Industry Update: the Latest Developments in the Field of Therapeutic delivery, September 2020

Timmins, Peter

doi:10.4155/tde-2020-0124

Cited by 3 publications

(1 citation statement)

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“…Pralsetinib capsules (Gavetro ™ , Blueprint Medicines) Another targeted oncology therapy in the news in December was pralsetinib (Gavetro ™ , Blueprint Medicines; MA USA), which received FDA approval for the treatment of advanced or metastatic thyroid cancer in patients having alterations -mutations and fusions -in RET (oncogenic rearranged during transfection) which can also drive other cancer types. Blueprint has ongoing collaboration with Genentech/Roche to develop pralsetinib in the treatment of other solid tumors and the partners had already received FDA approval for pralsetinib for the treatment of NSCLC associated with RET-alterations in September of 2020 [44]. Approximately 90% of patients with advanced medullary thyroid cancer carry RET mutations.…”

Section: Sotorasib Tablets (Amgen)mentioning

confidence: 99%

The Latest Developments in the Field of Therapeutic delivery, December 2020

Timmins

2021

Ther. Deliv.

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cell therapies • clinical trials • COVID-19 • drug delivery • gene therapy • mergers and acquisitions • product approvals • rare diseases • targeted therapeutics Business news Acquisitions, mergers, licensing Boehringer Ingelheim & NBE-TherapeuticsThe gain of a novel antibody-drug conjugate (ADC) capability through the acquisition of NBE-Therapeutics (Basel, Switzerland) was announced by Boehringer Ingelheim (Ingelheim, Germany), adding to its existing immune celltargeting assets and enhancing the company's cancer therapeutics portfolio [1]. The NBE-Therapeutics technology platform, immune-stimulatory ADC (iADC ™ ), brings together a tumor cell-targeted monoclonal antibody, linked to an immune-stimulatory cytotoxic anthracycline payload linked via unique enzymatic site-specific linker technology, SMAC-Technology ™ . The result is a less heterogenous payload distribution and improved serum stability compared to other ADC technologies [2]. The Boehringer Ingelheim Venture Fund has previously been one of the major institutional investors in NBE-Therapeutics. The acquisition also brings to Boehringer an emerging pipeline of ADCs, including the Phase I clinical asset NBE-002, an ADC targeted against ROR1, a tyrosine-protein kinase receptor expressed by various difficult-to-treat blood malignancies and solid tumors, including adenocarcinoma of the lung and triple negative breast cancer. Gilead Sciences & MYR GmbHGilead Sciences (CA, USA) and MYR GmbH (Bad Homburg, Germany) announced they had entered into a definitive agreement through which Gilead will acquire MYR. The deal brings to Gilead bulevirtide (Hepcludex ™ ), a lipopeptide antiviral agent that binds to the sodium taurocholate transporting peptide (NTCP) on the surface of hepatocytes and inhibits cell entry by viruses that employ it to gain entry. These include hepatitis B virus (HBV) and hepatitis delta virus (HDV). HDV is a significant form of viral hepatitis with high mortality rates, fast progression to fibrosis and cirrhosis and increased risk of liver cancer. It only occurs as a co-infection with HBV. First-in-class therapy bulevirtide subcutaneous injection is already conditionally approved by the European Medicines Agency and launched in France, Germany and Austria, with launches expected in other European markets during 2021. Trials of bulevirtide added on to tenofovir disoproxil fumarate (TDF) showed significantly greater reduction in viral RNA relative to TDF-only treatment. Trials of bulevirtide monotherapy are currently in progress. Submission to the US Food and Drug Administration (FDA) is planned for the second half of the year and the US FDA have already granted Orphan Drug and Breakthrough Therapy designations for bulevirtide in chronic HDV infection which may allow for an accelerated approval [3]. Lilly & Prevail TherapeuticsGene therapy company Prevail Therapeutics (NY, USA) has been acquired by Eli Lilly (IN, USA), bringing a new drug discovery and development modality to the acquirer. Prevail's adeno-associated virus-9 (AAV9) vector technol...

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Section: Sotorasib Tablets (Amgen)mentioning

confidence: 99%