On August 11, 2022 Paige, a global leader in clinical AI applications for pathology, reported it will partner with Sonora Quest Laboratories, the local market leader in clinical diagnostics in the state of Arizona, to implement a fully digital pathology workflow at its laboratories (Press release, Paige AI, AUG 11, 2022, View Source [SID1234618168]). The goal of the digital transformation project is to improve existing diagnostic workflows and accelerate precision diagnoses for patients across Arizona.

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Under the partnership, Paige will provide Sonora Quest with the complete suite of Paige’s AI-enabled digital pathology solutions, including the FullFocus viewer, Paige Prostate Detect and Paige Breast. Paige Prostate Detect is the first AI-based pathology product to receive de novo marketing authorization from the FDA, allowing in vitro diagnostic (IVD) use via Paige’s FDA-cleared FullFocus digital pathology viewer.

"The implementation of Paige products at Sonora Quest further validates our ability to scale and deploy our technology to meet the demands of a high-volume commercial laboratory," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "AI software like Paige Prostate Detect can serve as a built-in second opinion to promote diagnostic confidence and help reduce diagnostic errors. We believe that our integrated solution can ultimately streamline and improve patient care."

Using the power of data, AI, cloud-based platforms, and partnerships, Sonora Quest aims to elevate patient care, accelerate precision diagnosis to improve diagnostic and health outcomes, lower the cost of care, and improve the human care experience for patients and staff alike. Through virtualization and better care orchestration, cases can be routed anywhere within the network to be read, scaling access to specialists, optimizing workloads, and decreasing the rate of interpretation errors.

"Our ultimate goal is to accelerate workflows for the lab and help clinicians confirm a diagnosis to get a patient the right course of treatment as quickly as humanly possible," said David A. Dexter, Sonora Quest President and CEO. "By intelligently integrating data from imaging to pathology and genomics data, as well as patient-reported outcomes, we can help clinicians gain a more holistic understanding of a patient’s health and condition. By also collaborating with our partners in Pathology Specialists of Arizona, we enable highly experienced health care professionals with the ability to share this patient data across enterprises and between sites. Ultimately, this will lead to more precise and personalized care, with treatment tailored to the needs and characteristics of that patient."

Sonora Quest Laboratories, a joint venture between Banner Health and Quest Diagnostics, is part of the nation’s largest integrated laboratory system with approximately 3,800 employees. Performing more than 97 million diagnostic tests per year, Sonora Quest Laboratories offers a comprehensive test menu that encompasses routine, molecular, prescription drug monitoring, genetic/genomic, women’s health, and pathology testing services for more than 33,000 patients every day throughout Arizona.

"On behalf of the University of Arizona and the Banner University Medical Center of Tucson, we thank the Sonora Quest Leadership and Mr. David Dexter for including us from the beginning of the program. Since the 1990s, we have included digital pathology in medical teaching and research. The future is bright for incorporating statewide telepathology, particularly to bring cutting-edge diagnosis and treatment to remote and underserved populations. We are excited to close the gap in health care disparities," said Dr. Achyut Bhattacharyya, Professor and Chair of the Department of Pathology, University of Arizona.

On August 11, 2022 The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer (Press release, Menarini Group, AUG 11, 2022, View Source;Advanced-or-Metastatic-Breast-Cancer [SID1234618167]). The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.

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The FDA grants Priority Review designation to medicines that it considers having the potential to provide significant improvements over current SOC in the safety and effectiveness of the treatment, diagnosis, or prevention of serious conditions. The FDA granted Fast Track designation for elacestrant in 2018.

"The FDA’s acceptance of our NDA with Priority Review marks an important regulatory milestone for our company," commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. "We look forward to working with the FDA during its review of this submission, which addresses a new potential therapeutic option for a major unmet need in the management of patients with advanced or metastatic breast cancer after resistance builds in the earlier lines of the treatment."

The NDA submission was supported by results of the Phase 3 data from the EMERALD study. EMERALD met both of its pre-specified primary endpoints of progression-free survival (PFS) in the overall population and in patients with the ESR1 mutation (mESR1) compared to SOC endocrine monotherapy; the trial’s comparator arms were investigators’ choice of either fulvestrant or an aromatase inhibitor. The PFS rate at 12 months with elacestrant was 22.32% vs. 9.42% with SOC in the overall population, and 26.76% vs. 8.19% in the ESR1 mutation population. The clinical trial data showed that elacestrant reduced the risk of disease progression or death by 30% in all patients and by 45% in patients with ESR1 mutation. The data also showed a manageable safety profile.

Elacestrant is an investigational compound and is not approved by any regulatory authorities. The Marketing Authorization Application (MAA) has also been submitted to European Medicines Agency (EMA) in July 2022. More information about clinical trials with elacestrant is available at www.clinicaltrials.gov.

The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc (NASDAQ: RDUS), who conducted and successfully completed the EMERALD study. Based on the positive phase 3 data, Stemline, with the support of Radius, submitted a New Drug Application (NDA) in June 2022 to the FDA. The Menarini Group is now fully responsible for global registration, commercialization and further development activities for elacestrant. Stemline, headquartered in New York City, will commercialize elacestrant if approved by the FDA. Stemline is focused on bringing transformational oncology treatments to cancer patients, and currently commercializes a novel targeted treatment for patients with blastic plasmacytoid dendritic cell neoplasm in both the United States and Europe.

About Elacestrant (RAD1901) and the EMERALD Phase 3 Study

Elacestrant is an investigational selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced or metastatic breast cancer. In 2018, elacestrant received Fast Track designation from the FDA. Preclinical studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study enrolled 477 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).

On August 11, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported financial results and business highlights for the quarter ended June 30, 2022 (Press release, Aptevo Therapeutics, AUG 11, 2022, View Source [SID1234618166]).

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Business Highlights

On June 9, 2022, the Company reported positive preliminary data from the on-going Phase 1b trial evaluating lead candidate, APVO436 for the treatment of acute myeloid leukemia (AML). Results included:
Data from cohort 1 (combination therapy) that showed a total of four out of 11 response-evaluable patients (36%) experienced remission while on therapy, as of June 9, 2022
Cohort 3 (monotherapy) also yielded two patients with clinical activity
Also on June 9, 2022, the Company reported that a patient with high-risk myelodysplastic syndrome (MDS) enrolled in the dose escalation phase of the APVO436 clinical trial remained stable and continued treatment with APVO436, exceeding 18 months of therapy
ALG.APV-527 remains on track for IND submission in the second half of 2022, following a pre-IND meeting with the FDA held during the second quarter
Presented preclinical data for APVO442, for the potential treatment of prostate cancer, in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Aptevo expects to announce the addition of a new molecule to the pre-clinical pipeline by the end of the year
"We are very pleased to have announced clinical activity data in six patients from our on-going APVO436 Phase 1b expansion trial and are encouraged with results that show responses in both combination and monotherapy arms, which will potentially yield multiple clinical development paths in later stage trials. We also intend to share a more comprehensive clinical update later this year," said Marvin White, President and CEO of Aptevo. "Overall, we saw a lot of momentum in the second quarter, with APVO436 leading the way. Adding to the momentum is the planned clinical entry of ALG.APV-527 for the treatment of solid tumors and the introduction of a new pipeline candidate, both of which are expected to occur by the end of the year. Together, achievement of these milestones has the potential to translate into significant value for our shareholders in the future."

Second Quarter 2022 Financial Results Summary

Cash Position : Aptevo had cash, cash equivalents and restricted cash of $30 million as of June 30, 2022. This includes $0.5 million of restricted cash that is expected to be released before the end of the year

Royalty Revenue: For the six months ended June 30, 2022 and June 30, 2021, royalty revenue was $3.1 million and $5.5 million, respectively. Royalty revenue for 2022 reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR, as discussed in the following paragraphs.

During the quarter, the Company successfully renegotiated its Royalty Purchase Agreement with HCR. The Amendment to Royalty Purchase Agreement resulted in Aptevo recognizing a $37.2 million gain during the quarter, which allowed us to be compliant with Nasdaq’s Listing Rule 5550(b)(1) ("Rule") requiring the Company to have at least $2.5 million of stockholders’ equity. This Amendment to Royalty Purchase Agreement allowed us to regain compliance with the Rule in a way that was non-dilutive for our shareholders.

Under the Amendment, Aptevo will not recognize royalty revenue on net sales of RUXIENCE (rituximab-pvvr) paid by Pfizer to HCR on a go-forward basis. The Amendment does not affect cash already collected from HCR or the potential $22.5 million in milestone payments we may collect in the future based on achievement of RUXIENCE sales milestones in 2022 and 2023. RUXIENCE is a trademark of Pfizer.

Research and Development Expenses : For the three months ended June 30, 2022, research and development expenses decreased by $0.8 million, to $3.9 million from $4.7 million for June 30, 2021. The decrease was primarily due to lower spending on preclinical projects and employee costs. The decrease was partially offset by higher spending on our APVO436 clinical trial as we continue to dose patients in our Phase 1b Expansion program.

General and Administrative Expenses : For the three months ended June 30, 2022, general and administrative expenses decreased by $0.4 million, to $3.7 million from $4.1 million for June 30, 2021. The decrease is primarily due to lower employee costs and lower costs related to responding to stockholder activism matters.

Other Income (Expense), Net: Other income (expense), net consists primarily of gain on extinguishment of liabilities, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other income, net was $35.4 million for the three months ended June 30, 2022, as compared to $2.3 million other expense, net for the three months ended June 30, 2021. The change in other income (expense), net is primarily related to the above-described Amendment to Royalty Purchase Agreement.

Discontinued Operations: For the three months ended June 30, 2022 and 2021, we collected $0.2 and $0.1 million in deferred payments from Medexus related to IXINITY sales, respectively. Pursuant to our LLC Purchase Agreement, the rate for deferred payments increased from 2% to 5% of net sales as of June 30, 2022.

Net Income (Loss) : Aptevo’s net income for the three months ended June 30, 2022, was $28.0 million or $5.58 per share, as compared to a net loss of $7.9 million or $1.75 per share for the corresponding period in 2021.

On August 11, 2022 Vyant Bio, Inc. ("Vyant Bio" or "Company") (Nasdaq: VYNT) is an innovative biotechnology company reported that reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, AUG 11, 2022, View Source [SID1234618165]). The Company’s proprietary central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning. Today, Vyant Bio announced that it will release its financial results for the second quarter and first half ended June 30, 2022, on Monday, August 15, 2022. Vyant Bio will host an investor conference call and webcast on Monday, August 15, 2022 at 4:30 pm ET.

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Jay Roberts, Chief Executive Officer, Andy LaFrence, Chief Financial Officer, and Robert Fremeau, PhD, Chief Scientific Officer, of Vyant Bio will provide an update on the business, scientific, and financial progress made during the second quarter and first half of 2022. Management will also be taking audience questions that are submitted in advance only. Investors may submit written questions via e-mail to: [email protected]

Event: Vyant Bio Investor Conference Call and Webcast for the Second Quarter and First Half 2022
Date: Monday, August 15, 2022
Time: 4:30 pm ET
Dial In: Toll Free: 1.844.369.8770 Conference ID: 46372
Webcast: View Source
The event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

On August 11, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, Synthetic Biologics, AUG 11, 2022, View Source [SID1234618164]).

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"We are pleased with the steady progress that continues to support the advancement of our novel OV platform and further underscores the potential value of our lead candidate, VCN-01, designed to address devastating cancers with high unmet need through a differentiated and potentially transformative mechanism of action," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We have made the strategic decision to rationalize our spend and prioritize our oncology program, which is expected to extend cash runway into the first quarter of 2024. We believe this sharpened approach has the potential to drive near-term value for our shareholders and propel us forward to key milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023."

Recent Program Developments:

The acquisition of VCN Biosciences transformed Synthetic Biologics’ pipeline with the addition of VCN’s lead clinical-stage drug candidate, VCN-01, an intravenous oncolytic adenovirus (OV), as well as preclinical stage VCN-11, which incorporates a proprietary albumin binding domain in the virus shell which is intended to improve systemic delivery by enabling the virus to coat itself in albumin and thereby evade neutralizing antibodies (NAbs).
Initiated the investigator sponsored Phase 1, open-label, non-randomized clinical trial evaluating VCN-01 in combination with mesothelin-directed lentiviral transduced human chimeric antigen receptor modified T cells (huCART-meso) for patients with pancreatic and serous epithelial ovarian cancers (NCT05057715).
Corporate Update:

On July 25, 2022, the Company’s common stock began trading on a split-adjusted basis. The Company’s common stock continues to trade on the NYSE American under the stock ticker "SYN" but under the new CUSIP number 87164U409.
Anticipated Milestones:
VCN-01

Initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of Leeds (H2 2022).
Data from the VCN-01 Phase 1 investigator sponsored study in and head and neck cancer to be presented at a major medical meeting (Q3 2022)
Initiation of a Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients (Q4 2022).
Initiation of a Phase 2/3 study of VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2 2023).
SYN-004

Topline data read out from the first cohort of the SYN-004 study in allo-HCT patients (H2 2022) followed by initiation of the second cohort (Q4 2022).
Quarter Ended June 30, 2022 Financial Results

General and administrative expenses increased to $1.5 million for the three months ended June 30, 2022, from $1.3 million for the three months ended June 30, 2021. This increase of 19% primarily comprised of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit fees, and public relations expenses and VCN administrative expenses not included in prior year. The charge related to stock-based compensation expense was $86,000 for the three months ended June 30, 2022, compared to $83,000 the three months ended June 30, 2021.

Research and development expenses increased to $3.5 million for the three months ended June 30, 2022, from approximately $1.9 million for the three months ended June 30, 2021. This increase of 80% is primarily the result of VCN research expenses related to VCN-01 not incurred in the prior year and to a lesser extent higher manufacturing expense for SYN-020, costs incurred related to our Phase 1a clinical trial of SYN-020 and expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we plan for and initiate enrollment for our phase 2 clinical trial for VCN-01 in PDAC, phase 2/3 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue with supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $27,000 for the three months ended June 30, 2022, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2021.

Other income was $17,000 for the three months ended June 30, 2022 compared to other income of $2,000 for the three months ended June 30, 2021. Other income for the three months ended June 30, 2022 is primarily comprised of interest income of $26,000 offset by an exchange loss of $9,000. Other income for the three months ended June 30, 2021 is primarily comprised of interest income.

Cash and cash equivalents totaled $52.3 million as of June 30, 2022, compared to $67.3 million as of December 31, 2021. Cash and cash equivalents totaled approximately $53.5 million as of August 1, 2022.

On July 29, the company closed a private placement of Series C and Series D convertible preferred stock with MSD Credit Opportunity Master Fund, L.P. Total gross proceeds from the offerings, before deducting discounts, financial advisor fees and other estimated offering expenses, were $3 million.

Conference Call

Synthetic Biologics will host a conference call at 8:30 a.m. ET today to review second quarter 2022 operational highlights and financial results. Investors may participate in the live call via telephone by dialing (800) 289-0571 (domestic) or (929) 477-0324 (international) and using the conference ID: 7145566. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "News & Media" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.