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Aptose to Participate in Two Biotech Events in January 2022

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.

AstraZeneca and Ionis close agreement to develop and commercialise eplontersen

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]).

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

Personalis to Participate in the 24th Annual Needham Virtual Growth Conference

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]).

Therapeutic Solutions International Awarded Landmark Patent for Cancer and COVID-19 Treatment

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])."

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’."

Valemetostat New Drug Application Submitted in Japan for Treatment of Patients with Adult T-Cell Leukemia/Lymphoma

On December 28, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for valemetostat, a potential first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma (ATL) (Press release, Daiichi Sankyo, DEC 28, 2021, View Source [SID1234597813]).

ATL is a rare and aggressive type of peripheral T-cell lymphoma that occurs with greater frequency in parts of Japan and other regions.1,2 Patients with ATL face a poor prognosis with current therapies.3 Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are few options available.1,4

The Japan NDA submission of valemetostat is based on pivotal phase 2 study results in Japanese patients with three aggressive subtypes of relapsed/refractory ATL, recently presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.

"Valemetostat would potentially be the first dual inhibitor of EZH1 and EZH2 to be approved anywhere in the world and could provide a new type of targeted therapy option for patients with relapsed/refractory ATL, which represents one of the most significant unmet medical needs in Japan," said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. "Valemetostat is the fifth innovative oncology medicine from our pipeline to be submitted for regulatory approval in Japan in the past three years."

About Adult T-Cell Leukemia/Lymphoma

Adult T-cell leukemia/lymphoma (ATL) is a rare and aggressive type of peripheral T-cell lymphoma (PTCL) that is caused by human T-cell lymphotropic virus type 1 (HTLV-1).1 More than 3,000 new cases of ATL are diagnosed each year worldwide.5 ATL occurs with greater frequency in regions where the HTLV-1 virus is endemic including southwest Japan, Central and South America and central Australia.3 Cases are also observed in North America and Europe, and incidence of ATL is rising in non-endemic areas.3 In Japan, there are approximately 1,000 new ATL cases and over 1,000 deaths due to ATL annually.6

ATL has the poorest prognosis compared to other types of PTCL, with a five-year overall survival rate of about 14%.7 A median survival time of approximately eight months (252 days) was reported for patients in Japan with the most common acute ATL subtype.5

Treatment of ATL is based on subtype and consists primarily of intensive multi-drug chemotherapy regimens.3 Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are few options available.1,4 Additional therapies are needed to improve the prognosis of ATL in Japan and worldwide.1,3

About Valemetostat

Valemetostat is a potential first-in-class dual inhibitor of EZH1 and EZH2 currently in clinical development in the Alpha portfolio of Daiichi Sankyo. A potent and selective small molecule inhibitor, valemetostat is designed to counter epigenetic dysregulation by targeting both the EZH1 and EZH2 enzymes.8

The valemetostat development program includes VALENTINE-PTCL01, a global pivotal phase 2 trial in patients with relapsed/refractory PTCL and ATL; a pivotal phase 2 trial in patients with relapsed or refractory ATL in Japan; and, a phase 1 study in patients with relapsed/refractory NHL in the U.S. and Japan. Valemetostat received ODD from the U.S. Food & Drug Administration for the treatment of PTCL in December 2021, ODD from the Japan MHLW for the treatment of relapsed/refractory ATL in November 2021 and SAKIGAKE Designation from the Japan MHLW for the treatment of adult patients with relapsed/refractory PTCL in April 2019.

Valemetostat is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

About the Pivotal Phase 2 Study

The pivotal, open-label, multi-center, single-arm phase 2 study evaluated efficacy and safety of valemetostat (200 mg dose daily) as monotherapy in patients with relapsed/refractory ATL who were previously treated with mogamulizumab or at least one systemic chemotherapy in case of intolerance/ contraindication for mogamulizumab and with no history of allogenic hematopoietic stem cell transplant.

The primary endpoint is objective response rate (ORR) assessed by independent efficacy assessment committee. Secondary endpoints include investigator-assessed ORR, best response in tumor lesions, complete remission rate, tumor control rate, time to response, duration of response, progression-free survival, overall survival and safety. A total of 25 patients were enrolled in the study in Japan. For more information, visit ClinicalTrials.gov.

About Daiichi Sankyo Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.