On June 6, 2016 Mirna Therapeutics, Inc. (Nasdaq: MIRN), a clinical stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics, reported the presentation of clinical data at the 52nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Mirna Therapeutics, JUN 6, 2016, View Source [SID:1234513072]). Investigators reported on the clinical activity of an ongoing, dose-finding Phase 1 trial of MRX34 (miR-34 mimic), Mirna’s lead microRNA therapeutic, in patients with a variety of advanced solid tumors.

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!

In an oral presentation (Abstract # 2508 "MRX34, a Liposomal miR-34 Mimic, in Patients with Advanced Solid Tumors: Final Dose-Escalation Results from a First-in-Human Phase 1 Trial of microRNA Therapy"), David S. Hong, M.D., study author and Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, presented results showing MRX34’s impact on a broad number of oncogenes and immune pathways, and on the investigational therapy’s safety profile and clinical activity.

"The potential of microRNA therapeutics to simultaneously repress multiple oncogenic and immune-evasion pathways represents an exciting new approach to treating cancer," commented Dr. Hong. "In this early study, we are seeing compelling anti-cancer activity, including tumor shrinkage with notable durations of response, supporting further clinical study of MRX34."

Data highlights include:

Manageable safety profile of MRX34 when administered at the maximum tolerated dose (MTD) with dexamethasone.
Broad, dose-dependent microRNA target engagement with MRX34, including delivery to tumor sites in patients.
Four confirmed partial responses (PRs) for up to 54 weeks in duration. This includes patients with late-stage, metastatic cancers including hepatocellular carcinoma (liver cancer), renal cell carcinoma (kidney cancer) and acral melanoma (skin cancer). Timing of these responses and the safety profile observed suggest a potential immune component to MRX34 antitumor activity.
Stable disease in an additional 15 patients for more than four cycles of therapy (approximately three months), ranging from 79-386 days.
Vincent O’Neill, M.D., Mirna’s Chief Medical Officer commented, "We’re pleased to report our clinical progress to date with the first microRNA candidate for cancer. MRX34 is a promising, first-in-class therapeutic candidate with potential as a single agent and in combination with targeted and immune therapies. With the safety profile and recommended dose established, we look forward to advancing the development of MRX34 into Phase 2 later in 2016."

The presentation may be accessed from the Events & Presentations section of the Company’s website.

On June 6, 2016 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported the results from a study evaluating the performance of its gene expression profile (GEP) test, DecisionDx-Melanoma, in 334 new melanoma patients (Press release, Castle Biosciences, JUN 6, 2016, View Source [SID:1234513096]). The data confirmed the positive results from two previously published multicenter clinical validation studies demonstrating the test’s ability to identify patients’ risk of melanoma recurrence in the 5 years following diagnosis. The data were presented in a poster session at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. A second, independent, prospective study of DecisionDx-Melanoma was also presented further confirming the results of the three prior multicenter studies.

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!

Expanded Multicenter Performance Study

In a study titled "Performance of a 31-Gene Expression Profile in a Previously Unreported Cohort of 334 Cutaneous Melanoma Patients" (Abstract # 9581), 334 cutaneous melanoma tumors from 12 centers in the U.S. were analyzed using the DecisionDx-Melanoma test. Tumors were classified as either low-risk Class 1 or high-risk Class 2. The test’s prognostic results were compared to actual clinical outcomes over a 5-year period, as well as traditional methods for disease staging and prognosis including sentinel lymph node (SLN) biopsy, ulceration, Breslow thickness and mitotic rate. Study endpoints included recurrence-free survival (RFS), defined as time to either a regional or distant metastatic event; distant metastasis-free survival (DMFS), defined as time to any metastatic event beyond the regional node; and melanoma-specific survival (MSS), defined as time from diagnosis to death documented as specifically resulting from melanoma. A summary of the results is below:

RFS DMFS MSS
5-year rate # of events 5-year rate # of events 5-year rate # of events
Class 1 (n=181) 86% 29 91% 19 98% 5
Class 2 (n=153) 51% 69 60% 54 75% 31
The study also highlighted the GEP test’s ability to predict which patients are not likely to recur (Negative Predictive Value, or NPV) when used by itself, and in combination with other standard prognostic techniques such as SLN biopsy. While both the DecisionDx-Melanoma test and SLN biopsy were shown to have strong sensitivity to detect patients at risk of metastasis, a combination of the two was the most effective. Results include:

MSS SLN Status GEP Class SLN + GEP
Sensitivity 67% (49-81%) 86% (71-95%) 94% (81-99%)
Specificity 72% (66-77%) 59% (53-65%) 48% (42-54%)
PPV 22% (15-31%) 20% (14-28%) 18% (13-24%)
NPV 95% (91-97%) 97 (94-99%) 99% (95-100%)
95% confidence interval shown in parentheses

Study authors also combined previously studied populations, reviewing the total of 514 patient cases from validation and performance studies of the GEP test to date. Results from the Stage I/II and Stage III patients are shown below:

MSS Stage I/II (n=356) Stage III (n=158)
Sensitivity 80% (52-96%) 87% (70-96%)
Specificity 65% (60-70%) 32% (24-41%)
PPV 9% (5-15%) 24% (16-33%)
NPV 99% (96-100%) 91% (79-98%)
95% confidence interval shown in parentheses

"These study results confirm the prognostic accuracy of this GEP test, demonstrating its ability to provide prognostic information that is independent of and additive to conventional staging," commented Jonathan S. Zager, MD, FACS, lead study author and Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments at the Moffitt Cancer Center. "For melanoma-specific survival, combining this GEP test with SLN status improves sensitivity to 94% and Negative Predictive Value to 99% over SLN status or the GEP test alone – providing support for low-risk management/surveillance plans for Class 1 patients. For Class 2 patients, increased surveillance per guidelines for high-risk patients appears to be warranted."

"We are extremely pleased with the continued strong performance of our GEP test," commented Federico A. Monzon, M.D., FCAP, Chief Medical Officer of Castle Biosciences. "The test, when used with standard melanoma staging tools, provides the most accurate prognostic information from which to plan follow-up care. In addition to improving patient care, the GEP test offers the opportunity to improve clinical trial design to advance adjuvant treatment in patients who have a Class 2, high-risk test result."

Second, Independent, Prospective Study Also Presented

Also at the meeting, a study titled "Prospective Validation of Gene Expression Profiling in Primary Cutaneous Melanoma" (Abstract #9565), was presented by Eddy C. Hsueh, M.D., Professor and Director, Division of Surgical Oncology, St. Louis University Hospital. This study evaluated 159 prospectively enrolled melanoma patients undergoing SLN biopsy and successful testing with the DecisionDx-Melanoma GEP test. The data show that GEP classification is significantly associated with early recurrence in patients diagnosed with melanoma. With a median follow-up time of 18 months, the study found a Negative Predictive Value of 98% for disease-free survival. To date, all Stage III patients with a Class 1 result are recurrence free. The DecisionDx-Melanoma test correctly identified 16 of 18 patients who had recurrence events as high-risk (Class 2). Overall the high-risk Class 2 group had a 38% recurrence rate. Patients who were both high-risk Class 2 and Stage III had a 77% recurrence rate compared to 43% with Stage III status alone.

"An important milestone in test development is demonstrated consistency in prospective studies," added Derek Maetzold, President and CEO of Castle Biosciences. "This prospective study represents the second such DecisionDx-Melanoma study presented in the last six weeks, and provides further independent confirmation for the consistent results seen in Castle Biosciences’ sponsored multicenter studies."

About Melanoma
Cutaneous melanoma is diagnosed in approximately 76,000 people in the U.S. each year, according to the American Cancer Society. Seventy-five percent are diagnosed as Stage I or II, meaning there is no evidence of the melanoma spreading beyond the primary tumor. It is not the most prevalent form of skin cancer, but it is the most aggressive. Unlike other more common skin malignancies such as basal cell and squamous cell carcinomas, melanoma often spreads to other parts of the body, either via the lymphatic or blood system, resulting in cancers of distant organs including the brain or lungs. So, while it represents just 4% of skin cancers, melanoma accounts for about 80% of skin cancer-related deaths.

On June 6, 2016 Peloton Therapeutics, Inc., a drug discovery and development company focused on advancing first-in-class, small molecule cancer therapies targeting unexploited molecular vulnerabilities, reported first-in-human Phase 1 clinical data on its lead investigational candidate, PT2385, at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL (Press release, Peloton Therapeutics, JUN 6, 2016, View Source [SID:1234513120]). PT2385 is the first clinical stage antagonist of hypoxia inducible factor-2α (HIF-2α), a transcription factor implicated in the development and progression of kidney and other cancers.

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!

In an oral presentation titled "A Phase 1 Dose-Escalation Trial of PT2385, a first-in-class oral HIF-2α Inhibitor, in Patients with Advanced Clear Cell Renal Cell Carcinoma," it was shown that PT2385 was well tolerated with no dose-limiting toxicities and had pharmacologic activity with encouraging clinical efficacy.

Patients with advanced clear cell renal cell carcinoma (ccRCC) and at least one prior therapy with a VEGF inhibitor were treated with PT2385 to determine the recommended Phase 2 dose and evaluate safety, pharmacokinetics and pharmacodynamics.
Twenty-six patients were enrolled in dose escalation and received PT2385 from 100 to 1800 mg twice per day. Patients were heavily pretreated prior to study entry, with greater than 50 percent having four or more prior therapies. Exposure increased with doses up to the 800 mg cohort without a further increase from 800 to 1800 mg. No dose limiting toxicities were observed at any dose level. Circulating plasma levels of the HIF-2α transcriptional target erythropoietin (EPO) rapidly decreased with treatment with PT2385 and remained suppressed. Based on safety, pharmacokinetic and EPO pharmacodynamic data, 800 mg twice per day was selected as the recommended Phase 2 dose. An additional 25 patients were enrolled in an expansion cohort at the recommended Phase 2 dose.

Among the 51 patients in total, the most common all-grade adverse events (AEs) were anemia, peripheral edema and fatigue. No cardiovascular AEs were noted. To date, one patient had a complete response, three patients had a partial response, and 16 patients had stable disease for 16 or more weeks. Ten percent of patients remain in this ongoing clinical trial for at least one year.
"Research at our institution has shown than HIF-2α is strongly implicated in renal cell carcinoma. PT2385 is the first agent to target this transcription factor and is very well tolerated. Its efficacy in patients with advanced clear cell renal cell carcinoma is promising," said Toni Choueiri, M.D., from the Dana-Farber Cancer Institute and Harvard Medical School, the senior author of the study.
"We are encouraged by the initial efficacy results in this heavily pretreated population and the fact that PT2385 does not have the cardiovascular toxicities of most other kidney cancer treatments, most notably VEGFR tyrosine kinase inhibitors. In light of this favorable safety profile and preclinical evidence of synergistic activity of our HIF-2α antagonists in combination with immune checkpoint inhibitors shown at the recent AACR (Free AACR Whitepaper) conference, we have opened a clinical trial of PT2385 in combination with nivolumab (Opdivo). Additionally, we are planning clinical studies of PT2385 as monotherapy and with other combination regimens," said John Josey, Ph.D., Peloton’s Chief Executive Officer.

About PT2385
PT2385 is a first-in-class small molecule inhibitor of hypoxia-inducible factor-2α (HIF-2α), a transcription factor implicated in the development and progression of kidney cancer. It is currently being investigated in a Phase 1 clinical trial for the treatment of advanced or metastatic clear cell renal cell carcinoma (ccRCC). Loss of the von Hippel-Lindau tumor suppressor (VHL) is the key oncogenic event in up to 95% of patients with ccRCC. With the loss of the VHL protein (pVHL), the transcription factor HIF-2α accumulates and drives the unbalanced expression of numerous gene products. Preclinical data indicate that orally bioavailable PT2385 disrupts HIF-2α activity in ccRCC and thereby blocks the expression of multiple tumorigenic factors responsible for unrestrained cancer cell growth and proliferation, tumor angiogenesis, and suppression of anti-tumor immune responses characteristic of ccRCC.

About Renal Cell Cancer
The American Cancer Society estimates that more than 62,000 new cases of kidney cancer will be diagnosed and more than 14,000 people will die from this disease this year. The National Cancer Institute reports that the prognosis for any treated renal cell cancer patient with progressing, recurring, or relapsing disease is poor, regardless of cell type or stage.
About Peloton Therapeutics

On June 6, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported updated safety and efficacy data from an ongoing clinical phase 1/2a study evaluating the anti-CD38 antibody MOR202 alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom) plus dexamethasone (Dex) in 63 heavily pre-treated patients with relapsed/refractory multiple myeloma (MM) (Press release, MorphoSys, JUN 6, 2016, View Source [SID:1234513073]). Data were reported during a poster presentation at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. The updates compared to the last presentation of data from this ongoing trial in December 2015 refer in particular to the combination cohorts of MOR202 (8 mg/kg) plus IMiDs.

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!

In the five-patient cohort receiving 8 mg/kg MOR202 in combination with Pom/Dex, two patients reached a complete response (CR) and two patients a minor response (MR) (one of which is unconfirmed). Among the four patients treated with 8 mg/kg MOR202 in combination with Len/Dex and with a scheduled response assessment after one treatment cycle, two reached a partial response (PR) and one a very good partial response (VGPR).

MOR202 could be given in doses of up to 16 mg/kg as a 2-hour infusion to all patients. Infusion-related reactions (IRRs) were observed in 14% of evaluated patients (10% grade 1, 4% grade 2) and were mainly limited to the first infusion.

Moreover, first biomarker data on CD38 expression on plasma cells derived from bone marrow of all five MM patients with available second biopsies, suggested that the CD38 target molecule was preserved during MOR202 therapy comparing values at baseline and at cycle 2 day1.

"We are very pleased with the updated clinical results for MOR202 in multiple myeloma, in particular with two complete responses out of five patients treated with MOR202 plus Pom/Dex. Since we last reported data in December 2015, new and deep responses have been reported with MOR202 in combination with IMiDs. On the safety side, we were pleased to observe that MOR202 could be given to all patients in a 2-hour infusion time, with infusion-related reactions of grade 1 and 2 in only 14% of patients," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The dose escalation study will continue as planned, focusing on the combination treatment, in particular the upcoming cohorts of 16mg/kg MOR202 plus Pom/Dex and Len/Dex."

MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma. Data are from an ongoing clinical phase 1/2a, open-label, multi-center, dose-escalation study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 alone and in combination with the immunomodulatory drugs pomalidomide (Pom) and lenalidomide (Len) plus dexamethasone (Dex) in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 alone and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.

MOR208: Updated results confirm responses. Subgroup analysis shows target lesion shrinkage in patients with stable disease and activity of MOR208 independent of the response to a prior rituximab treatment

In addition, MorphoSys today presented updated clinical data including a subgroup analysis of a phase 2a study with the anti-CD19 antibody MOR208 in relapsed/refractory patients with various subtypes of non-Hodgkin’s lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL). All patients had received at least one prior rituximab-containing therapy.

According to the subgroup analysis data presented today, in addition to patients achieving a partial or complete response (PR, CR), a clinical benefit was also observed in other patients treated with MOR208. The majority of patients (5/6 DLBCL and 12/16 iNHL) with stable disease (SD) also had a reduction in the size of the target lesions – despite the short treatment period of 3 cycles according to protocol. This resulted in a disease control rate of 40% in DLBCL and 73% in iNHL patients. Moreover, progression-free survival (PFS) with MOR208 therapy was observed to be comparable in rituximab refractory and non-refractory NHL patients (median PFS 5.3 versus 6.6 months, HR 0.85, 95% CI 0.45-1.6, p=0.59). Thus, MOR208 has demonstrated in this trial activity independent of the response to a prior anti-CD20 therapy. Updated data for the overall trial population furthermore revealed that after 12 months the PFS rate was 40% in both DLBCL and iNHL patients. Nine patients treated with MOR208 are still in remission (7 CRs, 2 PRs), the longest responses currently ongoing for 26 months.

"We are very happy with the updated clinical trial results with MOR208," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "We are impressed by the duration of responses of up to 26 months with MOR208 as a single-agent in heavily pre-treated patients with relapsed/refractory NHL. We were further pleased to observe a decline in the size of the tumor lesions in many in the subgroup of patients with stable disease even when treated for a short period of 3 cycles only. Overall, the updated clinical data presented at ASCO (Free ASCO Whitepaper) strongly support our strategy to develop MOR208 in B cell malignancies, in particular our planned combination trials in DLBCL and CLL."

MOR208 is an anti-CD19 antibody with a proprietary modification to the Fc portion in clinical development to treat B cell malignancies. The open-label, phase 2a, multicenter study was designed to assess the activity and safety of weekly doses of 12 mg/kg MOR208 as a single agent in 92 pre-treated patients with various subtypes of relapsed/refractory NHL patients. According to the data observed, MOR208 showed a low level of infusion reactions. The overall response rate (ORR) of MOR208 reached 36% in the DLBCL subgroup and 33% in iNHL patients (both based on evaluable patients). Based on all patients with DLBCL and iNHL in the study, the ORR was 26% and 29%, respectively.

In addition, the trial design of a phase 2 study of MOR208 (COSMOS trial) was presented at the ASCO (Free ASCO Whitepaper) 2016 Annual Meeting. The trial is planned to evaluate MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), in patients no longer responding to or no longer tolerating Bruton’s tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib). After the discontinuation of several combination trials of idelalisib with other compounds, this planned trial is currently under review and discussions with regulatory authorities are ongoing. MorphoSys is currently exploring alternative study designs to evaluate MOR208 in a combination trial in CLL/SLL patients previously treated with a BTK inhibitor.

The posters presented at the Annual ASCO (Free ASCO Whitepaper) Meeting, June 6, 2016, 8:30 am CDT (2:30 pm BST, 3:30 pm CEST), can be downloaded from the Company’s website.

Abstract #8012
M. Raab et al: MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed or refractory multiple myeloma: Data from clinically relevant cohorts from a phase 1/2a study.

Abstract #7545
W. Jurczak et al: Subgroup analyses of diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma cohorts from a phase 2a study of single-agent MOR208 in patients with relapsed or refractory non-Hodgkin’s lymphoma (R-R NHL).

Abstract #TPS7572
C.-M. Wendtner et al: A phase 2 study of MOR208 plus idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor.

MorphoSys will hold on June 6, 2016 at 6:30 p.m. CDT (June 7, 2016 0:30 a.m. BST, 1:30 a.m. CEST) an Investor & Analyst Event at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. KOLs will present the new clinical data for MOR208 and MOR202. A replay and the presentation will be made available at View Source Live-Webcast: http://morphosys.equisolvewebcast.com/investor-event-6-6-16

On June 6, 2016 IntegraGen, a leading provider of genomic solutions which transform molecular information into clinical action, reported the presentation of positive clinical results on its miR-31-3p biomarker during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago (Press release, Integragen, JUN 6, 2016, View Source [SID:1234513098]). The data presented demonstrates that IntegraGen’s proprietary miR-31-3p biomarker is predictive for both survival and treatment response in patients receiving anti-EGFR therapy. These results are based on an analysis of the expression of miR-31-3p in tumors from 370 RAS wild-type (WT) metastatic colorectal cancer (mCRC) patients enrolled in the FIRE-3 clinical trial (AIO KRK-0306). The data presented represents the first study comparing miR-31-3p expression in mCRC patients treated in first line with anti-EGFR vs. anti-VEGF therapy.

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!

In addition to confirming miR-31-3p is predictive of improved outcomes for mCRC patients treated with anti-EGFR therapy, the study also demonstrated that patients with a miR-31-3p expression below a pre-defined threshold treated with FOLFIRI plus cetuximab have a one year longer median overall survival, a 40% reduction in mortality risk, and a better treatment response compared to patients treated with FOLFIRI plus bevacizumab. No difference in outcomes were seen between the two groups in patients with miR-31-3p expression above the pre-defined threshold. These results suggest that testing miR-31-3p expression in RAS WT mCRC patients can help identify which 1st line biologic therapy may be most beneficial.

"Our results show that miR-31-3p can predict which mCRC patients will have improved outcomes when treated in first line with cetuximab compared to bevacizumab when combined with FOLFIRI therapy," said Professor Volker Heinemann, from the Department of Medical Oncology and Comprehensive Cancer Center at University Hospital Grosshadern in Munich, Germany and lead investigator for the FIRE-3 study. "These findings are extremely significant clinically since nearly two-thirds of the patients with RAS wild-type tumors in our study had low miR-31-3p expression levels and would therefore benefit from being treated with cetuximab versus bevacizumab as first line therapy for mCRC."

"The results from this study provide strong clinical evidence that IntegraGen’s miR-31-3p biomarker can predict the benefit of anti-EGFR therapy in mCRC patients," stated Dr. Bernard Courtieu, IntegraGen’s CEO. "The data presented at this year’s ASCO (Free ASCO Whitepaper) meeting in patients enrolled in the landmark FIRE-3 study demonstrates that RAS wild-type mCRC patients would benefit from the analysis of miR-31-3p expression prior to the determination of which biologic agent to utilize as first line therapy. This aligns with a more personalized approach to cancer care and contributes to the ability to tailor therapies to patients who are more likely to have clinical benefit of these therapies."

Dr. Courtieu also added that "IntegraGen is currently pursuing options for offering a commercial test based on the miR-31-3p biomarker to physicians and their patients, which we estimate represents a $100 million market opportunity worldwide."

ABOUT THE FIRE-3 CLINICAL TRIAL

The FIRE-3 clinical trial is an independent, randomized, controlled Phase III trial conducted in Europe and led by Ludwig-Maximilians University in Munich, Germany. The study compares outcomes of KRAS Exon 2 wild-type (WT) stage IV colorectal cancer patients randomized to receive FOLFIRI therapy (5-FU, folinic acid and irinotecan) in combination with either cetuximab or bevacizumab.