Amgen shares hit after analysts expose buried FDA trial halt

FierceBiotech | September 13, 2019

Thursday, Amgen posted what appeared to be a fairly innocuous update about its drug Kyprolis and other pipeline assets, but a deeper read turned up a nasty surprise.  About midway through its release, the U.S. biopharma revealed matter-of-factly that a phase 1 dose escalation clinical trial for its drug AMG 397, an oral small molecule MCL1 inhibitor, in blood cancers has been hit with a clinical hold. The hold was handed out by the FDA given a “safety signal for cardiac toxicity.” And that’s not all: After AMG 397 showed some potential safety issues, Amgen has voluntarily halted enrollment for another early-stage test for AMG 176, given that it too is an MCL-1 inhibitor. This is a big deal for Amgen’s pipeline, given these programs are seen as among the company’s more promising emerging oncology developments. Shares in the company were down nearly 1% after the news was brought into the public consciousness through analysts at SVB Leerink. In a note to clients headed “Did One of the Key Oncology Pipeline Pillars Just Crack?” the firm notes that while the exact nature of this cardiac signal in the trial was not disclosed, “animal studies suggest that loss of MCL-1 activity can be associated with sudden onset heart failure.

Spotlight

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Spotlight

Food is not only a central part of our daily lives; how food is produced, distributed and consumed is also at the centre of important nutrition, environmental and social challenges the world faces today. Our food system is under stress and in need of profound transformation if it is to provide the broadest possible access to healthier, more diverse and environmentally sustainable nutrition moving forward.

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Thermo Fisher Scientific and Qatar Genome Program Partner to Advance Precision Medicine

Thermo Fisher Scientific | May 24, 2022

Thermo Fisher Scientific, the world leader in serving science, and Qatar Genome Program (QGP), a member of Qatar Foundation (QF), have partnered with the goal of accelerating genomic research and clinical applications of predictive genomics in Qatar as a step toward expanding the benefits of precision medicine across Arab populations globally. Under the agreement, Thermo Fisher and Qatar Genome Program will develop an Axiom* custom genotyping array for pan-Arab populations using whole genome sequencing data from 19 Arab countries. The array, with about 800,000 variants, aims to help drive scientific research and insights into conditions including diabetes, cardiovascular and metabolic diseases, autism, inherited genetic disorders and cancer. Once available through Thermo Fisher’s global commercial channels in late 2022, the array is intended to provide a cost-effective alternative to whole genome sequencing for Arab populations, enabling increased diversity in large genome-wide studies. Qatar’s national vision is to provide a high standard of living for our people, and that includes providing access to genomics data, technology and insights to improve population health across the country, Our collaboration with Thermo Fisher will not only help us advance precision medicine in Qatar but also among people of Arab identity worldwide.” Dr. Radja Badji, genome operations manager at Qatar Genome Program. Thermo Fisher began working with Qatar Genome Program in 2018 to establish the first microarray designed specifically for the Qatari population. The Q-Chip detects genetic alterations that increase individuals’ risk of both prevalent and rare diseases. As part of the new agreement, the organizations will continue to refine algorithms and define clinically actionable content to assess polygenic risk scores, a measure of disease risk, and clinically relevant variants, including those related to pharmacogenomics. Thermo Fisher’s Axiom microarray technology is designed to help accelerate precision medicine, and we are honored to partner with the Qatar Genome Program as they take bold steps to leverage the power of genomics to improve the standard of care for human health, Together, we’re creating building blocks for implementing comprehensive precision medicine initiatives at scale for population health.” Chad Carter, vice president and general manager of microarray genetic solutions at Thermo Fisher Scientific. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. About the Qatar Genome Program The Qatar Genome Program is an ambitious population-based project aimed at positioning Qatar among the pioneering countries in the implementation of precision medicine. Whole genome sequencing and other omics data is being combined with phenotypic data within the Qatar Biobank, providing a resource for breakthrough research discoveries and to help policy makers set future healthcare priorities for Qatar.

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MEDICAL

Invenshure Launches MEKanistic Therapeutics™

Invenshure | June 03, 2022

Venture studio Invenshure announces the launch of MEKanistic Therapeutics, a biotechnology company redefining precision oncology. Co-inventors and pioneers in the MEK inhibitor field, Judith Sebolt-Leopold, PhD, and Christopher Whitehead, PhD, MBA, have rationally designed a drug that blocks two, key pathways (EGFR and PI3K) used to signal cancer cell growth, with a single molecule. In preclinical studies, this first-in-class dual inhibitor shows unparalleled tumor shrinkage without the toxicity generally associated with current kinase inhibitors. MEKanistic is using cutting edge computational tools to not only understand how these pathways work, but also design medications that perfectly fit within those sites to inhibit the spread of cancer. We have two unique advantages. First, our lead drug's expanded therapeutic window means dramatically reduced side effects for cancer patients. Second, when it's paired with existing cancer therapies, our drug makes them much more effective, We are excited to partner with Pfizer Global R&D veterans, Drs. Leopold and Whitehead, to propel this important technology forward into clinical trials." Danny Cunagin, CEO of MEKanistic. MEKanistic will be launching a round of funding in the coming weeks to support the translation of our lead candidate (MTX-531) towards IND approval later this year with the anticipation of initiation of Phase 1 clinical trials in early 2023. MTX-531's initial application targets head and neck cancers with 900,000 cases worldwide per year. Ultimately, this drug has possible future applications for colon/rectal, esophageal, pancreatic, and some breast cancers. Our work could potentially impact millions of people each year." Chief Scientific Officer, Dr. Sebolt-Leopold. About Invenshure™ Invenshure is a venture studio that scours university research labs for novel and disruptive technologies ready for commercialization. Invenshure partners with top scientists, physicians, and researchers from the most trusted institutions in healthcare and technology. The company focuses on high-growth sectors including biotech, genomics, healthcare IT, diagnostics, cloud computing technologies, and wireless technologies.

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INDUSTRIAL IMPACT

ProPhase Labs to Announce Formation of a Subsidiary ProPhase BioPharma, Inc.

ProPhase Labs, Inc. | June 29, 2022

ProPhase Labs, Inc., a diversified biotech, genomics, and diagnostics company manufacturing homeopathic and health products, announced the formation of a new wholly-owned subsidiary, ProPhase BioPharma, Inc. (PBIO), for the development and licensing of new therapeutic compounds, drugs, and biotechnology. The subsidiary will be focused on advancements in technology across the biochemical industry and creating and developing new solutions that can transform the outcomes of healthcare. The company has also entered into a license agreement with a wholly-owned subsidiary of DSS, Inc., Global BioLife, Inc. (Global BioLife), for Equivir G and Equivir, proprietary compounds that were developed by Global Research and Discovery Group (GRDG). According to the terms of the contract, ProPhase Labs will be the only company that can develop and sell Equivir G and Equivir, globally. “We are thrilled to announce the formation of ProPhase BioPharma, our new wholly-owned subsidiary tasked with licensing and developing novel drugs, compounds, and biotechnology. We are equally pleased with our first licensing agreement for Equivir and Equivir G, which we believe have significant potential to improve human health outcomes worldwide.” Ted Karkus, ProPhase Lab’s Chief Executive Officer He further added, “We plan to pursue commercialization of Equivir as an OTC supplement, leveraging our distribution in over 40,000 Food Drug and Mass retail stores and online direct to consumer. We also look forward to applying to the FDA for an IND for Equivir G as a prescription antiviral.” Frank. D. Heuszel, Chief Executive Officer of DSS, said “We are excited to team up with ProPhase Labs, which will apply its nearly three decades of experience enhancing the health of the public to Equivir, which we believe to be a ground-breaking treatment that will positively impact health in the U.S. and globally.”

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