On May 25, 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, reported that it has entered into a collaboration and supply agreement with Agenus Inc., an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, to support a clinical trial evaluating the combination of OBT076 with the anti-PD1 checkpoint inhibitor (CPI) balstilimab (Press release, Oxford BioTherapeutics, MAY 25, 2022, View Source [SID1234615056]).
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OBT has observed near complete responses in two chemotherapy-refractory advanced cancer patients with low to no PD-L1 expression after 2-5 cycles of OBT076 and 1-2 cycles of a CPI, indicating preliminary signs of clinical activity. Immuno-blood profiling during translational work on these patients revealed a potential novel immuno-oncology mechanism for immune system reactivation and tumor shrinkage.
OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus´ proprietary CPI, balstilimab. Balstilimab is an PD-1 blocking antibody currently in clinical development in several solid tumor indications.
"I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "Our preliminary data suggest that depletion of CD205+ immuno-suppressive cells and subsequent T-cell activation after OBT076 treatment followed by a single cycle of a CPI coincides with the rapid resolution of the primary tumor, as well as metastases, and we believe that balstilimab is the ideal combination agent for these studies."
Under the terms of the agreement, OBT will be the sponsor of the combination trial and responsible for operational execution, and Agenus will provide drug supply and scientific support.
"We look forward to collaborating with Oxford BioTherapeutics to bring this novel combination to patients," said Steven O’Day, MD, Chief Medical Officer of Agenus. "The clinical data generated with OBT076 in advanced solid tumors is promising, and we believe will broaden the therapeutic benefit of balstilimab observed across treatment-resistant tumors."
The study will be conducted in the US as well as in several European countries including France, Germany, Belgium and Greece, and will focus on patients with solid tumors including lung, gastric and ovarian cancer.
"Our initial Phase 1 findings suggest that OBT076 may activate the immune response against the tumor through a potentially novel mechanism in some patients; based on these encouraging results, we are advancing OBT076 into the next stage of clinical development in combination with a CPI," said Rahim Fandi, MD, PhD, Chief Medical Officer (CMO) of Oxford BioTherapeutics. "With their deep experience in the field of immune-oncology, Agenus is the ideal partner for us in this next stage of OBT076’s development."
About OBT076
OBT’s lead clinical program, OBT076, an ADC utilizing an ImmunoGen toxin, initiated expansion in a U.S. Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT076 is advancing into Phase 1b trials assessing the efficacy of OBT076 as a monotherapy as well as in combination with a CPI in both checkpoint-naïve and resistant patients with solid tumors. Subsequent disease-specific Phase 2a trials are planned in non-small cell lung, ovarian and gastric cancer patients. OBT is also planning for later-stage trials of OBT076, including in combination with a CPI.