Atara Biotherapeutics, Inc.

PISCATAWAY, N.J., Sept. 14, 2024 /PRNewswire/ -- The year 2024 marks a milestone year for continuous advancements in Cell and Gene Therapy (CGT). The global launch of Amtagvi, a Tumor-Infiltrating Lymphocyte (TIL) therapy, has ushered in a new era for solid tumor treatment using cell therapy. PM359, the world's first lead editing therapy, has been approved for clinical trials, signaling another leap forward in gene editing technology. Meanwhile, INT2104, the first in vivo edited CAR-T therapy, is set to enter clinical trials, greatly expanding the development pathway for CAR-T therapies... Alongside this flourishing growth, both opportunities and challenges arise. How to carve out new frontiers in the vast and promising yet risky CGT market and precisely navigate the path forward has become a key focus for the entire industry and beyond. On November 20, 2024, the "2024 GenScript Biotech Global Forum • London," themed "Unlock the Full Potential of Cell and Gene Therapies," will bring together leading global experts to discuss the future of CGT development, driving progress and transformation within the industry. This year's forum is packed with highlights, including the presence of Dr. James Wilson, a distinguished scientist in the field of gene therapy. Also making an appearance is Miguel Forte, a leading figure who spans academia, industry, and regulatory sectors. Ying Huang, CEO of Legend Biotech, will represent the industry as a featured guest. The gathering of so many esteemed experts promise not only a feast of ideas and insights but also the stimulation of innovative thinking and the promotion of cross-sector collaboration, driving the CGT industry towards robust growth. We look forward to witnessing the birth of more groundbreaking innovations and opening a new chapter in industry development at this forum. As a leader in the biotech industry, GenScript is committed to fostering dialogue and collaboration by establishing a professional global platform for exchange, with the goal of advancing innovation in the Cell and Gene Therapy (CGT) sector. GenScript has successfully hosted two previous global forums during JPM Week, and as part of the GenScript Biotech Global Forum series, the London forum will also focus on the latest developments in CGT. It will bring together global industry leaders to envision the future together. Click the link and register with the invitation code GS2024 by September 15 for free entry. James Wilson, a prominent figure in the field of gene therapy, will attend the forum and participate actively. Renowned for his groundbreaking work in Adeno-Associated Virus (AAV) vector design and application, Dr. Wilson has made significant contributions. His team developed several safe and effective AAV vectors that have successfully transitioned from the lab to clinical practice, greatly advancing gene therapy and offering new hope to patients with rare genetic diseases. Today, this industry titan has successfully transitioned from academia to the business world, with two new companies spun out from the University of Pennsylvania: GEMMA Biotherapeutics and Franklin Biolabs. GEMMA is focused on developing innovative therapies for rare diseases, with a pipeline that includes PBGM01 for GM1 gangliosidosis, PBKR03 for Krabbe disease, and PBML04 for metachromatic leukodystrophy. Franklin, on the other hand, is a contract research organization (CRO) for gene therapy companies, offering comprehensive solutions from discovery to development and distribution. At this forum, James Wilson will focus on the field of gene therapy, sharing his wealth of experience and insights. Meanwhile, for this forum, we are honored to invite Miguel Forte, a key figure in the field of Cell and Gene Therapy who spans academia, industry, and regulatory sectors. He will deliver a keynote speech focusing on the current state of CGT, analyzing future development opportunities and addressing the urgent challenges that lie ahead, providing attendees with comprehensive knowledge sharing and strategic guidance. Miguel Forte is a versatile leader in the field of Cell and Gene Therapy, with over 20 years of deep experience in academia, industry, and regulatory affairs. Dr. Forte has held significant roles at international pharmaceutical companies such as BMS and UCB, where he was deeply involved in the development, launch, and business expansion of several key products, gaining extensive experience in product development and commercialization. During his tenure as Chief Medical Officer and Chief Operating Officer at TxCell, Dr. Forte demonstrated exceptional strategic development skills, leading the company through a successful IPO and multiple funding rounds, significantly advancing the development of CGT products. Subsequently, Dr. Forte served as CEO of Zelluna Immunotherapy and Bone Therapeutics, where he not only led Zelluna through critical financing and initiated an allogeneic CGT development strategy for solid tumors but also directed Bone through strategic restructuring, multiple financings, and important acquisitions. Notably, his previous roles at the Portuguese and European Medicines Agency (EMA) have provided Dr. Forte with a wealth of experience in drug approval and regulatory policy development. Currently, Miguel Forte serves as the CEO and Co-Founder of Kiji Therapeutics, a company focused on offering new treatment options for patients with refractory diseases using advanced gene editing technologies and cell engineering. Its pipeline primarily concentrates on CGT therapies for solid tumors. His extensive experience and insights will provide a comprehensive, multidimensional perspective on the industry, offering valuable inspiration. This forum also features several thematic discussions that delve deeply into hot topics across the entire industry chain, including technological innovations and breakthroughs in cell therapy, advances in gene therapy and mRNA vaccines, challenges in CGT manufacturing, and future pathways for CGT from an investment perspective. In the roundtable discussion on technological innovations and breakthroughs in cell therapy, leaders from major CGT companies, such as Ying Huang, CEO of Legend Biotech, Pascal Touchon, President and CEO of Atara Biotherapeutics, Biao Zheng, CEO of Bangio Biotech, and Jason Foster, CEO of Ori Biotech, will participate. Cilta-cel, a cell therapy product from Legend Biotech, has recently received approvals from the FDA and the European Commission for use in second-line treatment of multiple myeloma. Also, it has been approved for market release in China, promising to benefit more patients. Atara Biotherapeutics has launched Ebvallo, the world's first off-the-shelf T cell therapy, marking the dawn of the off-the-shelf cell therapy era. BRL Medicine's new-generation allogeneic CAR-T therapy, TyU19, has been successfully applied to refractory autoimmune diseases, enriching the application scenarios of CAR-T therapies. The proprietary fully automated and standardized CGT manufacturing platform from Ori Biotech is set to significantly reduce production costs, bringing the goal of increased patient accessibility closer. During the roundtable, industry leaders from the pioneering companies will discuss how CAR-T therapies are transcending boundaries, transitioning from hematological malignancies to new frontiers in solid tumor treatments. They will analyze the latest advancements and challenges in TIL therapies, CAR-T therapies, and allogeneic cell therapies, while also forecasting the breakthroughs and urgent challenges in the CGT field. Their insights will provide strategic guidance for high-level industry development, aiming to extend the benefits of CGT therapies to a broader patient population. In addition, there are numerous compelling highlights that you simply cannot afford to miss: Cutting-edge Technology Sharing: Leading biotech companies will present their latest research achievements focused on the entire CGT industry chain. Attendees will gain profound insights into innovative technologies and explore how to achieve breakthroughs for successful clinical application. Engage with International Experts: Renowned international experts will gather to discuss hot topics in the CGT field, including cutting-edge technological innovations and breakthroughs, as well as industrialization challenges and opportunities. Attendees will have the opportunity to interact and engage in in-depth discussions with global industry leaders. Investment & Financing Collaboration Opportunities: The forum provides a global stage for exchange and collaboration, where investors, researchers, and executives from around the world will explore future trends and potential opportunities in the CGT industry, uncovering collaborative prospects and charting a grand blueprint for synergistic development. Further exciting content will be updated continuously. The "2024 GenScript Biotech Global Forum•London" will offer profound inspiration and reflection for professionals, scholars, and entrepreneurs in the CGT field. Let us join top global thought leaders to address the potential challenges of the next decade in CGT, and drive the industry towards new heights through innovation and collaboration. Click the link and register with the invitation code GS2024 by September 15 for free entry. Contact us: [email protected] SOURCE GenScript Biotech Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Plus, news about Anthos, Ascendis, Royalty Pharma, Semnur, Sonoma, Atara, Feldan, Indivior, Aelis Farma and Acepodia: Vaxcyte launches $1B offering: The raise comes fresh off the company’s pneumococcal vaccine data that sent its stock $PCVX soaring on Tuesday. Vaxcyte selected VAX-31 to advance to a Phase 3 trial in mid-2025 over another vaccine, VAX-24. It can tack on an additional $150 million if all the options are exercised. — Max Gelman Genentech to lay off 93 staffers: In another round of layoffs, Roche’s Genentech is cutting 93 roles at its South San Francisco site starting in October, according to a Californian WARN notice. The site houses over 40 buildings and includes scientific research, manufacturing and other business functions. Genentech said earlier this year that it has plans to cut around 400 workers and restructure its portfolio . — Anna Brown Anthos Therapeutics suggests patients can stay on experimental anticoagulant before surgery: The company on Tuesday shared additional data from a clinical study of its once-monthly factor XI antibody treatment in people with atrial fibrillation, suggesting they do not need to interrupt treatment with abelacimab before elective procedures. In the study, people on the control arm received Xarelto and were allowed to stop taking it 24 to 48 hours prior to their procedure. Seven of 852 patients (0.8%) in the abelacimab arm had major procedure-related bleeds, compared to 6 of 428 (1.4%) in the Xarelto arm. — Lei Lei Wu Ascendis snags $150M in new Royalty Pharma deal: Less than a month after snagging FDA approval for Yorvipath, Ascendis is selling off US royalties of the hypoparathyroidism drug. In exchange for paying $150 million upfront, Royalty Pharma gets 3% royalties on new US sales. The length of the payments is contingent on how quickly Royalty earns back its investment. — Max Bayer Semnur hits Wall Street via SPAC: The company is merging with special-acquisition company Denali Capital Acquisition Corp. in a $2.5 billion deal. Semnur is owned by Scilex Holding Company, which itself took the SPAC route to go public in 2022. — Max Bayer Sonoma Biotherapeutics records $45M milestone: The payment from Regeneron Pharmaceuticals stems from a deal inked in 2023 to develop and commercialize T cell therapies for inflammatory bowel disease and two other undisclosed indications. — Jaimy Lee Atara Biotherapeutics seeks $36M: The company raised the money in a registered direct offering, getting funding from Redmile Group, EcoR1 Capital and Adiumentum Capital Management. An unnamed “large public biotechnology company” also participated in the offering. — Max Gelman Feldan Therapeutics closes $21M Series B: The money will go toward completing a Phase 1/2a trial for the company’s non-invasive intralesional treatment for basal cell carcinoma, which is meant to be an alternative to surgery. Genesys Capital and Fonds de solidarité FTQ co-led the round . — Katherine Lewin Indivior, Aelis Farma drug fails Phase 2b trial: A study investigating a treatment for patients with moderate-to-severe cannabis use disorder didn’t hit the primary or secondary endpoints. The primary endpoint was the proportion of participants who reduced their cannabis use to one day or less per week. Indivior said it will not exercise an exclusive option to license the global rights to the treatment. — Katherine Lewin Acepodia inks Pfizer Ignite collab: The company is collaborating with Pfizer Ignite to advance its off-the-shelf cell therapies to treat autoimmune diseases. Financial terms weren’t disclosed. Acepodia said it retained all rights to its lead program, ACE1831, and Pfizer Ignite “will provide strategic guidance and resources.” — Max Bayer

REDWOOD CITY, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced the appointment of Jakob Dupont, M.D., to its Board of Directors. Dr. Dupont brings more than two decades of experience in the field of oncology and immuno-oncology. With the appointment of Dr. Dupont, Executive Partner at Sofinnova Investments, Dr. Jim Healy, M.D., Ph.D., also at Sofinnova, will be stepping down as Lead Independent Director. In addition, Frank D. Lee will be departing the Board and Brian O’Callaghan, CEO of Deep Genomics, will be assuming the role of Chair. “Jakob has deep experience in successfully developing therapies that help cancer patients, and we are honored to have him join our Board of Directors. Jakob’s proven track record and knowledge in drug development will be beneficial as we continue to advance our pipeline and support our collaborations,” said Willie Quinn, Chief Executive Officer. “Jim and Frank have provided excellent counsel to Bolt and on behalf of the whole Board of Directors, I would like to thank them for their insights and dedication. I am also excited that Brian is stepping forward to be Chair of the board, and we all look forward to his leadership.” Dr. Dupont is Executive Partner, Private Equity at Sofinnova Investments. Prior to joining Sofinnova, Dr. Dupont was Global Head of Research & Development and Executive Vice President at Atara Biotherapeutics, where he led the development and regulatory approval of EBVallo ® . He also served as Chief Medical Officer at Gossamer Bio. Before Gossamer Bio, Dr. Dupont served as Vice President and Global Head of Breast and Gynecologic Cancer Development for Genentech/Roche, where he was responsible for the global development of Herceptin ® , Perjeta ® , Kadcyla ® , and Tecentriq ® , among others, and where he previously led the development of Avastin ® for Gynecologic and Breast Cancers when starting his industry career. He serves as a Board Member for Avenzo Therapeutics, Pyxis Oncology, and Imugene, and is on the Scientific Advisory Board for Flagship Pioneering. Dr. Dupont earned his bachelor’s degree from Vassar College, his master’s degree from New York University, and his M.D. from the Joan & Sanford I. Weill Medical College of Cornell University. “I’m pleased to join the Bolt Biotherapeutics Board of Directors,” said Jakob Dupont, M.D., Executive Partner, Private Equity, Sofinnova Investments. “The recent strategic restructuring has left Bolt in an enviable position of having an ongoing clinical trial with a first-in-class Dectin-2 agonist and a near-clinical ISAC program targeting Claudin 18.2. Additionally, Bolt has the resources, in the form of cash, platform technology, and a solid team, to pursue its mission of harnessing the power of the immune system to improve lives and eradicate cancer. I look forward to sharing my experience with the Bolt team as they advance their pipeline programs through clinical development.” About Bolt Biotherapeutics, Inc. Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes BDC-3042, a first-in-class agonist antibody that activates macrophages by targeting Dectin-2, and BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-3042 is currently in a Phase 1 dose escalation trial that includes patients with any of seven different solid tumor types. BDC-4182 is supported by strong in vitro and in vivo data demonstrating potent anti-tumor activity, and activities are underway to support the initiation of clinical trials in 2025. Bolt Biotherapeutics is also developing additional Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding the advancement and success of our BDC-3042 clinical trial, the potential initiation of clinical trials for BDC-4182, the anti-tumor potency, safety and tolerability, and characteristics of our product candidates, the initiation of future clinical trials, the potential value of collaborations, and the expected duration of our cash runway, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website at . Investor Relations and Media Contact: Matthew DeYoung Argot Partners (212) 600-1902 boltbio@argotpartners.com