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IceCure Medical Announces First Peer Reviewed Publication for the 3-Year Interim Analysis of the ICE3 Trial on Cryoablation of Low-Risk, Early-Stage Breast Cancer

On September 13, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of the next generation minimally invasive cryoablation technology that destroys tumors by freezing, reported that the first peer reviewed article "Cryoablation Without Excision for Low-Risk, Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial" was published in the Annals of Surgical Oncology with Dr. Richard Fine, MD, FACS, an ICE3 investigator who serves as Program Director of the Breast Surgical Oncology Fellowship and as Director of Research and Education at the West Comprehensive Breast Center in Germantown, TN, as the lead author (Press release, IceCure Medical, SEP 13, 2021, View Source [SID1234587654]).

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"Having a peer reviewed publication of the ICE3 Clinical Study[1] interim results in a well-respected medical journal represents a major milestone for IceCure in solidifying the efficacy and adaptation of its minimally invasive solution by the broader medical community for the treatment of certain breast cancers," stated IceCure CEO, Eyal Shamir. The article reports the results previously announced on April 29, 2021 at the American Society of Breast Surgeons Annual Meeting, that at a mean of 34.83 months following treatment with ProSense Cryoablation System, only 2.06% (4 of 194 patients) experienced cancer recurrence.

The journal article concludes that "breast cryoablation presents a promising alternative to surgery while offering the benefits of a minimally-invasive procedure with minimal risks."[2] Study author Dr. Fine stated that "the 3-year ICE3 trial results highlighting the efficacy and safety of the procedure in this patient group are extremely promising for breast cryoablation. Being able to provide a minimally-invasive option for treating appropriate low risk patients represents a dramatic improvement in care – the procedure is quick, painless and can be delivered with local anesthesia in doctor’s office, with minimal recovery time and excellent cosmetic outcomes."

Dr. Richard Fine will be presenting his findings on cryoablation at the upcoming Mayo Clinic School of Continuous Professional Development Conference "Breast Cancer Care: Innovation, Disruptive Technologies and Early Adopters 2021" in Rochester, MN on Friday, September 17, 2021. Scott Peairs, IceCure US Commericial Director, will be on site at the exhibit.

Harbour BioMed Announces Phase I Study Positive Results on Next-Generation Anti-CTLA-4 Antibody HBM4003

On September 13, 2021 Harbour BioMed ("HBM", HKEX: 02142) reported that positive results from its phase I dose escalation clinical trial of HBM4003 in solid tumors in Australia (the "phase I study") (Press release, Harbour BioMed, SEP 13, 2021, View Source [SID1234587652]). The clinical data abstract has been presented by way of an e-poster at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

The data received from the phase I study, as the first clinical evidence of next generation anti-CTLA-4 fully human heavy-chain only antibody (HCAb) in solid tumors, showed favorable safety and encouraging efficacy profile of HBM4003. All treatment-related adverse events (TRAEs) to the extent discovered during the phase I study were manageable and reversible. The initial anti-tumor efficacy of HBM4003 monotherapy was encouraging, especially two respondents who underwent multiple therapies responded to HBM4003 monotherapy.

The Phase I Study Design

The phase I study is an open-label, multi-center study on subjects with solid tumors to receive HBM4003 at dose levels of 0.3mg/kg QW (28-day cycle), 0.45mg/kg Q3W (21-day cycle), and 0.6mg/kg Q3W (21-day cycle). The primary endpoint for the dose escalation stage is proportion of patients with dose-limiting toxicity (DLT).

Key Results of the Phase I Study

(i) 20 patients with advanced solid tumors have been treated at four Australian sites where the phase I study was conducted, with 13 out of 20 patients (65%) having received 2 or more prior regimens and with 8 patients (40%) having received PD-1 treatment.
(ii) HBM4003 treatment demonstrated favorable safety profile. No toxicity reported was related to lung, kidney, heart or endocrine system.
(iii) A dosage of 0.45 mg/kg Q3W was recommended as the phase II dose for dose expansion.
(iv) A total of 15 patients had post-treatment tumor assessments. One hepatocellular carcinoma (HCC) patient had confirmed partial response (PR) and another prostate cancer patient achieved a prostate surface antigen (PSA) response with tumor remaining stable disease (SD) up to 24 weeks. Nine patients had SD with tumor shrinkage in 3 patients.
(v) For the HCC patient with PR, extended clinical benefit was observed after treatment discontinuation. Tumor reduction reached 64.4% for target lesions and non-target lesions were no longer detectable 16 weeks after the last dose.

"We are extremely pleased to announce the positive results of this study at ESMO (Free ESMO Whitepaper) Congress 2021, one of the top international academic conferences. The anti-tumor efficacy of HBM4003 with the good safety profile and tolerability is encouraging. With high expectations on the promising therapeutic value of HBM4003, the Company has proceeded with multiple global phase Ib/IIa trials in solid tumors." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combo-therapy.

Abstract for MIV-818 phase 1b monotherapy for ESMO Congress published

On September 13, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that the Abstract entitled "Phase 1 study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM)" has been released on the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) website (View Source) (Press release, Medivir, SEP 13, 2021, View Source [SID1234587651]).

The results from the completed phase 1b monotherapy dose escalation part of the study will be presented by

Dr Debashis Sarker, King´s College, London, as an e-poster (number 527P) at ESMO (Free ESMO Whitepaper) on Thursday September 16. Medivir will host a conference call to update on the progress and plans for the MIV-818 program at 15.00 CET on September 16.

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Hummingbird Bioscience Announces US FDA Clearance of IND for First-in-Human Phase 1 Trial of HMBD-002 in Patients with Advanced Solid Tumors

On September 13, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, reported that the U.S. Food and Drug Administration (FDA) has approved the initiation of a Phase 1 clinical trial of HMBD-002, Hummingbird’s anti-VISTA neutralizing antibody (Press release, Hummingbird Bioscience, SEP 13, 2021, View Source [SID1234587650]). HMBD-002 is being developed for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).

HMBD-002 is an IgG4 monoclonal antibody, rationally engineered with high affinity and specificity to bind and block the activation of VISTA, a protein that enables tumors to suppress and escape the immune system. HMBD-002 accomplishes this without depleting VISTA expressing immune cells that play important roles in the immune response. In pre-clinical cancer models, treatment with HMBD-002 could counteract immune suppression, as indicated by the decreased infiltration of immune-suppressing myeloid cells into the local tumor environment and the increased activity of T cells. Pre-clinical studies also show that HMBD-002 as a monotherapy, and in combination with pembrolizumab (an immune checkpoint inhibitor), significantly inhibited tumor growth, with no observed toxicity.

The Phase 1, multi-center, open-label trial will evaluate HMBD-002, as a monotherapy and in combination with pembrolizumab. Safety and tolerability will initially be assessed in a dose escalation study in patients with advanced solid malignancies, where the maximum tolerated or tested dose (MTD) and recommended Phase 2 dose (RP2D) will be identified. The anti-cancer activity of HMBD-002 will then be evaluated in a dose expansion study examining HMBD-002 as a monotherapy in patients with previously treated TNBC and NSCLC, or in combination with pembrolizumab in patients with TNBC, NSCLC, and other VISTA-expressing malignancies.

Correlative studies will assess pre- and post-treatment markers of immune activity in the periphery and the tumor microenvironment. The development of HMBD-002 into the clinic is supported by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

"VISTA is an exciting but complex new immune checkpoint protein. With Hummingbird’s proprietary Rational Antibody Discovery platform, we used machine learning and computational biology to predict the optimal drug binding site on VISTA in order to develop an antibody therapy that could effectively block and neutralize its activity. As such, HMBD-002’s mechanism of action is highly differentiated from other anti-VISTA drug candidates. We look forward to advancing the clinical development of HMBD-002 for cancer patients where VISTA is involved in suppressing immune response," said Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder of Hummingbird Bioscience.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for the treatment of multiple cancers that have strong evidence of VISTA mediated suppression, both as a monotherapy and in combination with PD-1 inhibitor.

HMBD-002 advanced to clinical trials with a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

Immunovia enters licensing agreement with JW BioScience for pancreatic cancer biomarkers

On September 13, 2021 Immunovia AB (publ) ("Immunovia"), a diagnostic company that develops and sells highly accurate blood tests for the early detection of cancer, reported that Immunovia has strengthened its patent protection for pancreatic cancer biomarkers by obtaining a global license from the South Korean company JW BioScience’s IP portfolio (Press release, JW Pharmaceutical, SEP 13, 2021, View Source [SID1234587649]).

The license agreement gives Immunovia global commercial rights for two biomarkers for early detection of pancreatic cancer. The biomarkers are also part of Immunovia, Inc.’s IMMray PanCan-d biomarker signature. Immunovia discovered these pancreatic cancer biomarkers independently of JW BioScience and have now fully secured intellectual property rights.

The details and deal size of this contract are not disclosed as agreed by both parties.

Patrik Dahlen, CEO of Immunovia, said, "We are delighted to enter into this agreement that further secures relevant IP and validates our biomarker discovery approach. By entering into this agreement, Immunovia and JW BioScience will also evaluate possibilities for commercial collaboration to enable early detection of pancreatic cancer in the Korean market."

Eun-Kyung Hahm, CEO of JW Bioscience, said, "This contract is an important milestone for JW’s unique IP position and a recognition of the excellence of JW technology in the global market." She also added that, "JW will be able to further strengthen its commercial and technological competitiveness through the collaboration with Immunovia."

Immunovia has a strong and extensive IP portfolio consisting of seven patent families, covering biomarkers in pancreatic cancer.