Aurinia Acquires New Pipeline Assets Targeting Autoimmune and Kidney Diseases
VICTORIA, British Columbia – (COMMERCIAL THREAD) – Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the addition of two new assets that will expand the Company’s portfolio of rare autoimmune and kidney diseases.
“Over the past year, in anticipation of expanding and diversifying our development pipeline, we have brought additional expertise on large and small molecules that uniquely matches Aurinia’s focus on immunology and nephrology, ”said Peter Greenleaf, President and CEO of Aurinia. . “These transactions are transformational for Aurinia as they allow us to leverage our existing R&D capabilities and commercial experience to support a balanced pipeline and advance innovative therapeutic solutions to help people living with rare autoimmune diseases. ”
AUR200: recombinant Fc protein targeting BAFF / APRIL
The first program, AUR200, was acquired through Aurinia purchasing all of the common shares of Thunderbolt Pharma, Inc. (Thunderbolt), a private company. AUR200 is a recombinant Fc fusion protein designed to specifically block B cell activation factor, known as BAFF, and A ligand inducing proliferation, known as AVRIL. BAFF and APRIL promote the survival and differentiation of B lymphocytes and have been shown to play a major role in the pathogenesis of certain autoimmune and nephrological conditions.
For the acquisition, Aurinia made a total upfront payment of $ 750,000 to Thunderbolt shareholders and will be responsible for future regulatory steps after a new investigational drug (IND) is accepted by the Food and Drug Administration (FDA) of United States or equivalent authority. . Additionally, Thunderbolt shareholders will receive a low single-digit royalty on all future net sales. AUR200 is currently under preclinical development with the expected submission of an IND to the FDA by the end of 2022.
“Inhibition of BAFF / APRIL has been widely studied and established as an important approach to manage the immunological response,” said Neil Solomons, MD, medical director of Aurinia. “We are encouraged by the AUR200’s unique profile and its first-rate potential and look forward to sharing more data and updates on this exciting program. ”
AUR300: modulation of M2 macrophages via the CD206 link
The second program, AUR300, was obtained through a global licensing and research agreement with Riptide Bioscience Inc. (Riptide), a private company. AUR300 is a novel therapeutic peptide that modulates M2 macrophages (a type of white blood cell) via the macrophage mannose receptor CD206. Deregulation of M2 macrophages leads to fibrosis. AUR300 acts to reduce M2 deregulation and decrease inflammatory cytokines, and therefore may have important clinical applications for autoimmune and fibrotic diseases.
Riptide has long-standing expertise in interpreting the etiology of fibrosis, including the discovery of lysyl oxidase and procollagen. As part of the deal, Aurinia paid Riptide an upfront fee of US $ 6 million. Additional milestone payments are due at certain stages of development, clinical and regulatory, and royalties will be payable upon commercialization. The clinical development of the AUR300 is expected to begin in the first half of 2023.
“Both of these programs are rooted in solid science and at the forefront of approaches to the treatment of autoimmune, fibrotic and kidney diseases,” said Rob Huizinga, PhD, RN, CNeph (C), executive vice president of the research, Aurinia. “Significant research has been conducted to date on BAFF / APRIL inhibition and macrophage modulation and we are convinced that these two approaches offer high potential for several autoimmune diseases as we advance them in the clinic. ”
Aurinia is a fully integrated biopharmaceutical company focused on providing therapies to treat targeted patient populations who are affected by serious illnesses with a high unmet medical need. The Company recently launched the first FDA-approved oral therapy indicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia’s head office is in Victoria, British Columbia; its American mall is in Rockville, Maryland; and the Company focuses its development efforts on a global scale.
Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities laws and forward-looking statements within the meaning of applicable US securities laws. These forward-looking statements or information include, without limitation, statements or information regarding: the timing of the transition of the AUR200 and AUR300 into clinical development; whereas the acquisitions of AUR200 and AUR300 are transformational for Aurinia; Aurinia’s belief that the mechanism of action of the AUR300 peptide may have important clinical applications for autoimmune or fibrotic diseases; the deadline for filing an IND for AUR200 and AUR300; Aurinia’s belief that AUR200 has the potential to be a unique and best-in-class BAFF / APRIL inhibitor; Aurinia’s conviction that AUR200 and AUR300 are at the forefront of approaches for the treatment of autoimmune, fibrotic and renal diseases; and Aurinia’s belief that macrophage modulation and BAFF / APRIL inhibition have high potential in several autoimmune diseases. It is possible that such results or conclusions will change. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, ” may ”and other similar words and phrases, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained in this document, including, among others, assumptions about: assumptions relating to Aurinia’s cash depletion rate for operations; and that Aurinia’s third-party service providers will comply with their contractual obligations. Although Aurinia’s management believes that the assumptions made and the expectations represented by such statements or information are reasonable, there can be no assurance that forward-looking information will prove to be accurate.
Forward-looking information, by its nature, is based on assumptions and involves known and unknown risks, uncertainties and other factors that may cause Aurinia’s actual results, performance or achievements to differ materially from the results. , future performances or achievements expressed or implied. by this forward-looking information. If one or more of these risks and uncertainties materialize, or if the underlying assumptions prove to be incorrect, actual results could differ materially from those described in the forward-looking statements or information. These risks, uncertainties and other factors include, among others, the following: actual future financial and operational results of Aurinia may differ from its expectations; Aurinia may have to pay unforeseen expenses; the unknown impact and challenges imposed by the COVID-19 pandemic on Aurinia’s business operations, including non-clinical, clinical, regulatory and commercial activities; the future prospects of the AUR200 and AUR300 may not be what Aurinia anticipated, or Aurinia may not be able to take full advantage of the opportunities presented by the AUR200 and AUR300; Aurinia’s third-party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia’s assets or business activities may be subject to litigation which may give rise to litigation or other legal action. Although Aurinia has attempted to identify factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performance or , achievements or actual events are not as expected, estimated or expected. In addition, many factors are beyond Aurinia’s control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Therefore, you should not place undue reliance on forward-looking statements or information.
All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information relating to Aurinia, including a detailed list of risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent annual report on Form 10-K available by accessing the Analysis and Recovery System electronic documents from Canadian Securities Administrators. (SEDAR) at www.sedar.com or the United States Securities and Exchange Commission’s Electronic Document Collection and Retrieval System (EDGAR) website at www.sec.gov/edgar , or on Aurinia’s website at www.auriniapharma.com.