On November 15, 2018 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported the presentation of clinical and preclinical data supporting the development of TP-0903 for the treatment of patients with solid tumors (Press release, Tolero Pharmaceuticals, NOV 15, 2018, View Source [SID1234531405]). TP-0903 is an oral, small molecule inhibitor of the AXL receptor tyrosine kinase. Key findings from syngeneic mouse models suggest that TP-0903 has immune activating potential leading to enhanced host immune responses in tumor models.

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 data will be presented at the 2018 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Dublin. Posters will be on display from 10:00 a.m. to 2:00 p.m. GMT on Nov. 16 in the Exhibition Hall of the Convention Centre Dublin.

"There is a significant need to develop new cancer therapeutic solutions aimed at strengthening the body’s own immune response," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "AXL kinase is an important oncolytic target; we are encouraged by the findings of TP-0903 showing the inhibition of AXL kinase, demonstrating enhanced host immunity. We look forward to further developments of TP-0903 in counteracting AXL-mediated effects."

The data show that TP-0903 treatment alters tumors by suppressing the mesenchymal phenotype of the cancer cells and favoring a tumor microenvironment amenable to an immune response. Preclinical models in immune competent animals show modulation of immune cell populations, including neutrophils, regulatory T-cells, and dendritic cells, in the tumors. Additionally, the predictive power of soluble AXL levels in the serum of cancer patients as a biomarker to select patients likely to benefit from TP-0903 treatment will be presented.

Recent data suggest that AXL kinase is involved in tumor cell proliferation and development of resistance to chemotherapeutics. TP-0903 is an AXL receptor tyrosine kinase inhibitor, which has showed nanomolar activity in biochemical assays. In this preclinical study, the immune modulating capabilities were assessed using immunohistochemical and real-time PCR techniques in syngeneic mouse models of solid tumors.

The associated abstract #413, PB-076, is available on the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) meeting program website.

About TP-0903
TP-0903 is an investigational oral, small molecule inhibitor of the AXL receptor tyrosine kinase (RTK), which has demonstrated effectiveness in cell-based and animal models of human cancers. The first-in-human Phase 1/1b study is underway identifying the safety and tolerability profile of TP-0903. In addition, the study is analyzing the pharmacodynamics of TP-0903 by assessing biomarkers in patients’ samples before and after treatment with TP-0903, including markers of immune suppression.

About AXL Kinase
AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers. It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.1,2

On November 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the third quarter of 2018 (Press release, Nanobiotix, NOV, 15, View Source [SID1234531455]).

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
Total revenue for the third quarter of 2018 amounted to € 21,816. This brings total revenue for the first nine months of 2018 to € 95,120, which is in line with the Company’s expectations.
All of the revenues generated by the Company during the third quarter of 2018 come from services that Nanobiotix
crossed-charged to its partners in accordance with our agreed upon development program operational activities.
In July 2018, Nanobiotix launched a non-dilutive financial partnership with the European Investment Bank (EIB) to boost its research, development and innovation activities. The financing agreement permits the Company to borrow up to €40 million in loans from EIB over the next five years subject to the Company’s achievement of a set of agreed performance criteria. We expect this financing agreement to enable Nanobiotix to accelerate both the development of the Company’s NBTXR3 clinical trial in advanced Head and Neck cancers and to support its European go-to-market strategy.

In September 2018, Nanobiotix presented an update on data from its NBTXR3 development program at the International Conference on Immunotherapy Radiotherapy Combinations. The presentation included updated data related to the Company’s follow-up for its Phase I/II clinical trial in advanced Head and Neck cancers in elderly and frail patients ineligible for cisplatin or intolerant to cetuximab. The data suggests the potential of NBTXR3 to impact survival for this advanced cancer patient population. In addition, the Company presented data obtained from the immuno biomarker study in its randomized Phase II/III clinical trial in soft tissue sarcoma. This data indicated that NBTXR3 activated by EUI- 1202982973v22 radiation therapy could modulate the antitumor immune response.
Finally, the Company’s in vivo investigation of NBTXR3’s mode of action inducing distant immune response on CT26
tumoral model produced data that continues to support the rationale for the use of NBTXR3 activated by radiation
therapy to seek to transform tumors into an in situ cancer vaccine and its potential use in combination with
immunotherapeutic agents.
***
Next financial press release: revenue for Q4 2018 by February 28, 2019
About NBTXR3
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
• tumors through physical cell death
• metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and
Nanobiotix believes it has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient populations evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III
clinical trial.
NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or
oropharynx in elderly and frail patients that are unable to receive chemotherapy or cetuximab and have very limited therapeutic
options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of tumors.
Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the
U.S. Food and Drug Administration (FDA) to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1
antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).
The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally
advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and prostate adenocarcinoma.
The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.

On November 15, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported that management will host a conference call to discuss corporate updates today at 8:30 a.m. ET (Press release, Epizyme, NOV 15, 2018, View Source [SID1234531362]).

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 in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5172457. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast also will be archived for 60 days following the call and presentation

On November 15, 2018 Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, reported the appointment of Mickey Mikitani as chief executive officer (Press release, Rakuten Aspyrian, NOV 15, 2018, View Source [SID1234531388]). Mr. Mikitani, a global business leader, will also continue in his role of chairman. In conjunction, former CEO Miguel Garcia-Guzman, Ph.D. will transition to serve as Rakuten Aspyrian’s vice chairman and chief scientific officer to continue to build the company’s pipeline and drive innovation.

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!

Rakuten Aspyrian also announced the appointment of Takashi Toraishi, Ph.D. as chief operating officer. Dr. Toraishi will oversee clinical trials and commercialization of Rakuten Aspyrian’s products, as well as manage the growth of the organization.

"With our Photoimmunotherapy platform, Rakuten Aspyrian holds tremendous potential to offer alternative options for treating cancer," said Mr. Mikitani. "As CEO, I will harness this potential as we build a fully integrated biopharmaceutical company with research, development and world-wide commercialization capabilities. Our mission is to develop and commercialize a strong pipeline of treatment options based on Photoimmunotherapy to create a new platform for cancer treatments."

Mr. Mikitani joined the company as chairman in 2016 and has provided strategic direction and investment to support its corporate and clinical development. He is also the Chairman and CEO of Rakuten, Inc. [RKUNF], a leading Japanese global innovation company in e-commerce, communications and fintech, with the mission to contribute to society by creating value through innovation and entrepreneurship. Rakuten is also recognized as the Official Innovation and Entertainment Partner of one of the world’s most admired soccer clubs, FC Barcelona, as well as the jersey partner of NBA Champions, the Golden State Warriors.

Mr. Mikitani was awarded the Legion of Honour by the French government in recognition of contributions to the economy and culture of France. He also serves on the boards of the Tokyo Philharmonic Orchestra and Lyft, Inc. Mr. Mikitani received his B.A. of Commerce at Hitotsubashi University in Tokyo and his MBA at Harvard Business School. At Harvard, he was awarded the Alumni Achievement Award, one of the school’s highest honors.

Prior to his appointment as chief operating officer, Dr. Toraishi led operations as president of Rakuten Aspyrian Japan. Previously he was president of new service development company at Rakuten, Inc., where he spearheaded company-wide innovation initiatives and multiple joint ventures, shared economy and other companies. For nine years, Dr. Toraishi worked with McKinsey & Company, Tokyo, completing his tenure as partner and consultant to global medical device and equipment companies. He started his career as an assistant professor of engineering at the University of Tokyo and led the nuclear chemistry division of the Japan Atomic Energy Agency. Dr. Toraishi received his B.A. of Engineering and his Master of Engineering at the University of Tokyo, his Licentiate of Engineering, Nuclear Chemistry at the Royal Institute of Technology at Stockholm, as well as his Ph.D. in Nuclear Chemistry from the University of Tokyo.

On November 15, 2018 DCprime bv, a clinical stage biotechnology company focused on cancer immunotherapies, reported that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II (Press release, DCPrime, NOV 15, 2018, View Source [SID1234531456]). Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.

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!

Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: "We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse."

The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.

Dr Jeroen Rovers, Chief Medical Officer at DCprime added: "Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study."

Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).