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WuXi Biologics and NBE-Therapeutics Announce Comprehensive ADC Development and Manufacturing Partnership

On April 8, 2019 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and NBE-Therapeutics (NBE), a privately owned Swiss biotech company developing best-in-class, next-generation antibody-drug conjugate (ADC) products, reported a comprehensive development and manufacturing partnership for NBE’s first ADC lead product NBE-002 (anti-ROR1) (Press release, WuXi Biologics, APR 8, 2019, View Source [SID1234535055]). NBE-002 is a best-in-class immune-stimulatory ADC (iADC) treatment against the ROR1 cancer target and is planned to enter into clinical trials in mid 2020 in triple negative breast cancer and other indications.

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NBE-Therapeutics develops next-generation iADC products with the aim to improve the outcome for cancer patients, as it continues to develop iADCs based on its proprietary technology platforms. With its proprietary SMAC-TechnologyTM to generate site-specifically conjugated ADCs and its proprietary highly-potent anthracycline toxin platform, NBE has the ability to develop highly targeted treatments with long-lasting anti-tumor immunity. The partnership with WuXi Biologics will enable the supply of NBE’s product for clinical trials under Investigational New Drug (IND) applications worldwide. With the establishment of state-of-the-art integrated biologics solution center, WuXi Biologics provides comprehensive one-stop service to global partners for antibodies, ADC drug substances and drug products.

Dr. Ulf Grawunder, CEO of NBE-Therapeutics commented, "We are excited about our partnership with WuXi Biologics, which we consider one of the world-leading CDMOs for manufacturing of biologic therapeutics. WuXi Biologics will be a strong partner for our next step in the development of our highly promising cancer treatments with long-lasting anti-tumor immunity. This collaboration will accelerate the transition of our preclinical iADC development programs to clinical validation. We look forward to working with WuXi Biologics over the coming years to deliver improved treatment options for global cancer patients."

"We are glad that NBE-Therapeutics with one of the best ADC platforms in the industry selected WuXi Biologics as their long-term partner for its first highly promising anti-ROR1 ADC program. It is another testament to the premier quality and global excellence of our integrated services, which continue to drive rapid expansion of our market share in Europe. We are excited in working with 7 companies on over 10 programs in Switzerland alone," said Dr. Chris Chen, CEO of WuXi Biologics. "Through our global quality, world-class technical capabilities and unparalleled capacity, we aim to empower any global partners to discover, develop and manufacture any biologics to benefit patients worldwide."

Medpace Holdings, Inc. to Report First Quarter 2019 Financial Results on April 29, 2019

On April 8, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its first quarter 2019 financial results after the market close on Monday, April 29, 2019 (Press release, Medpace, APR 8, 2019, View Source [SID1234535053]). The Company will host a conference call the following morning, Tuesday, April 30, 2019, at 8:30 a.m. ET to discuss these results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 8067378.

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, April 30, 2019 until 12:00 p.m. ET on Tuesday, May 14, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 8067378.

Genprex Collaborators Report Positive TUSC2 and Checkpoint Blockade Preclinical Data at the 2019 AACR Annual Meeting

On April 8, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its collaborators from The University of Texas MD Anderson Cancer Center ("MD Anderson") presented positive preclinical data for the combination of the TUSC2 gene with an anti-PD1 antibody, pembrolizumab, for the treatment of lung cancer in a poster presented at the American Association of Cancer Research Meeting 2019 (Press release, Genprex, APR 8, 2019, View Source [SID1234535051]). The TUSC2 gene is a tumor suppressor gene, the active agent in Genprex’s Oncoprex immunogene therapy.

The poster, entitled "Development of an improved humanized patient-derived xenograft, Hu-PDX, mouse model for evaluation of antitumor immune response in lung cancer" showed that TUSC2 combined with checkpoint blockade was more effective than checkpoint blockade alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. The TUSC2 treatment with the checkpoint inhibitor pembrolizumab slowed tumor growth significantly. Pembrolizumab previously had no effect on tumor growth in non-humanized mice. The data also demonstrated the Hu-PDX model as an improved platform for evaluation of immunotherapy.

"This sophisticated model gets one step closer to recapitulating certain functions of the human immune response within a manageable scientific animal model and allows us to further test our hypotheses of how a more complex immune system could interact with aggressive cancers when primed by drugs, such as Oncoprex, in humans," said Julien L. Pham, MD, MPH, President and Chief Operating Officer of Genprex. "These data further support and solidify existing preclinical data showing that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy and could result in a stronger antitumor response compared to either agent alone. It also demonstrates how Oncoprex could be used in combination with other immunotherapies as a viable treatment option for late-stage non-small cell lung cancer."

Poster Presentation Details:

Date/Time: Wednesday, April 3, 2019 from 8 a.m. to 12 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B
Session: Immunomodulators and Response to Therapy
Title: Development of an improved humanized patient-derived xenograft, Hu-PDX, mouse model for evaluation of antitumor immune response in lung cancer
Authors: Ismail M. Meraz, Mourad Majidi, Feng Meng, RuPing Shao, Min Jin Ha, Shinya Neri, Bingliang Fang, Steven H. Lin, Peggy T. Tinkey, Elizabeth J. Shpall, Jeffrey Morris, Jack A. Roth. UT MD Anderson Cancer Ctr., Houston, TX

Following the AACR (Free AACR Whitepaper) annual meeting, the poster will also be made available on Genprex’s website at genprex.com.

Schrödinger Receives Clinical-Stage Milestone Payment from Sanofi Collaboration

On April 8, 2019 Schrödinger reported receipt of a milestone payment from Sanofi (EURONEXT: SAN, NASDAQ: SNY) to mark the advancement into the clinic of an autoimmune therapy discovered as part of a multi-year, multi-target collaboration between the two companies (Press release, Schrodinger, APR 8, 2019, View Source [SID1234535050]).

Under the terms of the collaboration, Schrödinger provides advanced molecular simulation and computational design expertise to Sanofi across multiple stages of drug discovery, from target analysis and lead optimization to identification of a development candidate. The companies are currently advancing programs in oncology and autoimmune disease.

"We’re delighted to see this program move into the clinic and we look forward to continued collaboration with Sanofi in order to accelerate the development of breakthrough treatments with the potential to address unmet medical needs in cancer and autoimmune diseases," said Karen Akinsanya, Ph.D., Schrödinger’s chief biomedical scientist.

The work with Sanofi is one of several partnerships Schrödinger has established with leading biotech and pharmaceutical companies around the world. These collaborations leverage Schrödinger’s physics-based computational platform to enable rapid iterations of design and analysis of potential therapeutic compounds. Such collaborations have already led to several clinical-stage assets and two FDA-approved oncology drugs. More than two dozen additional programs are moving through discovery and development, in indications ranging from metabolic disorders to neurodegenerative diseases.

Inovio Achieves Third Cancer Indication Milestone for MEDI0457 Phase 2 Development

On April 8, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that it achieved a third indication milestone from AstraZeneca resulting from dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in combination with durvalumab targeting cervical, anal, penile, and vulvar cancers associated with the human papilloma virus (HPV) (Press release, Inovio, APR 8, 2019, View Source [SID1234535049]). The milestone achievement for this multi-indication trial is the third MEDI0457-related Phase 2 milestone from AstraZeneca; two previous milestone payments resulted from initiating Phase 2 combination trials targeting head and neck and cervical cancers. Financial arrangements were not disclosed.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "This Phase 2 milestone stresses the potential breadth of MEDI0457 in treating multiple HPV-associated cancers. Inovio’s goal is to lead the HPV-treatment market from pre-cancers with its lead product VGX-3100 to cancers with MEDI0457 along with our partner AstraZeneca."

In several on-going Phase 2 cancer-indication trials, AstraZeneca is evaluating MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with HPV-associated head and neck, cervical, anal, penile, and vulvar cancers. Inovio is developing its HPV monotherapy VGX-3100 for pre-cancerous indications in a Phase 3 trial for cervical dysplasia; and in Phase 2 trials for vulvar and anal dysplasia.

About MEDI0457 and VGX-3100

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which AstraZeneca in-licensed from Inovio) is under evaluation by AstraZeneca to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2) and anal (Phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.

Under the 2015 agreement, AstraZeneca acquired exclusive rights to Inovio’s INO-3112, now called MEDI0457. MEDI0457 targets cancers caused by HPV types 16 and 18 which are responsible for more than 70 percent of cervical pre-cancers and cancers and are involved in the development of other tumors. Within the broader license and collaboration agreement, AstraZeneca and Inovio are co-developing one additional DNA-based cancer therapy product not included in Inovio’s current product pipeline, which AstraZeneca has exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments for these additional cancer vaccine products and will be eligible to receive royalties on worldwide net sales.

About Durvalumab

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.