Biohaven’s Troriluzole Failure; Daiichi/ AZ’s Enhertu; Fujifilm & Manufacturing Spree; J&J’s Darzalex Faspro

Biohaven’s Troriluzole Dwindles Again In Alzheimer’s After Anxiety 

Biohaven Pharmaceuticals had put too much faith in its third-generation prodrug, Troriluzole. The company has tested the efficacy of the drug in more than one indication, including generalized anxiety disorder (GAD), obsessive-compulsive disorder, spinocerebellar ataxia and Alzheimer’s disease (AD). However, it seems the drug continues to disappoint the company one after another.

After the drug failed to produce better outcomes in anxiety, failed to meet primary outcomes in OCD, the company announced that their chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body, has even flunked in Phase 2/3 clinical trial as a symptomatic treatment in mild-to-moderate Alzheimer’s disease (AD). 

Thus, the company has decided to wrap up the trials for AD. This is not something new in the Alzheimer’s disease market. Despite the availability of scientific evidence, extensive R&D, and investment of huge amounts, no new drug has managed to walk the carpets. Several have failed and abandoned with the plight and the cost of the disease seemingly growing with each year passing. 

A Sweet Year For Daiichi/ AZ As Enhertu Gets FDA Approval For Gastric Cancer

The U.S. Food and Drug Administration has given the nod to Daiichi Sankyo’s and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Enhertu is an antibody-drug conjugate (ADC) that comprises a humanized anti-HER2 IgG1 monoclonal antibody. The approval is based on the positive results from the randomised Phase 2 trial conducted in Japan and South Korea. 

With the approval, Enhertu has become the first HER2-directed medicine approved in a decade for patients with HER2-positive metastatic gastric cancer. It is already approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.  The company has future plans to pursue the trials for the drug across a broad range of HER2 targetable cancers.

Fujifilm Increases Legroom In Cell And Gene Therapy, Plans For New Manufacturing Facility  

Fujifilm and the Center for Advanced Biological Innovation and Manufacturing (CABIM) has secured USD 76 million in financing and also signed a lease for a 40,000 square-foot site in Watertown, Massachusetts at The Arsenal on the Charles, owned and operated by Alexandria Real Estate Equities. 

CABIM, the industry-academia research and development consortium, is a joint effort of Fujifilm, Harvard University, Massachusetts Institute of Technology, Cytiva (formerly part of GE Healthcare Life Sciences), and Alexandria Real Estate Equities, Inc. CABIM plans to help make new therapeutics, medicines, and technologies accessible to patients and strengthen Greater Boston’s position as the world’s life science capital. The plan is to build eight clean rooms, with a configuration to produce both cell and viral vector products within the physical space. 

Fujifilm is trying everything to build its position in the cell and gene therapy domain even stronger. With its CDMO arm, Fujifilm Diosynth Biotechnologies exploring more in-depth into the domain, and showing a shited interest in its viral vector capabilities for Covid-19 vaccines, will procure GMP2 contract process development and manufacturing services as part of its role in the new manufacturing and innovation centre.

Janssen has announced that its Darzalex Faspro has received the USFDA approval for adults with newly diagnosed light chain amyloidosis. The drug was originally developed by Genmab in 2012 and was in-licensed to Janssen. 

Darzalex Faspro is a combination of daratumumab and hyaluronidase-fihj, a subcutaneous formulation of daratumumab. It is the only CD38-directed antibody that has got approval for subcutaneous injection for multiple myeloma, and now it has been given the nod for AL amyloidosis. The drug is approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) and is the first and only FDA-approved therapy for patients with this indication. 

AL amyloidosis affects over 4000 people each year in the US, and about 30% of patients with AL amyloidosis die in the first year after diagnosis. Today’s approval is nothing less than a breakthrough in the AL amyloidosis market.