- Industry veteran Dr. Olson moves from Enthera’s Board to take the helm as CEO
- Ent001 Phase 1a trial in healthy volunteers completed with positive topline safety results
- Company has initiated enrollment for Ent001 Phase 1b trial in patients with moderately to severely active ulcerative colitis
Milan, Italy, January 23, 2024 – Enthera Pharmaceuticals (“Enthera”), a clinical-stage biotech company developing first-in-class antibody therapeutics targeting the Insulin Growth Factor Binding Protein (IGFBP) family for selected inflammatory diseases, today announced the appointment of Lisa M. Olson, Ph.D., as the company’s Chief Executive Officer. Dr. Olson joins Enthera’s management team with over two decades of leadership experience in the biopharmaceutical industry including a successful career at AbbVie. She previously served as a member of Enthera’s Board of Directors and Chair of the Scientific Advisory Board.
Enthera also announced completion of Ent001’s Phase 1a single-ascending dose trial in healthy volunteers, establishing a positive safety and tolerability profile and enabling the start of the Phase 1b multiple ascending dose trial in ulcerative colitis (UC) patients. UC is a chronic gastrointestinal disease, and while treatment options using immune suppressors are efficacious, they still fail to provide a durable and long-term response for many patients with moderately to severely active disease. Ent001 is a monoclonal antibody targeting the IGFBP3/TMEM219 pathway, which plays a critical role in gut mucosal integrity and is dysregulated in patients with inflammatory bowel diseases (IBD), including UC.
“We are entering the new year with positive momentum in Enthera’s corporate and clinical evolution with Lisa’s appointment as CEO and important progress with Ent001. The Enthera team will benefit from Lisa’s scientific and R&D expertise and leadership experience cultivated across the pharmaceutical and biotechnology industries. We are thrilled to have her join as CEO,” said Silvano Spinelli, Chairman of the Enthera Board of Directors.
“I look forward to working with the Enthera team to further drive Ent001’s clinical development trajectory. We have defined an exciting opportunity with Ent001 for the long-term treatment of ulcerative colitis, a disease that continues to negatively impact the lives of many patients,” added Dr. Lisa M. Olson, CEO of Enthera. “My goal is to ensure we deliver on the potential of Ent001 in the clinic and to achieve our ambitious corporate objectives for 2024.”
Ent001 Clinical Development Updates
Enthera completed its single ascending dose (SAD) Phase 1a trial evaluating Ent001 in healthy volunteers, thereby laying the groundwork for evaluation in patients with IBD and other indications, including type 1 diabetes (T1D), where the IGFBP3/TMEM219 pathway also plays a key pathogenetic role. The Phase 1a trial was conducted in the Netherlands and involved 30 healthy volunteers who received single ascending doses of Ent001 or placebo administered by intravenous infusion. The trial results established a very positive safety and tolerability profile for Ent001 without any observations of drug-related clinically relevant adverse reactions up to the highest dose tested (10mg/kg). The pharmacokinetics (PK) were linear, and the exposures reached in this study fully cover the concentrations that are predicted to be effective in patients, based on the maximum effective dose in animal disease models of UC.
Based on this, Enthera has initiated a multiple ascending dose (MAD) Phase 1b clinical trial in patients with moderately to severely active UC.
The Phase 1b multicenter, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, immunogenicity and PK of multiple ascending doses of Ent001 in up to 40 patients with moderately to severely active UC. The trial will also analyze pharmacodynamic responses by measuring peripheral and colon tissue biomarkers of IGFBP3/TMEM219 pathway inhibition to demonstrate proof of mechanism in patients with active colitis. Patients will be dosed up to week 12 to collect exploratory efficacy data and evidence of the compelling mucosal healing effect observed in preclinical models of colitis.
About Dr. Lisa M. Olson, CEO of Enthera
Prior to joining Enthera, Dr. Olson most recently served as the Chief Scientific Officer of Magenta Therapeutics where she was responsible for the strategic direction and execution of the company’s research and development efforts. Before this, Dr. Olson held various leadership positions at AbbVie and Abbott Laboratories for fifteen years, culminating in her role as Vice President Immunology Discovery and Site Head of the AbbVie Bioresearch Center. During her time at AbbVie she successfully advanced 15 molecules into clinical development including Rinvoq™ (upadacitinib) for the treatment of several conditions, including UC. Dr. Olson joined Abbott following her time as a Research Fellow in Inflammation and Immunology at Pfizer, Inc. Dr. Olson started her career as an Assistant Professor at Washington University School of Medicine following a post-doctoral cardiovascular fellowship at the University of Chicago. She holds a Ph.D. from the University of Illinois at Urbana-Champaign and a B.S. from Iowa State University.
About Enthera Pharmaceuticals
Enthera Srl is a clinical-stage biotech company developing first-in-class antibody therapeutics to transform the treatment paradigm in inflammatory bowel diseases (IBD) and type 1 diabetes (T1D) by re-establishing stem cell capabilities. Enthera’s pioneering approach capitalizes on the key discovery of the IGFBP3/TMEM219 pathway, which is involved in stem cell and beta cell apoptosis in the gut and pancreas, respectively. Enthera’s lead program, Ent001, which is
currently in Phase 1 clinical development, has the potential to restore the original intestinal mucosal structure in IBD and the endogenous pancreatic stem cell compartment in T1D, resulting in the restoration of organ function.
Enthera is a private company headquartered in Milan, Italy and founded in 2016 by Prof. Paolo Fiorina and Dr. Francesca D’Addio with BiovelocITA, Italy’s first biotech accelerator. Enthera’s discovery engine and assets are protected by a broad portfolio of patents. The company is backed by Sofinnova Partners, AbbVie, JDRF T1D Fund, Roche Venture Fund, and several private investors.
For further information: www.entherapharmaceuticals.com
Enthera Pharmaceuticals
Lisa M. Olson Ph.D., CEO
info@entherapharmaceuticals.com
Trophic Communications
Valeria Fisher or Veronika Máté
+49 175 8041816 or +49 160 90816161
enthera@trophic.eu
(GLOBE NEWSWIRE) — SAB Biotherapeutics (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing a fully-human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced that Katie Ellias has been appointed to the Company’s Board of Directors.
With Ms. Ellias’ appointment, the SAB Biotherapeutics Board is composed of ten directors, eight of whom are independent. Ms. Ellias serves as a Managing Director at the JDRF T1D Fund LLC, a venture philanthropy fund with approximately $200 million in assets, including an investment in SAB. Ms. Ellias joined the T1D Fund in 2018 where she has led a number of investments in companies developing T1D-oriented therapies. She has also served as a director on the board of several companies, including, DiogenX, Veralox Therapeutics, i2O Therapeutics, and Capillary Biomedical.
Ms. Ellias joined the T1D Fund from Endeavour Vision, a Geneva-based growth stage venture fund. She was previously Principal at Sofinnova Partners, Paris, a leading early-stage life sciences fund. Ms. Ellias has also held roles in business development with Medtronic and started her career at McKinsey & Company. She holds an M.B.A. in Healthcare Management from the Wharton School at the University of Pennsylvania and a B.A. in International Relations and Political Science from Yale University.
“Katie’s exceptional experience and deep expertise in T1D are a natural fit for SAB’s Board of Directors,” said Samuel J. Reich, Executive Chairman of SAB. “SAB is well-positioned for growth; thus, we are grateful for the insight and impact Katie will bring to our Board as we look to change the T1D treatment paradigm.”
Ms. Ellias said, “SAB is well-positioned at a critical inflection point in T1D. I’m inspired by what the company is building and honored to join their Board of Directors.”
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics (SAB) is a clinical-stage biopharmaceutical company focused on developing fully 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 type 1 diabetes (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, fully-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/.
Forward-Looking Statements
Certain statements made herein 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, the closing of each tranche of the Company’s private placement offering, the timely funding to the Company by each investor in the private placement offering, financial projections and future financial and operating results (including estimated cost savings and cash runway), the outcome of and potential future government, and other third-party collaborations or funded 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, as amended, 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.
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