On January 13, 2020 Genmab A/S (Nasdaq: GMAB) reported that it has reached the first milestone in its collaboration with AbbVie (Press release, Genmab, JAN 13, 2021, View Source [SID1234573956]).. A USD 40 million milestone payment was triggered by the first patient dosed in the Phase 3 study of subcutaneous epcoritamab versus investigator’s choice of chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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"We are very pleased that the first Phase 3 study of epcoritamab has been activated at multiple clinical sites and the first cancer patient has been dosed. We look forward to continued rapid progress in this exciting and rapidly broadening development program," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Epcoritamab is being co-developed by Genmab and AbbVie.

The milestone will be reflected in Genmab’s 2021 guidance, which will be published on February 23, 2021.

About the Study
The Phase 3, open-label, randomized study (GCT3013-05, NCT04628494) will include approximately 480 patients with relapsed or refractory DLBCL who failed or are ineligible for autologous stem cell transplant (ASCT). Patients will be randomized to receive either subcutaneous epcoritamab or one of two chemotherapy regimens as per investigator’s choice, either rituximab, gemcitabine and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). The primary endpoint of the study is overall survival.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.1 CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.2,3 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

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]).

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"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 Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company with a broad pipeline of biotherapeutics in development, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma (Press release, Inhibrx, JAN 13, 2021, View Source [SID1234573954]). INBRX-109 is a precisely engineered tetravalent single domain antibody (sdAb)-based therapeutic candidate that agonizes death receptor 5 (DR5) to induce tumor selective programmed cell death.

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Fast Track designation is granted by the FDA upon the request of the sponsor to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening diseases. Depending upon the stage of the product’s development, the sponsor must also provide FDA with nonclinical or clinical data to demonstrate the drug’s potential to address unmet medical needs for such a disease or condition. Investigational drug products with Fast Track designation may benefit from early and frequent communication with the FDA, and are eligible for rolling submission and FDA review of its future marketing application. The designation was granted to INBRX-109 based on preliminary data from the chondrosarcoma expansion cohort of the Phase 1 clinical trial of INBRX-109.

"There are currently no approved agents for the treatment of unresectable or metastatic conventional chondrosarcoma, and we are excited about the potential of this treatment to meaningfully improve the outcome for patients," said Mark Lappe, CEO of Inhibrx. "We look forward to working closely with the FDA throughout the clinical development of INBRX-109."

A potential registration-enabling Phase 2 study of INBRX-109 has been discussed with the FDA and will be designed as a randomized, blinded, placebo-controlled study in unresectable or metastatic conventional chondrosarcoma with progression-free survival as the primary endpoint. Inhibrx expects to start dosing patients in this potentially registration-enabling study in the second or third quarter of this year.

About the Inhibrx sdAb Platform

Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities, potentially capable of enhanced cell signaling or conditional activation. An additional benefit of this platform, these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

Initially, Inhibrx is pursuing targets with early clinical validation, such as DR5, where other therapeutics have demonstrated liabilities. In addition, Inhibrx is developing a portfolio of sdAb based therapeutic candidates in a variety of indications for both known and novel targets.

On January 13, 2021 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, JAN 13, 2021, View Source [SID1234573953]).

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"The successful completion of this final step in our scaled-up clinical grade manufacturing of REQORSA marks a key manufacturing milestone for Genprex, and is credited to the hard work and commitment of both our internal manufacturing group and our manufacturing partners," said Rodney Varner, President and Chief Executive Officer of Genprex. "This production provides supply of REQORSA for our two upcoming Acclaim clinical trials and advances our mission to develop innovative new treatments for non-small cell lung cancer patients greatly in need of effective therapy options."

Genprex recently announced the successful completion of the technology transfer of its manufacturing process for the production of REQORSA from the major research institution where it was previously manufactured to experienced commercial Contract Development and Manufacturing Organizations (CDMOs). The Company also reported the completion of the manufacturing scale-up for the clinical-grade production of REQORSA, subject to final testing that was underway. Passing all lot release specifications marks the successful completion of Genprex’ manufacture of REQORSA in a scaled-up clinical production in accordance with the current Good Manufacturing Practices (cGMP) required by the U.S. Food and Drug Administration (FDA) in advance of commercial approval of a drug product.

Clinical-grade REQORSA has been shipped and delivered to its first cold storage depot. From there, REQORSA supply will be delivered to the clinical trial sites pending FDA clearance to commence the clinical trials. This production run will supply the Company’s upcoming Acclaim-1 and Acclaim-2 clinical trials that combine REQORSA with Tagrisso (marketed by AstraZeneca) and with Keytruda (marketed by Merck & Co., Inc.), respectively, both of which are on track to be initiated in the first-half of 2021.

On January 13, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that Dr. Amit Kumar, Anixa’s Chief Executive Officer, will present at B. Riley’s Inaugural Oncology Investor Conference to be held January 20-21, 2021 (Press release, Anixa Biosciences, JAN 13, 2021, View Source [SID1234573952]).

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Dr. Kumar will participate in a fireside chat presentation to discuss Anixa’s recent accomplishments and anticipated milestones. Company management will also be available to participate in online one-on-one meetings with investors who are registered to attend the conference.

Anixa’s presentation will be live webcast at 10:30 a.m. PST on January 21, 2021. The presentation will be open to registered conference attendees, institutional investors and investor relations professionals, who may register to view the live webcast at https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup. After completion of the event, a replay of the presentation will be publicly available on the Anixa website at View Source