On September 05 2018, Roche reported that it was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months (Press release, Hoffmann-La Roche, SEP 5, 2018, View Source [SID1234529354]). The extension allows the FDA time to review additional information requested in support of the sBLA. FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date. The FDA is expected to make a decision on approval by December 05, 2018. In May 2018, TECENTRIQ in combination with Avastin, carboplatin and paclitaxel was granted Priority Review from the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the Phase III IMpower150 study.

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About NSCLC
Lung cancer is the leading cause of cancer death globally.[1] Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[2] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.[3]

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved across several types of cancers including advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and recurrent glioblastoma. Avastin is approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.

About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

On September 4, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported that it has secured a $15 million investment from Alpha Holdings, Inc. (KOSDAQ: 117670) as part of a value focused, fundamental strategic investment centered on the clinical development of OncoSec’s lead immunotherapy product candidate, TAVO (tavokinogene telseplasmid) (Press release, OncoSec Medical, SEP 4, 2018, View Source [SID1234529254]). TAVO enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with powerful immune-stimulating functions.

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"This investment from Alpha Holdings is a testament to the growth of OncoSec and the momentum building behind our rapidly advancing TAVO programs, which are designed to enable the intratumoral delivery of IL-12 to stimulate the body’s immune system to target and attack cancer," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "In addition to increasing our current capital, aligning with Alpha Holdings provides an opportunity to strengthen our presence in South Korea and Asia, while developing a long-term relationship with a company that, like OncoSec, recognizes the potential of our TAVO platform to expand the larger, multibillion-dollar checkpoint market, which has yet to be fully unlocked across multiple cancer types."

Alpha Holdings is a leading Korean company engaged in the design, development, service and manufacture of system semiconductors, as well as the development of biotechnologies and thermal compound materials. Since 2002, Alpha Holdings has successfully carried out many projects as a major partner of Samsung Advanced Foundry Eco-system (SAFE) of Samsung Electronics. Alpha Holdings, a listed company in the KOSDAQ Market, was founded in 2002 and is headquartered in Seongnam, South Korea.

"In targeting opportunities for growth, we believe the biotechnology sector and the immunotherapy space in particular, offer significant potential," said Hee Do Koo, President and Chief Executive Officer of Alpha Holdings. "Our investment in OncoSec is a prime example of this vision and our mission to align ourselves with biotechnology companies developing innovative technologies to treat large patient populations in need of new, more efficacious treatment modalities."

Under the terms of the agreement, Alpha Holdings has committed to purchase a total of $15 million worth of shares of common stock from OncoSec at $1.50 per share. The purchase is to be made in two tranches, each subject to a six-month holding requirement. Further details of the transaction can be found in the Form 8-K filed by the Company describing the agreement

On September 4, 2018 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that its collaborator ProMab Biotechnologies, Inc. ("ProMab") will present at the CAR-TCR Summit 2018 being held from September 4th – 7th, 2018 in Boston, Massachusetts (Press release, Helix BioPharma, SEP 4, 2018, View Source [SID1234530406]).

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Dr. Vita Golubovskaya, Director, R&D, BD of Promab Biotechnologies will present on September 5th at 12:25pm. The title of the presentation is "Novel CAR-T Cells Against Solid and Hematological Cancers". Dr. Golubovskaya’s presentation will include certain preclinical data from the multiple myeloma project currently in collaboration with Helix.

Helix continues to aim for a possible first-in-human CAR-T study in 2019. To achieve this goal, Helix’s wholly-owned Polish subsidiary Helix Immuno-Oncology ("HIO") will be leading the preclinical and clinical development program in Poland prioritizing a possible European clinical submission. Helix and HIO are engaging experts to advise on the program and are currently securing the necessary financial resources to meet the project timelines.

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.