announced interim results from this study on October 5, 2023. ProSense is approved in Italy for numerous indications, including breast cancer.

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In the single-site study conducted between January 2022 and January 2024, ultrasound-guided cryoablation using ProSense was performed on 39 women aged 60-92, who had biopsy-proven malignant lesions, and were deemed inoperable due to advanced age and comorbidities, or who refused surgery. Patients were monitored at 1, 3, 6 and 12 months post-procedure, at which time the tumor size reduction rate was evaluated by ultrasound. Also at 12 months post-procedure, the effectiveness of the procedure was further evaluated by core needle biopsy on the post-procedural scar (inside the breast at the site of the tumor) and contrast enhanced mammography ("CEM") to determine the presence or absence of residual tumoral cells and effectiveness of cryoablation.

The median breast cancer tumor size reduction rates reported in the study were as follows:

1 month: 27.8%
3 months: 60.9%
6 months: 100.0%
12 months: 100.0%

"These are phenomenal results of 100% median tumor size reduction in as little as 6 months and its effectiveness demonstrated by correlation between CEM outcomes versus biopsy at 12 months after our minimally invasive procedure that takes up to 40 minutes. We are so pleased that women in this study, who were deemed inoperable, benefitted from cryoablation," stated IceCure CEO Eyal Shamir. "We are working hard to get ProSense approved, available and affordable for as many women as possible in a number of countries around the world. This independent study is further validation of our mission, and we thank Dr. di Naro for her initiative in leading the study and giving patients options that save and prolong lives."

About ProSense

The ProSense Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens that door to fast and convenient office-based procedure for breast tumors.

On February 26, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has completed bioanalytical method development under its prior agreement with Altasciences and plans to further engage Altasciences to perform a key study of mouse blood and plasma analysis from samples collected in Hoth’s sponsored scientific research conducted at NC State University (Press release, Hoth Therapeutics, FEB 26, 2024, View Source [SID1234640474]). The blood and plasma samples collected are part of a dose response study in a humanized mouse model. The upcoming study will use the newly validated bioanalytical method developed at Altasciences to test the amount of HT-KIT from the dose response study and help determine how long HT-KIT remains in the blood stream post dosing.

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"We continue to make strides in moving HT-KIT from the lab to patients and this further analysis will help us with that process as a final step in the preclinical development that allows us to finalizing the protocols in our upcoming IND-enabling," stated Robb Knie, Chief Executive Officer. "We are pleased to further engage Altasciences on these studies given its great reputation for full-service solutions including preclinical safety testing, clinical pharmacology and bioanalysis."

On February 26, 2024 GC Cell, a fully integrated cell therapy pioneer reported a strategic partnership with BioCentriq, a cell therapy contract development and manufacturing organization (CDMO) and US affiliate of GC Cell (Press release, GC Cell, FEB 26, 2024, View Source [SID1234640473]). This important partnership lays the foundation to bring GC Cells’ proven cell-based immunotherapy, Immuncell-LC to the North American market. The execution of a Process Transfer Agreement with BioCentriq effectively lays the foundation for the U.S. launch of Immuncell-LC through utilization of BioCentriq’s cell therapy process development, analytical method development and manufacturing expertise.

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"The Process Transfer Agreement between GC Cell and BioCentriq initiates the groundwork for introducing Immuncell-LC to the U.S. market" said James Park, CEO of GC Cell. Our partnership with BioCentriq underscores our commitment to bringing innovative cancer therapies to patients in need across North America, marking a significant milestone in GC Cell’s global expansion strategy."

"We are thrilled to partner with GC Cell to bring Immuncell-LC, a proven autologous cell therapy to the U.S. Market. Our partnership further enables our mission of Delivering Hope to cancer patients with significant unmet medical needs" said Jennifer Manning, Chief Commercial Officer, BioCentriq.

Immuncell-LC is the only commercially available adoptive cell therapy treatment of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events.

On February 26, 2024 J INTS BIO reported that the Phase 1/2 clinical study of its Novel Oral 4th Generation EGFR TKI "JIN-A02" for the treatment of NSCLC has been accepted for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting to be held in San Diego USA from 5 to 10 April (Press release, J INTS BIO, FEB 26, 2024, View Source [SID1234640472]).

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The American Association for Cancer Research (AACR) (Free AACR Whitepaper) is an authoritative cancer society and is considered one of the world’s top three societies in the field of cancer, along with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper). J INTS BIO will present a poster during the "Phase I Clinical Trials in Progress" session, which will be held on April 8 from 1:30 to 5:00 p.m.

The topic of the presentation is "Phase 1/2 clinical trial of JIN-A02, a 4th generation EGFR-TKI for 3rd generation EGFR-TKI resistant patients in EGFR mutated advanced/metastatic non-small cell lung cancer".

‘JIN-A02’, a 4th generation EGFR-TKI, selectively binds to C797S, a mutation that leads to resistance to the use of 3rd generation EGFR-TKIs (such as Osimertinib, Lazertinib), in the treatment of EGFR+ NSCLC. ‘JIN-A02’ is highly selective for and strongly inhibits NSCLC with C797S double or triple mutations and is expected to show efficacy against intracranial tumors due to its high blood-brain barrier permeability.

In August last year, J INTS BIO registered the first patient for the global Phase 1/2 clinical trial of ‘JIN-A02’ at Severance Hospital in Korea. This clinical study is currently recruiting patients with EGFR mutation-positive and advanced NSCLC at in Korea, including Asan Medical Center and the National Cancer Center, and the University of California (U.C. Irvine).

The dose escalation part of the study is now at its 4th dose level, and despite the preceding low dose levels, early efficacy responses were observed in targeted lesions, especially in patients with the C797S mutation. J INTS BIO plans to expand the number of clinical trial sites globally and in Korea, this will include Seoul National University Hospital, Samsung Seoul Hospital, and Seoul St. Mary’s Hospital.

A J INTS BIO official said, "The global clinical trial for ‘JIN-A02’ is progressing well and is receiving interest in the global market."

Details of the AACR (Free AACR Whitepaper) presentation will be released on April 8th.

On February 26, 2024 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will participate in a fireside chat at the Leerink Partners Global Biopharma Conference, Miami Beach, Florida, on Monday, March 11, 2024 at 11:20 AM ET (Press release, Compugen, FEB 26, 2024, View Source [SID1234640471]).

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A live webcast of the presentation will be available on the Investor Relations section of Compugen’s website at www.cgen.com. A replay will be available following the live event.