On February 8, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that UnitedHealthcare (UHC) now covers the Guardant360 CDx liquid biopsy test for patients enrolled in its commercial policies for all FDA-approved companion diagnostic indications (Press release, Guardant Health, FEB 8, 2023, View Source [SID1234626981]). The test is used by oncologists as a companion diagnostic to assess if patients are eligible for a targeted therapy for advanced or metastatic breast or non-small cell lung cancer (NSCLC).

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 Guardant360 CDx test was the first blood test approved by the FDA for comprehensive genomic profiling for all solid tumors, and it is now FDA-approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In December 2019, Guardant360 became the first liquid biopsy to be broadly covered by Medicare for use across the vast majority of advanced solid tumors. The new policy coverage by UnitedHealthcare is in addition to existing coverage of the Guardant360 CDx test under UHC Medicare Advantage policies for comprehensive genomic profiling of all solid tumors.

"We are pleased that UnitedHealthcare has taken this important step to make comprehensive genomic profiling more accessible to patients with advanced lung and breast cancer," said Helmy Eltoukhy, Guardant Health co-CEO. "The biomarker identification available through the Guardant360 CDx blood test can enable oncologists to quickly identify patients who may benefit from a therapy targeted to their specific type of mutation to help improve their outcomes. We believe this important decision will help expand patient access to genomic profiling across additional tumor types and healthcare plans in the coming years."

This year, an estimated 236,740 adults in the U.S. will be diagnosed with lung cancer, which is the leading cause of cancer death worldwide.1 Non-small cell lung cancer, the most common type in the U.S., represents about 82% of all lung cancer.2 Worldwide, female breast cancer has now surpassed lung cancer as the most commonly diagnosed cancer and is the fifth leading cause of death. This year, an estimated 287,850 women in the United States will be diagnosed with invasive breast cancer, and 51,400 women will be diagnosed with non-invasive (in situ) breast cancer.3 Due to the expanded coverage decision, the Guardant360 CDx test will now be covered for comprehensive genomic profiling for all lives covered by UnitedHealthcare, the largest U.S. national health insurer in commercial and Medicare Advantage markets.

On February 8, 2023 Takeda (TSE:4502/NYSE:TAK) reported that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. ("Lakshmi") from Nimbus Therapeutics, LLC ("Nimbus"), on February 8, 2023 (EST), as set forth in the share purchase agreement, following clearance from the United States Federal Trade Commission and a satisfaction of other closing conditions (Press release, Takeda, FEB 8, 2023, View Source [SID1234626980]). The agreement had been announced on December 13, 2022: "Takeda to Acquire 100% Ownership of Nimbus Therapeutics’ TYK2 Program Subsidiary".

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!

Following the completion of this transaction, Takeda has now acquired TAK-279, formerly known at Nimbus as NDI-034858. With Phase 2b data to be presented in Q4 FY2022 and Phase 3 study in psoriasis expected to start in 2023, TAK-279 has the potential to demonstrate best-in-class efficacy, safety and convenience in psoriasis as well as multiple other immune-mediated diseases, including inflammatory bowel disease, psoriatic arthritis and systemic lupus erythematosus. This acquisition strengthens Takeda’s growing late-stage pipeline and potentially expands its portfolio and patient impact across multiple indications, reinforcing Takeda’s ability to maintain strong growth globally in the mid- to long-term.

"With our plan to acquire announced in December, we are excited to have promptly added TAK-279, a highly selective oral TYK2 inhibitor with truly transformative potential for patients in multiple diseases, to our late-stage pipeline," said Ramona Sequeira, president, global portfolio division, at Takeda. "This program closely aligns with our strategy and expertise in immune-mediated diseases, and we look forward to sharing more details of our development plans soon."

Under the terms of the agreement and following the closing of the transaction, Takeda will pay Nimbus approximately 4 billion USD upfront, after adjusting items including closing indebtedness and closing account payable of Lakshmi. Takeda will also make two milestone payments to Nimbus of 1 billion USD each upon achieving annual net sales of 4 billion USD and 5 billion USD of products developed from the TAK-279 program.

Takeda expects that the financial impact on its consolidated operating results for the fiscal year ending March 31, 2023 (FY2022), as a result of the completion of the transaction, is immaterial. There is no change in Takeda’s FY2022 consolidated forecasts for operating results or the management guidance.

On February 8, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that Joseph Ferra, Interim Chief Executive Officer and Chief Financial Officer of Elevation Oncology, will present at SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 4:20 pm ET (Press release, Elevation Oncology, FEB 8, 2023, View Source [SID1234626979]).

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!

A live webcast and replay of the event will be available on the Events page of the Company’s Investor Relations website at View Source

On February 8, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company will host a virtual R&D Day at 10:00 am – 1:30 pm ET / 7:00 – 10:30 am PT on Wednesday, February 22, 2023 (Press release, Poseida Therapeutics, FEB 8, 2023, View Source [SID1234626978]).

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!

Poseida’s third-annual R&D Day will feature its executive leadership and scientists for a morning of presentations and fireside chats with special guest speakers exploring the future of cell and gene therapy. The program will highlight the Company’s proprietary genetic engineering platform technologies, differentiated allogeneic CAR-T programs, and novel approaches to gene therapy as well as ongoing collaborations with Roche and Takeda.

External speakers will include George M. Church, Ph.D., a pioneer in the fields of genetics and synthetic biology and Chair of Poseida’s Gene Therapy Scientific Advisory Board; Madhu Natarajan, Ph.D., Head of the Rare Diseases Drug Discovery Unit at Takeda; and Christine Brown, Ph.D., Professor, City of Hope, a CAR-T cell expert and member of Poseida’s Immuno-Oncology Scientific Advisory Board.

Registration for this virtual event and access to the live webcast will be available on the Investors & Media section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for 90 days following the presentation.

On February 8, 2023 ReviR Therapeutics, a privately held developer of a suite of small molecule RNA-targeting technologies for cancer and other genetically-defined diseases, and Asieris Pharmaceuticals, a global biopharma company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported that they have entered into a research collaboration and option-to-license agreement aimed at discovering and developing innovative treatments for genitourinary (GU) tumors and other related serious diseases, leveraging ReviR’s proprietary RNA-targeted technologies (Press release, Asieris Pharmaceuticals, FEB 8, 2023, View Source [SID1234626977]).

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 collaboration will include multiple oncology targets, with the goal of improving patient outcomes. According to the agreement, Asieris will be utilizing ReviR’s innovative RNA modulation technologies, named BindeR and SpliceR, to identify and develop new therapeutics that target RNA to treat cancer.

ReviR combines computational and high throughput drug discovery technologies with the goal of delivering next generation medicines to patients. Its VoyageR AI platform integrates computational approaches to drug traditionally undruggable RNA targets. Initially, ReviR’s focus is in CNS, oncology, and genetically defined disease indications.

"We are pleased to be collaborating with ReviR, an innovative biopharmaceutical company focused on the development of RNA-targeting small molecule therapies,” said Alice Chen, Ph.D., Vice President, Discovery Biology and Head of Translational Research, at Asieris. "We believe that our in-house R&D expertise on small molecule oncology drug discovery, combined with ReviR’s proprietary RNA-targeted technologies, will speed the benefit to patients. We will continue to adhere to our differentiated R&D strategy, focus on genitourinary tumors and related diseases, expand global reach of our innovation to deliver novel drug products for patients in China and globally."

"Asieris is a global biopharma company specialized in the development of GU oncology therapies, and we are excited to be working with them to discover new treatments for indications of interests," stated Paul August, Ph.D., Chief Scientific Officer of ReviR Therapeutics. "Our BindeR and SpliceR platform technologies have the potential to advance therapeutics for undruggable cancer targets, and we believe this collaboration will accelerate the discovery of new treatments for patients."

"The cooperation with Asieris will provide ReviR with access to the specialized knowledge, and specialized resources to validate the effectiveness of our RNA targeted small molecule platforms." said Peng Yue, Ph.D., CEO of ReviR Therapeutics. "Importantly such a collaboration will enable us to partake in synergistic endeavors with a highly proficient team of seasoned experts at Asieris, which would undoubtedly lead to novel discoveries and breakthroughs in the small molecule, RNA targeting field. As the first of many partnerships to come for ReviR, we believe that collaboration will greatly augment our efforts to enhance patient outcomes and further the field of cancer research."