Legend Biotech's CAR-T Therapy Carvykti Nominated for Prestigious Prix Galien Award
Legend Biotech
Tumor Cell Immunotherapy Developer
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
The other day, the U.S. GalenFundThe Galien Foundation has announced the list of nominees for the 2023 Prix Galien USA Awards. Known as the "Nobel Prize of the pharmaceutical industry," the Galien Award is recognized as the highest honor in the pharmaceutical and biomedicine sectors, acknowledging outstanding scientific innovations that improve human health.
The 2023 Galien Award nominations include Best Biotechnology Product, Best Pharmaceutical Agent, and the newly established BestRare DiseasesProduct Award (Best Product for Rare/Orphan Diseases) in three categories. They were all obtained within the recent five years in the United States.FDAProducts that have been approved for marketing and have the potential to significantly impact human health. Judges will evaluate the products based on their scientific and health impact, without considering sales data.
Notably, Carvykti (cilta-cel, ciltacabtagene autoleucel), jointly developed by Janssen, a subsidiary of Johnson & Johnson, and Legend Biotech, has been nominated for the first time this year. Carvykti is aCAR-TThe therapy expresses a chimeric antigen receptor that contains a 4-1BB co-stimulatory domain and two antibody domains targeting BCMA. It was approved by the FDA for marketing in February last year and received conditional approval from the EU in May for the treatment of adult patients with relapsed or refractory multiple myeloma. In June this year, the two companies submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA to expand the indication range of Carvykti to include patients who have previously received at least one treatment (including a proteasome inhibitor and oneImmunityAdult patients with relapsed and lenalidomide-resistant multiple myeloma.
"We are extremely honored to evaluate and recognize the astonishing products submitted by individuals who have dedicated their lives to discovering, developing, and distributing life-saving solutions around the world," said Dr. Michael Rosenblatt, Chair of the Galien Awards Committee. "These awards represent an unyielding determination to pursue innovations that transform lives, and we are thrilled to announce the nominees for the 2023 awards."
The 2023 Galien Award candidate list is as follows:
Best Biotechnology Product Award (Candidate Product)
|
Company |
Product/Therapy |
Introduction |
|
Albireo |
Bylvay |
Ileal Bile Acid Transporter Small Molecule Inhibitor |
|
Amgen & AstraZeneca |
Tezspire |
Targeted Anti-Thymic Stromal Lymphopoietin (TSLP) Monoclonal Antibody |
|
argenx |
Vyvgart |
Neonatal Fc Receptor (FcRn) Blocker |
|
BeiGene |
Brukinsa |
BTK Small Molecule Inhibitor |
|
Bristol-Myers Squibb |
Camzyos |
Small Molecule Allosteric Modulators of Cardiac Myosin |
|
Daiichi Sankyo & AstraZeneca |
Enhertu |
Antibody-drug conjugates (ADC) targeting HER2 |
|
ImmunoGen |
Elahere |
ADC Targeting Folate Receptor Alpha (FRα) |
|
Jazz |
Rylaze |
Components of Multi-Drug Chemotherapy Regimens for Hematologic Malignancies |
|
Janssen |
Tecvayli |
Bispecific Antibody Targeting BCMA |
|
Janssen& Legend Biotech |
Carvykti |
CAR-T Therapy Targeting BCMA |
|
Merck & Co. |
Vaxneuvance |
Pneumococcal 15-valent Conjugate Vaccine |
|
Pfizer |
Prevnar 20 |
Pneumococcal 20-valent Conjugate Vaccine |
|
Regeneron |
Evkeeza |
ANGPTL3-Targeted Monoclonal Antibody |
|
Regeneron& Sanofi |
Dupixent |
Targeted IL-4 Monoclonal Antibody |
|
Seagen |
Adcetris |
CD30-targeted ADC |
|
VBI Vaccines |
PreHevbrio |
The Third-Generation Hepatitis B Vaccine |
|
XVIVO Perfusion |
XPS with STEEN Solution |
Lung Transplant Medical Devices |
Best Pharmaceutical Product Award (Candidate Products)
|
Company |
Product/Therapy |
Introduction |
|
Alkermes |
Lybalvi |
A combination tablet consisting of olanzapine and samidorphan |
|
Amylyx |
Relyvrio |
Sodium Phenylbutyrate and Taurursodiol Oral Fixed-Dose Combination |
|
Aurinia |
Lupkynis |
Calcineurin Small Molecule Inhibitors |
|
Blueprint Medicines |
Ayvakit |
Tyrosine Kinase Small Molecule Inhibitors |
|
Blueprint Medicines |
Gavreto |
RET Small Molecule Inhibitor |
|
Deciphera |
Qinlock |
Small Molecule Protein Kinase Inhibitors |
|
Eli Lilly and Company |
Mounjaro |
GIP and GLP-1 Receptor Dual Agonist |
|
Epizyme |
Tazverik |
EZH2 Inhibitor |
|
Genentech |
Vabysmo |
Ang-2 and VEGF-A Targeting Bispecific Antibody |
|
Gilead Sciences |
Sunlenca |
HIV Capsid Inhibitor |
|
Incyte |
Pemazyre |
FGFR Small Molecule Inhibitor |
|
Incyte |
Opzelura |
JAK1/JAK2 Small Molecule Inhibitor |
|
Ironshore |
Jornay PM |
New Formula of Methylphenidate |
|
Janssen |
Rybrevant |
Targeted EGFR/MET Bispecific Antibody |
|
Mayne |
Nextstellis |
Drospirenone and Estradiol Compound Tablets |
|
Mirum |
Livmarli |
Apical Sodium-dependent Bile Acid Transporter (ASBT) Small Molecule Inhibitors |
|
Sumitomo Pharma America |
Myfembree |
Combination Therapy: 40 mg Relugolix, 1 mg Estradiol, and 0.5 mg Norethindrone Acetate |
|
Sumitomo Pharma America |
Orgovyx |
Gonadotropin-Releasing Hormone (GnRH) Receptor Small Molecule Antagonists |
|
Pfizer |
Braftovi + Mektovi |
BRAF Small Molecule Inhibitor + MEK Small Molecule Inhibitor |
|
Pfizer |
Cibinqo |
JAK1 Small Molecule Inhibitor |
|
Roche |
Ocrevus |
Targeted CD20 Monoclonal Antibody |
|
Sanofi |
Tzield |
Targeted CD3 Monoclonal Antibody |
|
Servier |
Tibsovo |
IDH1 Small Molecule Inhibitor |
|
ViiV Healthcare |
Apretude |
HIV Integrase Small Molecule Inhibitors |
Best Rare Disease Product Award (Candidate Product)
|
Company |
Product/Therapy |
Introduction |
|
Boehringer Ingelheim |
Spevigo |
IL-36R-targeted monoclonal antibody |
|
CSL / uniQure |
Hemgenix |
Hemophilia B Gene Therapy Targeting Coagulation Factor IX |
|
Horizon |
Tepezza |
Targeted IGF-1R Monoclonal Antibody |
|
Immunocore |
Kimmtrak |
Targeting gp100 and CD3 Bispecific Protein |
|
Sanofi |
Xenpozyme |
Human Acid Sphingomyelinase Recombinant Protein |
The 2023 Galien Award will be announced on October 26th local time this year. Which products will win the "Nobel Prize in the pharmaceutical industry" crown, let us wait and see.
Source:
https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2023-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-301887177.html?tc=eml_cleartime