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Homology Medicines Announces Plan to Evaluate Strategic Options for the Company and its Genetic Medicines Programs, including HMI-103 Gene Editing Candidate for PKU
July 27 2023 - 04:05PM
GlobeNewswire Inc.
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Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that it has completed a review of its business, and the Board of Directors has approved a plan to evaluate strategic alternatives to maximize shareholder value. Earlier today, Homology reported encouraging initial data from the first dose level in the Phase 1, dose-escalation trial evaluating gene editing candidate HMI-103 in adults with classical phenylketonuria (PKU), which showed it was generally well-tolerated in all three participants and resulted in a meaningful reduction in plasma phenylalanine (Phe) in two participants as of the data cut-off date of July 26, 2023. Despite these encouraging data, based on the current financing environment and Homology’s anticipated clinical development timelines, Homology will not be further developing its programs and will be instituting a related reduction in force while it explores options for the Company and its assets, including HMI-103. Homology has retained TD Cowen as its strategic financial advisor.
MWM
4 años hace
$PFE buys at $12 a share, I say this is a pretty good level to start a position...
Homology Medicines Announces $60 Million Equity Investment from Pfizer Inc.
BEDFORD, Mass., November 9, 2020 – Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that Pfizer Inc. (NYSE: PFE) has agreed to make a $60 million equity investment in Homology. Pfizer has agreed to purchase 5,000,000 of Homology’s common stock at a price of $12.00 per share, as part of the Pfizer Breakthrough Growth Initiative, which was announced earlier this year. The purchase by Pfizer is expected to close on or about November 10, 2020.
“With the positive clinical data from the dose-escalation phase of our pheNIX Phase 1/2 trial for adults with phenylketonuria (PKU) and our plans to move to the expansion phase of the trial, both of which we announced last week, we believe Pfizer’s investment in Homology is a testament to their enthusiasm for our PKU gene therapy and gene editing programs to treat people living with this disease,” stated Arthur Tzianabos, Ph.D., President and Chief Executive Officer of Homology Medicines.
“Pfizer Rare Disease has a 30-year heritage of developing treatment options for patients with some of the greatest unmet needs, including in the area of rare metabolic disorders,” said Seng Cheng, Ph.D., Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Disease Research Unit. “Our investment in Homology represents 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 is a good strategic fit with our rAAV-associated gene therapy portfolio.”
In connection with the investment, Pfizer’s Dr. Cheng will join Homology’s Scientific Advisory Board to participate in matters 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. Additionally, 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, together with the anticipated proceeds of $60 million from the Pfizer equity investment, Homology expects cash resources to fund operations into 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 liver-tropic AAVHSC15 vector. Homology has received Fast Track Designation and orphan drug designation for HMI-102 from the U.S. Food and Drug Administration (FDA), and orphan drug designation from the European Medicines Agency (EMA). HMI-103 is an investigational, nuclease-free gene editing product candidate in IND-enabling studies for pediatric patients with PKU, whose livers are rapidly dividing. 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 Phenylketonuria (PKU)
PKU is a rare inborn error of metabolism caused by a mutation in the PAH gene. PKU results in a loss of function of the enzyme phenylalanine hydroxylase, which is responsible for the metabolism of phenylalanine (Phe), an amino acid obtained exclusively from the diet. If left untreated, toxic levels of Phe can accumulate in the blood and result in progressive and severe neurological impairment. 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 U.S. with approximately 350 newborns diagnosed each year. The worldwide prevalence of PKU is estimated to be 50,000 people.
About Homology Medicines, Inc.
Homology Medicines, Inc. is a genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicines in vivo either through a gene therapy or nuclease-free gene editing modality across a broad range of genetic disorders. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a particular focus on rare diseases, and intellectual property covering its suite of 15 AAVHSCs. Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines. For more information, please visit www.homologymedicines.com.
MWM
4 años hace
Pfizer Invests $120 Million in Biotechnology Innovation Through the Pfizer Breakthrough Growth Initiative
First four investments of new program created to support clinical-stage biotechnology companies
New investments include companies focused on Oncology, Rare Disease, and Inflammation & Immunology
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that, during the second half of 2020, it invested a total of $120 million in four clinical-stage biotech companies as part of the Pfizer Breakthrough Growth Initiative (PBGI). Through PBGI, Pfizer is investing up to $500 million in biotechnology companies, providing funding and access to Pfizer’s scientific expertise to help ensure the continuity of promising clinical development programs of potential future strategic interest to Pfizer.
Pfizer’s initial PBGI investments include:
$10 million in Vancouver, BC-based ESSA Pharma (Nasdaq: EPIX), a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer.
$25 million in Cambridge, Mass.-based Trillium Therapeutics (Nasdaq: TRIL), a clinical-stage immuno-oncology company focused on developing innovative therapies for the treatment of cancer. In addition, Jeff Settleman, Senior Vice President and Chief Scientific Officer of Pfizer’s Oncology Research & Development Group, was named to Trillium’s Scientific Advisory Board.
$25 million in Cambridge, Mass.-based Vedanta Biosciences, a privately held clinical-stage company focused on developing a new category of therapies for immune-mediated diseases based on rationally defined consortia of human microbiome-derived bacteria. In addition, Michael Vincent, Senior Vice President and Chief Scientific Officer of Pfizer’s Inflammation & Immunology Research Unit, will join Vedanta’s Scientific Advisory Board.
$60 million in Bedford, Mass.-based Homology Medicines (Nasdaq: FIXX), a clinical-stage genetic medicines company focused on treatments for rare genetic diseases with significant unmet medical needs. In addition, Seng Cheng, Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Disease Research Unit, has joined Homology’s Scientific Advisory Board for matters related to Homology’s gene therapy and gene editing programs for phenylketonuria (PKU).
“Pfizer has a long history of collaborating across the healthcare ecosystem with the shared goal of turning great science into innovative new medicines,” said Debbie Baron, Senior Vice President of Business Development, Pfizer. “Our investments in Homology, Vedanta, Trillium, and ESSA reflect our commitment to find new and creative ways to leverage Pfizer’s resources to deliver breakthroughs to patients.”
Established in June 2020, the Pfizer Breakthrough Growth Initiative focuses on non-controlling equity investments primarily in public companies with small- to medium-sized market capitalizations and mature private companies that are developing clinical-stage assets aligned with Pfizer’s core areas of focus: Internal Medicine, Inflammation & Immunology, Oncology, Rare Disease, Vaccines, and Hospital. In addition to equity, Pfizer looks to strengthen collaboration through participation on company and scientific advisory boards, as well as securing certain strategic rights when of mutual fit.
Biotechnology companies interested in learning more may contact pbgi@pfizer.com.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Disclosure Notice: The information contained in this release is as of January 12, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about the Pfizer Breakthrough Growth Initiative (PBGI) and Pfizer’s initial PBGI investments in ESSA Pharma, Trillium Therapeutics, Vedanta Biosciences and Homology Medicines, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development; uncertainties regarding the ability of the Pfizer Breakthrough Growth Initiative to identify investment candidates; uncertainties regarding the success of investments by the Pfizer Breakthrough Growth Initiative; uncertainties and variables inherent in business operating and financial performance, including, among other things, competitive developments and general economic, political, business, industry, regulatory and market conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; uncertainties regarding the impact of COVID-19; and competitive developments.
MWM
4 años hace
$FIXX love the news and connection with $PFE
Homology Medicines Announces $60 Million Equity Investment from Pfizer Inc.
BEDFORD, Mass., November 9, 2020 – Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that Pfizer Inc. (NYSE: PFE) has agreed to make a $60 million equity investment in Homology. Pfizer has agreed to purchase 5,000,000 of Homology’s common stock at a price of $12.00 per share, as part of the Pfizer Breakthrough Growth Initiative, which was announced earlier this year. The purchase by Pfizer is expected to close on or about November 10, 2020.
“With the positive clinical data from the dose-escalation phase of our pheNIX Phase 1/2 trial for adults with phenylketonuria (PKU) and our plans to move to the expansion phase of the trial, both of which we announced last week, we believe Pfizer’s investment in Homology is a testament to their enthusiasm for our PKU gene therapy and gene editing programs to treat people living with this disease,” stated Arthur Tzianabos, Ph.D., President and Chief Executive Officer of Homology Medicines.
“Pfizer Rare Disease has a 30-year heritage of developing treatment options for patients with some of the greatest unmet needs, including in the area of rare metabolic disorders,” said Seng Cheng, Ph.D., Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Disease Research Unit. “Our investment in Homology represents 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 is a good strategic fit with our rAAV-associated gene therapy portfolio.”
In connection with the investment, Pfizer’s Dr. Cheng will join Homology’s Scientific Advisory Board to participate in matters 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. Additionally, 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, together with the anticipated proceeds of $60 million from the Pfizer equity investment, Homology expects cash resources to fund operations into 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 liver-tropic AAVHSC15 vector. Homology has received Fast Track Designation and orphan drug designation for HMI-102 from the U.S. Food and Drug Administration (FDA), and orphan drug designation from the European Medicines Agency (EMA). HMI-103 is an investigational, nuclease-free gene editing product candidate in IND-enabling studies for pediatric patients with PKU, whose livers are rapidly dividing. 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 Phenylketonuria (PKU)
PKU is a rare inborn error of metabolism caused by a mutation in the PAH gene. PKU results in a loss of function of the enzyme phenylalanine hydroxylase, which is responsible for the metabolism of phenylalanine (Phe), an amino acid obtained exclusively from the diet. If left untreated, toxic levels of Phe can accumulate in the blood and result in progressive and severe neurological impairment. 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 U.S. with approximately 350 newborns diagnosed each year. The worldwide prevalence of PKU is estimated to be 50,000 people.
About Homology Medicines, Inc.
Homology Medicines, Inc. is a genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicines in vivo either through a gene therapy or nuclease-free gene editing modality across a broad range of genetic disorders. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a particular focus on rare diseases, and intellectual property covering its suite of 15 AAVHSCs. Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines. For more information, please visit www.homologymedicines.com.
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