This week in clinical trials: 15th-19th January 2024

Continuing our clinical trials updates of 2024, in this instalment we look back at developments in life sciences research and development announced during the week of 15th to 19th January, from early-stage onwards. Included in that glance are positive developments in protecting the immuno-compromised against circulating Omicron variants, as well as targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, and more.

Read on further for ongoing weekly news from studies across the globe.

During the week of 15th to 19th January:

Biotech ExeVir Bio has announced new data demonstrating that its XVR012 (a ‘cocktail’ of XVR013m and XVR014) is highly potent in neutralising currently circulating COVID-19 Omicron variants, offering hope of protection for the immuno-compromised and elderly.

ExeVir develops robust heavy chain-only antibody therapies for broad protection against infectious diseases and all authorised SARS-CoV-2 therapeutic antibodies that have been used in the clinic have shown severe to complete loss of virus neutralisation potency against currently circulating variants, including highly prevalent E.G.5.1, HV.1, and BA.2.86.1.

ExeVir is a spin out of VIB, the leading Belgium-based life sciences research institute. It is backed by strong investors, including Fund+, which led the series A of EUR 42 million, together with an international consortium, including UCB Ventures, SFPIM, V-Bio Ventures, VIB, Wallonie Entreprendre, Noshaq, Vives IUF, and SambrInvest.

ExeVir is harnessing its llama-derived antibody (VHH) technology platform to generate multi-specific antibodies for prophylaxis and treatment of infectious diseases, with an initial focus on prevention of COVID-19 for the immunocompromised patient population, including active chemotherapy, immunosuppressive drugs, solid organ transplantation, haematological malignancies, AIDS patients, and for the elderly, where there remains a high unmet need due to the limitations of current vaccines and therapeutic approaches.

XVR012 (a blend of components XVR013m and XVR014) targets three distinct epitopes highly conserved across the broad sarbecovirus subgenus of Coronaviridae to minimise the risk of viral escape. XVR013m and XVR014 neutralise both SARS-CoV-1 and SARS-CoV-2 viruses.

ExeVir is currently gearing up to start the clinical development of both the combination XVR012 this year, as well as its individual components XVR013m and XVR014.

Also in the pipeline are XVR021, which targets dengue, and XVR031, which is for pandemic preparedness.

Clinical-stage biopharma Nurix Therapeutics (PDF) has received US FDA Fast Track designation for NX-59478, the company’s selective Bruton’s tyrosine kinase (BTK) degrader, for the treatment of relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (r/r CLL/SLL) after at least two lines of therapy, including a BTK inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2) inhibitor.

The designation comes on the heels of positive Phase 1a/1b clinical trial data evaluating daily oral dosing of BTK degrader NX-5948 in patients with r/r B-cell malignancies, as shared at the American Society of Hematology (ASH) annual meeting held in December 2023, with NX-5948 data demonstrating preliminary efficacy with a favourable safety profile.

In the ASH presentation, six of seven patients in the CLL population that received doses ranging from 50 to 200 mg demonstrated clinical benefit with three partial responses (PR). NX-5948 was well-tolerated across all doses tested, with no dose limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) and no treatment emergent adverse events (TEAEs) that resulted in drug discontinuation.

San Francisco, California-headquartered Nurix develops targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases.

Arthur T Sands, president and CEO of Nurix, commented that the Fast Track designation was “especially timely” given the company’s plans to “accelerate enrolment in the Phase 1 trial”.

Synendos Therapeutics AG has announced that it has been granted European Medicine Agency (EMA) Clinical Trial Authorisation for its first-in-class Endocannabinoid System modulator, SYT-510.

Synendos has spent over a decade developing innovative Endocannabinoid System (ECS) treatments for neuropsychiatric, neuroinflammatory, and other Central Nervous System (CNS) disorders. The randomized, double-blind, placebo-controlled Phase 1 ‘first-in-human’ clinical trial will investigate the safety, tolerability, and pharmacokinetics of single-ascending doses of SYT-510 in healthy adult participants.

Synendos is developing selective endocannabinoid reuptake inhibitors (SERIs) that influence the balance of the ECS in a novel mode of action. By rebalancing and restoring endogenous cannabinoid levels dysregulated in certain pathological conditions, there is the potential to rebalance brain function in a holistic and pro-homeostatic way to treat neuropsychiatric disorders, including Post-Traumatic Stress Disorder (PTSD).

Spun out of the University of Bern and incorporated in April 2019, the company’s novel technology stems from more than 10 years of solid research on endocannabinoid biology and pharmacology carried out by co-founders, Professor Jürg Gertsch and Dr Andrea Chicca.

Dr Chicca commented: “With no new treatments available in this area for over 25 years, advances are desperately needed. By addressing this unmet need […] we have the potential to offer those struggling with anxiety, mood, and stress-related disorders a differentiated, safe, and effective way to alleviate symptoms through the holistic rebalancing of brain physiology.”

Clinical stage oncology company Oxford BioTherapeutics(PDF) has announced that the first patient has been dosed in a Phase 1b trial investigating OBT076 in patients with Adenoid Cystic Carcinoma (ACC) of the head and neck.

OBT076, is an innovative ADC with a potential dual mechanism of action in treating patients with ACC, a rare, aggressive type of cancer which represents 2% of head and neck cancers and about 20% of salivary gland malignancies. OBT076 targets the CD205 receptor on tumour cells, as well as certain immune suppressive cells in high-risk cancer patients. The CD205 receptor is highly overexpressed in solid and liquid tumours with high unmet need, including gastric, lung, and ovarian cancer.

The Phase 1b trial is being sponsored by Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC), a European oncology and radiotherapy consortium specialising in clinical and laboratory research specifically for the benefit of head and neck cancer patients.

The trial will be carried out in patients with recurrent or metastatic ACC of the head and neck from an anticipated 15 study sites across the GORTEC network in France, Belgium, and Switzerland. It will investigate OBT076 both as a monotherapy and in combination with balstilimab, a PD-1 blocking antibody, accessed through a clinical collaboration agreement from Agenus.

OBT076 is also currently being evaluated in Phase 1 clinical trials in the US and Europe across several advanced solid tumour indications, including gastric, endometrial, ovarian and non-small cell lung (NSCLC) cancer.