On October 4, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a publication from The University of Texas, MD Anderson Cancer Center entitled, "Pan-Cancer Landscape and Functional Analysis of ERBB2 Mutations Identifies Poziotinib as a Clinically Active Inhibitor and Enhancer of T-DM1 Activity (Press release, Spectrum Pharmaceuticals, OCT 4, 2019, View Source [SID1234540055])." The publication appears in the Oct 3, 2019 online issue at View Source(19)30384-8 and will be published in a future print issue of Cancer Cell.

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"Our analysis is the largest ever conducted to understand the diversity of HER2 mutations across 25 cancer types, including more than 200,000 patients from cBioPortal, MD Anderson, Foundation Medicine, and Guardant Health," said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson. "In our pre-clinical study of 11 EGFR/HER2 tyrosine kinase inhibitors, poziotinib was the most potent HER2 mutant-selective TKI tested, and in our initial clinical cohort we found that poziotinib was highly active in NSCLC patients with HER2 exon 20 mutations. Our findings indicate that poziotinib may be well-suited to target HER2 mutations with a constricted binding pocket. Furthermore, we have determined from pre-clinical data that poziotinib is synergistic with a HER2-targeting antibody-drug conjugate, providing a rationale for combinations to move forward into the clinic."

Spectrum is studying poziotinib in ZENITH20, a company-sponsored, open-label, single-arm, multi-center, global Phase 2 study of non-small cell lung cancer (NSCLC) patients.

"The publication of these latest research findings from MD Anderson on poziotinib in the journal Cancer Cell continues to strengthen the evidence of the potential benefit of poziotinib in the treatment of lung cancer," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "This quarter, we plan to disclose topline data from the first cohort of the company-sponsored ZENITH20 study, which is analyzing previously-treated NSCLC patients with exon 20 mutations in EGFR. By mid-2020 we also expect topline data from cohort 2, which is studying previously treated NSCLC patients with exon 20 mutations in HER2. We look forward to the top line data from the ZENITH20 study this quarter and continue to expand the poziotinib program, based on emerging science, to other areas of opportunity."

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.

About ZENITH20

The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) have completed enrollment of previously-treated NSCLC patients with exon 20 mutations. Cohort 3 (EGFR) and 4 (HER2) are currently enrolling first-line NSCLC patients with exon 20 mutations. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). In July 2019, three new cohorts were added to the ZENITH20 study that are all currently enrolling patients. Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.

On Oct. 03, 2019, PDS Biotechnology Corporation ("PDS Biotechnology") (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of multi-functional immunotherapeutic products, reported a modification of the clinical trial collaboration agreement with a subsidiary of Merck (known as MSD outside the United States and Canada) to evaluate the combination of PDS’s lead Versamune-based immunotherapy, PDS0101, with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase II clinical trial (Press release, PDS Biotechnology, OCT 3, 2019, View Source [SID1234583939]). The planned clinical trial will now evaluate the efficacy and safety of the combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection and is expected to be initiated in the first quarter of 2020.

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The modification to the clinical trial design now allowing evaluation of PDS0101 in combination with KEYTRUDA as first-line treatment comes as a result of Merck’s recent approval by the FDA on June 10, 2019 for KEYTRUDA as monotherapy in patients whose tumors express PD-L1 (CPS ≥1) or in combination with platinum and fluorouracil (FU) for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.

"We are honored to collaborate with Merck, a proven leader in the field of immuno-oncology to evaluate novel investigational combination therapies that have the potential to further improve the lives of cancer patients," said Dr. Lauren V. Wood, Chief Medical Officer of PDS." The recently updated clinical outcome findings of the PDS0101 phase 1 human clinical trial demonstrate unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses (regression/ elimination of pre-cancerous lesions) in the majority of evaluable patients treated with PDS0101 monotherapy, and a lack of dose limiting toxicities at all tested doses (PDS press release September 19, 2019). Preclinical data demonstrating the novel multi-functional mechanism of action of the Versamune platform technology and the resulting superior T-cell induction and unique regression of advanced tumors were published in the June 2019 issue of the Journal of Immunology.

PDS Biotechnology’s lead product candidate, PDS0101 (Versamune-HPV) is a proprietary clinical stage immunotherapeutic administered by subcutaneous injection being developed to treat HPV-associated cancers. These include cancers such as head and neck cancers and anal cancers, both of which are widely reported to be increasing in frequency over the last decade, and cervical cancer.

Details of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Versamune is a registered trademark of PDS Biotechnology Corporation, Berkeley Heights, NJ, USA.

On October 3, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the first quarter of fiscal year 2020, which ended August 31, 2019 (Press release, AngioDynamics, OCT 3, 2019, View Source [SID1234540038]).

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"Our top-line and gross-margin performance in the quarter was in line with our expectations," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We continue to build momentum and remain focused on driving growth by creating a suite of disruptive and differentiated technology. The divestiture of the NAMIC Fluid Management business allowed us to begin the year with a strong balance sheet, enabling strategic acquisitions like Eximo Medical, Ltd., which we announced this morning. Additionally, we continue to make steady progress with site initiation in our NanoKnife DIRECT study for pancreatic cancer."

First Quarter 2020 Financial Results

Net sales for the first quarter of fiscal 2020 were $66.0 million, an increase of 3.3%, compared to $63.9 million a year ago and representing a decline of 1.0% organically. Excluding the impact of Asclera, sales of which were discontinued during fiscal year 2019, net sales grew 5.6% year over year and grew 1.3% organically. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $14.0 million, an increase of 20.9% from $11.6 million a year ago, led by sales of the Company’s BioSentry Tract Sealant System, the Alatus and IsoLoc balloon products, NanoKnife, and Solero.
Vascular Interventions and Therapies ("VIT") net sales were $28.9 million, an increase of 1.1%, compared to $28.6 million a year ago. Excluding last year’s Asclera Sales of $1.4 million in the first quarter, VIT grew 6.4%, as strong growth in sales of the Company’s AngioVac and Thrombolytic product line offerings was partially offset by a decline in the overall Core VIT business.
Vascular Access net sales were $23.2 million, a decrease of 2.7% from $23.8 million a year ago, as lower sales of Ports and PICCs negatively offset growth in the Midlines and Dialysis businesses.
U.S. net sales in the first quarter of fiscal 2020 were $52.9 million, an increase of 2.8% from $51.5 million a year ago, and International net sales were $13.1 million, an increase of 5.3% from $12.4 million a year ago.

Gross margin for the first quarter of fiscal 2020 was 57.9%, an increase of 170 basis points compared to the first quarter of fiscal 2019, driven primarily by productivity and supply chain improvements as well as positive product mix.

The Company recorded a net loss from continuing operations of $1.3 million, or a loss of $0.03 per share, in the first quarter of fiscal 2020. This compares to a net loss from continuing operations of approximately $5.7 million, or a loss of $0.15 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the first quarter of fiscal 2020 was $3.2 million, or $0.08 per share, compared to adjusted net income of $0.7 million, or $0.02 per share, in the first quarter of fiscal 2019.

Adjusted EBITDAS in the first quarter of fiscal 2020, excluding the items shown in the reconciliation table below, was $7.3 million, compared to $5.4 million in the first quarter of fiscal 2019.

In the first quarter of fiscal 2020, the Company used $6.5 million in operating cash flow and had capital expenditures of $1.4 million. As of August 31, 2019, the Company had $83.6 million in cash and cash equivalents and no debt outstanding.

Fiscal Year 2020 Financial Guidance

The Company continues to expect fiscal year 2020 net sales to be in the range of $280 to $286 million and gross margin to be in the range of 58% to 59%, inclusive of the Eximo acquisition.

Separately, the Company is updating its expectations for full-year adjusted earnings per share to account for investments related to the full-market launch of the products acquired from Eximo, anticipated in the second half of fiscal year 2020, and now expects adjusted earnings per share in the range of $0.10 to $0.15.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2020 first quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13694372.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, October 3, 2019, until 11:59 p.m. ET on Thursday, October 10, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13694372.

On October 3, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported a poster highlighting new preclinical duvelisib (COPIKTRA) data that will be presented at the 5th International Conference on New Concepts in Lymphoid Malignancies, which is hosted by the European School of Haematology (ESH), and is taking place October 3-5, 2019, in Estoril, Portugal (Press release, Verastem, OCT 3, 2019, View Source [SID1234540039]). The poster features preclinical research that compared duvelisib with idelalisib in preclinical models of mantle cell lymphoma (MCL). COPIKTRA is not approved for use in MCL, diffuse large B-cell lymphoma (DLBCL), or marginal zone lymphoma (MZL).

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"These data highlight MCL as a B-cell malignancy which expresses both PI3K-delta and PI3K-gamma in the malignant B cells, in addition to the role of PI3K-gamma which has already been established in cells of the supportive tumor microenvironment," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem Oncology. "Accordingly, the data show superior anti-cancer activity of the dual PI3K-delta/gamma inhibitor duvelisib compared to the PI3K-delta inhibitor idelalisib in these preclinical MCL models. At Verastem Oncology, we are working to expand into additional lymphoid malignancy indications and these data provide additional support for the future study of duvelisib through clinical trials in patients with MCL."

Duvelisib in Preclinical Models of MCL

MCL is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) that is incurable. The purpose of this research was to gain a functional understanding of the distinctive features associated with the malignant cells in MCL, with the goal of identifying potential new treatment strategies. PI3K-delta is known to be equally expressed in all B-cell malignancies and this research revealed that primary MCL cells show elevated expression of PI3K-gamma relative to primary cells from other B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL). These preliminary data suggest that high levels of PI3K-gamma in MCL cells correlate with poorer disease outcomes.

The researchers then examined the effects of inhibition of specific PI3K isoforms, including PI3K-alpha, PI3K-delta (idelalisib), PI3K-gamma, and dual PI3K-delta/gamma (duvelisib), on the migration and proliferation of malignant lymphocytes from patients with MCL. These preclinical models showed that inhibition of both PI3K-delta and gamma reduced the proliferation of MCL cells whereas inhibition of PI3K-delta alone had no effect. The functional role of PI3K-delta and gamma in MCL cells was further differentiated from that of PI3K-delta alone. PI3K-delta and gamma more effectively inhibited CCL21-induced migration of MCL cell lines and primary MCL cells than did PI3K-gamma inhibition alone. Inhibition of PI3K-delta or PI3K-alpha did not affect CCL21-induced migration of MCL cells. These data suggest that when PI3K-gamma is aberrantly expressed by MCL cells, these cells become reliant on this PI3K isoform for chemokine-induced migration and tissue residency. Thus, duvelisib may have potential in MCL therapy by restricting entry, retention, and proliferation of the malignant cells within the mantle zone.

Details for the ESH 2019 poster presentation are as follows:

Title: Aberrantly Expressed PI3Kγ Contributes to Cell Proliferation and Co-Operates with PI3δ to Mediate CCL21-Induced Migration in Mantle-Cell Lymphoma: Therapeutic Implications for Duvelisib
Lead author: Kathy Till, University of Liverpool
Date and time: Thursday, October 3, 2019, beginning at 7am through the end of the conference
Location: Poster Area

A PDF copy of this poster presentation will be available here after the meeting.

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safely and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full Prescribing Information for complete boxed warning

Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

Please see accompanying full Prescribing Information, including Boxed Warning.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On October 3, 2019 Biodesix, Inc., reported it has been issued U.S. Patent Number 10,422,729, which covers the Biodesix Collection Device (BCD) (Press release, Biodesix, OCT 3, 2019, View Source [SID1234540040]). The new device offers improved ease of use in blood sample collection for diagnostic testing, compared to current standard methods.

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"This device is intuitive and very easy to use," remarked Susan Garwood, M.D., Pulmonary and Advanced Bronchoscopy Lung Cancer Specialist with Centennial Medical Center in Nashville, part of the HCA TriStar division. "The Biodesix Collection Device enables the opportunity for a fast, simple collection process. Enhancing patient comfort while retaining accuracy is of top concern for all professionals drawing patient blood samples."

The BCD, currently in use with the Biodesix Nodify XL2 test, replaces the need for processing samples used for proteomic testing on-site and shipping blood tubes, which often requires cold-chain logistics during transit to the testing laboratory. This reduces the need for processing equipment such as centrifuges in the clinic, improves sample stability during transit and eliminates the need for single-use, bulky shipping containers containing materials such as Styrofoam that are not only costly but also have a negative environmental impact.

"The BCD is designed for exceptional laboratory test performance and surpasses similar collection methods by combining multiple sample processing steps, including specimen collection and reproducible sample separation with ambient shipping. Specimen stability has been demonstrated with analytic measures of proteins using highly sensitive mass spectrometry methods," said Gary Pestano, Ph.D., chief development officer at Biodesix.

"Our commitment to innovation continues to improve the customer experience," commented Scott Hutton, chief operating officer at Biodesix. "We are as focused as ever on supporting healthcare professionals and their patients by providing increasingly valuable information to physicians using a noninvasive blood collection. The new BCD significantly reduces cost and environmental impact over current sample collection practices, and we are excited to not only use this for our own tests but to make it available for broad use across the industry."

Biodesix is planning to use the new BCD in all current and future proteomic testing and also make the device available for purchase by labs and diagnostic companies wishing to use this novel technology for their own sample processing and testing. To see how the BCD is used to collect specimens for the Nodify XL2 test visit this link.