On January 13, 2020 Amgen (NASDAQ: AMGN) reported strategic collaborations with leading diagnostic companies Guardant Health, Inc. and QIAGEN N.V. to develop blood- and tissue-based companion diagnostics (CDx), respectively, for investigational cancer treatment AMG 510 (Press release, Amgen, JAN 13, 2020, View Source [SID1234553123]). AMG 510 is the first KRASG12C inhibitor to advance to the clinic for investigation in treatment of multiple tumor types. KRAS G12C is one of the most frequently mutated oncogenes in human cancers. The agreements with both companies will initially focus on CDx tests for non-small cell lung cancer (NSCLC) but allow for further development of the diagnostic tests for Amgen’s other oncology clinical development programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Amgen is committed to driving broad accessibility to biomarker testing in order to select appropriate patients who will directly benefit from targeted treatments," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "With one in eight patients with NSCLC having KRAS G12C, there’s a critical need to improve access to high quality diagnostics and more routine screening. Collaborating with QIAGEN and Guardant Health to have both tissue- and blood-based diagnostic tests available will help to identify patients with NSCLC who may benefit from AMG 510."

Amgen will work with QIAGEN to develop a tissue-based diagnostic test utilizing its therascreen platform to identify patients whose cancers have the KRAS G12C mutation. QIAGEN will also pursue global regulatory approvals, including Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA). To enable biomarker testing in patients for whom insufficient tissue remains a challenge, Amgen is also collaborating with Guardant Health to develop a liquid biopsy CDx. Guardant360 CDx is a multi-tumor comprehensive NGS (Next Generation Sequencing) test that is being developed to identify patients with actionable alterations, in this instance with the KRAS G12C mutation in NSCLC. Guardant Health will seek global regulatory approvals for the test, including a PMA from the FDA.

AMG 510 is currently enrolling patients in a potentially registrational Phase 2 study (CodeBreak 100). The FDA granted Orphan Drug Designation to AMG 510 for previously treated metastatic NSCLC and colorectal cancer with KRAS G12C mutation and Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation.

Amgen established RAS as the first actionable biomarker in metastatic colorectal cancer and is now pioneering the development of KRAS mutation specific inhibitors in lung cancer and other solid tumors with AMG 510.

About KRAS
The subject of almost four decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C is found in approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.3 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein.4 Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

On January 13, 2020 Innovent Biologics, Inc. ("Innovent" or the "Company") (HKEX: 01801), a biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported that the Company has entered into an out-license agreement with Coherus BioSciences, Inc. ("Coherus",Nasdaq: CHRS), a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market, to commercialize Innovent’s biosimilar candidate to Avastin (bevacizumab) (IBI305) in the United States and Canada (Press release, Innovent Biologics, JAN 13, 2020, View Source [SID1234553122]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Coherus plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in late 2020 or early 2021 depending on FDA interaction timing, and to launch directly upon approval. IBI305 successfully completed a large Phase 3 safety and efficacy study in China, and the application was filed for approval and was accepted by the National Medical Products Administration ("NMPA") in China in January 2019, and subsequently granted priority review status. Also, under the terms of the agreement, Coherus has a non-exclusive option to license Innovent’s biosimilar to Rituxan (rituximab) (IBI301) for development and commercialization in the United States and Canada. IBI301 was filed for approval and accepted by the NMPA in China in June 2019 with priority review status.

"The clinical efficacy and safety results of IBI305 compared with bevacizumab in advanced, first-line, non-squamous NSCLC patients were presented at the 55th Annual Meeting of the ASCO (Free ASCO Whitepaper) in 2019. With the encouraging results, IBI305 is expected to be high-quality and effective therapy for patients with solid tumors," said Michael Yu, Ph.D., Founder, Chairman and CEO of Innovent. "UDENYCA, has been the most successful biosimilar launch in the United States, and made Coherus the obvious partner of choice. Coherus and Innovent share a very similar mission, vision and set of values. We are pleased to be working together to expand the products’ presence in the U.S. and benefit more patients globally."

"We are excited to enter into a strategic collaboration with one of the premier Chinese biologics companies," said Denny Lanfear, Chairman and CEO of Coherus. "Innovent is an impressive fully-integrated organization delivering substantial benefits to the healthcare system and patients in China with their first approved and successfully commercialized PD-1. Its oncology therapeutics complement UDENYCA and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States."

According to the terms of the agreement, Coherus will pay up to US$45 million for upfront and milestones payments for IBI305. In addition, Coherus will also pay double-digit percent of royalty payments based on future sales of IBI305. Financial terms for IBI301 will be the same when optioned.

On January 13, 2020 Genome & Company (KONEX: 314130) is reported that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications (Press release, Genome & Company, JAN 13, 2020, View Source;company-announces-a-clinical-trial-collaboration-and-supply-agreement-with-merck-kgaa-darmstadt-germany-and-pfizer-300985435.html [SID1234553121]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of this agreement, Genome & Company will be the sponsor of the study, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for the phase 1/1b clinical trial that is expected to be commenced in 2020 in the U.S. Both parties will have access to the clinical data.

The combination trial is designed to be a first-in-human (FIH) study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

"GEN-001 has been developed as the backbone of Genome & Company’s immuno-oncology pipeline, and we are delighted to collaborate with the global leaders in oncology such as Merck KGaA, Darmstadt, Germany and Pfizer on this phase 1/1b clinical trial for this combination of GEN-001 and avelumab. We are excited to investigate how the preclinical data of this combination will be translated to humans. We look forward to initiating this clinical trial in the coming months," said Dr. Jisoo Pae, CEO of Genome & Company.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

About GEN-001

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.

On January 13, 2020 Imaging Endpoints reported that the U.S. Patent and Trademark Office has issued Patent No. 10,332,634 – "Systems And Methods For Reliably Diagnosing Breast Cancer Using Quantitative Textural Analysis" to Imaging Endpoints and its inventor, Chief Medical Officer Ron Korn, M.D., PhD (Press release, Imaging Endpoints, JAN 13, 2020, View Source [SID1234553120]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This breakthrough radiomic evaluation tool allows for rapid diagnosis of the nature of a patient’s breast abnormalities from standard mammography images. The technology enables a real-time evaluation that is otherwise available only through an invasive biopsy and avoids the time involved in obtaining and processing the biopsied tissue.

Imaging Endpoints is honored and excited to share with the market this patented technology that could provide patients and physicians the advantage of faster, less invasive information that is critical to treatment decisions and patient outcomes.

Imaging Endpoints is a pioneer and global leader in the non-invasive interrogation of tumors and diseased tissues by analyzing diagnostic images to identify imaging patterns linked to tumor biology. In cancer patients, image analysis provides a non-invasive, low-risk approach to assessing tumor biology prior to therapy and an objective pathway for monitoring treatment responses. The method of using signals detected on image data to characterize tumor biology is based on underlying tumor biology, growth kinetics and other drivers of oncologic transformation which may have novel expression patterns on standard of care radiological images. When used alone or in combination with other factors, a unique imaging phenotype may be developed to characterize lesions using both qualitative and quantitative approaches. Thus insights into the biologic processes of tumors may be measured, derived, inferred or predicted with the discovery of imaging phenotypes. This coupled with imaging’s ability to provide a comprehensive and real-time assessment of the entire tumor and its micro-environment make quantitative imaging an attractive tool for rapid assessment and prognosis.

The Breast Imaging Reporting and Data System (BI-RADS) was established by the American College of Radiology to assign mammogram screenings into discrete categories of perceived severity. A follow-up biopsy is typically recommended for BI-RADS category 4 and higher. However, biopsies ultimately confirm that many BI-RADS 4 designations are benign. Consequently, many women undergo painful and expensive biopsies only to find that the tumor is benign due to the rate of false positives.

Ronald Korn, M.D., PhD commented: "A reliable imaging signature for differentiating between malignant and non-malignant BI-RADS 4 mammographic lesions has remained elusive until now. The Imaging Endpoints invention provides a biomarker signature for determining whether a lesion identified in a breast image is malignant. The signature is derived from processing mammography data using a Quantitative Textural Analysis platform (TexRAD); generating respective histograms and related quantitative metrics, and performing logistical regression to yield a model predictive signature. Imaging Endpoints believes that its technology offers a real-time advantage with rapid results, however additional studies are needed to further validate the correlation of the signature with pathologic variables."

Imaging Endpoints currently offers imaging CRO services for the use of its advanced imaging technologies in clinical trials, and is actively seeking partners to commercialize its technologies for routine patient care.

On January 13, 2020 Contextual Genomics, a leading cancer genomics company, and Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California, reported that they have signed an agreement enabling Lab Genomics to offer Contextual Genomics’ quality assured Next Generation Sequencing (NGS) based ctDNA cancer genomic testing to patients in Southern California and other parts of the United States (Press release, Contextual Genomics, JAN 13, 2020, View Source [SID1234553119]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of their agreement, Lab Genomics will offer the FOLLOW IT panel, a test detecting cell-free circulating tumour DNA in plasma to patients diagnosed with cancer. The FOLLOW IT panel is a multiplex, NGS genomic assay designed for rapid deployment into labs around the world. The FOLLOW IT assay evaluates the mutation status of cell-free circulating tumour, identifying the somatic mutations that have the greatest potential to impact treatment decisions.

Michael Ball, Contextual Genomics’ Chief Executive Officer, said "We are pleased to announce this important relationship with Lab Genomics. The availability of quality-assured cost-effective rapid turnaround time ctDNA testing as a result of this partnership will be of tremendous benefit to many patients suffering from solid tumour cancers, avoiding the need for more invasive tissue biopsies. We look forward to working with Lab Genomics to bring this more precise personalized care to cancer patients within their territory."

"At Lab Genomics, our mission is to deliver a suite of unmatched molecular diagnostic services to our customers, to provide preventive, predictive, personalized services," said Leena Dalal, Founder of Lab Genomics. "This partnership with Contextual Genomics, adding FOLLOW IT liquid biopsy cancer testing for our customers, provides a critical less invasive alternative testing option for cancer patients where tissue biopsy is difficult or not available. We look forward to continuing to support the best quality of life possible for all patients and FOLLOW IT will be an important part of our oncology offering."