ALX Oncology Receives Orphan Drug Designation from the European Commission for Evorpacept for the Treatment of Patients with Gastric Cancer
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced that its next-generation CD47 blocker, evorpacept, has received orphan drug designation (ODD) from the European Commission for treating gastric cancer patients. This designation covers both gastric cancer and gastroesophageal junction adenocarcinoma. The U.S. FDA had previously granted ODD to evorpacept for the same indication in January 2022.
Dr. Sophia Randolph, Chief Medical Officer at ALX Oncology, highlighted the significance of this regulatory achievement and the growing recognition of evorpacept's potential in improving clinical outcomes for gastric cancer patients. The company plans to present data from ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with other drugs for HER2-positive gastric cancer, in the second half of 2023.
The EC grants orphan drug designation to medicines treating rare conditions affecting no more than five in 10,000 people in the EU. This status provides financial and regulatory incentives, including ten years of market exclusivity if approved for marketing.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) ha annunciato che il suo blocker di CD47 di nuova generazione, evorpacept, ha ricevuto la designazione di farmaco orfano (ODD) dalla Commissione Europea per il trattamento dei pazienti con cancro gastrico. Questa designazione riguarda sia il cancro gastrico che l'adenocarcinoma della giunzione gastroesofagea. La FDA degli Stati Uniti aveva precedentemente concesso l'ODD a evorpacept per la stessa indicazione nel gennaio 2022.
La Dr.ssa Sophia Randolph, Chief Medical Officer di ALX Oncology, ha sottolineato l'importanza di questo risultato normativo e il crescente riconoscimento del potenziale di evorpacept nel migliorare gli esiti clinici per i pazienti con cancro gastrico. L'azienda prevede di presentare i dati dallo studio ASPEN-06, un trial randomizzato di Fase 2 di evorpacept in combinazione con altri farmaci per il cancro gastrico HER2-positivo, nella seconda metà del 2023.
La Commissione Europea concede la designazione di farmaco orfano a medicinali che trattano condizioni rare che colpiscono non più di cinque persone su diecimila nell'UE. Questo status fornisce incentivi finanziari e normativi, inclusa dieci anni di esclusiva di mercato se approvato per la commercializzazione.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) anunció que su bloqueador de CD47 de próxima generación, evorpacept, ha recibido la designación de medicamento huérfano (ODD) de la Comisión Europea para tratar pacientes con cáncer gástrico. Esta designación abarca tanto el cáncer gástrico como el adenocarcinoma de la unión gastroesofágica. La FDA de EE.UU. había otorgado anteriormente la ODD a evorpacept para la misma indicación en enero de 2022.
La Dra. Sophia Randolph, Directora Médica de ALX Oncology, destacó la importancia de este logro regulatorio y el creciente reconocimiento del potencial de evorpacept para mejorar los resultados clínicos en pacientes de cáncer gástrico. La empresa planea presentar datos de ASPEN-06, un ensayo aleatorizado de Fase 2 de evorpacept en combinación con otros medicamentos para el cáncer gástrico HER2-positivo, en la segunda mitad de 2023.
La Comisión Europea otorga la designación de medicamento huérfano a los medicamentos que tratan condiciones raras que afectan a no más de cinco de cada diez mil personas en la UE. Este estatus proporciona incentivos financieros y regulatorios, incluida una exclusividad de mercado de diez años si se aprueba para comercialización.
ALX Oncology Holdings Inc. (Nasdaq: ALXO)는 차세대 CD47 차단제인 evorpacept가 희귀의약품지정 (ODD)을 유럽연합 집행위원회로부터 위암 환자 치료를 위해 승인받았다고 발표했습니다. 이 지명은 위암과 위식도 접합부 선암을 모두 포함합니다. 미국 FDA는 2022년 1월 동일한 적응증으로 evorpacept에 대해 ODD를 이전에 승인하였습니다.
ALX Oncology의 최고 의료 책임자인 소피아 랜돌프 박사는 이번 규제 성과의 중요성과 evorpacept가 위암 환자의 임상 결과를 개선할 잠재력에 대한 인식 증가를 강조했습니다. 이 회사는 2023년 하반기에 HER2 양성 위암 치료를 위한 다른 약물과 병용한 evorpacept의 무작위 2상 시험인 ASPEN-06의 데이터를 발표할 예정입니다.
유럽연합 집행위원회는 EU 내 10,000명 중 5명 이하의 사람에게 영향을 미치는 희귀질환 치료제를 희귀의약품으로 지정합니다. 이 지위는 마케팅 승인이 이루어질 경우 10년의 시장 독점권을 포함한 재정적 및 규제적 인센티브를 제공합니다.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) a annoncé que son bloqueur de CD47 de nouvelle génération, evorpacept, a reçu la dénomination de médicament orphelin (ODD) de la Commission européenne pour le traitement des patients atteints de cancer gastrique. Cette désignation couvre à la fois le cancer gastrique et l'adénocarcinome de la jonction gastro-œsophagienne. La FDA américaine avait précédemment accordé l'ODD à evorpacept pour la même indication en janvier 2022.
Dr. Sophia Randolph, Directrice Médicale d'ALX Oncology, a souligné l'importance de cette réussite réglementaire et la reconnaissance croissante du potentiel d'evorpacept pour améliorer les résultats cliniques des patients atteints de cancer gastrique. L'entreprise prévoit de présenter des données de l'étude ASPEN-06, un essai randomisé de Phase 2 d'evorpacept en combinaison avec d'autres médicaments pour le cancer gastrique HER2-positif, dans la seconde moitié de 2023.
La Commission européenne accorde la désignation de médicament orphelin aux médicaments traitant des maladies rares touchant pas plus de cinq personnes sur dix mille dans l'UE. Ce statut offre des incitations financières et réglementaires, y compris une exclusivité de marché de dix ans si le produit est approuvé pour la commercialisation.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) gab bekannt, dass sein nächstgenerativer CD47-Blocker, evorpacept, von der Europäischen Kommission die Orphan Drug Designation (ODD) für die Behandlung von Magenkrebspatienten erhalten hat. Diese Bezeichnung umfasst sowohl Magenkrebs als auch Adenokarzinom des gastroösophagealen Übergangs. Die US-amerikanische FDA hatte evorpacept bereits im Januar 2022 für den gleichen Anwendungsbereich ODD gewährt.
Dr. Sophia Randolph, Chief Medical Officer von ALX Oncology, hob die Bedeutung dieses regulatorischen Erfolgs und das wachsende Bewusstsein für das Potenzial von evorpacept zur Verbesserung der klinischen Ergebnisse bei Magenkrebspatienten hervor. Das Unternehmen plant, in der zweiten Hälfte des Jahres 2023 Daten aus der ASPEN-06-Studie, einer randomisierten Phase-2-Studie zu evorpacept in Kombination mit anderen Medikamenten für HER2-positiven Magenkrebs, zu präsentieren.
Die EU-Kommission vergibt die Orphan Drug Designation an Arzneimittel, die seltene Erkrankungen behandeln, von denen nicht mehr als fünf von zehntausend Menschen in der EU betroffen sind. Dieser Status bietet finanzielle und regulatorische Anreize, einschließlich einer zehnjährigen Marktexklusivität, wenn das Produkt für die Vermarktung genehmigt wird.
- Evorpacept received orphan drug designation from the European Commission for gastric cancer treatment
- Evorpacept previously received orphan drug designation from the FDA for gastric cancer treatment
- Orphan drug designation provides regulatory and financial incentives, including potential market exclusivity
- Upcoming presentation of ASPEN-06 Phase 2 trial data in the second half of 2023
- None.
SOUTH SAN FRANCISCO, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that evorpacept, a next-generation CD47 blocker, has received orphan drug designation (“ODD”) from the European Commission (“EC”) for the treatment of patients with gastric cancer. This ODD indication includes both gastric cancer and gastroesophageal junction adenocarcinoma (collectively “GC”). The U.S. Food and Drug Administration (“FDA”) also granted ODD to evorpacept for the treatment of patients with GC as previously announced in January 2022.
“Receiving orphan drug designation from both the EC and the FDA represents a significant regulatory achievement for ALX Oncology and signifies the growing recognition of evorpacept as a potential new drug to improve clinical outcomes in patients with GC,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. “Evorpacept has demonstrated promising and consistent anti-cancer activity in the solid tumor setting, and we look forward to presenting data in the second half of 2023 for ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with trastuzumab, paclitaxel and CYRAMZA® (ramucirumab) for the treatment of patients with HER2-positive GC.”
Orphan drug designation is granted by the EC for medicines in development to treat rare conditions affecting no more than five in 10,000 people in the European Union, provided there is no other satisfactory treatment option or the medicine can be of significant benefit to those affected by the condition. Medicines that are granted orphan drug designation by the EC qualify for financial and regulatory incentives including protocol assistance, possible exemptions or reductions in certain regulatory fees, and, if approved for marketing, ten years of market exclusivity in the European Union.
About Gastric Cancer and Gastroesophageal Junction Cancer (section to be updated)
Gastric cancer begins in the cells lining the inner wall of the stomach and spreads through the outer layers and eventually the body as it grows. Approximately 17 percent of all GC patients have HER2-positive disease, and the five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease (SEER). The National Cancer Institute estimates there will be over 26,000 newly diagnosed cases of GC and 11,000 deaths in the U.S. in 2023. In comparison, GC is significantly more common in Europe with over 130,000 newly diagnosed cases and 96,000 deaths in 2020 (Globocan).
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
FAQ
What is the significance of evorpacept receiving orphan drug designation from the European Commission for ALXO?
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