Evelo Bio Moves Ahead with EDP1815 Mid Stage Trial

Evelo Biosciences Inc. (EVLO) announced that its lead drug candidate EDP1815 will now be a part of TACTIC-E clinical trial. The trial is designed to assess the safety and efficacy of certain experimental therapies in the preventing and treating various complications related to COVID-19.

TACTIC-E is a Phase 2/3 randomized trial and will involve up to 469 patients in each arm. The participants will be the patients suffering from COVID-19 who have identified risk factors for developing severe complications. These will be patients who are deemed to be at risk of progressing to the intensive care unit or death. Mark Bodmer, Ph.D., chief scientific officer of Evelo, said, “The recent results with dexamethasone suggest that an oral agent, such as EDP1815, with potentially broad anti-inflammatory effects, could help prevent the severe complications of COVID-19, reducing the impact of the disease on individual patients and the demand on hospitals.” The drug candidate has the potential to tackle the inflammatory aspect of COVID-19 without immunodepression.

The trial will randomize the eligible patients equally. These cohort will either be put into one of the active arms or will be given standard of care alone. Cohort 1 of active arm will be given EDP1815 in addition to standard of care, while cohort 2 will receive a combination of ambrisentan and dapagliflozin in addition to standard of care. Cohort 3 will be given only standard of care.

The primary endpoint for the trial is the decline in the number of patients who develop severe complications such as ventilation, organ failure or death. Secondary endpoints include metrics such as duration of oxygen therapy, stay in hospital, change in biomarkers related to COVID-19 progression and time to show clinical improvement. The company plans to carry interim analysis throughout the trial to assess results for signals of safety and efficacy.

Evelo expects the interim data from the trial to be out in the fourth quarter of 2020. The company plans to hold meeting with global regulatory agencies for further progression, provided Phase 2/3 yield positive data.

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EDP1815 has the potential to provide positive results for treating COVID-19 as it can utilize the connect between intestinal mucosal immunology and systemic inflammation. This mechanism is helpful for treating a broad range of inflammations without using immunosuppressant. The development of severe COVID-19 is deemed to be related to cytokine storm and hyperinflammation. EDP1815 may stem such proliferation by modulating multiple immune pathways related to cytokine storm.

Apart from TACTIC-E trial, EDP1815 is also being tested for treating psoriasis. The company has submitted its Investigational New Drug application for Phase 2 clinical trial. Its Phase 1b clinical trial data showed the drug candidate’s ability to limit the production of several inflammatory cytokines such as IL-6, IL-8, TNF, and IL-1b. In preclinical models, it has shown the potential to resolve inflammation across TH1, TH2, and TH17 pathways, down-regulating several cytokines such as TNF, IL-4, IL-5, IL-6, IL-12p40, IL-13, and IL-17. Many of these cytokines are involved in the cytokine storm related to COVID-19.

If EDP1815 manages to receive the approval for treating COVID-19, then Evelo has the capacity to quickly scale up its manufacturing schedules for ensuring proper supply of the drug. The company may also take up the drug candidate for its use in other diseases such as influenza, which is also highly effected by hyperinflammation and influenza. In its preclinical model testing, EDP1815 did not show any activity on type 1 interferons, which are considered important for anti-viral responses.

HOOKIPA Reports Positive Phase 2 Interim Data for HB-101

HOOKIPA Pharma Inc. (HOOK) reported positive Phase 2 interim safety and immunogenicity results for its CMV vaccine candidate HB-101. The company is looking to report preliminary efficacy data and updated safety and immunogenicity data by the end of this year.

The primary endpoints for the trials were safety and B cell and T cell immunogenicity. The participants were blinded and randomized in 2:1 ratio. They were given either HB-101 or placebo. These patients had been given either 2 or 3 doses prior to transplantation, depending on the transplantation schedule.

For the purpose of interim analysis, all 30 CMV-negative patients who had been transplanted by the cutoff date and had valid results were evaluated for CMV-neutralizing antibody titers on the day of transplantation. 19 of these patients were given HB-101 while the remaining were on placebo. All the five patients who were administered three doses of the drug candidate mounted CMV-neutralizing antibodies while three out of the fourteen patients who were administered only two such doses also showed similar results.

25 CMV-negative patients who had been transplanted in time for this interim analysis were evaluated for cellular immune responses to CMV on the day of transplantation. All three evaluable patients who were administered three doses of HB-101 and one of the two patients who were given only two doses mounted a CMV-specific cellular immune response.

The data also demonstrated that the drug candidate was well tolerated with fewer adverse events in patients suffering from end-stage kidney disease.

Theratechnologies Releases Upbeat SORT1+ Data

Theratechnologies (THTX) reported positive preclinical data for two of its peptide-drug conjugate candidates TH1902 and TH1904. The data demonstrated that both the drug candidates have robust potential to inhibit vasculogenic mimicry at very low doses while chemo agents docetaxel and doxorubicin failed to display any impact at therapeutic doses. Theratechnologies plans to file an IND for a clinical trial assessing TH1902 before the end of 2020.

Vasculogenic mimicry is the process where the formation of microvascular channels promote metastatic, resistant and aggressive cancer cells. The data showed that in both ovarian cancer and TNBC, SORT1 is highly expressed in cancer cells related to the VM process.

TH1902 and TH1904 are SORT1-targeting peptide-drug conjugates and are conducive to controlling VM at very low doses. Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies, said, “We believe that our SORT1+ technology is one of the most promising advances in the treatment of cancer in many years. As our oncology programs progress through clinical development, we hope to continue to demonstrate that our SORT1+ technology could become a new paradigm in cancer treatment.”

Theratechnologies has developed a peptide for specifically targeting Sortilin receptors. Various cancers including triple negative breast cancer and skin cancer are characterized by overexpression of SORT1, which is instrumental in protein internalization, sorting and trafficking. The company had conjugated its investigational novel peptide with commercially available anti-cancer drugs such as docetaxel, doxorubicin or tyrosine kinase inhibitors for specifically targeting Sortilin receptors.

Theratechnologies is a commercial-stage biopharmaceutical company. It mainly focuses on developing treatments for orphan medical conditions. Its data demonstrates superior safety profile for TH1902 in comparison to docetaxel as it did not lead to neutropenia even after the administration of six treatment cycles. Docetaxel, on the other hand, induced neutropenia even with a single 15mg/kg dose.

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