Roche’s Potential Hemophilia Blockbuster and Lung Cancer Drug Succeed in the Clinic


Roche has enjoyed a dream start to the week with both its immuno-oncology candidate, Tecentriq, and its hemophilia A drug, Hemlibra, succeeding in the clinic.

Roche’s week started with a bang as two of its drug candidates achieved positive results in Phase III trials. Tecentriq and Hemlibra are being tested for the treatment of advanced lung cancer and hemophilia A, respectively.  The back-to-back successes gave Roche’s stock price a 6% boost, giving it a market cap of CHF 210B (€180B), with investors jumping on the chance to climb on board now that the company appears to be on a roll.

Tecentriq has been used in combination with Avastin, a monoclonal antibody that interferes with cancer growth and spread, and chemotherapy. Full results will be released next month, but the preliminary data suggest that the triple therapy significantly improved progression-free survival and risk of death as a first-line treatment in a group of lung cancer patients.

Hemlibra, a bispecific antibody that binds both factor IXa and factor X, two factors that are vital for natural coagulation, could be a blockbuster in the hemophilia field. On Friday, the candidate received accelerated approval from the FDA based on earlier clinical data, but it has now demonstrated superior prophylaxis in comparison with factor VIII, without the thrombotic events that had been problematic in previous studies.

Spirits will be high at Roche HQ, situated in Basel, Switzerland.

Roche’s news has not made such happy reading for its competitors. Shire recently received orphan drug designation for its hemophilia A gene therapy, but today saw its stock price fall by almost 4%. Roche has also succeeded where AstraZeneca failed, whose combination of combination of durvalumab and the CTLA 4 immunotherapy tremelimumab missed its progression-free survival target.

Roche will now hope to be in pole position to bring its highly performing candidates to the market, in the hemophilia and non-small cell lung cancer fields, which are thought to be worth $25B (€21B) by 2024 and $12B (€10B) by 2025, respectively.


Images – kongkanglp / shutterstock.com; Oliver Foerstner / shutterstock.com

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Austrian Biotech’s Vaccine Against Tropical Virus Moves Nicely Through Phase II


Chikungunya fever could be the next big global outbreak. Reassuringly, Themis’ vaccine has so far performed well in a Phase II study.

Vienna-based biotech, Themis, develops urgently needed vaccines against diseases, which have the potential to be the next global outbreak. The company has announced encouraging preliminary Phase II results for its vaccine against chikungunya fever. Next, Themis will hope that the study’s final results, which are expected in 2018 and 2019, continue to suggest that its vaccine could provide effective protection from the tropical disease.

Chikungunya fever is a viral infection transmitted by Aedes mosquitoes. It originates in Africa but increased global travel and rising temperatures have caused the mosquitoes carrying the virus to spread. Over the last four years, there have been over 1.7 million cases across 45 countries. The virus causes sudden fever and severe joint pain, which can become chronic.

Themis’ candidate is a modified measles vaccine that expresses antigens from the Chikungunya virus.  The vaccine delivers the viral antigens directly to macrophages and dendritic cells, which triggers a strong immune response. The vector is able to replicate so continuously expresses antigens after immunization, resulting in long-term immunity.

The standard measles vaccine that is used as the backbone of the virus.

Unfortunately, tropical diseases are often forgotten about until a major outbreak takes place and lives are lost. Thankfully, biotech has stepped in and is taking a number of different approaches to tackle these deadly diseases. Swiss biotech, Humabs, isolated an antibody against Middle East Respiratory Syndrome and has programs against Zika and Dengue viruses at the preclinical stage. Oxford University spin-out, Oxitec, has opened a factory in Brazil to continue producing a genetically engineered Aedes aegypti mosquito, which can limit the population size.

Earlier this year, Themis was boosted by a grant of £3M (€3.3M) from Innovate UK to push the vaccine towards Phase III, and it can be pleased with the progress made so far. The money from Innovate UK will help Themis to prepare for Phase III, by giving it the funds to conduct a small phase I study in the UK to validate the vaccine’s correlate of protection and identify a protective antibody threshold.

It is refreshing to see a company learning from our mistakes in the fight against previous outbreaks like Ebola and Zika. There has already been one major outbreak of Chikungunya fever back in 2015, so let’s hope that Themis has its vaccine ready if or when there is another.


Images – khlungcenter / shutterstock.com; Themis

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Swiss Biotech Gets €12M as its Alzheimer’s Candidate Enters Phase II


AC Immune’s Anti-Tau antibody for the treatment of Alzheimer’s disease has reached Phase II, prompting milestone payments from Genentech.

Today, the first patient in a Phase II trial was dosed with AC Immune’s anti-Tau antibody for the treatment of Alzheimer’s disease. This triggered a milestone payment of CHF 14M (€12M) from its collaborator, Genentech, as part of an agreement worth more than CHF400M (€384M). AC Immune recently achieved an IPO of €52.5M on the NASDAQ and its market cap stands at $683M (€585M). The Phase II study will determine the antibody’s efficacy and safety.

AC Immune’s anti-Tau monoclonal antibody is based on the company’s SupraAntigen technology. They are generated by injecting the SupraAntigen constructs into mice and selecting antibodies that break up aggregated forms of misfolded proteins. The anti-Tau antibody has a high specificity for abnormal forms of the Tau protein and catches it as it moves in the extracellular space of the brain.

Within the Alzheimer’s field, it remains hotly debated whether abnormal tau proteins or amyloid-beta is the best approach to treating the disease. Tau proteins accumulate inside brain cells and then spread, while amyloid-beta forms plaques and oligomers around the outside of brain cells. But, AC Immune has covered all bases by also developing a SupraAntigen against amyloid-beta, Crenezumab, which is currently undergoing two phase III clinical trials.

Despite notable failures from Eli Lilly and Merck, AC Immune has chosen continue pursuing an antibody approach for the treatment of Alzheimer’s. The company has chosen a field that is searching frantically for a treatment or cure for a disease that is rapidly increasing in prevalence. Araclon Biotech’s vaccine and Probiodrug’s drug to prevent the formation of amyloid-beta plaques are currently offering some hope to the field.


Media – Orawan Pattarawimonchai / shutterstock.com; AC Immune

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Personalized Breast Cancer Treatment Coming Soon with Help from Spanish Biotech


Inbiomotion has published the results of a Phase III study looking at its MAFTest to personalized approaches to the disease. Inbiomotion, based in Barcelona’s biotech hub, works on a highly selective biomarker for breast cancer. A Phase III study demonstrated that …

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