Product Development

Nektar/Syndax NKTR-214 and entinostat combo for melanoma has logical mechanism but underwhelming entinostat data draws expert pause

Nektar Therapeutics’ (NASDAQ:NKTR) NKTR-214 potential combination with Syndax Pharmaceuticals’ (NASDAQ:SNDX) entinostat has drawn mixed expert response on its potential to deliver efficacy impact in metastatic melanoma.

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Bionomics’ BNC210 has experts question loose links to predict efficacy success in Phase II for PTSD; more assured on safety

Bionomics (ASX:BNO) has weak precedence to predict efficacy success in its Phase II trial for post-traumatic stress disorder (PTSD), experts said, disputing some industry analysts commenting that BNC210’s successes in other trials could spell primary efficacy success in the indication. Experts said the links are loose, while one expert noted that animal models showed strong results but translation into human benefit remains unproven.

Safety, however, seems to be of lower concern, with its mechanism of action known to have low sedation or impact on cognition.

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Alnylam’s patisiran, Ionis’s inotersen in hATTR amyloidosis have varied strengths and weaknesses to call market winner, experts say

If approved, Alnylam Pharmaceuticals' (NASDAQ:ALNY) patisiran and Ionis Pharmaceuticals’ (NASDAQ:IONS) inotersen, both for hereditary transthyretin-related (hATTR) amyloidosis, have market strengths and weaknesses, experts said, in contrast to an analyst’s prediction of patisiran’s market superiority.

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Nightstar's and AGTC’s gene therapies for X-linked retinitis pigmentosa have unclear efficacy potential but low safety concern in Phase I/II, experts say

Preclinical success for Nightstar Therapeutics' (NASDAQ:NITE) and Applied Genetic Technologies’ (NASDAQ:AGTC) gene therapies for X-linked retinitis pigmentosa (XLRP) has experts on the fence of translation into the clinic. While animal studies have shown strong protein expression and even visual function recovery, a lack of understanding of XLRP-led photoreceptor cell death precludes confidence for a benefit in clinical trials, they said.

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Eiger’s Phase II ubenimex for lymphedema evokes mostly expert optimism based on earlier data, mechanism

Eiger BioPharmaceuticals’ (NASDAQ:EIGR) ubenimex for lymphedema triggered mostly optimistic expert expectations for the Phase II primary outcome. They pointed to positive clinical results of a molecule with a similar MOA and preclinical data with ubenimex that supports that mechanism.

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Pharma underutilises avenues to attract, retain trial patients; advocacy influence rising, delegates at Arena International say

Pharma can better attract patients to clinical trials through working with patient advocacy groups to generate feasible trial designs and offering to offset trial costs, said delegates at Arena International’s Outsourcing in Clinical Trials UK and Ireland 2018.

Speakers also touched on the need for trial recruitment and retention improvements, with a focus on the use of social media for recruitment and consistent communication between patients and trial sites -- during and after trials -- to ensure patient retention and continued involvement in future studies.

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Immunomedics’ sacituzumab has insufficient dataset to pursue accelerated approval despite impressive ORR in HR+ Her2-negative breast cancer, experts say

Immunomedics’ (NASDAQ:IMMU) Phase I/II sacituzumab govitecan hormone receptor positive (HR+) Her2-negative breast cancer data may not be enough for an accelerated approval despite showing clinically significant responses in a heavily pretreated population and a similar path adopted in triple-negative breast cancer (TNBC), experts said.

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Roche’s first-line NSCLC IMpower131 and IMpower150 Tecentriq studies struggle to find efficacy leverage over Merck’s Keytruda, experts say

Roche’s Tecentriq (atezolizumab) may have fallen behind Merck’s (NYSE:MRK) Keytruda (pembrolizumab) in the first-line non-small cell lung cancer (NSCLC) population following ASCO releases, experts said.

Heading into ASCO, analysts were looking to analyze full IMpower150 and IMpower131 data to understand the market scenario for Tecentriq versus Keytruda, especially considering the latter’s positive Keynote-189 data of Keytruda/paclitaxel with Eli Lilly’s Alimta (pemetrexed) in nonsquamous NSCLC, which was presented at AACR in April.

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Celgene’s Phase III Abraxane/gemcitabine needs to best adjuvant pancreatic cancer SOCs but efficacy success bar unclear

Celgene is testing Abraxane (nab-paclitaxel), which is approved to treat metastatic pancreatic cancer, as an adjuvant therapy in a late-stage trial, and will need to show superior overall survival (OS) data compared to what doctors currently use as standard of care.

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Shorter antibiotic courses have health benefits but more evidence needed before prescription overhaul

An investigator-sponsored clinical trial presented at the recent European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) conference in Madrid, Spain indicated a seven-day antibiotic course delivered similar outcomes to a 14-day course for Gram-negative bacteremia. Whilst there are health benefits to a shortened treatment, more studies are needed to change prescribing behaviors, experts noted.

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