ERYTECH Announces FDA’s Authorization to Proceed with Phase 3 Trial for Eryaspase in Pancreatic Cancer in the United States
- Investigational New Drug Application reviewed and accepted
- Enrollment of US patients expected to begin in Q3 2019
- Clinical trial authorizations now obtained in all twelve participating countries
LYON, France and CAMBRIDGE, Mass. , May 13, 2019 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, today announced the acceptance by the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for eryaspase, consisting of the enzyme L-asparaginase encapsulated inside donor derived red blood cells. The acceptance of the IND will enable ERYTECH to initiate enrollment at US trial sites for its ongoing pivotal Phase 3 TRYbeCA1 trial evaluating eryaspase in second-line pancreatic cancer.
TRYbeCA1 is expected to enroll approximately 500 patients with second-line metastatic pancreatic cancer at more than 120 clinical sites in Europe and the United States. In this trial, eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim efficacy analysis is planned for when approximately two-thirds of events have occurred. The trial started enrolling patients in Spain in September 2019 and is now actively enrolling patients in several European countries. The notification for the study to proceed in the US comes in addition to clinical trial authorizations received in eleven European countries.
“There is a high unmet need for therapeutic options in pancreatic cancer, particularly in metastatic patients who have progressed on first-line chemotherapy. With the FDA’s acceptance of the eryaspase IND, we are excited to initiate US trial sites and to begin enrolling patients in TRYbeCA1,” stated Iman El Hariry, Chief Medical Officer of ERYTECH. “We have been pleased with the level of interest and enrollment from European TRYbeCA1 sites thus far and will look to build upon the momentum we have in Europe with investigators in the US. We anticipate that the first US patient enrolled in TRYbeCA1 will be in the third quarter of 2019. ”
“We are very pleased to learn that the FDA has reviewed our IND and is allowing ERYTECH to proceed with the initiation of the TRYbeCA1 study in the United States. This is good news for patients with pancreatic cancer in the USA that now have another clinical trial opportunity to combat this deadly disease” commented Dr. Manuel Hidalgo, Chief, Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York Presbyterian Hospital.
About pancreatic cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.
About ERYTECH: www.erytech.com
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs.
ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival. The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of triple-negative breast cancer. ERYTECH is also developing erymethionase, which consists of methionine-gamma-lyase encapsulated in red blood cells to target methionine-dependent cancers.
ERYTECH produces product candidates at its GMP-approved manufacturing site in Lyon, France, and at the American Red Cross in Philadelphia, USA. A large-scale GMP manufacturing facility has recently completed construction in Princeton, New Jersey, USA.
ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
CFO & COO
Mathilde Bohin / Louis-Victor Delouvrier
|+33 4 78 74 44 38
|+33 1 44 71 98 52
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, business and regulatory strategy, expansion of manufacturing capacity and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding the potential of ERYTECH’s product pipeline, its clinical development of eryaspase, and the timing of ERYTECH’s preclinical studies and clinical trials and announcements of data from those studies and trials. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company’s Securities and Exchange Commission (SEC) filings and reports, including in the Company’s 2018 Document de Référence filed with the AMF on March 29, 2019 and in the Company’s Annual Report on Form 20-F filed with the SEC on March 29, 2019 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
INDKALDELSE til ordinær generalforsamling i FLSmidth & Co. A/S2.6.2020 14:46:17 CEST | pressemeddelelse
Company Announcement No. 10-2020 Bestyrelsen indkalder herved til ordinær generalforsamling fredag den 26. juni 2020 kl. 16.00 på selskabets adresse, Vigerslev Allé 77, 2500 Valby. Af hensyn til alles sikkerhed og for at mindske risikoen for smittespredning af COVID-19 henstiller vi til, at vores aktionærer ikke møder op fysisk på generalforsamlingen, men brevstemmer eller giver fuldmagt og følger generalforsamlingen via livestreaming på hjemmesiden. Ledelsen vil også være meget begrænset repræsenteret for at mindske smitterisikoen. Dagsorden: Bestyrelsens beretning om selskabets virksomhed i 2019Forelæggelse og godkendelse af årsrapport for 2019Godkendelse af honorarer til bestyrelsen: a. Endelig godkendelse af honorarer for 2019 Bestyrelsen foreslår uændret godkendelse af honorarerne for 2019, som blev forhåndsgodkendt af generalforsamlingen i 2019. Honorarerne er baseret på et grundhonorar på DKK 450.000 (”Grundhonoraret”) med dobbelt honorar til næstformanden og tredobbelt honorar
NOTICE TO CONVENE the Annual General Meeting of FLSmidth & Co. A/S2.6.2020 14:46:17 CEST | Press release
Company Announcement No. 10-2020 The Board of Directors hereby convenes the Annual General Meeting to be held on Friday 26 June 2020 at 4 pm (CET) at the offices of the company, Vigerslev Allé 77, DK-2500 Valby. To protect everyone’s safety and reduce the risk of COVID-19 spreading, we recommend that shareholders refrain from attending the general meeting in person and instead cast their votes by postal vote or proxy and attend the live webcast of the general meeting via the web site. The number of representatives from the management will be reduced to reduce the risk of infection. Agenda: The Board of Directors' report on the company’s activities in 2019.Presentation and approval of the 2019 Annual Report.Approval of the Board of Directors’ fees: a. Final approval of fees for 2019. The Board of Directors proposes unchanged approval of the fees for 2019 that were pre-approved by the general meeting in 2019. The fees are based on a base fee of DKK 450,000 (the “Base Fee”) with twice tha
Decisions of Sampo plc’s Annual General Meeting2.6.2020 14:00:00 CEST | Press release
SAMPO PLC DECISIONS OF GENERAL MEETING 2 June 2020 at 3:00 pm Decisions of Sampo plc’s Annual General Meeting The Annual General Meeting of Sampo plc, held today on 2 June 2020, decided to distribute a dividend of EUR 1.50 per share for 2019. The record date for dividend payment is 4 June 2020 and the dividend will be paid on 11 June 2020. The Annual General Meeting adopted the financial accounts for 2019 and discharged the Board of Directors and the CEO from liability for the financial year. The Annual General Meeting elected eight members to the Board of Directors. The following members were re-elected to the Board: Christian Clausen, Fiona Clutterbuck, Jannica Fagerholm, Johanna Lamminen, Risto Murto, Antti Mäkinen and Björn Wahlroos. Georg Ehrnrooth was elected as a new member to the Board. The Members of the Board were elected for a term continuing until the close of the next Annual General Meeting. At its organizational meeting, the Board elected Björn Wahlroos as Chairman and Ja
Cargotec completes the ownership change of joint venture in China2.6.2020 12:00:00 CEST | Press release
CARGOTEC CORPORATION, PRESS RELEASE, 2 JUNE 2020 AT 1 PM (EEST) Cargotec has completed the sale of its share of the joint venture Rainbow-Cargotec Industries Co., Ltd (RCI) in China. As part of the agreement, Cargotec acquired certain operations and assets of the joint venture from Jiangsu Rainbow Heavy Industries Co., Ltd. (RHI), and approximately 160 employees have moved over from RCI to Kalmar. On 11 May 2020, Cargotec announced plans to sell its 49% share of the joint venture to the other owner RHI. RHI now owns 100% of the former joint venture, and the new name of the company is Rainbow Industries Co. Ltd. (RIC). RIC will continue as Cargotec’s subcontractor and provide assembly services for Cargotec’s business areas Kalmar and MacGregor at the factory in Taicang, China. The change aims to simplify Cargotec’s global supply chain operations. Simplification is needed mainly because the number of complex automation projects has been growing in the past couple of years. The arrangemen
Result of Riksbank reversed auctions SEK Municipal Bonds2.6.2020 11:30:00 CEST | Press release
Result of Riksbank reversed auctions SEK Municipal Bonds Results of auctions Municipal BondsAggregateAuction date6/2/2020Maturity2023Tendered volume, mln SEK750 +/- 750Volume offered, mln SEK156Volume bought, mln SEK50Number of bids3Number of accepted bids1Credit Class 1Maturity, QuarterQ1Maturity, QuarterQ2Maturity, QuarterQ3Maturity, QuarterQ4Volume Offered, mln SEK50Volume Offered, mln SEK0Volume Offered, mln SEK0Volume Offered, mln SEK0Volume bought, mln SEK50Volume bought, mln SEK0Volume bought, mln SEK0Volume bought, mln SEK0Number of bids1Number of bids0Number of bids0Number of bids0Number of accepted bids1Number of accepted bids0Number of accepted bids0Number of accepted bids0Average yield0.120 %Average yield-Average yield-Average yield-Lowest accepted yield0.120 %Lowest accepted yield-Lowest accepted yield-Lowest accepted yield-Highest yield0.120 %Highest yield-Highest yield-Highest yield-% accepted at lowest yield100.00% accepted at lowest yield-% accepted at lowest yield-% a
UPM Plywood is planning to scale down plywood production in Finland2.6.2020 11:00:00 CEST | Press release
(UPM Plywood, Lahti, 02.06.2020 at 12:00) – UPM Plywood is planning to permanently close its Jyväskylä plywood mill, which is producing spruce and birch plywood. The company starts a consultation process concerning the entire personnel working at the mill. UPM Jyväskylä plywood mill employs 167 people. The Profitability of Jyväskylä plywood mill has been weak for a long time, even during periods of high-demand. Despite investments as well as savings and improvement activities, the profitability has not improved to a sustainable level. Competition in the birch plywood market is increasing constantly. New birch plywood capacity has been built especially in Russia, where the production cost level is significantly more competitive than in Finland. If realized, the planned actions would strengthen UPM Plywood’s overall competitiveness and performance in the long run. “In Finland, a full run of the capacity has not been feasible due to the terms in the woodworking industry. In addition, repe