On April 27, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that results from a large prospective process-intervention study that evaluated genetic testing practices in the obstetrics-gynecology setting will be presented at the 2018 ACOG annual meeting in Austin, Texas (Press release, Myriad Genetics, APR 27, 2018, View Source [SID1234525795]). The key findings are that 23.8 percent of patients qualified for genetic testing based on National Comprehensive Cancer Network (NCCN) guidelines and 5.5 percent of patients who underwent testing were found to carry a pathogenic mutation.

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"Myriad is committed to helping obstetricians and gynecologists incorporate genetic testing into their practices and help expand patients’ access to personalized medicine," said Royce (Terry) Adkins, M.D., FACOG, board certified ob-gyn physician and vice president of Medical Affairs, Myriad Genetic Laboratories. "Importantly, this study found that process-intervention strategies and the myRisk Hereditary Cancer test can help doctors find women at increased risk of hereditary breast and ovarian cancers so that steps can be taken to lower their risk."

The study data are summarized below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about ACOG annual meeting news and updates by using the hashtag #ACOG18.

Title: Hereditary Cancer Genetic Testing in Community-Based Obstetrics and Gynecology Settings.
Presenters: Mark S. DeFrancesco, M.D., FACOG, Women’s Health Connecticut and
Richard N. Waldman, M.D., FACOG, Associates for Women’s Medicine.
Date: Saturday, April 28, 2018, 3:30 to 4:30 p.m. CST.
Poster Location: Session K, #3K.

The study evaluated the impact of incorporating routine hereditary cancer risk assessment, counseling and follow-up genetic testing in the community obstetrics-gynecology practice setting. The trial included two large obstetrics-gynecology practice groups in two states with five practice sites. The process intervention included baseline process assessment, refinement of clinic-specific patient screening workflows and tools and training in hereditary cancer risk screening and follow-up. Outcomes related to hereditary cancer screening and testing were measured during an eight-week post-intervention period. Patients and providers also were surveyed about satisfaction with the process.

The results show that 3,811 women were screened for hereditary cancer risk. Among those screened, 23.8 percent met NCCN guidelines for genetic testing. Of those screened, 39 percent agreed to undergo genetic testing with the myRisk Hereditary Cancer test. Importantly, the myRisk Hereditary Cancer test found pathogenic mutations in more than five percent of women tested. All healthcare providers in this study said they would continue to use the established hereditary cancer risk assessment process. Additionally, 98.8 percent of patients referred for genetic testing were able to understand the information provided and 97.6 percent were satisfied with the overall process.

"This study demonstrates that it is feasible and beneficial to incorporate hereditary cancer screening, education and testing into community obstetrics-gynecology practices," said Mark DeFrancesco, M.D., study investigator and managing partner at Westwood Women’s Health in Waterbury, Connecticut, a division of Women’s Health Connecticut. "Patients and providers were satisfied, and integrating multigene panel testing in this setting identified patients with significant cancer risks who would not otherwise have been identified."

The findings from this study also support an ACOG position statement called Access to Genetic Testing, which was released in January 2018.

"Importantly, this study supports the ACOG position that obstetrician-gynecologists are qualified to counsel and order genetic tests by incorporating hereditary cancer screening into routine practice," said Richard N. Waldman, M.D., study investigator and president of Associates for Women’s Medicine. "Understanding a woman’s hereditary cancer risk can dramatically impact medical management to prevent or delay cancer occurrence and to inform cancer care."

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 28 clinically-significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

On April 27, 2018 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its first quarter 2018 financial results after the market close on Monday, April 30, 2018 (Press release, Medpace, APR 27, 2018, View Source [SID1234525797]). The Company will host a conference call the following morning, Tuesday, May 1, 2018, at 9:00 a.m. ET to discuss these results.

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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 5992038.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, May 1, 2018 until 12:00 p.m. ET on Tuesday, May 15, 2018. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 5992038.

On April 27, 2018 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) requested that the Company provide additional CMC information in support of its IND application for COM701, initially submitted in late March 2018 (Press release, Compugen, APR 27, 2018, View Source [SID1234525798]). COM701 is a first-in-class immuno-oncology therapeutic antibody targeting PVRIG. FDA recommended a lower starting dose of COM701 for the trial, which now requires a more sensitive COM701 assay detection method for this dose. The FDA informed the Company that the IND application review can be completed and the application can be taken off clinical hold once the requested information is provided by Compugen. The IND is intended to support initiation of a planned Phase 1 clinical trial of COM701 in patients with advanced solid tumors. This trial is not yet active at any investigational sites and has not recruited any patients.

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"We are working closely with the FDA to provide the additional information requested as quickly as possible. In anticipation for FDA clearance, site selection activities in multiple centers in the United States are currently ongoing to allow future patient enrollment, and we look forward to evaluating COM701 in a clinical setting," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We continue to be encouraged by the preclinical data for COM701, which suggest that targeting PVRIG may be a primary means of stimulating an anti-tumor immune response in certain cancers that may be unresponsive to available treatments."

The Company will continue to provide updates on this matter as appropriate.

On April 27, 2018 Innate Pharma reported that it presented new data at the AACR (Free AACR Whitepaper) Annual Meeting, April 14-18, in Chicago, including preliminary data suggesting promising anti-tumor activity of the combination of monalizumab and cetuximab in patients with platinum pretreated SCCHN (Press release, Innate Pharma, APR 27, 2018, View Source [SID1234525774]).

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On May 3, 2017 Stainwei Biotech, Inc. (Stainwei), a Chinese biotech company located in Biobay industrial park in Suzhou, China, reported that it has received a patent certificate (Patent No. US9,580,498) issued by the United States Patent and Trademark Office (USPTO) for its novel humanized anti-VEGF monoclonal antibody (mAb code name: hPV19) (Press release, Suzhou Stainwei Biotech, APR 27, 2018, View Source [SID1234525751]). This patent was issued through a pathway of PCT application (PCT/CN2013/086542) filed by Stainwei in 2013. Prior to receiving the US patent, Stainwei has already received two patent certificates for this antibody from China Intellectual Property Office in 2015 and 2016. Stainwei is dedicated to innovation and development of novel therapeutic antibody drugs targeting cancers, age-related macular degeneration (AMD) and immune-related diseases.

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A phase I clinical trial evaluating the safety and efficacy of hPV19 in cancer patients is ongoing in China. According to the data released by the company, hPV19 has a unique antigen recognition site (epitope), composed of amino acid sequences different from other commercially available antibodies targeting the same antigen. In both in-vitro and in-vivo experiments, hPV19 showed a 6-8 times higher biological activity than Avastin (generic name: bevacizumab, Roche/Genentech’s anti-VEGF mAb, the world’s first and so far still the only FDA-approved anti-VEGF mAb drug on the market). "In pre-clinical animal studies and early stage clinical trials in cancer patients, hPV19 has also demonstrated an excellent safety and tolerance profile," said Dr. Qunmin Zhou, the company’s co-founder. "We are excited to test its efficacy in the ongoing clinical trials. We are also excited to hopefully bring to the market a unique, non-biosimilar, and stronger therapeutic agent that can benefit our patients."

Meanwhile, Stainwei has filed a PCT patent application for a new formulation of hPV19 mAb intended for the treatment of age-related macular degeneration (AMD), diabetic macular edema (DME) and other eye-disorders associated with VEGF-mediated vascular over-growth. Stainwei has completed preclinical experiments and an application for Investigational New Drug (IND) in AMD and DME will be submitted to China-FDA soon.

The company’s another promising product is a novel anti-PD-1 monoclonal antibody named hAb21 (humanized IgG4-kappa version). hAb21 binds to human PD-1 antigen at a unique site (epitope), which is different from that of Keytruda (Merck) and Opdivo (Bristol-Myers Squibb). hAb21 has shown a remarkable anti-tumor activity in human PD-1 gene knock-in mouse models.

View Source

Figure: Effect of hAb21 mAb on tumor growth in knock-in mice expressing human PD-1 （Human PD-1 gene knock-in mice were inoculated with 1×106 syngeneic MC38 tumor cells. When tumors reached 50 mm3 in size，mice were randomized into 3 groups. Intra-peritoneal (i.p) injections with 200 ug mAb (pembrolizumab or hAb21) or saline were given on days 6, 10, 13 and 17 after inoculation. A: Tumor growth in early-stage; B: Tumor growth in both early- and later-stage）.

As illustrated in the above figure, syngenic MC38 tumors implanted in the PD-1 gene knock-in mice were completely rejected within 7-10 days without re-growth thereafter in all 6 mice in the group treated with hAb21. Furthermore, repeated MC38 tumor inoculation was performed to those mice on day 30, and tumors were again completely rejected within 10-14 days without further hAb21 treatment. All 6 mice survived to day 60 and received MC38 inoculation for the third time (experiment on-going). In the same knock-in mice treated with Keytruda (pembrolizumab), complete tumor rejection was observed in only 1 out of 6 mice, while initial tumor regression followed by re-growth after the completion of Keytruda treatment were found in the other 5 mice, which all died of tumor progression.

Based on these encouraging results, Stainwei has filed a patent application for hAb21, and is currently carrying out IND-enabling studies. An IND indication for advanced solid tumors is expected to be submitted to China-FDA and US-FDA in the second-half of 2017.