International AIDS Vaccine Initiative, Inc.

A large Phase 3 trial will evaluate whether the M72/AS01E vaccine candidate can protect adolescents and adults from pulmonary tuberculosis Clinical trial site at University of the Witwatersrand, Johannesburg, South Africa, is first of up to 60 sites in seven countries The M72/AS01E vaccine candidate could be the first new TB vaccine in 100 years if proven effective CAMBRIDGE, Mass., March 19, 2024 /PRNewswire/ -- The Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate is now underway, with first doses given in South Africa, where TB takes a heavy toll. If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century. Globally, according to the World Health Organization, an estimated 10.6 million people fell ill with TB in 2022 and 1.3 million died — over 3,500 people per day. The disease primarily affects people in low- and middle-income countries, and those at highest risk are often living in poverty, with poor living and working conditions and undernutrition. In South Africa alone, around 280,000 people are diagnosed with TB each year. "The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries," said Emilio A. Emini, Ph.D., CEO of the Gates MRI. "Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine's potential." The Gates MRI, a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome. The M72/AS01E vaccine candidate has been in development since the early 2000s. It was originally designed and clinically evaluated by the biopharma company GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) and was funded by GSK and in part by the Gates Foundation. In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial and will provide the adjuvant post licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response. Making vaccines accessible and affordable for communities in areas of high disease burden in the long-term is a priority for all trial partners. The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3. To this end, the Gates MRI, GSK, Wellcome and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access, should the trial be successful; from supporting research and building an evidence-base for the potential impact of the vaccine and community requirements for uptake, to collaborating with multilateral, regional and country partners required to introduce the vaccine. Additionally, the trial funders are planning to establish an international advisory group comprised of representatives from all these groups to provide input on the overall program. Developing and ensuring access to global health products is a complex task. As such, global collaboration and strong partnerships are a core component of planning for future access to the candidate vaccine. "Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities," said Dr. Lee Fairlie, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand, Johannesburg, South Africa, and national principal investigator for the trial in South Africa. "South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals." At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine. "After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners' expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world," said Deborah Waterhouse, CEO, ViiV Healthcare and President, Global Health, GSK. While TB is one of the world's deadliest infectious diseases — and the leading cause of death amongst people living with HIV — the only available TB vaccine, BCG, dates back to 1921. It protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium. "If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic," said Alemnew Dagnew, M.D., who leads development of M72/AS01E at the Gates MRI. "I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative." Dagnew noted that TB is both a health problem and a socioeconomic problem. He said the disease primarily affects people during their prime working years, leaving families without income and children without parents. Almost half of TB-affected households face costs higher than 20% of their household income. "We must continue to move with urgency to develop and equitably deliver innovative tools with the potential to transform the prevention, diagnosis, and treatment of TB. The start of the Gates MRI's M72 TB vaccine candidate Phase 3 clinical trial marks a pivotal moment in the fight to end TB, which devastatingly afflicts the world's most vulnerable communities. We think this trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools. The Gates Foundation remains committed to supporting local and global partners to accelerate the solutions needed to save lives and reduce suffering from this preventable disease," said Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation. Alex Pym, Director of Infectious Disease at Wellcome, said: "While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB. Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful." It is anticipated that it will take up to five years to complete the trial, followed by data analysis and then preparation for submission of data to regulatory authorities. In GSK's Phase 2b trial, M72/AS01E provided approximately 50% protection (13/1626 versus 26/1663) against progression to active pulmonary tuberculosis for three years in Mycobacterium tuberculosis-infected HIV-negative adults, which was unprecedented in decades of TB vaccine research. The World Health Organization estimates that over a 25-year time span, that level of protection could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion for TB affected households. About the Bill & Melinda Gates Medical Research Institute (Gates MRI) The Bill & Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health. For further information please visit . For more information, contact: [email protected] Logo -

Fireside Chat, moderated by Hartaj Singh of Oppenheimer & Co., will be held on Wednesday, January 24, 2024, at 12:00pm ET PLYMOUTH MEETING, Pa., Jan. 22, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, today announced that it will participate in a virtual fireside chat on the potential treatment of Recurrent Respiratory Papillomatosis (RRP). INOVIO's President and CEO, Dr. Jacqueline Shea, and Chief Medical Officer, Dr. Michael Sumner, will be joined by Dr. Simon Best, Otolaryngologist at Johns Hopkins University and a Principal Investigator in INOVIO's Phase 1/2 trial with INO-3107. The fireside chat, titled "RRP - Disease Treatment Dynamics & Urgent Need for Therapeutic Modalities," will take place on Wednesday, January 24, 2024, at 12:00pm ET. Hartaj Singh, MBA, Managing Director of Biotechnology Equity Research at Oppenheimer & Co. Inc., will moderate the discussion. A replay of the event will be made available shortly after its conclusion and will be archived for 90 days under the Events and Presentations page on the investor relations section of the INOVIO website following the event. Panel Participants Simon Best, MD, is an Associate Professor of Otolaryngology – Head & Neck Surgery at Johns Hopkins Hospital. He is a fellowship-trained laryngeal surgeon whose clinical interests are focused on voice and airway disorders, with a particular interest in RRP. He had led an NIH-funded laboratory focused on RRP, participated in clinical trials, spearheaded novel treatment paradigms, and sees patients from across the world for this disease. In addition, he treats the full range of voice disorders, including in professional voice users and singers, vocal cord paralysis, laryngeal cancer, precancerous vocal cord dysplasia, benign laryngeal lesions (polyps, cysts, nodules), and laryngeal and tracheal stenosis. Dr. Jacqueline Shea has served as INOVIO's President and Chief Executive Officer (CEO) since May 2022. Dr. Shea joined the company in March 2019 as Chief Operating Officer (COO), serving as a key member of the executive team. Dr. Shea has more than 25 years' experience in the life sciences and biotech industries. Prior to joining INOVIO, she was the CEO at Aeras, a not-for-profit organization dedicated to developing new vaccines against tuberculosis (TB). She also held executive roles at Emergent BioSolutions and was the General Manager and Vice President of The Oxford-Emergent Tuberculosis Consortium. Dr. Shea has dedicated much of her career to developing innovative products to prevent and treat infectious diseases. Dr. Shea received a BSc Hons in Applied Biology from the University of Bath and a Ph.D. from the National Institute for Medical Research in the UK. Dr. Michael Sumner leads INOVIO's clinical-stage pipeline of DNA medicines. Dr. Sumner received his medical degree from the University of London, is a member of the Royal College of Physicians, and holds a Master of Business Administration. He brings 30 plus years of extensive pharmaceutical, medical and clinical experience driving many late-stage product approvals and supporting successful commercial products globally across multiple therapeutic areas. He previously served as CMO of Orexo AB since 2013 and prior to that held numerous European- and US-based leadership roles at Novartis, CSL Behring, Novo Nordisk and Shire Pharmaceuticals. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit . Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Thomas Hong, (267) 440-4298, thomas[email protected] SOURCE INOVIO Pharmaceuticals, Inc.

BOSTON and MONTREAL, Dec. 19, 2023 /PRNewswire/ - enGene Holdings Inc. ("enGene,"Nasdaq: ENGN), a clinical-stage genetic medicines company whose lead program is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced the appointment of Lota S. Zoth, CPA, as a member of the Board of Directors and Audit Committee Chair. "The addition of Lota to our Board is another milestone in our progression as a public genetic medicines company, and we are fortunate to welcome her counsel and depth of experience as a leader," said Jason D. Hanson, Chief Executive Officer of enGene. "Lota's distinguished history of operational and financial leadership strengthens our Board of Directors, and we look forward to her perspective and insights as we advance our pivotal trial of EG-70 in NMIBC, as well as our mission to mainstream gene therapy for the benefit of underserved patients." Ms. Zoth has more than two decades of experience in senior financial and accounting roles, including as Senior Vice President and Chief Financial Officer of MedImmune, Inc. and Senior Vice President, Controller and Chief Accounting Officer of PSINet, Inc. She also spent nearly a decade with Ernst & Young leading auditing efforts for flagship clients. Ms. Zoth is an experienced Board of Directors member, having served in various roles at other companies, including Board Chair, Lead Independent Director, and Audit Committee Chair, as well as on Compensation, Transaction, Finance and Special Strategic Committees. She is currently serving on the Boards of the publicly traded companies Lumos Pharma, Inovio Pharmaceuticals, and 89 Bio. Her past Board experience includes Zymeworks, Spark Therapeutics, Aeras, Orexigen Therapeutics, Circassia Pharmaceuticals, Hyperion Therapeutics, and Ikaria. "enGene is a truly differentiated company with a compelling vision, promising pipeline, and near-term potential to have a meaningful impact in the lives of patients living with BCG-unresponsive NMIBC," said Ms. Zoth. "I am honored to join the Board of Directors and to serve as Audit Committee Chair to help build a successful future for enGene and patients in need." About enGene enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene's lead program is EG-70 for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), a disease posing a high clinical burden. EG-70 is being evaluated in an ongoing Phase 2 pivotal study. EG-70 was developed using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company. For more information, visit enGene.com. Forward-Looking Statements Some of the statements contained in this press release may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). enGene's forward-looking statements include, but are not limited to, statements regarding enGene's expectations, hopes, beliefs, intentions, goals, strategies, forecasts and projections. The words "anticipate", "appear", "approximate", "believe", "continue", "could", "estimate", "expect", "foresee", "intend", "may", "might", "plan", "possible", "potential", "predict", "project", "seek", "should", "would", and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: enGene's goal of mainstreaming gene therapy, enGene's product pipeline and the near-term potential to have a meaningful impact in the lives of patients living with BCG-unresponsive NMIBC. Many factors, risks, uncertainties and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company's ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient registration for clinical trials and acquire technologies complimentary to, or necessary for, its programs; the Company's ability to address diseases with high clinical needs; the Company's ability to retain commercial rights to EG-70 in the United States and commercialize EG-70 independently, while selectively partnering outside of the United States; the Company's plans and ability to secure regulatory approval, to execute product development, manufacturing process development, preclinical and clinical development efforts successfully and on anticipated timelines; enGene's ability to design mainstream gene therapy and bring genetic medicines to community clinics across the globe; and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission ("SEC") on EDGAR, including those described in the "Risk Factors" section of the Company's Current Report on Form 8-K, filed with the SEC on October 31, 2023 (copies of which may be obtained at sedarplus.ca or ). You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene's assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. SOURCE enGene