Kyverna Therapeutics, Inc.

Plus, news about Astellas, Clover, ElevateBio, Monopar, Idorsia and Neurocrine Biosciences: Vera Therapeutics plans $300M offering: The California biotech is selling shares after presenting Phase 2b data for an experimental drug called atacicept over the weekend. The company shared 96-week data for patients with immunoglobulin A nephropathy. — Kyle LaHucik Abeona Therapeutics resubmits rare skin disease therapy: Back in April, the FDA rejected Abeona’s cell therapy, called pz-cel, requesting more information about manufacturing. Abeona is developing pz-cel for recessive dystrophic epidermolysis bullosa, a rare genetic skin disease. — Lei Lei Wu Astellas yanks Izervay’s submission in Europe: The company said it withdrew its marketing authorization application for Izervay, a C5 protein inhibitor for geographic atrophy secondary to age-related macular degeneration. Astellas did not detail feedback from the Committee for Medicinal Products for Human Use, but said it is still “confident” in Izervay’s risk-benefit profile and will continue to engage with regulators in Europe and elsewhere. There are currently no treatments approved for GA secondary to AMD outside of the US, where Izervay was greenlit in August of last year. — Ayisha Sharma Clover releases early RSV vaccine data: The Shanghai-based biotech said its bivalent vaccine candidate, SCB-1019, produced “comparable” levels of RSV neutralizing antibodies to GSK’s Arexvy at 28 days in a Phase 1 test. Based on these data, Clover plans to advance the asset into studies focused on re-vaccination next year. — Ayisha Sharma ElevateBio lays off 4%: The genetic medicines company, which employs about 500 people, is ending its preclinical cellular engineering work, a spokesperson told Endpoints News on Monday. The Waltham, MA-based biotech laid off about 13% of its staff in October 2023. It’s one of the most well-funded private biopharma startups after having raised about $1.25 billion, including its $401 million Series D last year. Partnerships with companies like Novo Nordisk, Moderna, Kyverna and Affini-T are unaffected, the spokesperson confirmed. — Kyle LaHucik Monopar Therapeutics prices $19.2M offering: The Chicago-area biotech sold shares to Janus Henderson, RA Capital and others. A few days ago, Monopar licensed a Wilson disease drug candidate from AstraZeneca’s Alexion. — Kyle LaHucik Idorsia ends work with Neurocrine Biosciences: The companies were developing Idorsia’s T-type calcium channel blocker for patients with a rare form of pediatric epilepsy. The treatment failed a Phase 2 study in 2022, and further analysis led to the decision to stop work. — Jaimy Lee

Enriches Board's expertise in corporate strategy and business development, with vast experience leading biopharmaceutical companies through rapid growth and creating value across innovative therapeutic platforms, including cell therapy EMERYVILLE, Calif., Oct. 21, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the appointment of biotechnology executive and cell therapy veteran Mert Aktar as an independent director to its Board of Directors. Mr. Aktar has over two decades of biopharmaceutical experience, melding more than a decade of technical leadership in cell and gene therapy with a proven track record in corporate development. "We are delighted to welcome Mert to Kyverna's Board of Directors as we continue to advance KYV-101 into later stages of development and build on Kyverna's CAR T leadership in autoimmune diseases," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "Mert brings an impressive track record of building businesses and creating value through visionary operational leadership, strategic transactions and his understanding of drug development and manufacturing. Mert's strategic experience and deep technical expertise in cell therapy will be invaluable as we chart a course to bring the transformative power of CAR T treatments to as many patients as possible." Mr. Aktar currently serves as Chief Executive Officer of Receptive Bio, a privately held biotech company, and holds Board positions with UCLA Technology Development Group and ReAlta Life Sciences. Prior to joining Receptive Bio, Mr. Aktar was the Senior Vice President and Global Head of Corporate Development & Strategy at Kite Pharma. In this position, Mr. Aktar played a key role in establishing Kite's global leadership in cell therapy, architecting strategy and executing numerous deals, which strengthened Kite's R&D portfolio and drove its global expansion. Previously, Mr. Aktar held senior leadership positions at various biotech and large pharma organizations, across diverse modalities and therapeutic areas. Most notably, he helped shape Shire's transformation into a global rare disease leader, facilitating numerous multi-billion-dollar transactions as Global Head of Hematology and Immunology Business Development and earlier leading large-scale manufacturing operations as Global Head of Engineering. Mr. Aktar holds an M.B.A. from MIT Sloan School of Management, a B.S. in Chemical Engineering from Worcester Polytechnic Institute and an M.S. in Engineering Management from Tufts University. "I am thrilled to join the Board of Directors at this critical time in Kyverna's maturation and growth. CAR T is a powerful modality with the potential to revolutionize patient care. Kyverna stands at the forefront in bringing this innovation to patients with autoimmune disease, having already demonstrated encouraging efficacy and safety across initial datasets with KYV-101," said Mr. Aktar. "I look forward to working with the Kyverna Board and leadership to successfully advance the KYV-101 development program forward and scale the organization for future growth." About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the proposed contributions of Mr. Aktar on Kyverna's Board of Directors; Kyverna's prospects and ongoing clinical trials, KYV-101's safety, efficacy and commercial prospects; Kyverna's pipeline and the potential for Kyverna's CAR T-cell therapies to be well suited for use in B cell-driven autoimmune diseases. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, please visit . Contact: Precision AQ on behalf of Kyverna Therapeutics Investors: [email protected] Media: [email protected] SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Tim Hunt, CEO of the Alliance for Regenerative Medicine, provides welcome remarks at 2024 Cell & Gene Meeting on the Mesa. / Greg Slabodkin Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that investments reached $10.9 billion in the first half of this year—outpacing 2019’s $9.8 billion total—but far below the pandemic peak. While the cell and gene therapy industry has been hit with investment headwinds since the high levels seen in 2020 and 2021, there are indications that a recovery might be in the offing, according to data presented Monday at the 2024 Cell & Gene Meeting on the Mesa by the Alliance for Regenerative Medicine. Investments of $10.9 billion in the first half of this year are already ahead of 2019’s $9.8 billion total, Tim Hunt, CEO of the Alliance for Regenerative Medicine (ARM), which hosts the annual conference, said in his welcome remarks kicking off the three-day meeting. Still, both numbers pale in comparison to the $19.9 billion and $22.7 billion in investments made in 2020 and 2021, respectively, with levels falling to $12.6 billion in 2022 and $11.7 billion in 2023. For the cell and gene therapy sector, it’s been a “very challenging” two to three years, Hunt said. “It’s been uniquely challenging for smaller organizations that are preclinical. It’s been challenging for platform companies. It’s just not been an easy environment.” Hunt pointed out that that the nearly $11 billion raised in the first half of 2024—which has “nearly eclipsed” all of 2023—primarily went to “later-stage companies” with advanced clinical trials and human data. “It’s a little bit of a tale of haves and have-nots in our sector,” Hunt said. “There is money out there. I think people know that. The problem is a lot of it is locked up and it’s not flowing in through VCs to early startups. There’s been a dearth of IPOs.” However, ARM is hopeful “that the gears will start to unlock a little bit more as we see interest rates come down and other things stabilizing,” according to Hunt. A New Normal, Cell Therapies on the Rise In a panel session on investing in cell and gene therapy at Meeting on the Mesa, David Lederman, managing director of capital markets at investment bank Chardan, agreed the sector is starting to see a little bit of a “thaw.” Jason Russell, managing director and global head of biotechnology at Morgan Stanley, made the case that the Federal Reserves’ interest rate cut in September “certainly has downstream implications for more risk-oriented assets and access to capital” in the cell and gene therapy space. “We’re definitely in recovery mode. Things feel a lot better than they did say in 2022 and 2023. Capital formation for later stage assets is really going well,” Russell said. “We’re making our way back to what’s hopefully a normal functioning market that can help support innovators and capital in this sector.” This mirrors trends seen in the broader biotech industry . Still, Mizuho Securities analyst Jared Holz told BioSpace last month that if industry observers were expecting a sudden gold rush of fundraising and IPOs as a result of the Federal Reserve’s recent rate cut, that’s unlikely to happen . “I don’t see the floodgates opening necessarily, because the last time that we were kicking out 50 or more IPOs a year, the broader sector was negatively impacted by that,” Holz said. “Be careful what you wish for. Too many IPOs in this space I think is actually a very, very meaningful negative for publicly traded equities.” At Meeting on the Mesa this week, Russell acknowledged that many IPOs is arguably “unhealthy” and “not conducive to a really well-functioning, long term market.” So far, he said, there have been 15 biotech IPOs in 2024, including Kyverna Therapeutics’ upsized $319 million IPO in February to support its pipeline of anti-CD19 CAR T therapy candidates. Scott Gottlieb, former FDA commissioner and partner at venture capital firm New Enterprise Associates, in a fireside chat at the conference said that the work around autoimmune diseases and CAR T therapies is “hugely exciting” to investors and could be at an inflection point. “In the next couple of years, I do think that some of the work with CAR T in the autoimmune indications looks so transformative that that’s going to capture a lot of popular attention,” Gottlieb said. Jefferies analyst Kelly Shi in a Monday deep dive analysis for investors wrote that in 2024 more than 20 CAR T programs have entered autoimmune trials with data readouts showing that CAR T therapies “could achieve clinical benefits across multiple autoimmune indications” as “preliminary data from leading programs have shown evidence of B-cell depletion and immune reset, supporting durable drug-free potential of cell therapies.” The bottom line, according to Shi: “CD19 CART’s potential to achieve drug-free remission remains an intact hypothesis to support clinical development for this drug class.” Overall, Hunt sees 2024 as the “breakthrough year for cell therapies” due to major advances. This has translated into sizable fundraises this year for cell therapy companies, including Capstan Therapeutics’ oversubscribed $175 million Series B financing and ArsenalBio’s $325 million Series C funding round last month, he said.