LABP Landos Biopharma Inc.

2.94
-0.17  -5%
Previous Close 3.11
Open 3.04
52 Week Low 3.01
52 Week High 16.989
Market Cap $118,292,817
Shares 40,235,652
Float 4,757,162
Enterprise Value $15,622,816
Volume 207,976
Av. Daily Volume 98,099
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Upcoming Catalysts

Drug Stage Catalyst Date
Omilancor (BT-11)
Crohn’s Disease
Phase 2
Phase 2
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NX-13
Ulcerative Colitis
Phase 1b
Phase 1b
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LABP-104
Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Omilancor (BT-11)
Ulcerative Colitis
Phase 2
Phase 2
Phase 2 data displayed clinical remission in 36.1% of the 880 mg group and 35.5% of the 440 mg group during the blinded maintenance phase. Both dose cohorts had 10% of patients report an AE of ulcerative colitis worsening, noted October 4, 2021. Additional phase 2b study required prior to Phase 3 initiation, noted November 15, 2021.
NX-13
Crohn’s Disease
Phase 2
Phase 2
Phase 2 trial to commence 1H 2022.

Latest News

  1. Enhancing Focus on High-Impact Clinical-Stage Programs to Ensure Optimal Path to Commercialization

    Refining Ulcerative Colitis Clinical Development Plans for Omilancor to Generate Additional Phase 2b Data Prior to Initiating Pivotal Phase 3 Program

    Determining Optimal Enrollment for Phase 2 Clinical Study of Omilancor in Crohn's Disease and Phase 1b Study of NX-13 in UC

    Initiated Dosing for LABP-104 in Healthy Volunteers in October 2021 with Results Expected in 1H 2022

    Corporate Update Conference Call Scheduled for 8:00 am ET Today

    BLACKSBURG, Va., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a clinical-stage biopharmaceutical company utilizing its…

    Enhancing Focus on High-Impact Clinical-Stage Programs to Ensure Optimal Path to Commercialization

    Refining Ulcerative Colitis Clinical Development Plans for Omilancor to Generate Additional Phase 2b Data Prior to Initiating Pivotal Phase 3 Program

    Determining Optimal Enrollment for Phase 2 Clinical Study of Omilancor in Crohn's Disease and Phase 1b Study of NX-13 in UC

    Initiated Dosing for LABP-104 in Healthy Volunteers in October 2021 with Results Expected in 1H 2022

    Corporate Update Conference Call Scheduled for 8:00 am ET Today

    BLACKSBURG, Va., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update on its clinical development plans.

    "Landos is well-positioned to continue its evolution as a biopharmaceutical company. In parallel with our search for Landos' next leader, our Board, leadership team and advisors are reviewing our product development strategies and clinical plans to ensure that we are focusing on the most value-enhancing near-and long-term opportunities," said Tim Mayleben, Interim President and CEO of Landos. "Landos has already established itself as a research and discovery leader based on the productivity of the LANCE Advanced A.I. platform. Leveraging that success, we are taking steps to evaluate and optimize our product development and clinical strategies, and we will be prioritizing our three clinical-stage product candidates, omilancor, NX-13, and LABP-104, and concentrating on the immune-mediated inflammatory disease indications of ulcerative colitis, Crohn's disease, Eosinophilic Esophagitis, Systemic Lupus Erthematosus, and Rheumatoid Arthritis. In addition, we will be reviewing our preclinical programs to optimize the priorities and sequence of these product candidates and their respective clinical applications. We believe that narrowing our focus on advancing our core, high-impact clinical-stage programs will support the strongest outcomes for these product candidates and best position Landos for regulatory approval and commercial success in the future. We look forward to providing continued updates on our progress and deliver value for patients and our shareholders."

    Clinical Development Updates

    Omilancor

    Omilancor is a novel, oral, gut-restricted LANCL2 agonist in development for the treatment of ulcerative colitis (UC), Crohn's disease (CD) and Eosinophilic Esophagitis (EoE) as a once-daily oral treatment.

    • In October 2021, Landos presented positive translational data from the Phase 2 trial of omilancor in mild-to-moderate UC at United European Gastroenterology Week (UEGW). Patients remaining on omilancor after the induction phase of the trial maintained low Mayo scores and showed little to no symptoms beyond 1 year of treatment, with nearly 90% of patients achieving remission thresholds in stool frequency and rectal bleeding after 36 weeks of open-label treatment.



    • Prior to initiating a pivotal Phase 3 study, Landos plans to leverage the results of the prior Phase 2 study of omilancor in mild-to-moderate UC patients to design and initiate a Phase 2b study in 2022. The Phase 2b study is expected to provide additional data to inform the pivotal Phase 3 study design and support regulatory approval.



    • Enrollment in the Phase 2 trial of omilancor in moderate-to-severe CD continues. Landos is actively evaluating the sample size to ensure the Company optimizes the powering of its data. Given the ongoing evaluation, Landos is removing prior guidance for the timing of top-line results.



    • Landos plans to file an orphan drug designation application for pediatric UC patients in Q4 2021.

    NX-13

    NX-13 is a novel, oral, gut-restricted NLXR1 agonist in development for the treatment of UC and CD as a once-daily oral treatment.

    • In October 2021, Landos presented results of its Phase 1a trial of NX-13 in healthy volunteers at UEGW 2021. The trial met all primary and secondary endpoints. The data also demonstrated a signal of efficacy in terms of lowering fecal calprotectin levels, increasing IL-10 concentrations and decreasing IL-6 concentrations in plasma.



    • Enrollment in the Phase 1b trial of NX-13 in the U.S. and Europe continues. Landos is actively evaluating the sample size to ensure the Company optimizes the powering of its data. Given the ongoing evaluation, Landos is removing prior guidance for the timing of top-line results.

    LABP-104

    LABP-104 is a novel, oral, systemically distributed LANCL2 agonist in development for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) as a once-daily oral treatment. LABP-104 activates the LANCL2 pathway to restore the immune system to homeostasis through the enhancement of regulatory T cell (Treg) function and increasing mitochondrial metabolism.

    • In September 2021, Landos announced that the preclinical results of LABP-104 in SLE were accepted for an oral presentation at the American College of Rheumatology Convergence 2021 in November. The presentation will highlight how oral treatment with LABP-104 resulted in enhanced Treg function, maintained kidney function and reduced type I interferon signaling.



    • Landos received FDA clearance in October 2021 of an IND for LABP-104 for the treatment of SLE and RA. A Phase 1 trial has been initiated to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. Top-line results from this study are expected in 1H 2022.

    Summary of Third Quarter 2021 Financial Results

    Cash, Cash Equivalents and Marketable Securities:

    As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $102.7 million, which it believes will be sufficient to fund planned operations through the end of 2023.

    Research and Development ("R&D") Expenses:

    Research and development expenses were $9.3 million for the three months ended September 30, 2021 compared to $7.0 million for the three months ended September 30, 2020. The increase of $2.3 million was primarily attributable to increased costs associated with ongoing development activities related to omilancor, NX-13 and LABP-104.

    General and Administrative ("G&A") Expenses:

    General and administrative expenses were $3.1 million for the three months ended September 30, 2021 compared to $1.5 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to increases in D&O insurance costs and administrative expenses related to increased headcount.

    Other Income (Expense):

    Other expense, net was $0.2 million for the three months ended September 30, 2021 compared to other income, net of $0.2 million in the three months ended September 30, 2020. The change of $0.4 million was due to amortization of bond premium from investment activity and the gains (losses) from foreign exchange.

    Conference Call Information

    Landos will host a corporate update conference call today at 8:00 am ET. A webcast for this call can be accessed at https://ir.landosbiopharma.com/, or by dialing 1-877-317-6789 (Toll Free) or 1-412-317-6789 (International) and asking to join the Landos Corporate Update call. The webcast will be archived and be available for replay on the Company's investor relations website.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. Using the LANCE® platform, the Company discovers new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways at the interface of immunity and metabolism. Landos' lead product candidate, omilancor, targets the LANCL2 pathway and is a novel oral, gut-restricted, small molecule first-in-class therapeutic in development for the treatment of ulcerative colitis, Crohn's disease and Eosinophilic Esophagitis. Landos' second product candidate, NX-13, targets the NLRX1 pathway and is a novel, oral, gut-restricted small molecule first-in-class therapeutic in development for the treatment of ulcerative colitis. Landos discovered and is also developing LABP-104, a novel, oral systemically distributed small molecule first-in-class therapeutic targeting the LANCL2 pathway for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

    For more information, please visit www.landosbiopharma.com.

    Cautionary Note on Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the "Company"), including statements about the Company's strategy, clinical development and regulatory plans for its product candidates, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "anticipate", "plan", "expect", "may", "will", "could", the negatives thereof, variations thereon and similar expressions, or any discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other similar risks. Risks regarding the Company's business are described in detail in its Securities and Exchange Commission ("SEC") filings, including in its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, which are available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that the Company makes from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts

    Andi Rose / Tanner Kaufman / Kara Sperry

    Joele Frank, Wilkinson Brimmer Katcher

    212-355-4449

    Landos Biopharma, Inc.

    Unaudited Condensed Consolidated Balance Sheets

    (in thousands, except share and per share amounts)

     September 30,

    2021
     December 31,

    2020
    Assets     
    Current assets:     
    Cash and cash equivalents$17,893  $2,416 
    Marketable securities, available for-sale 84,777   25,718 
    Incentive and tax receivables 3   154 
    Prepaid expenses and other current assets 1,645   202 
    Deferred offering costs    1,398 
    Total current assets 104,318   29,888 
    Property, plant and equipment, net 780   444 
    Total assets$105,098  $30,332 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)     
    Current liabilities:     
    Accounts payable$10,114  $8,606 
    Accrued liabilities 726   1,939 
    Other current liabilities 255   489 
    Total current liabilities 11,095   11,034 
    Other liabilities 85   276 
    Total liabilities 11,180   11,310 
    Commitments and contingencies     
    Convertible preferred stock, $0.01 par value; no shares authorized, issued or outstanding as of September 30, 2021; 11,260,608 shares authorized, issued and outstanding as of December 31, 2020; aggregate liquidation preference of $70,254 as of December 31, 2020     73,037 
    Stockholders' equity (deficit)     
    Common stock, $0.01 par value; 200,000,000 shares authorized, 40,053,157 and 12,767,909 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively 401   71 
    Additional paid-in-capital 167,440   1,633 
    Accumulated other comprehensive income 131   10 
    Accumulated deficit (74,054)  (55,729)
    Total stockholders' equity (deficit) 93,918   (54,015)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$105,098  $30,332 



    Landos Biopharma, Inc.

    Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     
      2021  2020   2021  2020  
    Revenue – License Fee$ $  $18,000 $  
    Operating expenses:          
    Research and development 9,344  6,966   28,120  15,379  
    General and administrative 3,059  1,453   8,300  3,898  
    Total operating expenses 12,403  8,419   36,420  19,277  
    Loss from operations (12,403) (8,419)  (18,420) (19,277) 
    Other income (expense):          
    Gain (loss) from foreign exchange (10) 84   3  37  
    Other income (expense), net (191) 105   92  437  
    Other income (expense), net (201) 189   95  474  
    Net loss$(12,604)$(8,230) $(18,325)$(18,803) 
    Net loss per share, basic and diluted$(0.32)$(0.67) $(0.50)$(1.56) 
    Weighted-average number of shares used to compute net loss per share, basic and diluted 39,962,069  12,260,804   36,662,627  12,068,515  
    Net loss$(12,604)$(8,230) $(18,325)$(18,803) 
    Unrealized gain on available-for-sales securities 273  25   121  113  
    Comprehensive loss$(12,331)$(8,205) $(18,204)$(18,690) 

     



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  2. BLACKSBURG, Va., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma Inc. (NASDAQ:LABP) today announced that it will report third quarter 2021 financial results and host a conference call to provide a corporate update on November 15, 2021.

    Following the release of the financial results, Landos will host a live webcast at 8:00 am ET. The webcast can be accessed through the Company's investor relations website at https://ir.landosbiopharma.com/, or by dialing 1-877-317-6789 (Toll Free) or 1-412-317-6789 (International) and asking to join the Landos Corporate Update call. The webcast will be archived and be available for replay on the Company's investor relations website.

    About Landos Biopharma
    Landos Biopharma is a clinical-stage biopharmaceutical…

    BLACKSBURG, Va., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma Inc. (NASDAQ:LABP) today announced that it will report third quarter 2021 financial results and host a conference call to provide a corporate update on November 15, 2021.

    Following the release of the financial results, Landos will host a live webcast at 8:00 am ET. The webcast can be accessed through the Company's investor relations website at https://ir.landosbiopharma.com/, or by dialing 1-877-317-6789 (Toll Free) or 1-412-317-6789 (International) and asking to join the Landos Corporate Update call. The webcast will be archived and be available for replay on the Company's investor relations website.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. Using the LANCE® platform, the Company discovers new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways at the interface of immunity and metabolism. Landos' lead product candidate, omilancor targets the LANCL2 pathway and is a novel oral, gut-restricted, small molecule first-in-class therapeutic in development for the treatment of ulcerative colitis and Crohn's disease. Landos' second product candidate, NX-13, targets the NLRX1 pathway and is a novel, oral, gut-restricted small molecule first-in-class therapeutic in development for the treatment of ulcerative colitis. Landos discovered and is also developing LABP-104, a novel, oral small molecule first-in-class therapeutic targeting the LANCL2 pathway for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

    For more information, please visit www.landosbiopharma.com.

    Contact

    Andi Rose / Tanner Kaufman / Kara Sperry

    Joele Frank, Wilkinson Brimmer Katcher

    212-355-4449



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  3. Josep Bassaganya-Riera Steps Down as Chairman, President and CEO

    Tim M. Mayleben Appointed Interim President and CEO

    Chris Garabedian Appointed Chairman of the Board

    BLACKSBURG, Va., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma Inc. (NASDAQ:LABP), a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel oral small-molecule therapeutics for patients with autoimmune diseases, today announced that Josep Bassaganya-Riera, Ph.D., has stepped down as Chairman, President and Chief Executive Officer, effective immediately. Tim M. Mayleben, a member of the Landos Board, has been appointed Interim President and CEO. Chris Garabedian, also a Landos Director, has been appointed…

    Josep Bassaganya-Riera Steps Down as Chairman, President and CEO

    Tim M. Mayleben Appointed Interim President and CEO

    Chris Garabedian Appointed Chairman of the Board

    BLACKSBURG, Va., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma Inc. (NASDAQ:LABP), a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel oral small-molecule therapeutics for patients with autoimmune diseases, today announced that Josep Bassaganya-Riera, Ph.D., has stepped down as Chairman, President and Chief Executive Officer, effective immediately. Tim M. Mayleben, a member of the Landos Board, has been appointed Interim President and CEO. Chris Garabedian, also a Landos Director, has been appointed Chairman of the Board. Dr. Bassaganya-Riera will serve as an advisor to the Company to ensure a smooth transition.

    The Company's Board will initiate a search process to identify its next CEO.

    Mr. Garabedian said, "Josep has built our company from the ground up. Under his visionary leadership, Landos has made tremendous progress advancing and expanding its pipeline of first-in-class oral therapeutics for patients with autoimmune diseases. With seven product candidates in the pipeline across three novel mechanisms, Josep and the Board agree that this is the right time to transition to our next phase of leadership. The Landos Board is actively engaged in a search process to identify a leader with public company and significant clinical development experience that can manage a complex pipeline across multiple indications and realize the full potential of Landos' promising portfolio. On behalf of the Board and everyone at Landos, I want to thank Josep for his vision in creating a truly innovative and science-driven entrepreneurial culture, which has brought success and set the company up for a promising future. We look forward to continuing to benefit from his perspectives as an advisor and shareholder as we now focus on advancing our lead clinical programs and continue to drive sustainable, long-term value for our shareholders."

    Mr. Garabedian continued, "The Board of Directors has appointed Tim Mayleben as Interim CEO to lead the Company during this transition period as we focus on building a highly-experienced leadership team through this important next phase of development. Tim brings more than two decades of leadership experience in the development and approval of innovative therapies. Since joining our Board, he has played an invaluable role in helping Landos navigate the market as a publicly traded company while advancing strategies for our high-impact clinical stage assets. With Tim's leadership, we believe Landos is well positioned to continue advancing as we work to identify Josep's successor."

    Mr. Mayleben commented, "It is a great honor to serve as Interim CEO during this important time for Landos. I have long viewed Landos as a pioneer in our industry, and since joining the Board, I have gained an even deeper appreciation for the important role we have in developing first-in-class oral therapeutics that will address the unmet needs of patients with autoimmune diseases. I believe Landos is well-positioned for the future and look forward to collaborating with the entire team to deliver on our mission to discover and develop novel oral small-molecule therapeutics for patients with autoimmune diseases. As we work to identify the next leader of Landos, we will be reviewing our clinical development and commercialization plans to help ensure that we are focusing on the most value-enhancing near-and long-term opportunities." 

    "I am proud of our significant achievements since our founding in January of 2017," said Dr. Bassaganya-Riera. "Thanks to the incredible passion and dedication of the team, in these four years we have transformed our vision of creating safe, effective treatments into a cutting-edge precision medicine platform with proprietary A.I., drug discovery capabilities and a strong potential to help patients around the world. As I redirect my efforts from Landos towards broadly strengthening our innovative ecosystem, I am confident that with our efforts, Landos remains well-positioned to address the therapeutic gap in the current treatment paradigm for autoimmune diseases. I look forward to continuing to support the Company in an advisory capacity and as a shareholder, as the Company advances its strategic objectives and continues to deliver enduring value for all our stakeholders."

    About Tim Mayleben

    Mr. Mayleben has served on the Landos Board of Directors since May 2021. He most recently served as the President, CEO and Director of Esperion Therapeutics, Inc. where he led the development and marketing approval of the first novel, oral LDL-cholesterol lowering medicines approved in almost two decades, Nexletol and Nexlizet. Mr. Mayleben has more than two decades of executive leadership experience in the life science industry including as former President, CEO and Board member of Vericel Corporation (formerly Aastrom Biosciences, Inc.), former President, COO and Board member of Virtual Radiologics (formerly Nighthawk Radiology Holdings, Inc), and former COO and CFO of the original Esperion Therapeutics, Inc. until its acquisition by Pfizer, Inc. in 2004. Mr. Mayleben also serves as an Independent Board member of Marinus Pharmaceuticals and Kaleo, Inc. where he also serves as non-executive Chairman.

    Mr. Mayleben earned an M.B.A., with distinction, from the J.L. Kellogg Graduate School of Management at Northwestern University, and a B.B.A. from the University of Michigan, Ross School of Business.

    About Chris Garabedian

    Mr. Garabedian founded Xontogeny in June of 2016 to support multiple promising technologies from early development through clinical proof-of-concept, and has served on the Landos Board of Directors since September 2017. In 2017, he joined Perceptive Advisors to develop their Venture Fund strategy and is Portfolio Manager of the Perceptive Xontogeny Ventures Funds, which supports early-stage companies with Series A investments across biotech, medtech and healthtech. Mr. Garabedian has a broad base of experience and a track record of success over his decades long experience in the biopharma industry. He served as the President and CEO of Sarepta Therapeutics from 2011 to 2015, overseeing the turnaround of a company that is now a commercial stage leader in the genetic technology space after leading the development of the company's Duchenne Muscular Dystrophy program. Prior to Sarepta, he led Corporate Strategy for Celgene from 2007 to 2010. Prior to Celgene, he served in a number of global commercial and corporate development leadership roles at Gilead from 1997 to 2005.

    About Landos Biopharma

    Landos Biopharma is a clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. Using the LANCE® platform, the Company has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Its lead product candidate, omilancor targets the LANCL2 pathway and is a novel oral, gut-restricted, small molecule first-in-class therapeutic currently being prepared for global pivotal Phase 3 trials for the treatment of ulcerative colitis, in an active Phase 2 trial in Crohn's disease, and is anticipated to initiate Phase 1 studies in eosinophilic esophagitis in 2022. Omilancor is also being studied in a topical formulation for psoriasis and atopic dermatitis. Landos has another novel, oral, gut-restricted small molecule drug candidate, NX-13, that is being investigated in an active Phase 1b trial in ulcerative colitis. NX-13 targets the NLRX1 pathway. Landos discovered and is also developing LABP-104, a novel, once-daily oral small molecule drug candidate targeting the LANCL2 pathway initially for the treatment of systemic lupus erythematosus and rheumatoid arthritis.

    For more information, please visit www.landosbiopharma.com.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the "Company"), including statements about the Company's business activities; the Company's future expectations and plans and prospects for the Company; the potential of the Company's pipeline programs; and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates, the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications, risks relating to management and key personnel changes and other similar risks. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts

    Investors

    Marek Ciszewski, J.D.

    Landos Biopharma

    562-373-5787

    Media

    Andi Rose / Tanner Kaufman / Kara Sperry

    Joele Frank, Wilkinson Brimmer Katcher

    212-355-4449



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  4. Phase 1 trial is underway with topline results expected in the first half of 2022

    Represents Landos' seventh IND cleared overall and the second IND cleared for LABP-104, a potentially first-in-class therapeutic candidate for systemic lupus erythematosus and rheumatoid arthritis

    BLACKSBURG, Va., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for LABP-104, a novel, oral, systemically delivered LANCL2 agonist, for…

    Phase 1 trial is underway with topline results expected in the first half of 2022

    Represents Landos' seventh IND cleared overall and the second IND cleared for LABP-104, a potentially first-in-class therapeutic candidate for systemic lupus erythematosus and rheumatoid arthritis

    BLACKSBURG, Va., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for LABP-104, a novel, oral, systemically delivered LANCL2 agonist, for the treatment of rheumatoid arthritis (RA). The FDA has recently cleared an IND application for LABP-104 for the treatment of systemic lupus erythematosus (SLE). Landos has initiated a Phase 1 trial of LABP-104 for the treatment of RA and SLE in healthy volunteers and expects to report topline results in the first half of 2022.

    "Our team continues to successfully and timely deliver on the goals we set out at the beginning of the year, notably to clear three INDs in 2021. The FDA clearance of the LABP-104 IND application in RA is Landos' seventh successful IND approval derived from our LANCE A.I. platform in less than four years," commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "LABP-104 has reduced inflammatory cell infiltration and its LANCL2 mechanism showed significantly less risk for toxicities than biologic and JAK inhibitor treatments currently available. As RA patients are prone to relapse, we are inspired by the opportunity to develop a candidate that could potentially redefine the treatment paradigm as a therapy that helps maintain clinical remission and overall survival for these patients, while improving their quality of life."

    Like omilancor, Landos's Phase 3-ready therapeutic candidate for UC, LABP-104 targets the anti-inflammatory receptor LANCL2, a novel mechanism for enhancing Treg function and decreasing TNF production. In a collagen-induced mouse model of arthritis, oral treatment with LABP-104 provided protection from severity of disease, including a significant reduction of redness and swelling in addition to overall paw size. Consistent with the validated actions of the LANCL2 pathway in other indications, with once-daily oral dosing, LABP-104 significantly reduced the numbers of Th17 and T follicular helper cells in the spleen while increasing the number of CD25high FOXP3+ Tregs.

    The Phase 1 trial is a randomized, placebo-controlled, double-blind, ascending dose, multi-cohort study designed to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. A total of 56 healthy volunteers will be enrolled in two parts – a single ascending dose study (SAD) and then a multiple ascending dose study (MAD), during which the participants will be randomized to five cohorts receiving single oral doses of LABP-104 or placebo in the SAD and to three cohorts receiving three oral doses of LABP-104 or placebo once daily for seven days in the MAD. The primary endpoint will measure the safety and tolerability of LABP-104. Secondary endpoint will measure the pharmacokinetics of LABP-104. We expect to report topline results of the Phase 1 trial in the first half of 2022. Additional information about the Phase 1 LABP-104 trial for SLE and RA is available at clinicaltrials.gov (NCT050​19950).

    About Rheumatoid Arthritis (RA)

    Rheumatoid arthritis (RA) is an autoimmune disease characterized by over-activation of the immune system and increased immune cell infiltration that results in chronic pain and loss of mobility due to excessive inflammation that swell joints and erode bone and cartilage. Current therapies in RA have limitations tied to safety and efficacy and are often accompanied by a high risk of severe side effects and co-morbidities. Furthermore, RA requires chronic treatment to maintain clinical remission. RA affects 1.3 million patients in the United States, with the number of new cases expected to increase as the elderly population grows. According to Global Data, in 2021, sales of prescription drugs to treat RA are estimated to total $20.9 billion. The US currently comprises approximately 74% of the total global prescription sales.

    About LABP-104

    LABP-104 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. LABP-104 is currently in clinical development for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). To date, treatment with LABP-104 has reduced the production of interferon alpha in human PBMCs from SLE patients and provided protection from clinical disease and tissue pathology in mouse models of lupus. Landos has initiated a Phase 1 trial of LABP-104 in healthy volunteers for the treatment of SLE and RA, with topline results expected the first half of 2022. In preclinical models of RA, LABP-104 has resulted in decreased tissue-damaging Th17 and Tfh cells with increased protective Tregs for RA. Landos owns an issued patent on LABP-104 in the U.S., a number of foreign patent applications, and an international patent application available for filing in additional foreign countries and regions through the Patent Cooperation Treaty.

    About Landos Biopharma

    Landos Biopharma is a late-clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases. Using the LANCE® platform, the Company has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Its lead product candidate, omilancor targets the LANCL2 pathway and is a novel oral, gut-restricted, small-molecule potentially first-in-class therapeutic currently being prepared for global pivotal Phase 3 trials for the treatment of ulcerative colitis, in two active Phase 2 trials in Crohn's disease, and is anticipated to initiate Phase 1 studies in eosinophilic esophagitis in 2022. Omilancor is also being studied in a topical formulation for psoriasis and atopic dermatitis. NX-13 is a novel, oral, gut-restricted small-molecule drug candidate that targets the NLRX1 pathway and is currently in an active Phase 1b trial in ulcerative colitis. NX-13 targets the NLRX1 pathway. Landos' seventh new clinical product candidate, LABP-104, is in an active Phase 1 trial for systemic lupus erythematosus and rheumatoid arthritis, guided by a proprietary 15-gene precision medicine companion diagnostic developed by its LANCE® advanced A.I. platform. Additional product candidates in Landos' expansible inflammation and immunology pipeline are in preclinical and IND-enabling stages of development. For more information, please visit www.landosbiopharma.com.

    Cautionary Note on Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the "Company"), including statements about the Company's strategy, clinical development and regulatory plans for its product candidates, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "anticipate", "plan", "expect", "may", "will", "could", the negatives thereof, variations thereon and similar expressions, or any discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other similar risks. Risks regarding the Company's business are described in detail in its Securities and Exchange Commission ("SEC") filings, including in its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, which are available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that the Company makes from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic.  In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:

    Marek Ciszewski, J.D.

    Landos Biopharma

    562-373-5787

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943



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  5. Topline results are expected in the first half of 2022

    A whole blood LABP-104 precision medicine signature will be assessed during the trial

    BLACKSBURG, Va., Oct. 28, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, today announced the Company has dosed the first subject in a Phase 1 study of LABP-104, a potentially first-in-class oral, small-molecule LANCL2 agonist, for the treatment of systemic lupus erythematosus (SLE).

    "We are pleased to announce the initiation of the first clinical trial investigating LABP-104, marking Landos' sixth novel clinical…

    Topline results are expected in the first half of 2022

    A whole blood LABP-104 precision medicine signature will be assessed during the trial

    BLACKSBURG, Va., Oct. 28, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases, today announced the Company has dosed the first subject in a Phase 1 study of LABP-104, a potentially first-in-class oral, small-molecule LANCL2 agonist, for the treatment of systemic lupus erythematosus (SLE).

    "We are pleased to announce the initiation of the first clinical trial investigating LABP-104, marking Landos' sixth novel clinical program addressing the unmet clinical needs of patients with autoimmune diseases," said Dr. Josep Bassaganya-Riera, Chairman, President, and CEO of Landos. "Our LANCE platform coupled with our agile entrepreneurial culture continues to deliver high value shots on goal. There are approximately 1.5 million patients in the U.S. suffering from SLE with very limited therapeutic options. Leveraging our LANCE platform to develop a proprietary LABP-104 transcriptional response signature in blood holds promise to identify the SLE patients that may benefit the most from oral LABP-104 treatment. We are excited to advance LABP-104 as the first potential precision medicine-based therapeutic candidate for SLE into clinical testing."

    The Phase 1 trial is a randomized, placebo-controlled, double-blind, ascending dose, multi-cohort study designed to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. A total of 56 healthy volunteers will be enrolled in two parts – a single ascending dose study (SAD) and then a multiple ascending dose study (MAD), during which the participants will be randomized to five cohorts receiving single oral doses of LABP-104 or placebo in the SAD and to three cohorts receiving three oral doses of LABP-104 or placebo once daily for seven days in the MAD. The primary endpoint will measure the safety and tolerability of LABP-104. Secondary endpoint will measure the pharmacokinetics of LABP-104. We expect to report topline results of the Phase 1 trial in the first half of 2022.  Additional information about the Phase 1 LABP-104 trial is available at clinicaltrials.gov (NCT050​19950).

    By using the LANCE® Advanced A.I. platform, Landos has developed a 15-gene LABP-104 transcriptional response signature in whole blood that could be used as a companion diagnostic to better characterize the subsets of lupus patients that can benefit the most from oral treatment with LABP-104. This precision medicine signature will be further validated as an exploratory endpoint in Phase 1 and 2 SLE studies.

    About Systemic Lupus Erythematosus (SLE)

    Systemic lupus erythematosus (SLE) is the most common type of the autoimmune disease lupus. In SLE, the immune system attacks its own tissues, causing widespread inflammation and tissue damage. SLE can affect multiple organs and systems including skin, joints, kidneys, brain, blood cells, lungs and heart. SLE is commonly treated with corticosteroids and antimalarials that aim to lower the interferon alpha response, which elicit strong antiviral activities in target cells. However, current therapeutic options for SLE can cause serious side effects, including the potential for cardiovascular damage, increased risk of infections, sepsis and pneumonia. Newly-FDA-approved therapies for SLE are infusions into a vein in the arm that can cause upper respiratory tract infections, bronchitis, infusion-related reactions and herpes zoster (shingles). As such, there is a high unmet medical need for an alternative oral frontline therapy for the estimated 1.5 million SLE patients in the US and approximately 5 million patients globally, with an estimated market value of approximately $1.6 billion by 2028 and a growth rate of 5.6%.

    About LABP-104

    LABP-104 is an oral, once-daily, systemically-distributed, small-molecule therapeutic candidate which activates LANCL2, a surface-membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, LABP-104 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with LABP-104 has reduced the production of interferon alpha in human PBMCs from SLE patients and provided protection from clinical disease and tissue pathology in mouse models of lupus. We own an issued patent on LABP-104 in the U.S., a number of foreign patent applications, and an international patent application available for filing in additional foreign countries and regions through the Patent Cooperation Treaty.

    About Landos Biopharma

    Landos Biopharma is a late-clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to discover and develop novel therapeutics for patients with autoimmune diseases. Using the LANCE® platform, the Company has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Its lead product candidate, omilancor targets the LANCL2 pathway and is a novel oral, gut-restricted, small-molecule potentially first-in-class therapeutic currently being prepared for global pivotal Phase 3 trials for the treatment of ulcerative colitis, in two active Phase 2 trials in Crohn's disease, and is anticipated to initiate Phase 1 studies in eosinophilic esophagitis in 2022. Omilancor is also being studied in a topical formulation for psoriasis and atopic dermatitis. NX-13 is a novel, oral, gut-restricted small-molecule drug candidate that targets the NLRX1 pathway and is currently in an active Phase 1b trial in ulcerative colitis. NX-13 targets the NLRX1 pathway. Landos' sixth new clinical product candidate, LABP-104, is in an active Phase 1 trial for systemic lupus erythematosus guided by a proprietary 15-gene precision medicine companion diagnostic developed by its LANCE® advanced A.I. platform. Additional product candidates in Landos' expansible inflammation and immunology pipeline are in preclinical and IND-enabling stages of development. For more information, please visit www.landosbiopharma.com.

    Cautionary Note on Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the "Company"), including statements about the Company's strategy, clinical development and regulatory plans for its product candidates, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "anticipate", "plan", "expect", "may", "will", "could", the negatives thereof, variations thereon and similar expressions, or any discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other similar risks. Risks regarding the Company's business are described in detail in its Securities and Exchange Commission ("SEC") filings, including in its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, which are available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that the Company makes from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic.  In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:

    Marek Ciszewski, J.D.

    Landos Biopharma

    562-373-5787

    Michael K. Levitan (investors)

    Solebury Trout

    646-378-2920

    Hannah Gendel (media)

    Solebury Trout

    646-378-2943

     



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