Pharmaceutical

ImaginAb Inc., a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. to supply 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients. Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing ...

ImaginAb Inc., a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. (NYSE: PFE) to supply 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients.

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients.

Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. In addition, ImaginAb will provide technical, clinical, and regulatory support to Pfizer. ImaginAb will receive license fees and payments for manufacturing and other support. No other terms were disclosed.

This agreement expands upon the relationship between the companies following the pre-competitive alliance between ImaginAb, Pfizer and other global pharmaceutical companies which focused on the development of 89Zr CD8 ImmunoPET technology. The alliance, announced on October 14, 2019 , has assisted in advancing the 89Zr CD8 Immuno-PET technology.

Commenting on the announcement, Ian Wilson, Chief Executive Officer of ImaginAb said: "Pfizer continues to be a great partner and supporter of our efforts to develop this innovative PET imaging technology, and we are delighted to expand our relationship further.

Wilson continued "Imaginab is actively investing in the clinical and global supply chain development of 89Zr CD8 Immuno-PET agent to provide simple turnkey access to this novel technology. Our goal is to enable the widespread use and adoption of 89Zr CD8 Immuno-PET technology, which will help our partners to predict therapeutic efficacy and treatment outcomes in cancer patients more precisely and earlier in a clinical trial. Working with leading pharmaceutical companies such as Pfizer, will help us achieve our goal."

"CD8 T cells play such a pivotal role in immunotherapy of many cancers and our 89Zr CD8 Immuno-PET is one of the most widely used imaging technology used by pharmaceutical and biotech companies to track CD8 T cells in patients."

For further information please contact:

ImaginAb
Ian Wilson
Email: info@imaginab.com
Phone: +1 310 645 1211

About ImaginAb

ImaginAb Inc. is biotechnology company focused on developing radiopharmaceutical imaging and therapy agents. ImaginAb engineers antibody fragments called minibodies that maintain the exquisite specificity of full-length antibodies while remaining biologically inert in the body. Used with widely available PET scan technology, these novel minibodies illuminate high-value molecular targets, providing physicians with a whole-body picture of immune activity. ImaginAb is advancing a pipeline of minibodies against oncology and immunology targets including the 89Zr CD8 ImmunoPET targeting CD8 T cells. ImaginAb's products have the potential to improve patient care and lower healthcare costs. The Company is backed by top tier venture capital firms and strategic corporate firms including, Adage Capital, The Cycad Group, Norgine ventures Jim Pallotta of the Raptor Group, The Parker Institute for Cancer Immunotherapy, and Merck (MSD) Pharma.

For more information about ImaginAb's pipeline and technology, visit www.imaginab.com .

About CD8 ImmunoPET

The 89Zr CD8 Immuno-PET agent ([89Zr]-Df-IAB22M2C) is a [89Zr]-labeled minibody that binds the CD8 receptor on human T cells and is used for quantitative, non-invasive PET imaging of CD8 T cells in patients. CD8 T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases. As such, quantitative imaging of CD8 T cells can be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes.

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SOURCE ImaginAb, Inc.

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Adaptimmune Announces Appointment of Cintia Piccina as Chief Commercial Officer

Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announces the appointment of Cintia Piccina as Chief Commercial Officer effective January 31, 2022.

"I am delighted to welcome Cintia to our leadership team. She brings extensive commercial experience, including in cell and gene therapy, that will be key as we prepare to submit our first BLA for afami-cel this year, and build our commercial capabilities to support the launch of this initial product and future next-gen cell therapies within our MAGE-A4 franchise. Her fresh perspective and leadership abilities will support our continued growth in our mission to design and develop cell therapies for people with cancer," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer.

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Merck Announces Second-Quarter 2022 Dividend

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company's common stock for the second quarter of 2022. Payment will be made on April 7, 2022 to shareholders of record at the close of business on March 15, 2022.

About Merck

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 Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age

  • First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies' Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

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Merck Provides U.S. and Japan Regulatory Update for Gefapixant

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck's New Drug Application (NDA) for gefapixant, the investigational, non-narcotic, orally administered selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. In March 2021, Merck announced that the FDA accepted the company's NDA for gefapixant. In the CRL, the FDA requested additional information related to measurement of efficacy. The CRL was not related to the safety of gefapixant. Merck is reviewing the letter and will meet with the agency to discuss next steps.

"We remain committed to advancing gefapixant for patients with refractory or unexplained chronic cough and will work with the FDA to address the agency's feedback," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "We believe there is a significant unmet need to help patients manage their chronic cough, as there are no available treatment options indicated in the U.S. specifically for this condition."

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Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency

Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA's comments and will work with the agency to determine an appropriate path forward.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220121005474/en/

"We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families."

Regulatory applications for somatrogon have been submitted to several countries around the world for review. Earlier this week, Japan's Ministry of Health, Labour and Welfare approved NGENLA® (somatrogon) Inj. 24 mg Pens and 60mg Pens, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. In 2021, Health Canada approved NGENLA ® for the long-term treatment of pediatric patients who have GHD, and Australia's Therapeutic Goods Administration (TGA) approved NGENLA ® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone. Furthermore, in December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending somatrogon for marketing authorization in the EU, to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. A decision from the European Commission (EC) is expected in early 2022.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.

About Growth Hormone Deficiency

Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 children. 1,2 In children, this disease can be caused by genetic mutations or acquired after birth. 1,3 Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, a child's height may be affected and puberty may be delayed. 1,3,4 Without treatment, affected children will have persistent growth attenuation and a very short height in adulthood. 3,4 Children may also experience other problems with physical health and mental well-being. 3,4

Pfizer Rare Disease

Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

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 150 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 21, 2022. Pfizer and OPKO assume 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 an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the U.S. for once-weekly treatment of pediatric patients with growth hormone deficiency, including its 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, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; uncertainties regarding the company's ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when drug applications may be filed in any other jurisdictions for any potential indication for somatrogon; whether and when the BLA pending with the FDA for somatrogon for the treatment of pediatric patients with growth hormone deficiency may be approved and whether and when regulatory authorities in any jurisdictions may approve any such other applications that may be pending or filed (including the application filed in the EU), which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's and OPKO's business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Report on Form 10- K for the fiscal year ended December 31, 2020 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov , www.pfizer.com , and www.opko.com .

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com .

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BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder Treatment With BETR-001

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has received a written response from the U.S. Food and Drug Administration (FDA) to its pre-investigational new drug (pre-IND) application for the treatment of MDD with BETR-001. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD) and is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials. The FDA response is in general agreement with the Company's planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling non-clinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.

"We are very pleased with the outcome of the BETR-001 pre-IND meeting with the FDA. The response from the FDA confirms that our current program will support the filing of BETR-001's IND application and initiation of human clinical trials by the third quarter of this year. Being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches. Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year," said BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian.

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