A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Start Date20 Jan 2020

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with AMG-199

100 Translational Medicine associated with AMG-199

100 Patents (Medical) associated with AMG-199

News (Medical) associated with AMG-199

02 Jan 2023

·www.prnewswire.com

Propulsion of Pancreatic Cancer Pipeline as Novel and Extensive 170+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of pancreatic cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Pancreatic Cancer drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Eli Lilly and Company, CARsgen Therapeutics, and several others. LAS VEGAS, Jan. 2, 2023 /PRNewswire/ -- DelveInsight's ' Pancreatic Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline pancreatic cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the pancreatic cancer pipeline domain. Key Takeaways from the Pancreatic Cancer Pipeline Report DelveInsight's pancreatic cancer pipeline report depicts a robust space with 150+ active players working to develop 170+ pipeline therapies for pancreatic cancer treatment. Key pancreatic cancer companies such as FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc.Amgen, Biomea Fusion, and others are evaluating pancreatic cancer drugs to improve the treatment landscape. Promising pancreatic cancer pipeline therapies in various stages of development include Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72, PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. In December 2022, Targovax ASA announced that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy. In December 2022, Bluestar Genomics, Inc. announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics' proprietary epigenomic methods for the detection of the disease. In December 2022, iOnctura BV, a clinical-stage biotech developing novel cancer therapies, had been granted €17.5 million ($18.6 million) funding from the European Investment Council's (EIC) accelerator program to develop IOA-289 for pancreatic cancer.The EIC's funding consists of a grant of €2.5 million ($2.7 million) and €15 million ($16 million) of equity investment. In December 2022, In the Phase I/II CodeBreaK 100 trial, the KRAS G12C inhibitor sotorasib achieved meaningful anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer, according to researchers at The University of Texas MD Anderson Cancer Center. The results of the trial, published in the The New England Journal of Medicine, indicate an objective response rate of 21.1% and a median time-to-response of 1.5 months, with 84% of patients experiencing disease control. Median progression-free survival was 4 months, and overall survival was 6.9 months. In December 2022, Oncolytics Biotech® Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation. In December 2022, RemeGen Co., Ltd. announced that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been granted ODD twice for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Panbela Therapeutics, Inc. announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela's application for orphan designation of ivospemin ( SBP-101) in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA). In September 2022, Qualigen Therapeutics, Inc. announced the presentation of two posters on QN-302 at the AACR 8th Special Conference on Pancreatic Cancer. The data presented include information on the compound's safety, tolerability, and efficacy in a pancreatic cancer model. The poster included preclinical toxicology data that showed QN-302 does not produce adverse toxicological reactions in mouse models at therapeutic doses. In in vitro tests, QN-302 inhibits acetylcholinesterase (AChE) by 53% and muscarinic receptor (M2) by 70% at 1 µM. Request a sample and discover the recent advances in pancreatic cancer drugs @ Pancreatic Cancer Pipeline Report The pancreatic cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage pancreatic cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the pancreatic cancer clinical trial landscape. Pancreatic Cancer Overview Pancreatic cancer develops in the pancreas tissues, an abdomen organ located behind the stomach's bottom portion. The pancreas secretes hormones that help control blood sugar and enzymes that aid digestion. Pancreatic cancer is a condition in which malignant (cancer) cells develop in pancreatic tissues. The pancreas can develop tumors in various ways, including malignant and noncancerous tumors. However, the precise causes of pancreatic cancer are unknown. Individuals diagnosed with pancreatic cancer before the tumor develops or spreads have an average life expectancy of pancreatic cancer of 3 to 3.5 years. Pancreatic cancer symptoms may include jaundice, dark urine, weight loss, loss of appetite, fatigue, and others. A pancreatic cancer diagnosis is difficult because symptoms are frequently confused with those of other disorders, such as irritable bowel syndrome. The extent of the cancer determines the treatment of pancreatic cancer options. Pancreatic cancer treatment options may include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Learn more about the diseases and pancreatic cancer diet @ Pancreatic Cancer Tests A snapshot of the Pancreatic Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging pancreatic cancer treatment options @ Pancreatic Cancer Clinical Trials Pancreatic Cancer Therapeutics Assessment The pancreatic cancer pipeline report proffers an integral view of pancreatic cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Pancreatic Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Oral, Parenteral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine Therapeutics Assessment By Mechanism of Action: Connective tissue growth factor inhibitors, Poly(ADP-ribose) polymerase 1 inhibitors, Poly(ADP-ribose) polymerase 2 inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Growth differentiation factor 15 inhibitors, Endothelin B receptor antagonists, Image enhancers Key Pancreatic Cancer Companies: FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc., Amgen, Biomea Fusion, and others. Key Pancreatic Cancer Pipeline Therapies: Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72,PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. Dive deep into rich insights for pancreatic cancer research; visit @ New Treatment for Pancreatic Cancer Table of Contents For further information on pancreatic cancer prevention, reach out @ Pancreatic Cancer Drug Treatment Related Reports Pancreatic Cancer Epidemiology Pancreatic Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted pancreatic cancer epidemiology in the 7MM. Pancreatic Cancer Market Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Advanced Pancreatic Cancer Market Advanced Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key advanced pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, among others. Advanced Pancreatic Cancer Pipeline Advanced Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Metastatic Pancreatic Cancer Market Metastatic Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Metastatic Pancreatic Cancer Pipeline Metastatic Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Fast TrackOrphan DrugClinical ResultImmunotherapy

04 Mar 2021

·medcitynews.com

Amgen’s $1.9B Five Prime deal adds to cancer drug pipeline and Asia strategy

Amgen, which is looking to bolster its cancer drug pipeline and build its presence in Asia, is acquiring Five Prime Therapeutics in a $1.9 billion deal that checks off both goals. On Thursday, Amgen announced it has agreed to pay $38 cash for each share of Five Prime, a more than 70 percent premium to the company’s closing stock price on Wednesday. Five Prime develops immuno-oncology drugs and targeted cancer therapies. The jewel of the South San Francisco-based biotech’s pipeline is bemarituzumab (usually shortened to “bema”), an antibody ready to advance to Phase 3 testing in gastric cancer. “This deal advances our strategic imperative to grow our business internationally, and in Asia-Pacific in particular, where gastric cancer is highly prevalent and where we previously stated we expect to generate roughly 25% of revenue growth over the next 10 years,” Amgen Chief Financial Officer Peter Griffin said on a conference call. For Five Prime, acquisition by the Thousand Oaks, California-based pharma giant represents a lifeline following a series of clinical and financial setbacks in recent years that left much of the biotech’s fortunes resting on its lead antibody drug. Gastric cancer accounts for more than one million cancer diagnoses globally and is the third leading cause of cancer deaths worldwide, trailing only lung and colorectal cancers. Five Prime does not aim to address all gastric cancers. The company designed bema to target fibroblast growth factor receptor 2 (FGFR2), a tumor growth protein overexpressed in an estimated 10% of gastric cancer patients. In 2019, with encouraging safety results from a small Phase 1 study, Five Prime set out to jump straight into Phase 3. The company began enrolling patients, while at the same time hunting for a partner that could execute the full clinical trial. According to Five Prime’s 2019 annual report, the plan was to conduct an early analysis to assess efficacy of the treatment. Depending on the outcome, the company could continue the trial as a Phase 3 test, stop the study, or amend the clinical trial design. Five Prime noted in the report that even if it received clearance from the independent data monitoring committee to proceed with the Phase 3 plan, carrying out that study would require securing a pharma partner to pay for it. But potential partners told the company it was unlikely to land a collaborator without data from previously untreated patients with gastric or gastroesophogeal cancers. Last year, the company pivoted from its Phase 3 plan and instead began a randomized Phase 2 study. The Phase 2 results came through last November, showing that the Five Prime drug, in combination with standard of care chemotherapy, met the study’s main goals compared to treatment with chemotherapy alone. But the results were not without problems. Inflammation of the cornea, as well as stomatitis, which is inflammation of the mouth and lips, were higher in the bema group. Also, more patients dropped out of the treatment group than the control arm. David Reese, Amgen’s executive vice president of research and development, said corneal inflammation was not unexpected because the protein that bema targets is also expressed on corneal cells. That problem can be addressed in future studies with eye drops. Reese added that stomatitis was less of a driver in patients dropping out of the study. The inflammation is a known side effect of the chemotherapy, he said. Amgen will proceed with a Phase 3 test of bema. Gastric cancer is the lead target, but Reese said the pharma giant will also explore other cancers driven by FGFR2b, such as squamous cell carcinoma of the lung, breast and ovarian cancers, and other solid tumors. Looking further down the road, Reese said Amgen would explore combinations with other types of cancer drugs, such as checkpoint inhibitors and tyrosine kinase inhibitors. Acquisition by Amgen marks the latest twist in a long road for Five Prime. Founded in 2002 by Bay Area biotech veteran Lewis “Rusty” Williams, the company set out with drug discovery technology that identified proteins on cells that contribute to disease. The company used that technology to design protein drugs addressing those targets, leveraging the platform into partnerships with bigger companies including GlaxoSmithKline, UCB, and Bristol Myers Squibb. In 2013, with drugs for inflammatory diseases and cancer in clinical testing, Williams took Five Prime public, raising $62.4 million in an IPO priced at $13 per share. Some of Five Prime’s drugs found their way into testing in combination with cancer therapies from its partners. Cabiralizumab, a Five Prime antibody developed to block a protein called colony-stimulating factor-1, was tested in combination with BMS’s nivolumab. But the drug disappointed in 2017 after data from an early-stage test showed higher than expected toxicity. In early 2019, Five Prime restructured to save cash. Jobs in research, pathology, and manufacturing were eliminated. Later that year, the biotech restructured again and eliminated most of its workers involved in discovering drug targets and creating therapeutic proteins. According to a Five Prime securities filing, most of the company’s lab equipment was auctioned off last April. Five Prime implemented the corporate shakeups to keep its focus on the cancer drugs that had already reached clinical testing. Cabiralizumab was still one of those drugs. But a little more than a year ago, the antibody failed a mid-stage study in pancreatic cancer. BMS had acquired rights to that drug as part of an alliance that started in 2015. After the Phase 2 failure, the pharma giant said it would not sponsor additional tests of that Five Prime antibody. At that point, shares of Five Prime were trading at around $4.50 each. BMS remains a partner on two other Five Prime cancer programs. SeaGen is the company’s only other remaining collaborator, with an antibody drug conjugate in preclinical development for an undisclosed disease target. In 2017, Zai Labs licensed rights to develop and commercialize bema in China, Hong Kong, Macau, and Taiwan. The Shanghai-based company is responsible for developing and commercializing the drug in those markets. Amgen will inherit that agreement and will receive a royalty on Zai Lab’s future net sales. Among Five Prime’s programs, partnered and internal, Bema was furthest along in clinical development. Amgen will evaluate Five Prime’s earlier-stage programs on an asset-by-asset basis, Reese said. Bema is set to join an Amgen pipeline that has gastric cancer drug candidates in early clinical development. AMG199 addresses gastric cancer that overexpresses the protein mucin-17. AMG910 is in development for gastric cancer that expresses the protein CLDN18.2. Reese said that the Five Prime drug is appropriate for Amgen’s strategy to develop targeted cancer therapies. “One of our beliefs is that the future of oncology broadly is the marriage of immuno-oncology and precision medicine targeting specific molecular alterations, and I think this fits nicely within that broader strategic rubric in a complement to the other assets in our portfolio,” he said. The boards of directors of both companies have approved the transaction, which is expected to close in the second quarter of this year. If Five Prime receives a superior offer, or if the company backs out of the agreement, it must pay Amgen a $76 million termination fee, according to terms of the merger agreement.

CollaborateAntibodyAcquisitionIPO

100 Deals associated with AMG-199

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrooesophageal junction cancer	Phase 2	Germany	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	South Korea	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	France	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	Austria	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	Taiwan Province	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	United States	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	Japan	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	Spain	Amgen, Inc.	20 Jan 2020
Gastrooesophageal junction cancer	Phase 2	Netherlands	Amgen, Inc.	20 Jan 2020
Pancreatic Cancer	Phase 2	Spain	Amgen, Inc.	20 Jan 2020

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