On July 12, 2018 Targovax ASA (OSE: TRVX), a clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors, and SOTIO, a biotechnology company owned by the PPF Group, reported that the first patient has been dosed with ONCOS-102 in the SP015 phase I/II clinical trial in patients with prostate cancer, combining the Company’s immune-priming adenovirus ONCOS-102, with SOTIO’s DCVAC/PCa, an active cellular immunotherapy (Press release, Targovax, JUL 12, 2018, View Source [SID1234527678]).

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!

The first patient has been dosed with ONCOS-102 at the Motol University Hospital in Prague, by the principal investigator Dr. Ladislav Jarolím. One additional trial site is planned to be opened in the UK later this year.

SP015 (Eudra CT: 2015-004314-15) is a Phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of ONCOS-102 and DCVAC/PCa in men with advanced metastatic castration-resistant prostate cancer. The study aims to enroll up to 15 patients across centers in the Czech Republic and United Kingdom. The trial builds on the hypothesis that ONCOS-102 may enhance the anti-tumor immune responses generated by dendritic cells loaded with tumor antigens, and thus may help the immune system to overcome evasion strategies employed by tumors.

"We are excited to have started our fourth combination study of ONCOS-102, which will examine safety, immune activation and efficacy alongside DCVAC/PCa in prostate cancer patients," said Magnus Jäderberg, CMO of Targovax. "Finding the right combination treatments is crucial to boost the response rate to immunotherapies, and in this particular trial we are testing the hypothesis of whether intratumoral delivery of ONCOS-102 and its transgene payload, GM-CSF, can provide a trafficking signal that enhances recruitment of the DCVAC dendritic cells to the prostate tumor site."

Radek Špíšek, CEO of SOTIO, said: "By combining an autologous active cellular therapy with an oncolytic virus, we had to overcome various regulatory and operational challenges. We are very happy to have succeeded in initiating such complex trial, the first of its kind ever conducted in Czech Republic and the CEE region. The SP015 clinical trial will help us to gather critical evidence necessary to develop innovative immunotherapies for the treatment of cancer that threatens one in five men globally."

About ONCOS-102

Targovax’s proprietary ONCOS platform uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS-102 is Targovax’s lead adenovirus-based pipeline product – a purposefully engineered human serotype 5 adenovirus optimized to induce systemic anti-tumor T cell responses in cancer patients. ONCOS-102 has completed a Phase I clinical study and is being tested in further combination clinical trials in several solid tumor indications.

About DCVAC/PCa:

DCVAC/PCa was the first SOTIO product to enter clinical research. DCVAC/PCa is an active cellular immunotherapy treatment for prostate cancer patients; DCVAC/PCa is produced individually for each patient using the patient’s own dendritic cells (that are part of the immune system), to induce an immune reaction against tumor antigens. SOTIO has been sponsoring five Phase II clinical trials and one global Phase III (VIABLE) clinical trial in patients with prostate cancer. Another Phase II and Phase I/II clinical trials are conducted in ovarian cancer and lung cancer indications.

On July 12, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that the first patient has been dosed in XmAb20717-01 (DUET-2), a Phase 1, first-in-human, clinical trial of XmAb20717, a bispecific antibody that simultaneously targets PD-1 and CTLA-4 immune checkpoints for the treatment of multiple advanced solid tumors (Press release, Xencor, JUL 12, 2018, View Source [SID1234527677]).

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!

"Built on the scaffold of Xencor’s XmAb bispecific Fc domain, XmAb20717 is the most advanced candidate in our suite of tumor microenvironment activators," said Paul Foster, M.D., chief medical officer at Xencor. "The dual blockade of PD-1 and CTLA-4 with XmAb20717 may promote superior T cell activation and proliferation compared to anti-PD-1 alone, and we look forward to studying its safety, tolerability and therapeutic activity in clinical trials."

By the end of 2018, Xencor expects to file Investigational New Drug applications for two additional tumor microenvironment activators including XmAb23104, a PD-1 x ICOS bispecific antibody, as well as XmAb22841, a CTLA-4 x LAG-3 dual checkpoint inhibitor.

DUET-2 is a Phase 1 multiple-dose, dose-escalation study that will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of intravenous administration of XmAb20717 in patients with selected advanced solid tumors. For more information about DUET-2 please visit to View Source (identifier: NCT03517488).

On July 12, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reported dosing of the first patient in the phase 2 innovaTV 207 clinical trial evaluating the activity, safety and tolerability of tisotumab vedotin as monotherapy in selected solid tumors with high Tissue Factor expression (Press release, Seattle Genetics, JUL 12, 2018, View Source;p=RssLanding&cat=news&id=2357993 [SID1234527676]). Tissue Factor is overexpressed in a broad range of solid tumors that are associated with a poor prognosis. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor antigen on the surface of cancer cells and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. Tisotumab vedotin is being developed in collaboration with Genmab A/S. The potentially pivotal phase 2 trial innovaTV 204 evaluating tisotumab vedotin for patients with cervical cancer who have relapsed and/or progressed after standard of care treatment was recently initiated.

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!

"The initiation of the phase 2 innovaTV 207 basket trial will enable us to explore the safety and activity of tisotumab vedotin in several tumor types where Tissue Factor is also expressed and is intended to inform a potentially broad development program that maximizes the opportunity for this ADC beyond cervical cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

The phase 2 innovaTV 207 trial is a global, multicenter, open label basket trial that will enroll up to 200 adult patients with relapsed, locally-advanced or metastatic disease in one of four cohorts: colorectal cancer, squamous non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, and squamous cell cancer of the head and neck (SCCHN). Patients will be treated with single-agent tisotumab vedotin every three weeks. The primary endpoint of the trial is confirmed objective response rate (ORR) defined as the proportion of patients who achieve a confirmed complete or partial response. Key secondary endpoints include confirmed and unconfirmed ORR, disease control rate, duration of response, progression-free survival, overall survival, safety and tolerability.

For more information about the phase 2 innovaTV 207 clinical trial of tisotumab vedotin, please visit www.clinicaltrials.gov, (Identifier: NCT03485209).

About Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). In cancer biology, Tissue Factor is a protein involved in tumor cell signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, Tissue Factor was selected as a target for an ADC approach. In an earlier study, tisotumab vedotin demonstrated an encouraging response rate and manageable safety profile in patients with relapsed, recurrent and/or metastatic cervical cancer.

Tisotumab vedotin is being co-developed by Seattle Genetics, Inc. and Genmab A/S.

On July 12, 2018 PRA Health Sciences, Inc. (NASDAQ:PRAH) reported it will release its second quarter results after the market closes on Wednesday, August 1, 2018 (Press release, PRA Health Sciences, JUL 12, 2018, View Source;p=RssLanding&cat=news&id=2358083 [SID1234527675]). The Company will also host a conference call on Thursday, August 2, 2018 at 9:00 a.m. (ET) to discuss the results with members of the investment community.

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!

To participate via telephone, investors and analysts should dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes prior to the call start time. The conference ID for the call is 9692658. An audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 9692658.

A live audio broadcast will be available on the investor relations section of the PRA Health Sciences website. Following the teleconference, an audio playback of the call will be available at the same website.

On July 12, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer (the "Company"), reported its unaudited revenues for the second quarter of 2018 (Press release, Nanobiotix, JUL, 12, View Source [SID1234527674]).

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!

Activity and results during the second quarter of 2018

The Company generated €73k during the second quarter of 2018, which is fully in line with the Company’s
expectations. Most of the revenue was generated from services that Nanobiotix crossed-charged to its partners as per its operational activities.

In April, Nanobiotix presented preclinical data showing that NBTXR3 nanoparticles can activate the cGAS-STING
pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 in Chicago, Illinois, USA (April
14-18, 2018). These observations support the rationale for using NBTXR3 with radiation therapy in combination with
immunotherapeutic agents and/or STING agonist to transform tumors into an in-situ cancer vaccine.

Nanobiotix also announced that it will cooperate with The University of Texas MD Anderson Cancer Center, Houston
TX, USA, to run immunotherapeutic pre-clinical research in lung cancer, combining NBTXR3 and Nivolumab. This
project with MD Anderson, one of the world’s leading oncological research centers, will provide an unparalleled ability
to develop pre-clinical data using NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of
Opdivo). Nanobiotix reported that it has been selected to enter Euronext’s Tech40 label, recognizing the best performing Tech SMEs listed on Euronext markets.

In May, Nanobiotix announced that it is launching a research collaboration with Weill Cornell Medicine to begin
nonclinical studies to evaluate the impact of NBTXR3 on cGAS-STING pathway in mammary cancers. The research
collaboration between Weill Cornell Medicine, based in New York City, and Nanobiotix will be conducted over the
course of one year, with the goal of continuing the exploration of the role of NBTXR3 in Immuno-Oncology.
In June, Nanobiotix announced positive phase II/III topline data in Soft Tissue Sarcoma with NBTXR3. The trial achieved its primary endpoint of pathological Complete Response Rate and its secondary endpoint in operability (R0 rate). NBTXR3 demonstrated significant superiority and clinical benefits for patients compared to the standard of care. The safety profile was confirmed. This randomized trial validated the first-in-class mode of action of NBTXR3.

The positive results from this study support and further validate the Company’s European regulatory strategy of the
previously submitted CE marking application in soft tissue sarcoma. The Company will submit the new data as a
supplement to the European Notified Body in a timely manner.

The Company will present the results at an upcoming international medical conference.
The clinical validation of NBTXR3’s physical mode of action in a very heterogeneous and hard-to-treat disease
strengthens the universal profile of the product and confirms the development strategy in multiple indications.
Currently, the Company is evaluating NBTXR3 in seven clinical trials with a focus on head and neck cancers and
Immuno-Oncology programs.