On January 13, 2021 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that it has entered into a collaboration with QIAGEN to provide comprehensive genomic profiling tests and clinical decision support to molecular labs (Press release, Personal Genome Diagnostics, JAN 13, 2021, View Source [SID1234573973]).

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 non-exclusive agreement, PGDx will be responsible for the distribution of the PGDx elio oncology products and kitted solutions. Laboratories that purchase the PGDx elio products will have an option to receive from QIAGEN standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories will receive access to QIAGEN’s QCI Interpret One for rapid, evidence-based reporting for next-generation sequencing (NGS) oncology tests at scale. Advancing cancer diagnostics and making precision medicine more accessible to healthcare systems, laboratories, and patients worldwide is a key focus of both parties.

Cancer guidelines increasingly call for comprehensive molecular profiling to optimize treatment planning and inform care. PGDx elio tissue complete, the first FDA-cleared comprehensive genomic profiling kit, is used to identify alterations in the tumor and inform treatment decisions for patients with advanced solid tumors. QCI Interpret One enables clinical labs to deliver oncologist-ready variant interpretation reports from NGS tests faster and with greater precision than ever before. The kitted PGDx system allows molecular laboratories anywhere to perform this advanced genomic testing of cancer in a more efficient, standardized, and accurate manner. By providing tests and interpretation support that can be run locally and automating the data analysis process, PGDx and QIAGEN are enabling the adoption of precision medicine in healthcare systems across the country, no matter where a patient seeks treatment.

"PGDx elio tissue complete is a first of its kind FDA cleared kit to enable any molecular lab to perform comprehensive tumor profiling. It is important for our customers to be able to stay up to date with clinical guidelines and evidence supporting variant interpretation to maximize the value of NGS data in improving clinical care," said Megan Bailey, Chief Executive Officer of PGDx. "We’ve built the PGDx elio software to deliver robust, high quality variant calls. The addition of QIAGEN clinical decision support software for our customers provides labs an option for a comprehensive solution that will enable more informed treatment decisions for clinicians and patients."

On January 13, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported that it has entered into a research collaboration for molecular targeted radiotherapies with Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM, Chief Executive Officer and Chairman of the Board: Sandesh Seth, "Actinium") (Press release, Astellas, JAN 13, 2021, View Source [SID1234573913]). This collaboration is a component of Astellas’ initiative to develop "theranostics" as part of its Rx+ business1.

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!

Theranostics is a combined term of "therapeutics" and "diagnostics", defined as a treatment protocol or concept in which healthcare professionals assess lesion sites and simultaneously determine the appropriate treatment for each patient2. Through utilization of a diagnostic agent developed in parallel with a therapeutic agent that shares the same target, it may be possible to identify patients in advance who would benefit from the treatment. This approach may help healthcare professionals provide more efficient and effective treatment.

In this collaboration, the potential therapeutic effect will be assessed by combining certain targeted oncology drugs that were discovered by Astellas based on its drug discovery capabilities cultivated thus far with Actinium’s nuclear medicine technology which utilizes an alpha particle-emitting radioisotope3 (Actinium-225). Astellas is already conducting pre-clinical trials of the diagnostic agents on the target　molecule．When a promising therapeutic drug candidate is identified in the course of this collaboration, clinical trials for the theranostics may be initiated.

Through its Rx+ business, Astellas aims to realize a society where people can live in their own way, both physically and mentally through scientifically based on scientific evidence. Astellas aims to optimize therapeutic approach by improving diagnostic and surgical accuracy and maximize patient outcomes. The development of theranostics that integrates diagnostics and therapeutics is part of this effort.

Astellas has already reflected the impact from this collaboration in its financial forecast of the current fiscal year ending March 31, 2021.

On January 13, 2021 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported operational and preliminary financial highlights for the fourth quarter and fiscal year ended December 31, 2020 (Press release, Quanterix, JAN 13, 2021, View Source [SID1234573955]).

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!

"While last year brought extraordinary challenges for the world, it also amplified the critical potential of our precision health strategy to address acute issues associated with the spread of COVID-19 virus and longer-term health concerns resulting from the infection," said Kevin Hrusovsky, Chairman, Chief Executive Officer and President, Quanterix and Founder of Powering Precision Health (PPH). "Our timely pivot to address the pandemic enabled us to keep our employees safe and by year-end, deliver a robust suite of novel COVID-19 testing solutions to support the battle in 2021. Our advances in ultra-sensitive proteomics testing enable top researchers to tackle important COVID challenges and accelerate our Neurology tools strategy with vital new additions to our assay menu supporting both Alzheimer’s and COVID-19 research and diagnostics. We enter 2021 with short and long-term growth catalysts fueling our potential to scale our powering precision health strategy."

Operational Highlights:

Awarded an $18.2M contract with the NIH through its RADx initiative to accelerate the continued development and scale-up of a novel SARS-CoV-2 antigen test.
Received FDA Emergency Use Authorizations for novel SARS-COV-2 antigen test (after year-end) and for semi-quantitative antibody test, underscoring our longstanding science-first mentality and deep dedication to the highest standards of quality and scientific rigor across our business.
Leveraging the unparalleled ultra-sensitivity of Simoa, enabled several leading researchers globally, including at the NIH, to begin tackling leading-edge COVID challenges, such as establishing potential for blood based anti-viral endpoints for new drug therapies and understanding the long-term complications of COVID-19.
Expanded our differentiated Neurology menu to include tau phosphorylated at threonine 181 (pTau-181), a highly specific biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma as well as launched Neuro Multiplex assays associated with many neurodegenerative diseases yielding high growth potential. Our biomarker portfolio is now supporting leading Alzheimer’s programs globally.
Novartis’ multiple sclerosis (MS) drug KESIMPTA (ofatumumab), which utilized Nf-L as secondary endpoint, was approved by the FDA.
Quanterix’ Simoa technology was highlighted in a record 443 new publications in 2020, bringing total Simoa-specific inclusions to over 1,120. Also, was invited to present at several marquis symposiums showcasing our Precision Health vision and potential to catalyze asymptomatic medicine.
Instrument installed base increased by 34% to 535, despite access challenges posed by COVID-19. This includes 93 HD-X placements with over 50% new installations and 84 new SR-X and SP-X placements.
Solidified Simoa’s technological leadership by achieving a 100x sensitivity improvement in a pilot of the digital enzyme-linked immunosorbent assay (ELISA) that powers the Company’s HD-X and SR-X Ultra-Sensitive Biomarker Detection Systems.
Entered into a non-exclusive royalty-bearing license agreement with Abbott Laboratories, to grant Abbott access to Quanterix’ portfolio of bead-based technology patents for use in in-vitro diagnostic (IVD) applications.
Realized multi-category revenue partnership with one of the largest multi-national, healthcare payor groups, with execution of multiple population surveillance studies, creating beachhead for our vision for the future of precision medicine, where early and non-invasive disease detection has the potential to transform life and healthcare costs.
Successfully raised $97.6 million in gross proceeds through our follow-on offering, further strengthening our balance sheet with growth capital.
William Geist joined Quanterix as Chief Operating Officer to help us sustain and grown our strong momentum across numerous digital biomarker platforms.
Preliminary Non-Audited Financial Highlights:

Q4 2020

Expects GAAP revenue of $24-26 million; Non-GAAP revenue of $20-22 million.(1)
Non-GAAP revenue, which excludes revenue from the RADx contract, represents an increase of approximately 32% over prior Q4, driven by growth in Consumables and Accelerator Services revenue.
Full Year 2020

Expects GAAP revenue of $84-86 million; Non-GAAP revenue of $67-69 million.(2)
Non-GAAP revenue, which excludes revenue from the RADx contract and the Abbott license agreement, represents an increase of approximately 20% over prior year, despite COVID customer activity and access challenges, driven by growth in Accelerator Services revenue.
(1) Non-GAAP revenue for Q4 excludes approximately $4 million in RADx-related revenue, which is included in GAAP revenue and subject to adjustment pending finalization of contract accounting for Q4.

(2) Non-GAAP revenue for full year excludes the approximate $4 million in Q4 RADx-related revenue noted above, plus an additional $1.9 million of RADx revenue and $11.2 million in revenue relating to the Abbott license agreement recognized in Q3, all of which is included in GAAP revenue.

The estimated unaudited financial results as of and for the fourth quarter and full fiscal year ended December 31, 2020 presented above are preliminary and are subject to completion of our quarter-end and year-end closing procedures and further financial review. This preliminary financial information has not been audited by our independent auditing firm. Our actual results may differ from these estimates as a result of the completion of our quarter-end and year-end closing procedures, review adjustments and other developments that may arise between now and the time our financial results for the fourth quarter and year are finalized.

Presentation at JP Morgan Healthcare Conference

As previously announced, Kevin Hrusovsky will give a corporate update at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 13, 2021 at 3:40 p.m., EST (12:40 p.m., PST). A live webcast of the session will be made available to attendees and public listeners at View Source;kiosk=true.

Replays of the webcasts will be available for a limited period following the conference.

On January 13, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Aldeyra Therapeutics, JAN 13, 2021, View Source [SID1234573974]). Aldeyra also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the amount of shares of common stock sold in the offering, at the public offering price, less the underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the offering are to be sold by Aldeyra, with net proceeds to be used for the continued development of Aldeyra’s lead compound, reproxalap, and its other product candidates, as well as for working capital and other general corporate purposes.

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!

Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering.

The shares of common stock described above are being offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on July 27, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at [email protected], or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 13, 2021 Taiho Pharmaceutical Co, Ltd., (hereinafter Taiho) reported that it and Astex Pharmaceuticals (UK), (hereinafter Astex), both Otsuka group companies, have granted an exclusive license under their joint, small-molecule drug discovery program targeting SHP2 to Merck & Co., Inc., Kenilworth, NJ, USA, known as MSD outside the United States and Canada (hereinafter MSD) through a subsidiary (Press release, Taiho, JAN 13, 2021, View Source [SID1234573914]).

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!

An option for MSD to acquire the exclusive license to the Astex-Taiho SHP2 program was included as part of the strategic oncology collaboration between MSD, Astex and Taiho, announced in January 2020. The collaboration focuses on the discovery and development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.

SHP2, a dephosphorylating enzyme, is a signaling molecule which regulates various cellular processes including cell proliferation and differentiation, and acts as a regulator in the activation of the RAS signaling pathway such as KRAS.*1

"We are delighted to have extended the breadth of our strategic oncology collaboration with MSD to encompass assets from the joint Astex-Taiho SHP2 program", said Teruhiro Utsugi, Ph.D., managing director at Taiho. "This will allow for a number of important drug-drug combinations to be explored as potential new treatment modalities for patients."

In exchange for providing MSD with an exclusive global license to their small molecule SHP2 inhibitor candidates, Taiho and Astex will receive an option-exercise fee payment and will be eligible to receive further undisclosed payments contingent upon the achievement of clinical, regulatory and sales milestones for SHP2 products, as well as tiered royalties on sales. MSD will be solely responsible for funding all further research and development and will be responsible for commercialization of SHP2 products globally. Taiho has retained co-commercialization rights in Japan and an option to promote SHP2 products in specific areas of Southeast Asia.

"We are pleased with the discovery research progress and collaboration with Taiho and Astex as we seek to develop new small molecule candidates for the treatment of cancer," said Nick Haining, vice president, Discovery Oncology and Immunology, MSD Research Laboratories. "We look forward to working more extensively with Taiho and Astex on the SHP2 pathway and accelerating this promising research which has the potential to impact a number of cancer types."

Harren Jhoti, Ph.D., president and CEO of Astex Pharmaceuticals (UK), commented,

"Together with our Taiho colleagues, we are delighted to extend our strategic alliance with MSD to include assets from our joint SHP2 program that have been generated using our leading fragment-based drug discovery approach."