Editas Medicine to Present New Data Demonstrating Progress Towards Creating Genome Editing Medicines at the American Society of Gene & Cell Therapy Annual Meeting

On April 30, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that 10 scientific abstracts, including three from research collaborations, have been accepted for presentation at the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Editas Medicine, APR 30, 2018, View Source;p=RssLanding&cat=news&id=2345605 [SID1234525852]). The meeting will take place May 16-19 in Chicago. The Company is presenting data on its pipeline and platform technologies to support ongoing development programs.

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Key Editas Medicine presentations at ASGCT (Free ASGCT Whitepaper) will include data demonstrating:

EDIT-101, the Company’s experimental medicine for the treatment of Leber Congenital Amaurosis type 10, administered to non-human primates via subretinal injection was well-tolerated;
Therapeutically relevant editing levels in non-human primates regardless of pre-existing or induced immunity to Staphylococcus aureus Cas9;
Specificity of EDIT-101 with no verified off-targets in the human genome as assessed by a two-staged approach using orthogonal methods;
In vitro validation of an exon deletion editing strategy with the potential to treat Usher Syndrome type 2a (USH2A)-associated retinal disease;
In vivo proof-of-concept in animal models for developing a CRISPR-based medicine for the treatment of ocular herpetic keratitis caused by latent herpes simplex virus-1 (HSV-1); and
Fetal hemoglobin induction by editing of novel therapeutic sites identified through saturation genomic CRISPR screening of the beta-globin locus as a potential treatment for sickle cell anemia.
In addition, Editas Medicine’s Chief Scientific Officer will speak at the ASGCT (Free ASGCT Whitepaper) Gene Editing Workshop, a pre-meeting program, on May 15.

"We are making significant scientific advances in our programs to unlock the potential of CRISPR genome editing for making medicines," said Charles Albright, Ph.D., Chief Scientific Officer, Editas Medicine. "At ASGCT (Free ASGCT Whitepaper), we will showcase our recent scientific advances as we make progress towards the clinic and towards our goal of making medicines for people living with serious diseases."

The complete list of Editas Medicine presentations is below. Abstracts can be accessed on the ASGCT (Free ASGCT Whitepaper) website at View Source

Oral Presentation:
Evaluation of Tolerability and Immunogenicity of EDIT-101 Following Subretinal Injection in Non-human Primate
Date/Time: May 18, 4:00 – 4:15 p.m.
Location: Salon A-5
Session: Preclinical Pharmacology and Toxicology Studies and Assessment of Gene Therapy in Large Animal Models

Editas Medicine Poster Presentations:

Treatment of Herpetic Keratitis with CRISPR/Cas9 Gene Editing in a Rabbit Disease Model
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases) I

Potent HbF Induction Following ssODN-Mediated Repair of Cas9-Induced DSB at the HBG Promoter in CD34+ HSPC
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases I

Saturated Mutagenesis Surrounding Beta-globin Locus Identifies Novel Therapeutic Targets for Fetal Globin Induction and Treatment of Sickle Cell Anemia
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases I

Improving Efficacy of CAR T cells Through CRISPR/Cas9 Mediated Knockout of TGFbR2
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Cancer – Targeted Gene & Cell Therapy I

Efficient Targeted Integration in Human T cells with CRISPR-Cas9 for the Treatment of X-Linked Hyper-IgM Syndrome
Date/Time: May 17, 5:15 – 7:15 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases II

Gene Editing Specificity Assessment for EDIT-101, an LCA10 Therapeutic Candidate
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Pharmacology/Toxicology Studies or Assay Development

Research Collaboration Poster Presentations (Editas Medicine Author):

Development of an Assay to Detect Pre-existing Anti-Cas9 Antibodies and an Estimate of the Prevalence of Anti-Staphylococcus- and Streptococcus-Cas9 Antibodies in the US Population
Date/Time: May 17, 5:15 – 7:15 p.m.
Location: Stevens Salon C, D
Session: Gene Targeting & Gene Correction II

Preclinical Modeling Highlights the Therapeutic Potential of the Adoptive Transplant of Gene Corrected T cells in X-Linked Hyper-IgM Syndrome
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases

Evaluation of Therapeutic Potential of Human USH2A Gene Lacking Exon 13 (USH2A-∆Ex13) for Restoring Ciliogenesis
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases)

Medpace Holdings, Inc. to Report First Quarter 2018 Financial Results on April 30, 2018

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.

Compugen Reports on Status of Investigational New Drug Application for COM701, a First-in-Class Immuno-Oncology Therapeutic Antibody

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.

AACR 2018

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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Stainwei Granted US Patent for anti-VEGF Monoclonal Antibody and its anti-PD-1 mAb demonstrating prolonged anti-tumor activity in pre-clinical studies

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.