Thunderbolt Pharma, Inc.

Cristina Arias/Cover/Getty Images GlaxoSmithKline has denied reports that they were interested in acquiring Canada’s Aurinia Pharmaceuticals. The UK’s Mail issued a statement on Sunday, October 31, claiming the UK-based pharma giant was preparing to bid on Aurinia. A GSK spokesperson told Reuters the report was not true. On October 22, Bloomberg News claimed that U.S.-based Bristol Myers Squibb was interested in buying Aurinia. This caused Aurinia stock to pop by almost 27%. It has been up nearly 50% since, giving the company a market value of approximately $4.2 billion. Aurinia focuses on autoimmune diseases. Today they announced updated interim data from the AURORA 2 continuation study of Lupkynis (voclosporin) for lupus nephritis (LN) in patients with systemic lupus erythematosus (SLE). They plan to present the data on November 8 during Plenary Session III at The American College of Rheumatology (ACR) Convergence 2021. Lupkynis is the first drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of lupus nephritis. It is also the first drug of Aurinia’s to be approved. It is expected to hit $1 billion in sales, the so-called blockbuster bar, by mid-decade. Currently, the only competition for the drug is GlaxoSmithKline’s Benlysta, which is an injectable biologic. That would certainly be a reason for GSK to be interested, particularly since the patents on Benlysta will expire in a few years. In today’s interim analysis, patients receiving Lupkynis maintained meaningful decreases in proteinuria. And estimated glomerular filtration rate (eGFR), an essential measurement of kidney function, stayed stable through month 30. “In this updated interim analysis, reductions in proteinuria were sustained with no impact on renal function at a total of 30 months of treatment with voclosporin,” said Amit Saxena, assistant professor, department of medicine at NYU Langone Medical Center and presenting author of the AURORA 2 study. “The consistent outcomes over time reinforce confidence in Lupkynis as an important treatment choice for people experiencing the dangerous manifestation of lupus nephritis.” In addition to Lupkynis, in August, Aurinia acquired two new drugs for its pipeline. The first, AUR200, was picked up by buying all the common stock of Thunderbolt Pharma. AUR200 is a recombinant Fc fusion protein that specifically blocks B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL). These two molecules promote B cell survival and differentiation and are associated with certain autoimmune and nephrology diseases. Aurinia made an upfront payment of $750,000 (US) for the drug and will be responsible for future regulatory milestones once the FDA accepts its investigational new drug (IND) submission or any equivalent regulator. Thunderbolt shareholders will be eligible for low single-digit royalties on any future sales. The second drug is AUR300, which is picked up via a global licensing and research deal with Riptide Bioscience. AUR300 is a novel peptide that modulates M2 macrophages, a type of immune cell, by way of the macrophage mannose receptor CD206. M2 macrophage dysregulation drives fibrosis and AUR 300 would seem to decrease this dysregulation and inflammatory cytokines. Rob Huizinga, Aurinia’s executive vice president of Research, said at the time, “Both of these programs are rooted in strong science and at the leading edge of approaches for the treatment of autoimmune, fibrotic, and kidney diseases. Significant research has been done to date in both BAFF/APRIL inhibition and macrophage modulation and we are confident both approaches offer high potential across multiple autoimmune diseases as we advance them into the clinic.” GSK and BMS aren’t the only companies rumored to be interested in Aurinia. Both Switzerland’s Roche and Japan’s Otsuka Pharmaceutical are on the list of possible suitors.

Rumors of a big pharma acquisition have shot up stock prices for Canada's Aurinia Pharmaceuticals. Bristol Myers Squibb is reportedly courting the biopharma to strike a buyout deal. Bristol Myers recently made a run for Acceleron Pharma and its promising Pulmonary Arterial Hypertension drug but was beat out by Merck in an $11.5 billion deal. Moving on from the heartbreak of a lost bid, the global biopharma may rebound by sweetening its autoimmune portfolio instead. While both companies are declining to comment, Bloomberg's unnamed sources say that no final decision has been made and clarify that BMS may pull back from the deal at any time. Aurinia recently made history with the first oral drug approved by the FDA for the treatment of lupus nephritis, a serious kidney-related progression of systemic lupus erythematosus. This is the first drug to snag U.S. approval for the Canadian company. The drug, commercialized as Lupkynis, is expected to achieve blockbuster status before the middle of the decade, meaning over $1 billion in annual sales. Its only competition currently on the market is injectable biologic Benlysta from GlaxoSmithKline. While the two drugs have not had a head-to-head comparison study done, a Lupkynis study showed a 41% complete renal response in 52 weeks versus Benlysta’s response of 30% at the end of 104 weeks. Benlysta has been approved for other lupus indications since 2011 but added approval for treating LN patients just last December. Currently, Lupkynis is only approved for lupus nephritis but additional formulations for other indications are already in the works. Aurinia’s pipeline will also bring two more autoimmune hopefuls to BMS, should it go through with the buyout. These pipeline candidates were scooped up in August, just eight months after Lupkynis’ approval. The first is in pre-clinical development to block the B-cell Activating Factor and A Proliferation-Inducing Ligand to control the pathogenesis of autoimmune and nephrology conditions. This asset was locked in through a $750,000 stock buyout of Thunderbolt Pharma. Through a $6 million upfront payment, a second candidate was secured with California-based Riptide. An IND submission is anticipated by the end of next year. An M2 macrophage modulator is also in the works, with clinical development expected to start in 2023. Aurinia’s stock has shot up over 36% in the past five days, thanks to the acquisition rumors. These are record high numbers for the Canadian company. Experts anticipate the price tag for its acquisition in the ballpark of $7-8 billion.

After the historic approval of their first-ever drug in January, Aurinia Pharmaceuticals was out looking for what's next for their company. Today the Canadian biotech announced the acquisition of two new pipeline assets that align with its focus on autoimmune and kidney-related disease. The first new program slotted into the pipeline was scooped up in a $750,000 stock buyout of Thunderbolt Pharma. If AUR200 snags approval down the road, shareholders will receive some royalties as well. The asset is a recombinant Fc fusion protein that blocks BAFF and APRIL ligands, two known promoters of B cell survival and differentiation. These two have been shown to play a lead role in managing immunologic response, particularly in autoimmune and kidney diseases. AUR200 is already in pre-clinical development with sights set on an IND submission by the end of next year. Aurinia also secured another asset for its pipeline through a global licensing and research agreement with a California-based drug firm. Aurinia is giving Riptide $6 million up front with additional milestone payments and royalties on the table. AUR300 modulates a type of white blood cells called M2 macrophages. The peptide therapeutic reduces M2 dysregulation, which drives fibrosis, and reduces inflammatory cytokines. Clinical development is anticipated during the first half of 2023. "Both of these programs are rooted in strong science and at the leading edge of approaches for the treatment of autoimmune, fibrotic, and kidney diseases," said Rob Huizinga, Aurinia's VP of Research. "Significant research has been done to date in both BAFF/APRIL inhibition and macrophage modulation and we are confident both of these approaches offer high potential across multiple autoimmune diseases as we advance them into the clinic." In the dead of winter amidst a global pandemic, Aurinia experienced its first success with the FDA's approval of its lupus nephritis (LN) oral therapy. The first oral drug approved for patients with LN representing an important milestone. Of the estimated 200-300,000 Americans in the US with systemic lupus erythematosus (SLE), one third or more had already developed LN by the time of their lupus diagnosis. Up to 30% of patients with LN eventually experience kidney failure or end-stage renal disease. Aurinia's Lupkynis, in combination with standard-of-care, reduced urine protein creatinine ratio by 50% twice as fast as standard-of-care alone. A higher portion of patients treated with the drug also achieved complete renal response at 24 weeks. Improved response rates were shown in all parameters across immunologically-active classes of LN studied. A month before approval, Aurinia partnered with Japan's Otsuka Pharmaceutical Co. to develop and commercialize oral Lupkynis for LN in the European Union, Japan, as well as the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. The company also expanded its relationship with Swiss company Lonza to build a dedicated manufacturing capacity to produce the drug. GlaxoSmithKline's approval for its intravenous and subcutaneous injectable treatment for LN was approved just 32 days before Aurinia had its day. Benlysta was first made available in March 2011 for both adults and children with SLE. The label was then able to expand indications to cover LN patients as well in December. It was the first drug ever approved for the treatment of LN.