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Enlivex Receives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial

On February 23, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies (Press release, Enlivex Therapeutics, FEB 23, 2023, View Source [SID1234627605]). The clearance of the Phase I/II by the AEMPS follows recent announcements by the Company that (i) the study received IND clearance from the U.S. Food And Drug Administration for recruitment of patients in the U.S., (ii) the independent Data Safety Monitoring Board has completed its prespecified data review for the first cohort of patients in the Phase I/II trial and (iii) the Israeli Ministry of Health had reviewed the data and provided regulatory clearance to continue the study and open the subsequent high dose monotherapy and combination cohorts.

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The Phase I/II multi-center clinical trial (clinicaltrials.gov Identifier: NCT05581719) has been designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.

The Phase I/II trial was initiated following encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer, and additional models that demonstrated statistically significant survival benefit when Allocetra was combined with a PD1 or CTLA-4 checkpoint inhibitors in a murine model of peritoneal mesothelioma.

Einat Galamidi, MD., Vice President, Medical of Enlivex, stated "We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain. We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024."

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

Cantargia advances TRIFOUR trial to randomized stage following promising early safety and efficacy of nadunolimab in triple-negative breast cancer

On February 23, 2023 Cantargia (Cantargia AB) (NASDAQ Stockholm: CANTA) reported favorable safety and promising early signs of efficacy following an initial analysis of the phase Ib part of the clinical trial TRIFOUR (Press release, Cantargia, FEB 23, 2023, View Source [SID1234627659]). In collaboration with the Spanish Breast Cancer Group (GEICAM), this trial investigates the IL1RAP-binding antibody nadunolimab (CAN04) in combination with chemotherapy for treatment of triple-negative breast cancer (TNBC). In 12 patients treated long enough for evaluation, the response rate was well above previously reported data for chemotherapy alone. The trial is now expanding into the randomized phase II part where the combination will be compared to a control group given chemotherapy only.

TNBC is a difficult-to-treat disease which accounts for 10-15% of all breast cancer cases. To date, 15 first- or second-line patients with metastatic TNBC have been enrolled and treated in the dose-escalation part of the phase Ib/II trial TRIFOUR. In an early efficacy assessment based on 12 patients, one showed confirmed complete response, while five showed confirmed partial response, equaling a preliminary response rate of 50%. This compares favorably to the historical response rate of approximately 30% reported for gemcitabine and carboplatin alone [1], the chemotherapy doublet used in combination with nadunolimab in the trial. Among the other six evaluated patients, four showed stable disease and two showed progressive disease.

The combination showed an acceptable safety profile, in line with previous trials combining nadunolimab and chemotherapy. Notably, prophylactic use of G-CSF was incorporated to the study protocol to control neutropenia. TRIFOUR, which is conducted at 24 clinical sites in Spain, will immediately progress to the randomized phase II part, which may include up to 98 additional patients. An interim futility analysis is planned for Q4 2023. Data from the study are also planned for presentation in H2 2023.

"These initial results in triple-negative breast cancer are exciting for several reasons. Most importantly, they show an early signal of efficacy in line with our previous data in pancreatic cancer and non-small cell lung cancer, which further illustrates the magnitude of opportunities for nadunolimab. Based on these results, we look forward to immediately progressing into the controlled part of this trial, and continuing our fruitful collaboration with GEICAM," said Göran Forsberg, CEO of Cantargia.

"Triple-negative breast cancer is a very aggressive type of breast cancer with limited therapeutic options. The initial results from the TRIFOUR trial are very promising, and certainly warrant further investigation of nadunolimab in the subsequent, randomized, part of the study," said Dr. Agostina Stradella, medical oncologist, member of GEICAM, and Principal Investigator in TRIFOUR at the Catalan Institute of Oncology, Duran i Reynals Hospital.

Additionally, various biomarker analyses will be performed on patient samples collected in TRIFOUR. The FERO Foundation, a private Spanish entity dedicated to the promotion of cancer research, recently awarded GEICAM with a grant for a research project aiming to identify predictive markers of nadunolimab efficacy. This project will be based on TRIFOUR patient samples and provide further insights into the mechanisms behind the apparent synergy between nadunolimab and chemotherapy.

Theralink® Technologies Begins Receiving Payments from Third Party Payors for its Advanced Breast Cancer Assay, Achieving Key Milestone

On February 23, 2023 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for advanced breast cancer, reported that the Company has begun receiving payments from third party payors for its advanced breast cancer assay (Press release, Theralink Technologies, FEB 23, 2023, View Source [SID1234627658]).

Mick Ruxin, M.D., CEO of Theralink said, "We are extremely pleased to bring our game-changing testing technology to all beneficiaries in the U.S. Access to the latest cancer testing technology is paramount in order to make informed treatment decisions that will affect patient outcomes. The milestone of receiving third party payor paymentsis a testament to the value that Theralink provides to cancer patients and their oncologists by way of actionable information for expanded treatment options."

Theralink empowers physicians with new sources of actionable information with its patented, predictive, proteomic biomarker assay that assists oncologists with treatment decisions for their advanced breast cancer patients. Theralink’s patented Reverse Phase Protein Array (RPPA) technology measures the tumor cell levels of activated proteins, which no other US technology can do in a commercial, multiplexed environment. These activated proteins are the primary targets of most FDA-approved therapies and investigational drugs.

Dr. Ruxin concluded, "The above announcement speaks to our continued business growth and clinical influence as we work in a collaborative way with several U.S.-based cancer programs and private community practices as well as other stakeholders to improve access to care for all Americans affected by cancer."

Amplia’s FAK inhibitor program to be presented at Next Generation Kinase Inhibitors Summit

On February 23, 2023 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that Amplia Head of Translational Biology, Dr Terrie-Anne Cock, will present a lecture at the 2nd Next Generation Kinase Inhibitors Summit currently underway in Boston, USA (Press release, Amplia Therapeutics, FEB 23, 2023, View Source;[email protected] [SID1234627657]).

The presentation, entitled ‘Targeting Focal Adhesion Kinase (FAK) for the treatment of cancer and fibrotic diseases’ describes preclinical and Phase 1 clinical data for Amplia’s lead FAK inhibitor AMP945. A copy of the presentation, to be given at Friday 6:30am AEDT, is attached to this announcement.

Amplia CEO, Dr Chris Burns, commented: "Being invited to present our research at such a highly respected, industry-focused conference devoted to kinase inhibitor drug development, reflects the importance of our research at Amplia and our standing in the kinase field, internationally. Further, it allows us to promote the quality of the work being conducted at Amplia to biotech and pharma companies around the world."

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

Novocure Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Company Update

On February 23, 2023 Novocure (NASDAQ: NVCR reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, NovoCure, FEB 23, 2023, View Source [SID1234627656]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields ("TTFields").

"2022 was a year of solid execution for Novocure," said William Doyle, Novocure’s Executive Chairman. "In 2022, we generated over half a billion dollars in net revenues, expanded our international footprint, introduced our next generation arrays and announced results from multiple, successful pilot studies; and we have excellent momentum to start 2023. We announced that our pivotal LUNAR study met its primary overall survival endpoint and we have now completed enrollment in our pivotal PANOVA-3 study in pancreatic cancer and are just two patients away from completing enrollment in our pivotal METIS study in brain metastases from non-small cell lung cancer. Our teams are executing well and their achievements are building the foundations for the future of Novocure. We are looking forward to an eventful 2023."

"In my time at Novocure, I have never felt more engaged or excited," said Asaf Danziger, Novocure’s Chief Executive Officer. "The positive top-line readout from the pivotal LUNAR study marked the beginning of a transformational 24 months for Novocure. LUNAR is the first of four pivotal studies we expect to read out in the next two years which could dramatically increase the number of patients eligible for Tumor Treating Fields."

Financial updates for the full year and fourth quarter ended December 31, 2022:

Total net revenues for the year were $537.8 million, an increase of 1% year-over-year.
We recorded $32 million in revenue from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage. We believe collections from previously denied claims were largely exhausted in 2022 and the remaining outstanding claims will take time to collect. As such, we expect future net revenue to more closely reflect core drivers of net revenue: number of active patients on therapy, duration of therapy, and net released price per month.
Total net revenues for the quarter were $128.4 million, a decrease of 4% year-over-year.
The United States, EMEA and Japan contributed $98.6 million, $17.0 million, and $7.9 million in quarterly net revenues, respectively.
Net revenues were impacted by the volume of cash collections from aged claims in the U.S., the ongoing impact of German coverage updates and foreign exchange fluctuations.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million.
Gross margin for the quarter was 78%.
Research, development and clinical studies expenses for the quarter were $54.8 million, a decrease of 4% from the same period in 2021.
Sales and marketing expenses for the quarter were $49.6 million, an increase of 27% from the same period in 2021.
General and administrative expenses for the quarter were $38.1 million, an increase of 23% from the same period in 2021.
Net loss for the quarter was $37.3 million with loss per share of $0.36.
Adjusted EBITDA* for the quarter was $(10.5) million.
Cash, cash equivalents and short-term investments were $969.4 million as of December 31, 2022.
Operational updates for the fourth quarter ended December 31, 2022:

As of December 31, 2022, there were 3,430 active patients on therapy, a decrease of 4% year-over-year. Active patients from North America, EMEA and Japan contributed 2,191, 870 and 369 active patients, respectively.
1,373 prescriptions were received in the quarter, a decrease of 4% year-over-year. Prescriptions from North America, EMEA and Japan contributed 956, 312 and 105 prescriptions, respectively.
Quarterly updates and achievements:

In February 2023, we announced that the final patient has been enrolled in the pivotal PANOVA-3 study in locally advanced pancreatic cancer.
In January 2023, we announced the top-line results for our pivotal LUNAR study in NSCLC. The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies (either immune checkpoint inhibitors or docetaxel) alone. The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors ("ICI"), as compared to those treated with ICI alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone.
Today, we are announcing the election of Dr. Allyson J. Ocean to the Board of Directors. Dr. Ocean serves as a medical oncologist and Associate Professor of Clinical Medicine at Weill Cornell Medicine.
Following receipt of CE Mark for its new array in November 2022, Novocure successfully began treating patients through the company’s European limited market release. The new thinner and lighter arrays are designed for more efficient TTFields delivery and greater comfort for patients with glioblastoma.
Anticipated clinical milestones:

Data from the pivotal LUNAR study in non-small cell lung cancer (1H 2023)
Data from the pivotal INNOVATE-3 study in recurrent ovarian cancer (2H 2023)
Top-line data from the pivotal METIS study in brain metastases (Q1 2024)
Data from the pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2022 financial results at 8:00 a.m. EST today, Thursday, February 23, 2023. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided..

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.