On August 11, 2022 PsiOxus Therapeutics, Ltd. (PsiOxus), a clinical-stage biotechnology company developing a novel platform technology for the targeted delivery of therapeutic transgenes to solid tumors, reported the appointment of Howard Davis, Ph.D., as Chief Executive Officer (Press release, PsiOxus Therapeutics, AUG 11, 2022, View Source [SID1234618170]). Dr. Davis will be based in the greater Boston metropolitan area where he will establish the company’s U.S. operations. He succeeds interim CEO Priya Mande who will continue to serve the company in the new role of Chief Operating Officer and U.K. President.

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"Howard joins us at a critical stage for PsiOxus, as we rapidly progress our NG-350A and NG-641 immuno-oncology programs through early clinical studies and leverage our novel T-SIGn platform to further expand our pipeline," said Duncan Higgons, Chairman of the Board of PsiOxus. "We believe Howard’s exceptional leadership skills combined with his extensive experience across all phases of the product development lifecycle will help PsiOxus realize the full promise of its platform."

"PsiOxus has developed a groundbreaking platform in the T-SIGn viral vector system and the company’s pipeline has the potential to truly revolutionize the treatment of solid tumors," said Dr. Davis. "With the team’s rapid advancement of the NG-350A and NG-641 programs into the clinic, we anticipate a significant flow of clinical data in the coming quarters. I am thrilled to join the PsiOxus team at this exciting juncture and look forward to leading the company into its next chapter as we seek to deliver on our mission to positively impact the lives of people living with cancer."

Dr. Davis brings more than 20 years of experience to PsiOxus having served in diverse roles across VC-backed biotech and large pharma companies spanning a broad range of therapeutic areas including neuroscience, ophthalmology, immunology, and rare diseases. Most recently, Dr. Davis worked with Atlas Venture on the launch of Third Harmonic Bio, a clinical stage immunology company where he served as COO with responsibility for business development, new product planning, finance, HR, legal / IP, and IT. During his tenure, he spearheaded fundraising efforts that secured $155 million in private financing to support the company’s advancement of its lead clinical stage molecule. Earlier in his career, Dr. Davis served as a Principal at Flagship Pioneering where he focused on expanding the firm’s portfolio of corporate strategic partnerships while also supporting new company creation efforts. Prior to Flagship, Dr. Davis held roles of increasing responsibility at Biogen and Novartis across a range of functional areas including commercial, manufacturing, pipeline program leadership and corporate strategy. He began his industry career at Boston Consulting Group where he advised both large pharma and biotech clients. Dr. Davis holds a Bachelor of Science degree in Chemical Engineering from Yale University and a Ph.D. in biomedical engineering from the Harvard University / Massachusetts Institute of Technology Division of Health Sciences & Technology.

"Howard is uniquely positioned to lead PsiOxus through its next phase of growth as we establish our U.S. presence to support preparations for late-stage clinical development, expanded partnerships, and U.S.-focused financing activities. I would like to thank Priya Mande for her leadership of the company during the CEO search process, and we look forward to her continued valuable contributions as COO and U.K. President," said Mr. Higgons.

On August 11, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that its subsidiary, LucidDx Labs Inc. ("LucidDx Labs"), has launched four new Lucid Test Centers in Orange County, California, the Dallas-Fort Worth, Texas metropolitan area, Palm Beach County, Florida and Columbus, Ohio (Press release, Lucid Diagnostics, AUG 11, 2022, View Source [SID1234618169]).

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Patients in these metropolitan areas with chronic heartburn, also known as gastroesophageal reflux disease ("GERD"), and an order from their own physician or from a telemedicine physician provided to them after a self-referral, can now undergo a brief, non-invasive, office-based test to detect esophageal precancer before it progresses to deadly esophageal cancer, using Lucid’s EsoGuard DNA Esophageal Test ("EsoGuard") on samples collected using its EsoCheck Cell Collection Device ("EsoCheck"). Lucid believes EsoGuard is the first and only commercially available test capable of serving as a widespread tool to prevent esophageal cancer deaths, through early precancer detection in at-risk GERD patients.

"We are excited to launch the second stage of our Lucid Test Center program, an important pillar of our growth strategy, in several new major metropolitan areas including in the three largest U.S. states," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "During the first stage we covered seven, mostly medium-sized, metropolitan areas in the Southwest and Pacific Northwest, which allowed our team to hone our sales processes targeting primary care physicians and to build a robust compliance program. With stage two, during which we project to open centers in nine new metropolitan areas this year, we are establishing a broader, national footprint using demographic and other analytics to select high-value target locations across the country. We are also able to place test centers in locations where existing sales personnel are already having success calling on specialists and institutions and where our prospects for local private payor coverage is strongest as a result of our growing participation in preferred provider networks."

The test centers are staffed with Lucid-employed nurse practitioners who use EsoCheck to collect surface esophageal cells which are sent to LucidDx Labs for EsoGuard testing. The new Lucid Test Centers operate in leased medical office suites located in Lake Forest, California, Las Colinas, Texas, Delray Beach, Florida, and Columbus, Ohio. The Lake Forest Lucid Test Center is co-located with LucidDx Labs’ CLIA certified, CAP accredited commercial clinical laboratory. Lucid estimates that a single nurse practitioner can perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office lease costs with only a few tests per week.

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing element—the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. An updated American College of Gastroenterology clinical practice guideline and an American Gastroenterological Association clinical practice update both endorse nonendoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s CLIA-certified, CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing.

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.