On August 10, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it received scientific advice from the European Medicines Agency’s ("EMA") Committee for Medicinal Products for Human Use ("CHMP") for surufatinib for the treatment of patients with advanced neuroendocrine tumors ("NET") (Press release, Hutchison China MediTech, AUG 10, 2020, https://www.chi-med.com/chi-med-plans-to-submit-maa-for-surufatinib/ [SID1234563258]). Based on the CHMP advice, we have concluded that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a marketing authorization application ("MAA"). Given that no filing issues were identified, the MAA submission is planned for 2021, following submission for the U.S. Food and Drug Administration ("FDA") new drug application ("NDA").

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!

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Chi-Med currently retains all rights to surufatinib worldwide.

About Surufatinib Development
NET in the U.S., Europe and Japan: In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019. A U.S. FDA NDA submission is being prepared, to be followed by a MAA submission to the EMA in Europe. All such interactions are based on the robust data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. that began in November 2015 (clinicaltrials.gov identifier: NCT02549937).

Non-pancreatic NET in China: In November 2019, a NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration ("NMPA") and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in patients with advanced non-pancreatic NET in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the Independent Data Monitoring Committee ("IDMC") to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress ("ESMO") (clinicaltrials.gov identifier: NCT02588170).

Pancreatic NET in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. Following an interim analysis review conducted in January 2020 by the IDMC that recommended the registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821), we submitted our second NDA to the China NMPA and are now waiting for formal acceptance. The results of this study will be presented at ESMO (Free ESMO Whitepaper) 2020.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.), Tuoyi (toripalimab, developed by Shanghai Junshi Biosciences Co. Ltd.) and Tyvyt (sintilimab, developed by Innovent Biologics, Inc.), which are approved in China.

On August 10, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that a study published by the NCI-sponsored cancer intervention and surveillance modeling network (CISNET) in the Journal of the National Cancer Institute reported that by comparing the incremental cost-effectiveness of CTC, PillCam, mtSDNA (Cologuard) and mSEPT9 (Epi proColon), the study revealed that of these CRC screening alternatives annual screening with Epi proColon is cost-effective (Press release, Epigenomics, AUG 10, 2020, View Source [SID1234563257]). Annual screening with Epi proColon had an incremental cost-effectiveness ratio (ICER) of $63,253 per QALYG. Other efficient strategies were CTC screening every 5 years (ICER: $1,092 per QALYG) and annual (but not every three years) mtSDNA screening (ICER: $214,974 per QALYG), which were not optimal given the willingness-to-pay threshold ($100,000 per QALYG).

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!

Jorge Garces, President and CSO of Epigenomics AG: "CISNET microsimulation models are the gold-standard by which the American Cancer Society (ACS), United States Preventative Services Task Force (USPSTF), and other clinical societies base their guideline recommendations for CRC screening. This study supports the findings from another recent study published in Cancer Medicine and adds to the mounting evidence indicating that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer as effectively or better than other approved methods and most importantly highlights the opportunity for the Epi proColon blood test to serve as the test of choice for those currently resistant to colonoscopy and stool-based screening methods."

The JNCI publication analyzed the clinical effectiveness and performance of various screening strategies under five different scenarios:

1. Screening from age 50 through 75 years in an-average risk population, with perfect adherence to screening, diagnostic follow-up and surveillance recommendations.

2. Assuming screening from age 45 to age 75 with outcomes presented per 1,000 45-year olds at 100% adherence.

3. Using the model version that was used to inform the 2016 USPSTF screening guidelines, in which screening starts at 50 years of age and does not account for the increasing incidence. 100% adherence assumed.

4. Assuming that 90% of the people that participated in a previous round would participate in a subsequent round, and 15% of the people that did not participate in the previous round would participate in the subsequent round. An 80% adherence to diagnostic follow-up and surveillance was assumed.

5. Assuming 12% of advanced adenomas and 18% of colorectal cancers are systematically missed by the mSEPT9.

Under all scenarios examined, annual Epi proColon was more cost-effective than Cologuard. The authors also conclude that ultimately, the best test is the "one that gets done".

Greg Hamilton, CEO of Epigenomics AG: "This is an important publication as it further validates the clinical and cost-effectiveness of Epi proColon. It is also timely as we await the preliminary National Coverage Determination (NCD) from CMS later this month".

As the JNCI authors clearly state: "A well-established microsimulation model demonstrates that for people who are unwilling to be screened with FIT or colonoscopy, annual screening with the mSEPT9 is the test of choice given its cost-effectiveness profile compared to CTC, PillCam and mtSDNA."

Epigenomics will hold a conference call on Tuesday August 11, 2020 at 9:30am ET (3:30pm CET) to discuss the publication in more detail and answer questions. Please use the link in the Financial Calendar on the Epigenomics.com website to join the conference call.

On August 10, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Dr Christine Wilkinson Blanc has been appointed Chief Medical Officer with immediate effect (Press release, Nordic Nanovector, AUG 10, 2020, View Source [SID1234563254]). Dr Wilkinson Blanc is a seasoned pharmaceutical physician with broad experience in oncology and haematology with both large pharmaceutical and emerging biotechnology companies. She has over 25 years of experience in the pharmaceutical industry and has led multiple clinical studies across all phases for a wide range of indications.

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!

Dr Wilkinson Blanc joins us through her relationship with Weatherden, a specialist clinical development consulting and execution company. She has been Medical Director of Phi-Medics for 10 years, during which time she has provided clinical development consultancy services across oncology and haematology to pharma and biotech companies. The clients she has supported include Roche, Pierre Fabre, Innate Pharma, IPSEN and Antisoma. She was also the Chief Medical Officer of Psioxus Therapeutics between 2013 and 2016.

Prior to this, Dr Wilkinson Blanc was Medical Director in Oncology for a number of companies including Ariad Pharma, Roche, GE Healthcare and Aventis.
Dr Wilkinson Blanc gained her medical qualification, as well as a specialisation in Medical Biology, at the Universities of medicine of Lille and Lyon, France.

Dr Wilkinson Blanc will work with Dr Dominic Smethurst, Nordic Nanovector’s current Interim CMO for a short period to ensure a smooth handover of activities.

Lars Nieba, Interim Chief Executive Officer, commented: "I would like to thank Dominic his dedication and valuable contributions to the advancement of the Company. I am very pleased that Christine has joined Nordic Nanovector as CMO. Her vast experience in clinical development, particularly in oncology and haematology, will be invaluable as we focus our resources and energy on completing the PARADIGME study."

Dr Christine Wilkinson Blanc said: "I am excited to be joining Nordic Nanovector as it works to ensure the completion of PARADIGME in a timely fashion. Betalutin is an exciting one-time treatment which has shown very promising efficacy data in advanced follicular lymphoma. With a clear development path following the recent successful Interim Analysis, I am looking forward to making an important contribution to bring this novel drug candidate to this fragile patient population, which is clearly in need of much improved treatment options."

On August 10, 2020 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for unmet medical need, reported that it will be announcing its results for the second quarter 2020 on Tuesday 18 August 2020 (Press release, BerGenBio, AUG 10, 2020, View Source [SID1234563253]). A webcast presentation by BerGenBio’s senior management team will take place at 10:00 am CET.

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!

The live webcast link will be available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The second quarter report and presentation will be available on the Company’s website in the Investors/Financial Reports section from 7:00 am CET the same day.

On August 10, 2020 Saniona (OMX: SANION) ("Saniona" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported that its Board of Directors has resolved on a directed issue of 30,660,374 shares to a number of U.S. and international institutional investors and sector specialists based on the authorization granted by the Annual General Meeting held on 6 May 2020 (the "Directed Issue") (Press release, Saniona, AUG 10, 2020, View Source [SID1234563249]).

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!

The new shares were issued at a subscription price of USD 2.12 per share (SEK18.50), and represents a discount of approximately 45 per cent compared to the volume weighted average price (VWAP) on Nasdaq Stockholm for the period of the last 45 days up to and including 7 August 2020.
Through the Directed Issue, the Company will receive gross proceeds of USD 65 million (approximately SEK 567 million).
The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well as the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.
Comment from Rami Levin, President & CEO of Saniona

"The participation of multiple well-respected U.S. and International institutional healthcare investors in this financing led by RA Capital Management demonstrates the significant potential of Saniona’s rare disease pipeline. With this financing, we will be able to further increase shareholder value by advancing Tesomet to registration for approval, moving our early-stage pipeline into the clinic, and building our U.S. organization. We believe achieving these milestones will position us as potentially the first treatment for two rare diseases, hypothalamic obesity and Prader-Willi Syndrome" said Rami Levin, President and CEO of Saniona.

The Directed Issue

The Board of Directors of Saniona has, in accordance with the issue authorization granted by the Annual General Meeting on May 6, 2020, resolved on a directed issue of 30,660,374 shares at a subscription price of USD 2.12 per share (SEK 18.50), consequently raising gross proceeds of USD 65 million (approximately SEK 567 million) before deduction of costs related to the transaction.

The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.

The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4). The subscription price per share of USD 2.12 (SEK 18.50) has been established through arms’ length negotiations with a number of institutional investors over a period of time. The Company’s Board of Directors is therefore of the opinion that the subscription price has been set at market terms and accurately reflects current market conditions and demand. The reasons for the deviation from the shareholders’ preferential right were mainly to diversify the shareholder base with financially strong and well reputable U.S. and Swedish institutional investors and sector specialists and to enable a capital raise in a time and cost-efficient manner. It is the assessment of the Board of Directors that the Directed Issue is beneficial to the Company and hence for all existing shareholders.

Through the Directed Issue, the number of shares in the Company will increase by 30,660,374 to 61,043,690, and the share capital will increase by SEK 1,533,018.70 to SEK 3,052,184.50. The Directed Issue entails a dilution of approximately 50 per cent for existing shareholders, based on the number of shares in the Company after the Directed Issue.

In connection with the Directed Issue, the Company has agreed pursuant to a lock-up undertaking, subject to customary exceptions, not to issue additional shares or other securities for a period of 90 days following settlement of the Directed Issue. In addition, in connection with the Directed Issue, members of the Board of Directors and management of Saniona have agreed not to sell any shares or other securities in the Company for a period of 90 days following the settlement of the Directed Issue, subject to customary exceptions and furthermore subject to that warrants of series TO2 (where the exercise period runs between 7 September 2020 – 21 September 2020) or shares subscribed through exercise of such warrants are not covered by the lock-up undertaking.

A prospectus relating to the listing of the shares in the Directed Issue on Nasdaq Stockholm is expected to be approved and registered by the Swedish Financial Supervisory Authority ("SFSA") on or about 13 August, 2020, i.e. before the new shares are subject to trading on Nasdaq Stockholm.

The completion of the Directed Issue is subject to certain customary conditions of the investment agreement entered into by the Company with the investors in connection with the Directed Issue, whereby the investors may for customary reasons terminate the placing in full if it occurs before settlement of the placing.

Financial and legal advisors

Oppenheimer & Co. Inc. and ABG Sundal Collier AB acted as Joint Bookrunners ("Joint Bookrunners") while Setterwalls Advokatbyrå AB acted as legal advisor to Saniona in relation to Swedish law and Goodwin Procter LLP acted as legal advisor to Saniona in relation to US law.