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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.

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Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML

PRNewswire | July 27, 2023

Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib). The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy. US Intended Use The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered. The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered. The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered. The test is for use on the 3500xL Dx Genetic Analyzer. "FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO, CEO, and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients." AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis. Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan. About Invivoscribe Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.

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Cell and Gene Therapy, MedTech

NKGen Biotech, Inc. Announces First Patient Dosed in Phase I Clinical Trial of SNK02, Allogeneic NK Cell Therapy Product Candidate

globenewswire | August 29, 2023

NKGen Biotech, Inc. a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer (“NK”) cell therapies, today announced the first patient has been dosed in a Phase I, multi-center, open-label, dose-escalation study evaluating its cryopreserved investigational allogeneic blood-derived NK cell therapy (“SNK02”). In October 2022, the Food and Drug Administration allowed NKGen’s Phase I SNK02 clinical trial to proceed per its Investigational New Drug application. NKGen previously announced a proposed business combination with Graf Acquisition Corp. IV (NYSE: GFOR.U, GFOR, GFOR.WS). This Phase I clinical trial is evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, will be administered as an intravenous infusion, weekly for eight weeks. SNK02 consists of NK cells isolated from healthy donor peripheral blood mononuclear cells. NKGen’s proprietary allogeneic manufacturing process is technically capable of producing hundreds of thousands of potential doses of NK cell therapies from materials collected from a single donor. Processed SNK02 cells are expected to possess 99% purity and very high receptor expression rates. Its cryopreservation process allows the Company to maintain significant cytotoxicity, potentially making SNK02 an accessible investigational off-the-shelf candidate for clinical trials treating malignancies with an emphasis on solid tumors. “We are excited to have dosed our first patient in the Phase I SNK02 clinical trial in refractory cancer patients with limited treatment options,” said Paul Y. Song, M.D., CEO of NKGen. “SNK02 seeks to be one of the first cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration. We believe the lack of lymphodepletion has the potential to better preserve the already fragile immune function of heavily pre-treated cancer patients with advanced disease. If successful, this therapy may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors where a robust T-cell response is needed.” About NKGen NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapies. NKGen is headquartered in Santa Ana, California, USA. About Graf Acquisition Corp. IV (“Graf”) Graf is a blank-check company incorporated as a Delaware corporation and formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses.

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Medical, Industry Outlook

Massive Bio and CureMatch Announce Groundbreaking Partnership to Revolutionize Cancer Treatment through AI and Clinical Trial Accessibility

Businesswire | July 24, 2023

Massive Bio, an AI-powered platform connecting patients with clinical trials and CureMatch, a healthcare technology company leveraging Knowledge Representation & Reasoning (KRR) AI for precision medicine support for oncology, and have announced a transformative partnership aimed at revolutionizing cancer treatment through advanced genomics, artificial intelligence, and expansive clinical trial accessibility. Massive Bio and CureMatch will leverage their cutting-edge technologies to provide oncologists and their patients unprecedented access to potentially lifesaving clinical trials, personalized cancer treatments, and comprehensive reports on the most effective therapies based on individual patients' profiles. Selin Kurnaz, CEO and Co-Founder of Massive Bio, highlights the potential of this alliance: "This partnership with CureMatch combines the power of precision medicine with the most advanced AI-driven clinical trial matching. It disruptively accelerates the drug development process, offering faster access to advanced therapies for patients." Navid Alipour, CEO of CureMatch, also emphasized the transformative potential of the partnership. "CureMatch is thrilled to join forces with Massive Bio. By integrating our personalized oncology platform with their AI-driven clinical trial matching system, we can reach more patients and provide the best possible treatment options. Our mission is to improve the quality of life for countless patients and contribute to the global fight against cancer." In this game-changing alliance, CureMatch will harness its distinctive platform to identify patients who stand to benefit most from groundbreaking clinical trials, thereby magnifying the reach and impact of Massive Bio's trials. Simultaneously, Massive Bio will employ its cutting-edge AI capabilities to process a wealth of patient clinical health data, including variables such as cancer type, demographics, geographic location, and historical data. By weaving this intricate data mosaic with CureMatch's customized reports, Massive Bio will expertly determine potential matches for appropriate clinical trials. This pioneering approach not only streamlines patient identification but also propels drug development and fortifies personalized treatment strategies. As a result, this transformative partnership presents a highly compelling opportunity for similar future partners looking to fuel the future of precision oncology. Dr. Arturo Loaiza-Bonilla, Co-Founder of Massive Bio, believes the collaboration will not only contribute to cancer treatment innovation but will also play a vital role in reducing disparities in clinical trial participation. "This partnership addresses a critical gap in oncology research, providing an opportunity for all patients, regardless of their geographical location, to access cutting-edge treatments." By leveraging the expertise and technological capabilities of both organizations, the partnership aims to facilitate the referral of patients to clinical trials, thus increasing access to potential therapies for cancer patients. As a result, patients worldwide stand to benefit from advanced precision medicine delivered locally, improving health outcomes and reducing healthcare costs. About Massive Bio Massive Bio is at the forefront of empowering cancer patients to discover their optimal treatment options. Utilizing AI to enhance equitable access and precision targeting for clinical trial matching, drug matching, and drug development, Massive Bio is committed to breaking down barriers in clinical trial enrollment, fostering value-based oncology decisions, and facilitating data-driven cancer treatment. Serving over three dozen pharmaceutical companies, contract research organizations, and hospital networks, Massive Bio has earned recognition from the National Cancer Institute with an SBIR contract. Founded in 2015 by a team of clinical, technology, and M&A executives, Massive Bio boasts a global presence with nearly 100 people across 12 countries. For further details, please visit www.massivebio.com, https://askfiona.ai, https://drarturo.ai or interact with us on our social media channels. About CureMatch CureMatch, Inc. is a digital health company focused on personalized medicine and combination therapy in oncology. CureMatch's Decision Support System guides oncologists in the selection of cancer drugs that are personalized for individual patients based on their molecular tumor profile.

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Medical

Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML

PRNewswire | July 27, 2023

Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib). The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy. US Intended Use The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered. The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered. The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered. The test is for use on the 3500xL Dx Genetic Analyzer. "FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO, CEO, and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients." AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis. Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan. About Invivoscribe Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.

Read More

Cell and Gene Therapy, MedTech

NKGen Biotech, Inc. Announces First Patient Dosed in Phase I Clinical Trial of SNK02, Allogeneic NK Cell Therapy Product Candidate

globenewswire | August 29, 2023

NKGen Biotech, Inc. a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer (“NK”) cell therapies, today announced the first patient has been dosed in a Phase I, multi-center, open-label, dose-escalation study evaluating its cryopreserved investigational allogeneic blood-derived NK cell therapy (“SNK02”). In October 2022, the Food and Drug Administration allowed NKGen’s Phase I SNK02 clinical trial to proceed per its Investigational New Drug application. NKGen previously announced a proposed business combination with Graf Acquisition Corp. IV (NYSE: GFOR.U, GFOR, GFOR.WS). This Phase I clinical trial is evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, will be administered as an intravenous infusion, weekly for eight weeks. SNK02 consists of NK cells isolated from healthy donor peripheral blood mononuclear cells. NKGen’s proprietary allogeneic manufacturing process is technically capable of producing hundreds of thousands of potential doses of NK cell therapies from materials collected from a single donor. Processed SNK02 cells are expected to possess 99% purity and very high receptor expression rates. Its cryopreservation process allows the Company to maintain significant cytotoxicity, potentially making SNK02 an accessible investigational off-the-shelf candidate for clinical trials treating malignancies with an emphasis on solid tumors. “We are excited to have dosed our first patient in the Phase I SNK02 clinical trial in refractory cancer patients with limited treatment options,” said Paul Y. Song, M.D., CEO of NKGen. “SNK02 seeks to be one of the first cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration. We believe the lack of lymphodepletion has the potential to better preserve the already fragile immune function of heavily pre-treated cancer patients with advanced disease. If successful, this therapy may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors where a robust T-cell response is needed.” About NKGen NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapies. NKGen is headquartered in Santa Ana, California, USA. About Graf Acquisition Corp. IV (“Graf”) Graf is a blank-check company incorporated as a Delaware corporation and formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses.

Read More

Medical, Industry Outlook

Massive Bio and CureMatch Announce Groundbreaking Partnership to Revolutionize Cancer Treatment through AI and Clinical Trial Accessibility

Businesswire | July 24, 2023

Massive Bio, an AI-powered platform connecting patients with clinical trials and CureMatch, a healthcare technology company leveraging Knowledge Representation & Reasoning (KRR) AI for precision medicine support for oncology, and have announced a transformative partnership aimed at revolutionizing cancer treatment through advanced genomics, artificial intelligence, and expansive clinical trial accessibility. Massive Bio and CureMatch will leverage their cutting-edge technologies to provide oncologists and their patients unprecedented access to potentially lifesaving clinical trials, personalized cancer treatments, and comprehensive reports on the most effective therapies based on individual patients' profiles. Selin Kurnaz, CEO and Co-Founder of Massive Bio, highlights the potential of this alliance: "This partnership with CureMatch combines the power of precision medicine with the most advanced AI-driven clinical trial matching. It disruptively accelerates the drug development process, offering faster access to advanced therapies for patients." Navid Alipour, CEO of CureMatch, also emphasized the transformative potential of the partnership. "CureMatch is thrilled to join forces with Massive Bio. By integrating our personalized oncology platform with their AI-driven clinical trial matching system, we can reach more patients and provide the best possible treatment options. Our mission is to improve the quality of life for countless patients and contribute to the global fight against cancer." In this game-changing alliance, CureMatch will harness its distinctive platform to identify patients who stand to benefit most from groundbreaking clinical trials, thereby magnifying the reach and impact of Massive Bio's trials. Simultaneously, Massive Bio will employ its cutting-edge AI capabilities to process a wealth of patient clinical health data, including variables such as cancer type, demographics, geographic location, and historical data. By weaving this intricate data mosaic with CureMatch's customized reports, Massive Bio will expertly determine potential matches for appropriate clinical trials. This pioneering approach not only streamlines patient identification but also propels drug development and fortifies personalized treatment strategies. As a result, this transformative partnership presents a highly compelling opportunity for similar future partners looking to fuel the future of precision oncology. Dr. Arturo Loaiza-Bonilla, Co-Founder of Massive Bio, believes the collaboration will not only contribute to cancer treatment innovation but will also play a vital role in reducing disparities in clinical trial participation. "This partnership addresses a critical gap in oncology research, providing an opportunity for all patients, regardless of their geographical location, to access cutting-edge treatments." By leveraging the expertise and technological capabilities of both organizations, the partnership aims to facilitate the referral of patients to clinical trials, thus increasing access to potential therapies for cancer patients. As a result, patients worldwide stand to benefit from advanced precision medicine delivered locally, improving health outcomes and reducing healthcare costs. About Massive Bio Massive Bio is at the forefront of empowering cancer patients to discover their optimal treatment options. Utilizing AI to enhance equitable access and precision targeting for clinical trial matching, drug matching, and drug development, Massive Bio is committed to breaking down barriers in clinical trial enrollment, fostering value-based oncology decisions, and facilitating data-driven cancer treatment. Serving over three dozen pharmaceutical companies, contract research organizations, and hospital networks, Massive Bio has earned recognition from the National Cancer Institute with an SBIR contract. Founded in 2015 by a team of clinical, technology, and M&A executives, Massive Bio boasts a global presence with nearly 100 people across 12 countries. For further details, please visit www.massivebio.com, https://askfiona.ai, https://drarturo.ai or interact with us on our social media channels. About CureMatch CureMatch, Inc. is a digital health company focused on personalized medicine and combination therapy in oncology. CureMatch's Decision Support System guides oncologists in the selection of cancer drugs that are personalized for individual patients based on their molecular tumor profile.

Read More

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