Merck & Co. Inc. is wading into the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor space with a phase III program testing oral peptide MK-0616’s effect on knocking down low-density lipoprotein cholesterol. The first subjects are enrolling in two 24-week, registrational studies: Coralreef Lipids and Coralreef HeFH. The Rahway, N.J.-based firm also plans to kick off a phase III cardiovascular outcomes study called Coralreef Outcomes by the end of this year. PCSK9 drugs approved in the U.S. include subcutaneously administered Leqvio (inclisiran, Novartis AG), Praluent (alirocumab, Sanofi SA), and Repatha (evolocumab, Amgen Inc.).

SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine

SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid. “Our success in stabilizing vaccines at elevated temperatures with our proprietary vaccine patch technology platform has been of particular interest for use in low- and middle-income countries because of the potential to minimize or completely avoid cold-chain refrigeration,” Vaxxas CEO David Hoey told BioWorld.

With Sandoz’s MS approval, a biosimilar goes after big game

Biosimilars continue to pose cheaper alternatives to their established, blockbuster counterparts. The U.S. FDA has approved Tyruko (natalizumab-sztn) from Sandoz Inc., the generics business of Novartis AG. It is the first biosimilar to Biogen Inc.’s blockbuster Tysabri (natalizumab), an injectable for treating adults with relapsing forms of multiple sclerosis. Both drugs are also now approved to induce and maintain clinical response and remission in adults with moderately to severely active Crohn’s disease with evidence of inflammation, who have had an inadequate response to, or cannot tolerate, conventional therapies and tumor necrosis factor-α inhibitors. Tysabri brought in a hefty $2.03 billion for Biogen in 2022. Analysts say Tyruko’s launch may be imminent.

Clinical trial data down from 2021 but up 18% from 2019

The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the 2,402 in 2021 and down from 2020’s 2,096, but up 18.15% from 2019’s 1,747. By indication, the first seven months of 2023 saw therapeutic updates for cancer therapies at 32% of the total, followed by neurology/psychiatric indications at 14% and infection with 9%.

Multiple KRAS targeting strategies paving way for combination therapies

KRAS-mutated tumors were once untreatable. In fact, KRAS was something of a poster child for so-called undruggability. However, different attempts ultimately had success, and there are currently two FDA-approved KRAS inhibitors for this mutation, Lumakras (sotorasib, Amgen Inc.) and Krazati (adagrasib, Mirati Therapeutics Inc.), to treat non-small-cell lung cancer and colorectal cancer. In addition, several laboratories are investigating other strategies to address other mutations and uses.

BioWorld Insider Podcast – The struggle is real: The first half of 2023 was an uphill climb

Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit.

Also in the news

Akebia, Alentis, Alloksys, Aprea, Astrazeneca, Bioxytran, Celyad, Collegium, Comanche, CVS, Elucida Oncology, Excepgen, Exelixis, Eyenovia, Gilead, Immunomic, Merck, Mindbio, Nkgen, Novaliq, Peak, Rayzebio, Recce, Roche, Stempeutics, Tarsier, Taysha Gene Therapies