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Nanobiotix revenue for the 2nd quarter of 2018

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]).

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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.

ImmunoGen Announces Conference Call to Discuss Its Second Quarter 2018 Operating Results

On July 12, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Company will host a conference call at 8:00 a.m. ET on Friday, July 27, 2018 to discuss its second quarter operating results (Press release, ImmunoGen, JUL 12, 2018, View Source [SID1234527673]). Management will also provide a brief update on the business.

Conference Call Information
To access the live call by phone, dial 719-785-1753; the conference ID is 2275763. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through August 10, 2018.

Genmab Enters Strategic Partnership with Immatics to Discover and Develop Next Generation Bispecific Cancer Immunotherapies

On July 12, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has entered into a research collaboration and exclusive license agreement with privately owned Immatics Biotechnologies GmbH (Immatics), to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications (Press release, Genmab, JUL 12, 2018, View Source [SID1234527670]). The deal strengthens Genmab’s position in immuno-oncology by combining Genmab’s proprietary technologies and antibody know-how with Immatics’ XPRESIDENT targets and T-cell receptor (TCR) capabilities. Genmab will receive an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or TCR-based bispecific therapeutic product concepts.

Genmab may elect to progress any resulting product candidates, and will be responsible for development, manufacturing and worldwide commercialization. For any products that are commercialized by Genmab, Immatics will have an option to limited co-promotion efforts in selected countries in the EU.

"This collaboration with Immatics gives us the opportunity to combine our unique technologies and expertise to create differentiated novel next-generation therapies. We very much look forward to this exciting partnership in the field of cancer immunotherapy," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Carsten Reinhardt, M.D., Ph.D., Chief Medical Officer and Managing Director of Immatics, commented: "We are very pleased to join forces with one of the world-leading biotechnology companies to develop and advance novel and highly active cancer therapeutics. This collaboration underpins Immatics’ leadership in intracellular tumor target identification and T-cell receptor engineering." Dr. Reinhardt further said: "Our bispecific TCR technology exhibits exceptional potency and favourable pharmacokinetic properties by combining Immatics’ proprietary T-cell engaging format with our high-affinity and highly specific T-cell receptors as reported at AACR (Free AACR Whitepaper) 20181."

Under the terms of the agreement, Genmab will pay Immatics an upfront fee of USD 54 million and Immatics is eligible to receive up to USD 550 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.

Today’s news does not impact Genmab’s 2018 Financial Guidance.

New Preclinical Results on Onxeo’s AsiDNA™, First-in-Class DNA Repair Inhibitor, Point to Strong Synergy and Reversion of Tumor Resistance when combined to PARP inhibitors

On July 12, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported new positive results from preclinical studies of AsiDNA, its first-in-class DNA Repair inhibitor, in combination with PARP inhibitors (PARPi) (Press release, Onxeo, JUL 12, 2018, View Source [SID1234527668]). The results of these extensive studies with different PARPi point to the ability of AsiDNA to prevent the occurrence of resistance and even to reverse the acquired resistance of the tumor cell after PARPi treatments. Furthermore, they show that the combination has a strong synergistic anti-tumor activity in in vitro and in vivo models of solid tumors resistant to PARPi (HR proficient). Together with the preliminary data on the activity and safety of AsiDNA expected in Q4 2018 from the DRIIV-1 clinical trial, these results support clinical development of AsiDNA in combination with PARP inhibitors, which should start from year-end 2018.

Judith Greciet, Chief Executive Officer of Onxeo, said: "Onxeo is conducting an ambitious development program for AsiDNA, notably translational, in combination with various anti-cancer agents in order to provide strategic information aimed at determining the indications and combinations to target in further clinical development as soon as the first results from DRIIV-1 are available. Assessing the combination of AsiDNA with PARPi is a priority, as their mechanisms of action are very complementary in indications with high unmet medical needs. Sales for the PARPi class are already substantial in ovarian cancer and are expected to increase markedly in the near-term as products gain access to multiple additional oncology indications. Our recent studies indicate that AsiDNA in combination with PARPi could enable PARPi to overcome the requirement of a genetic mutation such as BRCA-, and show a strong synergistic activity versus PARPi alone. Moreover, the combination appears to both prevent the occurrence of resistance to PARPi and reverse the acquired resistance, which may considerably expand treatment duration with PARPi. A treatment combining AsiDNA and PARPi could therefore significantly broaden the patient population eligible to PARPi and improve their efficacy, which is of great interest to the scientific community, the pharmaceutical industry and the patients for its potential to address resistant cancers."

AsiDNA is a first-in-class DNA repair inhibitor in the field of DNA Damage Response (DDR) that mimics double-stranded DNA breaks in tumor cells, activating repair pathways, diverting repair enzymes from the target and finally depleting the cell through a unique mechanism of agonist and decoy.

Data show that in in vitro models of HR proficient TNBC (triple negative breast cancer) and SCLC (small cell lung cancer), AsiDNA maintains PARP1 expression, the repair enzyme inhibited by PARP inhibitors, and abrogates the occurrence of resistance to PARPi, including in models of cancers resistant to PARPi. Down regulation of the PARP1 enzyme is one of the mechanisms that supports the occurrence of resistance to PARPi inhibitors1. As AsiDNA hyper-activates repair enzymes, an up regulation of PARP1 expression following treatment with AsiDNA or with AsiDNA associated to PARPi support the use of AsiDNA to maintain the sensitivity to PARPi treatment.

Furthermore, combination treatment of olaparib with AsiDNA more than doubles the complete response rate observed with olaparib alone (71% vs. 33%) in an in vivo model of HR proficient TNBC model and inhibits tumor growth in a humanized Patient-Derived Xenograft (PDX) mice model of ovarian cancer resistant to olaparib. PDX models are considered highly predictive of clinical behavior2.

The Company will submit the detailed results of these preclinical studies to leading peer-reviewed publications and international scientific conferences.

Francoise Bono, Chief Scientific Officer of Onxeo, concluded: "These most recent data validate our disruptive approach to DNA-targeting and confirm the broad opportunities for our lead molecule thanks to its unique mechanism of action. Our team has built an extremely solid body of preclinical evidence, both in-vitro and in highly predictive humanized in-vivo models, which shows the potential of AsiDNA to reverse the resistance to PARP inhibitors and the strong synergy of their combination. This is the first part of our extensive translational plan which aims at confirming the full potential of AsiDNA in combination with other anticancer agents such as chemotherapies or epigenetic compounds, including belinostat. Additional data on these other possible combinations will be available after the summer to further inform the clinical development of AsiDNA in combinations offering the potential for significant therapeutic improvement."

Roche announces submission of supplemental New Drug Application for Venclexta for people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy

On July 12, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported submission of a supplemental New Drug Application (sNDA) to the United States (U.S.) Food and Drug Administration (FDA) for Venclexta (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for treatment of people with previously untreated acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy (Press release, Hoffmann-La Roche, JUL 12, 2018, View Source [SID1234527663]). The submission is based on the results of two phase Ib/II studies that evaluated Venclexta in combination with azacitidine or decitabine (M14-358 study) or LDAC (M14-387 study) in this patient population. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and commercialised by AbbVie outside of the U.S.

"Nearly 20,000 people will be diagnosed with AML in the U.S. this year, and many of them are not eligible to receive standard intensive chemotherapy," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "AML is an aggressive disease with the lowest survival rate of all leukaemias, and we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible."

Data recently presented from the phase Ib M14-358 study showed Venclexta in combination with azacitidine or decitabine resulted in a complete remission rate (with or without full recovery of normal blood cell count; CR/CRi) of 73% in patients treated with Venclexta at a dose of 400 mg.2 After more than a year of follow-up, the observed median overall survival (OS) across all Venclexta dose groups in the study was 17.5 months (95% CI: 12.3-not reached).2 The most common Grade 3-4 adverse events (occurring in 10% or more patients) were low white blood cell count with fever, low white blood cell count, anaemia, low platelet count and decreased potassium levels.2

Additionally, results from the phase Ib/II M14-387 study of Venclexta in combination with LDAC showed a CR/CRi rate of 62% in patients treated with Venclexta at a dose of 600 mg.3 After more than a year of follow-up, the observed median OS was 11.4 months (95% CI: 5.7-15.7).3 The most common Grade 3-4 adverse events (occurring in 10% or more patients) were low white blood cell count with fever, decreased potassium levels, pneumonia, disease progression, decreased phosphate levels, high blood pressure and sepsis (blood infection).3

The FDA previously granted two breakthrough therapy designations for Venclexta in previously untreated AML ineligible for intensive chemotherapy, either in combination with hypomethylating agents or LDAC, based on results from these two studies. Recently, the FDA approved Venclexta in combination with Rituxan (rituximab) for the treatment of people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. A robust clinical development programme is ongoing in several other cancer types.

About the M14-358 study
The M14-358 study (NCT02203773) is an open-label, phase Ib dose escalation and expansion study evaluating the safety and efficacy of Venclexta in combination with hypomethylating agents, azacitidine or decitabine, in 212 patients who are 60 years or older with previously untreated AML unfit to receive intensive chemotherapy. Study endpoints included CR/CRi, OS and safety.

About the M14-387 study
The M14-387 study (NCT02287233) is an open-label, phase Ib/II dose escalation and expansion study evaluating the safety and efficacy of Venclexta in combination with LDAC in 94 patients who are 60 years or older with previously untreated AML unfit to receive intensive chemotherapy. Study endpoints included CR/CRi, objective response rate (ORR), OS and safety.

About Venclexta
Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in AML has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and commercialised by AbbVie outside of the U.S.

Together, the companies are committed to further research with Venclexta, which is currently being evaluated in phase III clinical trials for several types of blood cancers. In the U.S., Venclexta has been granted four Breakthrough Therapy Designations by the FDA: in combination with Rituxan for people with relapsed or refractory CLL; as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated AML ineligible for intensive chemotherapy; and in combination with LDAC for people with untreated AML ineligible for intensive chemotherapy.

About Acute Myeloid Leukaemia
AML is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow.4 AML is the most common type of aggressive leukaemia in adults.1 It has the lowest survival rates of all types of leukaemia.5 Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.6,7 Approximately 20,000 people in the U.S. and 18,000 in Europe are diagnosed with AML each year.8,9