REGiMMUNE Limited Licenses the Rights to Develop and Commercialize RGI-2001 To San Fu Biotech in Major Asian Countries
01 Abril 2023 - 10:18AM
Business Wire
REGiMMUNE Limited (REGiMMUNE), a biotech company focused on
creating innovative immunotherapies for immune disorders and
cancer, and San Fu Biotech (SFB), a subsidiary of San Fu Chemical
Co., Ltd. (4755.TW) have entered a licensing agreement to develop
and commercialize RGI-2001 for the prophylaxis of acute
Graft-versus-host disease (aGvHD) in major Asian countries.
RGI-2001, with the novel mechanism to improve existing
treatments, is a potentially first-in-class small molecule drug
candidate targeted for preventing aGvHD, a life-threatening
complication resulting from allogeneic hematopoietic stem cell
transplantation (HSCT). GvHD is a systemic disorder that occurs
when the graft's immune cells recognize the host as foreign and
attack the recipient’s body cells or organs, and leads to skin
rash, liver problems, abdominal pain or cramps, diarrhea, and
increased risk for infections. Patients undergoing allogeneic HSCT
have a high-risk of developing aGVHD associated with significant
morbidity and mortality. Despite the use of prophylactic
immunosuppressive therapy, clinically significant aGvHD develops in
20%-40% of HLA-matched related and unrelated allogeneic HSCT and
severe cases contribute to non-relapse mortality.
Under the terms of agreement, REGiMMUNE and SFB will collaborate
closely to accelerate the development of RGI-2001 in major Asian
countries and will conduct clinical trials to study the efficacy of
the drug in aGvHD. Together, both parties intend to submit an
Investigational New Drug Application to the Taiwan Food and Drug
Administration to initiate clinical trials in Taiwan for the
prophylaxis of aGvHD before the end of 2023. SFB will pay to
REGiMMUNE development milestones and royalties on net profit upon
successful commercialization of RGI-2001. SFB also retains the
first rights of negotiation to develop and commercialize RGI-2001
for new indications in the authorized territories.
RGI-2001 of REGiMMUNE, awarded Orphan Drug Designation by the US
FDA in GvHD in 2012, has completed the phase II clinical trial
targeting at the prophylaxis of aGvHD in the US. The efficacy and
safety results were positive. Furthermore, RGI-2001 was selected
for oral presentation at the American Society of Hematology (ASH)
annual meeting in December 2022 and planned to submit phase III IND
to US FDA in Q4 of 2023.
Kenzo Kosuda, Chief Executive Officer and President,
REGiMMUNE Limited, said: “This agreement underscores our focus
and commitment to improve the incumbent therapies of aGvHD
prevention and treatment. The fast-growing patients with GvHD in
Asia create a high unmet need for more effective treatments.”
“We are pleased to collaborate with SFB and San Fu Chemical
Group which has a long history in Taiwan. The Group’s abundant
biomedical resources, expertise and innovative strategy make San Fu
a strong commercial partner for REGiMMUNE in Asia. Together, we
look forward to expediting the development of RGI-2001 in this
important market.”
Simon H.H. Wu, SFB & San Fu Chemical Group Chairman,
emphasized: “We are excited to add RGI-2001 to our growing
portfolio of innovative therapeutic agents. This enhances our
autoimmune pipeline and aligns with our long-term research and
development strategy. RGI-2001 has demonstrated promising results
in phase II studies in the US and we look forward to working
together with REGiMMUNE to deliver treatments that will benefit the
lives of patients.”
About RGI-2001
RGI-2001 is a liposomal formulation of an
alpha-galactosylceramide (alpha-GalCer) analog. Alpha-GalCer is a
ligand for CD1d expressed on antigen presenting cells and invariant
natural killer T cells (iNKT). Liposomal alpha-GalCer promotes
tolerogenic immune cascades, resulting in the activation and
expansion of regulatory T cells (Tregs).
RGI-2001 is REGiMMUNE’s lead drug candidate currently in Phase 3
planning for the prophylaxis of acute graft-versus-host disease
(aGVHD).
About REGiMMUNE Limited
REGiMMUNE is a clinical-stage biopharmaceutical company focused
on creating innovative immunotherapies by harnessing the power of
regulatory T cells (Tregs). REGiMMUNE is creating a pipeline of
novel product candidates that either enhance Treg activities for
immune diseases or suppress Treg activities for cancer.
About San Fu Biotech
San Fu Biotech, a wholly-owned subsidiary of San Fu Chemical,
develops first-in-class new drugs to address unmet medical needs,
such as cancer tumors, autoimmune disease and ophthalmology, for
benefiting patients around the world.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230401005026/en/
Charlie Hsu Chief Financial Officer REGiMMUNE Ltd. Tel: +886 2
2555 3377 #511 Email: charlieh@regimmune.com