Category Archives: Biotech Companies USA

Xeno Biosciences Announces New CEO and Financing

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Xeno Biosciences Inc., a clinical stage drug discovery and development company advancing therapeutics for the treatment of obesity and metabolic diseases, announced today a change in executive leadership as of September 2023, and the completion of an additional financing round in February of 2024. This financing of $1.15M will fund a Phase 1b trial of the company’s lead compound, Xen-101, in obese individuals. The trial is expected to have top line results by the end of the year.

The new president and CEO, Dennis D. Kim, MD, MBA, has 25 years of obesity and metabolic drug development expertise experience and has brought multiple obesity and metabolic disease drugs to the clinic and to market, including Byetta® (exenatide), Symlin® (pramlintide), Contrave® (bupropion/naltrexone), and seladelpar. He has been involved in numerous IPO’s/secondary offerings and has been the chief medical officer of multiple public companies, most recently at CymaBay Therapeutics, where he oversaw the design and execution of seladelpar Phase 3 Pivotal Program.

“I’m excited to be spearheading the development of Xeno’s new oral obesity drug which has been shown to have high tolerability in initial Phase I trial and has a novel mechanism of action.” said Dr. Dennis Kim. “I have dedicated my career to this area of science and medicine. After many years of development, I am truly gratified to see obesity pharmaceuticals as having the potential to impact the lives of billions of people around the world. There is a strong unmet need for a drug with the profile of Xen-101 and I look forward to our Phase 1b clinical trial results in obese adults in the near future.”

“Dennis has an extraordinary depth of knowledge and is highly respected in the obesity field; I could not imagine anyone more perfect to lead our company,” said Jeff Arnold, Chairman and a Director at Xeno since 2017. “We are delighted that he has decided to join us and lead this exciting project.”

For more information about Xeno Biosciences please contact Dr. Dennis Kim at dk23@xenobiosciences.com.

About Xeno Biosciences Inc.

Xeno Biosciences Inc. is a privately held drug development company dedicated to finding safe and effective treatments for obesity and metabolic diseases. Xeno is advancing its lead development candidate, XEN-101, to address the unmet need for an effective, well-tolerated, orally administered obesity treatment. With a new understanding of the underlying mechanism of action of Roux-en-Y Gastric Bypass Surgery (RYGB), Xeno has developed a substitute for gastric bypass in a daily oral pill. XEN-101 has been shown to have wide safety margins and high tolerability in initial clinical trials.

Dennis D. Kim, MD, MBA

Dr. Dennis Kim is a scientist and a physician executive who brings 25 years of clinical research and biopharmaceutical industry experience to Xeno Biosciences. Dr. Kim served in a variety of senior executive positions in the industry, most recently as Chief Medical Officer at CymaBay, Emerald Biosciences, and Zafgen, Inc., as well as at Orexigen Therapeutics as the Senior Vice President of Medical Affairs. He also held various senior management positions at Amylin Pharmaceuticals, Inc. for over 7 years, including Executive Director of Corporate Strategy and Program Medical Lead for the development and commercialization of Byetta® (exenatide) for the treatment of type 2 diabetes.

Dr. Kim completed his fellowship in Endocrinology/Metabolism at the University of California, San Diego (UCSD) School of Medicine during which time he investigated the pathophysiology of diabetes and metabolic syndrome. He is extensively published in top peer-reviewed medical and scientific journals with over 50 publications to his name. Dr. Kim also received an MBA degree with honors from UCSD Rady School of Management with an emphasis on biotech structure and strategy.

The securities sold in the aforementioned private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States in the absence of an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the aforementioned shares. In addition, this press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and the company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contacts

Dr. Dennis Kim

dk23@xenobiosciences.com

Jacques Banchereau, PhD Appointed as Chief Scientific Officer at Javelin Biotech

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WOBURN, Mass.–(BUSINESS WIRE)–Javelin Biotech, Inc., a leading technology company specializing in human tissue chip platforms for biopharma research, is delighted to announce the appointment of Jacques Banchereau, PhD as its Chief Scientific Officer (CSO). Banchereau is an internationally recognized immunologist and molecular biologist, renowned for his groundbreaking contributions to the field of immunology and drug discovery.

Over his distinguished 35-year career, Dr. Banchereau has shown exceptional leadership in both academic and industrial research. Having held esteemed roles such as Professor and Director of Immunological Sciences at the Jackson Laboratory for Genomic Medicine, Chief Scientific Officer at Hoffman-La Roche, CSO at Immunai, and Adjunct Professor of Immunobiology at Yale School of Medicine, he has consistently demonstrated his expertise in driving forward scientific inquiry and pharmaceutical innovation.

In his role at Javelin Biotech, Banchereau will oversee the company’s scientific strategy, leveraging his vast experience and expertise to drive the development of cutting-edge technology for the modeling of human diseases. His appointment underscores Javelin Biotech’s commitment to innovation and scientific excellence in the field of biotechnology.

“We are thrilled to welcome Jacques to the Javelin Biotech team,” said Murat Cirit, PhD, CEO of Javelin Biotech. “His outstanding achievements and leadership in immunology and drug discovery make him a valuable addition to our company. We are confident that his expertise will play a pivotal role in advancing our research efforts and driving our mission to support the development of novel treatments for organ-specific diseases.”

Banchereau expressed his excitement about joining Javelin Biotech, stating, “I am honored to be part of a company that is dedicated to pushing the boundaries of scientific research. Javelin Biotech’s innovative technology has the potential to revolutionize the way we understand and treat complex diseases, and I look forward to contributing to its success.”

About Javelin Biotech:

Javelin Biotech is a biotechnology company focused on humanizing preclinical drug discovery with a predictive platform that merges human tissue chips with digital twin technology to develop better medicines faster. The Javelin platform enables the creation of accurate and physiologically relevant models of human tissues, providing valuable insights into disease mechanisms and drug responses, allowing biopharmaceutical companies to reduce their reliance on animal studies and develop better drugs faster.

For more information, visit www.javelinbiotech.com.

Contacts

Kevin O’Handley

media@javelinbio.com
(781) 995-3099

Allurion Closes $48 Million Convertible Senior Secured Note Financing with RTW Investments

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  • Simplifies capital structure through prepayment of existing term loan
  • Reduces annual interest expense, providing increased near-term cash flow and operational flexibility
  • Extends expected cash runway in advance of AUDACITY FDA trial read-out
  • Strengthens long-term partnership with RTW Investments.

NATICK, Mass.–(BUSINESS WIRE)–Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated to ending obesity, today announced the closing of a $48 million convertible senior secured note financing with certain entities managed by RTW Investments, LP (“RTW”). Proceeds will be used to repay in full the Company’s obligations under its existing term loan with Fortress Credit Corp., reducing the Company’s interest expense and increasing operational flexibility.

Management anticipates this transaction will better position the business for the future. Of note, the convertible notes reduce the interest rate on the Company’s debt to 6%, lengthen the maturity over Allurion’s existing term loan by nearly four years, from June 2027 to April 2031, and allow for interest payments to be made in-kind for the first three years. The net benefit of these changes, together with the amended terms of Allurion’s existing Royalty Interest Financing Agreement with RTW, extends the Company’s expected cash runway in advance of the AUDACITY FDA trial read-out, which is anticipated by year-end.

“RTW’s investment underscores our shared belief in the long-term potential of the Allurion Program,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “Our impressive clinical results and continued growth in procedural volume in our foreign markets give us confidence that Allurion will be a significant player in obesity management. The investment furthers our long-term partnership with RTW and provides us additional flexibility to achieve our long-term goals,” Dr. Gaur continued.

“We are pleased to strengthen our relationship with Allurion as it continues its mission to end obesity around the world. The Allurion Program is a proven weight-loss method, and we eagerly await the results of its U.S. FDA trial,” said Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW Investments, LP.

About the Notes

The notes bear interest at the rate of 6% per annum, with the Company’s option to pay interest in kind for the first three years, and mature on April 16, 2031. The notes may be converted at the option of the noteholders into common stock of Allurion, subject to certain conditions and limitations, at a 35% conversion premium to the lower of (i) the 30-day VWAP at signing and (ii) the price per share in the Company’s next equity offering. The Company has agreed to customary registration rights with respect to the shares of common stock issuable upon conversion of the notes. The notes may be redeemed by Allurion at its option under certain circumstances following the fourth anniversary of the date of issuance.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Additional information about the notes and the terms of the note purchase agreement will be filed with the U.S. Securities and Exchange Commission (the “SEC”) and will be available on the SEC’s website at www.sec.gov.

About Allurion

Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com

Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.

About RTW

RTW Investments, LP is a global, full life-cycle investment firm and company builder that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and/or academics developing them.

Forward-Looking Statements

This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the simplification of Allurion’s capital structure, availability of cash runway, operational flexibility, procedure growth, Allurion’s expectations for, and market acceptance of, the Allurion Program, and Allurion’s ability to compete with other weight loss products, improve its market position, scale its business and achieve long-term goals. Forward-looking statements are predictions, projections and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain and maintain regulatory approvals for and successfully commercialize the Allurion Program, including the Allurion Balloon and the Allurion Virtual Care Suite (“VCS”), (ii) the timing of, and results from, our clinical studies and trials, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property, (v) the impact of the COVID-19 pandemic, the Russia and Ukraine war, and the Israel-Hamas conflict on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities, including those for the VCS platform, (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates, and (viii) the ability of Allurion to comply with the covenants and terms and conditions of the note purchase agreement. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Allurion’s Annual Report on Form 10-K filed on March 26, 2024 and other documents filed by Allurion from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.

Contacts

Global Media:
Cedric Damour, PR Manager

Allurion Technologies, Inc.

+33 7 84 21 02 20

cdamour@allurion.com

Investors
Mike Cavanaugh, Investor Relations

ICR Westwicke

+1 617 877-9641

mike.cavanaugh@westwicke.com

Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor

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VENT-02 demonstrated robust pharmacodynamic modulation, a broad therapeutic index, and potential for once-daily dosing

VENT-02 provided full target coverage with a single dose

No dose-limiting toxicities or serious adverse events observed

Initiation of clinical trials in CNS diseases expected beginning in the second half of 2024

WALTHAM, Mass. & MONTREAL–(BUSINESS WIRE)–Ventus Therapeutics, a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor. The Phase 1 trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers.

“We are pleased with the results of this trial in which VENT-02 demonstrated a broad therapeutic index and complete target coverage, underscoring its potential to treat diseases of the CNS as well as peripheral diseases with high unmet needs,” said Xavier Valencia, M.D., Head of Clinical Development at Ventus. “Our next trial for VENT-02, a Phase 1b trial in patients with Parkinson’s disease, will evaluate multiple doses and dose regimens against a placebo control and assess a collection of markers that map multiple components of inflammation to disease activity. Based on the promising pharmacodynamic and safety data from this Phase 1 trial and our clinical development plans, we believe VENT-02 is poised to demonstrate best-in-class potential.”

In this Phase 1 clinical trial, VENT-02 was well-tolerated, with no dose-limiting toxicities or serious adverse events reported and only mild or moderate treatment-related adverse events observed. The moderate adverse events included headache and nausea and were only observed at a dose multiple times higher than the intended therapeutic doses.

VENT-02 demonstrated full target engagement through 100% inhibition of IL-1ß in the blood in an ex vivo whole blood challenge assay, significant drug levels in the CSF for 24 hours, and robust reduction of inflammatory biomarkers such as hsCRP. Based on the half-life and target coverage observed in the trial, VENT-02 has demonstrated the potential for once-daily dosing.

“The excellent properties of VENT-02 are a reflection of Ventus’ industry-leading exploration of NLRP3, including demonstrating proof-of-concept in preclinical studies in multiple disease-relevant models, validating biomarkers, and collaborating with academic institutions and the Michael J. Fox Foundation,” said Ventus President and CEO, Marcelo Bigal, M.D., Ph.D. “As a result, we are ready to bring VENT-02 into Parkinson’s disease and other pre-defined diseases where the CNS plays an important role, capitalizing on innovative trials that we are crafting to be informative in reducing risk in the future steps of clinical development. In addition, we expect that our planned trials will allow us to explore the potential impact of NLRP3 inhibition across multiple patient populations suffering from serious diseases.”

Ventus expects to initiate a Phase 1b trial of VENT-02 in patients with Parkinson’s disease in the second half of 2024 and a Phase 2 trial in patients with treatment-refractory epilepsy in 2025.

About NLRP3

NLRP3 is the best understood member of a family of proteins known as inflammasomes. Inflammasomes are multiprotein complexes that regulate the innate immune system and are involved in intracellular surveillance of danger and pathogen signals that trigger an intense inflammatory response, including the release of IL-1β and IL-18 and the induction of pyroptosis, an inflammatory form of cell death. Therapeutic inhibition of NLRP3 can prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL-18 as well as pyroptosis. Aberrant activation of the NLRP3 inflammasome has been associated with systemic conditions, including fibrotic, dermatological, and rheumatological diseases, and is a key driver of disease pathology in several neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and treatment-refractory epilepsy.

About Ventus Therapeutics

Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying deep protein science expertise and a proprietary computational chemistry platform to develop novel small molecule therapeutics for immunology, inflammation, and neurology disorders. Using its proprietary drug discovery platform, ReSOLVE™, the company screened its first target in 2020, selected three development candidates in 2022, and advanced its two wholly-owned product candidates into the clinic in 2023: VENT-03, a potent, selective, oral cGAS inhibitor in Phase 1, and VENT-02, a potent, brain-penetrant, oral NLRP3 inhibitor in Phase 1. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted NLRP3 inhibitor, to Novo Nordisk A/S. These programs exemplify Ventus’ robust discovery capabilities and focus on differentiated programs for multi-indication immunology and neurology targets. For more information, please visit www.ventustx.com and engage with Ventus on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause Ventus’ actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other similar expressions. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing, progress, and results of Ventus’ clinical trials, the anticipated timing of initiation and completion of trials, the period during which the results of the trials will become available, and Ventus’ development plans. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Ventus’ control, you should not rely on these forward-looking statements as predictions of future events. Such risks include, but are not limited to, the risk that Ventus is unable to further advance VENT-02 and VENT-03 in clinical development, obtain regulatory approval, and ultimately commercialize VENT-02 and VENT-03, or experience significant delays in doing so; that Ventus will require substantial additional funding to finance its operations; that the development and commercialization of pharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable; and that Ventus’ success depends on its, its current and future licensors’, and its exclusive licensees’ ability to obtain, maintain, enforce, and protect its intellectual property and its proprietary technologies. Forward-looking statements included herein are based upon information available to Ventus as of the date of this press release, and while Ventus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and Ventus’ statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Ventus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.

Contacts

Media
Dan Budwick

1AB

dan@1abmedia.com

KYinno – Boost your drug discovery with innovative products and services

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KYinno is a leading preclinical contract research organization (CRO) dedicated to providing tailored solutions in in vitro and in vivo pharmacology, cell line engineering, therapeutic target identification, and antibody discovery. Leveraging our proprietary assets, including over 3000 engineered cell lines, innovative bispecific and tri-specific antibody discovery mouse models, the comprehensive MPSA-AB5000 panel with screening capabilities for 5000 antibody specificities, and the cutting-edge KY-AITM antibody development artificial intelligence platform, we empower our clients to accelerate their research and development endeavors.

Located at F2 Building, Yizhuang Biomedical Park, No. 88, Kechuang Six Street, Beijing, P.R. China, 101111, and 204 Second Avenue, Waltham, MA 02451, USA, KYinno operates globally to serve the diverse needs of the biotechnology and pharmaceutical industries. Our team consists of highly skilled professionals committed to delivering exceptional results and exceeding expectations.

At KYinno, we are dedicated to advancing scientific discovery and therapeutic innovation. Learn more about how we can collaborate with you to achieve your research goals by visiting our website at www.kyinno.com.

KYinno – preclinical CRO – contract research organization – in vitro pharmacology – in vivo pharmacology – cell line engineering – therapeutic target identification – antibody discovery – engineered cell lines – bispecific antibodies – trispecific antibodies – antibody screening – antibody specificity screening – MPSA-AB5000 panel – KY-AITM antibody development platform – artificial intelligence platform

S2 Genomics Announces Groundbreaking Single Cell FFPE Sample Prep Isolation Product

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LIVERMORE, Calif.–(BUSINESS WIRE)–S2 Genomics, a pioneer in tissue sample preparation systems, today announced the launch of its latest product, the Singulator™ 200+ System, an automated sample prep isolation system for single cell formalin-fixed, paraffin-embedded (FFPE) tissues. This cutting-edge solution addresses an unmet need in the market by automating sample preparation for the first time, offering a faster, more accurate, more efficient process for researchers and manufacturers.

The new FFPE sample prep isolation system is designed to isolate nuclei from FFPE tissue slices, enabling single-nucleus RNA sequencing (snRNA-Seq) for FFPE samples. This advancement is a game-changer for cancer-focused researchers who require precise and reliable sample preparation to drive forward their research and development efforts.

Jonathan Schimmel, President and CEO of S2 Genomics, expressed his enthusiasm for the new product: “The FFPE sample prep isolation system is a testament to our commitment to continuing innovation and excellence in the field of single cell genomics. By automating what was once a manual and time-consuming process, we are empowering researchers to conduct their work more effectively and efficiently than ever before.”

The introduction of the FFPE sample prep isolation product is expected to have a profound impact on the field of oncology research, where the quality and speed of sample preparation are crucial for the success of genomic assays.

Earlier this year, S2 Genomics announced that it had raised $16 million in Series A funding to accelerate commercial adoption of its benchtop Singulator platform, which uses single-use cartridges to enable reproducible, rapid, and automated tissue dissociations into single cell or nuclei suspensions.

For more information about the FFPE sample prep isolation system and other S2 Genomics products, please visit us at s2genomics.com or connect with us on LinkedIn or Twitter.

About S2 Genomics: S2 Genomics, Inc. is a leader in the field of tissue sample preparation for single-cell genomics assays. The company’s innovative Singulator platform uses single-use cartridges to enable reproducible, rapid, and automated tissue dissociations into single cell or nuclei suspensions, advancing research in neuroscience and oncology.

[For Research Use Only, Not for Diagnostic Procedures]

Contacts

Nicole Rapicavoli, Vice President of Marketing, nicole@s2genomics.com

Merck’s Corporate Venture M Ventures Arm Backs Nucleai to Advance Its First-in-class Spatial AI Biomarker in Active Clinical Enrollment

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The Extension Funds Nucleai to Advance Its First-in-Class Spatial AI Biomarker in Active Clinical Enrollment

Investment Expands Deployments of AI-Powered Spatial Biomarker Technology, Strengthening Companion Diagnostics for ADCs, Bi-specifics, and Immunotherapies

M Ventures is the corporate strategic venture arm of Merck KGaA, Darmstadt, Germany

CHICAGO–(BUSINESS WIRE)–Nucleai, a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, has secured a $14 million investment led by M Ventures, the corporate venture capital arm of Merck KGaA, Darmstadt, Germany, and supported by existing investors, bringing the total funding to $60 million. The investment enables Nucleai to further deploy its AI algorithms for the prospective enrollment of patients in clinical trials – a first in the field and a significant advancement in personalized solutions tailored to the distinct needs of patients.

The funding exemplifies Nucleai’s growing momentum in the life sciences industry, evidenced by collaborations with over 60 percent of the top 20 biopharma companies, venture backing from renowned investors like Section 32 and Sanofi Ventures, and now with M Ventures. The funding will accelerate the deployment of Nucleai’s spatial analysis technology that transforms a static biopsy slide into a dynamic AI-guided action plan, empowering pathologists with the intelligence to anticipate and navigate complex diseases, like cancer, with unmatched precision.

By integrating AI algorithms for prospective patient enrollment in clinical trials, Nucleai is spearheading a first-in-field approach to personalized medicine. This process is crucial for enhancing the accuracy of treatment targeting and activation within the body, particularly for advanced therapeutics such as antibody-drug conjugates (ADCs) and bi-specifics. Nucleai’s platform tailors therapy strategies to the intricate cellular landscape of each patient, optimizing clinical trial participant selection. This personalized approach not only improves the likelihood of successful clinical outcomes but also significantly contributes to the speed and efficiency of bringing new therapies to market.

Leveraging AI and machine learning (ML), Nucleai analyzes pathology images and spatial data at the cellular and tissue levels. The proprietary technology extracts detailed patterns and features from medical images, offering profound insights into the tumor microenvironment, cellular morphology, and spatial relationships between different cell types. These capabilities advance drug development, refine biomarker discovery, and improve the precision of therapeutic targeting, ultimately leading to more effective and personalized treatment options for patients.

Avi Veidman, CEO and Co-Founder of Nucleai, said, “M Ventures’ investment boosts our ability to scale and deploy our spatial AI technology for patient enrollment in clinical trials and supports our work in the rapidly emerging areas of immunotherapies, antibody-drug conjugates, and bi-specifics. Our vision is that every next-generation therapeutic is accompanied with an AI-enabled companion diagnostic, ensuring that each patient’s treatment pathway is informed and efficacious. This funding positions us to scale spatial AI, not just to intercept but anticipate the complex behavior of diseases.”

Noga Yerushalmi, Investment Director at M Ventures, who is appointed to the board of Nucleai, stated, “Nucleai’s technology stands out by being the first spatial AI tool used by pathologists for clinical trial patient selection that is directly connected to a drug development program, setting them apart from other companies. Nucleai’s biology-driven mindset and their multimodal approach, which combines traditional pathology data with spatial biology data, allows for more accurate predictions of treatment responses, aligning perfectly with our commitment to optimise speed of new therapies to reach patients.”

By moving beyond traditional pathology’s analog analysis, Nucleai leverages AI to create dynamic, digital maps from biopsy samples, uncovering the complex interactions at play within tissue. This innovation marks a shift in disease diagnosis and treatment, offering an in-depth contextual view that underpins the development of novel therapeutics.

About Nucleai

Nucleai is the leading AI-powered spatial biomarker company, driving innovation at the intersection of technology and healthcare. Leveraging military intelligence-grade geospatial analytical methods, it intercepts, interprets, and analyzes complex cellular conversations and spatially oriented interactions within tissue samples, translating them into actionable insights. Nucleai’s platform empowers pathologists and researchers with an AI-powered data-rich action plan, paving the way for more informed decisions in the development of bi-specifics, antibody-drug conjugates (ADCs), and immunotherapy. Nucleai’s investors include Section 32, Sanofi, Vertex Ventures, M Ventures, and Debiopharm Innovation Fund. It is headquartered in Israel and Chicago. For more information, please visit www.nucleai.ai.

About M Ventures

M Ventures is the strategic, corporate venture capital arm of Merck KGaA, Darmstadt, Germany. From its headquarters in the Netherlands and offices in Germany, USA and Israel, M Ventures invests globally in transformational ideas driven by innovative entrepreneurs. Taking an active role in its portfolio companies, M Ventures teams up with management teams and co-investors to translate scientific discoveries into commercial success. M Ventures focuses on identifying and financing novel solutions to some of the most difficult challenges, through company creation and equity investments in fields that will impact the vitality and sustainability of Merck KGaA, Darmstadt, Germany’s current and future businesses.

http://www.m-ventures.com/

Contacts

Consort Partners for Nucleai

nucleai@consortpartners.com

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

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Ivonescimab alone or combined with chemotherapy led to intracranial responses among 34% of patients with brain metastases at baseline – 23% achieved a complete response

All patients who did not achieve an intracranial response demonstrated stable disease or non-progression by RANO criteria irrespective of cohort

Median intracranial PFS of 19.3 months observed across combined cohorts of ivonescimab administered as monotherapy or in combination with chemotherapy

No cases of intracranial bleeding were observed in these patients with brain metastases

Detailed safety and anti-tumor activity updates from Phase II trial for ivonescimab plus chemotherapy in multiple NSCLC settings, including 1L squamous NSCLC

MIAMI–(BUSINESS WIRE)–$SMMT–Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic. Two posters featuring updated ivonescimab data will be displayed from 12:00 to 12:45pm Central European Time. The posters will also be made available on our website after the presentation period.


The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC. This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.

Notably, median intracranial progression-free survival was 19.3 months across all patients analyzed. Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria. All patients who did not achieve a response demonstrated stable disease or non-progression; no patients experienced intracranial disease progression at the time of the initial follow-up scan. No cases of intracranial bleeding complications were observed in these patients.

“We are pleased to see ivonescimab’s favorable intracranial response rates and median intracranial progression-free survival as well as promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC,” said Dr. H. Jack West, Vice President of Clinical Development at Summit. “We are grateful for the patients and clinical investigators supporting these trials, and our ongoing collaboration with our partners at Akeso.”

The second poster titled, “Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Non-Small Cell Lung Cancer” includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first-line treatment of squamous and non-squamous advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). Summarized updates in NSCLC patients with EGFR mutations after a tyrosine kinase inhibitor (TKI) and NSCLC patients who have received prior PD-(L)1 plus doublet chemotherapy treatment are included as well.

Of significance, first-line advanced or metastatic squamous NSCLC patients experienced a median PFS of 11.1 months (95% CI: 9.5 – 16.3 months). In addition, first-line patients with advanced or metastatic non-squamous tumors experienced a median PFS of 13.3 months (95% CI: 8.3 – 16.4 months). Median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months. The frequency of treatment-emergent adverse events (TEAEs) leading to the discontinuation of ivonescimab was 11.1% and 2.8%, respectively, in patients with squamous and non-squamous tumors. The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. West, with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK) with contribution by Summit staff.

Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:

  • HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (NCT05184712)
  • HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (NCT05899608)

About the ELCC 2024 Posters

Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer

ELCC Presentation No.: 68P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases

ELCC Presentation No.: 174P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow us on X @summitplc.

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Appendix: Glossary of Critical Terms Contained Herein

Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.

Avidity – Avidity is the accumulated strength of multiple binding interactions.

Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.i

Baseline – The condition of a patient at the start of the clinical trial; a patient’s health status upon starting a clinical trial prior to receiving therapy.

Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.ii

Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.iii

Intracranial – Within the cranium or skull.

PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.iv

PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells. v

PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.

PFS – Progression-Free Survival.

RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.

SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.

T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.vi

Tetravalent – A tetravalent molecule has four binding sites or regions.

Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.vii

VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.viii

i Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

ii Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6)

iii US National Cancer Institute, a part of the National Institute of Health (NIH). https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed March 2024.

iv Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

v Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

vi Cleveland Clinic. https://my.clevelandclinic.org/health/body/24630-t-cells. Accessed March 2024.

vii MD Anderson Cancer Center. https://www.mdanderson.org/cancerwise/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html. Accessed March 2024.

viii Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

Contacts

Contact Summit Investor Relations:
Dave Gancarz

Chief Business & Strategy Officer

Nathan LiaBraaten

Senior Director, Investor Relations

investors@smmttx.com

Astrocyte Pharmaceuticals Announces FDA Clearance of its Investigational New Drug Application for AST-004

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Green Light for Phase 2 Trial of AST-004 in Acute Ischemic Stroke Patients

GROTON, Conn., March 12, 2024 (GLOBE NEWSWIRE) — Astrocyte Pharmaceuticals Inc., a clinical-stage biopharmaceutical company committed to advancing cerebroprotective therapies for individuals suffering from stroke, traumatic brain injury (TBI), and concussion, has announced today the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, AST-004, for acute ischemic stroke. The company is preparing to initiate a Phase 2 clinical trial. The IND application clearance also paves the way for additional studies further exploring AST-004 in stroke, as well as TBI, and concussion.

Currently, only ~5% of stroke patients receive pharmaceutical therapy, largely due to the short treatment windows of available thrombolytic medicines, as well as their need for imaging before those treatments can be initiated. AST-004 was developed with the potential to treat all stroke patients. Unlike existing therapies, treatment with AST-004 is designed for use without the need for imaging in the emergency room and for use at any point after diagnosis. And it has the potential to treat stroke occurring in any sized blood vessel in the brain.

The upcoming Phase 2 trial in acute ischemic stroke patients builds upon the recent successful stroke clinical trial designs used by medical device companies, heralding a new era in patient care. “The past decade has witnessed a transformative shift in stroke trials, thanks to sophisticated imaging techniques that enable high-quality real-time characterization of stroke and ensure selection of homogeneous study groups,” said Dr. Kevin Sheth, Co-Director of the Center for Brain & Mind Health at the Yale School of Medicine and Chief Medical Advisor to Astrocyte. “The new study of AST-004 will first focus on treating those stroke patients with large vessel occlusions, offering hope to significantly diminish brain damage.”

AST-004 is an innovative small molecule therapy that has demonstrated exceptional promise in preclinical studies. In a critical non-human primate stroke model, a significant reduction in brain lesion growth by 64% and an overall lesion size decrease by 45% were observed with a high dose (as reported in ‘The Journal Stroke’ in 2022). Astrocyte previously completed two Phase 1 safety trials in Europe, involving 80 participants in total, and saw no significant adverse effects or safety concerns.

Dr. William Korinek, CEO of Astrocyte Pharmaceuticals, commented, “Since our founding in 2014, we have been focused on demonstrating the potential of cerebroprotective benefits of AST-004. Our robust preclinical program and Phase 1 studies have laid the foundation for our ongoing development efforts, and we are eager to move forward with the planned Phase 2 study. Stroke is the second leading cause of death globally, and the need for advances in treatment is enormous. We believe AST-004 can be part of that solution.”

About Astrocyte Pharmaceuticals Inc.

Astrocyte Pharmaceuticals Inc. is a privately held, clinical-stage drug discovery and development company dedicated to accelerating the recovery and well-being of brain injury patients. The company is committed to proving the cerebroprotective benefits of enhancing astrocyte function and advancing breakthrough therapeutic agents for treating brain injury resulting from stroke, traumatic brain injury, concussion, and neurodegenerative disorders such as Alzheimer’s disease. For more information on Astrocyte Pharmaceuticals Inc. and the AST-004 program, please visit us at Astrocyte Pharmaceuticals Inc.  

Forward-Looking Statement

This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans, and projections regarding the company’s financial position, results of operations, market position, product development, and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert, or change any of them and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and the company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Media contact:
Kimberly Macleod – kim@kmacconnect.com
info@astrocytepharma.com 

Seismic Therapeutic – Preclinical Data for Novel Immunoglobulin Sculpting Enzyme

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WATERTOWN, Mass.–(BUSINESS WIRE)–Seismic Therapeutic, Inc., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.

S-1117 is a novel engineered pan-IgG protease for the potential treatment of a range of chronic and acute autoantibody mediated diseases, including the chronic neuromuscular autoimmune disorder, myasthenia gravis. The presentation at the AAN annual meeting will outline key preclinical in vitro and in vivo results supporting the differentiated profile of S-1117 compared to therapeutic benchmarks in chronic autoantibody mediated diseases. S-1117 addresses multiple mechanisms of autoimmunity by lowering IgG and immune complex levels, reducing IgG effector functions and cleaving the antigen receptor (BCR) on memory B cells. Moreover, in a mouse pharmacokinetic model, S-1117 was able to achieve deep, sustained and rapid reduction in human IgG.

Presentation details:

Title: Preclinical Pharmacology of S-1117, a Novel Engineered Fc-fused IgG Cleaving Enzyme, for Chronic Treatment of Autoantibody-mediated Diseases

Session: P4 – Autoimmune Neurology: Peripheral Autoimmunity

Date: Monday, April 15, 2024

Time: 11:45 a.m. – 12:45 p.m. MT

Area: 14

Poster number: 018

Abstract number: 6869

About Seismic Therapeutic

Seismic Therapeutic™ is a biotechnology company making a major shift in how immunology therapies are discovered and developed, enabled by machine learning. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life sciences investors and is located in the Boston biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

Contacts

Media Contact
Kathryn Morris, The Yates Network

914-204-6412

kathryn@theyatesnetwork.com

Seismic Therapeutic to Present Preclinical Data for Novel Immunoglobulin Sculpting Enzyme at AAN Annual Meeting