15-02-2018 .
LINK : Seattle Genetics (Nasdaq: SGEN) has announced its third deal in as many weeks.
The US biotech has signed a licensing agreement with PharmaMar (MCE: PHM), a Spain-based company that specializes in the discovery and development of innovative marine-derived drugs for cancer.
The deal gives Seattle exclusive worldwide rights to certain PharmaMar proprietary molecules for the development, manufacture and commercialization of antibody-drug conjugates (ADCs) or other drug conjugates incorporating PharmaMar payloads.
Seattle will pay $5 million upfront on signing, followed by milestones if it takes a product into clinical development.
PharmaMar is also eligible for potential approval and sales milestones as well as royalties, once a product receives regulatory approval and is commercialized.
PharmaMar’s Marine Payloads unit is focused on new, structurally diverse molecules with novel mechanisms of action that provide an opportunity to develop next generation ADCs. These payloads are highly potent, with sub-nanomolar cytotoxic activity.
Seattle’s deal with the Madrid-based company comes just days after the announcement of its collaboration and license agreement with Pieris Pharmaceuticals (Nasdaq: PIRS), aimed at developing multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers.
Under the terms of that accord, Seattle will pay Pieris a $30 million upfront fee, tiered royalties on net sales up to low double-digits, and up to $1.2 billion in total success-based payments across three product candidates.
In late January it was also announced that Seattle was to pay around $614 million to acquire Cascadian Therapeutics (Nasdaq: CASC) and its most advanced program tucatinib, an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, colorectal, ovarian and gastric.
Por lo Qué Hasta la Obtención de los Resultados Completos ... Más la Elaboración del Dossier ... Más la Evaluación de las Agencias ... Nos Podemos Ir al 2027 .
15 febrero 2018
YONDELIS® ( Trabectedin ) in Ovarian Cancer: Is It Now a Standard of Care ? .
Clin Oncol (R Coll Radiol). 2018 Feb 8.
Ventriglia J, Paciolla I, Cecere SC, Pisano C, Di Napoli M, Arenare L, Setola SV, Losito NS, Califano D, Orditura M, Pignata S.
Abstract
In patients with recurrent ovarian cancer, the choice of second-line therapy is complex. Several factors have to be considered, such as platinum-free interval (PFI), residual toxicity from the previous treatments, BRCA1/2 gene mutation status. Trabectedin is a minor groove DNA binder derived from a marine organism that has shown efficacy in different settings in ovarian cancer therapy.
It has been approved in the treatment of partially platinum sensitive (PPS) (PFI between 6 and 12 months) relapsed ovarian cancer according to the statistically significant progression-free survival (7.3 versus 5.8 months) and overall survival (22.2 versus 18.9 months) benefit compared with single-agent pegylated liposomal doxorubicin (PLD) in the OVA 301 phase III trial.
This drug has been shown to prolong the time to first subsequent treatment and improve the efficacy of further platinum-based chemotherapy.
The role of trabectedin/PLD followed by platinum combination compared with the reverse sequence in PPS is actually in evaluation in the INOVATYON phase III study, which will clarify the best sequence to be adopted in this setting.
Trabectedin has been shown to be active in patient carriers of BRCA mutations, probably for its mechanism of action directly affecting DNA and it is actually tested as a single agent in some phase III trials in BRCA mutated and BRCAness ovarian cancer patients.
Trabectedin is also active on the immune system. There is, therefore, the rational for new trials of a combination with immune checkpoint inhibitors.
© 2018 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Ventriglia J, Paciolla I, Cecere SC, Pisano C, Di Napoli M, Arenare L, Setola SV, Losito NS, Califano D, Orditura M, Pignata S.
Abstract
In patients with recurrent ovarian cancer, the choice of second-line therapy is complex. Several factors have to be considered, such as platinum-free interval (PFI), residual toxicity from the previous treatments, BRCA1/2 gene mutation status. Trabectedin is a minor groove DNA binder derived from a marine organism that has shown efficacy in different settings in ovarian cancer therapy.
It has been approved in the treatment of partially platinum sensitive (PPS) (PFI between 6 and 12 months) relapsed ovarian cancer according to the statistically significant progression-free survival (7.3 versus 5.8 months) and overall survival (22.2 versus 18.9 months) benefit compared with single-agent pegylated liposomal doxorubicin (PLD) in the OVA 301 phase III trial.
This drug has been shown to prolong the time to first subsequent treatment and improve the efficacy of further platinum-based chemotherapy.
The role of trabectedin/PLD followed by platinum combination compared with the reverse sequence in PPS is actually in evaluation in the INOVATYON phase III study, which will clarify the best sequence to be adopted in this setting.
Trabectedin has been shown to be active in patient carriers of BRCA mutations, probably for its mechanism of action directly affecting DNA and it is actually tested as a single agent in some phase III trials in BRCA mutated and BRCAness ovarian cancer patients.
Trabectedin is also active on the immune system. There is, therefore, the rational for new trials of a combination with immune checkpoint inhibitors.
© 2018 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
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