On November 10, 2020 Medikine, Inc., a preclinical-stage biopharmaceutical company developing innovative peptide-based agonists of cytokine receptors relevant to cancer treatment, reported that it will deliver three poster presentations at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2020), which is being held virtually November 9-14, 2020 (Press release, Medikine, NOV 10, 2020, View Source [SID1234570641]). The posters highlight preclinical data on three recombinant Fc-fusions incorporating peptides discovered using Medikine’s platform technology, including:

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A potent and selective agonist of the IL-7 receptor that is composed of the IL-7Ra and gc receptor subunits. A key attribute of this novel fusion protein is the avoidance of cytokine neutralizing antibodies, which has been reported to occur with recombinant forms of IL-7.
A potent and selective agonist of a form of the IL-2/15 receptor that is composed of the IL-2/15Rb and gc receptor subunits. Unlike other approaches that attempt to diminish the binding of IL-2 or IL-15 to their respective alpha receptor subunits, the Medikine fusion protein is designed de novo to be devoid of interaction with the alpha subunits, a desired feature for immuno-oncology applications.
A bispecific recombinant Fc fusion protein incorporating both IL-7R and IL-2/15Rbgc agonist peptides that demonstrates agonist activity on both receptors. This approach could provide beneficial, non-overlapping immune cell regulation for cancer therapy. The project also demonstrates the potential utility of the peptides in creating bispecific fusions that provide targeting and/or complementary pharmacology.
William J. Dower, Ph.D., a Medikine founder and chief scientific officer, will present the following posters during the virtual poster hall, November 11-14 from 9 a.m. to 5 p.m. EST:

Poster 566 – MDK-202: An empirically-designed peptidyl agonist of the IL-2/15βγc receptor, devoid of Rα interaction, unrelated to IL-2 or IL-15, and fused to an Fc-domain for PK enhancement.
Poster 567 – MDK1319/MDK-701: A potent fully efficacious peptidyl agonist of IL-7Rαγc, designed with no reference to cytokine or receptor structure and unrelated to IL-7, fused to an Fc-domain for PK enhancement.
Poster 691 – MDK-271: A dual function molecule consisting of empirically-designed peptidyl agonists of IL-2/15Rβγc and IL-7Rαγc, unrelated to IL-2, IL-15, or IL-7, incorporated into a bispecific Fc fusion protein.
"Medikine is focused on exploring the unique advantages of empirically designed, peptide-based activators of heterodimeric cytokine receptors over traditional approaches involving modifications of natural cytokines. This work builds on previous discoveries of peptide agonists for the homodimeric receptors for erythropoietin and thrombopoietin by members of the Medikine team," said Ronald W. Barrett, Ph.D., CEO and chairman of Medikine. "We are pleased to present these innovations at SITC (Free SITC Whitepaper) and are now moving the IL-7R and IL-2/15Rbgc agonist programs into development. We believe our product candidates have the potential to offer differentiated and beneficial features over modified/engineered IL-7, IL-2 and IL-15 proteins."

On November 10, 2020 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Lipocine, NOV 10, 2020, View Source [SID1234570640]).

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Third Quarter and Recent Corporate Highlights

Completed patient enrollment in the LPCN 1144 Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, a paired-biopsy study in confirmed pre-cirrhotic NASH subjects
Top-line results for change in liver fat data measured by MRI-PDFF (primary endpoint) expected in January 2021 and 36-week biopsy and MRI-PDFF data expected mid-2021
Announced the peer-reviewed publication of LPCN 1144 Liver Fat Study results, "LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease in Hypogonadal Males" in Hepatology Communications
Presented two abstracts at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America ("SMSNA")
A study on the potential use of oral testosterone in COVID-19 highlighted key clinical evidence suggesting that low testosterone levels may play an important role on clinical outcomes
Results from a 24-day, open-label, single-arm, multicenter study confirming the validity of a fixed dose approach to orally administering TLANDO in hypogonadal men without the need for dose titration.
Ongoing Activities and Upcoming Milestones

Presenting results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis ("NASH") features will be presented at The Liver Meeting Digital Experience, hosted by the American Association for the Study of Liver Diseases ("AASLD") on November 13, 2020
Announcing decision from U.S. Food and Drug Administration ("FDA") on the New Drug Application ("NDA") for TLANDO
Third Quarter Ended September 30, 2020 Financial Results
Lipocine reported a net loss of $4.3 million, or ($0.07) per basic and diluted share, for the quarter ended September 30, 2020, compared with a net loss of $3.1 million, or ($0.12) per basic and diluted share, in the quarter ended September 30, 2019.

Research and development expenses were $2.5 million for the quarter ended September 30, 2020, compared with $1.7 million for the quarter ended September 30, 2019. The increase in research and development expenses during the three months ended September 30, 2020 was primarily due to a $280,000 increase in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a $278,000 increase in commercial manufacturing costs related to TLANDO, a $160,000 increase in personnel expense, as well as increases in other R&D expenses of $56,000.

General and administrative expenses were $1.9 million for the quarter ended September 30, 2020, compared with $1.4 million for the quarter ended September 30, 2019. The increase in general and administrative expenses during the three months ended September 30, 2020 was primarily due to a $259,000 increase in legal costs, a $240,000 increase in personnel costs, and a $4,000 increase in other general and administrative expenses. These increases were offset by a $28,000 decrease marketing expense and a $17,000 decrease in administrative travel expenses.

As of September 30, 2020, we had $18.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019. Additionally, as of September 30, 2020 and December 31, 2019 we had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA.

Nine Months Ended September 30, 2020 Financial Results
Lipocine reported a net loss of $16.5 million, or ($0.32) per basic and diluted share, for the nine months ended September 30, 2020, compared with a net loss of $9.7 million, or ($0.40) per basic and diluted share, for the nine months ended September 30, 2019.

Research and development expenses were $7.3 million for the nine months ended September 30, 2020, compared with $5.6 million for the nine months ended September 30, 2019. The increase in research and development expenses during the nine months ended September 30, 2020 was primarily due to a $2.9 million increase in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a $430,000 increase in personnel expense, and a $50,000 increase in other research and development expenses. These increases were offset by a $1.7 million decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study in the first half of 2019, a $50,000 decrease in contract manufacturing costs for LPCN 1107, and a $46,000 decrease in costs for TLANDO XR.

General and administrative expenses were $5.9 million for the nine months ended September 30, 2020, compared with $4.0 million for the nine months ended September 30, 2019. The increase in general and administrative expenses during the nine months ended September 30, 2020 was primarily due to a $1.9 million increase in legal costs and a $228,000 increase in personnel costs. These increases were offset by a $77,000 decrease in administrative travel expense, a $68,000 decrease in marketing expense and a $43,000 decrease in other general and administrative expenses.

On November 10, 2020 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, reported its financial results for the quarter ended September 30, 2020 (Press release, Seneca Biopharma, NOV 10, 2020, View Source [SID1234570639]).

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Business Highlights for 2020 to date.

During 2020, the Company achieved the following business milestones:

Completed offerings resulting in net proceeds of over $14.7 million.

Continued progress on both the Company’s out-licensing effort to partner NSI-566 and NSI-189 programs and initiative to in-license or acquire novel therapeutics.

Appointed Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer.

Announced the completion of the last subject’s follow-up assessment in the Company’s non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke.

Announced that as a result of feedback received from the FDA, Seneca believes that the existing Phase 1 and 2 trial results support moving into a Phase 3 clinical study for ALS.

Completion of the Company’s stem cell manufacturing facility in Suzhou, China which will be used to manufacture NSI-566 for clinical trials within China.
Financial Results for the Quarter Ended September 30, 2020

Cash Position and Liquidity: At September 30, 2020, cash was approximately $12.7 million as compared to approximately $15.8 million at June 30, 2020.

Operating Loss: Operating loss for the quarter ended September 30, 2020 was $2.3 million compared to a loss of $2.1 million for the comparable 2019 period. For the nine-month period ended September 30, 2020, the operating loss was $6.3 million versus $6.5 million for the nine months ended September 30, 2019. The decrease in operating loss for 2020 was primarily due to a decrease in R&D expenses as we continue to wind down the clinical programs. This decrease was partially offset by an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as compared to the same period of 2019.

Net Loss: Net loss for the quarter ended September 30, 2020 was $2.3 million, or $0.13 per share, compared to a loss of $1.8 million, or $0.59 per share on a post-reverse stock-split basis, for the same period in 2019. For the 2020 nine-month period the net loss was $11.8 million, or $0.93 per share versus a net loss of $6.3 million, or $4.80 per share for the same period in 2019. The 2020 increase in net loss was primarily attributed to a non-cash expense of $5.6 million related to the January 2020 warrant inducement transaction.

On November 10, 2020 Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported that CEO Nadav Kidron will present a company overview at the H.C. Wainwright 6th Annual Israel Conference (Press release, Oramed Pharmaceuticals, NOV 10, 2020, View Source [SID1234570637]).

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Presentation Details:

H.C. Wainwright 6th Annual Israel Conference

Presenter: Nadav Kidron, CEO

Date: Thursday, November 12, 2020

Time: 11:30 AM ET

On November 10, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported it will present new immunotherapy data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, taking place November 9-14, 2020 (Press release, Natera, NOV 10, 2020, View Source [SID1234570635]).

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Natera will present four posters demonstrating the ability of Signatera to monitor response to immunotherapy in colorectal and breast cancer.

"Tumor-informed circulating tumor DNA tests have broad clinical utility across cancer types," said Georges Azzi, MD, oncologist at Holy Cross Health in Ft. Lauderdale, Florida and co-author of one of the posters presented. "I am excited to partner with Natera to further explore early indications of treatment response, or lack thereof, using this novel technology."

"We have consistently demonstrated the clinical utility of MRD testing with Signatera to help patients detect recurrence earlier, and we are now seeing evidence of Signatera’s ability to effectively monitor immunotherapy treatment," said Alexey Aleshin, MD, Natera’s Senior Medical Director of Oncology. "The studies we are presenting at SITC (Free SITC Whitepaper) showcase Signatera’s broadened capability to evaluate immunotherapy treatment response, an area in which there is a significant unmet need for more optimal diagnostic tools."

Details about the abstracts are as follows:

Abstract #23 | Poster Presentation
Presenter: Pashtoon Kasi, MD, MS

Circulating tumor DNA (ctDNA) serial analysis during progression on PD-1 blockade and later CTLA-4 rescue in patients with mismatch repair deficient metastatic colorectal cancer

A case series of three patients with mismatch repair deficient (dMMR), high microsatellite instability metastatic colorectal cancer (CRC), who progressed on PD-1 inhibitor pembrolizumab and were being treated with CTLA-4 inhibitors (nivolumab and ipilimumab). All patients were monitored with radiological imaging and serial ctDNA assessments using Signatera. ctDNA levels were corroborated by imaging in all cases and predicted tumor responses weeks ahead of imaging, supporting the use of ctDNA as a dynamic biomarker for response to immunotherapy.

Abstract #24 | Poster Presentation
Presenter: Pashtoon Kasi, MD, MS

Utility of tumor-informed molecular residual disease assays in patients with complete response to immune checkpoint blockade

Data regarding neoadjuvant usage of immunotherapy pertaining to mismatch repair deficient tumors is limited to-date. This poster describes two patients with advanced, non-metastatic dMMR tumors undergoing immune checkpoint blockade (ICB) therapy. Both patients achieved robust and dramatic responses to ICB therapy, with complete clearance of ctDNA and no evidence of residual disease radiologically, supporting the clinical decision to defer surgery and radiation. These data highlight a potential use of ctDNA-based MRD testing to help inform "watch & wait" approaches.

Abstract #25 | Poster Presentation
Presenter: Georges Azzi, MD

Line of therapy adjustment in a patient with advanced triple-negative breast cancer (TNBC) by using personalized ctDNA test for treatment response monitoring

A case study of a patient with advanced TNBC whose clinical course was tracked using ctDNA and radiologic imaging. After surgery, the patient tested positive for MRD using Signatera, but negative when assessed using a tumor-naive assay. Serial ctDNA analysis over the course of the patient’s treatment enabled detection of lack of response and acquired resistance to therapy as much as 80 days earlier compared to imaging.

Abstract #26 | Poster Presentation
Presenter: Charles J. Schneider, MD, FACP

ctDNA clearance and radiographic resolution of lymph node metastasis in a patient with metastatic microsatellite stable colorectal cancer on immunotherapy

A case study of a patient with metastatic CRC with high tumor mutational burden (TMB) and CEA-low phenotype. The patient was MRD positive following initial surgical resection of the metastatic lesion, with ctDNA continuing to rise as a result of lymph node involvement. Upon receiving two rounds of immunotherapy, the patient showed complete clearance of ctDNA, correlating with radiologic resolution of metastatic disease. This suggests that ctDNA can serve as a dynamic biomarker of disease status, which may be more useful for monitoring treatment response, regardless of CEA expression.

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.