PAND Pandion Therapeutics Inc.

60.2
+0.39  (+1%)
Previous Close 59.81
Open 59.65
52 Week Low 10.28
52 Week High 60.71
Market Cap $1,777,098,100
Shares 29,519,902
Float 10,297,890
Enterprise Value $508,920,739
Volume 2,354,318
Av. Daily Volume 288,475
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Drug Pipeline

Drug Stage Notes
PT101
Healthy volunteers
Phase 1
Phase 1
Phase 1a trial achieved primary objective of safety and tolerability - January 4, 2021. Phase 1a/2b trial in ulcerative colitis expected to start mid-2021 and Phase 2 clinical trial in systemic lupus erythematosus expected to start 2H 2021

Latest News

  1. Acquisition Adds Pipeline of Candidates Targeting a Broad Range of Autoimmune Diseases

    Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pandion Therapeutics, Inc. (NASDAQ:PAND) today announced that the companies have entered into a definitive agreement, under which Merck, through a subsidiary, will acquire Pandion, a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, for $60 per share in cash. This represents an approximate total equity value of $1.85 billion.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005318/en/

    "This acquisition builds upon Merck's…

    Acquisition Adds Pipeline of Candidates Targeting a Broad Range of Autoimmune Diseases

    Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pandion Therapeutics, Inc. (NASDAQ:PAND) today announced that the companies have entered into a definitive agreement, under which Merck, through a subsidiary, will acquire Pandion, a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, for $60 per share in cash. This represents an approximate total equity value of $1.85 billion.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005318/en/

    "This acquisition builds upon Merck's strategy to identify and secure candidates with differentiated and potentially foundational characteristics," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Pandion has applied its TALON technology to develop a robust pipeline of candidates designed to re-balance the immune response with potential applications across a wide array of autoimmune diseases."

    Pandion is advancing a pipeline of precision immune modulators targeting critical immune control nodes. The company's lead candidate, PT101, is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of ulcerative colitis and other autoimmune diseases. Earlier this year, Pandion announced that PT101 had completed a Phase 1a clinical trial, which achieved its primary objective of safety and tolerability. The company's pipeline also includes PD-1 agonists in development for numerous autoimmune diseases.

    "Pandion grew out of our founders' personal and scientific mission to change the way patients living with autoimmune diseases are treated. In just a few years, we have taken that mission from idea to clinical proof of mechanism with PT101, our lead IL-2 mutein. We are proud that Merck has recognized our team's innovation and drive in creating a pipeline of diverse candidates that activate natural immune regulatory mechanisms and thereby have the potential to achieve better clinical responses for patients," said Dr. Rahul Kakkar, chief executive officer, Pandion Therapeutics. "We believe Merck is well positioned to bring our novel approach to the millions of those living with autoimmune diseases, and we look forward to seeing these molecules progress in the clinic."

    Under the terms of the acquisition agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Pandion. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Pandion's shares of fully-diluted common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the successful completion of the tender offer, Merck's acquisition subsidiary will be merged into Pandion, and any remaining shares of common stock of Pandion will be canceled and converted into the right to receive the same $60 per share price payable in the tender offer. The transaction is expected to close in the first half of 2021.

    Credit Suisse Securities (USA) LLC acted as financial advisor to Merck and Covington & Burling LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Pandion and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor.

    About Regulatory T Cells (Tregs)

    Tregs act as a control node within the immune system and can inhibit the activity of several different pro-inflammatory immune cell types. Tregs are critical for self-tolerance, or the ability of the immune system to recognize a hosts' cells and not produce an immune attack against them. Defects in Tregs result in multi-organ inflammation and their dysfunction is associated with many autoimmune diseases. Multiple third-party clinical trials suggest that expansion of Tregs by low-dose IL-2 can benefit patients with autoimmune diseases.

    About PT101

    PT101 is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells for the treatment of autoimmune diseases. In autoimmune diseases, the immune system inappropriately attacks a host's cells, and targeting Tregs could allow the immune system to regain control and return to homeostasis. PT101 has completed a Phase 1a clinical trial, which achieved its primary objective of safety and tolerability. In the trial, PT101 demonstrated proof of mechanism by selectively expanding Tregs in healthy volunteers.

    Important Information About the Tender Offer

    The tender offer described in this press release (the "Offer") has not yet commenced. This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Pandion Therapeutics, Inc. ("Pandion") or any other securities. At the time the planned tender offer is commenced, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed by Merck Sharp & Dohme Corp. ("Merck") and Panama Merger Sub, Inc., a wholly-owned subsidiary of Merck, with the Securities and Exchange Commission (the "SEC"), and a solicitation/recommendation statement on Schedule 14D-9 will be filed by Pandion with the SEC. The offer to purchase shares of Pandion common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO.

    INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

    Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and Pandion will file annual, quarterly and current reports and other information with the SEC. Merck's and Pandion's filings with the SEC also will be available to the public from commercial document-retrieval services and at the SEC's website at www.sec.gov.

    About Pandion Therapeutics

    Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion's TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion's lead product candidate PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com and engage with us on Twitter @PandionTX or on LinkedIn.

    About Merck

    For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Pandion Therapeutics Forward-Looking Statements

    This press release contains "forward-looking statements" that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding PT101 as a potential treatment for patients with autoimmune diseases, the timing of future clinical trials of PT101, the Company's strategy and clinical development plans, timelines and prospects, and information related to the proposed acquisition of Pandion are forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition, the parties' ability to satisfy the conditions to the consummation of the tender offer and the other conditions to the consummation of the acquisition; statements about the expected timetable for completing the transaction; and the anticipated timing of closing of the proposed acquisition. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Pandion's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; initiate preclinical studies and clinical trials of PT101 and its other product candidates; advance PT101 and its other product candidates in preclinical research and clinical trials; replicate in clinical trials positive results found in preclinical studies; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives; risks related to the satisfaction of waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all; uncertainties as to how many of Pandion's stockholders will tender their shares of Pandion common stock in the tender offer and the possibility that the acquisition does not close; the possibility that competing offers may be made; risks related to obtaining the requisite consents to the acquisition, including, without limitation, the timing (including possible delays) and receipt of clearance under the Hart-Scott-Antitrust Improvements Act of 1976, as amended; disruption from the transaction making it more difficult to maintain business and operational relationships; and significant transaction costs. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to 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.

    Merck & Co., Inc., Kenilworth, N.J., USA Forward-Looking Statements

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (https://www.sec.gov/).

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  2. WATERTOWN, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Pandion Therapeutics, Inc. (NASDAQ:PAND), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, today presented preclinical data on PT001, the Company's tissue-tethered PD-1 agonist, at the Network for Pancreatic Organ Donors with Diabetes (nPOD) 13th Annual Scientific Meeting. The research, done in collaboration with St Vincent's Institute of Medical Research in Australia and funded by JDRF and the JDRF T1D Fund, showed that PT001 treatment delayed the onset of hyperglycemia in a mouse model of Type 1 diabetes.

    PD-1 plays a critical role in immune homeostasis and its dysfunction is linked to…

    WATERTOWN, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Pandion Therapeutics, Inc. (NASDAQ:PAND), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, today presented preclinical data on PT001, the Company's tissue-tethered PD-1 agonist, at the Network for Pancreatic Organ Donors with Diabetes (nPOD) 13th Annual Scientific Meeting. The research, done in collaboration with St Vincent's Institute of Medical Research in Australia and funded by JDRF and the JDRF T1D Fund, showed that PT001 treatment delayed the onset of hyperglycemia in a mouse model of Type 1 diabetes.

    PD-1 plays a critical role in immune homeostasis and its dysfunction is linked to the development of autoimmune diseases, such as Type 1 diabetes, lupus and vitiligo. PD-1 is an inhibitory receptor located on conventional T cells, which, when activated, promotes the attenuation of an immune attack. PT001 is designed to agonize, or activate, PD-1 receptors to reduce aberrant immune responses in tissues expressing mucosal addressin cell adhesion molecule (MAdCAM), such as the gastrointestinal tract, liver, and inflamed pancreas.

    "With tissue-tethered immunomodulation, we're able to increase locally the concentration of our therapeutic candidates, driving robust responses in animal models that are not possible with their untethered counterparts. We believe this opens the door for Pandion to be at the forefront of addressing localized autoimmune diseases in a new, more targeted way," said Jo Viney, Ph.D., President, Co-Founder and Chief Scientific Officer of Pandion. "The data presented at nPOD give us confidence in pursuing a tissue-tethered approach for T1D and other autoimmune diseases of the pancreas in collaboration with JDRF and Astellas. We are in the process of lead optimization for the PT001 program and expect to nominate a development candidate in the first half of this year."

    The Company plans to develop PT001 for autoimmune diseases of the gut and liver, and potentially pancreas. Pandion is also pursuing additional pancreas tethers as part of its collaboration with Astellas to discover and develop novel compounds for autoimmune diseases of the pancreas, including Type 1 diabetes.

    The presentation, "A Novel PD-1:MAdCAM Bifunctional Antibody for the Treatment of T1D," was authored by D. Rios, L. Edwards, S. Alioto, M. Proschitsky, R. Taylor, S. Litwak, G. Jhala, H. Thomas, I. Mascanfroni, N. Higginson-Scott, K. Kis-Toth, K. Otipoby, and J Viney and is available on the Company's website: https://pandiontx.com/our-science/posters-presentations/.  

    About Pandion Therapeutics

    Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion's TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion's lead product candidate PT101, a combination of an interleukin-2 mutein effector module fused to a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com and engage with us on Twitter @PandionTX or on LinkedIn.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy and clinical development plans, timelines and prospects, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Pandion's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; initiate preclinical studies and clinical trials of PT101 and its other product candidates; advance PT101 and its other product candidates in preclinical research and clinical trials; replicate in clinical trials positive results found in preclinical studies; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to 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.

    Contacts

    Media:

    Kathryn Morris

    The Yates Network

    914-204-6412

    Investors:

    Michelle Avery

    Pandion Therapeutics

    857-273-0444



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  3. WATERTOWN, Mass., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Pandion Therapeutics, Inc. (NASDAQ:PAND), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, today announced that Rahul Kakkar, M.D., Chief Executive Officer of Pandion Therapeutics, will present at the upcoming 10th Annual SVB Leerink Healthcare Conference on Thursday, February 25, 2021, at 9:20 a.m. ET.

    A live webcast of the presentation will be available in the Investors and News section of Pandion Therapeutics' website at https://www.pandiontx.com/. A replay of the webcast will be available shortly following the presentation.

    About Pandion Therapeutics
    Pandion Therapeutics is developing…

    WATERTOWN, Mass., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Pandion Therapeutics, Inc. (NASDAQ:PAND), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, today announced that Rahul Kakkar, M.D., Chief Executive Officer of Pandion Therapeutics, will present at the upcoming 10th Annual SVB Leerink Healthcare Conference on Thursday, February 25, 2021, at 9:20 a.m. ET.

    A live webcast of the presentation will be available in the Investors and News section of Pandion Therapeutics' website at https://www.pandiontx.com/. A replay of the webcast will be available shortly following the presentation.

    About Pandion Therapeutics

    Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion's TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion's lead product candidate PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com and engage with us on Twitter @PandionTX or on LinkedIn.

    For further information, please contact:

    Media:

    Kathryn Morris

    The Yates Network

    914-204-6412

    Investors:

    Michelle Avery

    Pandion Therapeutics

    857-273-0444

     



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  4. -Phase 1a trial achieved primary objective of safety and tolerability
    -PT101 induced potent and selective expansion of regulatory T cells exceeding levels associated with clinical benefit in third-party clinical trials across multiple autoimmune diseases
    -PT101 maintained selectivity for regulatory T cells at all doses tested
    -Phase 1a/2b clinical trial in ulcerative colitis expected to start mid-2021 and Phase 2 clinical trial in systemic lupus erythematosus expected to start second half 2021
    -Phase 1a results to be presented in a conference call scheduled today at 8:30 a.m. ET

    WATERTOWN, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Pandion Therapeutics (NASDAQ:PAND) today announced positive top-line data from its Phase 1a single-dose, healthy volunteer…

    -Phase 1a trial achieved primary objective of safety and tolerability

    -PT101 induced potent and selective expansion of regulatory T cells exceeding levels associated with clinical benefit in third-party clinical trials across multiple autoimmune diseases

    -PT101 maintained selectivity for regulatory T cells at all doses tested

    -Phase 1a/2b clinical trial in ulcerative colitis expected to start mid-2021 and Phase 2 clinical trial in systemic lupus erythematosus expected to start second half 2021

    -Phase 1a results to be presented in a conference call scheduled today at 8:30 a.m. ET

    WATERTOWN, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Pandion Therapeutics (NASDAQ:PAND) today announced positive top-line data from its Phase 1a single-dose, healthy volunteer clinical trial, demonstrating proof of mechanism of PT101, an engineered IL-2 mutein fused to a protein backbone, in development for ulcerative colitis (UC), systemic lupus erythematosus (SLE), and other autoimmune diseases.

    In the Phase 1a clinical trial, PT101 was observed to be well-tolerated and there were no serious adverse events.

    PT101 selectively expanded total regulatory T cells (Tregs), with a mean maximal increase up to of 3.6-fold over baseline. A subset of activated Tregs with high CD25 expression, known as CD25 bright Tregs, expanded, with a mean maximal increase of up to 72.5-fold over baseline. There was no evidence of expansion of natural killer T (NK) cells and pro-inflammatory conventional T (Tconv) at any dose studied. In third-party clinical trials using low-dose native IL-2, a two-fold increase in total Tregs was associated with clinical benefit across multiple autoimmune diseases.

    "Native IL-2 has been the subject of several clinical trials across a range of autoimmune diseases due to its ability to activate a normal immune regulatory response and improve disease activity. However, its therapeutic use has been hampered by native IL-2's undesired activation of the pro-inflammatory side of the immune system," said Scott Snapper, M.D., Ph.D., Chief, Division of Gastroenterology, Hepatology and Nutrition; Director, Inflammatory Bowel Disease Center at Boston Children's Hospital and Professor of Medicine at Harvard Medical School. "PT101's high selectivity for and expansion of Tregs could allow for a fulsome exploration of the potential of this mechanism in autoimmune diseases, and I look forward to seeing its continued clinical development by Pandion."

    The Phase 1a randomized, blinded clinical trial enrolled 56 healthy volunteers across seven cohorts who each received a single subcutaneous fixed dose of PT101 ranging from 1 mg to 10 mg, or placebo. Subjects were followed for 28 days after dosing and evaluated for safety and tolerability as well as pharmacokinetic and pharmacodynamic measures. These measures were selected to assess the potency and selectivity of PT101 in order to establish proof of mechanism.

    All adverse events observed in the trial were low grade (Grade 1 or 2) and self-limited. The most common adverse events were skin reactions of itching, redness or pain near or around the site of injection of PT101. In laboratory tests, some subjects showed transient elevations of eosinophils, a type of white blood cell, that were self-limited in nature and did not require medical treatment. The Company believes the eosinophil elevation may be related to the IL-2 mechanism of PT101.

    Expansion of both total Tregs and the CD25 bright Treg subset was observed throughout the dose range, as depicted in the table below. Peak expansion of Tregs was observed between days 8 and 10. At doses of 3.5 mg and above, PT101 induced a two-fold or greater expansion of total Tregs in more than 80% of subjects. Tregs returned to baseline or near-baseline over the 28-day follow-up period, supporting the Company's plan to utilize a dosing regimen of every four weeks in future clinical trials.

     Placebo

    (n=14)
    1 mg

    (n=6)
    3.5 mg

    (n=12)
    5 mg

    (n=12)
    7.5 mg

    (n=6)
    10 mg

    (n=6)
    Mean peak fold expansion of Total Tregs (SEM)1.4 (±0.08)1.8 (±0.31)3.6 (±0.66)3.5 (±0.37)3.4 (±0.57)3.2 (±0.24)
    Mean peak fold expansion of CD25 bright Treg subset (SEM)3.4 (±0.49)8.6 (±3.33)72.5 (±26.39)54.1 (±8.89)51.6 (±17.17)37.4 (±6.93)

    SEM= standard error of the mean

    "These data show PT101 meaningfully expanded regulatory T cells while maintaining a high degree of selectivity," commented John Sundy, M.D., Ph.D., Chief Medical Officer of Pandion Therapeutics. "We believe this combined potency and selectivity could provide meaningful clinical benefit for patients with many different autoimmune diseases. Therefore, following the completion of the regulatory process, we plan to initiate a Phase 1b/2a clinical trial in patients with UC in mid-2021 and a Phase 2 clinical trial in patients with SLE in the second half of 2021."

    Full data from the trial are expected to be presented at upcoming medical meetings.

    Conference Call and Webcast Information

    Pandion will hold a conference call and webcast to review the Phase 1a clinical data of PT101 today at 8:30 a.m. ET. To participate in the conference call, please dial +1 833-693-0533 (US toll-free number) or +1 661-407-1572 (international participants) and use the passcode 6051816. Investors may also access a live audio webcast of the call and slides for the discussion via the Investors & News section of the Company's website, www.pandiontx.com. A replay of the webcast will be available on the Company's website shortly after the presentation ends.

    About Regulatory T Cells (Tregs)

    Tregs act as a control node within the immune system and can inhibit the activity of several different pro-inflammatory immune cell types. Tregs are critical for self-tolerance, or the ability of the immune system to recognize a hosts' cells and not produce an immune attack against them. Defects in Tregs result in multi-organ inflammation and their dysfunction is associated with many autoimmune diseases. Multiple third-party clinical trials suggest that expansion of Tregs by low-dose IL-2 can benefit patients with autoimmune diseases.

    CD25 bright Tregs are a subset of Tregs with high expression of CD25 (also known as the IL-2 receptor alpha subunit). It has been reported that CD25 bright Tregs may be a more active subset of Tregs with enhanced immune regulatory function.

    About PT101

    PT101 is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells for the treatment of autoimmune diseases. In autoimmune diseases, the immune system inappropriately attacks a host's cells, and targeting regulatory T cells could allow the immune system to regain control and return to homeostasis. PT101 has completed a Phase 1a clinical trial, which met its primary endpoint of safety and tolerability. In the trial, PT101 demonstrated proof of mechanism by selectively expanding Tregs in healthy volunteers.

    About Pandion Therapeutics

    Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion's TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion's lead product candidate PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com and engage with us on Twitter @PandionTX or on LinkedIn.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding PT101 as a potential treatment for patients with autoimmune diseases, the timing of future clinical trials of PT101, the Company's strategy and clinical development plans, timelines and prospects, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Pandion's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; initiate preclinical studies and clinical trials of PT101 and its other product candidates; advance PT101 and its other product candidates in preclinical research and clinical trials; replicate in clinical trials positive results found in preclinical studies; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to 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.

    Contacts

    Media:

    Kathryn Morris

    The Yates Network

    914-204-6412

    Investors:

    Michelle Avery

    Pandion Therapeutics

    857-273-0444



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  5. Strengthens senior leadership team with appointments of Donald Johns, M.D., as Chief Medical Officer and Katina Dorton, J.D., MBA, as Chief Financial Officer

    NodThera, a biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat chronic inflammation, today announced the expansion of its senior leadership team with the appointments of Donald Johns, M.D., as Chief Medical Officer and Katina Dorton, J.D., MBA, as Chief Financial Officer.

    Dr. Johns is an accomplished drug development leader and board-certified clinical neurologist who previously served as Chief Medical Officer and Executive Vice President of Medical and Scientific Affairs at Syntimmune, prior to the company's acquisition by Alexion…

    Strengthens senior leadership team with appointments of Donald Johns, M.D., as Chief Medical Officer and Katina Dorton, J.D., MBA, as Chief Financial Officer

    NodThera, a biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat chronic inflammation, today announced the expansion of its senior leadership team with the appointments of Donald Johns, M.D., as Chief Medical Officer and Katina Dorton, J.D., MBA, as Chief Financial Officer.

    Dr. Johns is an accomplished drug development leader and board-certified clinical neurologist who previously served as Chief Medical Officer and Executive Vice President of Medical and Scientific Affairs at Syntimmune, prior to the company's acquisition by Alexion Pharmaceuticals. Ms. Dorton is a recognized and internationally experienced financial executive, corporate director and public company CFO. Ms. Dorton's industry expertise includes roles in healthcare, life sciences and investment banking, including experiences at Repare Therapeutics and AVROBIO, Inc.

    NodThera is advancing a portfolio of potent and selective inhibitors of the NLRP3 inflammasome that reduce both IL-1β and IL-18, pro-inflammatory cytokines which are known to play a role in chronic inflammation underlying a wide range of diseases. The pipeline includes brain penetrant NLRP3 inhibitors for central nervous system (CNS) indications.

    "We welcome Don and Katina to the team as we continue to advance our portfolio of differentiated NLRP3 inhibitors to capitalize on the opportunity to exploit the well-understood, but still untapped therapeutic potential of the NLRP3 inflammasome across a broad spectrum of diseases," said Adam Keeney, Ph.D., President & Chief Executive Officer of NodThera. "Don is an accomplished clinician with an impressive track record who brings a wealth of innovative clinical development experience. Katina brings capital markets experience and has built financial, legal and operational functions to support companies through aggressive growth, including IPO preparation. Their combined contributions will add significant value as we continue to advance NodThera's portfolio through clinical development and additional financing rounds."

    "The NLRP3 inflammasome is one of the most exciting emerging areas of therapeutic science. NodThera's best-in-class molecules have great potential to address the unmet medical need in patients with a wide range of inflammatory disorders," said Dr. Johns. Ms. Dorton adds, "By leveraging innate immunity, NodThera's platform has the potential to blaze a new path forward in a wide range of disorders, and I am excited to join the rest of the experienced leadership team in this effort."

    Dr. Johns brings more than 25 years of experience in the development of novel treatments for serious diseases, including autoimmune and CNS disorders. Prior to his role at Syntimmune, Dr. Johns served in key leadership positions at Biogen and the Novartis Institutes for Biomedical Research (NIBR). He has contributed to numerous investigational new drug applications (INDs), first-in-human studies and conclusive proof-of-concept studies in a broad spectrum of CNS and autoimmune diseases, as well as four successful new drug applications (NDAs). Prior to joining the pharmaceutical industry, he was a neurologist clinician-scientist at Johns Hopkins and Harvard Medical School. Dr. Johns earned his B.A. from Vanderbilt University and his M.D. from the Yale University School of Medicine.

    Ms. Dorton currently serves on the board of directors for Fulcrum Therapeutics (NASDAQ:FULC), Pandion Therapeutics, Inc. (NASDAQ:PAND) and US Ecology (NASDAQ:ECOL). She most recently served as Chief Financial Officer of Repare Therapeutics, a synthetic lethality and DNA repair-focused oncology company. Prior to Repare, Ms. Dorton served as Chief Financial Officer of AVROBIO, a lentiviral gene therapy company. Earlier in her career, she served as a managing director in investment banking for Morgan Stanley and Needham & Company and as an associate attorney at Sullivan & Cromwell. Ms. Dorton received her J.D. from the University of Virginia School of Law, her MBA from George Washington University and her B.A. from Duke University.

    About NodThera

    NodThera is a biotechnology company developing a new class of potent and selective NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. Led by an experienced management team, NodThera is leveraging new insights into inflammasome biology and chemistry to build a platform of highly differentiated small molecule NLRP3 inhibitors. The company was founded by Epidarex Capital and further financed by 5AM Ventures, Cowen Healthcare Investments, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera was founded in 2016 and maintains offices in Cambridge, UK, Seattle, WA and Boston, MA. For more information please visit www.nodthera.com.

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