On March 17, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that financial results for the three-month period and full year ended December 31, 2021 (Press release, Spectrum Pharmaceuticals, MAR 17, 2022, View Source [SID1234610285]).

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"We have made significant progress against our core business objectives including the acceptance of the poziotinib NDA and resubmission of the eflapegrastim BLA to the FDA. We have also recently released positive data in front-line NSCLC patients harboring HER2 exon 20 insertion mutations," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Additionally, we have strengthened our strategic corporate partnerships, restructured our operations, and are focused on advancing our mission."

Pipeline Updates

Eflapegrastim, a novel long-acting G-CSF

The company has resubmitted the Biologics License Application (BLA) with an expected six-month review for eflapegrastim following remediation of manufacturing deficiencies. The FDA has indicated that a reinspection of the drug substance manufacturing facility in South Korea will be required.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20 mutations

The New Drug Application (NDA) was accepted for review by the FDA under a Fast Track designation. The NDA is based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The agency has set a Prescription Drug User Fee Act (PDUFA) date of November 24, 2022. There is no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
Data from Cohort 4 of the ZENITH20 study in patients with treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations were recently delivered in an oral presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2022. The results showed a confirmed objective response rate (ORR) of 41% (95% CI:30%-54%), as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the tyrosine kinase inhibitor (TKI) class. Notably, on-target AEs were reduced with BID dosing.
Preclinical data showing synergy of poziotinib combined with KRAS inhibitors in KRASG12C mutant specific cell lines, was presented in a poster titled "Pan-ErbB inhibition enhances activity of KRASG12C inhibitors in preclinical models of KRASG12C mutant cancers" at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (AACR-NCI-EORTC) (Free AACR-NCI-EORTC Whitepaper). The data showed that inhibition of EGFR, HER2, HER3, and HER4 (Pan ErbB) signaling was synergistic when combined with KRASG12C inhibitors.
Corporate Updates

As of December 31, 2021, Tom Riga, who had been serving as Chief Commercial and Chief Operating Officer became President and Chief Executive Officer of Spectrum Pharmaceuticals and joined the Board of Directors. On February 23, 2022, Kurt Gustafson, Chief Financial Officer, provided notice of his resignation to pursue other professional opportunities. His last day at the company is March 18, 2022. The company has initiated a selection process to name a new chief financial officer.
Hanmi Pharmaceutical completed a $20 million strategic equity investment in Spectrum in January 2022, which included revisions to the licensing agreement for eflapegrastim and poziotinib.
Juhyun Lim was appointed to the company’s Board of Directors. Ms. Lim currently serves as President, Global Strategy and Planning at Hanmi Science and Hanmi Pharmaceutical, where she leads the execution of corporate strategy and investment. She also serves as Director, Healthcare Investment at Hanmi Ventures.
Strategic restructuring with a ~30% staff reduction and ~20-25% reduction in operating cash burn was announced in January 2022 to focus the company’s development activities on late-stage assets, poziotinib and eflapegrastim. Further development activity for its early-stage pipeline have been deprioritized.
Three-Month Period Ended December 31, 2021 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $39.8 million, or $0.26 per basic and diluted share, in the three-month period ended December 31, 2021, compared to net loss of $49.9 million, or $0.36 per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $18.0 million in the quarter, as compared to $47.2 million in the same period in 2020. Selling, general and administrative expenses were $18.9 million in the quarter, compared to $15.7 million in the same period in 2020.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $26.4 million, or $0.17 per basic and diluted share, in the three-month period ended December 31, 2021, compared to non-GAAP net loss of $28.9 million, or $0.20 per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $16.7 million, as compared to $17.1 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $10.2 million, as compared to $12.3 million in the same period in 2020.

Twelve-Month Period Ended December 31, 2021 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $158.4 million, or $1.02 per basic and diluted share, in the twelve-month period ended December 31, 2021, compared to net loss of $171.3 million, or $1.38 per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $87.3 million for the year, as compared to $109.4 million in the same period in 2020. Selling, general and administrative expenses were $60.4 million for the year, compared to $60.4 million in the same period in 2020.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $120.7 million, or $0.78 per basic and diluted share, in the twelve-month period ended December 31, 2021, compared to non-GAAP net loss of $120.9 million, or $0.97 per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $79.2 million, as compared to $75.6 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $42.8 million, as compared to $47.2 million in the same period in 2020.

Cash Position and Guidance

Spectrum reported cash, cash equivalents, and marketable securities of approximately $100.6 million as of December 31, 2021, compared to $180 million at December 31, 2020. In January, the company received a $20 million strategic equity investment from Hanmi. The additional cash, combined with the restructuring, is expected to extend the company’s cash runway into 2023.

Conference Call

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on March 17, 2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On March 17, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the following statement regarding a lawsuit filed by Illumina that seeks to challenge Guardant Health’s ownership and authorship of a portion of its intellectual property and to suppress competition in the market (Press release, Guardant Health, MAR 17, 2022, View Source [SID1234610284]).

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Commenting on the lawsuit, John Saia, the company’s SVP, General Counsel and Corporate Secretary, said: "At Guardant Health, our mission for the last 10 years has been to develop groundbreaking blood tests that improve cancer care and save patients’ lives. Nearly a decade after these patents were filed, Illumina’s lawsuit frivolously challenges our ownership and authorship of our intellectual property, which is the backbone of our vital work. We believe Illumina is using the courts to retaliate against us for registering concerns about the antitrust implications of Illumina’s acquisition of Grail – another provider of blood-based cancer tests – and in an attempt to slow us down in the marketplace as we get ready to launch our blood test to screen for early signs of colorectal cancer. Despite these efforts, our long-term supply agreement with Illumina remains in force and our work for patients will not be interrupted. However, we cannot stand by and allow unfair practices in the marketplace or false claims to be made about our intellectual property, which we will vigorously defend. The stakes are too high for the cancer patients who rely on our important work."

On March 17, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported the upcoming oral presentation of the discovery and initial clinical utility of a novel signature that identifies patients with head and neck squamous cell carcinoma (HNSCC) that may benefit from treatment beyond typical surgical resection (Press release, GeneCentric Therapeutics, MAR 17, 2022, View Source [SID1234610283]). The presentation will be made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, one of the world’s largest and long-standing scientific gatherings in the field of cancer research, which is being held in New Orleans, Louisiana, April 8-13, 2022. The results to be presented are from an ongoing collaboration with Jose P. Zevallos, MD, MPH, at the Washington University School of Medicine in St. Louis and Neil Hayes, MD, MPH, at the University of Tennessee Health Science Center’s Center for Cancer Research to discover and develop new prognostic and/or predictive signatures and related tests to aid in the selection of treatments for HNSCC.

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Multiple independent retrospective datasets were utilized as part of the initial signature discovery, including those providing for its initial clinical utility. Oral cavity HNSCC patients with lymph node-negative disease, who are typically treated with surgical resection without additional radiation and/or chemotherapy, were identified as mesenchymal or non-mesenchymal based upon the novel RNA-based signature. For the nearly one-quarter who were mesenchymal, survival was 2.4-fold worse compared to the remaining non-mesenchymal patients. A future diagnostic test, based upon this signature and related clinical findings, potentially may be used to ‘upstage’ patients typically receiving only surgical reduction to become candidates for the addition of radiation and/or chemotherapy.

"I am excited to present our initial findings from this important collaboration with my colleagues at Washington University School of Medicine and GeneCentric evaluating molecular subtypes for head and neck cancer," said Neil Hayes, MD, MPH, GeneCentric co-founder and Director of the University of Tennessee Health Science Center’s Center for Cancer Research. "In this study, our new RNA-based signature identified a significant population of patients who typically only undergo surgical resection based upon their lymph node status but have poor prognosis, making them likely candidates for additional treatment options such as radiation and/or chemotherapy."

Full results from the initial molecular analysis and clinical utility from this study, as well as potential future applications, will be presented at the conference. Further demonstration of clinical utility is ongoing, as well as initial test development discussions with several commercial reference laboratories.

Details regarding the presentation are provided below and will be available following the meeting at View Source

Title: Prognostic and predictive applications from mesenchymal gene expression subtype analysis for early-stage, HPV(-) head and neck squamous cell carcinoma

First Author: Neil Hayes, MD, MPH, Department of Medical Oncology, University of Tennessee Health Science Center’s Center for Cancer Research, Memphis, Tennessee

Abstract Number: 2142

Session: Session MS.CL11.02 – Biomarkers 2

Date: April 11, 2022

Time: 3:20-3:35 PM CST

About Head and Neck Cancer

Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers worldwide, and in the United States it is estimated that there were approximately 66,000 new cases and 14,00 deaths in 2021. The 5-year overall survival for Stage I-II and III-IV HNSCC is approximately 70-90% and 40-60%, respectively. Oral cavity HNSCC is the most common head and neck cancer, accounting for one-third of cases with a majority HPV-negative and associated with tobacco use. While the treatment of HNSCC depends on multiple tumor and patient-related factors, the three main treatments are surgical resection, radiation therapy and chemotherapy. Patients with early-stage lymph node-negative tumors are generally treated with surgical resection, but treatment for those with more advanced lymph node-positive tumors often includes radiation and/or chemotherapy.

On March 17, 2022 ZAP Surgical Systems, Inc. reported that Unicancer, a leading academic promoter of oncology clinical trials and medical equipment purchasing health cooperation group for 19 French comprehensive cancer centers, has selected the ZAP-X Gyroscopic Radiosurgery platform for cranial stereotactic radiosurgery (Press release, ZAP Surgical Systems, MAR 17, 2022, View Source [SID1234610282]). Carefully chosen by domain experts including neurosurgeons, radiation oncologists, and medical physicists, Unicancer awarded ZAP-X as technology-of-choice for their member institutions.

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Radiosurgery, also commonly referred to as SRS, is well recognized as an alternative to surgery for effectively treating many brain tumors, including brain metastases and functional disease. Unique from surgery however, radiosurgery requires no incision, no pain, and patients often immediately return to normal activities.

"Highly specialized treatments such as SRS require highly specialized tools. ZAP-X’s dedication to treating only cranial indications was critical in our selection process", states Luc Delporte, Director of Purchasing and Access to Innovation at Unicancer. "While multi-purpose radiation delivery systems, commonly used to treat prostate and lung cancers, are readily available, the tailor-made design of ZAP-X for delivering world-class SRS will allow us to optimally protect healthy brain tissue and seek the best patient outcomes available."

Using a distinctive gyroscopic design, the ZAP-X platform delivers hundreds of uniquely angled ionizing beams to precisely sculpt radiation to the unique contours of targeted tumors.

ZAP-X is also recognized for being the first and only dedicated intracranial SRS platform to no longer require hosting volatile radioactive isotopes in the clinical setting. Additionally, ZAP-X is acclaimed for being the first and only vault-free SRS delivery system, thus typically eliminating the need for providers to build costly shielded radiation treatment rooms.

On March 17, 2022 Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) EGFR exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA for this indication (Press release, Foundation Medicine, MAR 17, 2022, View Source [SID1234610281]).

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EGFR mutations are the second most common oncogenic drivers in NSCLC. Deletions in exon 19 and substitutions in exon 21 account for roughly 85 percent of observed EGFR mutations in NSCLC.1 As a companion diagnostic for therapies targeting these mutations in NSCLC, FoundationOneCDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.

"Cancer treatment decision-making is growing more complex as we learn more about the mutations that drive cancers to grow and new treatments become available to target those changes," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "We believe securing a third group companion diagnostic approval for FoundationOne CDx is another critical step toward simplifying the decision-making process for oncologists and their patients by allowing them to uncover all FDA approved treatment options for this indication through one test."

In addition to driving efficiency in clinical care, this approval is part of an innovative, efficient regulatory approach that simplifies the companion diagnostic approval process for Foundation Medicine’s biopharma partners developing EGFR inhibitor therapeutics targeting EGFR exon 19 deletions or exon 21 alterations in NSCLC while maintaining rigorous quality standards.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source