On January 6, 2022 Astex Pharmaceuticals, Inc. ("Astex") reported that the European Commission (EC) has granted orphan-drug designation (ODD) to the oral fixed dose combination of decitabine and cedazuridine (ASTX727) for the treatment of Acute Myeloid Leukemia (AML)1 (Press release, Astex Pharmaceuticals, JAN 6, 2022, View Source [SID1234598366]).

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ODD is granted by the EC to medicinal products intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating and which affects fewer than five in 10,000 people in the European Union (EU)2. The EC incentivises companies to develop medicines that provide significant benefit to those affected by rare conditions. ODD-granted therapies, such as ASTX727, entitle companies to 10 years of market exclusivity once the product is approved, among other benefits2. The ODD initiative plays a key role in facilitating and encouraging the development of these important medicines to potentially improve the lives of the 30 million people in the EU suffering from a rare disease2.

"The granting of ODD is a key and important step in the journey toward finding a new treatment option for patients with AML," said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd., Astex’s commercialization partner in Europe. "We will continue to collaborate with all key stakeholders, including the EC, to make this treatment available to patients in need."

Harold Keer MD, PhD, Chief Medical Officer of Astex Pharmaceuticals, Inc. said "AML continues to be a challenging disease area with high rates of relapse and low rates of five-year survival. The disease has a higher incidence rate in people aged over 60 years, which presents an important challenge as the population ages. The granting of ODD signifies that ASTX727 is considered to be a medicine that may potentially benefit those affected by this rare life-threatening condition."

ASTX727 is not approved for any indication in Europe and is not approved in any country for the treatment of AML.

About ASTX727

ASTX727 is an orally administered, fixed-dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine, an inhibitor of cytidine deaminase (CDA)3, 4. By inhibiting CDA in the gut and the liver, ASTX727 is designed to allow for oral delivery of decitabine over five days in a given cycle5. The phase 1 and phase 2 clinical study results have been published in Lancet Haematology and Blood, respectively5, 6.

ASTX727, under the brand name INQOVI, is approved in the U.S. and in Canada as follows:

U.S. and Canada Indications

INQOVI (decitabine and cedazuridine) tablets, for oral use, is approved for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups7.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%. Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is the most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of patients. Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.

Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.

Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors, and anti‑infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

Embryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment with INQOVI and for 6 months (females) or 3 months (males) after last dose.

ADVERSE REACTIONS

Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

The most common adverse reactions (≥ 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (>50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for at least 2 weeks after the last dose.

Renal Impairment: No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).

Please see the accompanying Full Prescribing Information

Commercialization of INQOVI in the U.S. and Canada is conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc., respectively. Astex, Otsuka and Taiho are all members of the Otsuka group of companies.

In Europe, ASTX727 is currently being evaluated within the ASCERTAIN phase 3 trial (EudraCT Number: 2018-003395-12) for the treatment of Acute Myeloid Leukemia (AML)8.

About Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults9. The median age at diagnosis is 70 years10. Within Europe, there is an increase in incidence of AML; this may be attributed to the ageing population: AML incidence in Europe has risen from 3.48 in 1976 to 5.06 patients per 100,000 people in 201310. Across Europe and all age groups, AML is notably more common in males than it is in females10. The outlook for patients diagnosed with AML has improved over time due to improved care and treatment, however between the years of 2000 and 2007, five-year survival for patients over 65 years-old was 17%10. After two courses of intensive induction therapy, 10 to 20% of younger and 50% of older AML patients do not achieve complete response (CR). While those that do obtain CR, 50-70% of these patients will relapse. Following relapse, prognosis for the patients is poor and treatment is challenging, with few therapeutic options available10.

On January 6, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the China National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, BeiGene, JAN 6, 2022, View Source;or-Third-Line-Treatment-for-Patients-with-Locally-Advanced-or-Metastatic-Non-Small-Cell-Lung-Cancer [SID1234598365]). A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021.

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"This latest approval for tislelizumab demonstrates BeiGene’s commitment to bringing innovative, impactful treatments to patients in need. With six approved indications in China, tislelizumab has the potential to reach and help the country’s large patient community, and our science-based commercial team of nearly 3,000 people in China is working to make it more broadly available to those who may benefit from this important immunotherapy," commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. "As our strategic oncology collaboration with Novartis deepens, we look forward to continued opportunities to expand access to tislelizumab globally and further explore its therapeutic potential."

"As its third approved lung cancer indication in China, today’s approval represents an important milestone, with tislelizumab now available in both front-line and second- or third-line care of NSCLC. We hope, as demonstrated in the promising results from the global RATIONALE 303 trial, that tislelizumab will become an important treatment option for these patients in China," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors at BeiGene. "Tislelizumab’s broad global development program of 13 Phase 3 trials and four pivotal Phase 2 trials is providing a growing body of clinical evidence on its efficacy and safety and establishing its therapeutic impact across multiple cancer types."

"In the global Phase 3 trial, tislelizumab demonstrated a significant improvement in overall survival and was well-tolerated in patients with previously treated NSCLC," said Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai Pulmonary Hospital, Director of Cancer Institute of Tongji University, and the principal investigator of the trial. "The NMPA’s approval of tislelizumab is welcoming news to the lung cancer community in China, and we hope this immunotherapy will help address the unmet needs in second- or third-line treatment of NSCLC."

The approval of tislelizumab was supported by clinical results from a randomized, open-label, global Phase 3 trial RATIONALE 303 (NCT03358875) comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy. A total of 805 patients in 10 countries across Asia, Europe, the Americas, and Oceania were enrolled in the trial, randomized 2:1 to either the tislelizumab arm or the docetaxel arm.

As announced in November 2020, the trial met the primary endpoint of overall survival (OS) at the planned interim analysis, as recommended by the independent Data Monitoring Committee (IDMC). Tislelizumab was generally well-tolerated, consistent with known safety risks from previously reported results across different tumor types, with no new safety signals identified. The results of the interim analysis of the trial were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and announced by BeiGene in April 2021.

About Non-Small Cell Lung Cancer

Lung cancer remains the second most common type of cancer and the leading cause of cancer-related death worldwide.1 NSCLC accounts for approximately 85% of all lung cancer cases and is usually diagnosed at an advanced stage.2 The five-year survival rate with treatment for stage IIIB and stage IV NSCLC is 5% and 2%, respectively.3 In China, the lung cancer incidence rate is increasing, with approximately 815,563 new cases in 2020.4,5

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has approved tislelizumab in six indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy. NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA, including for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).

In the U.S., a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 90 ongoing or planned clinical trials (over 70 clinical trials are ongoing) involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Since closing the collaboration in February 2021, the companies have accomplished key objectives in their collaboration, including filing the first biologics license application (BLA) for tislelizumab outside of China. The U.S. Food and Drug Administration (FDA) accepted for review the BLA submission for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022, and the companies are working closely together on launch preparation activities as well as other planned BLA submissions and combination strategies for tislelizumab within each company’s product portfolio and pipeline. Building upon that progress and the shared commitment to expanding patient access to new treatments, the companies have entered into a new agreement to collaborate on the development, manufacturing and commercialization of BeiGene’s investigational TIGIT inhibitor ociperlimab.

On January 6, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it will be featured as a presenting company at the H.C. Wainwright BioConnect Conference (Press release, PharmaCyte Biotech, JAN 6, 2022, View Source [SID1234598364]). The Conference is being held virtually on January 10-13, 2022.

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During the presentation, the Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, will provide an overview of the Company’s business and product pipeline.

Over 500 corporate presentations and panels are available on-demand from January 10-13, 2022. The pre-recorded presentation by PharmaCyte will be available on Monday, January 10, 2022, on the News & Media tab of PharmaCyte’s website at View Source

PharmaCyte’s presentation will also be available at View Source

Additionally, PharmaCyte will be publishing a press release in the coming weeks to update its shareholders on the progress PharmaCyte has made to lift the clinical hold the U.S. Food and Drug Administration placed on PharmaCyte’s planned Phase 2b clinical trial for the treatment of locally advanced, inoperable pancreatic cancer.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch PharmaCyte’s documentary video complete with medical animations at View Source

On January 6, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the H.C. Wainwright BioConnect Virtual Conference scheduled to take place from Monday, January 10 through Thursday, January 13, 2022 (Press release, Fortress Biotech, JAN 6, 2022, View Source [SID1234598363]). The company’s presentation will be available for on-demand viewing on Fortress’ website beginning Monday, January 10, 2022, at 7:00 a.m. EST and will remain available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the presentation.

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On January 6, 2022 Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") reported that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection (Press release, Knight Therapeutics, JAN 6, 2022, View Source;Announces-Approval-of-Halaven174–in-Colombia-1-6-2022 [SID1234598361]).

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Halaven (eribulin) injection is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatment for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven(eribulin) injection is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed. It is used in patients who have already been treated with an anthracycline, unless deemed unsuitable.

Halaven (eribulin) injection has shown to significantly improve overall survival in patients with advanced or metastatic breast cancer after anthracycline and taxane treatment. Halaven (eribulin) injection indicated extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to selected, major existing therapies1. Also, Halaven (eribulin) injection demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine in patients with locally advanced/recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies 2.

Breast cancer is now the most frequently diagnosed cancer in Colombian women. In 2020, an estimated 15,509 patients were diagnosed with breast cancer3. Further, approximately 1,500 patients in Colombia are diagnosed with soft tissue sarcoma each year, and liposarcoma, an area with high unmet medical need, represents the most common form of soft tissue sarcoma4.

"We’re pleased to announce the approval of Halaven (eribulin) injection in Colombia as it provides a new treatment option for metastatic breast cancer and liposarcoma," said Samira Sakhia, President & Chief Executive Officer. "Our Colombian team is focused on our oncology launches with the approval of Halaven (eribulin) injection and Lenvima (lenvatinib) and will be coordinating launch efforts with our teams throughout the region."

Knight has an exclusive license from Eisai to commercialize Lenvima (lenvatinib), Halaven (eribulin) injection, Fycompa (perampanel), and Inovelon (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven (eribulin) injection and Lenvima (lenvatinib).

About Halaven (eribulin) injection

Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype5-6. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells5-6.