This week’s guests are Erik Buntinx, CEO and founder of ANeuroTech; Stephen J. Matlin, CEO of Life Length; and Kees Melief, chief scientific officer at ISA Pharmaceuticals.
ISA Pharmaceuticals’ clinical trial using AMPLIVANT technology
A clinical trial using ISA Pharmaceuticals’ AMPLIVANT adjuvant technology started in April.
The trial, run by partner Scancell Holdings plc is a multicenter clinical trial, testing the Moditope vaccine Modi1. This first-in-human clinical trial brings Modi-1 to patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer using the AMPLIVANT adjuvant technology to boost immune response to the therapy.
The main study is an open label clinical trial. The initial part of the trial will assess the safety and immunogenicity of Modi-1. In addition, the effect of Modi-1 in promoting T-cell infiltration into the tumor will be assessed in a neoadjuvant cohort of patients with head and neck cancer treated with Modi-1, randomized to treatment with or without a checkpoint inhibitor, prior to the first surgical resection.
The Modi-1 peptides are linked to AMPLIVANT, a potent adjuvant and toll-like receptor (TLR) 1/2 agonist, which enhances the immune response 10-100 fold, resulting in highly efficient tumor clearance, including protection against tumor recurrence, in preclinical models.
AMPLIVANT is the subject of a worldwide non-exclusive licensing and collaboration agreement with Scancell for the manufacturing, development, and commercialisation of Modi-1.
Kees Melief, chief scientific officer, ISA Pharmaceuticals, said: “Adjuvants are crucial components of vaccines which boost efficacy, however there is lack of new, innovative, and effective adjuvants in development to add to a limited armamentarium. As such this is an important achievement and highlights the productive collaboration, we have with Scancell. The trial provides a further opportunity to demonstrate the potent adjuvant properties that AMPLIVANT confers on therapeutic vaccines to potentially benefit patients with a broad range of solid tumors.”
Professor Lindy Durrant, CEO of Scancell, said: “This is the first time we have taken a product from our Moditope platform into cancer patients and is a major step forward for Scancell and our collaboration with ISA Pharmaceuticals. We are very excited about the prospects for Modi-1 based on the dramatic regression of large tumors in our preclinical models.”
Positive news from trial for drug to treat major depressive disorder
A company working on treatments for people with mental health issues has had positive feedback from the development program of an anti-depressant targeting major depressive disorder (MDD).
ANeuroTech has just announced that after a successful pre-Investigational New Drug Application (IND) meeting, the US Food and Drug Administration (FDA) has given positive feedback on its pivotal phase 3b development program of ANT-01 as an adjunctive anti-depression drug for MDD.
Cognitive function
The ability to feel pleasure, used as a measure for the first time, and an improvement in cognitive function, have been included as a secondary endpoint in the phase 3b part of the clinical trial.
ANeuroTech will file for IND in the fourth quarter and apply for FDA Fast-Track Designation at the same time.
More than 60% of people with depression and associated cognitive problems are not helped by initial treatments or experience challenging side-effects.
ANeuroTech is developing ANT-01 as an adjunctive anti-depression drug with minimal or no side-effects. It is a low dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic developed by the late Dr Paul Janssen (founder of Janssen Pharmaceutica which merged with Johnson & Johnson) and marketed for more than 40 years in Europe at a high dose range for the treatment of psychotic disorders.
Erik Buntinx, CEO and founder of ANeuroTech, discovered through his clinical practice that ANT-01 has a unique high selectivity and affinity for the serotonin 5-HT2A and dopamine D4DR brain receptors, and shows potential as an adjunctive treatment with fewer side effects.
Buntinx said: “The FDA’s positive feedback for our phase 3b development program recognizes the excellent safety profile and strong efficacy data shown in studies of ANT-01 to date and is an important milestone as we prepare to initiate the study next year.”
First-line antidepressant
The pivotal phase 3b development program will assess the safety and efficacy of a single low (15mg) dose of ANT-01 combined with a first-line antidepressant versus placebo, in MDD patients with insufficient response to selective serotonin re-uptake inhibitor (SSRI) or selective noradrenaline serotonin re-uptake inhibitor (SNRI) treatment.
The phase 3b follows positive clinical data generated from earlier trials which the company says demonstrated superior antidepressant activity of ANT-01 with a favorable safety profile. The data also showed an improvement in the ability to feel pleasure and in cognitive function, which has not been demonstrated by any other antidepressant molecule. This will be further explored in the phase 3b program, which will recruit 300 patients at a number of US sites and is planned to begin in 2023.
ANeuroTech also announced that seasoned biotech entrepreneur, Rudi Pauwels, has joined the board of directors as executive chairman. Pauwels has more than 30 years’ experience in the biotech sector and has co-founded several successful biotech companies including Tibotec, Virco, Galapagos Genomics and Biocartis. He holds a PhD in Pharmaceutical Sciences from KU Leuven, where he met and was mentored by Janssen.
Buntix added: “It’s a great time to welcome Rudi to the team and partner with him to revitalize the unique drug discovery legacy of our mutual mentor, the late Dr Paul Janssen.”
Pauwels said: “ANT-01 has the potential to change the treatment paradigm for the 190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants. Erik’s passion and wealth of experience in treating patients with depression positions ANeuroTech at the forefront of mental health care, and I am excited about continuing this journey with the team, many of whom I had the pleasure of working with at the successful pharmaceutical company, Tibotec.”
Life Length obtains European authorization for prostate cancer diagnostic test PROSTAV
Following five years of clinical studies in Spain and the U.S, Life Length, Spain’s most accredited laboratory (and the only U.S. federal lab in the country) has received its Functional License from the Spanish Medical and Sanitary Products Agency along with the CE mark for its prostate cancer diagnostic assay, PROSTAV.
The clinical studies have been carried out with hospitals and urology centers in Spain and the U.S., including the Centro Médico Quirúrgico LYX, the Spanish hospitals 12 de Octubre, Ramón y Cajal, Reina Sofía and Infanta Margarita; and the U.S. hospitals Urological Research Network and Houston Methodist.
PROSTAV is a diagnostic blood test based on telomere measurement, offering its patented Telomere Analysis Technology in diverse fields ranging from preventive and personalized medicine with HEALTHTAV to the pharmaceutical, nutraceutical and cosmetic industries among others to clients in more than 35 countries.
PROSTAV’s purpose is to substantially improve prostate cancer diagnosis, the most frequent cancer, which will afflict 1 in 6 men in their lifetime and from which, in Spain alone, approximately 6,000 men die annually. Currently, the most used diagnostic, PSA, generates false negative results in up to 80% of the cases.
For this reason, hundreds of thousands of unnecessary biopsies are carried out each year in Europe alone; invasive, painful, costly procedures with potentially serious complications. PROSTAV seeks to eliminate more than 33% of these biopsies, avoiding this procedure for men who do not actually have cancer and generating a significant clinical benefit for these patients and substantial economic savings both for the public and private healthcare systems.
Stephen J. Matlin, CEO of Life Length said: “As June 11 is the World Day of Prostate Cancer, we are very pleased to communicate that PROSTAV is now approved for use in the European Union. Thanks to our work together with the participating institutions, we have been able to demonstrate that, from a simple blood sample, we can detect alterations in telomere distribution in men that have prostate cancer. Together with our extensive clinical database and the algorithms that we have developed, this allows us to issue a Result’s Report with high levels of specificity and sensitivity.
“Our test, the first in the world based on telomere variables authorized for clinical use in oncology, reflects our leadership in the sector and reaffirms the validity of our proprietary technology. We will continue to work in other areas of oncology and age-related diseases, where we believe we can bring additional clinically validated, innovative tests for improved diagnostics and healthcare globally.”
About Life Length
Life Length was founded in 2010 as a spin-off of the Spanish National Cancer Research Center with the objective of commercializing its Telomere Analysis Technology.
The company currently employs around 100 people. Its primary laboratories are in the Madrid Science Park (FPCM) in Cantoblanco where it carries out, among other assays, the world’s most precise telomere diagnostic measurements and related assays.
“Life Length has been part of the Madrid Science Park since 2016 as well as the Enterprise Europe Network which has been enormously supportive of us,” Matlin said.