Out of the starting gate

A roundup of clinical trial startups and progressions

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From cancer to amyotrophic lateral sclerosis and erectile dysfunction to celiac disease, we have a broad set of bases covered in our periodic roundup of clinical trials just starting out or entering new phases.
Combo of CV301 and durvalumab vs. colorectal and pancreatic cancers
COPENHAGEN, Denmark—Bavarian Nordic A/S in very early November announced that the first patient had been dosed in a clinical study evaluating the company’s targeted immunotherapy candidate CV301 and AstraZeneca’s PD-L1 inhibitor durvalumab in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancers.
Bavarian Nordic’s CV301 targets tumor-associated antigens, CEA and MUC1, which are overexpressed on multiple solid tumors, including colorectal and pancreatic cancers. Preclinical data has shown that vaccination resulted in the induction of tumor-specific T cells that infiltrated the tumor resulting in the upregulation of PD-L1 on tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.
CV301 is administered in an innovative manner designed to generate a potent and durable T cell response. Patients receive an enhanced priming regimen of the highly attenuated, non-replicating vaccinia virus MVA-BN-CV301 in four different injection sites on days 1 and 29, followed by boosters of the recombinant fowlpox virus FPV-CV301 at tapering intervals during the course of the treatment with durvalumab and maintenance chemotherapy.
“We are excited to continue demonstrating CV301’s potential in multiple cancers and combinations, particularly in a treatment setting in which checkpoint inhibition alone has yet to show significant benefit. The combination of a targeted cancer vaccine with a checkpoint inhibitor could result in a novel approach to fighting colorectal and pancreatic cancers, which are among the most difficult-to-treat malignancies to date,” said Paul Chaplin, president and CEO of Bavarian Nordic.
First patient treated with ILB for ALS
VIKEN, Sweden—On Nov. 2, TikoMed AB, a specialty pharmaceutical company focused on developing therapeutics for treating acute and degenerative neurological diseases, announced that the first patient with amyotrophic lateral sclerosis (ALS) has been treated with the company’s investigational drug ILB, in the ongoing clinical trial at Sahlgrenska University Hospital in Gothenburg, Sweden.
Anders Kristensson, CEO of TikoMed, commented, “With ILB, we present a potentially new class of drug which can address the underlying causes of neurodegeneration, as seen in a chronic disease such as ALS. We are committed to bringing ILB through our ALS clinical trial program and hopefully one step closer to ALS sufferers battling this fatal disease.”
TIKOMED will also be running a Phase 2 ALS study in collaboration with Birmingham University in Birmingham, U.K. In this trial, 15 patients with ALS will receive ILB for a 10-week treatment period.
Archer-1 trial of Betalutin plus rituximab begins dosing
OSLO, Norway—This fall saw Nordic Nanovector ASA announce that the first patient had been dosed in the Archer-1 trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL).
Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, so alternative targets are important. In addition, developing novel “chemo-free” regimens for patients as an alternative to chemotherapy is desirable.
Eduardo Bravo, Nordic Nanovector CEO, commented, “Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL.”
Enrollment begins with MED2002 for erectile dysfunction
GUILDFORD, U.K.—Futura Medical plc, a pharmaceutical company developing a portfolio of innovative products based on its proprietary transdermal DermaSys drug delivery technology, recently reported that the first patient had enrolled in the first European Phase 3 study (FM57), of MED2002, a topical glyceryl trinitrate (GTN) gel for the treatment of erectile dysfunction (ED). The Phase 3 study remains on track, with headline data expected by the end of 2019.
“We are pleased to announce the first patient enrollment in our first European Phase 3 trial with MED2002. This is an important milestone for Futura, building on the success of both the Phase 2 and PK data,” said James Barder, CEO of Futura Medical. “Futura is now in a position to build value by progressing the development of MED2002 through its planned Phase 3 studies, and we are excited to be moving closer to bringing an innovative, highly differentiated ED product to market that could help the many ED patients whose needs are not met by current treatments.”
Phase 2 enrollment begins for celiac disease vaccine in Australia and New Zealand
CAMBRIDGE, Mass.—In late October, ImmusanT Inc., a clinical stage company leveraging its Epitope-Specific Immuno-Therapy (ESIT) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, initiated enrollment in Australia and New Zealand for its Phase 2 RESET CeD study.
This trial will assess the safety, tolerability and efficacy of the company’s lead therapeutic candidate, Nexvax2, in patients with celiac disease who carry the immune recognition genes for HLA-DQ2.5. The latter accounts for approximately 90 percent of the celiac patient population, and Nexvax2 is designed to protect these patients from the effects of gluten exposure.
“Initial early development of Nexvax2 took place in Australia and New Zealand, and we are thrilled to be expanding our recently launched Phase 2 trial to patients from regions that have been with us from the beginning,” said Leslie Williams, CEO of ImmusanT. “Inadvertent gluten exposures can cause significant and long-term negative impacts on patient health. At ImmusanT, we are deeply committed to advancing Nexvax2 to protect celiac patients from the effects of inevitable gluten exposure.”

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