Den 21 december 2017 rapporterade Xspray Pharma att de ingått ett tillverknings- och leveransavtal med NerPharMa S.r.l, ett farmaceutiskt tillverkningsbolag i Milano, Italien, för produktion av sin ledande produktkandidat HyNap-Dasa (Press release, Xspray, DEC 21, 2017, View Source [SID1234523287]). Avtalet omfattar tillverkning av HyNap-Dasa för det kliniska prövningsprogrammet och för kommersiell produktion och inkluderar både läkemedelssubstans och färdig produkt. HyNap-Dasa är en av tre produktkandidater som Xspray för närvarande har under utveckling. Bolagets mål är att lansera HyNap-Dasa på den amerikanska marknaden 2021.

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!

Enligt villkoren i avtalet har Xspray kontrakterat NerPharMa för att tillverka läkemedelssubstans och färdig produkt för till kliniska program och framtida kommersiell försäljning. Xspray utvecklar HyNap-Dasa både som en fullständigt utbytbar variant av Sprycel som ska registreras i USA genom Abbreviated New Drug Application (ANDA) eller som en förbättrad produkt under 505(b)(2)-förfarandet. NerPharMa är ett farmaceutiskt tillverkningsbolag och dotterbolag till Nerviano Medical Sciences S.r.l. i Milano, Italien.

NerPharMas GMP tillverkningsanläggning är godkänd av både den italienska läkemedelsmyndigheten (AIFA), den nationella myndighet som ansvarar för läkemedelsreglering i Italien, och amerikanska Food and Drug Administration (FDA).

"Det här kontraktet är ett viktigt steg i vår utveckling av HyNap-Dasa," säger Per Andersson, vd för Xspray Pharma. "Vi är glada över att ha säkrat tillgången till GMP-produktion i en av amerikanska FDA godkänd anläggning av läkemedelssubstans och färdig produkt, det gäller för både våra fortsatta kliniska program men framför allt för vår framtida försäljning av produkt i USA."

"Vi är glada över att jobba med Xspray Pharma för att producera och tillgodose färdig produkt för deras utvecklings- och kommersiella behov," säger Angelo Colombo, vd för NerPharMa.

On December 21, 2017 Hookipa Biotech AG ("Hookipa"), a clinical stage biotech company pioneering an innovative class of immune activation therapies for oncology and infectious diseases, reported that CEO Joern Aldag will be presenting at the 36th Annual J.P. Morgan Healthcare Conference that is being held in San Francisco, CA from January 8-11, 2018 (Press release, Hookipa Biotech, DEC 21, 2017, View Source [SID1234522766]). The Company’s presentation is scheduled for Wednesday, January 10 at 04:30 PM Pacific Standard Time.

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!

Mr. Aldag will provide an overview of the Company´s strategy as well as an update on its development programs, including its progress on two proof-of concept clinical trials and its plan to expand its technology platform into other disease areas.

On December 21, 2017 Prima Biomed presented Investor Update (Presentation, Prima Biomed, DEC 21, 2017, View Source [SID1234522742]).

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!

On December 21, 2017 TARIS Biomedical LLC, a company developing targeted new therapies for millions of patients suffering from difficult-to-treat bladder diseases, reported that it has raised $25M in a Series B financing. This round was led by Yonghua Capital, with participation from new investors Bristol-Myers Squibb and Norma Investments, representing businessman Roman Abramovich (Press release, TARIS Biomedical, DEC 21, 2017, View Source [SID1234522767]). Existing investors Flagship Pioneering, Polaris Partners, and RA Capital Management, also participated in the Series B round.

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!

In a separate announcement (link), TARIS also announced that it has entered into a clinical research collaboration with Bristol-Myers Squibb to study the combination of Opdivo (nivolumab) and TARIS’ lead program TAR-200 (GemRIS) in the treatment of muscle invasive bladder cancer.

"We have made substantial progress on our lead programs in bladder cancer and overactive bladder," said Purnanand Sarma, Ph.D., President and CEO of TARIS. "Both programs demonstrate our unique approach to designing novel therapeutics that may dramatically change the management of these serious diseases. Funds from this round will be used to rapidly advance both indications through key clinical milestones."

"TARIS is thrilled to add new investors to our syndicate, and we are grateful to Flagship Pioneering, Polaris Partners, and RA Capital Management for their ongoing support," Sarma continued.

"We are excited to join the new and existing investors in this financing round, and to help TARIS build substantial long-term value as a focused urology company," said Moses Zhao, Managing Partner, North American Healthcare Investment for Yonghua Capital.

About the TARIS System

The TARIS System is designed to continuously release drugs in the bladder over weeks to months. It is deployed and retrieved using minimally-invasive, in-office procedures. This technology allows drug release to be tailored to match the needs of each disease.

On December 21, 2017 ABIVAX (Euronext Paris: FR0012333284 – ABVX), a biotechnology company harnessing the immune system to develop a functional cure for HIV and treatments for inflammatory/autoimmune diseases and cancer, reported that its senior management team will host institutional investor and partnering meetings at the LifeSci Advisors Corporate Access Event taking place in San Francisco, January 8-10, 2018 (Press release, Agilent, 21 21, 2017, View Source [SID1234522747]).

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!

To schedule a meeting with ABIVAX, investors can registeron the online system managed by the Company’s US investor relations firm, LifeSci Advisors, LLC, or make a request via e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it..">[email protected].