On February 4, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the China National Medical Products Administration (NMPA) has granted conditional approval to XOSPATA (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test (Press release, Astellas, FEB 4, 2021, View Source [SID1234574567]). Gilteritinib has been approved under an expedited pathway, following NMPA’s acceptance of gilteritinib for priority review in July 20201 and its inclusion in the third batch of overseas new drugs urgently needed in clinical settings in November 2020.2

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"Patients with relapsed or refractory AML with a FLT3 mutation are in urgent need of new treatment options," said Professor Ma Ju, Director of the Harbin Institute of Hematology, China. "As the first approved targeted therapy agent to treat relapsed or refractory AML with a FLT3 mutation in China, gilteritinib, which was approved under an expedited pathway, has enabled patients in China to have rapid access to a novel treatment option."

Gilteritinib has shown itself to be effective against two types of FLT3 mutation – FLT3 internal tandem duplication (FLT3-ITD) and FLT3 tyrosine kinase domain (FLT3-TKD). Impacting approximately 30% of AML patients,3 the FLT3-ITD mutation is associated with higher risk of relapse and shorter overall survival compared to wild-type FLT3.4,5 FLT3-TKD mutations impact approximately 7% of AML patients.3 The status of FLT3 mutation can change over the course of AML treatment, including after relapse. Confirming patients’ FLT3 mutation status at the time of relapse can help inform an appropriate and potentially targeted treatment approach.6

"Having a FLT3 mutation has a highly negative impact on prognosis for people living with AML," said Professor Wang Jianxiang, Vice Director of Institute of Hematology, Chinese Academy of Medical Sciences. "The approval of gilteritinib provides an important new option for Chinese patients that have relapsed or refractory AML with a FLT3 mutation, backed by substantial safety and efficacy data."

AML is a cancer that impacts the blood and bone marrow,7 and its incidence increases with age.8 It is one of the most common types of leukemia in adults.9 Every year, it is estimated that around 80,000 people in China are diagnosed with leukemia.10

"There is an urgent unmet need among FLT3-mutated relapsed or refractory AML patients, whose median survival is currently less than six months with chemotherapy," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development. "The expedited approval of gilteritinib is an important step in offering a new treatment option for doctors and patients in China. We look forward to offering gilteritinib as part of our commitment to developing innovative solutions for patients with hard-to-treat cancers with limited treatment options."

The approval was based on results from the Phase 3 ADMIRAL trial, published in the New England Journal of Medicine. Patients treated with gilteritinib had significantly longer overall survival (OS) than those who received salvage chemotherapy. Median OS for patients who received gilteritinib was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83), P=0.0004).11 Additional Chinese patient pharmacokinetics data from the ongoing Phase 3 COMMODORE trial were also reviewed.

The safety of gilteritinib was evaluated in 319 patients with relapsed or refractory AML who have received at least one dose of 120 mg gilteritinib daily.11 The most frequent all-grade adverse reactions (frequency ≥ 10%) with gilteritinib were alanine aminotransferase (ALT) increased (25.4%), aspartate aminotransferase (AST) increased (24.5%), anemia (20.1%), thrombocytopenia (13.5%), febrile neutropenia (12.5%), platelet count decreased (12.2%), diarrhea (12.2%), nausea (11.3%), blood alkaline phosphatase increased (11%), fatigue (10.3%), white blood cell count decreased (10%), and blood creatine phosphokinase increased (10%). One fatal adverse reaction of differentiation syndrome occurred in patients receiving gilteritinib. The most frequent (frequency ≥3%) serious adverse reactions were febrile neutropenia (7.5%), ALT increased (3.4%), and AST increased (3.1%). Other clinically significant serious adverse reactions included electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.3%).

Astellas has already reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2021.

On February 3, 2021 Henry Ford Cancer Institute reported that it is the first site in the world to activate two new treatments for glioblastoma (GBM), the deadliest form of brain cancer, as part of a patient-centered adaptive platform trial known as GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) (Press release, Kintara Therapeutics, FEB 3, 2021, View Source [SID1234577608]). Led by Global Coalition for Adaptive Research (GCAR), GBM AGILE tests multiple therapies for patients with newly-diagnosed and recurrent GBM.

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Henry Ford Cancer Institute was first-in-the-world to enroll a patient in GBM AGILE when enrollment began in 2019.

"We are excited for this major step forward in the GBM AGILE trial, and especially for the hope it provides those battling glioblastoma brain cancer," said Tom Mikkelsen, M.D., principal investigator for GBM AGILE at Henry Ford Cancer Institute, and medical director of the Precision Medicine Program and Clinical Trials Office at Henry Ford Health System. "Through global collaboration, GBM AGILE is making it possible for some of the world’s foremost experts in glioblastoma research and treatment to collaborate and advance the pace at which scientific and clinical breakthroughs can be achieved."

After opening at Henry Ford Cancer Institute, the two new interventions – VAL-083 from Kintara Therapeutics, Inc. and paxalisib from Kazia Therapeutics Limited– will subsequently open at more than 35 trial sites across the United States, with additional global sites in Canada, Europe and China to follow. VAL-083 is being evaluated in all three glioblastoma patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent. Paxalisib is being evaluated in newly-diagnosed unmethylated and recurrent glioblastoma.

VAL-083 is a "first-in-class" small molecule that has been studied in more than 40 Phase I and Phase II clinical trials in multiple indications sponsored by the National Cancer Institute. VAL-083 is independent of the MGMT resistance mechanism and has been granted Orphan Drug Designation for glioblastoma by the FDA and for Glioma by the European Medicines Agency. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent glioblastoma.

Paxalisib is a small molecule inhibitor of the PI3K / AKT / mTOR pathway. The PI3K pathway appears to be disordered in more than 85% of cases of glioblastoma, making this pathway a high-potential target for new glioblastoma therapies. Paxalisib is a potent inhibitor of the PI3K pathway, and has been shown to have an anti-tumor effect in animal models of glioblastoma. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation for glioblastoma by the FDA in August 2020.

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase II/III design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

On February 3, 2021 Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs, reported that data from non-human primate studies of the company’s proprietary fully human Interleukin 12 (IL-12) therapeutic candidate, SON-1010, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2021, April 10-15 and May 17-21 (Press release, Sonnet BioTherapeutics, FEB 3, 2021, View Source [SID1234576688]).

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Details of the abstract and poster presentation are as follows:

Title: Toxicity profile of interleukin 12 attached to a fully human albumin binding domain (FHABTM) in Cynomolgus macaques
Abstract Number: 1589
Session: Combination Immunotherapies
Presentation Type: E-poster
Date: Available for browsing on April 10, 2021 through June 21, 2012

On February 3, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will participate in the Cowen 42nd Annual Aerospace/Defense & Industrials Conference webcast (Press release, Leidos, FEB 3, 2021, View Source;Industrials-Conference/default.aspx [SID1234574999]).

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Roger Krone, Chief Executive Officer, will participate in a question and answer "fireside chat" on Thursday, February 11, 2021 at 11:00am ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for 90 days afterward.

On February 3, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported two subscription agreements with Gaoling and YHG, a company of Hillhouse Capital Group, and Vivo Opportunity Fund, L.P, a company of Vivo Capital VIII, LLC (Press release, InnoCare Pharma, FEB 3, 2021, View Source [SID1234574706]). The two investors subscribed 191,613,000 and 18,895,000 new shares respectively, for a total of 210,508,000 new Shares, representing about 16.33% of the existing total issued Shares of the Company as at the date of this announcement and approximately 14.04% of the total issued Shares of the Company as enlarged by the allotment and issue of the Subscription Shares. The subscription price of HK$14.45 per share represents an 8.32% premium to the average closing price of the five trading days immediately preceding the date of the Subscription Agreements (not including 2 February 2021).

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Hillhouse Capital has adhered to the philosophy of value investment, and Vivo Capital focuses on investing in high-quality companies in the fields of life science and healthcare. The two investors are fully in line with InnoCare’s core value of "Science Drives Innovation".

InnoCare has built an integrated new drug development platform and continues to build a more competitive product pipeline. In addition to the self-developed Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib, which was approved for marketing at the end of last year, InnoCare has developed over a balanced pipeline of 10 drug candidates for the treatment of malignant tumors and autoimmune diseases. For example, the company’s pan-FGFR inhibitor ICP-192, which is currently in being studied two phase II clinical trials for the treatment of cholangiocarcinoma and urothelial carcinoma in China, has shown promising early efficacy data in patients with FGFR gene alterations. At the same time, InnoCare is also conducting phase I clinical trials of ICP-192 in the United States. Second-generation pan-TRK inhibitor ICP-723 is in phase I clinical trials in China for the treatment of advanced or metastatic solid tumors carrying NTRK fusion genes, which include indications such as breast cancer, colorectal cancer, lung cancer, thyroid cancer, etc., as well as patients who are resistant to the first generation of TRK inhibitors. In addition, InnoCare has been conducting multi-center and multi-indication clinical trials of orelabrutinib in China and the United States, including a global phase II clinical trial for the treatment of multiple sclerosis.

Based on the long-term investments, Hillhouse Capital has attached great importance to the biotech sector and values company’s long-term growth capabilities. The strategic investment from Hillhouse demonstrated the recognition of InnoCare’s strong innovation capabilities.

As one of InnoCare’s early and cornerstone investors, Vivo Capital has shared many experiences and resources with InnoCare, helping the company become a leader in the innovative drug field.

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, "I am very pleased that Hillhouse Capital has joined as a strategic investor. At the same time, Vivo Capital has increased its holdings. The biotech industry needs continuous innovation and capital support. We believe that, through our joint efforts, InnoCare will develop more high-quality innovative drugs to benefit patients in China and around the world."