Invitae to Announce Third Quarter 2022 Financial Results on Tuesday, November 8, 2022

On October 25, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported that it will report its third quarter 2022 financial results on Tuesday, November 8, 2022, and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, OCT 25, 2022, View Source [SID1234622383]).

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!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To access the conference call, please register at the link below: View Source

Upon registering, each participant will be provided with call details and access codes.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

Acorda Third Quarter 2022 Update: Webcast/Conference Call Scheduled for November 1, 2022

On October 25, 2022 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a webcast/conference call in conjunction with its third quarter 2022 update and financial results on Tuesday, November 1 at 4:30 p.m. ET (Press release, Acorda Therapeutics, OCT 25, 2022, View Source [SID1234622382]).

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 participate in the Webcast, please use the following registration link:

View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, you will receive an email 2 hours prior to the start of the Webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on November 1, 2022 until 11:59 p.m. ET on December 1, 2022. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); reference code 945092. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Novartis Third Quarter and Nine Months 2022

On October 25, 2022 Novartis reported its third quarter and nine months 2022 sales data (Presentation, Novartis, OCT 25, 2022, View Source [SID1234622378]).

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!


FDA Accepts NMP’s Clinical Trial Application for Development of NMK89 as Imaging Agent for Cancer Diagnosis

On October 25, 2022 Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan, reported that the U.S. Food and Drug Administration (FDA) has recently accepted NMP’s Investigational New Drug (IND) application to initiate a first-in-human phase I clinical study of "NMK89 (development code)," which is an imaging agent currently developed for cancer diagnostic use in cancer theranostics (a fusion of therapeutics and diagnostics) (*1) (Press release, Nihon Medi-Physics, OCT 25, 2022, View Source [SID1234622377]). The clinical study can now be started.

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!

NMK89 is an RI (*2)-labeled humanized anti-MUC5AC (*3) antibody to which zirconium-89, a diagnostic radionuclide, is labeled and has been investigated in non-clinical studies conducted by NMP and Sumitomo Pharma Co., Ltd. as an imaging agent for the diagnosis of MUC5AC-expressing cancer. It has been reported that MUC5AC is highly expressed in pancreatic cancer, liver cancer, colon cancer, gastric cancer, and lung cancer, among others. Non-clinical studies have confirmed that NMK89 accumulates in tumors transplanted with cell lines expressing MUC5AC.

NMP is developing NMK89 in one of the research projects (*4) adopted by the Japan Agency for Medical Research and Development (AMED) to enable early commercialization of theranostics for use in nuclear medicine.

NMP is conducting the phase I study of NMK89 in the U.S. NMP will promptly begin clinical studies of therapeutic drugs by leveraging the data on NMK89, obtained from the phase I study, to swiftly materialize it as long-awaited theranostics.

Notes:
(*1) It is a therapeutic concept in which RI-imaging diagnostics is used in advance to determine whether the drug reaches the target protein in the patient and to provide treatment with the radionuclide modified for therapeutic use. This enables therapies that are more closely aligned with a diagnosis and is expected to contribute to personalized medicine and the effective utilization of medical costs.

(*2) Radioisotopes – Radiation they emit is used for cancer treatment and diagnosis.

(*3) Mucin subtype 5AC – A type of mucin which is the main component of mucus secreted by animal epithelial cells. It is generally expressed in normal tissues of the stomach and trachea but is also reported to be highly expressed in pancreatic cancer and several other cancers.

(*4) The research project known as "Development of Antibody Labeling Therapies (with Alpha-Particle) and Companion Diagnostics, in Parallel with Maintenance of Drug Research Facilities to Embody the Concept of Theranostics" was adopted by AMED’s "Cyclic Innovation for Clinical Empowerment (CiCLE)" – FY2017 (2nd Conference).

SK bioscience and CEPI Sign Agreement to Develop mRNA Vaccines

On October 25, 2022 SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, reported that the Company made a new partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) for the development of mRNA vaccines to quickly respond to the spread of infectious diseases and to expand its vaccine portfolio (Press release, SK Bioscience, OCT 25, 2022, View Source [SID1234622376]).

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!

(from left) Richard Hatchett, CEO of CEPI, Park Min-soo, Second Vice Minister of the Ministry of Health and Welfare (MOHW), Chang Won (Andrew) Chey, Vice Chairman of SK discovery at the signing ceremony at Grand Walkerhill Seoul on October 25, 2022.
(from left) Richard Hatchett, CEO of CEPI, Park Min-soo, Second Vice Minister of the Ministry of Health and Welfare (MOHW), Chang Won (Andrew) Chey, Vice Chairman of SK discovery at the signing ceremony at Grand Walkerhill Seoul on October 25, 2022.
Richard Hatchett, CEO of CEPI, Park Min-soo, Second Vice Minister of the Ministry of Health and Welfare (MOHW), Chang Won (Andrew) Chey, Vice Chairman of SK discovery, and Jaeyong Ahn, CEO of SK bioscience attended the signing ceremony at Grand Walkerhill Seoul and discussed continuous cooperation between the two organizations for the development of mRNA vaccines.

The purpose of the agreement is that SK bioscience, which has secured the latest vaccine platform technologies such as cell culture, bacterial culture, and genetic recombination, expands its portfolio including the mRNA platform technology and establishes an R&D system that can prevent existing or unknown viruses in the future with global institutions. The Company will use the Japanese encephalitis virus (JEV) and Lassa virus to develop the mRNA vaccine platform.

SK bioscience is the CEPI’s first partner among global vaccine companies under the CEPI’s project of ‘RNA vaccine platform technologies and vaccine library development against emerging and select endemic infectious diseases’ to quickly respond to unknown infectious diseases (Disease-X) and solve the vaccine equity in low- and middle-income countries.

Under the agreement, SK bioscience will receive up to 140 million USD in R&D expenses from CEPI. Up to 40 million USD in initial funding will be made available to support phase 1/2 clinical trials of two mRNA vaccine platform projects. Pending results from phase 1/2 studies, a further $100 million in funding could be made available to support late-stage trials/licensure to further validate the mRNA platform and have it ready for use in outbreak situations.

SK bioscience and CEPI also agreed to expand cooperation on developing various vaccines based on the mRNA platform to respond to the spread of infectious diseases in low- and middle-income countries.

Earlier, SK bioscience had the partnership with the Bill & Melinda Gates Foundation in order to build the mRNA vaccine platform. The Company has been conducting the preclinical study on the mRNA vaccine platform using the COVID-19 virus with 2 million USD funded by the Foundation. The study is an important technology foundation for the collaboration project with CEPI.

SK bioscience will rapidly respond to the spread of infectious diseases based on the mRNA vaccine platform and global network. In particular, the Company plans to consolidate its global position by strengthening its portfolio with the mRNA vaccine platform and by developing new pipeline such as RSV vaccines, CMV vaccines, and anti-cancer vaccines using the mRNA platform.

The mRNA vaccine platform, which was first commercialized in the COVID-19 vaccine during the pandemic, is available for rapid mass production compared to existing platforms by utilizing genetic sequences. It is why the mRNA vaccine platform is considered to be proper in responding to the pandemic. In addition, the related market is expected to expand quickly due to the use possibility for developing treatments. According to Global Industrial Analyst (GIA), the global mRNA vaccine market will increase by 11.9% annually from 64.9 billion USD last year to 127.3 billion USD in 2027.

CEPI and SK bioscience are committed to enabling global equitable access to the vaccines they develop. Under the terms of the funding agreement, SK bioscience has committed to achieving equitable access to the outputs of this project including prioritization of supply for low-and middle-income countries, production of vaccine volumes required to meet public health needs, and affordable pricing, in line with CEPI’s Equitable Access Policy.

Richard Hatchett, CEO of CEPI said, "We are racing against the clock now, because we don’t know when the next pandemic virus will emerge. Key to making a future free of pandemics a reality is the ability to rapidly respond to the next Disease X with new vaccines and other countermeasures—in just 100 days. CEPI’s expanded partnership with SK bioscience will help kick start the world’s efforts to validate these mRNA platform technologies so that they can be used to create a library of vaccines ready for use against the next Disease X, bringing us another step closer achieving the 100 Days Mission, and preparing the world for the next pandemic."

Park Min-soo, Second Vice Minister of the Ministry of Health and Welfare (MOHW), said, "I would like to congratulate SK bioscience and CEPI’s partnership on development of mRNA vaccine. The Korean government will also make an effort to contribute to solving the vaccine issue as rapid vaccine development and vaccine equity are the most important to respond to the pandemic."

Chang Won Chey, Vice Chairman of SK discovery said, "We all agree that speed is the most important factor to protect humanity from the next life-threatening pandemic. Based on cooperation with global initiatives, including CEPI, we will achieve innovative vaccine development and ultimately contribute to promoting global public health."