On November 26, 2020 Golden Biotechnology Corp.(GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, reported that its new drug Antroquinonol (HOCENA) outperforms the other listing drugs for the treatment of relapsed AML (acute myeloid leukemia) patients in its Phase 2 clinical study conducted in Russia (Press release, Golden Biotechnology, NOV 26, 2020, View Source;outperforms-listing-drugs-in-relapsed-acute-myeloid-leukemia-301181008.html [SID1234571803]). The outcome measures demonstrated higher remission rates (50%, CR/Cri) and survival rates guaranteeing fewer patients will require blood transfusions. This has made high safety possible during breakthroughs for AML treatment with remarkable monotherapy without combined chemotherapy. The new drug Antroquinonol has been granted orphan drug designation (ODD) by the U.S. FDA for the treatment of AML in 2015. GoldenBiotech has achieved excellent breakthrough in the unmet medical needs in AML therapy which many global pharmaceutical companies are targeting.

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Breakthrough in AML Treatment! GoldenBiotech’s new drug clinical trial of Antroquinonol.
Clinical Results Summary:

*Primary Outcome Measure- overall remission rate (CR/CRi): 50%

*Secondary Outcome Measures

80% of patients showed that their blasts count were less than 5%
90% of patients did not need blood transfusion during trial period
100% of patients were all alive during trial period (6 months)
No serious side effect
The primary efficacy indicator results exhibit that the overall remission rate (CR/CRi) of patients with relapsed acute myeloid leukemia reaches 50%. This is higher than those of other listing drugs in their Phase 2 trial ranging approximately from 21%~33% in (CR/CRi). 80% of patients’ abnormal blasts counts in bone marrow or blood were decreased to be less than 5% after treatment. For the secondary outcome measures results the overall survival rate of patients with relapsed AML reached 100% by the 6th month after treatment. This amplifies the possibility of patients receiving bone marrow transplantation. Furthermore, 90% of patients do not need to undergo blood transfusion during treatment with Antroquinonol (Hocena). Oral treatments and the decrease in blood transfusions have greatly improved the quality of life of AML patients. There is no significant side effect (SAE) that has occurred during the 6-month treatment period. The dose trial is administered orally at home by taking 200 mg twice a day.

The trial of Antroquinonol (HOCENA), Protocol No. GHAML-2-001, was an open-label, non-randomized, Phase 2a study to evaluate efficacy and safety/tolerability profiles in adult patients with relapsed acute myeloid leukemia (AML) or at initial diagnosis when no intensive treatment is possible.

There is no standard treatment for relapsed/refractory adult acute myeloid leukemia (AML) patients. Based on the confidence achieved in the trial results for the treatment of second-line and recurrent AML patients, GoldenBiotech will apply the clinical trial (IND) to the U.S. FDA for the Phase 2 clinical trials as the first-line treatment of AML and continue to expand the spectrum of indications of Antroquinonol in other leukemia treatment fields including multiple myeloma (MM), chronic myelogenous leukemia (CML), and pediatric leukemia.

The majority of AML patients need to undergo blood transfusions and chemotherapy to kill cancer cells due to abnormal differentiation of blood cells and proliferation of myeloblasts. Current therapies are combined with chemotherapy often causing serious side effects resulting in poor prognosis of treatment for relapsed AML patients. AML ranks the second highest incidence in all leukemia but it has the highest mortality rate and the lowest five-year survival rate (about only 25%).

It is estimated that there will be about 62,000 patients with acute myeloid leukemia (AML) in 2020. According to the reports from GlobalData and other institutions, the global AML therapeutic drug market is expected to increase from USD 1.4 billion in 2019 to 5.1 billion in 2029 with a compound annual growth rate (CAGR) of 13.6%.

About Antroquinonol

Antroquinonol was discovered in 2006 by Golden Biotechnology Corp..Its compound structure, preparation methods and applicable indications have been protected with patents worldwide. The recent approved by FDA and undergoing clinical trial of new drug Antroquinonol is a Phase 2 clinical trial for mild to moderate COVID-19 hospitalized patients in the USA. This is the first Taiwanese new drug approved by FDA for the Phase 2 clinical trial in Covid-19. Antroquinonol has shown anti-viral, anti-inflammatory and anti-fibrotic characteristics in past animal studies, suggesting high likelihood in becoming successful treatment option for coronavirus-induced pneumonia.

Learn more about the trial and contact information: Antroquinonol – Covid-19 Clinical Trial.

Other pipelines include non-small cell lung cancer (NSCLC), pancreatic cancer, acute myeloid leukemia, hypercholesterolemia and hyperlipidemia, atopic dermatitis and hepatitis. Research on neurogenic disorders like Alzheimer’s disease (AD) treatment and prevention are also in good process. Antroquinonol has received ODD (Orphan drug designation) approval by US FDA for treatment of Acute Myeloid Leukemia(AML), Hepatocelluar carcinoma (Liver cancer, HCC) and Pancreatic Cancer in 2015. For ODD in Pancreatic cancer has also received approval by European EMA in 2017.

On November 26, 2020 In Elekta reported that second quarter, we managed to perform better than the overall radiotherapy market both in terms of orders and revenue despite continuous challenging circumstances (Press release, Elekta
, NOV 26, 2020, View Source [SID1234571802]). We also improved margins and stabilized cash flow. The launch of our new Harmony linac and regulatory clearances enhanced our product portfolio and strengthened our ability to deliver on our strategy of Precision Radiation Medicine.

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Gustaf Salford
President and CEO

Second quarter

Covid-19 continued to have a negative impact on Elekta’s growth in the quarter
Gross order intake amounted to SEK 3,627 M (4,036), corresponding to a 2 percent decrease in constant currency
Net sales were SEK 3,534 M (3,709), corresponding to a 3 percent growth in constant currency
Gross margin amounted to 40.9 (41.0) percent
EBITA increased by 39 percent to SEK 752 M (539), corresponding to an EBITA margin of 21.3 percent (14.5)
Earnings per share was SEK 0.98 (0.58) before/after dilution
Cash flow after continuous investments improved by SEK 128 M to SEK 362 M (234)
Launch of a new linac solution, Harmony
First six months

Gross order intake amounted to SEK 8,078 M (8,426), corresponding to a 1 percent growth in constant currency
Net sales were SEK 6,515 M (6,937), corresponding to a 1 percent decrease in constant currency
Gross margin amounted to 43.2 (41.7) percent
EBITA amounted to SEK 1,303 M (987), corresponding to an EBITA margin of 20.0 percent (14.2)
Earnings per share was SEK 1.55 (0.96) before/after dilution
Cash flow after continuous investments improved by SEK 939 M to SEK 389 M (-550)
Significant events after the quarter

The Board of Director has appointed Gustaf Salford as Elekta’s President and CEO with immediate effect.
Introduction of Elekta Studio with the ImagingRing providing a complete image-guided brachytherapy workflow to a single room.
1 After continuous investments.
2 Before / after dilution.
3 Based on constant currency.

On November 26, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported a partnership with the United Kingdom’s (UK) National Health Service (NHS) to help transform cancer outcomes by making GRAIL’s multi-cancer early detection blood test, Galleri, available to UK patients starting in 2021 (Press release, Grail, NOV 26, 2020, View Source [SID1234571798]).

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The commercial partnership program aims to confirm Galleri’s clinical and economic performance in the NHS system as a precursor to its routine use by the NHS.

The partnership program will involve approximately 165,000 people in the UK and includes two groups. The first will include 140,000 people over the age of 50 without any suspicion of cancer, and the second will include 25,000 people aged 40 and above with suspicious signs or symptoms of cancer. Based on data from this program, access to the test could be expanded to around one million people across 2024 and 2025 and may roll out to a larger population thereafter.

In a clinical validation study in the U.S., an earlier version of Galleri detected over 50 types of cancer with a low false positive rate of less than 1% through a single blood draw. Modeling data show that adding Galleri to existing standard of care has the potential to decrease the number of cancers diagnosed at late stage by nearly half, which could reduce the total number of cancer deaths in the UK by approximately one-fifth.

"Every year, nearly 200,000 people in the UK die from cancer. Many of these people are diagnosed too late for treatment to be effective," said Lord David Prior, Chair of NHS England. "This collaboration between the NHS and GRAIL offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer."

"We are building a world-leading diagnostics industry in the UK — not just for coronavirus, but for other diseases too," said Matt Hancock, Health and Social Care Secretary. "This exciting and ground-breaking new blood test from GRAIL will give us another tool to give more people the very best chance of survival, demonstrating how the UK continues to lead the way in using the latest innovative treatments to help patients. Many of us know a loved one who has battled against cancer and have seen first-hand the impact of this deadly disease."

Cancer is projected to soon become the world’s leading cause of death, with more than 1,000 people in the UK receiving a cancer diagnosis every day. The majority of cancers are found too late when outcomes are often fatal, because most deadly cancers have no available screening tests. In the UK, more than 80% of all cancer deaths are from cancers which don’t currently have any available recommended screening.

"The collaboration between GRAIL, NHS England, and the UK Government represents a novel approach to taking on one of the world’s biggest public health challenges," said Hans Bishop, Chief Executive Officer at GRAIL. "We are excited to partner with the UK Government to support the NHS Long Term Plan for earlier cancer diagnoses, and we are eager to bring our technology to patients in the UK, and potentially save many lives."

"The Long Term Plan for cancer is one I’ve been immensely supportive of since it was published in 2019, and I applaud the UK Government and the NHS for setting out these ambitious goals and road map to diagnosing cancers earlier," said Sir Harpal Kumar, President of GRAIL Europe. "Galleri, a simple blood test that’s capable of detecting more than 50 types of cancers, is a ground-breaking and potentially life-saving advance that could have a tremendous human and economic benefit."

Galleri is expected to be commercially available in the U.S. in 2021. It is currently available under investigational use in GRAIL’s first interventional study, PATHFINDER, where it is being used to guide clinical care.

On November 26, 2020 Egle Therapeutics SAS (Egle), an emerging biotechnology company focused on developing first-in class immunotherapies targeting immune suppressor regulatory T-cells (Tregs) for oncology and autoimmune diseases, reported that it has achieved the first milestone in its strategic research alliance with Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Egle Therapeutics, NOV 26, 2020, View Source [SID1234571797]). In the course of the strategic research alliance that was announced in June 2020, Egle will validate novel tumor-infiltrating regulatory T-cell (Treg) targets against which Takeda will develop potential therapies.

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Egle has leveraged its unique bioinformatic and translational capabilities to successfully identify targets that will now be pursued under the terms of the alliance. Upon achievement of the target identification, Egle will receive an R&D milestone payment and investment from Takeda.

Luc Boblet, CEO of Egle, commented "Reaching this first technical milestone marks our positive progress towards our joint goal with Takeda, of creating the next generation of differentiated immunotherapies against Tregs, and provides strong validation of the work being done at Egle. We look forward to continuing our productive alliance with Takeda while pushing further our internal programs through the equity component of the alliance."

"We have made great progress in our collaboration with Egle and are thrilled with the speed of which we identified our first novel Treg targets," said Loïc Vincent, Head, Oncology Drug Discovery Unit at Takeda. "We hope to build upon this momentum in the next phase of our partnership to enable and ultimately deliver new immuno-oncology therapeutic options."

On November 26, 2020 MaaT Pharma reported that updated results from its compassionate use program for lead microbiome therapeutic MaaT013 will be reported in an oral presentation at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 5 -8, 2020 (Press release, MaaT Pharma, NOV 26, 2020, View Source [SID1234571795]). The results include data from 29 patients with gastrointestinal, acute Graft-versus-Host-Disease (aGvHD) who were resistant to multiple lines of treatments and were treated with the full-ecosystem microbiome restoration biotherapeutic. MaaT Pharma provided the product to hospitals under an expanded access treatment program in France called Autorisation Temporaire d’Utilisation Nominative (ATUn). MaaT013 is an enema formulation of a microbiome biotherapeutic characterized by a consistent high diversity and richness of microbial species, derived from pooled donations from healthy individuals. The data will be presented by Dr. Florent Malard, MD, PhD, Associate Professor of Hematology at Saint-Antoine Hospital and Sorbonne University, who participated in the treatment program.

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Oral Presentation details:

Title: Successful and Safe Treatment of Intestinal Graft-Versus-Host Disease (GvHD) with Pooled-Donor Full Ecosystem Microbiota Biotherapeutic: Results from a 29 Patient-Cohort of a Compassionate Use/Expanded Access Treatment Program

Abstract No: 422

Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GvHD, Immune Reconstitution: Pathobiology and Predictive Biomarkers

Date/Time: Sunday, December 6, 2020 / 1:00 PM EDT

MaaT Pharma will announce the results through a press release on Monday, December 7, 2020.

The company is also investigating its lead biotherapeutic, MaaT013, in the HERACLES trial, a multi-center, single-arm, open-label Phase II clinical study in steroid-refractory, predominantly gastrointestinal aGvHD patients (NCT03359980).