On December 29, 2021 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 the Company is filing new patent applications in several countries for the treatment of all advanced solid tumors based on new clinical data showing that a patient with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, was cleared of all tumor lesions following treatment with Namodenoson, an A3 adenosine receptor (A3AR) ligand (Press release, Can-Fite BioPharma, DEC 29, 2021, View Source [SID1234597825]). These pending patent applications are the latest in Can-Fite’s growing IP portfolio covering its platform technology, as well as its drug candidate Namodenoson and its use in a variety of advanced cancers.

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Can-Fite’s Namodenoson, a small orally bioavailable drug that binds with high affinity and selectivity to A3AR, was recently found to clear all cancer lesions in a patient treated under an Open Label Extension program of its concluded Phase II study for the treatment of HCC. In the first quarter of 2022, Can-Fite expects to commence patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval.

"Can-Fite’s IP portfolio includes about 200 patents and pending patent applications in 16 patent families. Given the very strong new data on Namodenoson’s efficacy in advanced HCC, these latest patent filings seek to further fortify our IP position with respect to Namodenoson in liver cancer and also expand our pending claims for advanced disease in other cancer indications", stated Can-Fite’s Chairman, Dr. Ilan Cohn, a Senior and Founding Partner at Cohn De Vries Stadler & Co., a leading IP firm.

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 December 29, 2021 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS) reported that the company will participate in two separate biotech events in January 2022: the H.C. Wainwright BIOCONNECT Virtual Conference and the 11th Annual LifeSci Partners Corporate Access Event (Press release, Aptose Biosciences, DEC 29, 2021, View Source [SID1234597824]). The Aptose management team will be hosting investor meetings during both events.

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Details of the events are as follows:

Event: H.C. Wainwright BIOCONNECT Virtual Conference
Date: January 10-13, 2022
Time: Presentations available starting at 7:00 a.m., ET on January 10, 2022
Webcast: Accessible for registered conference attendees via the conference’s virtual platform.

Event: 11th Annual LifeSci Partners Corporate Access Event
Date: January 5-7, 2022
1×1 Meeting
Requests: Register and submit 1×1 meeting requests here.

On December 29, 2021 AstraZeneca reported that it has closed a global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX (Press release, AstraZeneca, DEC 29, 2021, View Source [SID1234597822]).

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The companies will jointly develop and commercialise eplontersen in the US, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.

Financial considerations
Under the terms of the agreement, the upfront payment from AstraZeneca to Ionis is $200m. AstraZeneca will make additional conditional payments of up to $485m following regulatory approvals. It will also pay up to $2.9bn of sales-related milestones based on sales thresholds between $500m and $6bn, plus royalties in the range of low double-digit to mid-twenties percentage depending on the region. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions.

The transaction will be funded with cash and is expected to be neutral to Core earnings in 2021. It will be accounted for as an intangible asset acquisition, recognised initially at the upfront amount, with any potential future milestone payments capitalised into the intangible asset as they are recognised.

Ionis will continue to manufacture and supply eplontersen for the existing clinical studies and process qualification. AstraZeneca will be responsible for commercial supply, with transition timing to be agreed by both parties. AstraZeneca will book all sales generated under the agreement.

The transaction does not impact AstraZeneca’s financial guidance for 2021.

Notes

Eplontersen
Eplontersen is a ligand-conjugated antisense (LICA) investigational medicine designed to reduce the production of transthyretin, or TTR protein, to treat all types of TTR amyloidosis (ATTR), a systemic, progressive and fatal disease.

TTR Amyloidosis (ATTR)
Cardiomyopathy and polyneuropathy due to ATTR are caused by aging or genetic mutations resulting in misfolded TTR protein and accumulation as amyloid fibrils in the cardiac myocardium and peripheral nerves, respectively. In patients with ATTR, both the mutant and wild type TTR protein builds up as fibrils in tissues, such as the peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid and bone marrow. The presence of TTR fibrils interferes with the normal functions of these tissues. As the TTR protein fibrils enlarge, more tissue damage occurs and the disease worsens, resulting in poor quality of life and eventually death. Worldwide, there are an estimated 300,000 – 500,000 patients with amyloid transthyretin cardiomyopathy (ATTR-CM)1,2 and 10,000 – 40,000 patients with amyloid transthyretin polyneuropathy (ATTR-PN).3

On December 28, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management will participate in the 24th Annual Needham Virtual Growth Conference on Tuesday, January 11, 2022 (Press release, Personalis, DEC 28, 2021, View Source [SID1234597815]).

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On December 28, 2021 Therapeutic Solutions International reported that receipt of a Notice of Allowance from the United States Patent and Trademark Office regarding its patent application entitled "Nutraceuticals for Suppressing Indolamine 2,3 Deoxygenase (Press release, Therapeutics Solutions International, DEC 28, 2021, View Source [SID1234597814])."

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To the knowledge of the Company, this is the first issuance of a patent on a nutraceutical supplement for stimulating the immune system by blocking immune suppressive activities used by cancer and viruses in the IDO pathway. The supplement, termed "QuadraMune" is commercially available on the Company website and through Amazon.

Numerous drugs such as Optivo, Yervoy, and Keytruda, have been approved by the FDA for treatment of cancers by boosting immunity though blocking immune inhibiting mechanisms. This class of drugs, called "checkpoint inhibitors" represent a 15.2 billion dollar a year market1.

"The indolamine 2,3 deoxygenase (IDO) pathway is believed to be one of the major immunological checkpoints based on the fact that small molecule blockade of this pathway results in immune mediated destruction of tumors in animals," stated Dr. Thomas Ichim, Board Member and Co-Inventor of the patent. "Unfortunately, prior approaches to suppress this pathway relied on toxic compounds which did not perform well in clinical trials, in part due to inability to administer sufficient doses without evoking toxicity. We are excited by the possibility that QuadraMune, a nutraceutical composition that is commercially available may act as a potent immune booster targeting the IDO pathway without drawbacks of other approaches."

In 20132 and subsequently in 20183, Dr. Ichim and colleagues published regression of breast cancer by inhibiting the IDO pathway using an RNA interference approach. The current data and patent granted are representation of years of basic scientific investigation on the relationship between IDO and the immune system.

"As a physician that sees firsthand the devastation caused by cancer and viruses, I am extremely excited about our ability to modulate critical immunological pathways using naturally occurring ingredients such as pterostilbene, thymoquinone, epigallocatechin gallate and sulforaphane," said Dr. James Veltmeyer, Chief Medical Officer of the Company and Co-Inventor of the patent. "What is particularly important is that after filing of our patents, numerous independent universities have validated the anti-COVID activity of the individual ingredients. These studies are summarized in our previous press release4."

"The acceptance of our data by the United States Patent Office in granting of the current patent is a major accomplishment for the Company," said Timothy Dixon, President and CEO, and Co-Inventor of the patent. "The Company has numerous patent applications filed covering multiple nutraceuticals and uses including; a) published patent application #16/866430 entitled ‘Nutraceuticals for the Prevention, Inhibition, and Treatment of SARS-Cov-2 and Associated COVID-19’, b) #16/898472 entitled ‘Nutraceuticals for Reducing Myeloid Suppressor Cells’ and c) #16/907335 entitled ‘Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity’."