EbeneInfo – CA – Homology Medicines Announces $ 60 Million Equity Investment of Pfizer Inc

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    BEDFORD, Messe, Nov 09 February 2020 (GLOBE NEWSWIRE) – Homology Medicines, Inc (Nasdaq: FIXX), a genetic drug company, today announced that Pfizer Inc (NYSE: PFE) has agreed to make $ 60 million equity investment in Homology Pfizer has agreed to purchase 5,000,000 common shares of Homology at a price of $ 1200 per share, as part of the Pfizer Breakthrough Growth Initiative, announced more early this year Pfizer purchase is expected to close on or around November 10, 2020

    « With the positive clinical data from the dose escalation phase of our phase 1/2 pheNIX trial for adults with phenylketonuria (PKU) and our plans to move into the expansion phase of the trial, which we both announced last week, we believe Pfizer’s investment in homology reflects their enthusiasm for our gene therapy and PKU gene editing programs to treat people with this disease ”, said Arthur Tzianabos, Phré, President and CEO of Homology Medicines

    “Pfizer Rare Disease has a 30-year legacy of developing treatment options for patients with some of the greatest unmet needs, including in the area of ​​rare metabolic disorders,” said Seng Cheng, Phré, Senior Vice President and Scientific Director of Pfizer Rare Disease Research Unit “Our investment in homology is another example of our commitment to collaborate with the biotechnology community. We believe gene therapy could help provide a potentially transformational therapeutic option for patients living with PKU and that it fits well with our portfolio of rAAV-associated gene therapy »

    As part of this investment, Dr. Pfizer Cheng will join Homology’s Scientific Advisory Board to participate in issues related to the development of the company’s PKU product candidates: HMI-102 gene therapy candidate for adults with PKU and HMI-103 gene editing candidate for pediatric patients with PKU In addition, the company has granted Pfizer a right of first refusal on future transactions involving these programs

    Homology intends to use the net proceeds of the offering to help fund its ongoing and planned PKU clinical trials, as well as the company’s central nervous system (CNS) programs Based on current projections , along with the expected $ 60 million proceeds from Pfizer’s equity investment, Homology expects cash resources to fund operations through the third quarter of 2022

    About HMI-102 Gene Therapy and HMI-103 Gene Editing Product Candidates HMI-102 is an investigational gene therapy in clinical development for the treatment of phenylketonuria (PKU) in adults HMI-102 is designed to encode the PAH gene, which is mutated in people with PKU, delivered via the tropic hepatic AAVHSC15 vector Homology has received Fast Track designation and orphan drug designation for HMI-102 from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Orphan Drug Designation HMI-103 is an investigational nuclease-free gene-editing product candidate in studies enabling IND for pediatric patients with PKU whose liver is dividing rapidly By delivering a functional copy of the PAH gene to replace the mutated copy in the genome, gene editing is the best approach for a potential one-time treatment for this population About Phenylketon uria (PKU) PKU is a rare inborn error in metabolism caused by a mutation in the PAH gene PKU causes loss of function of the enzyme phenylalanine hydroxylase, responsible for the metabolism of phenylalanine (Phe), an amino acid derived exclusively from diet If left untreated, toxic levels of Phe can build up in the blood and lead to progressive and severe neurological damage Currently, there are no treatment options for PKU that target the underlying genetic cause of the disease According to the National PKU Alliance, PKU affects nearly 16,500 people in the US with around 350 newborns diagnosed. Each year The worldwide prevalence of PKU is estimated at 50,000 people About Homology Medicines, Inc Homology Drugs, Inc is a genetic drugs company dedicated to transforming the lives of patients with rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease Homology’s proprietary platform is designed to use its adeno-associated virus vectors derived from human hematopoietic stem cells (AAVHSC) to deliver drugs accurately and efficiently genetic in vivo, either through gene therapy or a nuclease-free gene editing modality in a wide range of genetic disorders Homology di spose of a management team with a successful track record in the discovery, development and commercialization of therapeutic products with a particular focus on rare diseases, and intellectual property covering its sequel of 15 AAVHSC Homology finds its preclinical data compelling, its scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic drugs For more information, please visit www.approved drugscom

    Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 All statements in this press release that do not relate to historical facts should be considered as forward-looking statements , including, without limitation, statements regarding our expectations regarding when the Pfizer investment will close; our intended use of the proceeds of the Pfizer investment; the adequacy of our cash resources, together with the expected proceeds of $ 60 million from the Pfizer equity investment, to fund our operations; our expectations regarding the potential, safety, efficacy and regulatory and clinical progress of our product candidates; the plans and schedule for the phase 1/2 pheNIX trial, including the expansion phase and the potential for conversion to a registration trial; and our leadership position in the development of genetic drugs These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors which may cause our results, performance or achievements are significantly different from the future results, performances or achievements expressed or implied by the forecasts statements, including, but not limited to the following: the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies and clinical trials, and on general economic conditions ; we have and expect to continue to incur significant losses; our need for additional financing, which may not be available; the inability to identify other product candidates and to develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other undesirable consequences; risks related to the capabilities of our manufacturing plant; risks associated with the regulatory approval process; interim, top, and preliminary data may change as more patient data becomes available and is subject to audit and verification procedures that could result in significant changes to the final data; our product candidates may cause serious unwanted side effects; the inability to maintain our collaborations, or the failure of those collaborations; our dependence on third parties; failure to obtain US or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable tariff regulations, third party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; Intellectual Property Risks and Significant Costs of Operating as a Public Enterprise These and other significant factors discussed under “Risk Factors” in our Quarterly Report on Form 10-Q for quarterly period ended June 30, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release These forward-looking statements represent management’s estimates as of the date of this press release Although we may choose to update these forward-looking statements at some time in the future, we disclaim any obligation to do so, even if subsequent events change our view.

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    Homology Medicines, Pfizer, NASDAQ: FIXX, NYSE: PFE, Equity

    EbeneInfo – CA – Homology Medicines Announces $ 60 Million Equity Investment of Pfizer Inc
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    Source: https://www.globenewswire.com/news-release/2020/11/09/2122724/0/en/Homology-Medicines-Announces-60-Million-Equity-Investment-from-Pfizer-Inc.html

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