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United BioPharma Received IND Approval from China NMPA for a larger Phase 2 Trial with multi-dosing UB-621 to demonstrate optimal clinical efficacy in treatment of Recurrent Genital Herpes

Taipei, Taiwan – July 13th, 2021 –United BioPharma (UBP) announced today that its subsidiary company in Shanghai (China) has received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for a larger Phase 2 clinical trial with UB-621, an anti-HSV (Herpes Simplex Virus) monoclonal antibody, to evaluate its safety and efficacy in adults with recurrent Genital Herpes (RGH).

Earlier in an open label, dose-escalation Phase 1 study, UB-621 was demonstrated to be safe and well-tolerated in 15 healthy volunteers receiving a single subcutaneous (SC) injection of UB-621 at doses ranging from 0.1mg/kg to 5mg/kg. In particular, UB-621 was found to have a remarkably long half-life of approximately 25.3 days. The first phase 2 IND for a randomized, single-blinded, placebo-controlled study with single dose of UB-621 was approved by NMPA in late 2020. The current phase 2 study is further optimized with a larger number of trial subjects treated with repeat doses of UB-621, and with clinical-relevant endpoints that will support the subsequent phase 3 trial should the results of this new study meet the preset safety and efficacy targets.

Genital Herpes (GH) disease is a life-long HSV-2 infection of the genitalia and urogenital tract. It is one of the most common sexually transmitted infections and is a leading cause of genital ulcers around the world. Patients with genital herpes often suffer from recurring episodes of symptom outbreaks, which usually involve painful ulcerations. Genital Herpes has been viewed as a significant global public health problem, as it can also intensify and exacerbate the transmission of human immunodeficiency virus 1 (HIV-1).

Currently, there are no effective vaccines against HSV and most of current medications for genital herpes are generic nucleoside acyclovir analogues. Although there are several approved antiviral agents for treatment of GH outbreaks and for suppressive therapy, these antivirals are not always effective and could result in the development of drug resistance. Therefore, new interventions for effective prophylactic and therapeutic purposes are still in need. It has been reported that more than 50% of recurrent GH patients under daily long-term suppressive therapy with small molecule drugs experience at least one recurrent episode every year. Although resistant HSV infection is not common (0.1~0.6%) in immunocompetent patients, the prevalence increases to 3.5~10% in immunocompromised patients. Drug-resistant HSV infections may be treated with foscarnet, but this drug is known to its narrow therapeutic window and nephrotoxicity.

UB-621 is a novel, fully human monoclonal antibody that interferes with HSV infection by binding specifically to HSV envelope glycoprotein D (gD). It can neutralize both wild type HSV lab strains and multi-drug-resistant clinical isolates. Our pre-clinical and early clinical data show that UB-621 has the potential to suppress recurrence of genital herpes.

About UB-621
UB-621, a fully human IgG1 monoclonal antibody, functions to block viral entry through binding to the surface envelope glycoprotein D (gD) of HSV, type I and type II. UB-621 has been demonstrated to exhibit a high-affinity binding (Kd, 3.6 × 10-11 M) to gD protein and a high potency against both HSV-1 and HIV-2 infections. UB-621 also shows capability to inhibit cell-to cell spread of HSV-1 and HSV-2. Results in virus plaque reduction assays demonstrated that UB-621 is not only more potent than acyclovir (ACV) in inhibiting clinical HSV isolates of American and Asian origins, but also exerts marked neutralization activity towards ACV-resistant HSV strains from various sources. HSV disease animal model studies show that UB-621 exhibits both prophylactic and therapeutic activities, and can reduce severity of genital HSV-2 infection. In HSV-1 infected mice model, UB-621 can prevent virus transmission from eye infection site to neuron and to brain region.

A subcutaneous (SC) liquid formulation of UB-621 has been demonstrated safe and well tolerated in healthy volunteers in a Phase I study. UB-621 exhibits a long half-life of approximate 25 days, which may allow a monthly or quarterly dosing scheme to treat HSV infection. UB-621 is entering a Phase II clinical study with patients suffering from recurrent genital herpes.

About Recurrent Genital Herpes
Genital herpes is a common sexually transmitted disease (STD) caused by herpes simplex virus type 1 or 2, but most are infected by herpes simplex virus type 2. There are approximately 500 million genital herpes patients around the world, 38% of them may have 6 or more recurrences per year and 20% of them may have more than 10 recurrences during the first year. When symptoms occur, small blisters are usually produced around the genitals or anus, and then the blisters break into superficial ulcers that become painful. Superficial ulcers would heal within about two to four weeks without leaving scars. However, symptoms of genital herpes may recur after weeks or months.

About United BioPharma
United BioPharma (UBP) is a clinical stage biopharmaceutical company, founded in 2013 as a spin-off from UBIAsia, its parent company. UBP is dedicated to research, development and manufacturing of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP’s Headquarter is located in Taiwan, with subsidiary companies in Shanghai and Yangzhou, China, and liaison offices in the U.S. The company has a global team, highly passionate about developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable medicines to bring better life to the patients.

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United BioPharma Forward-Looking Statements
The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements.

News Contact:
Dr. Mei June Liao, Executive Vice President, Product Development
+886-3-5979288 # 6700