Pipeline

BK virus (BKV) is a common opportunistic polyomavirus for which there are four antigenically distinct genotypes (I-IV). Nearly all of us have been infected by BKV but have developed an immune response, which keep the virus inactive in our system. However, BKV can become reactivated in immunocompromised patients, most notably kidney transplant recipients who require an immune suppressive drug regime to prevent donor organ rejection. BKV reactivation and viral replication (BKV viremia / DNAemia) in kidney transplant patients can lead to potentially severe impacts and impairment of renal allograft function. Left unchecked BKV viremia can progress to BKV associated nephritis (BKVAN), additionally, BKV viremia and BKVAN are a leading cause of mid to late kidney allograft failure, second only to chronic allograft disease that leads to acute rejection. Currently, the only available approach to suppress BKV reactivation once BKV viremia is detected is to temporarily ween the immune suppressive drug regime to allow the patients’ immune system to control viral replication; however, this also exposes the allograft kidney to attack by the patient’s immune system. IDBiologics has a panel of anti-BKV mAbs, including a lead and back-up clinical candidates that are being developed as a prevention of BKV viremia / DNAemia and BKVAN.

Pan-Influenza (A+B) Seasonal influenza A virus (IAV) and influenza B virus (IBV) are the leading cause of respiratory virus morbidity and mortality globally, and occasionally “shifting” influenza strains emerge that can cause pandemic influenza outbreaks. Current seasonal influenza vaccines (including trivalent, quadrivalent and high dose quadrivalent) do not perfectly anticipate the predominate seasonal circulating viral strains and are likely to not protect against pandemic influenza strains. Vaccine effectiveness (VE) for seasonal influenza is often poor, ranging from 10% to 60% and frequently on the lower end in elderly populations. IDBiologics’ lead IAV-mAb was shown to have potent in vivo neutralizing activity against all IVA strains as well as the pre-pandemic IAV strains (H5N1 and H7N9). Additionally, IDBiologics has two lead IBV-mAbs that display efficacy in H1N1, H3N2, Victoria, and Yamagata (IBV) models. By combining two ultra-potent human mAbs (IVA-mAb + IVB-mAb) engineered to have a long duration of action (~6 months) we expect to achieve ~90% neutralizing efficacy against pan-influenza (A+B) and protect against pre-pandemic strains (e.g., H5, H7, H9). The pan-influenza (A+B) mAbs could be deployed as “off-the-shelf” each flu season and are expected to outperform seasonal flu vaccines – particularly in elderly and immune-compromised patients.

Respiratory Syncytial virus / Human metapneumovirus (RSV/HMPV) pose a significant health burden as a major cause of lower respiratory tract infection and hospitalization of infants, young children, the elderly and immunecompromised. Discovered in 2001, HMPV is closely related to RSV as both are in the Pneumoviridae family. In the U.S., HMPV circulates in distinct annual seasons beginning in winter and lasting through spring. HMPV, RSV, and influenza can circulate simultaneously during the respiratory virus season. Recently, the FDA approved RSV vaccines and anti-RSV mAbs to prevent RSV infection in children and adults; however, none of these have been shown to be effective against both RSV and HMPV. IDBiologics is developing a single human mAb (RSV-199) that cross-neutralizes both RSV and HMPV strains. RSV-199 offers enhanced protection against RSV A and B strains and HMPV in cotton rats, which highlight the mechanisms of broad neutralization and therapeutic potential of RSV-199. 

Zika virus (ZIKV) is endemic to Africa and Southeast Asia, and circulating today in Mexico, Central and Latin America and in 2015-2016 ZIKV spread to the Americas. ZIKV is transmitted by mosquitos and can be spread between humans by sexual transmission from infected partners. ZIKV infection during pregnancy can infect the developing fetus leading to Congenital Zika Syndrome (CZS), which can have devastating developmental consequences for the fetus. Current ZIKA prevention measures largely focus on reduction of mosquito bites and vector control, reduction of sexual transmission, or avoidance of areas with circulating ZIKV during pregnancy or when at risk for pregnancy. IDB002 is an ultra-potent neutralizing mAb that IDBiologics is developing as “off-the-shelf” Pre-Exposure Prophylaxis (PrEP) against ZIKV infection.

Rift Valley Fever virus (RVFV) is an emerging arbovirus and zoonotic threat to human and animal health with pandemic potential because of the global presence of its vectors and hosts. RVFV causes ongoing infections in Africa, with occasional increases in incidence related to the propagation of mosquitos. Outbreak episodes are characterized by mass livestock die-off events, particularly in young animals and abortions in pregnant females. Spill over events to humans occur by infected mosquito exposures or contact with the blood and/or organs of infected animals. Human-to-human transmission of RVFV has not been documented, but concern is growing that RVFV can be transmitted from mother to fetus in utero. In humans, disease presentation ranges from a mild influenza-like illness to more severe illness including encephalitis, fatal hemorrhaging, or ocular involvement resulting in permanent visual impairment. IDBiologics has two human monoclonal antibodies (mAbs) that directly inhibit RVFV replication, do not bind to the same critical residues, and demonstrate ultra-high potency in in vitro assays and in vivo studies. These mAbs have been engineered to have an extended half-life and are being developed for combination use for the treatment and prevention of RVFV in humans.

Enterovirus D68 (EV-D68) is one of more than 100 non-polio enteroviruses. EV-D68 (which was first identified in California in 1962) typically causes respiratory illness ranging from mild (cold-like symptoms) to more severe. Infected individuals can spread EV-D68 via coughing, sneezing or by touch contact. Children (infants to teenagers) are at most risk for infection and becoming ill since they may not have had previous exposures to these viruses. Adults can become infected with enteroviruses but are more likely to be asymptomatic or have only mild symptoms. There are no vaccines nor any treatments for EV-68 infection.