Sentinel Oncology enters exclusive collaboration with PharmaEngine Inc for SOL578

On November 26, 2020 Sentinel Oncology Limited reported that it has entered into a collaboration and license agreement with Taiwan based pharmaceutical company PharmaEngine, Inc. (TWO: 4162) to advance the development of SOL-578 , their checkpoint kinase 1 (Chk1) inhibitor (Press release, Sentinel Oncology, NOV 26, 2020, View Source [SID1234571836]). Under the terms of the agreement, PharmaEngine will fund IND enabling studies for SOL-578.

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Sentinel Oncology Limited is a drug discovery company passionate about the development of novel therapeutics to treat cancer patients for whom there is currently an unmet medical need. The company’s mission is to increase survival and improve outcomes for cancer patients with CNS tumors. SOL-578 is a best-in-class checkpoint kinase 1 (Chk1) inhibitor featuring high kinase selectivity and oral bioavailability which targets the DNA Damage Response (DDR) network.

Under the terms of the Agreement, Sentinel Oncology will receive an exclusivity payment and PharmaEngine will obtain an option to receive the exclusive rights to develop and commercialize SOL-578 worldwide. In the event that PharmaEngine completes the IND enabling studies and exercise its option, Sentinel Oncology will be eligible to receive an upfront and development milestone payments in addition to tiered royalties based on future worldwide net sales of SOL-578.

Robert Boyle, CEO of Sentinel Oncology commented: "We are very excited about the prospects for this programme and the collaboration with PharmaEngine will enable SOL-578 to reach clinical trials and provide a real benefit for patients for whom there is currently a poor prognosis".

NICE backs use of new treatment for multiple myeloma

On November 26, 2020 Sanofi reported that Patients with a difficult to treat form of multiple myeloma will now gain access to a new treatment on the NHS in England and Wales, after cost regulators issued final guidance on the use of Sarclisa (isatuximab) (Press release, Sanofi, NOV 26, 2020, View Source [SID1234571827]).

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Sarclisa, administered as an intravenous infusion, plus pomalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund (CDF) as an option for treating relapsed and refractory multiple myeloma in adults.

Routine NHS funding was not approved at this stage "because the cost-effectiveness estimates are uncertain as there are limitations in the clinical data" the Institute said.

However, its green light via the CDF will allow doctors to offer the treatment as an option for people who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed from their last treatment if they have had three previous forms of treatment, while more data is collated.

"Our independent appraisal committee has recognised more treatment options are needed for those with difficult-to-treat multiple myeloma," said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE.

"Some of the data our committee has already seen shows promise that isatuximab plus pomalidomide and dexamethasone delays the disease from progressing and increases how long people live compared with current treatment options.

"Its use via the Cancer Drugs Fund will add a fourth line treatment option while data from an on-going clinical trial and from NHS use is collected to establish whether it is cost effective."

The guidance is dependent on conditions laid out in a confidential managed access agreement for the treatment combination.

Around 500 people a year could benefit from treatment with the combination.

Breakthrough in AML Treatment: GoldenBiotech Reports New Drug Trial of Antroquinonol -Outperforms Listing Drugs in Relapsed Acute Myeloid Leukemia

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.

Interim report, May-October 2020/21

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.

GRAIL and UK Government to Make Galleri Multi-Cancer Early Detection Blood Test Available to Patients

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.