On September 4, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported it has initiated the second stage of the JASPER study that is designed to assess clinical benefit of ZEJULA in combination with an anti-PD-1 antibody in first-line non-small cell lung cancer (NSCLC) patients (Press release, TESARO, SEP 4, 2018, View Source [SID1234529255]). The decision to advance the trial was based on achieving the protocol defined response criteria in the initial cohort of 16 treated patients with high PD-L1 expression, of which 14 were evaluable for a response. Nine of the 14 patients had objective responses by RECIST criteria at the time of the analysis1; with all 14 patients experiencing tumor shrinkage.

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"These JASPER data provide preliminary evidence that the combination of ZEJULA and an anti-PD-1 antibody could be active as a first-line treatment for patients with non-small cell lung cancer and high levels of PD-L1 expression," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "In the second stage of the trial, 36 additional patients will be enrolled and treated with ZEJULA in combination with TSR-042, our anti-PD-1 antibody. TSR-042 is the foundation of our lung cancer strategy, and is also being studied as a monotherapy in our GARNET trial in anti-PD-(L)1 naïve patients who have progressed on chemotherapy, and in combination with TSR-022, our anti-TIM-3 antibody, in AMBER, a study in late-line NSCLC patients that have progressed after anti-PD-(L)1 therapy. We look forward to sharing lung cancer data from both GARNET and AMBER at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November."

About the JASPER Clinical Trial
JASPER is a Phase 2, open-label, single arm trial designed to evaluate the safety and efficacy of ZEJULA in combination with an anti-PD-1 antibody for the treatment of first-line NSCLC. Patients were enrolled in stage 1 of the study and received a starting dose of 200 milligrams of niraparib once per day and 200 milligrams Q3 weeks of an anti-PD-1 antibody. The primary endpoint of stage 1 of the study was objective response rate (ORR) per RECIST. Other endpoints include durability of response, disease control rate, progression free survival (PFS), overall survival (OS) and safety and tolerability.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

On September 4, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported publication of a preclinical study demonstrating that inhalation of a TLR9 agonist can stimulate effective immunity against lung tumors and complement the actions of PD-1 blockade to generate durable, systemic anti-tumor immunity (Press release, Dynavax Technologies, SEP 4, 2018, View Source [SID1234530120]). The paper titled Inhaled TLR9 Agonist Renders Lung Tumors Permissive to PD-1 Blockade by Promoting Optimal CD4+ and CD8+ T cell Interplay, by Dynavax scientists M.Gallotta, H. Assi, E. Degagné, S. Kannan, R.Coffman and C. Guiducci was published in the journal Cancer Research. The study demonstrated that combining an inhaled TLR9 agonist with systemic anti-PD-1 led to long-term survival in two different mouse lung tumor models, mediated by systemic immunity that eradicated tumors both in the lung and in distal organs. The study further delineated the distinctive mechanisms of action of these agents in the lung environment.

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Administration of the TLR9 agonist SD-101 into the lungs of mice with metastatic tumors generated anti-tumor responses that controlled or eliminated tumor growth in the lungs as well as in non-treated organs, including liver. Treatment with SD-101 resulted in ~90% decrease in tumor burden in both the lung and liver. This led to a significant increase in survival time, with a majority of mice surviving beyond 90-100 days. Treatment with SD-101 and anti-PD-1 resulted in a large increase of tumor-reactive T cells, which were required for anti-tumor activity. The durable control of liver metastases shows that local administration of SD-101 to the lung generates an anti-tumor T cell response capable of controlling tumor growth beyond the lung itself.

The TLR9 agonist used in these studies was SD-101, Dynavax’s lead clinical candidate currently being developed as an intratumoral agent in combination with anti-PD-1 therapy in patients with advanced melanoma and head and neck squamous cell carcinoma. Unpublished data demonstrates that another TLR9 agonist, DV281 – optimized for delivery to primary lung tumors and lung metastases – has equivalent activity in these models. These studies provide the preclinical rationale for the Phase 1b dose escalation study of inhaled DV281 currently being conducted by Dynavax in advanced non-small lung cancer patients (NCT03326752). DV281 and SD-101 stimulate potent Type 1 interferon induction along with maturation of dendritic cells into effective antigen-presenting cells. These combined actions lead to the increased numbers of cytotoxic T cells that are critical for the induction of effective systemic anti-tumor immunity.

On September 3, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, and The University of Cambridge reported that they have been granted a Knowledge Transfer Partnership (KTP) (Press release, STORM Therapeutics, SEP 3, 2018, View Source [SID1234561043]). The Grant, of up to £240,000, is to develop an analysis platform using the data warehouse software InterMine to help STORM advance its cancer research.

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STORM has established a pipeline of drug discovery programmes to develop novel, first-in-class drugs for the treatment of specific cancers and other diseases with high unmet medical need.

Keith Blundy, Chief Executive of STORM Therapeutics said: "Biology is an extremely fast paced, changing area. STORM is on the cutting edge of cancer research and keeping up with the data that is constantly being generated is vital. Previously, this data has been spread across a number of silos and gathering all of this information, as well as being able to analyse it efficiently, can be costly and prone to error. Through the KTP programme STORM is now partnered with an open-source data warehouse, InterMine, specifically for the integration and analysis of complex biological data, making it easy to query and analyse."

Gos Micklem, Principal Investigator for the InterMine project based at the Department of Genetics at the University of Cambridge said: "We are excited by this KTP award and the opportunity to collaborate with STORM. We see benefits on both sides – STORM gains our experience in large-scale data integration and the freely available open-source InterMine platform, while the adaptations that will be made to accommodate their data and interests will improve InterMine for the benefit of the broader community."

The KTP programme helps businesses in the UK by linking them with an academic organisation, enabling them to bring in new skills and the latest academic thinking to deliver a specific, strategic innovation project.

On September 3, 2018 BeiGene Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the National Medical Products Administration of China (NMPA, formerly known as CFDA), has accepted its new drug application (NDA) for its anti-PD-1 antibody, tislelizumab, for relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) (Press release, Boehringer Ingelheim, SEP 3, 2018, View Source [SID1234529412]).

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Since BeiGene and Boehringer Ingelheim started their collaboration in 2013, Boehringer Ingelheim’s biopharmaceutical contract manufacturing business, known as Boehringer Ingelheim BioXcellence, has been providing the Chemistry, Manufacturing, and Control (CMC) services for support of the tislelizumab. Boehringer Ingelheim assisted BeiGene with tislelizumab’s development through process and analytical method development, supply of GMP clinical material, and CMC filing support with the NMPA.

Tislelizumab is an investigational anti- PD-1 antibody being studied in a number of malignancies, such as relapsed/refractory classical Hodgkin’s Lymphoma, non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, mature T-and NK-cell lymphomas, and urothelial cancer. Boehringer Ingelheim Biopharmaceuticals (China) Ltd. is committed to providing BeiGene with full contract manufacturing support and supply of tislelizumab at the highest global quality standards to serve patients with this important medicine, if approved.

On August 31, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that Chief Scientific Officer Takashi Kei Kishimoto, Ph.D. will present on the poster entitled Ongoing Phase 2 Clinical Trial of SEL-212 Shows Sustained Reduction of Serum Uric Acid by Mitigating Formation of Anti-Uricase Antibodies at the 20thAsia Pacific League of Associations for Rheumatology Congress (APLAR), taking place 6-9 September 2018 at the Kaohsiung Exhibition Centre, Taiwan (Press release, Selecta Biosciences, AUG 31, 2018, View Source [SID1234529216]).

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