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Clovis Oncology’s Rucaparib ARIEL3 Study Data Published in The Lancet

On September 13, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that comprehensive data from the Phase 3 ARIEL3 study of rucaparib for maintenance treatment of advanced ovarian cancer were published online today in The Lancet (Press release, Clovis Oncology, SEP 13, 2017, View Source [SID1234520503]). The ARIEL3 study successfully achieved its primary and key secondary endpoints – improved progression-free survival (PFS) by both investigator review and blinded independent central review (BICR), respectively – in each of the three populations studied, as well as its exploratory endpoints.

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ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic mutations of BRCA (n=196); 2) HRD patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients (n=354), and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3 (n=564). The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. PFS was also improved in the rucaparib group compared with placebo by BICR, a key secondary endpoint, in all three populations. In addition, rucaparib improved objective response rate vs placebo among evaluable trial participants in all three study populations.

"The publication of the ARIEL3 data in this prestigious, peer-review journal reinforces the importance of identifying new therapies that provide meaningful clinical benefit to women with advanced ovarian cancer, and speaks to the high quality of the study design and the data we were able to deliver," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We extend our sincere thanks to the study investigators and authors, as well as the many patients, who supported and participated in ARIEL3."

"The extension in PFS in the ARIEL3 intent-to-treat population demonstrates that patients with platinum-sensitive ovarian carcinoma can derive robust clinical benefit from rucaparib maintenance treatment, regardless of their mutational status," said Robert L. Coleman, M.D., professor and vice chair, clinical research, in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center and the U.S. principal investigator for the ARIEL3 study. "Additionally, the ARIEL3 study was intentionally designed to deliver multiple, key insights that will help inform treatment decisions and management of advanced ovarian cancer patients going forward."

According to the paper published today, treatment emergent adverse events (TEAEs) in the ARIEL3 rucaparib group were generally managed with dose modifications and not associated with increased mortality or morbidity compared with the placebo group. Safety data from ARIEL3 demonstrate consistency with prior rucaparib studies.

In December 2016, Rubraca became the first PARP inhibitor approved by the U.S. Food and Drug Administration (FDA) as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. During the fourth quarter of 2016, a Marketing Authorization Application (MAA) was submitted and accepted in Europe for Rubraca in the same ovarian cancer-treatment indication.

Based on the ARIEL3 findings, Clovis Oncology plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA for a second line or later maintenance treatment indication in ovarian cancer by the end of October 2017. In early 2018, the Company plans to file an MAA in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.

About the ARIEL3 Clinical Trial

The ARIEL3 pivotal study of rucaparib is a confirmatory randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a complete or partial response to platinum-based chemotherapy. The study enrolled 564 patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. To be eligible for the study, participants had to have received at least two prior platinum-based treatment regimens, been sensitive to the penultimate platinum regimen, and achieved a complete or partial response to their most recent platinum-based regimen. There were no genomic selection criteria for this study. Trial participants were randomized 2:1 to receive 600 milligrams of rucaparib twice daily (BID) or placebo.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2016, rucaparib became the first PARP inhibitor approved by the U.S. Food and Drug Administration (FDA) as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. Studies open for enrollment or under consideration include ovarian, prostate, breast, pancreatic, gastroesophageal, bladder, lung and urothelial cancers. Clovis is also developing rucaparib in patients with mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD. Clovis holds worldwide rights for rucaparib.

About Ovarian Cancer

Ovarian cancer is the sixth deadliest cancer amongst women in Europe,i where more than 65,000 women are diagnosed annually.ii Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. The 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.iii Approximately one in four women with ovarian cancer have a germline or somatic BRCA mutation,iv and new treatment options are needed to treat unique patient populations.

bluebird bio Announces First Patient Treated in Expansion Cohort of CRB-401, Phase 1 Study of Anti-BCMA CAR T Therapy bb2121

On September 13, 2017 bluebird bio, Inc. (NASDAQ: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for serious genetic diseases and T cell-based immunotherapies for cancer, reported that the expansion cohort of the CRB-401 Phase 1 study of bb2121, an anti-BCMA CAR T therapy, has been initiated (Press release, bluebird bio, SEP 13, 2017, View Source [SID1234520502]). The objective of the CRB-401 study is to evaluate the safety and efficacy of bb2121 in patients with relapsed/refractory multiple myeloma and determine a recommended Phase 2 dose. bluebird bio and Celgene Corp. are jointly developing bb2121.

"The high response rate and sustained benefit seen with bb2121 in the recent data presented at the ASCO (Free ASCO Whitepaper) annual meeting in June are particularly gratifying given the limited therapeutic options available for the heavily pretreated patients with relapsed/refractory multiple myeloma participating in our study," said David Davidson, MD, chief medical officer, bluebird bio. "In the expansion stage of the CRB-401 study, we will be treating an additional cohort of patients with a dose range shown to be active in the prior dose escalation stage of the study to gain more experience with the safety, efficacy and durability of response of bb2121."

Patients in the expansion cohort will be treated at a dose range of 150 to 450 x 106 CAR+ T cells and will be required to have prior exposure to a proteasome inhibitor, an immunomodulatory agent and daratumumab.
About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D product candidate, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its LentiGlobin product candidate, currently in four clinical studies for the treatment of transfusion-dependent β-thalassemia, and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program partnered with Celgene. bb2121 is currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma.

bluebird bio also has discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.

bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington and Europe.

AVEO Oncology Announces Receipt of Payments from EUSA Pharma and CANbridge

On September 13, 2017 AVEO Oncology (NASDAQ:AVEO) reported the receipt of a $4 million research and development payment from EUSA Pharma related to the approval of FOTIVDA (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma in Europe, and a $0.5 million milestone payment from CANbridge related to manufacturing development activities for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate (Press release, AVEO, SEP 13, 2017, View Source;p=RssLanding&cat=news&id=2300267 [SID1234520501]).

"These payments further strengthen our balance sheet while demonstrating the value of our partnerships in advancing AVEO’s pipeline," said Michael Bailey, president and chief executive officer of AVEO. "Additionally, these payments add to our current cash on hand, which was expected to fund operations into the fourth quarter of 2018. We look forward to several additional key milestones in the coming quarters, including the expected presentation of tivozanib-nivolumab combination Phase 1 TiNivo study results this fall, and the anticipated readout of our pivotal Phase 3 TIVO-3 trial in the first quarter of 2018."

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $390 million in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives. In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. With European approval, AVEO will be eligible for up to $12 million in milestones from EUSA based on reimbursement and regulatory approvals. In the territories licensed to EUSA, thirty percent of milestone and royalty payments received by AVEO, excluding research and development payments such as the one announced today, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee. In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

In March 2016, AVEO announced an exclusive collaboration and license agreement, granting CANbridge worldwide rights to AV-203, excluding the United States, Canada, and Mexico. Under the terms of the collaboration and license agreement, AVEO is eligible to receive up to $132 million in future reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in the partnered territories.

AVEO has retained North American rights to tivozanib and AV-203.

Transgene: First Half-Year 2017 in Line with Our Objectives: All Clinical Programs Progressing and New Collaboration Agreements Signed

On September 13, 2017 Transgene (Paris:TNG), a biotechnology company focused on designing and developing viral-based immune-targeted therapies, reported its financial results for the six-month period ended June 30, 2017, and reviews the progress of it products portfolio since the beginning of the year (Press release, Transgene, SEP 13, 2017, View Source [SID1234520500]).

Philippe Archinard, Chairman and Chief Executive Officer of Transgene said: "Transgene is continuing to successfully execute its strategy. We are making progress with our clinical development plans with seven active trials as of today, and in parallel we are continuing to advance our cutting edge research program.

Four of the clinical trials are aiming to confirm the potential of TG4010 or Pexa-Vec in combination with immune checkpoint inhibitors (ICIs), including in two high unmet need indications, lung and liver cancer.

We have signed two collaborations, one with Bristol-Myers Squibb (BMS) covering a combination study with TG4010 in the first-line treatment of lung cancer, and one with Servier for the design of an optimized production process of allogenic CAR-T cells using our viral vectorization technology. These new deals build on our existing collaborations with BMS for TG4010 in the 2nd-line treatment of lung cancer and with Merck KGaA/Pfizer for TG4001 in head and neck cancers. We believe these agreements provide strong validation of the potential of our immunotherapy approach.

With our current funding, Transgene is well placed to progress its programs through to the end of 2018. We will continue to focus all of our energy to advance our multiple clinical trials and to seize the development opportunities that they could create for Transgene."

Product pipeline review

1. Therapeutic Vaccines

TG4010: combination trial with nivolumab (ICI); collaborations with Bristol-Myers Squibb

TG4010 is a therapeutic vaccine being developed in advanced-stage non-squamous non-small cell lung cancer (NSCLC). TG4010’s mechanism of action, excellent safety profile and existing clinical data make it a very suitable candidate for combinations with other therapies.

The clinical trials aim to confirm the synergies that are expected to result from the combination of a therapeutic vaccine and an ICI. The expected clinical benefits of the combination are an increase in the response rate, in the quality and in the duration of the response to current and future standards of care.

TG4010
+ Opdivo (ICI)
(nivolumab)
+ chemotherapy
Phase 2

Non-small cell lung cancer (NSCLC) – 1st-line

Collaboration deal signed in April 2017 with Bristol-Myers Squibb, that will supply nivolumab
Preparation of a Phase 2 clinical trial combining TG4010 with nivolumab and with chemotherapy in patients with tumor cells expressing low or undetectable levels of PD-L1
FDA IND approval granted to begin the clinical trial in the USA
First patient expected to be enrolled at the end of 2017
TG4010
+ Opdivo (ICI)
(nivolumab)
Phase 2
Non-small cell lung cancer (NSCLC) – 2nd-line

Trial of TG4010 in combination with nivolumab, that will be provided by Bristol-Myers Squibb, within a collaborative agreement with UC Davis Medical Center (USA) – Principal investigator: Dr. Karen Kelly
First patient treated in March 2017; the trial’s 4 sites are now open
First results expected beginning of 2018
TG4001: trial in combination with avelumab (ICI), based on a collaboration agreement with Merck KGaA and Pfizer

TG4001 is a therapeutic vaccine that has already been administered to more than 300 subjects in previous clinical trials. TG4001 has demonstrated good tolerability, a significant HPV clearance rate and promising efficacy results. Its mechanism of action and good safety profile make TG4001 an appropriate candidate for combinations with other therapies.

TG4001
+ Bavencio (ICI)
(avelumab)
Phase 1/2

HPV positive head and neck cancer – 2nd-line

Clinical collaboration agreement with Merck KGaA and Pfizer, for the supply of avelumab for the trial
Principal investigator: Prof. Christophe Le Tourneau (Institut Curie, Paris); multi-center trial
First patient expected to be treated shortly
TG1050: results expected in 2H 2017

TG1050 is a therapeutic vaccine for the treatment of chronic hepatitis B. At the end of 2015, Transgene started a study evaluating the safety and tolerability of TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy. The technology of TG1050 is also being developed in China, where Transgene operates a joint-venture with Tasly Biopharmaceutical Technology.

TG1050
+ Standard-of-
Care Antiviral
Phase 1/1b

Chronic hepatitis B

Results from the first part of the study to be presented at AASLD (October 2017)
Several patents granted, extending protection to 2032
2. Oncolytic viruses

Pexa-Vec: ongoing Phase 3 trial, initiation of the Phase 2 clinical combination trials

Pexa-Vec is an oncolytic virus designed to selectively target and destroy cancer cells through intracellular viral replication (oncolysis), and by stimulating the body’s immune response against cancer cells. Its mechanism of action and tolerability profile make it an appropriate candidate for use in combinations.

Pexa-Vec
+ sorafenib
(PHOCUS)
Phase 3

Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st-line

Clinical trial being conducted by SillaJen, Inc., Transgene’s partner
Ongoing recruitment. First patient treated in Europe in April 2017
Trial recruitment authorized in China (July 2017)
First data readout expected in 2019
Pexa-Vec
+ Opdivo (ICI)
(nivolumab)
Phase 2
Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st-line

Principal investigator: Prof. Olivier Rosmorduc (Pitié Salpêtrière, Paris)
First patient treated in July 2017; several active trial sites
First data readout expected in 2018
Pexa-Vec
+ metronomic
cyclophosphamide
Phase 1/2
HER2 negative breast cancer et soft tissue sarcoma (METROmaJX)

Principal investigator: Prof. Antoine Italiano (Institut Bergonié, Bordeaux); Sponsor : INCa
Positive results of the Phase 1 part presented at ESMO (Free ESMO Whitepaper) 2017 (Sept. 2017)
First patient of the Phase 2a part treated in April 2017
Pexa-Vec
+ Yervoy (ICI)
(ipilimumab)
Phase 1
Solid tumors (ISI-JX)

Principal investigator: Dr. Aurélien Marabelle, MD, PhD (Centre Léon Bérard, Lyon)
First patient treated in February 2017
First readout expected around the end of 2017
TG6002: preparation of first-in-human trial

TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and express the FCU1 gene in the cancer cells it has infected leading to the local production of 5-FU, a widely-used chemotherapy. TG6002 could potentially be used both in combination or as monotherapy in recurrent cancers.

TG6002
Phase 1

Glioblastoma

Principal investigator: Prof. J-Y Delattre (AP-HP, Paris), with the support of INCa (French national cancer institute)
First patient expected in the coming weeks
3. Research and preclinical portfolio

Research and preclinical highlights during the first half were:

The signing of a collaboration agreement with Servier in June 2017 aimed at designing an original process for the production of allogenenic CAR-T cells which would provide better yield and a reduced number of steps. This collaboration highlights Transgene’s expertise in viral vectorization;
A poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2017 and the publication of preclinical data supporting the clinical development of TG6002 in Cancer Research in July 2017;
The filing of several patent applications ensuring the protection of the innovative technologies developed by Transgene for new products (therapeutic vaccines and oncolytic viruses).
A R & D Day for investors on 22 June 2017 in Paris. At this meeting, Transgene presented its new generation of immunotherapies based on multifunctional (armed) oncolytic viruses aimed at improving the treatment of cancer.
Key financials

The Board of Directors of Transgene met on September 12, 2017, and reviewed the financial statements for the six-month period ended June 30, 2017. The Statutory Auditors have conducted a review of the interim consolidated financial statements. The half-year financial report is available on Transgene’s website, View Source

Key elements of the income statement

(in thousands of euros) June 30, 2017 June 30, 2016
Operating revenues 3,898 5,339
Research and development expenses (16,855) (12,504)
General and administrative expenses (3,066) (3,406)
Other revenue and (expenses), net (107) (128)
Operating expenses (20,028) (16,038)
Operating income / (loss) (16,130) (10,699)
Net income / (loss) (18,346) (11,639)
Net income / (loss) from discontinued operations - (514)
Comprehensive net income (18,346) (12,153)
Operating revenues amounted to €3.9 million for the first six months of 2017 compared to €5.3 million for the same period in 2016. Excluding the €1.3 million one-off revenue received from Sanofi Chimie in 2016, Transgene’s revenues remained stable compared to the first half of 2016.

Revenues from collaboration and licensing agreements amounted to €0.5 million for the first six months of 2017 versus €1.9 million in the same period in 2016, that included €1.3 million from Sanofi Chimie. Under the collaboration agreement with Servier signed in June 2017, Transgene invoiced an initial amount of €1.0 million. Revenue recognition of this amount will be spread over the initial term of the contract, i.e. 3 years.
Government financing of research expenditures amounted to €3.0 million for the first half of 2017, stable compared to the first half of 2016. These figures included a research tax credit of €3.0 million for the first six months of 2017 compared to €2.9 million for the same period in 2016.
Research and Development (R&D) expenses amounted to €16.9 million for the first half of 2017 compared to €12.5 million for the same period in 2016. This increase was mainly due to the milestone payment of €3.8 million ($4 million) to SillaJen, Inc. triggered by the first patient being recruited in Europe in the Phase 3 trial of Pexa-Vec (Phocus). External expenses for clinical projects also increased by €0.4 million with the development plan progressing notably with our products TG4010, Pexa-Vec and TG1050.

General and administrative expenses decreased to €3.1 million for the first half of 2017 compared to €3.4 million for the same period in 2016.

Net loss amounted to €18.4 million for the first half of 2017 compared to €12.2 million for the same period in 2016.

As of June 30, 2017, the Company’s cash, cash equivalents, available-for-sale financial assets and other financial assets amounted to €43.9 million versus €56.2 million as of December 31, 2016.
Cash burn was €12.3 million for the first half of 2017 compared to €8.2 million for the same period in 2016. This cash burn increase was mainly explained by the milestone payment to Sillajen in H1 2017.

Transgene confirms that it expects 2017 cash burn to be around €30 million, which includes an increase of expenses linked to clinical trials due to the acceleration of the clinical development plan and the milestone payment to SillaJen, Inc.

"Our results for the first six months of 2017 are in line with our expectations. We confirm our financial visibility through to the end of 2018", commented Jean-Philippe Del, Chief Financial Officer of Transgene.

As a reminder, the Company still benefits from access to further additional funding that can be activated in 2017: namely the second tranche of the European Investment Bank (EIB) loan (€10 million).

Actinium Pharmaceuticals Highlights Presence at the Society of Hematologic Oncology 2017 Annual Meeting

On September 13, 2017 Actinium Pharmaceuticals, Inc (NYSE American:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported that the Company will feature two posters highlighting its Actimab-A Phase 2 and Actimab-M Phase 1 clinical trials at the Society of Hematologic Oncology 2017 Annual Meeting (SOHO) (Press release, Actinium Pharmaceuticals, SEP 13, 2017, View Source [SID1234520499]). The posters will be presented as part of the Clinical Trials in Progress section.

"SOHO is an excellent opportunity to share the potential of our CD33 targeting alpha-particle therapy candidates with the greater hematology community," said Dr. Mark Berger, Actinium’s Chief Medical Officer. "We are excited to demonstrate the capacity of our Alpha Therapy platform to bring trials to the clinic addressing unmet clinical needs."

Actimab-A is enrolling patients in a multicenter Phase 2 trial for patients newly diagnosed with Acute Myeloid Leukemia who are age 60 and above and unfit for standard induction therapy. Actimab-M is a Phase 1 trial that is enrolling patients diagnosed with refractory Multiple Myeloma.

SOHO is expected to draw physicians, researchers, and industry leaders from across the nation and will be held at the Westin Galleria & Oaks in Houston, Texas from September 13th – 16th.

The details of the poster presentations are as follows:

Title: Trial in Progress: A Phase I/II Study of Lintuzumab-Ac225 in Older Patients with Untreated Acute Myeloid Leukemia
Abstract Number: AML-070

Title: Trial in Progress: Phase I Study of Actinium-225 (225Ac)-Lintuzumab in Patients with Refractory Multiple Myeloma
Abstract Number: MM-77

Date: Wednesday, September 13th, 2017
Time: 6:00 – 9:00 PM
Location: Westin Galleria

About Actimab-A

Actimab-A, Actinium’s most advanced alpha-particle candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer calls. Actinium-225 gives off high- energy alpha particles as it decays, which kill cancer cells and as actinium-225 decays it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML age 60 and above.

About Actimab-M

The Actimab-M trial uses a CD33 targeted therapy coupled to actinium 225 (the same agent used in the Actimab-A program), and is in a Phase 1 open label, dose escalation study for patients who have progressing disease after 3 prior multiple myeloma treatment regimens. The Phase 1 trial will estimate maximum tolerated dose (MTD), assess adverse events, measure response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate) as well as progression free survival (PFS) and overall survival (OS).