On January 22, 2021 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and Representative Director: Gyo Sagara; "ONO") and Helsinn Group (Lugano, Switzerland; CEO: Riccardo Braglia, "Helsinn") reported that ONO received the manufacturing and marketing approval of Adlumiz (generic name: anamorelin hydrochloride) Tablet 50mg ("Adlumiz"), a ghrelin receptor agonist, for the treatment of cancer cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer or colorectal cancer in Japan (Press release, Ono, JAN 22, 2021, View Source [SID1234605556]).

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!

　This approval is mainly based on the results from the following two clinical studies conducted in Japan in patients with cancer cachexia:

Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study in cancer cachexia patients with non-small cell lung cancer (ONO-7643-04)

Phase III multi-center, open-label, uncontrolled study in cancer cachexia patients with gastric, pancreatic or colorectal cancer (ONO-7643-05)

　Cancer cachexia is a complex metabolic disorder syndrome, characterized by decreased body weight (especially decreased muscle mass) and anorexia associated with cancer. It has been well documented that cancer cachexia causes a significant impact on patients’ quality of life and prognosis. To date, an effective treatment method for cancer cachexia has not yet been established.

　Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Anamorelin has shown effects in increasing body weight and muscle mass, as well as appetite in patients with cancer cachexia.

　Kiyoaki Idemitsu, Corporate Executive Officer and Executive Director, Clinical Development of ONO commented: "We are extremely pleased that Adlumiz has been approved for the indication of cancer cachexia in Japan. We believe that today’s approval can provide a promising new treatment option for the patients suffering from cancer cachexia for which there previously were no other approved treatment methods".

　Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: "We are delighted that Ono’s application has been successful for the treatment of cancer cachexia in Japan. This is an important milestone towards the improvement of the quality of life for all cancer cachexia patients, a condition that is still largely untreatable."

Overview of Adlumiz Tablet 50 mg
Product Name Adlumiz Tablet 50mg
Generic name (JAN) Anamorelin hydrochloride
Indication Cancer cachexia in the following malignant tumors:
Non-small cell lung cancer, gastric cancer, pancreatic cancer and colorectal cancer
Dosage and administration Usually, for adults, administer 100 mg of anamorelin hydrochloride at fasting state orally once a day.
Manufacturer/distributor Ono Pharmaceutical Co., Ltd.
Approval date January 22, 2021
Conditions for approval
Risk Management Plan should be designed and appropriately implemented.
A post-marketing use-results survey covering all cases should be performed until data on a certain number of patients have been accumulated after the launch of the product in order to collect safety and efficacy data as early as possible and take measures necessary for the proper use of the product.

On January 22, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the 12th Annual RNA Therapeutics Virtual Conference, a UK based online event taking place February 10-11, 2021 (Press release, PCI Biotech, JAN 22, 2021, View Source [SID1234585156]). The 2021 conference is set to explore the latest developments in RNA delivery agents and RNA-based therapeutics with the latest case studies on advanced mRNA technologies, oligonucleotide delivery, therapeutic applications and future trends and innovations. PCI Biotech is also a sponsor of the event.

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 Wednesday, February 10, 2021 at 13:10pm (CET), Dr. Anders Høgset, CSO, will present an overview of PCI Biotech’s proprietary platform technology, focusing on the delivery of RNA molecules, including the most recent data on the use of the fimaNAc delivery technology in the exciting field of RNA based therapies. The presentation slides will be made available through a separate press release around the timing of the presentation and the full presentation will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Scientific publications & presentations" after the event.

On January 22, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported the full-time appointment of Magnus Sjögren, MD, PhD as Chief Medical Officer (Press release, Herantis Pharma, JAN 22, 2021, View Source,c3272253 [SID1234577478]). Dr. Sjögren will assume the role of Chief Medical Officer effective as of 1st of May 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!

"We are delighted to add Magnus Sjögren to our management team. He brings an impressive skill set strongly complementary to our focus therapeutic areas at Herantis and a distinguished CV, making him our top choice for CMO. Dr. Sjögren joins at a key time for the company as we continue to advance and accelerate our neurological and lymphatic programs," said Craig Cook, CEO of Herantis Pharma. "This is such an exciting time for the company and his very successful track record in clinical research and translational medicine in neuroscience and other diseases will be a real asset for Herantis Pharma."

Dr Sjogren is a neuroscience expert with a focus on neurodegenerative diseases, and in addition has experience in other areas relevant to Herantis’ programs including oncology and inflammation. He has held several senior executive and scientific positions at major pharmaceutical and biotechnology companies, including Chief Medical Officer at DiaGenic, Vice President Global Exploratory Development at UCB Pharma, Global Head of Translational Medicine in Schering-Plough and Senior Clinical Research Director at AstraZeneca. He is highly knowledgeable on Herantis’ compounds, having consulted to the company for several years in our key programs. He is an Associate Professor at Gothenburg University, a Research Lecturer at Copenhagen University, a trained psychiatrist, and the author of more than 135 scientific publications. He received his Doctor of Medicine from Linköping University in Sweden, his PhD in clinical psychiatry, and his postdoc in clinical neuroscience from the University of Gothenburg, Sweden.

"Herantis represents truly novel clinical stage research in disease modifying therapies, using novel biological and gene therapy approaches. I am thrilled to be given the opportunity to oversee the clinical development of Herantis’ compelling pipeline programs in neurodegenerative and lymphatic diseases and very much look forward to working with the whole Herantis team as we advance our portfolio to provide innovative treatments that can make a real difference for patients," commented Dr. Sjögren, CMO of Herantis Pharma.

On January 22, 2021 Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, reported an update to the financial guidance for 2020 (based on preliminary and unaudited numbers) (Press release, Zealand Pharmaceuticals, JAN 22, 2021, View Source [SID1234576935]).

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!

Zealand expects increased general operating expense guidance by approximately 5-10% (total operating expenses of DKK 1,050 million to 1,100 million).

Zealand will announce the detailed and audited financial results, and expects to provide outlook for 2021, in the 2020 Annual Report to be released on 11 March 2021.

On January 22, 2021 Hamlet Pharma reported the inclusion of patients in the dose escalation study of bladder cancer in Prague (Press release, HAMLET Pharma, JAN 22, 2021, View Source;utm_medium=rss&utm_campaign=dose-escalation-study-initiated [SID1234574600]). The study will examine the efficacy and safety of our drug candidate Alpha1H at higher doses than used in the previously communicated clinical study.

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 preparation for Phase III trials, it is essential to optimize the treatment dose for patient safety and efficacy. As previously communicated, Alpha1H has shown clear efficacy as a standalone therapeutic agent in bladder cancer patients and is under continuous active development. Hamlet Pharma now initiates the dose-escalation program involving five times and ten times higher doses than those used in the previous part of the trial. The clinic in Prague has recruited the first patients into the study and several more patients have been identified as potential candidates for the dose-escalation study as well as for the combination part, which will be conducted in parallel. The team working with the clinical study is experienced and highly motivated to continue the investigations of Alpha1H, in order to define its potential new treatment of bladder cancer.

The Food and Drug Administration has declared bladder cancer a great unmet medical need, as very few new treatments are available for this patient group. Hamlet Pharma is committed to improving the treatment options, using Alpha1H alone and/or in combination with chemotherapeutic drugs. We feel confident that the recruitment of patients now will proceed, despite the COVID-19 pandemic. The staff is taking all necessary precautions for a safe recruitment and treatment of patients during the study.

"Continuing the clinical program and reaching patients in need of new therapies is our highest priority", says Catharina Svanborg, Chairman and Founder of Hamlet Pharma.

"Extensive clinical trial experience in the Hamlet Pharma team explains the efficient progression of the clinical trial program", says Mats Persson, CEO of Hamlet Pharma.