On March 14, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for its invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA" (Press release, Can-Fite BioPharma, MAR 14, 2022, View Source [SID1234610051]).

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Currently, Namodenoson (CL-IB-MECA) is being developed for two liver indications, liver cancer and NASH. The allowance granted by the US PTO opens the door for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The global liver disease treatment market was valued at approximately $20 billion in 2020 by Allied Market Research.

Can-Fite is currently enrolling patients in a Phase IIb trial of Namodenoson for the treatment of NASH, an advanced non-alcoholic fatty liver disease, for which there is no U.S. FDA approved treatment. Additionally, the Company expects to commence enrollment in a pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer (hepatocellular carcinoma CPB7).

Can-Fite’s robust IP portfolio includes patents that address NASH and liver cancer, issued in approximately 40 countries. Namodenoson has been out-licensed in select countries for the treatment of NASH and liver cancer with agreements that include upfront and milestone payments.

"This U.S. patent is a very important addition to our growing IP portfolio in liver diseases. It is very well timed with our Phase IIb NASH study and Phase III liver cancer trial. Both are high value indications in which our robust patent portfolio and Namodenoson’s safety and efficacy profile position Can-Fite for potential additional strategic distribution deals worldwide," stated Can-Fite CEO Dr. Pnina Fishman.

About NASH

There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. The U.S. National Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants among women and second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well.

About HCC

Hepatocellular carcinoma (HCC) is the most common form of liver cancer. HCC with underlying Child Pugh B7 (CPB7) is one of the most advanced forms of liver cancer. More than 800,000 people are diagnosed with liver cancer annually and approximately 700,000 die of the disease each year, according to the American Cancer Society. The HCC drug market is projected to reach $3.8 billion by 2027.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On March 14, 2022 NETRIS Pharma, a pioneer in the development of dependence receptor targeted cancer medicines, reported the start of enrollment of patients with advanced/metastatic solid tumors in its Phase I clinical study of NP137, a humanized monoclonal antibody targeting Netrin-1 (NCT02977195) (Press release, Netris Pharma, MAR 14, 2022, View Source [SID1234611179]). The study represents the first time a drug candidate targeting dependence receptors has been evaluated in humans. Dependence receptors are tumor suppressors that trigger cell death unless engaged by a ligand, in this case Netrin-1. Blocking Netrin-1 could re-introduce the natural tumor cell death pathway.

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"The launch of this first of its kind clinical trial represents a key milestone in the dependence receptor field as well as for NETRIS Pharma in our commitment to find new therapeutic solutions for cancer patients," said Patrick Mehlen, CEO and co-founder of NETRIS Pharma. "We see in this study the confirmation of the ability to translate the potential of our innovative approach on dependence receptors to a first application of a drug candidate in patients."

This open-label study includes a first phase of dose escalation, followed by an extension phase. The main objective of the dose escalation phase is to determine the maximum tolerated dose (MTD) of NP137 and the recommended Phase II (RP2D) dose. The main objective of the extension phase is to confirm the safety and tolerance of NP137 and collect preliminary clinical activity data.

The study will recruit a maximum of 44 patients in three French centers, the Centre Léon Bérard in Lyon (Prof. Philippe Cassier – principal investigator of the study), the Institut Claudius Régaud in Toulouse and the Institut Gustave Roussy in Villejuif.

"The new therapeutic approach developed by NETRIS Pharma explores a so far non-druggable pathway in oncology. It offers another avenue of research to help us achieve the precision medicine needed in treating cancer. If the Phase I safety profile, which is expected in 2017, is positive, NP137 may represent a major therapeutic advance in the management of cancer patients," said Prof. Jean-Yves Blay, Director General of the Centre Léon Bérard, Lyon.

About Dependence Receptors Concept
Cells depend on external signals for their survival. These signals are mediated by various transmembrane receptors and sensors, such as soluble trophic factors, cytokines, hormones. For any given required stimulus, withdrawal leads to programmed cell death (apoptosis). Data obtained over the past 15 years, pioneered by Prof Patrick Mehlen and his research team at the Cancer Research Center of Lyon – Centre Léon Bérard, argue for a novel form of signal transduction that actively induces cell death following stimulus withdrawal.

This "negative signal transduction" leading to cell death is mediated by specific dependence receptors that induce apoptosis in the absence of the required stimulus, but block apoptosis in its presence. The expression of various dependence receptors at the surface of the cells seems to create a state of dependence (or addiction) to their respective ligands. To date, more than twenty of such receptors have been identified.

About NP137
Most types of tumors have been shown to produce an abnormal amount of dependence receptors’ ligands, thus preventing cells from dying. For instance, the Netrin-1 ligand has been shown to be overexpressed in 60% of metastatic breast cancers, in more than 70% of ovarian cancers, 50% of lung cancers or 80% of melanoma. Its expression often correlates with disease severity and no therapy has ever been tested on this new pathway.

NP137, a humanized monoclonal antibody of isotype IgG1 directed against the ligand Netrin-1, is the first drug candidate developed by NETRIS Pharma. NP137 prevents the binding of Netrin-1 on its dependence receptors, thus re-inducing cell death and leading to tumor growth regression.

Pre-clinical studies show an anti-cancer effect of NP137 in mice, in monotherapy but also in combination with demethylating agents and chemotherapy agents. In addition, remarkable effects are observed on tumor relapse. A synergistic effect of NP137 with immune-checkpoint inhibitors has also been observed, opening novel strategies for clinical investigation.

On March 14, 2022 Sanofi reported The Phase 2 AMEERA-3 clinical trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), did not meet its primary endpoint of improving progression-free survival (PFS) as assessed by an independent central review (Press release, Sanofi, MAR 14, 2022, View Source [SID1234610015]). The trial evaluated amcenestrant as monotherapy compared to endocrine treatment of physician’s choice in patients with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who progressed on or after hormonal therapies. No new safety signals were identified and the safety profile of amcenestrant in AMEERA-3 was consistent with earlier studies.

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John Reed, MD, PhD
Head of Research and Development at Sanofi
"This Phase 2 trial evaluated amcenestrant as a monotherapy in a patient population with advanced disease where limited treatment options remain. While we are disappointed with the AMEERA-3 results, we continue to investigate amcenestrant in patients with earlier stages of breast cancer with different tumor profiles and where different standard of care treatments are used."

Sanofi will continue to assess data from the AMEERA-3 trial and work with investigators on the publication of the full results. The ongoing clinical trial program for amcenestrant continues as planned, including AMEERA-5 and AMEERA-6.

Amcenestrant is an optimized oral SERD that binds to the estrogen receptors (ER) in breast cancer cells to inhibit their normal function and trigger degradation so they can no longer be used by tumor cells to grow. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.

About the AMEERA-3 trial

AMEERA-3 was an open-label, Phase 2 randomized trial evaluating the efficacy and safety of amcenestrant as a monotherapy compared to single-agent endocrine treatment of the physician’s choice in patients with ER+, HER2- locally advanced or metastatic breast cancer with prior exposure to hormonal therapies. The primary objective of AMEERA-3 was to determine whether amcenestrant improved PFS assessed by an independent central review compared to endocrine monotherapy. The key secondary efficacy endpoint was overall survival and other secondary endpoints were objective response rate, disease control rate, clinical benefit rate and duration of response. The study also compared the overall safety profile in the two treatment arms and evaluated health-related quality of life in the two treatment arms based on patient-reported outcomes.

About the amcenestrant clinical program

The comprehensive development program for amcenestrant has been designed to evaluate its potential as an oral endocrine backbone therapy across treatment lines, including: as a single agent in second-line or later lines of treatment of ER+/HER2- metastatic breast cancer (MBC) (AMEERA-3), in combination with palbociclib in the first-line treatment of ER+/HER2- MBC (AMEERA-5), and to explore its potential in early-stage breast cancer patients in the adjuvant setting (AMEERA-6). Initiated in late 2020, the Phase 3 AMEERA-5 clinical trial is now fully enrolled. The Phase 3 AMEERA-6 trial, in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT) is now enrolling.

On March 14, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the fourth quarter and full year ending December 31, 2021 (Press release, Akoya Biosciences, MAR 14, 2022, View Source [SID1234610036]).

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"Our strong finish to 2021 demonstrates the continued and accelerating adoption of our leading spatial biology solutions and is a result of sound execution of our financial and strategic plans," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "We set another record in quarterly revenue, grew our installed base to nearly 700 instruments worldwide, and have approximately 500 publications on Akoya platforms to date. Highlighting our strong quarter was the commercial launch of the PhenoCycler-Fusion System and additional near-term menu offerings across protein and RNA, delivering the fastest, single-cell, multi-omic spatial biology solution in the market."

Fourth Quarter 2021 Financial Highlights

Total revenue was $16.2 million in the fourth quarter of 2021, compared to $12.9 million in the prior year period; an increase of 26%.
Product revenue was $12.9 million in the fourth quarter of 2021, compared to $10.5 million in the prior year period; an increase of 23%.
Services and other revenue totaled $3.2 million in the fourth quarter of 2021, compared to $2.4 million in the prior year period; an increase of 33%.
Gross profit was $10.2 million in the fourth quarter of 2021, compared to $7.9 million in the prior year period; an increase of 29%; and gross profit margin was 63.3% in the fourth quarter of 2021, compared to 61.3% in the prior year period.
46 instruments were sold in the fourth quarter of 2021; 21 PhenoCyclers, 25 PhenoImagers (which includes Fusion, HT, and earlier PhenoImager workflow instruments such as the Mantra and Vectra).
Instrument installed base of 697 as of December 31, 2021; 182 PhenoCyclers, 515 PhenoImagers.
Full Year 2021 Financial Highlights

Total revenue was $54.9 million for the FY 2021, compared to $42.4 million in the prior year; an increase of 29.5%.
Product revenue was $44.5 million for the FY 2021, compared to $33.4 million in the prior year; an increase of 33%.
Services and other revenue totaled $10.4 million for the FY 2021, compared to $9.0 million in the prior year; an increase of 16%.
Gross profit was $34.2 million for the FY 2021, compared to $25.9 million in the prior year; an increase of 32%; and gross profit margin was 62.3% for FY 2021, compared to 61.0% in the prior year.
147 instruments were sold for the FY 2021; 70 PhenoCyclers, 77 PhenoImagers.

Fourth Quarter 2021 Business Highlights

There were 278 publications in 2021 featuring Akoya’s platforms, as compared with 109 publications in 2020.
Akoya’s inaugural ‘Spatial Day’ held on December 15, 2021 featured a preview of our new integrated suite of solutions, including the PhenoCycler-Fusion System, novel spatial transcriptomics chemistry and universal protein chemistry, and additionally brought together academic, clinical, and industry leaders who highlighted how Akoya’s spatial phenotyping platforms are uniquely equipped to address key questions across discovery, translational, and clinical research.
Announced full commercial launch of the PhenoCycler-Fusion System, the fastest single-cell, multi-omic, spatial biology solution.
Announced a groundbreaking collaboration with PathAI to combine spatial biology with AI-powered tools to facilitate discovery of novel predictive biomarkers.
Announced a strategic partnership with Bio-Techne to deliver an automated spatial multiomics workflow using the RNAScope technology to enable comprehensive spatial phenotyping of RNA and protein biomarkers on the PhenoCycler-Fusion System.
Announced the securing of CLIA lab certification, a milestone for applying spatial biology technologies to accelerate precision cancer therapies.
Appointment of Marilee Moy as Chief People Officer, who brings more than 30 years of HR leadership experience at high-performing life sciences and technology companies and will be instrumental in defining and executing Akoya’s human resource strategy as the company enters a new phase of global growth.
$113.1 million of cash and cash equivalents as of December 31, 2021, well capitalized to deliver on our existing strategic plan.
2022 Outlook

The company, based on its current plans and initiatives, expects a full year 2022 revenue guidance range of $69-71 million.

Webcast and Conference Call Details

Akoya will host a conference call today, March 14, 2022, at 5:00 p.m. Eastern Time to discuss its fourth quarter and full year 2021 financial results. The dial-in numbers are (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 5291099. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On March 14, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling, in patients with advanced solid tumors (Press release, Guardant Health, MAR 14, 2022, View Source [SID1234610052]).

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MHLW also approved Guardant360 CDx as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo (nivolumab). In December 2021, MHLW granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS (sotorasib).

"The MHLW approval of Guardant360 CDx marks a significant milestone for Guardant Health and further reinforces the value blood-based testing brings to physicians and patients with advanced cancer. With a simple blood draw, a physician can conduct comprehensive genomic profiling of a patient’s tumor, then match that patient with the best available treatment option without the complications and delays of a tissue biopsy," said Helmy Eltoukhy, Guardant Health co-CEO. "Today’s approval further strengthens Guardant Health’s global commitment to transform cancer care by bringing innovative blood-based tests like Guardant360 CDx to physicians and advanced cancer patients in Japan."

About Guardant360 CDx

Guardant360 CDx is a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from the blood samples of patients with advanced solid tumors and identifies genetic alterations that may inform treatment decisions. On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx for comprehensive genomic profiling across all solid cancers and as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). This approval represented the first FDA-approved liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers.