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Sumitomo Dainippon Pharma Submits an Application of RETHIO for an Additional Indication of Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation for Malignant Lymphoma

On April 2, 2019 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura hereinafter called "Sumitomo Dainippon Pharma") has reported that on March 29 the company applied for a partial change in the marketing approval previously acquired in Japan for RETHIO 100 mg for I.V. infusion (generic name, thiotepa; hereinafter called "RETHIO") (Press release, Sumitomo Dainippon Pharma, FEB 2, 2019, View Source [SID1234605564]). The change applied for this time involves an additional indication of RETHIO for conditioning treatment prior to autologous hematopoietic stem cell transplantation (auto-HSCT) for malignant lymphoma.

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RETHIO is a drug indicated for conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors. Sumitomo Dainippon Pharma obtained the marketing approval for this drug on March 26, 2019 and plans to launch it after NHI drug price listing.

Malignant lymphoma, a hemocytes-derived cancer, is a disease that lymphocytes, a subpopulation of leukocytes (white blood cells), become cancerous. This disease occurs typically in lymphoid tissues, such as lymph nodes, spleens, and tonsils, but it also often develops in other sites. It has been reported that the incidence of malignant lymphoma is around ten in 100,000 persons in Japan annually, the most common hematapostema in Japanese adults. As with conditioning treatment prior to autologous HSCT for pediatric malignant solid tumors, the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs of the Ministry of Health, Labour and Welfare (MHLW) determined similarly high medical need in conditioning treatment prior to auto-HSCT for malignant lymphoma. Thus, Sumitomo Dainippon Pharma conducted Phase 1 trials in Japan and subsequently applied for the additional indication.

Sumitomo Dainippon Pharma believes that, upon approval of its additional indication, this drug will contribute to improved healthcare as a new treatment option for patients indicated for conditioning treatment prior to auto-HSCT for malignant lymphoma, a therapeutic area with high unmet medical need.

About autologous hematopoietic stem cell transplantation (auto-HSCT)
Autologous hematopoietic stem cell transplantation is a therapy that aims to reconstruct hematopoietic capacity via intravenous transfusion of normal hematopoietic stem cells of the patient himself/herself after eradicating intractable cancers by conditioning myeloablative treatment prior to transplantation using maximum levels of anti-cancer drugs or radiation.

About the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs
The Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs is a committee established to promote the development of unapproved or off-label drugs by pharmaceutical companies that are approved for use in Europe and the United States, etc., but not approved in Japan. It is organized under the Ministry of Health, Labour and Welfare of Japan and consists of academic experts in medical and pharmaceutical fields.

RhoVac announces that all patients completed the follow-up phase of the clinical phase I / II study

On April 2019 RhoVac AB ("RhoVac") reported that all prostate cancer patients who participated in the clinical phase I / II study with RhoVac’s drug candidate RV001, have completed their 9- and 12-month’s follow-ups (Press release, RhoVac, APR 2, 2019, View Source [SID1234555933]). This marks the completion of the clinical phase I / II study for the participating patients.

RhoVac’s clinical phase I / II study was conducted during the period of Q1 2017 to Q1 2019. The 22 patients recruited for this study had been diagnosed with prostate cancer and been treated with prostatectomy. Blood samples were drawn before, during and after the study to analyze the product-mediated immune response to the treatments. The results, reported in August 2018, showed a significant immune response in 86% of patients. The patients also participated in 3-, 6-, 9- and 12-month’s follow-ups to study the duration of the immune response. This follow-up phase is now completed as all 22 patients have had their final follow-up visit at the clinical site.

The last samples from the 9- and 12-month’s follow-up phase have now been sent to the University of Tübingen for immunological analysis. RhoVac expects to report these results mid-2019.

CEO Anders Ljungqvist comments:

– The company’s first clinical study, RhoVac-001, is now completed and only analyzes and final reporting of the follow-up phase remain. I am proud that RhoVac has completed this study within the set timeframe. A result we have largely achieved thanks to the highly dedicated patients who have participated in the study. This combined with an outstanding collaboration with Copenhagen Prostate Cancer Center at University Hospital, Copenhagen; Phase I unit Zelo at Bispebjerg and Frederiksberg Hospital, DanTrials ApS and T-cell Monitoring Group, the Department of Immunology at the University of Tübingen, Germany have all ensured that we have been able to communicate conclusive results according to time frame. Thank you very much to all the participants.

LIDDS announces a novel TLR9 agonist project and plan for Phase I clinical trial

On April 2, 2019 LIDDS AB reported that Clinical data shows that intratumoral delivery of TLR agonists in combination with immune checkpoint inhibitors can effectively treat solid cancers (Press release, Lidds, APR 2, 2019, View Source [SID1234555907]). NanoZolid technology is very suitable to provide sustained intratumoral release and minimize the need for repeated injections. LIDDS has performed pre-clinical studies with promising results using a TLR9 agonist formulated with NanoZolid.

Toll-like receptors (TLR) are a key target for the pharmaceutical industry in the fight against cancer. TLRs are expressed on various immune cells, including dendritic cells, and they initiate the body’s immune response. TLR activation can lead to an immunologically active or inflamed tumor environment which then recruits the cytotoxic T-cells necessary for an anti-tumor response in immunotherapy.

-The NanoZolid technology addresses key issues in developing TLR agonists as repeated intratumoral injections are needed using standard formulations, says Monica Wallter, CEO LIDDS.

-We will be focusing our project on TLR9, one of the most promising targets for increasing response and reversing resistance to immunotherapies. TLR9 agonists have been shown to be most effective when injected directly into a tumor, says Monica Wallter.

-A preclinical programme is ongoing to broaden the results obtained to date and we are now preparing for a Phase I clinical trial using NanoZolid combined with a TLR9 agonist. The first human study is planned to commence in 2020, says Monica Wallter.

Preclinical studies have shown that activation of TLR pathways can lead to potent immunological effects that generate anti-tumor immunity and shrink tumors. Most importantly, these effects can act in synergy with immune checkpoint inhibitors.

-There is significant commercial potential in this area of research and drug development and the market for TLR agonists is expected to be worth hundreds of millions of dollars over the coming years, says Monica Wallter.

The most relevant target cancers for the TLR9 project are head and neck cancer, prostate cancer and lymphomas. These cancers are diagnosed in around 2 million patients each year.

Toll-like receptors have been studied for many years and the emerging clinical data suggests that their time has come as important anti-cancer agents when used in combination with immune checkpoint inhibitors.

Nordic Nanovector: Promising results from preclinical studies with a novel CD37-targeted alpha therapy for B-cell tumours presented at TAT11

On April 2, 2019 Nordic Nanovector ASA (OSE: NANO) reported that promising results from its preclinical research collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours have been reported today in an oral presentation at TAT11, the 11th International Symposium on Targeted-Alpha-Therapy (1-4 April, Ottawa, Canada) (Press release, Nordic Nanovector, APR 2, 2019, View Source [SID1234553453]).

The research collaboration with Orano Med (formerly known as AREVA Med) was established in June 2016 to develop and investigate a next-generation targeted alpha therapy comprising Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) and the alpha-particle-generator lead-212 (212Pb) for the treatment of B-cell malignancies.

The results reported in an oral presentation given today describe promising findings from preclinical studies investigating the tolerability and dose-dependent efficacy of 212Pb-NNV003 in mouse models of chronic lymphocytic leukaemia (CLL) and Burkitt’s lymphoma (a type of non-Hodgkin’s lymphoma, NHL).

In the studies, 212Pb-NNV003 displayed a favourable toxicity profile after a single intravenous injection. In one study, 100% of mice with tumour xenografts were alive five months after the injection of 212Pb-NNV003, while only 50% of control mice receiving cold antibody where alive after 1.5 months.

Jostein Dahle, Chief Scientific Officer of Nordic Nanovector, said: "Our research collaboration with Orano Med continues to produce promising preclinical results and provides an early demonstration of the potential of 212Pb-conjugated CD37-targeted alpha therapy to treat leukaemias and lymphomas where there is no substantial tumour mass and tumour cells are near healthy tissues. This approach also may prove useful for CLL and NHL patients who have relapsed or become refractory to standard CD20-targeting agents that are used in front-line therapy. We look forward to further results from this research programme."

The oral presentation entitled 212Pb-NNV003 as a Novel Targeted Alpha Therapy for CD37 Positive B-cell Chronic Lymphocytic Leukaemia (CLL) and Non-Hodgkin’s Lymphoma (NHL) was given by Dr A. Saidi of Orano Med.

Alligator Bioscience: New preclinical data for ATOR-1144 demonstrate potential for activation of both the innate and the adaptive immune system, as well as direct anti-tumor effects

On April 2, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that new preclinical data on the drug candidate ATOR-1144 will be presented at the scientific conference AACR (Free AACR Whitepaper) (American Association for Cancer Research), held in Atlanta on March 29 – April 3, 2019 (Press release, Alligator Bioscience, APR 2, 2019, View Source [SID1234538667]). ATOR-1144 is a first-in-class bispecific tumor-localized antibody targeting the checkpoint inhibitor CTLA-4 and the co-stimulatory receptor GITR (Glucocorticoid-Induced TNFR family Related).

The new preclinical data demonstrate that ATOR-1144 works through several pathways: activation of effector T cells, depletion of regulatory T cells (Tregs) and tumor cells and activation of NK (natural killer) cells, with potential for enhanced tumor cell killing. In addition, GITR is shown to be expressed on tumor-infiltrating lymphocytes and neoplastic cells in tumor samples from e.g. head and neck, esophageal, ovarian cancer, melanoma and B and T cell lymphoma, allowing for direct tumor cell killing.

"We are excited to present ATOR-1144 to the scientific community. It is a novel tumor-localizing CTLA-4 bispecific antibody with the potential for enhanced immune-activation of both the adaptive and the innate immune system, as well as direct anti-tumor effects. These properties are likely to act in concert and give ATOR-1144 the potential for superior efficacy", said Per Norlén, CEO of Alligator Bioscience.

Dr Anne Månsson Kvarnhammar, Senior Scientist at Alligator, will present a poster (#4077) with the title: "ATOR-1144 is a tumor-directed CTLA-4 x GITR bispecific antibody that acts by depleting Tregs and activating effector T cells and NK cells" on Tuesday, April 2, 1:00 p.m. EDT (7:00 p.m. CEST). The poster will then be available on View Source

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 1:30 p.m. CEST on April 2, 2019.

About ATOR-1144
ATOR-1144 is a bispecific IgG1 antibody drug candidate targeting both CTLA-4 and GITR. It is a combination of a GITR specific antibody isolated from ALLIGATOR-GOLD, while the CTLA-4 part was developed by FIND optimization of CD86, a natural CTLA-4 ligand.