CD16a antagonists(Low affinity immunoglobulin gamma Fc region receptor III-A antagonists), CD33 inhibitors(Myeloid cell surface antigen CD33 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

+ [1]

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [2]

Active Indication-

Inactive Indication

Acute Myeloid LeukemiaHigh Risk Myelodysplastic SyndromeMast-Cell Leukemia

Originator Organization

University of Minnesota

Active Organization-

Inactive Organization

GT Biopharma, Inc.

License Organization-

Drug Highest PhaseDiscontinuedPhase 1/2

First Approval Date-

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 13371207

Clinical Trials associated with OXS-3550

NCT03214666

/ TerminatedPhase 1/2

GTB-3550 (CD16/IL-15/CD33)Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes, Refractory/Relapsed Acute Myeloid Leukemia and Advanced Systemic Mastocytosis

This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The hypothesis is that GTB-3550 TriKE® will induce natural killer cell function by targeting malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to tumor induced immunosuppression. Because CD16 is the most potent activating receptor on natural killer (NK) cells, this single agent may induce a targeted anti-CD33+ tumor response.

Start Date01 Jan 2020

Sponsor / Collaborator

GT Biopharma, Inc.

100 Clinical Results associated with OXS-3550

100 Translational Medicine associated with OXS-3550

100 Patents (Medical) associated with OXS-3550

Literatures (Medical) associated with OXS-3550

26 Jun 2018·Blood AdvancesQ2 · MEDICINE

161533 TriKE stimulates NK-cell function to overcome myeloid-derived suppressor cells in MDS

Q2 · MEDICINE

Article

Author: Hinderlie, Peter ; Brandt, Ludwig ; Curtsinger, Julie ; Spellman, Stephen R. ; Warlick, Erica ; Sarhan, Dhifaf ; Miller, Jeffrey S. ; Önfelt, Björn ; Guldevall, Karolin ; Felices, Martin ; Vallera, Daniel A. ; Lenvik, Todd ; Blazar, Bruce R. ; Cooley, Sarah ; Weisdorf, Daniel J.

Key Points161533 TriKE–treated MDS NK cells proliferate and become activated to overcome tumor-induced NK cell dysfunction. IL-15 induces the inhibitory checkpoint TIGIT on NK cells, but not when IL-15 is presented in the context of 161533 TriKE.

15 Jul 2016·Clinical Cancer ResearchQ1 · MEDICINE

IL15 Trispecific Killer Engagers (TriKE) Make Natural Killer Cells Specific to CD33+ Targets While Also Inducing Persistence,In VivoExpansion, and Enhanced Function

Q1 · MEDICINE

Article

Author: Lenvik, Alexander J. ; McCullar, Valarie ; Zhang, Bin ; Felices, Martin ; Panoskaltsis-Mortari, Angela ; Cooley, Sarah ; McElmurry, Ron ; Zhou, Xianzheng ; Weisdorf, Daniel J. ; Miller, Jeffrey S. ; Blazar, Bruce R. ; Vallera, Daniel A. ; Tolar, Jakub ; Verneris, Michael R. ; Schmohl, Joerg Uwe

AbstractPurpose: The effectiveness of NK cell infusions to induce leukemic remission is limited by lack of both antigen specificity and in vivo expansion. To address the first issue, we previously generated a bispecific killer engager (BiKE) containing single-chain scFv against CD16 and CD33 to create an immunologic synapse between NK cells and CD33+ myeloid targets. We have now incorporated a novel modified human IL15 crosslinker, producing a 161533 trispecific killer engager (TriKE) to induce expansion, priming, and survival, which we hypothesize will enhance clinical efficacy.Experimental Design: Reagents were tested in proliferation and functional assays and in an in vivo xenograft model of AML.Results: When compared with the 1633 BiKE, the 161533 TriKE induced superior NK cell cytotoxicity, degranulation, and cytokine production against CD33+ HL-60 targets and increased NK survival and proliferation. Specificity was shown by the ability of a 1615EpCAM TriKE to kill CD33-EpCAM+ targets. Using NK cells from patients after allogeneic stem cell transplantation when NK cell function is defective, the 161533 TriKE restored potent NK function against primary AML targets and induced specific NK cell proliferation. These results were confirmed in an immunodeficient mouse HL-60-Luc tumor model where the 161533 TriKE exhibited superior antitumor activity and induced in vivo persistence and survival of human NK cells for at least 3 weeks.Conclusions: Off-the-shelf 161533 TriKE imparts antigen specificity and promotes in vivo persistence, activation, and survival of NK cells. These qualities are ideal for NK cell therapy of myeloid malignancies or targeting antigens of solid tumors. Clin Cancer Res; 22(14); 3440–50. ©2016 AACR.See related commentary by Talmadge, p. 3419

News (Medical) associated with OXS-3550

02 Feb 2023

·www.globenewswire.com

GT Biopharma Issues Open Letter to Shareholders Detailing Recent Activities

BRISBANE, CALIFORNIA, Feb. 02, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, issued an open letter from the CEO to shareholders, detailing the Company’s recent activities. The full letter is published below: Dear GT Biopharma Shareholders, I am proud to say that we have made significant progress towards fulfilling our corporate mission. It remains our goal to bring to market, a novel camelid nanobody technology platform, with target-directed immunotherapy in the fight against cancers. At the moment, we have more than 6 promising pipeline assets in active preclinical development, targeting both solid tumors and hematological malignancies. On the corporate development side our board and executives continue to manage the task of taking GT Biopharma’s promising assets into the clinic. Earlier in the year, Manu Ohri, joined the executive leadership team as our chief financial officer to lead the Company’s finance team and I was appointed interim CEO in addition to my existing role as Executive Chairman. Operationally, we reached an exciting milestone in our development lifecycle and signed an agreement with Cytovance Biologics Inc. in the third quarter of fiscal 2022. The agreement covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. Food and Drug Administration for our lead investigational asset GTB-3650. GTB-3650, a second generation TriKE® will move forward in its development and we expect to file an IND submission in the first half of 2023. An IND submission for GTB-5550 in solid tumors is expected to follow thereafter. We are proud of the work that the team has performed in order to reach this juncture. As previously noted, GTB-3650 is in place of GTB-3550, the Company’s first generation, first-in-human TriKE®. The pivoting to GTB-3650 continues to be underpinned by the safety data that was carried forward from GTB-3550’s Phase 1 safety study. The therapeutic and commercial advantages of GTB-3650 as compared to GTB-3550 however are many and include: Traditional IgG monoclonal antibodies based on second generation camelid single-domain antibody technology;Improved potency and enhanced binding affinity;Similar preclinical safety profile; andCommercial manufacturing capabilities through arrangement with Cytovance. While the biotech capital markets continue to remain volatile, we remain well capitalized and expect our current cash runway to fund operations into 2023. Additionally, we remain actively engaged with the capital markets at large and have presented at numerous investment conferences throughout the year. On the scientific front, we continue to be an active participant in order to bring awareness of our technology and have presented at many of the important annual oncology medical meetings that have taken place thus far. Most recently, Dr. Jeff Miller presented a study at the American Society of Hematology's 64th Annual Meeting. The presentation highlighted the potential of a novel dual antigen targeting approach for the treatment of acute myeloid leukemia (AML), combining GT Biopharma’s Tri-specific Killer Engager (TriKE) with the induced pluripotent stem cell (iPSC) product platform of Fate Therapeutics, Inc. (NASDAQ:FATE). In addition, I am delighted to report that in mid-December of this year, Dr. Jeff Miller, renowned NK Cell Cancer Specialist, was appointed Consulting Chief Medical Officer to the Company. In conclusion, we have placed great emphasis in this past year to bring about the next stages of value creation on behalf of GT Biopharma’s shareholders. We have also taken capital allocation into consideration relative to the current market. While GTB-3650 and GTB-5550 both share the advantages of being a second generation TriKE, it is important to note that the significance of the commercial size for GTB-5550 for solid tumors is appreciably larger than the size of the hematologic cancer market at present. We are thankful that you have entrusted the senior executive leadership team with this charge, a matter that we do not take lightly. Furthermore, we believe that will be able to carry this momentum with us and look forward to sharing the next steps of our strategic operating plan with investors in the forthcoming year. We also want to thank our employees for whom GT Biopharma’s innovations would not be possible without their hard-won efforts. Wishing you and your family a wonderful New Year. Best regards, Michael BreenExecutive Chairman and Interim Chief Executive Officer About GT Biopharma, Inc.GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com. Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission. TriKE® is a registered trademark owned by GT Biopharma, Inc. Investor Relations Contacts: LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com212-915-2577

Phase 1Executive ChangeLicense out/inASHImmunotherapy

02 Feb 2023

·www.biospace.com

GT Biopharma Issues Open Letter to Shareholders Detailing Recent Activities - February 02, 2023

BRISBANE, CALIFORNIA, Feb. 02, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, issued an open letter from the CEO to shareholders, detailing the Company’s recent activities. The full letter is published below: Dear GT Biopharma Shareholders, I am proud to say that we have made significant progress towards fulfilling our corporate mission. It remains our goal to bring to market, a novel camelid nanobody technology platform, with target-directed immunotherapy in the fight against cancers. At the moment, we have more than 6 promising pipeline assets in active preclinical development, targeting both solid tumors and hematological malignancies. On the corporate development side our board and executives continue to manage the task of taking GT Biopharma’s promising assets into the clinic. Earlier in the year, Manu Ohri, joined the executive leadership team as our chief financial officer to lead the Company’s finance team and I was appointed interim CEO in addition to my existing role as Executive Chairman. Operationally, we reached an exciting milestone in our development lifecycle and signed an agreement with Cytovance Biologics Inc. in the third quarter of fiscal 2022. The agreement covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. Food and Drug Administration for our lead investigational asset GTB-3650. GTB-3650, a second generation TriKE® will move forward in its development and we expect to IND submission in the first half of 2023. An IND submission for GTB-5550 in solid tumors is expected to follow thereafter. We are proud of the work that the team has performed in order to reach this juncture. As previously noted, GTB-3650 is in place of GTB-3550, the Company’s first generation, first-in-human TriKE®. The pivoting to GTB-3650 continues to be underpinned by the safety data that was carried forward from GTB-3550’s Phase 1 safety study. The therapeutic and commercial advantages of GTB-3650 as compared to GTB-3550 however are many and include: Traditional IgG monoclonal antibodies based on second generation camelid single-domain antibody technology; Improved potency and enhanced binding affinity; Similar preclinical safety profile; and Commercial manufacturing capabilities through arrangement with Cytovance. While the biotech capital markets continue to remain volatile, we remain well capitalized and expect our current cash runway to fund operations into 2023. Additionally, we remain actively engaged with the capital markets at large and have presented at numerous investment conferences throughout the year. On the scientific front, we continue to be an active participant in order to bring awareness of our technology and have presented at many of the important annual oncology medical meetings that have taken place thus far. Most recently, Dr. Jeff Miller presented a study at the American Society of Hematology's 64th Annual Meeting. The presentation highlighted the potential of a novel dual antigen targeting approach for the treatment of acute myeloid leukemia (AML), combining GT Biopharma’s Tri-specific Killer Engager (TriKE) with the induced pluripotent stem cell (iPSC) product platform of Fate Therapeutics, Inc. (NASDAQ:FATE). In addition, I am delighted to report that in mid-December of this year, Dr. Jeff Miller, renowned NK Cell Cancer Specialist, was appointed Consulting Chief Medical Officer to the Company. In conclusion, we have placed great emphasis in this past year to bring about the next stages of value creation on behalf of GT Biopharma’s shareholders. We have also taken capital allocation into consideration relative to the current market. While GTB-3650 and GTB-5550 both share the advantages of being a second generation TriKE, it is important to note that the significance of the commercial size for GTB-5550 for solid tumors is appreciably larger than the size of the hematologic cancer market at present. We are thankful that you have entrusted the senior executive leadership team with this charge, a matter that we do not take lightly. Furthermore, we believe that will be able to carry this momentum with us and look forward to sharing the next steps of our strategic operating plan with investors in the forthcoming year. We also want to thank our employees for whom GT Biopharma’s innovations would not be possible without their hard-won efforts. Wishing you and your family a wonderful New Year. Best regards, Michael Breen Executive Chairman and Interim Chief Executive Officer About GT Biopharma, Inc. GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission. TriKE® is a registered trademark owned by GT Biopharma, Inc. Investor Relations Contacts: LifeSci Advisors Corey Davis, Ph.D. cdavis@lifesciadvisors.com 212-915-2577

Phase 1Executive ChangeLicense out/inASH

13 Sep 2022

·www.globenewswire.com

GT Biopharma Poster Presentation and Mini Oral Session at ESMO Congress 2022 Demonstrates GTB-5550 TriKE® Ability to Specifically Target and Efficiently Kill Multiple B7H3+ Solid and Hematologic Malignancies

BRISBANE, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, today announced highlights of an accepted abstract titled, “B7H3-Targeted Tri-specific Killer Engagers deliver IL-15 to NK cells but not T cells, and specifically targets solid tumors as a pan-tumor antigen strategy mediated through NK cells,” for poster presentation both virtually at the European Society for Medical Oncology ("ESMO") Congress 2022 being held at the Paris Expo Porte de Versailles from September 9-13, in Paris, France. GTB-5550 product candidate is in development for the treatment of B7H3 positive solid tumor cancers and multiple myeloma. GTB-5550 TriKE is a tri-specific molecule composed of a dual camelid nanobody that binds the CD16 receptor on NK cells, the single chain variable fragment (scFv) of an anti-B7H3 antibody, and human IL-15. Highlights of the abstract poster and mini-oral session include: GTB-5550 gives a robust and NK cell specific proliferation signal compared to IL-15 alone GTB-5550 specifically targets B7-H3+ cells GTB-5550 effectively induced NK cell degranulation and interferon gamma production in response to various prostate, brain tumor (atypical rhabdoid/teratoid), HNSCC, multiple myeloma, sarcoma, ovarian, and myeloid malignancies GTB-5550 TriKE In vivo activity in xenogeneic models of human tumor is underway and already validating in vitro studies “GT Biopharma’s TriKE platform harnesses the natural killing power of NK cells with protein therapeutics, not NK cell therapy. Our approach induces activation of NK cells via CD16 and IL-15 while targeting well-known tumor antigens, offering a potentially safer alternative to T-cell related immunotherapy without cytokine release syndrome and neurotoxicity and we expect to submit an Investigational New Drug (IND) application in 2023 in solid tumors,” said Michael Breen, Executive Chairman and Interim CEO of GT Biopharma.” About the Study Background IL-15, the homeostatic factor for NK cells is being clinically developed but it has little anti-tumor activity alone. GT Biopharma hypothesized that targeted delivery of IL-15 to NK cells along with Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) would impart NK cells with specificity to tumor antigens. As proof of concept, a clinical trial of GTB-3550 (a CD33- targeted Tri-specific Killer Engager (TriKE) in AML) induced endogenous NK cell expansion and activation in refractory AML patients. GTB-5550 (a B7H3 TriKE) was developed as a novel dual camelid (cam) TriKE containing wild type IL-15 and comprised of two cam engagers: targeting CD16 on NK cells and B7H3 on multiple solid tumors. Method The IL-15 activity of the B7H3 TriKE was measured in proliferation assays. Tumors were incubated with NK cells with or without B7H3 TriKE. In some tumors, CRISPR tech was used to knockout B7H3 to serve as a specificity control as well as B7H3 negative hematologic tumors. NK cell function was measured by flow cytometry and in live tumor imaging assays. Results B7H3 TriKE was titrated onto lymphocytes resulting in a dose- dependent proliferation of NK cells but not T cells. This was in marked contrast to rhIL-15, that stimulated both, suggesting different biologic activity of IL-15 when delivered through the camCD16 engager. camB7H3 was broadly expressed on prostate, head and neck, ovarian and glioblastoma cancers as well as multiple myeloma. We observed a B7H3 TriKE dose-dependent increase in CD107a degranulation and inflammatory cytokines to all B7H3 positive targets that was highly specific, with no response seen with B7H3 negative hematologic targets and control lines created with a CRISPR knockout of B7H3. Compared to rhIL-15, GTB-5550 given at molar equivalent dosing induced B7H3 killing in in a dose-dependent manner above that seen with rhIL-15 induced natural cytotoxicity. In vivo activity in xenogeneic models of human tumor is underway and already validating our in vitro studies. ESMO Congress 2022 presentation details: Poster Presentation Display (#755P) Title: “B7H3-Targeted Tri-specific Killer Engagers Deliver IL-15 to NK Cells But Not T Cells, And Specifically Targets Solid Tumors As a Pan-Tumor Antigen Strategy Mediated Through NK Cells” Session: Investigational Immunotherapy Speaker: Dr. Jeffrey S. Miller Location: 7.3.O - Orléans Auditorium Date and Time: Saturday, September 10, 2022 at 14:45 - 16:15 (CEST) ESMO Congress 2022 has published full abstracts on their website. GT Biopharma will post its poster on the company's website in the "Presentations" section during the conference. For abstract and event details please visit: https://www.esmo.org/meetings/esmo-congress-2022. About GT Biopharma, Inc. GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com.

CollaborateAntibodyCell TherapyImmunotherapy

100 Deals associated with OXS-3550

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	United States	GT Biopharma, Inc.	01 Jan 2020
High Risk Myelodysplastic Syndrome	Phase 2	United States	GT Biopharma, Inc.	01 Jan 2020
Mast-Cell Leukemia	Phase 2	United States	GT Biopharma, Inc.	01 Jan 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03214666 (GTB-3550, CTgov)	Phase 1/2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome \| Mast-Cell Leukemia	12	GTB-3550 TriKE® Phase I	szrokahbsj(oemfukgisw) = vdjryklctp jruyctnybf (hvijixzwck, uqbmxecupe - mykaeurwwo) View more	-	10 Nov 2022
NCT03214666 (GTB-3550, SITC2021)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes CD33+	-	GTB-3550 TriKE	xszgbdcjpl(toxifnrmvo) = Differential expression analysis (DEA) on mature NK cells (CD56+CD16+) at day 22 showed increased expression of the maturation marker CD57 and activation receptor NKG2D, while showing decreased expression of inhibitory KIR jcoqkawgdf (bgkugedskp ) View more	Positive	10 Nov 2021
NCT03214666 (PRNewswire) Manual	Phase 1/2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	9	GTB-3550 (early in the Study were treated with doses of)	(roqxdgiqjd) = eltoalhsyx wzreciceub (rqcnkbdrvf )	Positive	17 Mar 2021
NCT03214666 (PRNewswire) Manual	Phase 1/2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	9	GTB-3550 (increasing doses of)	(roqxdgiqjd) = zukplgypbw wzreciceub (rqcnkbdrvf ) View more	Positive	17 Mar 2021

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