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AltruBio Inc. moves forward with clinical development of Neihulizumab in Steroid-Refractory Acute Graft-versus-Host Disease after encouraging Phase 1a results.
Date:7/2/2020

AltruBio Inc. http://www.altrubio.com, a clinical stage biotech company, presented its phase 1a findings of Neihulizumab, a biologic for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD), at European Hematology Association (EHA) annual conference in June 2020. Led by hemato-oncologist Dr. Paul J Martin of the Fred Hutchinson Cancer Research Center, this single-arm, open-label Phase 1 single dose, dose-finding study demonstrated a 77% (10/13 patients) response rate after a single dose of Neihulizumab treatment with 69% (9/13) of patients responding after 28 days.

The study Lead, Dr. Paul Martin, stated, “The results of this single dose study showed that Neihulizumab has an acceptable PK and safety profile in patients with SR-aGVHD involving the skin. In addition, the results showed evidence of clinical activity in 10/13 patients.”

Dr. Judy Chou, President & CEO of AltruBio Inc., was encouraged by the results stating, “The high response rate of Neihulizumab in this study encourages us to move this drug candidate forward. SR-aGVHD continues to be a significant unmet medical need and further treatment options are required.”

These results support continued testing of neihulizumab in patients with SR-aGVHD with multiple dosing to further assess safety and efficacy. The multiple dose phase of the trial is currently ongoing.

About Neihulizumab.
Neihulizumab is an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes chronically activated T cells. This mechanism has been evaluated in four autoimmune and inflammatory diseases and has demonstrated clinical proof of concept and safety in more than 100 patients with psoriasis and psoriatic arthritis. This study drug is currently in Phase 2 trials for the treatment of refractory ulcerative colitis and in Phase 1 trials for the treatment of SR-aGVHD, with encouraging results in patients that are refractory to available therapies. Phase 1 trial for the treatment of front-line acute GvHD is currently initiated.

About acute Graft-versus-Host Disease.
Acute GvHD is a major complication following an allogeneic HCT. Somewhere between 30 and 70 percent of transplant recipients develop acute GvHD. Standard first –line treatment is systemic, high-dose glucocorticoid, with around 50% response rate and are associated with clinically significant side effects. Patients who do not respond to corticosteroid treatment are considered steroid-refractory. SR-aGVHD is a significant unmet medical need and novel, effective treatments are urgently needed.

The information presented here is not intended nor implied to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the advice of your physician or other qualified healthcare professional with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it.

About AltruBio Inc. (http://www.altrubio.com)
AltruBio is a privately held biotechnology company headquartered in the San Francisco Bay Area that is focused on developing novel antibody therapeutics for the treatment of immunological diseases with high unmet medical needs. Based on unique insights into immune tolerance and epitope dominance sciences, AltruBio’s pipeline includes two clinical stage product candidates: (i) Neihulizumab (AbGn-168H) an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes unwanted activated T cells with proof of mechanism in four autoimmune and inflammatory diseases, and (ii) AbGn-107, an antibody-drug conjugate (ADC) employing a unique enzyme cleavable hydrophilic self-immolative linker and targeting a gastrointestinal tumor antigen. AbGn-107 has demonstrated encouraging results in chemo-refractory gastric, pancreatic, colorectal and biliary cancers.

Note on Forward-Looking Statements
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as expects, believes, intends, and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, and risks related to the Company's ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law.

Read the full story at https://www.prweb.com/releases/altrubio_inc_moves_forward_with_clinical_development_of_neihulizumab_in_steroid_refractory_acute_graft_versus_host_disease_after_encouraging_phase_1a_results/prweb17229253.htm.


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