April’s top news stories

3rd May 2019 (Last Updated May 3rd, 2019 00:00)

Chinese clinical-stage biopharmaceutical company I-Mab Biopharma and German biotech company MorphoSys have begun the first dosed Phase III clinical study to assess investigational human CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients suffering from relapsed or refractory multiple myeloma; and A small clinical trial by researchers at the University of Edinburgh in the UK has showed that cilostazol and isosorbide mononitrate could prevent recurrence of stroke and vascular dementia. Drugdevelopment-technology.com wraps up the key headlines from April 2019.

April’s top news stories
I-Mab, MorphoSys begin dosed phase 3 clinical study of blood cancer drug. Credit: Helloquence on Unsplash.

I-Mab and MorphoSys begin Phase III study of blood cancer drug

Chinese clinical-stage biopharmaceutical company I-Mab Biopharma and German biotech company MorphoSys began the first dosed Phase III clinical study to assess investigational human CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients suffering from relapsed or refractory multiple myeloma.

MorphoSys has developed the investigational human CD38 antibody TJ202/MOR202, which is derived from MorphoSys’s HuCAL antibody technology.

I-Mab has the exclusive rights to develop and commercialise TJ202/MOR202 in China, Taiwan, Hong Kong, and Macau.


Trial finds heart drugs could help prevent stroke and dementia

A small clinical trial by researchers at the University of Edinburgh in the UK showed that cilostazol and isosorbide mononitrate could prevent the recurrence of stroke and vascular dementia.

The drugs are currently used to treat heart disease and angina, among other conditions.

Conducted in alliance with the University of Nottingham, the latest trial enrolled 57 patients who had a lacunar stroke, which is caused by damaged small blood vessels in the brain.


TC BioPharm begins Phase I trial of new cell therapy in AML

UK-based TC BioPharm commenced a Phase I clinical trial to evaluate a new allogeneic cell therapy TCB002 for the treatment of acute myeloid leukaemia (AML).

TCB002 is developed using activated and expanded gamma delta T cells from healthy donors, who are chosen to ensure that their cells are more effective against tumours compared to the patient’s own cells.

Gamma delta T cells, a subset of lymphocytes, are said to possess innate and adaptive immune properties. They also do not elicit ‘graft versus host’ rejection.


Gilead’s selonsertib fails in second Phase III trial for NASH

Gilead Sciences reported that selonsertib failed to meet the primary endpoint in the Phase III STELLAR-3 clinical trial performed in patients with bridging fibrosis (F3) caused by nonalcoholic steatohepatitis (NASH).

The announcement came two months after the apoptosis signal-regulating kinase 1 (ASK1) inhibitor failed to demonstrate positive outcomes in the Phase III STELLAR-4 study.

In the STELLAR-3 trial, the drug did not meet the primary endpoint of a ≥1-stage histologic improvement in fibrosis without worsening NASH at week 48.


Belite Bio to trial new therapy for macular degeneration

Biopharmaceutical firm Belite Bio received the US Food and Drug Administration (FDA) approval to conduct a Phase I clinical trial of LBS-008 (BPN-14967) to treat dry macular degeneration and Stargardt disease.

LBS-008 is an oral therapeutic designed to prevent the accumulation of toxins (A2E), which are by-products of vitamin A and cause progressive retinal cell death and permanent vision loss.

The therapy minimises and regulates the retinol-binding protein 4 (RBP4) that carries vitamin A to the eye. Belite Bio noted that LBS-008 does not directly affect the visual cycle of the eye.


GlycoMimetics doses first patient in trial of uproleselan to treat AML

GlycoMimetics dosed the first patient in a Phase III clinical trial to evaluate uproleselan (GMI-1271) for the treatment of adults with acute myeloid leukaemia (AML).

The trial is the second in a series of trials designed to evaluate uproleselan. It is being conducted under the support of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI).

In November last year, GlycoMimetics dosed the first patient in the initial Phase III clinical trial to evaluate uproleselan in combination with mitoxantrone, etoposide and ara-C (MEC) or fludarabine, ara-C and idarubicin (FAI).


MorphoSys and Galapagos launch Phase II atopic dermatitis trial

MorphoSys and Galapagos commenced a Phase II clinical trial, in alliance with Novartis Pharma, to assess subcutaneous MOR106 in combination with topical corticosteroids to treat moderate to severe atopic dermatitis.

MOR106 is a human monoclonal antibody that targets the IL-17C cytokine, which is preferentially expressed in the skin and linked to dermal inflammation.

As part of an agreement with MorphoSys and Galapagos, Novartis Pharma holds the exclusive licence to develop and commercialise MOR106 globally.


Cortexyme initiates new trial of Alzheimer’s medicine

Pharmaceutical company Cortexyme initiated a Phase II/III clinical trial to assess its investigational drug COR388 for the treatment of mild to moderate Alzheimer’s disease (AD).

Named GAIN, the new trial builds on the previous findings that Porphyromonas gingivalis, a pathogenic bacterium known to cause chronic periodontal disease, can infect the brain and lead to Alzheimer’s.

Studies in animal models demonstrated that the toxic gingipains proteins produced by the bacterium damage and destroy brain cells.


Provention Bio closes enrolment in PRINCE trial for Crohn’s disease

Biopharmaceutical firm Provention Bio concluded patient enrolment in the Phase IIa PRINCE clinical trial of PRV-6527 for the treatment of patients with moderate-to-severe Crohn’s disease.

The trial recruited 93 subjects who did not undergo prior biologic therapy or previously experienced inadequate response to at least one biologic drug.

Developed by Janssen Pharmaceuticals, PRV-6527 is an oral, selective small molecule inhibitor of Colony Stimulating Factor-1 Receptor (CSF-1R). Provention Bio licensed the compound from Janssen in 2017.


Gilead and Novo partner to trial combination therapy for NASH

Gilead Sciences entered a clinical collaboration with Denmark-based Novo Nordisk to evaluate a combination treatment for nonalcoholic steatohepatitis (NASH).

The companies intend to launch a proof-of-concept clinical trial of Novo Nordisk’s semaglutide in conjunction with Gilead’s cilofexor and firsocostat.

Semaglutide is a GLP-1 analogue originally developed to treat type 2 diabetes in adults. Cilofexor is a FXR agonist, while firsocostat is designed to inhibit ACC.