BEIJING – Known for its transgenic mouse platforms to develop antibodies, U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. closed a series C funding round July 9 to raise $102.8 million to advance its late-stage clinical programs and COVID-19 pipeline.

In an exclusive interview with BioWorld, Harbour Biomed CEO Jingsong Wang said the proceeds would mainly be used to advance HBM-9161, HBM-9036 and HBM-4003, as well as the fully human, neutralizing antibody 47D-11, being co-developed with Abbvie Inc. for COVID-19.

“We’ll have multiple phase II registrational trials for HBM-9161, an anti-FcRn monoclonal antibody. We already have four IND approvals in China, and we'll have more indication applications in the works,” Wang told BioWorld. “We also have HBM-9036 for dry eye indications, which is already in a phase III registrational trial.”

He added that HBM-4003 is in global clinical trials, and that there are multiple preclinical programs to be moved into the clinic.

“We expect there will be a series of milestones in the next few months,” Wang said.

Raising $327M in four years

Established in December 2016, Harbour Biomed has already drawn more than $327 million from five rounds of financing, attracting a diverse pool of investors.

The company secured $65 million from series A and A+ rounds and $85 million from the series B round between 2016 and 2018, followed by another $75 million from series B+ round in March.

The $102.8 million series C round was led by new investor Hudson Bay Capital, and followed by Orbimed, Country Garden VC, GTJA Investment Group, Octagon Capital and Sage Partners, with additional investment from existing investor Greater Bay Area Investment Fund.

Wang told BioWorld the company stands out for its innovative, differentiated portfolio that includes preclinical-stage candidates and those for highly unmet needs, as well as its technology platforms, which are used to work with global partners to build an extensive portfolio.

Harbour Biomed has more than 30 programs in its pipeline, with five in clinical trials. The biotech boasts two transgenic mouse platforms: H2L2, referring to two heavy chains and two light chains, and HCAb, referring to heavy-chain-only antibodies. The H2L2 platform generates conventional, full-length human antibodies, while the HCAb platform enables the development of differentiated, next-generation molecules, including bi- and multispecific antibodies, and also antibody fragment-based therapeutics.

“With our Harbour Mice platform, we incorporate the industry-leading single B-cell cloning technology to enhance the efficiency of antibody screening, from normally three to five months to complete down to one day,” Wang explained.

With the additional funding, Harbour Biomed is spearheading work for HBM-9161 (batoclimab) and HBM-9036 (tanfanercept) this year.

HBM9161 is in development to treat autoimmune indications by significantly reducing pathogenic IgG. The candidate has completed a phase I study in myasthenia gravis and is now in a phase Ib/IIa study in neuromyelitis optica spectrum disorder. The company received IND approvals in April and June, respectively, to start phase II/III trials of HBM-9161 in immune thrombocytopenia and Graves ophthalmopathy in China.

Meanwhile, HBM-9036 is a novel TNF receptor-1 fragment to treat dry eye disease by inhibiting TNFα. Last October, phase II trial results showed the candidate demonstrated favorable signals in clinical efficacy and safety in treating moderate to severe dry eye disease. Harbour Biomed is gearing up to move it to phase III registration trials in China.

Both HBM-9161 and HBM-9036 were in-licensed from South Korea's Hanall Biopharma Co. Ltd. for development and commercialization in greater China.

Another lead program is HBM-4003, a next-generation anti-CTLA4 monoclonal antibody to treat advanced solid tumors. The candidate was internally developed using the company’s HCAb platform. Preclinical studies showed HBM-4003 had promising antitumor activity and a favorable safety profile, which pointed to its potential as both a monotherapy and a potential combination therapy with other immuno-oncology drugs. HBM-4003 is soon to enter clinical trials in the U.S. and is waiting for the green light from China.

Speaking of the next step, Wang said the company would work on generating more clinical data and preparing for BLA submissions, product launch and manufacturing.

Other candidates in Harbour Biomed’s pipeline target PD-L1, CD73 and CCR8. It also boasts a string of bispecific candidates that aim at HER2xCD3, BCMAxCD3, PD-L1xTGFb, TAA1x4-1BB, TAAxCD3 and TAA2x4-1BB.

Of particular interest is a new candidate, an anti-CCR8 antibody. Wang said it was discovered internally and data will be released in an international scientific symposium. He called CCR8 “a very challenging target” to obtain antibodies for. He added that the company is also actively looking into combination therapies using its internal drug candidates.

Rapid response to COVID-19

Regarding its COVID-19 pipeline, Harbour Biomed entered a partnership with Abbvie in June to advance the fully human, neutralizing antibody 47D-11, which Harbour Biomed discovered together with Utrecht University and the Erasmus Medical Center. For therapeutic/prophylactic use, 47D-11 targets the conserved domain of the spike protein of SARS-CoV-2 to block infection by the virus. The cross-neutralizing features of 47D-11 may have the potential to address virus mutation and future related coronaviruses.

In March, Harbour Biomed also unveiled its joint efforts with Mount Sinai Health System, New York's largest academic medical system, to develop antibodies against SARS-CoV2 using its H2L2 Harbour Mice platform. Through this multiyear collaboration, Harbour Biomed aims to explore whether the approach could be used therapeutically or prophylactically.

“Work is moving very fast, and we do not have an exact timeline,” said Wang. “But in general, everything is exceeding what we normally see in terms of the rate of progression and the resources committed to this to meet the growing needs around the globe.”

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