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Ascentage Pharma’s Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia

On September 7, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL) (Press release, Ascentage Pharma, SEP 7, 2020, View Source [SID1234564706]). This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).

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The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. This ODD from the FDA qualifies APG-2575 for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by the FDA, and most importantly, 7 years of US market exclusivity upon approval for the treatment of CLL.

CLL is a form of leukemia among adults, characterized by progressive accumulation of abnormal lymphocytes cells in the peripheral blood, bone marrow and lymphoid tissues. The American Cancer Society estimates the U.S will have approximately 21,040 new cases of CLL and about 4,060 deaths from the disease in 2020[1]. The most recent SEERs update reiterates that the prevalence of CLL remains below 200,000 in the USA[2]. Development of Bruton tyrosine kinase (BTK) inhibitors and Bcl-2 inhibitors have improved the outcomes of patients with CLL; however, there is still the medical needs for therapies with improved safety profile and shortened ramp-up schedule that achieve deep responses with shorter duration of treatments especially for chemotherapy free regimens in CLL.

APG-2575 is a novel, orally administered Bcl-2 selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. APG-2575 is one of the few Bcl-2 selective inhibitors currently in active clinical development worldwide and the first China-developed Bcl-2 selective inhibitor having entered clinical trials in China. APG-2575 has received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US in a range of hematologic malignancies, including a global Phase Ib/II clinical study of APG-2575 as a single agent or in combination with other therapeutic agents in patients with relapsed/refractory CLL/ SLL (small lymphocytic lymphoma). The study is currently recruiting in US and Australia.

"At present, CLL still presents considerable unmet medical needs. APG-2575 is a key drug candidate in Ascentage Pharma’s pipeline targeting apoptosis. The APG-2575 received this ODD from the FDA shortly after the first ODD in WM, and this designation will be helpful in enhancing our communication with the FDA and expediting our development of APG-2575 in these rare cancer diseases," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "All the policy support and incentives as a result of this ODD will help us accelerate the global clinical development of APG-2575, which we hope will soon offer additional treatment options for patients with CLL."

References:

1. Cancer Statistics 2020, American Cancer Society

2. 2020 Cancer Incidence Data, Surveillance, Epidemiology, and End Results Program, National Cancer Institute

About APG-2575

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Ascentage Pharma has previously commenced Phase I studies of AGP-2575 single agent in China, Australia, and the United States. Since March 2020, the company has received approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, and is advancing clinical development of APG-2575 for a variety of hematologic malignancy indications, including relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, Waldenström macroglobulinemia, relapsed/refractory multiple myeloma, and relapsed/refractory acute myeloid leukemia. APG-2575 was recently granted two orphan drug designations by the US Food and Drug Administration in the treatment of Waldenström Macroglobulinemia and Chronic Lymphocytic Leukemia.

Gossamer Bio Announces Data Presentations at the Virtual European Respiratory Society International Congress 2020

On September 7, 2020 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will present four posters with data relevant to its GB001 and GB002 programs at the Virtual European Respiratory Society International Congress 2020, which takes place from September 7th through 9th (Press release, Gossamer Bio, SEP 7, 2020, View Source [SID1234564705]).

Details for presentations related to GB001, an oral DP2 antagonist for eosinophilic asthma and chronic rhinosinusitis (CRS), are as follows:

Session Type: E-Poster Session
Session Title: Clinical and laboratory pharmacology in asthma (Session 109)
Abstract Number: 2922
Poster Code: 1420
Poster Title: GB001 is a potent, insurmountable DP2 antagonist with long receptor residence time and extended pharmacodynamic effects
Link: View Source

Session Type: E-Poster Session
Session Title: Clinical and laboratory pharmacology in asthma (Session 109)
Abstract Number: 2915
Poster Number: 1421
Poster Title: GB001, a selective prostaglandin D2 receptor 2 antagonist, blocks signaling in the peripheral blood of healthy subjects
Link: View Source

Session Type: E-Poster Session
Session Title: Asthma science: novel targets and mechanisms (Session 193)
Abstract Number: 2885
Poster Number: 2902
Poster Title: GB001 potently inhibits PGD2 metabolite-induced DP2-mediated cell signaling and eosinophil activation
Link: View Source

Details for a presentation related to GB002, an inhaled PDGFR inhibitor for pulmonary arterial hypertension (PAH), are as follows:

Session Type: E-Poster Session
Session Title: Pathophysiology of pulmonary hypertension (Session 231)
Abstract Number: 2551
Poster Number: 3550
Poster Title: Pharmacologic characterization of GB002, a novel inhaled PDGFR kinase inhibitor in development for pulmonary arterial hypertension (PAH)
Link: View Source

Dr. Reddy’s Laboratories Announces the Launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Syringe in the U.S. Market

On September 7, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe, a therapeutic equivalent generic version of Faslodex (fulvestrant) Injection, 250 mg/5 mL (50 mg/mL), approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, SEP 7, 2020, View Source [SID1234564704]).

The Faslodex brand and generic market had U.S. sales of approximately $407 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe is available in a carton containing two 5 mL single-dose prefilled syringes.

Please click here full prescribing information.

Faslodex is a trademark of the AstraZeneca group of companies.

*IQVIA Retail and Non-Retail MAT June 2020

RDY-0820-306

Janssen Announces European Commission Decision for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)

On September 7, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has approved a variation to the marketing authorisation for IMBRUVICA (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients (Press release, Johnson & Johnson, SEP 7, 2020, View Source [SID1234564703]). The decision is based on data from the Phase 3 E1912 study that showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR).2,3 The study was designed and conducted in the United States (U.S.) by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the U.S. National Institutes of Health.2,3

The study evaluated 529 previously untreated patients with CLL aged 70 years or younger (median age, 58 years) who were randomly assigned to receive six cycles of ibrutinib plus rituximab (IR) (n=354), followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR (n=175).2

At a median follow-up of 37 months, patients treated with IR lived longer without disease progression, with a progression-free survival (PFS) rate of 88 percent, compared to 75 percent for patients treated with FCR (hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.22-0.52; p<0.0001).1 The study also showed an overall survival (OS) advantage for patients treated with the IR regimen.1 The primary study results were published previously in The New England Journal of Medicine, and with extended 48-month follow-up, as presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the initial treatment benefit is maintained.2,3

"Historically, chemotherapy with FCR has been the standard of care, or first treatment prescribed for patients with previously untreated CLL," said John Gribben, MD DSc, Professor of Medical Oncology at St Bartholomew’s Hospital, Barts Cancer Institute, Queen Mary, University of London. "This decision by the EC is an important step in being able to offer patients with CLL a non-chemotherapy option in the frontline setting, building on the established efficacy and safety we have come to expect from ibrutinib-based therapy."

"We are delighted with the EC’s decision approving the use of ibrutinib in combination with rituximab for these patients," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. "This new non-chemotherapy combination regimen can offer extended remission, as well as fewer chemotherapy-related side effects for patients living with CLL."

Adverse events for the IR arm were consistent with the known safety profiles for ibrutinib and rituximab.1 The most common adverse reactions seen with ibrutinib include diarrhoea, neutropaenia, musculoskeletal pain, rash, haemorrhage (e.g., bruising), thrombocytopenia, nausea, pyrexia, arthralgia, and upper respiratory tract infection.4 The most common serious adverse reactions (which may affect more than 1 in 20 people) include neutropenia, lymphocytosis, thrombocytopenia, pneumonia, and hypertension.4

"Ibrutinib is the most comprehensively studied Bruton’s tyrosine kinase (BTK) inhibitor with the longest follow-up across eight positive Phase 3 trials in CLL to date, and is recognised as an important advancement in treatment for patients with CLL," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "This latest milestone highlights our commitment to studying the full potential of ibrutinib and in developing regimens which can transform what a CLL diagnosis means for patients going forward."

This announcement comes after the U.S. Food and Drug Administration’s (FDA) approval of this expanded indication for ibrutinib in April 2020.

About ibrutinib
Ibrutinib is a once-a-day, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally.4 Ibrutinib blocks the BTK protein; the BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signalling is needed by specific cancer cells to multiply and spread.5 By blocking BTK, ibrutinib may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.6

Indications for which ibrutinib is approved in Europe include:4

Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with rituximab or obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 99 countries for at least one indication, and to date, has been used to treat more than 200,000 patients worldwide.7

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.8 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.9 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.10

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

THERADIAG will publish its 2020 half-year results on September 21, 2020 after market close and will hold a conference call on September 22

On September 7, 2020 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics of autoimmune diseases and Theranostics reported that it will publish its consolidated half-year results closed on June 30, 2020 and approved by the Board of Directors on September 17, 2020, Monday September 21, 2020 at 5:45 p.m. CEST (Paris time) (Press release, Theradiag, SEP 7, 2020, View Source [SID1234564701]).

Bertrand de Castelnau, Chief Executive Officer, will present these half-year results during a conference call on Tuesday, September 22, 2020, at 9:00 a.m. Paris time, and will answer questions from analysts and investors.

To access the conference call , please dial 01.72.72.74.03, followed
by the access code 24 52 93 51 #. To access the slideshow by internet , click on the following link: https: //www.anywhereconference.comConference=418950313&PIN=24529351&UserAudioMode=DATA .

The presentation will also be made available on the company’s website: View Source

The replay will also be available for a period of 90 days by dialing: 01 70 71 01 60 followed by the access code: 41 89 50 313 # then follow the instructions.

Next financial event in which Theradiag is participating:

-1 st October 2020: Seminar Health / Biotech – Portzamparc BNP Paribas Digital Format