Lupus Nephritis

Houston, Texas, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Autoimmunity BioSolutions is proud to announce that it will be presenting at the upcoming Sequire Investor Summit 2025. The 2025 Edition of the Sequire Investor Summit is scheduled for January 21st-23rd, 2025, at Condado Vanderbilt Hotel in San Juan, Puerto Rico, and once again promises to offer an array of exciting opportunities for funds, companies, and investors. Puerto Rico is home to many family offices, funds and wealthy investors due to its favorable tax benefits. It is one of the only places in the world that US Citizens can move and pay virtually no federal or state income taxes. Autoimmunity BioSolutions is thrilled to participate in this year's Sequire Investor Summit and looks forward to sharing its knowledge and expertise with attendees. Join us for an exciting and informative event that promises to be a highlight of the year for funds, companies, and investors alike. “I am thrilled to represent Autoimmunity BioSolutions at the Sequire Investor Summit in Puerto Rico and to continue developing relationships with the private and public healthcare sector on the island” - Said Gaddiel Galarza-Munoz, Co-founder & CSO from Autoimmunity BioSolutions. For more information about the Sequire Investor Summit, including registration details, please visit the official event website at https://puertorico.srax.com/ About Autoimmunity BioSolutions Autoimmunity BioSolutions (ABS) is a Houston-based biotech applying a precision approach to the treatment of autoimmune disease by developing a next-generation, immuno-corrective therapy to restore normal immune function (immune homeostasis) in a highly prevalent, genetically-defined subpopulation of autoimmune disease patients. This precision immunology approach aims to correct the root cause of pathology thereby providing improved benefits to the patients over the standard of care and has broad potential to treat numerous autoimmune diseases including progressive MS and lupus nephritis, which are severe forms of autoimmune disease with high unmet needs. About SRAXSRAX Inc. is a financial technology company that unlocks data and insights for publicly traded companies. Through its premier investor intelligence and communications platform, Sequire, companies can track their investors’ behaviors and trends and use those insights to engage current and potential investors across marketing channels. For more information on SRAX, visit srax.com and mysequire.com About DNA Holdings Venture Inc.:DNA Holdings Venture Inc. is dedicated to pioneering the next wave of financial innovation through the convergence of Web 3, cryptocurrency, AI, and capital markets. Our goal is to foster an ecosystem where advanced fund management, strategic advisory, and visionary infrastructure solutions for AI thrive. For further details, please contact investors@dna.holdings or visit www.dna.fund. Explore opportunities at DNADealDesk.com. CONTACTAutoimmunity BioSolutionsGaddiel Galarza-Munozgaddiel@abstherapeutics.com

BRISBANE, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that on January 8, 2025, the Compensation Committee granted inducement awards consisting of a non-qualified stock option to purchase 35,250 shares of Class A common stock and restricted stock units (RSUs) for 17,625 shares of Class A common stock to six new employees under the Inducement Plan. The Compensation Committee approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option granted on January 8, 2025 has an exercise price per share equal to $42.19, Vera’s closing trading price on January 8, 2025. Each stock option will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. Each of the RSUs will vest over four years, with 25% of the underlying shares vesting on each anniversary of February 20, 2025, subject to the new employee’s continued service relationship with Vera through the applicable vesting dates. The awards are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an applicable award agreement covering the grant. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

Kyverna Therapeutics\' new CEO Warner Biddle has identified stiff person syndrome, a rare autoimmune neurological disorder launched into public attention by Céline Dion\'s diagnosis, as the initial indication for the company\'s lead CAR-T program, KYV-101.\n About 100 days into the CEO role at Kyverna Therapeutics, Warner Biddle has determined the strategic priorities for the California biotech, which aims to deliver the first approved CAR-T therapy in an autoimmune disease.The former Kite Pharma executive has identified stiff person syndrome (SPS), a rare autoimmune neurological disorder launched into public attention by Céline Dion’s diagnosis, as the initial indication for Kyverna’s lead CAR-T program, CD19-directed KYV-101.Lupus, which spurred the industry’s ongoing gold rush for developing cell therapies against autoimmune diseases and originally KYV-101’s first indication, is instead taking the third place on Kyverna’s priority list, as myasthenia gravis occupies the second spot.SPS is “our tip of the spear that will allow us to establish a base as the first autoimmune CAR company,” Biddle said in an interview with Fierce Biotech ahead of this year\'s J.P. Morgan Healthcare Conference. “And then we’ll be able to build on that, and we’ll be able to amplify our presence with another neuroinflammation franchise but with the patient population that’s going to be about 10 times larger than SPS.”The biotech chief will outline his plan in detail during this week\'s conference. Biddle joined Kyverna in September after a stint as the commercial chief at Gilead’s cell therapy arm Kite Pharma. The task in front of him is to blaze a winning trail for a bellwether biotech that has lost nearly 90% in stock price since a high-profile IPO in February 2024.Interest in CAR-T therapies for autoimmune disease exploded last year, following a series of promising results in patients with systemic lupus erythematosus (SLE) from academic studies out of Germany. The enthusiasm led to Kyverna’s upsized IPO in 2024.As one of the first companies to report clinical CAR-T data in lupus, Kyverna’s KYV-101 is considered a benchmark that followers must at least match up to in order to remain in the game. For patients with heavily pretreated lupus nephritis, a single infusion of KYV-101 has shown it could achieve deep B-cell depletion and put an end to disease activity, restoring stable kidney function and normal complement levels, while eliminating the need for immunosuppressants and toxic steroids.But the field is quickly getting crowded. Besides large pharmas such as Bristol Myers Squibb and Novartis, a growing list of biotechs, including the likes of Cabaletta Bio and Cullinan Therapeutics, are eyeing lupus either with CAR therapy or T-cell engagers.And a patient relapse—although from a lower dose of KYV-101—after five months of treatment speaks to the potential challenge and many unknowns of the cell therapy industry’s push into autoimmune diseases. Kyverna is currently finishing enrolling in KYV-101’s phase 1 lupus nephritis trial, with the goal to report data from nine patients—including six at the target dose of 100 million cells—in the second half of 2025, according to Biddle. The phase 1 results will then be used to design the pivotal clinical trial.The company is focusing on lupus nephritis instead of the larger SLE population “because we believe that lupus nephritis patients are at the highest risk of progressing to late-stage renal disease,” he said. Lupus nephritis is a serious complication of SLE, or commonly referred to as lupus. About 40% of lupus patients could develop nephritis, and 60% of them are expected to fail standard treatments, according to Kyverna.“We’re not moving away from lupus,” Biddle said. “It’s still a key priority for us.”As the red-hot lupus indication is already full of competition, with different programs likely fighting over trial participants, Biddle has decided to use SPS as an entry point.SPS is a progressive disorder marked by debilitating muscle stiffness in the torso, arms and legs with no approved therapies. The rare disease gained wider public knowledge after Céline Dion’s diagnosis and her comeback performance at the 2024 Paris Olympics opening ceremony.Because there’s a significant unmet need and patients experience deteriorating symptoms over a short period of time, Kyverna believes it can execute on a clinical trial relatively quickly, thereby giving KYV-101 the opportunity to be the first CAR-T to launch in an autoimmune disease, Biddle explained.While a late addition to KYV-101’s clinical program, the phase 2 SPS trial, coded KYSA-8, has already accrued 40% of patients with full enrollment expected mid-2025. Kyverna expects to report top-line data from the pivotal trial in the first half of 2026, followed by an application in 2026. As to myasthenia gravis, for which KYV-101 is undergoing phase 2 testing in the KYSA-6 trial, Kyverna intends to confirm a registrational path with regulators in the first half of 2025 and report interim phase 2 data in the second half of the year.“It’s important for us to be hyper focused in the short term,” Biddle said. “We’re going to be focusing on delivering meaningful short-term catalysts in a capital-efficient way. But there’s still lots of opportunities for growth, and we’re going to use a data-driven approach to prioritize future indications.”Besides those three priority indications, KYV-101 is also being tested in multiple sclerosis and systemic sclerosis. Kyverna in December reported initial data from five patients in the phase 2 KYSA-7 multiple sclerosis study, although it was hard to draw any conclusions on efficacy.The company’s second candidate, KYV-102, is designed to remove the apheresis process in CAR-T manufacturing. Kyverna aims to file for an investigational new drug application in the second half of 2025.With cash runway into 2027, Kyverna is “building the internal expertise in order to deliver these key milestones,” Biddle said, but added that the company is open to partnerships, “if they can add and contribute to the future growth of our company.”