A Phase I Randomised, Double-Blinded, Placebo-Controlled, Single Ascending Dose Adaptive Design Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SAB-142 in Healthy Volunteers and participants with Type 1 Diabetes (T1D).

开始日期2023-11-28

申办/合作机构

SAB Biotherapeutics, Inc.

[+1]

100 项与 SAB-142 相关的临床结果

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100 项与 SAB-142 相关的转化医学

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100 项与 SAB-142 相关的专利（医药）

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项与 SAB-142 相关的新闻（医药）

2024-11-06

·GlobeNewswire-Health Care

SAB BIO Announces Third Quarter 2024 Financial Results and Provides Company Update

Company announced completed Phase 1 enrollment for SAB-142 with no observation of serum sickness. The company remains on track for a topline Phase 1 data readout by the end of the year. MIAMI, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), (“SAB” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today reported financial results for the second quarter ended September 30, 2024, and provided a company update. “This quarter we were pleased to report completed enrollment of SAB-142 Phase 1 study with no observed serum sickness,” notes SAB chairman and CEO Samuel J. Reich. “This year we have advanced our SAB-142 Type 1 diabetes program from preclinical through Phase I to Phase II ready, which illustrates SAB management’s ability to execute our business strategy according to plan. Enthusiasm for SAB-142 continues to grow among clinical advisors and the T1D patient community as the program advances, and we are well-positioned and on schedule for initiating a Phase II study in 2025.” Corporate Updates SAB provided a clinical trial progress update on September 9, 2024 at the European Association for the Study of Diabetes Annual Meeting. The update confirmed that SAB-142 has completed Phase 1 enrollment of all planned cohorts in healthy volunteers.SAB is now progressing to enroll patients with T1D in the last cohort of the study to establish safety, tolerability, pharmacokinetic and immunogenicity profile of SAB-142 in patients with T1D prior to initiation of an upcoming Phase II SAFEGUARD study in patients with new-onset T1D.Further, the target dose of SAB-142 2.5mg/kg is complete with no observation of serum sickness. Anticipated Milestones SAB-142 remains on track for a topline Phase 1 data readout by the end of the year. Q3 2024 Financial Updates Financial Guidance: Based on its current operating plans, if the Company receives funds upon the exercise of all outstanding Tranche B warrants, SAB would have cash sufficient to fund its operations into 2026. Cash Position: Cash, cash equivalents, and available for sale securities totaled $30.4 million as of September 30, 2024 compared to $56.6 million as of December 31, 2023. This decrease was driven primarily by continued research and related expenses as the Company advances its lead therapeutic candidates.Research and Development (R&D) Expenses: R&D expenses were $7.8 million for three months ended September 30, 2024, compared to $4.0 million for the three months ended September 30, 2023. R&D expenses were $22.6 million for nine months ended September 30, 2024, compared to $12.2 million for the nine months ended September 30, 2023. The increase was primarily due to prioritizing focus in the autoimmunity space with SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of T1D.General and Administrative Expense: G&A expenses were $3.5 million for the three months ended September 30, 2024, compared to $2.6 million for the three months ended September 30, 2023. G&A expenses were $11.5 million for the nine months ended September 30, 2024, compared to $8.9 million for the nine months ended September 30, 2023. G&A expenses grew primarily due to increased headcount to support the Company’s continued research activities and development of its product candidates.Non-operating Income: Non-operating income was $1.0 million for the three months ended September 30, 2024, compared to $0.2 million for the three months ended September 30, 2023. Non-operating income was $10.2 million for the nine months ended September 30, 2024, compared to $0.1 million of expense for the nine months ended September 30, 2023. This increase was primarily due to the change in fair value of warrant liabilities and an Australian research and development tax credit.Net Loss: Net loss was $10.3 million for the three months ended September 30, 2024, for an earnings per basic and diluted share of $(1.12), as compared to a net loss of $5.1 million for the three months ended September 30, 2023 for an earnings per basic and diluted share of $(0.97). Net loss was $22.7 million for the nine months ended September 30, 2024, for an earnings per basic and diluted share of $(2.45), as compared to a net loss of $19.3 million for the nine months ended September 30, 2023 for an earnings per basic and diluted share of $(3.79). About SAB BIO SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: https://www.SAB.bio/ and follow SAB on Twitter and LinkedIn. Forward-Looking Statements Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the impact members of SAB’s leadership team will have on the Company’s business and results of operations, the exercise of outstanding warrants for cash, our expected cash runway and the development and efficacy of our T1D program and other discovery programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Media Relations:Kaelan Hollon Vice President of Communications khollon@sab.bio Investor Relations:Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com Chris CalabreseLifeSci Advisorsccalabrese@lifesciadvisors.com

临床1期财报临床2期免疫疗法

2024-09-13

·GlobeNewswire-Health Care

SAB BIO CEO to Participate in Fireside Chat at 2024 Cantor Global Healthcare Conference

MIAMI, Sept. 13, 2024 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS) (the “Company” or “SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of T1D, today announced that Chairman and CEO Samuel J. Reich will be participating in a fireside chat at the 2024 Cantor Global Healthcare Conference, September 17-19th, 2024. Fireside Chat: September 18th, 2024, at 8:00 am ETLocation: New York, NYWebcast Registration Link: Here A recording of the webcast will be accessible through the “Events” section of the Company’s website at https://ir.sab.bio/news-events/events. About SAB BIO SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: www.SAB.bio and follow SAB on LinkedIn. Forward-Looking Statements Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the development and efficacy of our T1D program and other discovery programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Media Relations: Kaelan Hollonkhollon@sab.bio Investor Relations: Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com Chris CalabreseLifeSci Advisorsccalabrese@lifesciadvisors.com

免疫疗法

2024-09-09

·GlobeNewswire-Health Care

SAB BIO Provides SAB-142 Clinical Trial Progress Update at the European Association for the Study of Diabetes Annual Meeting

SAB-142 has completed Phase 1 enrollment of all planned cohorts in healthy volunteers and is progressing to enroll patients with type 1 diabetes in the last cohort of the study. Target dose of SAB-142 2.5mg/kg completed with no observation of serum sickness. SAB-142 remains on track for a topline Phase 1 data readout by the end of the year. MIAMI, Sept. 09, 2024 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS) (the “Company” or “SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today will offer a trial update on SAB-142 during its presentation at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid. SAB’s Executive Vice President and Chief Medical Officer Alexandra Kropotova, MD, MBA will present “Protecting pancreatic beta cells with multi-target immunotherapy: SAB-142.” SAB-142 is a first-in-class human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D. “We are pleased with the continued progress of SAB-142 and its emerging safety profile to date,” noted Dr. Kropotova on the data. “Our trial results to date definitively demonstrate a lack of serum sickness for our SAB-142 compound, which is a key differentiation compared to rabbit anti-thymocyte globulin. SAB-142 has demonstrated this fully human anti-thymocyte globulin has an improved safety benefit and the potential to preserve endogenous C-peptide and prevent the progression of type 1 diabetes. We continue to gather SAB-142 data that supports our commitment to developing a disease modifying immunotherapy to change the lives of people impacted by type 1 diabetes.” SAB commenced the Phase 1 clinical trial investigating safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142 in November 2023. The primary objective of the trial is two-fold: (1) to generate data on differentiated safety and immunogenicity of this human immunoglobulin, and (2) to establish a proof of biological activity (POBA) for SAB-142. The Phase 1 study is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 first in healthy volunteers and thereafter in participants with T1D. Enrollment of healthy volunteers has been completed for all planned cohorts. SAB has completed the dosing of 2.5mg/kg with SAB-142 – its targeted dose - with no observation of serum sickness. Additionally, SAB has elected to add a T1D patient cohort to establish safety, tolerability, pharmacokinetic and immunogenicity profile of SAB-142 in patients with T1D prior to initiation of an upcoming Phase II SAFEGUARD study in patients with new-onset T1D. SAB is now progressing to enroll patients with T1D to supplement the last cohort of the study. About SAB-142 SAB-142 is a human alternative to rabbit anti-thymocyte globulin (ATG). SAB-142’s mechanism of action is analogous to that of rabbit ATG, which has been clinically validated in multiple clinical trials for type 1 diabetes, demonstrating the ability to slow down disease progression in patients with new or recent onset of Stage 3 type 1 diabetes. Two clinical trials have shown that a single, low dose of 2.5mg/kg rabbit ATG has demonstrated the ability to modulate the body’s immune response to help slow beta cell destruction and preserve the ability of these cells to generate insulin, which the body needs to regulate blood sugar and carry out all human activities. SAB-142, like rabbit ATG, directly targets multiple immune cells involved in destroying pancreatic beta cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells. However, most humans treated with rabbit ATG develop serum sickness and anti-drug antibodies from exposure to the rabbit-derived antibody. SAB-142 is a human antibody, intended to allow safe, consistent re-dosing for type 1 diabetes, a lifelong chronic disease, without the potential risk of inducing major adverse immune reactions that can occur with the administration of an animal ATG. About SAB Biotherapeutics, Inc. SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system can generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: www.SAB.bio and follow SAB on LinkedIn. Forward-Looking Statements Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the development and efficacy of our T1D program and other discovery programs, including the results of our clinical studies related to SAB-142. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Kaelan Hollon Media Relations:khollon@sab.bio Investor Relations: Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com Chris CalabreseLifeSci Advisorsccalabrese@lifesciadvisors.com

临床1期免疫疗法临床2期AACR会议

100 项与 SAB-142 相关的药物交易

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