Aug 22 Pharma News

Themis Bioscience collaborates with Merck; Oncorus raises USD 80 M; GSK files for Japanese approval of anaemia drug

Themis Bioscience forms an Exclusive License and Research Alliance with MSD to Develop Vaccines

Themis Bioscience, a vaccine development firm, has collaborated with the MSD, a trademark company of the Merck. The agreement is an exclusive license with MSD for the discovery and development of measles vaccines to fight cancer. Under the terms of the agreement, Themis will advance the development of the vaccines against a specific disease which remains undisclosed. MSD, on the other hand, will be providing funding and investment in Themis. The collaboration will enable Themis eligible for obtaining development and sales milestone payments of approximately USD 200 million.
Themis, Austran biotech, has a sophisticated vaccine platform and a comprehensive pipeline using the advanced understanding of the immune system. The company has successfully completed the Phase II clinical trials of its vaccine against Chikungunya and it's going to begin the Phase III studies. Furthermore, the company plans to start clinical trials of its Zika and Lassa fever vaccines while working to get the first of its oncology programs into humans.

Oncorus nets USD 80 Million to advance oncolytic virus

Oncorus has raised USD 79.5 Million in a Series B financing. The company announced to use the proceedings to advance oncolytic viruses. Its lead candidate ONCR-177, into the clinic in early 2020. ONCR-177 is an intratumorally administered oncolytic virus clinical candidate for multiple solid tumour indications. ONCR-177, like Amgen’s Imlygic, the only approved oncolytic virus, it is built on a herpes simplex virus and is delivered intratumorally.
In 2017, WHO estimated that there are about 3.7 billion people under the age 50 (67%) with HSV-1 infection globally and an estimated 417 million people aged 15-49 (11%) worldwide were affected with HSV-2 infection. The current HSV Infection market is mainly dependent on antiviral drugs and their generic versions. The market is flooded with already approved antiviral therapies such as Sitavig (Acyclovir), Denavir (penciclovir), Valtrex (valaciclovir), Famvir (famciclovir), Zovirax (Acyclovir sodium), Lipsovir (Acyclovir/hydrocortisone cream), and Abreva (docasanol 10%). Many novel therapies are in the late phase of development, targeting a better preventive and therapeutic approach. Upcoming drugs and preventive and therapeutic vaccines have the potential to start a new era in the treatment of herpes simplex virus infection. The US has the highest share of the 2016 market for HSV infections followed by EU5 and Japan.

GSK submits JNDA for daprodustat for patients with renal anaemia due to chronic kidney disease

GlaxoSmithKline, submitted the Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare in a quest for commercial approval of daprodustat. Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), approved for the renal anaemia due to chronic kidney disease (CKD) treatment. Daprodustat developed to deliver an orally-convenient treatment option is beneficial to an estimated 10.9 million patients suffering from CKD in Japan, and of these, 32% have anaemia. The therapy option viably combats the administration and storage challenges.
According to Melissa E et al. 2014, 14.0% of the US adult population had CKD in 2007–2010. Moreover, another study conducted by Steven F. et al. 2018, in patients with stage 3 CKD, 22.2% of patients with diabetes were anaemic, increasing to 52.4% in stage 4 CKD. Currently, the treatment paradigm for Anemia in Chronic Kidney Disease involves the use of Iron therapies, Erythropoietin stimulating agent (ESA) therapies, Red Blood Transfusions, Vitamin B12 & Folic Acid Supplements and nutrition.
Traditional molecules for intravenous administration may cause rare but fatal anaphylactic reactions (especially for high molecular weight iron dextran), severe hypotension due to ‘labile’ iron (iron sucrose or iron gluconate) or need to be given at repeated small doses with a long infusion time in order to avoid toxicity (iron gluconate and iron sucrose). To overcome this, several key players besides GlaxoSmithKline like Akebia Therapeutics, FibroGen and many others are working on developing therapies for the treatment of Anemia in Chronic Kidney Disease.

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