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10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]

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MediciNova to Present at the 98th Annual Meeting of the Chemical Society of Japan

On January 16, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova has accepted an invitation to present at the 98th Annual Meeting of the Chemical Society of Japan to be held in Funabashi-city, Chiba in Japan (Press release, MediciNova, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326908 [SID1234523151]). The presentation entitled "Drug Repositioning: An Experience at MediciNova" will be presented by Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.

Presentation details are as follows:

Session Date and Time: March 21, 2018, 3:00 – 3:30 pm.

Session Title: Advanced Technology Program

Location: Nihon University, Funabashi City, Chiba, Japan

Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development in recurrent Head and Neck Cancer, including Fast Track designation granted by the FDA, initiation of clinical studies in Japan, and plans to start pivotal studies, which will incorporate the evaluation of anti-cancer immune responses, in early 2018

On January 16, 2018 Aspyrian Therapeutics, Inc., a biotechnology company developing precision-targeted cancer therapies based on a proprietary Photoimmunotherapy (PIT) platform, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RM-1929, a first-in-class precision targeted therapy, for treatment of patients with locoregional recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) that have failed 2 lines of therapies (Press release, Rakuten Aspyrian, JAN 16, 2018, View Source [SID1234535086]).

"I am very excited by the progress that Aspyrian has made building on game-changing innovation," said Hiroshi "Mickey" Mikitani, Chairman of Aspyrian. "Aspyrian is aiming to conquer cancer, for life – some might see this as wildly ambitious but we are humbly committed to this as the end goal."

RM-1929 is currently being tested in an ongoing Phase 2 study in recurrent Head and Neck cancer (Study RM-1929/101, NCT02422979). Enrollment has been completed and Aspyrian expects to report top-line data in the second half of 2018. Aspyrian also recently completed a successful end-of-phase 2 meeting with the FDA to discuss interim clinical data from this Phase 2 study. The design of pivotal studies was also discussed, including clinical strategies to potentially support accelerated approval under Subpart E, Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses, Code of Federal Regulations, Title 21, Volume 7. Based on the FDA feedback, Aspyrian plans to initiate the first global pivotal study for RM-1929, to treat recurrent Head and Neck cancer, within the first quarter of 2018.

"We are extremely pleased that the FDA has granted Fast Track designation for RM-1929, a first-in-class precision targeted therapy, for treatment of patients with locoregional recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) that have failed 2 lines of therapies. The Fast Track designation recognizes the potential of RM-1929 to address the large unmet medical need in this clinical setting," said Dr. Merrill Biel, MD, PhD, Chief Medical Officer of Aspyrian. "The interim results of the Phase 2 study showed improvement in the clinically meaningful endpoints of Overall Response Rate, Progression Free Survival and Overall Survival compared to the historical data for the standard of care treatments currently available to these patients. These data support the potential for RM-1929 to control this disease while preserving normal healthy tissues in the head and neck area that are so critical to maintaining the patient’s quality of life and we look forward to initiating the pivotal clinical trials."

Pivotal studies will include evaluation of RM-1929 as a single agent and in combination with immunomodulators to treat both locoregional and metastatic head and neck cancer lesions. Studies conducted by Aspyrian have shown that treatment with RM-1929 can induce not only rapid tumor destruction, but also drive innate and adaptive anti-cancer immune responses.

"I congratulate the Aspyrian team for successfully driving the progression of RM-1929 towards pivotal studies in recurrent Head and Neck cancer, to start in early 2018. We are delighted that the FDA granted Fast Track designation to RM-1929 for the treatment of patients with recurrent Head and Neck cancer, illustrating their recognition of the large unmet medical need for this severe disease. Based on the interim Phase 2 data, we believe that RM-1929 as a single agent has the potential to offer effective treatment options for patients that have failed all existing therapies, providing the opportunity to treat with curative intent" said Miguel Garcia-Guzman, President and CEO of Aspyrian. "In addition, based on our preclinical and clinical data, we expect that RM-1929-mediated tumor destruction may serve to trigger innate and adaptive anti-cancer immune responses that have the potential to enhance the destruction of the patient’s cancer. Aligned with the visionary leadership of our Chairman Hiroshi Mikitani and our commitment to develop the best possible treatment options for patients, we plan to initiate additional trials evaluating combination treatments of RM-1929 with immunomodulators in early 2018. The combination trials are designed to explore synergistic effects of RM-1929 together with activation of T-cell mediated anti-cancer responses."

In order to advance RM-1929 into clinical studies in Japan, Aspyrian successfully submitted a Clinical Trial Notification (CTN) application for RM-1929 to the PMDA and has initiated a Phase 1, single center, open label clinical study in Japanese patients with recurrent Squamous Cell Head and Neck Cancer.

In addition to RM-1929, Aspyrian is progressing preclinical development of other new proprietary immune oncology approaches that have the potential to eliminate the immunosuppressive behavior associated with tumor microenvironments, and to elicit adaptive systemic immune responses. This approach is anticipated to destroy tumors that are resistant to other classes of immune modulators, such as anti-PD1 antibodies. Preclinical data have shown that Aspyrian’s immune oncology treatment modality has the potential to achieve robust tumor destruction mediated by tumor specific CD8+ T-cells and to elicit long-term cancer‑specific immune memory resulting in robust cancer vaccination. Aspyrian intends to expedite the development of these new immune oncology approaches into clinical studies.

First Patient Dosed in a Phase 2 Trial with Transgene’s TG4010 + Nivolumab + Chemotherapy for the First-Line Treatment of Lung Cancer (NSCLC)

On January 16, 2018 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotechnology company that designs and develops virus-based immunotherapies, reported the dosing of the first patient in the Phase 2 trial evaluating TG4010 in combination with Opdivo (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with low or no expression of PD-L1 by the tumor cells (Press release, Transgene, JAN 16, 2018, View Source [SID1234523195]).

The Phase 2 clinical trial is exploring the tolerability and efficacy of the combination regimen of Transgene’s TG4010, an investigational active immunotherapy against MUC1 tumor-associated antigen, with Bristol-Myers Squibb’s immune checkpoint inhibitor, Opdivo (nivolumab), which acts by overcoming immune suppression, and standard platinum doublet chemotherapy.
This multi-center single-arm trial will enroll up to 39 patients (without EGFR activating mutations or ALK-rearrangements), both in the USA and Europe. The trial has objective tumor responses rate (ORR) as primary endpoint. The study will also assess the safety and tolerability of the regimen together with other efficacy and immunological parameters. The first results are expected in H2 2018.
More information on the trial can be found on clinicaltrial.gov (NCT03353675).
This trial is conducted by Transgene under a clinical collaboration agreement with Bristol-Myers Squibb, which is supplying nivolumab (see press release dated April 25, 2017).

"Advanced lung cancer remains a devastating disease, in particular for patients whose tumors express low or undetectable levels of PD-L1. We are excited to start a trial that combines our active immunotherapy TG4010, with nivolumab and chemotherapy as a first-line treatment" said Maud Brandely, Chief Medical Officer of Transgene. "We believe that this trial could confirm the promising efficacy data that we previously obtained with TG4010 in combination with chemotherapy, and show that the triple regimen could be an attractive treatment option in this patient population."

Elisabeth Quoix, M.D., Head of the Department of Pulmonology at the University Hospital of Strasbourg, and coordinating investigator of the trial, added: "The three complementary mechanisms of action of TG4010, nivolumab and chemotherapy are believed to enhance the immune cellular response and lead to an increase in antitumor activity. This combination regimen aims at achieving a higher response rate, and ultimately an improvement in the survival rate in advanced-stage NSCLC patients."

The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of increased response rate, progression-free survival and overall survival in a randomized, double-blind, placebo-controlled Phase 2b trial in first-line treatment of patients with advanced non-squamous NSCLC (Quoix et al. Lancet Oncol. 2015).

About TG4010
TG4010 is an active immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is based on a modified Vaccinia virus (MVA), and has been shown to induce an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC). Its mechanism of action and excellent safety profile make TG4010 a very suitable candidate for combinations with other therapies, including immune checkpoint inhibitors and chemotherapy. The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC (Quoix et al. Lancet Oncol. 2015).
TG4010 is being investigated in combination with nivolumab (ICI) for the 2nd-line treatment of advanced NSCLC (NCT02823990) and for 1st-line treatment of NSCLC in combination with nivolumab and chemotherapy in patients whose tumors express low or undetectable levels of PD-L1 (NCT03353675).

About Non-Small Cell Lung Cancer
Lung cancer is one of the most common malignancies worldwide with an estimated 1.8 million new cases annually. It is also a leading cause of cancer-related deaths, accounting for an estimated 1.6 million deaths in 2012 (Source: GLOBOCAN 2012). Advanced lung cancer remains one of the cancer types with the worst prognosis (five-year survival rate for advanced NSCLC of less than 5%), underlining the still unmet need in this disease despite recent progress.

Ipsen and Exelixis announce phase 3 trial results of cabozantinib demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma

On January 16, 2018 Ipsen (Euronext:IPN; ADR:IPSEY) and Exelixis, Inc. (NASDAQ:EXEL) reported detailed results of the pivotal phase 3 CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC), which will be presented in a late-breaking oral session at the 2018 ASCO (Free ASCO Whitepaper)-GI Symposium being held in San Francisco, January 18-20, 2018 (Press release, Ipsen, JAN 16, 2018, View Source [SID1234523152]). In CELESTIAL, cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival (OS), the trial’s primary endpoint, at the planned second interim analysis (prespecified critical p value £ 0.021) for the population of second- and third-line patients enrolled in this study. Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). Median progression-free survival (PFS) was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95 percent CI 0.36-0.52; p<0.0001). Objective response rates per RECIST 1.1 were 4 percent with cabozantinib and 0.4 percent with placebo (p=0.0086). Disease control (partial response or stable disease) was achieved by 64 percent of the cabozantinib group compared with 33 percent of the placebo group.

In a subgroup analysis of patients whose only prior therapy for advanced HCC was sorafenib (70 percent of patients in the study), median OS was 11.3 months with cabozantinib versus 7.2 months with placebo (HR 0.70, 95 percent CI 0.55-0.88). Median PFS in the subgroup was 5.5 months with cabozantinib versus 1.9 months with placebo (HR 0.40, 95 percent CI 0.32-0.50). Adverse events were consistent with the known safety profile of cabozantinib.

Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center, New York and lead investigator on CELESTIAL, will present detailed findings, including analyses of OS and PFS in various patient subgroups, during Oral Abstract Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract, which begins at 2:15 p.m. PT on Friday, January 19, 2018.

"Patients with advanced hepatocellular carcinoma often have a poor prognosis and limited treatment options following prior systemic therapy," said Dr. Abou-Alfa. "The clinically significant benefits in both overall survival and progression-free survival shown in the CELESTIAL trial suggest that, if approved, cabozantinib could become an important addition to the treatment landscape for these patients."

"We are excited by the potential benefit cabozantinib may offer to patients with previously treated advanced hepatocellular carcinoma," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Given the worldwide prevalence of advanced hepatocellular carcinoma, there is a continued urgency to bring new treatment options to this patient population. We look forward to submitting our supplemental New Drug Application to the FDA for cabozantinib in the first quarter of 2018, and to further advancing our mission to help cancer patients recover stronger and live longer."

Alexandre Lebeaut, M.D., Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: " Patients diagnosed with advanced hepatocellular carcinoma urgently need new treatment options. The positive results of the pivotal phase 3 CELESTIAL trial are encouraging for both physicians and patients, and we have committed to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies. "

The most common (≥10 percent) grade 3 or 4 adverse events in the cabozantinib group compared to the placebo group were palmar-plantar erythrodysesthesia (17 percent vs. 0 percent), hypertension (16 percent vs. 2 percent), increased aspartate aminotransferase (12 percent vs. 7 percent), fatigue (10 percent vs. 4 percent), and diarrhea (10 percent vs. 2 percent). Treatment-related grade 5 adverse events occurred in six patients in the cabozantinib group (hepatic failure, esophagobronchial fistula, portal vein thrombosis, upper gastrointestinal hemorrhage, pulmonary embolism and hepatorenal syndrome) and in one patient in the placebo group (hepatic failure). Sixteen percent of patients in the cabozantinib arm and three percent of patients in the placebo arm discontinued treatment due to treatment-related adverse events.

Webcast for the Financial Community

Ipsen and its partner Exelixis will host a live briefing event for the financial community to discuss data presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI). The webcast event will be held following the closing of the ASCO (Free ASCO Whitepaper)-GI day’s sessions on Friday, January 19, 2018, beginning at 9:30 p.m. EST / 6:30 p.m. PST (local San Francisco time). During the briefing, Exelixis and Ipsen management, along with an invited guest, will discuss and provide context for the cabozantinib clinical data presented earlier that day at the Symposium. Ipsen previously announced that detailed results from the CELESTIAL trial will be the subject of a late-breaking oral presentation at ASCO (Free ASCO Whitepaper)-GI. CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma who have received prior treatment with sorafenib.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 2478857 to join by phone. A webcast replay will be archived on www.exelixis.com for one year. A telephone replay will also be available until 11:59 p.m. EST on January 26, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 2478857.

About the CELESTIAL Study

CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms during the blinded treatment phase of the study.

The primary endpoint for the trial is OS, and secondary endpoints include objective response rate and PFS. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.

Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial design assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90 percent power to detect a 32 percent increase in median OS (HR = 0.76) at the final analysis. Two interim analyses were planned and conducted at approximately 50 percent and 75 percent of the planned 621 events. At the first interim analysis conducted by the independent data monitoring committee the observed hazard ratio was 0.71 and the p-value was 0.0041, which did not cross the stopping boundary for the first interim analysis (p ≤ 0.0037).

On October 16, 2017, Ipsen announced that the independent data monitoring committee recommended that the trial be stopped for efficacy following review of the second planned interim analysis, as the trial had met its primary endpoint of OS (prespecified critical p value £ 0.021).

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Category: Uncategorized

10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]

MediciNova to Present at the 98th Annual Meeting of the Chemical Society of Japan

First Patient Dosed in a Phase 2 Trial with Transgene’s TG4010 + Nivolumab + Chemotherapy for the First-Line Treatment of Lung Cancer (NSCLC)

Ipsen and Exelixis announce phase 3 trial results of cabozantinib demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma