Highland Therapeutics Announces Appointment of Stephanie C. Read as President/CEO, Changes to Board of Directors – BioSpace

TORONTO--(BUSINESS WIRE)-- Highland Therapeutics Inc., a privately held pharmaceutical company that through its wholly owned subsidiary, Ironshore Pharmaceuticals Inc., is focused on the commercialization of JORNAY PM (methylphenidate HCl) extended-release capsules (CII) for patients with ADHD, today announced the appointment of Stephanie C. Read as President/Chief Executive Officer, the appointment of Scott Myers as Chair of the Board and the additions of Kevin Bain and Ildiko Mehes as independent members of the Board of Directors. Stefan Antonsson, who has been serving as interim CEO will return to his role as an independent director.

It is my pleasure to congratulate Ms. Read in her transition from the Board of Directors to President/CEO, said Scott Myers, recently appointed Chair of the Board. Ms. Reads leadership in product development, corporate strategy, business development and specialty care commercialization will be key to driving sustainable growth with JORNAY PM, while enabling diversification into new therapeutic areas. I look forward to working closely with her to create value for patients, our employees and stakeholders."

The Board is grateful to interim CEO Stefan Antonsson for providing strategic direction and leadership continuity as we completed the financial restructuring of the company. After a brief transition, Stefan will return to his role as an independent member of the Board of Directors.

Commenting on her appointment, Ms. Read said, Highland and its subsidiaries are a rare instance of a privately held company with an exciting commercial product and experiencing rapid growth. I am pleased to join this seasoned executive team who have been successful in developing and launching JORNAY PM. With new capital from our shareholders and fresh perspectives from the new Board, we have the opportunity to continue to develop our products, people, processes and culture as we explore additional populations who may benefit from JORNAY PM."

Board of Directors:

Scott Myers, Chair of Board

Mr. Myers is a proven executive who brings nearly three decades of global pharmaceutical and medical technology most recently as CEO of AMAG, sold to Covis Pharmaceuticals, SA in November of 2020. Mr. Myers is a serial CEO, serving as Chairman and Chief Executive Officer of Rainier Therapeutics, a clinical-stage biotechnology company focused on metastatic bladder cancer that was purchased by Fusion Pharmaceuticals in March of 2020. Prior to joining Rainier, Mr. Myers served as Chief Executive Officer, President and as a director of Cascadian Therapeutics Inc. prior to its acquisition by SeaGen in March of 2018. Mr. Myers also served as Chief Executive Officer of Aerocrine AB, a medical device company from 2011 to 2015 prior to its acquisition by Circassia. Mr. Myers is currently an independent director of Selecta Biosciences where he serves as the Chair of the Compensation and Benefits Committee, as well as a member of the Nominating and Governance Committee. Mr. Myers also serves as the Chairman of the Board and Chairman of the Nomination and Governance committees and is a member of the Audit Committee for Harpoon Therapeutics, a clinical stage oncology company. Mr. Myers is also Chairman of the Board for Sensorion, SA, a gene therapy company focused on inner ear diseases. Mr. Myers is also Chairman of the Board of Dynavax Technologies, a Hepatitis B vaccine and COVID Adjuvant commercial stage company.

Stefan Antonsson, Independent Director

Mr. Antonsson has over 30 years of commercial experience in the pharmaceutical industry, primarily as a senior marketing executive, and he has established a proven track record of contributing to the success of rapidly growing pharmaceutical companies. Stefan was a key member of the Richwood/Shire senior management team and played a leadership role in launching Adderall and developing Adderall XR, acquiring and launching Carbatrol, and initiating the development of Intuniv. Stefan has also held senior marketing positions with Pharmacia and Forest Laboratories and executive positions with Vela Pharmaceuticals and Xanodyne Pharmaceuticals. Stefan has also been involved in several entrepreneurial ventures which successfully developed, licensed, and commercialized CNS products. Stefan also completed a long-term consulting assignment as Senior Vice-President of Marketing for Supernus Pharmaceuticals where he was part of the senior management team that established the commercial function for the company and successfully launched two anti-epilepsy drugs. Stefan earned his BA from Columbia College and MBA from The Stern School of Business, NYU.

Kevin Bain, Independent Director and Chair of Audit Committee

Mr. Bain is currently Chief Corporate Development Officer of Cell Research Corporation, a Singapore-based biologics company. This is a clinical-stage company developing a platform of products using stem cells from the umbilical cord lining membrane. From early 2006 through mid-2020, Kevin worked in the generic pharmaceutical and biosimilar business in companies founded and led by Robert Wessman. Kevin joined Alvogen in August 2009 as Chief Financial Officer, with responsibility for all Finance and Information Technology functions for the global Alvogen business. In November 2015, Kevin moved to a sister company named Alvotech as Chief Financial Officer. He has led several financing rounds, raising more than $1.5 billion in total value. Prior to joining Alvogen and Alvotech he spent almost four years with Actavis as Vice President of Finance for the US business of Actavis. From mid-2001 to early 2006, Mr. Bain was VP of Finance with a division of Danaher Corporation. From 1979 to 2001, Mr. Bain held positions of increasing responsibility within the finance organization of the Johnson & Johnson Family of Companies in both Canada and the US, including Vice President of Finance for J&J Medical Products. Mr. Bain graduated from the Accounting program at Fanshawe College in London, Ontario, Canada, and later earned his Certified Management Accountant (CMA) designation. Kevin is currently a Board member and Chair of the Audit Committee of Akorn Pharmaceuticals, a leading US-based specialty pharmaceuticals company.

Ildiko Mehes, Independent Director

Ms. Mehes is an advisor to investment management firms, consulting firms and pharmaceutical companies about a wide range of risks and opportunities in the pharmaceutical industry. She previously spent 12 years at Teva Pharmaceuticals in a variety of business and legal roles including, most recently, Senior Vice President & General Counsel. Her areas of responsibility in the U.S. and Canada spanned New Product & Portfolio, R&D, Regulatory Affairs, and Legal Affairs. She has extensive expertise in intellectual property, including related to ADHD drugs, and also has significant pharmaceutical M&A experience. Prior to Teva, Ildiko was a pharmaceutical patent and commercial litigator. Ildiko is admitted to the Bars of Massachusetts and Ontario, Canada. She is also the recipient of several awards, including the National Post/ ZSA Canadian General Counsel Award for Litigation Management and the Association of Corporate Counsels Global Award for Litigation Management. Ildiko holds a B.A. (Honors) in Economics from Queens University, a J.D. from Osgoode Hall Law School, both in Canada, and completed the Advanced Management Program at the Wharton Business School.

Stephanie C. Read, Chief Executive Officer

In addition to serving as the newly appointed President/CEO, Stephanie will continue to have a seat on the Board of Directors. Ms. Read also serves as a Non-Executive Director on the Board of ALSP Orchid Acquisition Corporation I. Ms. Read's 24-year biopharmaceutical career spans Global Research and Development, Medical Affairs, Alliance Management, Commercial and Business Development and Equity Investing. All leadership roles have included driving transformational change within organizations to accelerate top- and bottom-line growth, and diversification of company portfolios. Ms. Read's therapy area expertise includes Psychiatry (inventorship of MYDAYIS), Gastroenterology, Oncology & Pain, Infectious Disease, Immunology and Rare Diseases. Ms. Read's industry appointments include the last 6.5 years with CSL as global VP, Corporate Strategy and Business Development, 7.5 years with AstraZeneca/MedImmune in a variety of Medical Affairs, Commercial and Business Development roles, and over six years with Shire PLC in R&D and Global Medical Affairs (including inventing, developing and launching new treatments for ADHD). Stephanie holds a M.Sc. in Biotechnology from The Johns Hopkins University and a B.Sc. in Biology from Virginia Tech.

WARNING: ABUSE AND DEPENDENCE

See full prescribing information for complete boxed warning.

See additional important safety information below.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including JORNAY PM, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

PREGNANCY AND LACTATION

Please visit http://ironshorepharma.com/labeling.pdf for additional important safety information and the Full Prescribing Information, including Boxed Warning, for JORNAY PM.

About Highland Therapeutics Inc.

Highland Therapeutics Inc. is a pharmaceutical company whose mission is to develop and commercialize innovative, patient-centric treatment options. Based in North Carolina, subsidiary Ironshore Pharmaceuticals Inc. is responsible for the sales, marketing and distribution of pharmaceutical products within the US. Based in Grand Cayman, subsidiary Ironshore Pharmaceuticals & Development, Inc. develops novel therapeutics by leveraging its proprietary drug-delivery technology.

Forward-Looking Statements

This press release contains forward-looking information, which reflects the companys current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the companys control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, the company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220426006027/en/

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Highland Therapeutics Announces Appointment of Stephanie C. Read as President/CEO, Changes to Board of Directors - BioSpace

An international consortium, led by IRB Barcelona and the biotechnology company Merus, reports the discovery of MCLA-158, the first clinical candidate…

image:Schematic depiction of MCLA-158 showing monovalent affinities of the EGFR (Fab232) and LGR5 (Fab072) Fab arms. view more

Credit: IRB Barcelona and Merus N.V.

Barcelona, 25 April 2022- Scientists from an international consortium led by Dr. Eduard Batlle, head of the Colorectal Cancer laboratory at IRB Barcelona, ICREA researcher and group leader of CIBER de Cncer (CIBERONC), together with the Dutch company Merus N.V., reveal the preclinical data that has led to the discovery of MCLA-158 and its mechanism of action on cancer stem cells. Named Petosemtamab, the antibody MCLA-158 prevents the onset of metastasis (that is, the spread of cancer to other vital organs) and slows the growth of primary tumours in experimental models of cancer.

Published today in Nature Cancer, the study also lays the groundwork for the use of organoids in the drug discovery process undertaken by pharmaceutical companies. Organoids are patient-derived samples that can be grown in the laboratory, and they reproduce certain aspects of the tumour compartment. Until now, their usefulness was being explored in personalised cancer medicinemeaning their value in helping physicians make decisions about the best treatment for each patient. However, for the selection of MCLA-158, a biobank of organoids from cancer patients was used for the first time to discriminate which new antibody, among hundreds, was most effective and believed to be most suitable for the majority of patients.

In October 2021, Merus N. V. reported preliminary data corresponding to interim efficacy analysis based on investigator review of its sponsored ongoing phase 1 dose expansion clinical trial investigating the safety, tolerability, and anti-tumour activity of MCLA-158 monotherapy in advanced head and neck squamous cell carcinoma (HNSCC). Three of seven HNSCC patients achieved partial responses, with one achieving complete response after the data cutoff date of August 2021. Tumour reduction was observed in all seven patients.

It is highly satisfying to see that our discoveries are helping patients. We started studying cancer stem cells 15 years ago. The journey to this point has been exciting but also very complex, and it has required a large investment of resources, as well as a great deal of work by many researchers. This study and the collaboration with Merus. N.V. reflects IRB Barcelona's focus: The medicine of the future starts here, says Dr. Batlle.

MCLA-158: a double-action antibody

Antibodies are proteins that are naturally produced by our bodies to recognise infectious agents or altered cells so that these can be removed by the lymphocytes of the immune system (white blood cells). The antibody described in this work, Petosemtamab (Peto, MCLA-158: LGR5 x EGFR Biclonics), is a bi-specific antibody that recognises two proteins, namely EGFR and LGR5, on the surface of cancer stem cells.

EGFR activity promotes uncontrolled cell growth, while LGR5 marks the surface of cancer stem cells, which are responsible for tumour expansion. Dr. Batlle's laboratory is recognised worldwide for its work on the identification and characterisation of colorectal cancer stem cells, and it has led work not only on the development of MCLA-158/ Petosemtamab but also on the characterisation of its mechanism of action.

In short, MCLA-158/ Petosemtamab degrades the EGFR protein in cancer stem cells that have the LGR5 marker, thereby blocking the growth and survival pathways in the cells that initiate and spread cancer. However, this antibody does not interfere with the functioning of healthy stem cells, which are essential for the proper functioning of tissues.

The MCLA-158 antibody is a potent inhibitor of colorectal cancer organoid growth and it blocks the initiation of metastasis, as well as growth in several preclinical models of cancer, including tumours of the head and neck, oesophagus, and stomach.

An organoid biobank for drug discovery

For the development and characterisation of this antibody, researchers from HUB Organoids built a large biobank comprising organoids derived from patients with colon cancer, organoids from colon cancer metastasis to the liver, and organoids from normal non-cancerous tissue. Scientists from OcellO B.V. (Crown Bioscience) performed high content screening with the organoids.

The use of organoids in the early stages of drug developmentin this case, therapeutic antibodiesfacilitates the identification of those that are effective for most patients or even against tumours carrying a specific mutation. Using organoids from healthy tissue, an additional advantage is the possibility to identify unwanted side effects of the drugs on organs. This approach has allowed the researchers to assess the harmful effects of the drug on healthy cells and thus withdraw antibodies with greater toxicity in the earliest stages of the study.

In the coming months, the company Merus N. V. plans to publish new data on the clinical trials underway with Petosemtamab. We are hopeful that the anti-tumour activity reported in the preliminary data will be confirmed, says Dr. Batlle.

This preclinical research published today in Nature Cancer includes work carried out within the framework of the suppresSTEM consortium, funded by the EU and involving collaborative work by various international research institutionsIRB Barcelona, the Hubrecht Institute and the Sanger Instituteand companies, namely Merus N. V. and OcellO B.V./Crown Bioscience. The Vall d'Hebron Institute of Oncology (VHIO), the Catalan Institute of Oncology (acronym ICO in Catalan) and the company Xenopat also collaborated in data for this publication.

Experimental study

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25-Apr-2022

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An international consortium, led by IRB Barcelona and the biotechnology company Merus, reports the discovery of MCLA-158, the first clinical candidate...

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