On February 13, 2019 Vaccibody AS, a clinical stage immuno-oncology company, reported that it has entered into a collaboration with Roche to explore a combination of Vaccibody’s VB10.16 and the PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced cervical cancer (Press release, Vaccibody, FEB 13, 2019, View Source [SID1234533281]). Vaccibody expects to start a phase II study with up to 50 patients in the second half of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Martin Bonde, CEO of Vaccibody, said: "We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with advanced cervical cancer." Agnete Fredriksen, President and CSO of Vaccibody added: "The combination of VB10.16 and atezolizumab is building on the positive data VB10.16 has generated as monotherapy in patients with precancerous cervical lesions. In this study, it was observed that VB10.16 creates a target for PD-1/PD-L1 checkpoint inhibitors, thereby providing a sound scientific rationale for combining VB10.16 with an immune-checkpoint inhibitor like atezolizumab in cervical cancer patients."

The planned study will assess the safety, tolerability, immunogenicity and efficacy of the VB10.16-atezolizumab combination in patients with advanced cervical cancer.

About VB10.16

VB10.16 is an investigational therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies. The drug candidate has demonstrated favorable 6M interim clinical data in a Phase I/IIa study in pre-cancerous HPV16 induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

About cervical cancer

Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide. An estimated 45,800 cases of cervical cancer will be diagnosed in the US and EU in 2019 and similarly an estimated 18,400 deaths from cervical cancer will occur in 2019. Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer. It has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It is detected in up to 60% of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers). Gardasil and Cervarix are preventive HPV vaccines which prevent infection of HPV, but these do not have an effect in already infected patients. A high percentage of the eligible population for the preventive vaccines does not get vaccinated, thus HPV infection and HPV+ cancer still requires effective therapeutic interventions. There is currently no available therapy treating HPV specifically.

On February 13, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), 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 company will hold a fourth quarter and full year 2018 financial results conference call and webcast on Wednesday, February 27, 2019, at 6:00 p.m. ET (Press release, BeiGene, FEB 13, 2019, View Sourcephoenix.zhtml?c=254246&" target="_blank" title="View Sourcephoenix.zhtml?c=254246&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2387405 [SID1234533301]). On the call, Company management will provide an overview of BeiGene’s financial results for the fourth quarter and full year 2018, and updates on recent business highlights and upcoming milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BeiGene will also host an in-person and webcast investor event in Hong Kong on Thursday, February 28, at 2:30 – 4:00 p.m. HKT (Thursday, February 28, at 1:30 – 3:00 a.m. ET) at the Island Shangri-La Hong Kong.

Financial Results Conference Call and Webcast Information
Investors and analysts are invited to join the conference call using the following dial-in information:
U.S. Toll-Free: (844) 461-9930
Hong Kong: 3011-4522
China: 400-682-8609
Conference ID: 8889396

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

Hong Kong Investor Event, Conference Call and Webcast Information
Hong Kong Investor Event
Date and Time: Thursday, February 28, at 2:30 p.m. HKT (Thursday, February 28, at 1:30 a.m. ET)
Location: Island Shangri-La, Hong Kong, Level 5, Ballroom A

A live webcast of the investor event can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

On February 13, 2019 Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, reported that it has signed an agreement with Novartis to acquire the US rights to Proleukin (aldesleukin, human recombinant interleukin-2) for up to $210m in cash, consisting of an upfront and deferred payments along with future sales related milestones (Press release, Clinigen Group, FEB 13, 2019, View Source [SID1234554017]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinigen already owns the rights to Proleukin outside the US, which it acquired in July 2018.

Highlights

Proleukin is indicated for metastatic melanoma and metastatic renal cell carcinoma in the US
Clinigen will be the exclusive global owner of the licensed version of this drug
Currently being used in around 80 active studies within the US across multiple disease areas
Has the potential to become an integral part of cancer combination therapies
Total consideration: up to $210m for US rights to Proleukin
Initial $120m payable
$60m deferred consideration over the 12 months following completion
A further $30m consideration based on sales milestones
In the year to 30 June 2018, in the US, Proleukin made revenue of $60.0m according to IQvia (IMS). Gross profit margin is expected to be similar to other specialty medicines within the Commercial Medicines division
The acquisition will be modestly EPS accretive in the current financial year as the product transitions to Clinigen, and at least 25% accretive in the first full financial year
Clinigen has increased its debt facility from £300m to £375m; terms of the extended debt remain unchanged with the facility in place until October 2023
Proleukin further diversifies the Commercial Medicines portfolio of niche hospital-only and critical care products. The Group currently owns three product assets within the US – Foscavir, Ethyol and Totect with commercial rights currently licensed to Pfizer (Foscavir) and Cumberland Pharmaceuticals (Ethyol and Totect)
Clinigen expects adjusted EBITDA* in the six months ended 31 December 2018 to be £41.8m (2017: £34.4m) representing 22% reported growth or 8% growth on an organic basis**, underlining how the Group continues to be highly cash generative.

On completion, the Group’s bank covenant leverage*** is expected to be around 2.4x net debt / EBITDA before reducing towards 2.0x by 31 December 2019.

The completion of the acquisition is subject to US anti-trust clearance and is expected to occur in April 2019.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"This highly earnings enhancing acquisition of US rights to Proleukin is significant to the whole Group not just the Commercial Medicines division.

"As part of Commercial Medicines, Proleukin is an excellent fit within our oncology and infectious disease medicines as well as diversifying our wider portfolio – it will be the largest product in the portfolio in terms of current sales. The product has significant potential for revitalisation, which will provide further breadth and diversity to the portfolio and material increases in revenues.

"For Clinigen as a whole, Proleukin creates an ideal platform to expand our existing footprint in the higher value US market and therefore enables us to exploit other opportunities across the business. This follows our acquisition last year of CSM and iQone which strengthened our Continental European footprint.

"At the financial level, the combination of this deal structure and the Group’s cash generative nature will ensure our debt profile reduces quickly over the next year."

On February 12, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that will report its fourth quarter and full year 2018 financial results on Tuesday, February 26, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 12, 2019, View Source [SID1234533267]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dynavax will host a conference call and live audio webcast on Tuesday, February 26, 2019, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events &Presentations" page in the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial (877) 423-9813 (domestic) or (201) 689-8573 (international) and refer to conference ID 13687416.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

On February 12, 2019 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in Italy occurred recently, with the first Italian patients being dosed (Press release, Blue Earth Diagnostics, FEB 12, 2019, View Source [SID1234533250]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth is committed to maximizing access to Axumin to clinicians and their patients across Europe. Today’s announcement is key milestone towards our goal."