Month: August 2016

Annual report and full year financial results

On August 2016 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its annual report and financial results for the year ended 30 June 2016 (Press release, Starpharma, AUG 30, 2016, View Source [SID:1234514814]).

Financial Results
Net cash burn (cash outflows before new capital) $17.5M[1]
Cash position at end of the year $46.0M
Net proceeds of $32.6M from equity placement and share purchase plan
Total revenue and other income $4.6M including the first US$2M DEP milestone from AstraZeneca
Reported loss $22.7M
Receipt of $3.4M R&D tax incentive

Operational Highlights
VivaGel
EU marketing approval for the VivaGel BV treatment and symptom relief product;
Licensing deal with Aspen for VivaGel BV treatment and symptom relief product in Australia and New Zealand with pre-launch activities well advanced;
Phase 3 clinical trials of VivaGel BV for the prevention of recurrent bacterial vaginosis (BV) more than 90% enrolled;
VivaGel active shows potent antiviral activity against Zika virus;
License for VivaGel condom in China for the Government market; and
Significant progression of commercial and regulatory activities for the VivaGel condom in important markets with approvals anticipated in coming months.
Drug Delivery
Signing of a multiproduct drug delivery license with AstraZeneca for DEP enhanced oncology molecule;
Second DEP candidate nominated by AstraZeneca under the license;
DEP docetaxel phase 1 clinical trial showing promising efficacy signals and advancing to the final expansion phase with no neutropenia or hair loss reported;
Extension of DEP programs with AstraZeneca adding a new DEP candidate from their portfolio;
Impressive preclinical results for both DEP cabazitaxel and Targeted DEP candidates in human cancer models; and
Two new Targeted DEP partnerships signed with world leading antibody-drug conjugate companies.
Agrochemicals
Adama licenses Priostar for the US market to create novel dendrimer-enhanced versions of 2,4-D, a major global agrochemical;
Signing of several new partnerships with leading agrochemical companies including major Japanese agrochemical business; and
Important progress and results for Priostar agrochemical internal programs.

Commenting on the 2016 financial year’s achievements and the outlook, Starpharma CEO, Dr Jackie Fairley, said:

"FY16 has been a significant year in Starpharma’s development as a company, with each of our business areas reaching important commercial milestones and a number of major development and regulatory accomplishments across our VivaGel, drug delivery and agrochemical portfolios".

"The year saw Starpharma sign the multiproduct DEP license with AstraZeneca, starting with a DEP enhanced oncology molecule, and rapidly expanding to a second candidate under that license. The relationship with AstraZeneca was recently further cemented when they added a completely new compound from their portfolio to the DEP collaborative programs. In the wider drug delivery portfolio, the phase 1 clinical trial of our internal candidate, DEP docetaxel, is showing promising efficacy signals and advancing into its final expansion phase with no neutropenia or hair loss reported. Also, we’ve seen impressive preclinical efficacy results for DEP cabazitaxel and our Targeted DEP candidates. The latter, generated a significant amount of industry interest and as a result we have very recently added two new partnerships with world leading antibody-drug conjugate (ADC) companies. It is great to have them working alongside Starpharma to exploit the unique benefits of the DEP technology for the development of the next generation of ADCs" she added.

"In the VivaGel portfolio we achieved a landmark for VivaGel BV this year – EU regulatory approval. This approval has been used to expedite regulatory processes in a number of markets as well as supporting a very active commercialisation and licensing program in preparation for product launch. The VivaGel BV phase 3 clinical trials for the prevention of recurrent BV are more than 90% enrolled. Thirdly, the deal with Sky and Land adds the large Chinese Government sector as a new market opportunity to the existing Ansell and Okamoto licenses for the VivaGel condom. We also anticipate FY17 will be another year of significant regulatory and commercial progress for the VivaGel condom product".

"Finally in our agrochemical portfolio, over the period we secured an important deal with the Adama license of Priostar to create new enhanced versions of a major global agrochemical 2,4-D, for the US market. We have also seen important progress with further promising field trial results for Priostar agrochemicals in our internal programs. In addition to Adama we signed a number of external partnerships including one with a major Japanese agrochemical company" Dr Fairley stated.

Net cash outflows from operating and investing activities for the year were $17.8 million (2015: $14.3 million), with cash reserves at 30 June 2016 of $46.0 million (2015: $30.8 million). The net loss after tax was $22.7 million (2015: $19.0 million), with the increase primarily a result of the VivaGel and DEPTM docetaxel clinical programs in progress, offset by an increase in revenue. Revenue increased for the year largely as a result of the first milestone (signature fee) from AstraZeneca under the multiproduct DEP license.

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Varian Expands Access to Advanced Cancer Care in Bolivia

On August 30, 2016 Varian Medical Systems (NYSE: VAR) reported the installation of a Clinac iX medical linear accelerator at Instituto Oncologico del Oriente Boliviano in Santa Cruz, Bolivia (Press release, Varian Medical Systems, AUG 30, 2016, View Source [SID:1234514797]). First patient treatments were started earlier in August.

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In addition to the installation of the Clinac iX, Varian in conjunction with its distributor in Bolivia, HP Medical, held a two day seminar in Santa Cruz, Bolivia for clinicians and radiation therapists. At the seminar, attendees were able to learn about the latest advances in cancer care treatment, including imaging, and treatment planning and delivery.

The seminar keynote speaker, Dr Beatriz Amendola, radiation oncologist, Innovative Cancer Institute stated, "By partnering with Varian on this successful first seminar in Bolivia, we were able to deliver important cancer care information to clinicians and therapists. I look forward to working with Varian and Dr. Oliver Pinto and Dr. Oscar Javier Urenda from the Oncology hospital and training more staff in in the future."

Designed to deliver a wide range of imaging and patient treatment options, the Clinac iX system offers features to facilitate advanced treatments including intensity- modulated radiation therapy (IMRT), image-guided radiation therapy (IGRT), and stereotactic radiosurgery. Instituto Oncologico del Oriente Boliviano will also be utilizing Varian Eclipse treatment planning software and ARIA information management system to manage, plan and deliver patient treatment.

"With the installation of the Clinac iX and the Varian software, we are now able to quickly deliver much needed cancer care treatment to a greater number of patients in Bolivia," said Dr. Oliver Pinto, head of Radiation Therapy, Instituto Oncologico del Oriente Boliviano.

"As was outlined in the Lancet Oncology Commission report in 2015, a lack of investment in radiotherapy services in the past has severely limited access to radiotherapy treatments worldwide," said Chris Toth, president, Oncology Systems Americas at Varian. "We are proud to be working with Instituto Oncologico del Oriente Boliviano, and making this advanced cancer fighting treatment available to a wider range of patients in Bolivia."

Radius Health Announces Three Presentations on RAD1901 at the San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2016

On August 30, 2016 Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported that it will present new data from multiple studies of RAD1901, an oral selective estrogen degrader, in ER-positive breast cancer at the San Antonio Breast Cancer Symposium Meeting December 6-10, 2016 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Radius, AUG 30, 2016, View Source [SID:1234514796]).

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Details for the abstracts related to RAD1901 are below:

Abstract Title: A Phase 1 Study of RAD1901, a Novel, Oral, Selective Estrogen Receptor Degrader (SERD), for the Treatment of ER-Positive Advanced Breast Cancer, Poster # 1454
Poster Session 4
Session Title: Treatment: Advanced Endocrine Therapy
Session Date: 12/8/2016
Session Time: 7:30 AM — 9:00 AM
Location: Hall 1

Abstract Title: A Phase 1 Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, to Determine Changes in the F-FES Uptake and Tumor Responses in ER-Positive, HER-2-Negative, Advanced Breast Cancer Patients, Poster # 1604
Poster Session 4
Session Title: Treatment, Advanced Endocrine Therapy
Session Date: 12/8/2016
Session Time: 7:30 AM — 9:00 AM
Location: Hall1

Abstract Title: RAD1901 Demonstrates Anti-Tumor Activity in Multiple Models of ER+ Breast Cancer Treatment Resistance, Poster # 1378
Poster Session 4
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2016
Session Time: 5:00 PM — 7:00 PM
Location: Hall 1

OncoMed Pharmaceuticals Completes Enrollment of Phase 2 PINNACLE Clinical Trial of Tarextumab in Small Cell Lung Cancer

On August 30, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical development-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported the completion of patient enrollment in the Phase 2 "PINNACLE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of small cell lung cancer (SCLC) (Press release, OncoMed, AUG 30, 2016, View Source [SID:1234514798]). The PINNACLE study enrolled 145 patients with extensive-stage SCLC who had not received prior treatment. Topline data from the Phase 2 trial are expected to be reported at the end of 2016 or in early 2017.

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"Our PINNACLE Phase 2 trial accrued patients more quickly than anticipated and we would like to thank the patients, their families, caregivers and the participating investigators and study site personnel for their participation. Small cell lung cancer is a difficult to treat cancer and unfortunately most patients survive a year or less. New and improved treatment options are needed for these patients," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "In a Phase 1b dose-escalating trial of tarextumab in small cell lung cancer we observed that patients who received standard-of-care chemotherapy in combination with tarextumab near or at the selected Phase 2 dose appeared to have deeper anti-tumor responses and improved survival outcomes, particularly in tumors that were high in certain Notch pathway genes. We look forward to seeing if these observations are maintained in our Phase 2 trial and anticipate reporting data from PINNACLE at the end of 2016 or in early 2017."

Patients enrolled in the PINNACLE trial were randomized into two study arms and received either 15mg/kg of tarextumab every three weeks in combination with six cycles of etoposide and platinum therapy followed by tarextumab maintenance to progression or six cycles of standard chemotherapy and a placebo. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival and overall response rate, pharmacokinetics, safety and biomarker analyses. Overall survival, progression-free survival and overall response rates will be assessed against elevated tumor expression of certain Notch pathway genes. The protocol for the Phase 2 trial was amended in May 2016 to enable the assessment of efficacy outcomes using Notch pathway genes Hes1, Hes6, Hey1 and Hey2 as a secondary endpoint.

The PINNACLE trial was conducted at 36 sites in the United States. Enrollment in the randomized, double-blinded, multi-center clinical study began in December 2014 and was completed three months ahead of schedule.

In the Phase 1b trial, all 26 patients evaluable for tumor response saw a reduction in target lesion size as measured by RECIST criteria, with an overall response rate of 77% and a 100% clinical benefit rate. Subjects receiving doses of tarextumab at or above 12 mg/kg plus chemotherapy achieved a median progression-free survival of 5.2 months and a median overall survival of 16 months. Results from OncoMed’s Phase 1b trial of tarextumab were most recently presented at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting.

About Small Cell Lung Cancer
According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in men and women and is by far the leading cause of cancer death. Small cell lung cancer is expected to make up about 10%-15% of the 224,390 newly diagnosed lung cancer cases and the 158,080 deaths estimated to occur in the U.S. in 20161. SCLC tends to grow and spread quickly, and is typically not discovered until it has metastasized to other parts of the body (extensive stage). The current standard of care in treating small cell lung cancer is the chemotherapeutic etoposide in combination with either cisplatin or caboplatin. In spite of a high sensitivity to chemotherapy and remission rates of up to 80% following initial treatment, the median overall survival is less than one year for patients with extensive stage disease2.

About Tarextumab (anti-Notch2/3, OMP-59R5)
Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is being studied in the "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer). Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

Oragenics Receives Supportive FDA Feedback for Initiating a Phase 2 Study Protocol for Oral Mucositis Treatment

On August 30, 2016 Oragenics (NYSE MKT: OGEN.BC), a leader in the development of novel antibiotics against infectious disease and developing effective treatments for oral mucositis (OM) reported that it has received feedback from the U.S. Food and Drug Administration (FDA) in response to the Company’s request for a Type C meeting, concerning Phase 2 study protocols for the Company’s OM therapeutic candidate, AG013. As part of the clinical protocol for the study, Oragenics expects to file the Investigational New Drug (IND) update in late 2016 and initiate the study with AG013 in the United States and Europe during early 2017.

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"We are pleased to have the FDA’s thorough feedback on protocol design for our Phase 2 trial and drug product manufacturing requirements for evaluating AG013 for the treatment of oral mucositis," said Alan Joslyn, Oragenics’ Chief Executive Officer and President. "This is an important milestone in our effort to potentially provide cancer patients with a new therapy for treatment of oral mucositis."

OM results in a painful inflammation and mucosal ulceration in the lining of the oral cavity, throat and esophagus and is one of the most commonly reported adverse events associated with cancer chemotherapy affecting up to 500,000 patients annually. OM has a negative effect on patient well-being and if severe, negatively affects a patient’s cancer treatment regimen. At present, no drug is approved to prevent the condition broadly and current therapies are primarily palliative in nature, only addressing symptom relief but not treating the underlying causes of the condition.

"Oral mucositis remains a major unmet need for cancer patients receiving cytotoxic radiation and chemotherapy," said Stephen T. Sonis, DMD, DMSc, Senior Surgeon, Divisions of Oral Medicine, Brigham and Women’s Hospital and the Dana-Farber Cancer Institute. Dr. Sonis continued, "As suggested by the results of pre-clinical and clinical studies, AG013 may provide a unique delivery platform for an effective intervention. I’m excited that its development program has completed this important first step in moving forward."

Through the genetic engineering of a food grade microbe, Lactococcus lactis (L. lactis), by the Actobiotics Division of Intrexon Corporation (NYSE: XON), in situ production and secretion of peptide therapeutics has been developed, including AG013, an oral rinsing solution designed to deliver human Trefoil Factor 1 (hTFF1) to protect and regenerate damaged mucosal lining of the oral cavity. Under an Exclusive Channel Collaboration Agreement with Intrexon, Oragenics has an exclusive worldwide license to develop and commercialize AG013 to treat oral mucositis in cancer patients.

A Phase 1B clinical trial with AG013 in 25 head and neck cancer patients at high risk for OM demonstrated that AG013 was safe and well tolerated. Data published in the journal Cancer showed a 35% reduction in the duration of ulcerative OM in AG013-treated patients vs placebo treated patients. Additionally over 30% of patients treated with AG013 were complete responders, defined as patients who did not develop OM, while all patients receiving placebo developed OM. A Phase 1 pharmacokinetic study in 10 healthy volunteers showed that live AG013 L. lactis adhered to the entire oral mucosal surface up to 24 hours after administration of the rinse.

AG013 has already been granted Orphan Drug status in the European Union and applications for Biologic License Application exclusivity and Fast Track designation with the FDA will be filed in the coming months.

About the Study Design

The Phase 2 double blind placebo controlled trial has been designed to evaluate the efficacy, safety, and tolerability of AG013 in patients being treated with standard regimens of concomitant chemoradiation therapy for common cancers of the head and neck. Not only is severe mucositis among the most common complications of treatment in this population, but its impact on patients’ ability to tolerate cancer therapy and risk of adverse health and resource use outcomes are frequent and devastating. Oragenics expects to announce additional information about the study design and timelines for the study once they are finalized.