On April 2, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the ‘‘Company’’) a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported preclinical data from studies currently being conducted under its collaborations with The University of Texas MD Anderson Cancer Center and the Weill Cornell Medical College (Press release, Nanobiotix, APR 2, 2019, View Source [SID1234534950]). These results were presented during two poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, currently taking place in Atlanta, Georgia, USA from March 29 to April 3, 2019.

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This initial pre-clinical set of NBTXR3/radiotherapy/IO combination data provides further insights into the immuneactivation caused by NBTXR3 and strengthens the understanding of the potential systemic effects provided by NBTXR3. Thus, the Company believes it formulates sound rationale to support its clinical development program investigating the combination of NBTXR3, radiotherapy and IO agents.

Enhancement of anti-PD-1 and anti-CTLA4 efficacy by NBTXR3 nanoparticles exposed to radiotherapy Poster #3225 Yun Hu1, Ping Zhang2, Audrey Darmon2, Maria Angelica Cortez1, Sébastien Paris2, James Welsh1 1MD Anderson Cancer Center, Houston, TX; 2Nanobiotix, Paris, France

In both 344SQ_P (sensitive to anti-PD-1 treatment) and 344SQ_R (resistant to anti-PD-1 treatment) lung cancer models, the combination of anti-PD-1 + radiotherapy + NBTXR3 demonstrated both better control of the treated tumor and the distant untreated tumor as well as increased survival when compared to monotherapy. Importantly, it was observed that this combination decreased spontaneous lung metastasis formation in the anti-PD-1 sensitive 344SQ_P model.

For the CT26.WT colon carcinoma model, as previously reported, NBTXR3 activated by radiotherapy generated an abscopal effect. It was observed that administration of anti-CTLA4 monotherapy demonstrated control of both treated and distant untreated tumors, potentially indicating that the CT26.WT was sensitive to a checkpoint inhibitor. The addition of radiotherapy to anti-CTLA4 only improved the tumor control modestly compared to antiCTLA4 alone. In contrast, the combination of anti-CTLA4 + radiotherapy + NBTXR3 in this trial showed the best control of the treated and distant untreated tumors, then any single agent or doublet combination.

NBTXR3 Potentiates Cancer-Cell Intrinsic Interferon beta Response to Radiotherapy Poster #3366 Maria Esperanza Rodriguez-Ruiz1, Karsten A Pilones1, Camille Daviaud1, Jeffrey Kraynak1, Audrey Darmon2, Sébastien Paris2 and Sandra Demaria1 1Department of Radiation Oncology, Weill Cornell Medicine, New York, USA; 2Nanobiotix, Paris, France

Data suggests that NBTXR3 enhances the effectiveness of radiation and improves tumor immunogenicity in murine breast cancer cell lines, via the induction of type-I interferon (IFN-I). In the study, NBTXR3 activated by radiotherapy amplified cancer cell intrinsic IFN-I response and showed a significant improvement in tumor control compared to radiotherapy alone with complete durable regression of tumors.-Ends

About NBTXR3

NBTXR3 is a first-in-class product candidate designed to destroy tumors and metastasis when activated by radiotherapy.

NBTXR3 has a high degree of biocompatibility and requires one single administration before the whole radiotherapy treatment. Nanobiotix believes NBTXR3 has the ability to fit into current worldwide standards of radiation care.

Nanobiotix’s broad clinical program includes seven clinical trials. In June 2018, Nanobiotix established human proof of concept for this first-in-class product candidate in its soft tissue sarcoma (STS) Phase III clinical trial. NBTXR3 is actively being studied in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients who are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results from these clinical studies have been observed from the ongoing Phase I/II trial regarding the local control of tumors.

Nanobiotix is also running an immuno-oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration 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) for the STS indication is ongoing in Europe

On April 2, 2019 Xynomic Pharma, a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corp. (Nasdaq: BCAC), reported that China, Spain and Poland authorities have approved Xynomic’s application to conduct potentially pivotal Phase 3 trial using Xynomic’s abexinostat, in combination with pazopanib, in patients with renal cell carcinoma (RCC) (Press release, Xynomic Pharmaceuticals, APR 2, 2019, View Source [SID1234534944]). Xynomic plans to initiate this trial in China, Spain, Poland and additional European countries in the first half of 2019. The same trial is currently ongoing in the United States and South Korea. According to a June 2018 research report by Grand View Research, RCC accounts for 1.8% of total adult malignancies globally and 3.4% of all new cancer cases in the United States. The global RCC pharmaceuticals market size is projected to reach US$ 4.6 billion in 2019.

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In addition, the Independent Ethics Committee at the Cancer Hospital Chinese Academy of Medical Sciences in Beijing, China’s number one ranked cancer specialty hospital according to Fudan University’s Hospital Management Institute, has approved Xynomic’s application to conduct two potentially pivotal Phase 2 trials, one to test abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma (DLBCL) and the other as a third-line mono therapy against follicular lymphoma (FL). According to Chinese Medical Association’s Chinese Society of Hematology, DLBCL and FL are the most prevalent and second most prevalent non-Hodgkin’s lymphoma subtype, respectively, in China.

On April 2, 2019 IGEM Therapeutics (IGEM), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer, reported the award of a £0.75 million grant from the UK’s innovation agency, Innovate UK (Press release, IGEM Therapeutics, APR 2, 2019, View Source [SID1234534942]). IGEM will use the Biomedical Catalyst Primer Award to develop novel IgE antibodies targeting HER2, a commercially-validated cancer antigen expressed on a variety of tumour types including breast, ovarian and gastric cancer.

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Currently marketed anti-HER2 IgG antibodies are only able to treat patients with cancers expressing high levels of HER2 antigen. The majority of HER2 positive patients have cancers expressing intermediate or low levels of HER2 and cannot be treated with anti-HER2 IgG antibodies. To address this substantial unmet medical need, IGEM is developing novel, human IgE antibodies that bind to HER2.

The epsilon constant region of IgE has evolved to fight complex, multicellular parasitic organisms resident in tissue by recruiting powerful immune effector cells such as macrophages, basophils and monocytes. IGEM believes that potent immune responses arising from IgE are suited to the destruction of solid tumours which also reside in tissue. Pre-clinical studies in the laboratory of IGEM Founder Dr Sophia Karagiannis at King’s College London have demonstrated superior efficacy with a number of IgE antibodies when compared to their IgG equivalents. IGEM is also developing anti-cancer IgE antibodies targeting folate receptor alpha and CSPG-4.

Dr Tim Wilson, Chief Executive Officer of IGEM, commented: "IGEM is a pioneer in the use of IgE antibodies to treat cancer. We are very pleased to have been awarded our second grant from Innovate UK. Our goal is to harness the potency of the IgE-mediated immune response and thereby provide patients with new safe and effective treatment options for these serious diseases".

On April 2, 2019 Geron Corporation (Nasdaq: GERN) reported that John A. Scarlett, M.D., Chairman and Chief Executive Officer, is scheduled to present a company overview at the 18th Annual Needham Healthcare Conference in New York at 3:30 p.m. ET on Tuesday, April 9, 2019 (Press release, Geron, APR 2, 2019, View Source [SID1234534940]).

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A live audio webcast of the presentation will be available on Geron’s website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company’s website for 30 days.

On April 2, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that Claire Roddie MB, PhD, FRCPath, honorary senior lecturer, Cancer Institute, University College London (UCL), presented today initial data from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell leukemia (ALL) as a late-breaking poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia (Press release, Autolus, APR 2, 2019, View Source [SID1234534937]).

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Relapsed / refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults is an area of significant unmet clinical need. Notably, no CD19 CAR T cell therapeutic has been approved to date for adults with r/r B-ALL. The key challenges identified in clinical studies testing standard CD19 CAR T-cells therapies in this setting are considerable toxicity associated with severe cytokine release syndrome (CRS) and high-grade neurological toxicity.

AUTO1 uses a novel CD19 binder that allows the CAR T cells to disengage rapidly after target cell encounter and kill. Preliminary data from the ongoing Phase 1/2 CARPALL trial of AUTO1 in pediatric ALL presented at the 1st European CAR T Meeting organized by European Hematology Association (EHA) (Free EHA Whitepaper) in February 2019 indicated that AUTO1 has a well-tolerated safety profile and did not induce high grade CRS in pediatric patients.

As of the data cutoff date of March 18, 2019 in the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult ALL patients, 13 patients were leukapheresed, and products for 12 patients were manufactured, including 7 with Autolus’ semi-automated, fully enclosed manufacturing process. Two patients are pending infusion. Among the 10 infused patients to date, the median age is 41 and 70% were male, with median lines of treatment of 4 (the range is 2-7). Five of the ten treated patients had ³ 50% BM blasts and were considered to be high-risk for severe CRS. Patients received a split dose based on disease burden for a total dose of up to 410 million cells.

Safety results

Using the Lee criteria, there were no patients with severe CRS (³ Grade 3), and 2 of 10 patients (20%) with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients (20%). None of the patients were admitted to intensive care due to CRS. One patient developed delayed Grade 3 neurotoxicity following high levels of CAR T expansion, which was quickly reversed with steroids. Four patients died while enrolled in the trial, two due to progression of leukemia and two due to sepsis, a common complication of advanced ALL.

Efficacy results

Nine patients were evaluable for response at 1 month and 8 (88%) had a molecular complete response. One patient died of sepsis before the one-month evaluation point. At a median follow up of 5 months (range 0.62-10.6 months), 6/10 patients are alive and continue to be in molecular remission. There continues to be evidence of ongoing B cell aplasia and CAR T persistence.

"AUTO1 delivered promising early remission rates, CAR T cell expansion and persistence in this adult ALL trial cohort," said Dr. Roddie. "Despite enrolling patients with high tumor burden, we believe the safety profile in the trial appears to compare very favorably to other CD19 CARs and is consistent with the safety profile of AUTO1 observed in pediatric patients in the CARPALL trial."

"These data from the ALLCAR19 study of AUTO1 in relapsed refractory ALL, while early, are encouraging, with a high response rate we now associate with CAR T cell therapies, but with a potentially improved safety profile. If AUTO1 continues to be associated with a lower incidence of adverse events with additional patients treated, this could represent an important advance for more vulnerable adult patients, as side effects of these therapies, including serious cytokine release syndrome and neurotoxicity, limit our ability to treat these individuals." said Krishna Komanduri, M.D., Kalish Family Chair in Stem Cell Transplantation and Director, Adult Stem Cell Transplant Program at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

"The strong persistence of the CAR T cells over time, coupled with the low frequency of severe CRS events seen in these patients, represent encouraging initial data for AUTO1 in relapsed/refractory adult ALL," said Dr. Christian Itin, chairman and chief executive officer of Autolus Therapeutics. "We expect AUTO1 in adult ALL to move into a registration trial towards the end of this year."

For information about the ALLCAR19 trial, visit View Source;rank=1

Conference Call Information

Autolus management will host a conference call featuring Dr. Roddie on Tuesday, April 2, 2019 at 8:00 am ET/ 1:00 pm BST to discuss the ALLCAR19 data presented at AACR (Free AACR Whitepaper). To listen to the webcast and view the accompanying slide presentation, please go to View Source

The call may also be accessed by dialing 866-679-5407 (U.S.) or 409-217-8320 (international) and referencing conference ID 7679666. After the conference call, a replay will be available for one week. To access the replay, please dial 855-859-2056 (U.S.) or 404-537-3406 (international) and enter conference ID 7679666.

About AUTO1

AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety—while maintaining similar levels of efficacy—compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, Autolus believes AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells’ abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights from UCL Business plc (UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1/2 trials, one in pediatric ALL and one in adult ALL.

About Adult Acute Lymphoblastic Leukemia

According to the American Cancer Society, acute lymphoblastic leukemia (ALL) is predicted to affect approximately 5,960 adults in the United States in 2018. Combination chemotherapy enables 90% of adult patients to experience CR (complete response). Despite this, the prognosis of adult ALL is still poor and has not changed significantly during the last two to three decades, with long-term remission rates limited to 30–40%. Approximately 50% of all adult ALL patients will relapse.