On January 4, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it expects revenues for the first fiscal quarter of 2021 ended December 31, 2020, to be in the range of $1.3 million to $1.6 million compared to revenues of $314,000 in the fourth quarter of fiscal 2020 (Press release, Applied DNA Sciences, JAN 4, 2021, View Source [SID1234573398]). The strong sequential growth in quarterly revenues is driven principally by demand for safeCircle, the pooled COVID-19 surveillance testing program offered by the Company’s wholly-owned subsidiary, Applied DNA Clinical Laboratories, LLC (ADCL), and from sales of its LineaCOVID-19 Assay Kit under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

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"Fiscal first-quarter revenues surged over fiscal fourth quarter, reflecting the first full quarter of revenue contribution from our safeCircle program. New client acquisitions drove a sequential improvement in ADCL revenues during each month of the quarter. We believe we are tapping into an unmet need for an accurate, painless, and fast COVID-19 risk mitigation option that can deliver ongoing, consistent, and highly accurate COVID-19 surveillance testing proactively. We expect continued uplift to revenues over the coming weeks as new clients ramp up their testing volumes, including Suffolk County (N.Y.) Government that signed on just two weeks ago with a six-month contract valued at up to $2.0 million, and as we onboard more new clients," said Dr. James A. Hayward, president and CEO, Applied DNA.

"Interest in our pooled surveillance testing modality is strong and growing. In the months ahead, our ADCL team is intensely focused on increasing testing throughput, developing new COVID-19 assays to detect mutations in SARS-CoV-2, offering expanded services via the Cleared4 return-to-work health safety platform, and client acquisition and retention through direct sales efforts and channel partners," concluded Dr. Hayward.

These preliminary unaudited results are based on management’s initial analysis of operations for the first fiscal quarter of 2021 ended December 31, 2020, and are subject to review and revision. The Company expects to issue full financial results for the first fiscal quarter of 2021 in mid-February.

About safeCircle
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the LineaCOVID-19 Assay Kit and Pooled Surveillance Testing
The LineaCOVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the LineaCOVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the LineaCOVID-19 Assay Kit.

On January 4, 2021 Ambrx reported that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting (Press release, Ambrx, JAN 4, 2021, View Source [SID1234573397]).

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"This is an important milestone for ARX788 that underscores the strong unmet medical need to develop new and effective treatment options for breast cancer patients whose tumors progressed on currently approved HER2 directed regimens," said Joy Yan, MD, PhD, Ambrx Chief Medical Officer. "It’s our mission to drive science forward to help bring innovative therapeutic options to cancer patients and we look forward to working closely with the FDA to optimize and expedite the development of ARX788." This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of ARX788.

About ARX788

ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is a Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin (trastuzumab) based antibody. ARX788 was designed for maximum performance in the preclinical setting by optimizing the number, position and chemical bonds that conjugate the cytotoxic AS269 payload to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of a Precision ADC. Ambrx licensed the China rights of ARX788 to its partner NovoCodex.

About HER2-positive Metastatic Breast Cancer

Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells. About 20% of breast cancers overexpress the HER2/neu gene, which causes these cancers to grow more aggressively. Unmet medical needs remain today in HER2-positive metastatic breast cancer. Many tumors progressed after currently approved HER2-targeted regimens.

On January 4, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., and Chief Financial Officer, Brad Dahms, will participate in the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021 (Press release, Selecta Biosciences, JAN 4, 2021, View Source [SID1234573396]).

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The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 6 a.m. EST on Monday, January 11, 2021.

A webcast will also be available in the Investors & Media section of the company’s website at www.selectabio.com.

On January 4, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will participate in the upcoming 39th Annual J.P. Morgan Healthcare Conference (Press release, Ascendis Pharma, JAN 4, 2021, View Source [SID1234573395]). Company executives will provide a business overview and update on the company’s pipeline programs.

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Details

Event 39th Annual J.P. Morgan Healthcare Conference
Location Virtual
Date Monday, January 11, 2021
Time 11:40 a.m. Eastern Time
A live webcast of the presentation will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the events for 30 days.

On January 4, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small-molecule drugs for the treatment of cancer and other life-threatening diseases, reported topline results from the CANTATA clinical study of the company’s glutaminase inhibitor telaglenastat in patients with advanced or metastatic renal cell carcinoma (RCC) (Press release, Calithera Biosciences, JAN 4, 2021, View Source [SID1234573394]). As compared to treatment with cabozantinib, the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression free survival (PFS) in the study population.

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The primary study endpoint is PFS by blinded independent review. The hazard ratio was 0.94 (p=0.65). Median PFS was 9.2 months among patients treated with telaglenastat and cabozantinib as compared to 9.3 months with cabozantinib and placebo. Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. The frequency and severity of adverse events in the telaglenastat-treated population were comparable to that of cabozantinib alone.

"We are disappointed that the CANTATA trial did not achieve its primary endpoint, particularly on behalf of the people living with advanced RCC, many of whom could benefit from additional treatment options with novel mechanisms of action to address this difficult-to-treat disease," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Based on the strong scientific rationale for telaglenastat in KEAP1/NRF2 mutant non-small cell lung cancer patients, and the safety profile observed in CANTATA, we remain dedicated to advancing our randomized KEAPSAKE trial."

Calithera will focus its financial resources on the ongoing KEAPSAKE trial, the ongoing trial of the arginase inhibitor CB-280 in cystic fibrosis patients and pipeline programs. As a result of the outcome of CANTATA, Calithera will reduce its workforce by approximately 35 percent to allow the company to focus on ongoing programs.

Calithera expects cash, cash equivalents and investments to be approximately $115 million at December 31, 2020 based on preliminary estimates, which management believes will be sufficient to meet its current operating plan through 2022, including the release of interim results of the KEAPSAKE trial and completion of the current cystic fibrosis study in 2021. Calithera anticipates the one-time severance-related charge associated with the workforce reduction to be approximately $1.3 million – $1.5 million, with the majority to be completed by the first quarter of 2021. More financial details will be provided by the company in its fourth quarter 2020 financial report in March 2021.

The information relating to cash, cash equivalents and investments is preliminary, has not been audited and is subject to change upon completion of the audit of Calithera’s financial statements as of and for the year ended December 31, 2020.

The CANTATA trial (NCT03428217) is a global, randomized, double-blind trial designed to evaluate the efficacy and safety of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic RCC who have been treated with one or two prior lines of systemic therapy, including at least one vascular endothelial growth factor (VEGF)-pathway targeted anti-angiogenic therapy or the combination of nivolumab and ipilimumab. The CANTATA trial enrolled 444 patients at multiple centers globally. Exelixis, Inc. provided cabozantinib for the trial through a material supply agreement with Calithera.

Calithera will submit the CANTATA results for presentation at a medical meeting.

Webcast and Conference Call Information

Calithera will hold a webcast today, Monday, January 4, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. To access the link to the webcast, which will be broadcast live in listen-only mode, or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. Alternatively, the call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4787 (international) and referring to conference ID 5824089. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

About Telaglenastat

Telaglenastat (CB-839) is an investigational, first-in-class, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. While normal cells use glucose to meet cellular energy demands, tumor cells have a unique oncometabolism that increases their dependence on glutamine to fuel growth and survival. Calithera is conducting the randomized Phase 2 KEAPSAKE trial to evaluate telaglenastat in patients with advanced non-small cell lung cancer harboring KEAP1/NRF2 mutations.