On May 12, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported several recent peer-reviewed publications that utilized the company’s GeoMx Digital Spatial Profiler (DSP) to discover spatially-resolved biomarkers (Press release, NanoString Technologies, MAY 12, 2020, View Source [SID1234557617]). GeoMx DSP is an integrated system comprised of hardware, software, and reagents, capable of being read out using either the nCounter Analysis System or Next-Generation Sequencing (NGS).

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 first of these papers entitled, "Multiplex digital spatial profiling of proteins and RNA in fixed tissue," was published in the journal Nature Biotechnology (View Source). In this paper, a team of scientists from NanoString provide the most complete description to date of the GeoMx DSP’s capabilities to spatial profile proteins and RNA in formalin-fixed paraffin-embedded (FFPE) tissue.

The study describes extensive validation of the performance of each multiplexed panel using FFPE cell lines and compares performance to standard methods such as traditional immunohistochemistry (IHC) and in situ hybridization (ISH). The publication also includes case studies of the use of GeoMx DSP across a variety of tissue types and disease areas, illustrating the platform’s flexibility in selecting regions of interest (ROI) for analysis. Examples of key applications enabled by the light directed, non-destructive, ROI selection include auto-segmentation of tumor and tumor microenvironment, hypothesis-free gridding of the entire tissue samples, contour mapping across tissue substructures, and rare cell profiling. In addition, this is the first peer-reviewed publication to detail the performance achieved when GeoMx DSP is read out using NGS, including data spatially profiling 1,400+ genes using a prototype version of the Cancer Transcriptome Atlas.

"Spatial biology is emerging as a fundamental area of research in both discovery and translational science," said Joe Beechem, Chief Scientific Offer and SVP of R&D for NanoString. "Together these papers demonstrate the power and flexibility of GeoMx DSP to span the entire continuum of research — discovering new biology, identifying disease biomarkers, and potentially enabling future diagnostic tests."

Two recent publications from David Rimm and colleagues at Yale University further highlight the translational capabilities of the GeoMx DSP platform. The first publication, "Digital quantitative assessment of PD-L1 using digital spatial profiling" was published in the Nature journal Laboratory Investigation (View Source). This publication highlights the dynamic range of digital counts, high correlation to IHC and quantitative IHC, and the reproducibility of the GeoMx DSP platform. GeoMx DSP was found to generate data comparable to well established industry standard IHC assays which include the FDA approved PD-L1 assay, lab-developed test assays and quantitative immunofluorescence.

Dr. Rimm’s group second paper titled, "Biomarkers associated with beneficial PD-1 checkpoint blockade in Non-Small Cell Lung Cancer (NSCLC) identified using high-plex digital spatial profiling" was published in the journal Clinical Cancer Research. The authors used GeoMx DSP to discover twelve spatially informed biomarkers that are predictive of response to PD-1 checkpoint blockade and associated with clinical outcomes in NSCLC patients. The researchers concluded that the ability to reliably quantify multiple targets from a single tissue has the potential to make GeoMx DSP ideally suited for developing companion diagnostic assays. (View Source).

"The robust quantification and molecular compartmentalization capabilities were critical in identifying immune compartment specific biomarker candidates for predicting response to PD-1 checkpoint blockade," said David Rimm, MD, PhD, Professor of Pathology and Medicine, Yale University. "These data provide confidence for discovering novel bioclassifiers as well as developing clinical applications, from prognostic assays to companion diagnostics, using the GeoMx DSP system."

On May 11, 2020, Galera Therapeutics, Inc. (the "Company") and Clarus IV Galera Royalty AIV, L.P. (the "Purchaser") reported that it entered into Amendment No. 1 (the "Amendment") to the Amended and Restated Purchase and Sale Agreement, dated November 14, 2018, by and among the Company, the Purchaser and the other parties thereto (the "Royalty Agreement"), which was filed as Exhibit 10.1 to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on October 11, 2019 (Filing, 8-K, Galera Therapeutics, MAY 12, 2020, View Source [SID1234557640]). The Purchaser is affiliated with Blackstone Life Sciences ("Blackstone"), successor in interest to Clarus Ventures.

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!

Under the Royalty Agreement, Blackstone previously agreed to pay the Company, in the aggregate, up to $80.0 million (the "Royalty Purchase Price"), in four tranches of $20.0 million each upon the achievement of specified clinical milestones in the Company’s Phase 3 ROMAN Trial. The Amendment increased the Royalty Purchase Price by $37.5 million to a total of $117.5 million by increasing the fourth tranche from $20.0 million to $37.5 million (the "Fourth Milestone Tranche") and adding a new $20.0 million tranche upon the achievement of an additional clinical enrollment milestone (the "New Milestone Tranche").

Pursuant to the Royalty Agreement, as amended by the Amendment, in connection with the payment of each tranche of the Royalty Purchase Price, the Company has agreed to sell, convey, transfer and assign to Blackstone all of its right, title and interest in a high single-digit percentage of (i) worldwide net sales of avasopasem and GC4711 (the "Products") and (ii) all amounts received by the Company or its affiliates, licensees and sublicensees with respect to Product-related damages (collectively, the "Product Payments") during the Royalty Period. The Royalty Period means, on a Product-by-Product and country-by-country basis, the period of time commencing on the commercial launch of such Product in such country and ending on the latest to occur of (i) the 12th anniversary of such commercial launch, (ii) the expiration of all valid claims of the Company’s patents covering such Product in such country, and (iii) the expiration of regulatory data protection or market exclusivity or similar regulatory protection afforded by the health authorities in such country, to the extent such protection or exclusivity effectively prevents generic versions of such Product from entering the market in such country.

The amended Royalty Agreement will remain in effect until the date on which the aggregate amount of the Product Payments paid to Blackstone exceeds a fixed single-digit multiple of the actual amount of the Royalty Purchase Price received by the Company, unless earlier terminated pursuant to the mutual written agreement of the Company and Blackstone.

On May 11, 2020, as partial consideration for the Amendment, the Company and the Purchaser entered into a warrant purchase agreement (the "Purchase Agreement") pursuant to which the Company issued two warrants (the "Warrants") to the Purchaser to purchase an aggregate of 550,661 shares (the "Warrant Shares") of the Company’s common stock, par value $0.001 per share ("Common Stock"), at an exercise price equal to $13.62 per share, subject to customary adjustments for stock splits, stock combinations and similar transactions. The first warrant is exercisable for 256,975 of the Warrant Shares and will become exercisable on payment of the Fourth Milestone Tranche and the second warrant is exercisable for 293,686 of the Warrant Shares and will become exercisable on payment of the New Milestone Tranche. The Warrants expire six years after the initial exercise date of each respective warrant.

Under the Purchase Agreement, the Company has provided the Purchaser with customary "piggyback" registration rights, allowing the Purchaser to include the Warrant Shares in certain "shelf" or "resale" registration statements of the Company filed under the Securities Act of 1933, as amended (the "Securities Act"), subject to certain limitations. The Purchase Agreement contains customary indemnification and procedural terms.

The issuance of the Warrants is exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering. The Purchaser has acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends have been affixed to the securities issued in this transaction.

On May 12, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported results for its third quarter ended March 31, 2020 (Press release, Palatin Technologies, MAY 12, 2020, View Source [SID1234557585]).

Third Quarter Fiscal Year 2020 Financial Highlights

●Net loss of $(5.4) million, compared to $(5.7) million for the comparable quarter of 2019;
●Operating expenses of $5.7 million, compared to $5.8 million for the comparable quarter of 2019;
●Other income was $331,007, compared to $35,648 for the comparable quarter of 2019; and
●As of March 31, 2020, the Company had $88.9 million in cash and cash equivalents, compared to $91.5 million as of December 31, 2019, and no debt.

Recent Business Highlights and Updates

●Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to advance the Company’s programs;
●A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020. Data readout is targeted for the fourth quarter of calendar year 2020;
●A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is delayed due to the pandemic and is now targeted to start in the first half of calendar year 2021; and
●AMAG has stated that they anticipate finalizing the divestiture of Vyleesi within the next several months.

"The entire Palatin team thanks healthcare workers across the nation for their selfless efforts in the treatment and care of COVID-19 patients, and I would also like to thank all of our employees for their dedication and commitment to ensure the advancement of our development programs and clinical trial patient support," said Carl Spana Ph.D., President and CEO of Palatin. "Although Palatin has experienced limited adverse impact on operations from the pandemic, we are cognizant there may be further disruptions to business activity based on a resurgence of the virus and have taken steps to be as prepared as possible for this potential outcome."

Dr. Spana further commented, "We continue to review AMAG’s process related to the divestiture of Vyleesi and their obligations under our license agreement and are prepared to take appropriate steps to protect our rights and Vyleesi’s significant value."

Programs Overview

Anti-Inflammatory / Autoimmune Programs

A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020, and active patients continue treatment and monthly clinic visits. Enrollment of additional cohorts has been delayed, but we anticipate restarting enrollment in June 2020. Data readout is targeted for the fourth quarter of calendar year 2020.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first half of calendar year 2021, with data readout in the first half of calendar year 2022.

The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an IND targeted for mid-calendar year 2021.

The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which FDA granted orphan drug designation, in the second half of calendar year 2021.

Hypoactive Sexual Desire Disorder ("HSDD") / Vyleesi (bremelanotide injection)

Due to the early commercial stage of Vyleesi and the sales and marketing strategy of our North American licensee AMAG Pharmaceuticals, Inc., including no charge for the first Vyleesi prescription, AMAG has not generated positive net sales through March 31, 2020. This has resulted in no royalties to Palatin during this period.

Vyleesi is the first as-needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG launched Vyleesi nationally in September 2019 through select specialty pharmacies with its established women’s health sales force.

In January 2020 AMAG announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America. In May 2020 AMAG stated that it is in negotiations regarding the divestiture of Vyleesi and will provide an update within the next few months.

Palatin continues to closely monitor AMAG’s process related to the divestiture of Vyleesi and AMAG’s obligations under the Vyleesi license agreement. Though sales of Vyleesi have been adversely affected by the COVID-19 pandemic, the Company believes that AMAG’s divestiture process has also adversely impacted Vyleesi sales. Palatin is prepared to take appropriate steps to protect its rights as the Vyleesi licensor and the significant value of the Vyleesi program.

Palatin continues discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during the second half of calendar year 2020 and calendar year 2021.

Natriuretic Peptide Receptor ("NPR") System Program

PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is now anticipated to start patient enrollment in the second half of calendar year 2020.

Genetic Obesity Program

Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

Third Quarter Fiscal Year 2020 Financial Results

Revenue

For the quarters ended March 31, 2020 and 2019, there were no revenues recorded.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2020 were $5.7 million compared to $5.8 million for the comparable quarter of 2019. The decrease in operating expenses was mainly due to the overall reduction in research and development expenses offset by an increase in general and administrative expenses.

Other Income/Expense, net

Total other income, net, was $331,007 for the quarter ended March 31, 2020, compared to total other income, net, of $35,648 for the quarter ended March 31, 2019. The difference is related primarily to the increase in investment income.

Net Loss

Palatin reported a net loss of $(5.4) million, or $(0.02) per basic and diluted share, for the quarter ended March 31, 2020, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2019.

The difference in financial results between the three months ended March 31, 2020 and 2019 was mainly attributable to the increase in other income, net.

Cash Position

Palatin’s cash and cash equivalents were $88.9 million as of March 31, 2020, compared to $91.5 million at December 31, 2019, and cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019.

Management believes that existing capital resources will be adequate to fund the Company’s planned operations through at least March 31, 2022.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on May 12, 2020 at 11:00 a.m. Eastern Time to discuss the results of operations for the quarter ended March 31, 2020 in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-204-4368 (US/Canada) or 1-323-994-2082 (international), conference ID 8845359. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 8845359. The webcast and telephone replay will be available through May 19, 2020.

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 May 12, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported financial and operating results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, Oncocyte, MAY 12, 2020, View Source [SID1234557602]).

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!

"Oncocyte has built remarkable momentum in 2020, and we have continued our strong execution across our programs to provide patients and doctors with actionable answers with the potential to improve outcomes," said Ron Andrews, Chief Executive Officer of Oncocyte. "We were thrilled to announce the recent final Medicare LCD from Palmetto, establishing Medicare coverage for DetermaRx, the first and only test for chemotherapy benefit prediction in patients with surgically resected early stage NSCLC. This is an incredibly important milestone for Oncocyte as it may lead to Medicare reimbursement for up to 70% of eligible early-stage NSCLC patients, and also is the first step in securing broader reimbursement with private payers that typically follow CMS decisions. Our onboarding of new sites continues at a rapid pace, despite the COVID-19 pandemic, and we are excited to have expanded the reach of DetermaRx to , India, the Middle East and Africa."

Mr. Andrews continued, "We have also advanced DetermaIO, our immunotherapy response prediction test, to commercial availability for research use only, and look forward to moving forward with opportunities in pharma services for immunotherapy trials, while also uncovering the potential utility of this test more broadly for clinical use in lung cancer and other types of solid tumors. These accomplishments, in combination with our on-track progress with DetermaRx, DetermaDx Clinical Validation and our expanding offerings for pharma services, make it clear that Oncocyte has reached a new era in its transformation to a leader in molecular diagnostics in lung cancer.

Recent Corporate Highlights

●DetermaRx

○Announced final Medicare local coverage determination (LCD) from Palmetto potentially establishing Medicare coverage for up to 70% of eligible early-stage lung cancer patients
○Announced commercial availability in January and now have 20 sites onboarded including a number of large healthcare systems
○Expanded international availability through a distribution agreement with CORE Diagnostics, providing commercial availability of DetermaRx in India, the Middle East and Africa
○Successfully pivoted to virtual physician engagement due to COVID-19 and continued efforts to increase adoption of DetermaRx with over 1,500 participants in online physician education programs
○ATS 2020 International Conference abstract selected for oral presentation with long-term follow-up data from a 195-patient study demonstrating the clinical utility of DetermaRx in identifying high-risk cancers that can recur rapidly if untreated, as well as the potential to safely reduce follow-up for low-risk patients to conserve healthcare resources and limit patient stress
○Abstract accepted for the 2020 ASCO (Free ASCO Whitepaper) Virtual Meeting detailing potential significant health economic savings provided by DetermaRx

●DetermaIO

○Completed CLIA validation of DetermaIO
○Announced commercial launch for research use only as a reliable and robust option for academic research and biopharma companies
○Advancing pharma services opportunities, including immunotherapy trials and development of companion diagnostics in lung cancer and other solid tumors
○Abstract accepted for presentation at the 2020 ASCO (Free ASCO Whitepaper) Virtual Meeting highlighting the potential utility of DetermaIO in triple-negative breast cancer (TNBC), in addition to NSCLC

●DetermaDx

○Announced successful completion of CLIA Validation Study
○Clinical Validation study on-track for completion in Q2 2020
ATS 2020 International Conference abstract selected for oral presentation with data highlighting clinical features of the IRENE (Immune Response for Nodule Evaluation) Study population, a 2,903-patient sample biobank from 62 sites across the U.S. The study identified significant differences in the management of pulmonary nodules including different rates of invasive procedures across the academic, community and Veterans Affairs settings. These findings highlight the clinical decision challenge in managing the use of invasive biopsies for lung nodule diagnosis that DetermaDx has the potential to address.

●Pharma Services

○Re-launch of pharma services offering with full suite of molecular analyses including tissue and blood-based technologies, proprietary platforms such as DetermaIO and TNBCType Assay, as well as custom next-generation sequencing and PCR services including whole exome sequencing, RNA-seq and targeted mutation panels
○With collaborators from MD Anderson Cancer Center, announced the peer-reviewed publication in PLOS One with data demonstrating the utility of the TNBCType Assay to inform triple-negative breast cancer drug development by identifying the most suitable cell lines to help biopharma and academic researchers develop new treatments

●Financial and Corporate

○In April, Oncocyte successfully completed a $10.7 million registered offering of common shares, priced at the market, directly with fundamentally driven, healthcare focused institutional investors. This transaction builds on the successful $7.6 million registered offering in January, further strengthening Oncocyte’s balance sheet to support the continued commercialization of DetermaRx and DetermaIO, as well as the continued development of DetermaDx and other programs.
○Moved Oncocyte’s administrative and executive headquarters to Orange County, California, in January 2020 with ongoing plans to construct a clinical diagnostic and research laboratory to eventually have full service labs on the west and east coasts.

First Quarter 2020 Financial Highlights

At March 31, 2020, Oncocyte had cash, cash equivalents and marketable securities of $16.9 million as compared to $22.5 million at December 31, 2019. In April 2020, Oncocyte completed a $10.7 million registered offering of common shares, priced at the market.

Prior to January 1, 2020, Oncocyte had no revenues. During the current quarter, Oncocyte commercialized DetermaRx and completed the acquisition of Insight Genetics, providing sources of revenue generation and other commercial opportunities for the first time since the company’s inception.

Under U.S. accounting principles, Oncocyte will be able to recognize revenues on an accrual basis of accounting once it has contracts for reimbursement from third-party payers or a history of experience of cash collections for the tests performed, or both. Until that time, Oncocyte expects to recognize revenue for tests performed on a cash basis. Accordingly, Oncocyte will incur and accrue cost of revenues and other operating expenses related to its diagnostic tests, including DetermaRx.

Beginning on January 31, 2020, Oncocyte’s consolidated financial statements and results also include the results from its wholly owned subsidiary, Insight Genetics, which Oncocyte acquired on that date.

For the first quarter ended March 31, 2020, Oncocyte reported a net loss of $7.7 million, or $(0.13) per share, as compared to $3.9 million, or $(0.08) per share, for the first quarter ended March 31, 2019.

Operating losses, as reported, for the first quarter of 2020 were $8.4 million, an increase of $4.4 million from $4.0 million as compared to the first quarter of 2019; and operating losses, on an adjusted basis, were $7.4 million, an increase of $4.2 million from $3.2 million as compared to the first quarter of 2019.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

Research and development expenses for first quarter of 2020 were $2.2 million as compared to $1.3 million for the same period in 2019, an increase of $0.9 million. The increase was primarily attributable to personnel and laboratory related expenses for clinical validation activities related to DetermaDx.

General and administrative expenses for the first quarter of 2020 were $4.6 million, as compared to $2.4 million for the same period in 2019, an increase of $2.2 million. The increase was mainly due to personnel and related expenses; investment banking expenses; legal, business development, investor relations expenses; and noncash stock-based compensation expenses due to additional equity grants. As noted above, Oncocyte transitioned from the Lineage Cell Therapeutics (formerly BioTime) Shared Services agreement in the latter half of 2019, and established its own administrative, human resources, legal, finance and accounting functions and teams. This transition also includes the termination of the Shared Facilities agreement with Lineage as of December 31, 2019. In addition, Oncocyte moved its administrative and executive headquarters to Orange County, California, in January 2020 with ongoing plans to construct a clinical diagnostic and research laboratory to eventually have full service labs on the west and east coasts.

Sales and marketing expenses for the three months ended March 31, 2020, were $1.5 million, as compared to $0.2 million for the same period in 2019, an increase of $1.3 million. The increase was primarily due to ramping up in sales and marketing activities, including key hires, for commercialization of DetermaRx.

Cash used in operations was approximately $6.9 million for the first quarter of 2020 as compared to approximately $6.7 million during the first quarter of 2019, which is in line with Oncocyte’s expectations as the first quarter of each year is generally the largest cash use quarter of the year due to the timing of payments of annual merit increases and other payments. Oncocyte also paid some nonrecurring, acquisition-related legal and other costs of approximately $0.5 million in the first quarter of 2020.

Conference Call

The Company will host a conference call today, May 12, 2020, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13703079. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: View Source

On May 12, 2020 Legend Biotech Corporation ("Legend"), a global clinical stage biopharmaceutical company engaged in the discovery and development of novel cell therapies, reported that Legend and Noile-Immune Biotech, Inc. ("Noile-Immune"), a biotechnology company focusing on the development of innovative cancer immunotherapies, have entered into a license agreement whereby Legend will have the right to develop CAR-T and/or TCR-T cell therapies incorporating Noile-Immune’s PRIME (proliferation-inducing and migration-enhancing) technology secreting both IL-7 and CCL19 (Press release, Legend Biotech, MAY 12, 2020, View Source [SID1234557618]). The PRIME technology is designed to improve proliferation and trafficking into solid tumors of both engineered CAR-T and/or TCR-T cells, as well as the patient’s own T cells.

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 pleased to enter this strategic collaboration with Noile-Immune Biotech, allowing us to bring together our growing portfolio of solid tumor pipeline programs with Noile-Immune’s PRIME technology," said Dr. Frank Fan, Chief Scientific Officer and Co-founder of Legend Biotech. "Utilizing Noile-Immune’s innovative technology platform, we aim to bolster Legend’s novel CAR-T/TCR-T platforms to develop cutting-edge therapeutic candidates in our mission to deliver highly impactful treatments to patients living with cancer."

"As cell therapies evolve to include solid tumors, it becomes clear that improving CAR-T cell trafficking to tumor sites is important for potent tumor cell killing" said Dr. Yuan Xu, Chief Executive Officer and Board Member of Legend Biotech. "This collaboration demonstrates our commitment to invest in highly innovative technologies as we seek to deliver therapies that address the needs of patients with solid tumor cancers."

"It is a great advancement to establish a strategic collaboration with Legend Biotech, a clinical stage biopharmaceutical company that has shown promise in the development of gene-modified T cell therapies," said Dr. Koji Tamada, Scientific Founder and External Director of Noile-Immune Biotech. "From a scientific perspective, with the combination of our PRIME technology and the innovative programs of Legend Biotech, our goal is to generate effective therapeutic candidates for the treatment of various solid tumor types that may yield a novel benchmark for immunotherapy in cancer patients."

"This new partnership is one more confirmation of the interest of global CAR-T experts for our PRIME technology," said Dr. Hidenobu Ishizaki, Chief Executive Officer and Co-Founder of Noile-Immune Biotech. "This collaboration will be invaluable in our efforts to accelerate the development of innovative cellular immunotherapy. We look forward to working with the Legend Biotech team and bringing potentially breakthrough cancer therapies to patients."

Under the multi-year collaboration agreement, Legend and Noile-Immune will work together on up to two select cancer targets. Legend will gain the right to incorporate the PRIME technology into its CAR-T and/or TCR-T cell programs and will provide to Noile-Immune a total of up to $70M per selected target for certain development, regulatory and commercial milestone payments. Noile-Immune will also be entitled to receive mid-single digit royalties on net sales of any resulting products.