On December 1, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the combination of ONCOS-102 and pembrolizumab (Keytruda) has demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma (Press release, Targovax, DEC 1, 2020, View Source [SID1234572029]).

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In this two-part, open label phase 1 trial the combination of ONCOS-102 and the anti-PD1 checkpoint inhibitor (CPI) pembrolizumab has been tested in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 CPI. This is a particularly challenging patient population, which is resistant to approved immunotherapies and has few treatment alternatives available.

For the trial overall, tumor responses were observed in 7 out of 20 evaluable patients treated with the ONCOS-102 and pembrolizumab combination, translating into an ORR of 35% by RECIST 1.1 criteria.

In addition, there were multiple examples of responses in non-injected lesions, including 2 patients where a non-injected lesion completely disappeared, indicating that ONCOS-102 can induce systemic anti-tumor immunity.

Prof. Jedd Wolchok, Investigator, Memorial Sloan Kettering Cancer Centre, New York said: "Checkpoint inhibitors have had a significant impact on the way we treat melanoma; however, a subset of patients still does not respond or become resistant to treatment. Therefore, there is a high medical need for immune activating agents to overcome resistance to checkpoint blockade. ONCOS-102 is one such agent that can re-sensitize patients to anti-PD1 therapy. Although these are early data, observing objective responses with some occurring in non-injected lesions in this first exploratory phase 1 trial is encouraging, and we will follow with great interest as ONCOS-102 moves forward into later-stage development."

The trial was designed with two parts assessing different dosing regimens. In Part 1, 9 patients were given 3 intra-tumoral ONCOS-102 injections during the first week, followed by systemic treatment with pembrolizumab every third week for up to 24 weeks. As reported in July 2019, preliminary tumor responses were observed in 3 out of 9 patients in at least one CT scan (see link here). 1 patient has since been determined as non-evaluable (trial inclusion criteria not met), and these numbers have now been updated to 3 out of 8 patients with ORR for Part 1.

12 more patients were enrolled in Part 2 of the trial, where an extended dosing regimen of 12 intra-tumoral ONCOS-102 injections was tested; 4 injections during the first two weeks followed by concomitant administration of ONCOS-102 and pembrolizumab from week 3 and every third week for up to 24 weeks. Tumor responses were observed in 4 out of the 12 patients in at least one CT scan. Notably, the patients in Part 2 had markedly more advanced disease than in Part 1, with the majority diagnosed as stage IV metastatic melanoma when entering the trial. Importantly, both regimens had favorable tolerability profiles, with no safety concerns.

These data are very strong compared to other therapies in development for the same indication in combination with anti-PD1 CPI, including TLR-9 agonists and other oncolytic viruses, which have reported ORR of ca. 25-30%. As such, the observed ONCOS-102 response rate and effect in non-injected lesions can be considered class-leading for the treatment of anti-PD1 refractory malignant melanoma.

Oystein Soug, Chief Executive Officer of Targovax, commented: "These impressive efficacy data in anti-PD1 refractory melanoma are the most important clinical results for Targovax to date. The data clearly confirm our hypothesis that ONCOS-102 can benefit cancer patients resistant to checkpoint inhibition by triggering local and systemic immune activation. They also provide evidence of clinical efficacy and establishes ONCOS-102 as one of the most promising combination partners to checkpoint inhibitors. We will now carefully analyze the immunological data and are planning for a confirmatory melanoma trial for the ONCOS-102 and checkpoint inhibitor combination."

The trial (NCT03003676) was conducted at three sites in the US and one site in Norway, with Memorial Sloan Kettering CC being the coordinating site.

Online presentation:

Targovax management will present the data in a live webcast 2 December 2020 at 10:00 CET. You can join the webcast here. It will be possible to ask questions during the presentation. A replay of the webcast will be available in the Investor section under "Presentations" after the event.

On December 1, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, DEC 1, 2020, View Source [SID1234572028]).

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The quarterly dividend on the Series E Preferred Stock is payable on January 4, 2021 to holders of record at the close of business on December 14, 2020.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from October 1, 2020 through December 31, 2020. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

On December 1, 2020 The U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer (Press release, US FDA, DEC 1, 2020, View Source [SID1234572026]).

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Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection.

"Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer," said Alex Gorovets, M.D., acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research. "With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body."

Prostate cancer is the third most common form of cancer in the United States. It is estimated that there will be more than 190,000 new cases of prostate cancer and an estimated 33,000 deaths from this disease in 2020, according to the National Cancer Institute. While computed tomography (CT) scans, magnetic resonance imaging (MRI) scans and bone scans are conventional methods commonly used to image patients with prostate cancer, these approaches are limited in detection of prostate cancer lesions. F 18 fluciclovine and C 11 choline are two other PET drugs that are approved for prostate cancer imaging. However, they are only approved for use in patients with suspected cancer recurrence.

Once administered via injection, Ga 68 PSMA-11 binds to PSMA, which is an important pharmacologic target for prostate cancer imaging because prostate cancer cells usually contain elevated levels of the antigen. As a radioactive drug that emits positrons, Ga 68 PSMA-11 can be imaged by PET to indicate the presence of PSMA-positive prostate cancer lesions in the tissues of the body.

The safety and efficacy of Ga 68 PSMA-11 were evaluated in two prospective clinical trials with a total of 960 men with prostate cancer who each received one injection of Ga 68 PSMA-11. In the first trial, 325 patients with biopsy-proven prostate cancer underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11. These patients were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis. Among the patients who proceeded to surgery, those with positive readings in the pelvic lymph nodes on Ga 68 PSMA-11 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology. The availability of this information prior to treatment is expected to have important implications for patient care. For example, it may spare certain patients from undergoing unnecessary surgery.

The second trial enrolled 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy, and thus had biochemical evidence of recurrent prostate cancer. All of these patients received a single Ga 68 PSMA-11 PET/CT scan or PET/MR scan. Based on the scans, 74% of these patients had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one body region (bone, prostate bed, pelvic lymph node, or extra-pelvic soft tissue). In patients with positive Ga 68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 91% of cases. Thus, the second trial demonstrated that Ga 68 PSMA-11 PET can detect sites of disease in patients with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy.

No serious adverse reactions were attributed to Ga 68 PSMA-11. The most common adverse reactions to Ga 68 PSMA-11 were nausea, diarrhea and dizziness. There is a risk for misdiagnosis because Ga 68 PSMA-11 binding may occur in other types of cancer as well as certain non-malignant processes which may lead to image interpretation errors. There are radiation risks because Ga 68 PSMA-11 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.

The FDA granted approval to the University of California, Los Angeles and the University of California, San Francisco.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On December 1, 2020 Sun BioPharma, Inc. (Nasdaq: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported the change of its corporate name to Panbela Therapeutics, Inc. effective December 2, 2020 (Press release, Sun BioPharma, DEC 1, 2020, View Source [SID1234572025]). The Company’s trading symbol will also change from SNBP to PBLA at the opening of the markets on December 2, 2020. As a result of the change, the CUSIP number for the company’s common stock will also change to 69833Q100. Stockholders are not required to exchange their existing share certificates or warrants for new certificates or warrants bearing the new name. The name change does not affect the company’s capital structure or the rights of the company’s stockholders, and no action is required by existing stockholders.

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About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in the company’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial. For more information, please visit View Source .

On December 1, 2020 PierianDx, the leading clinical genomics informatics company, reported an expanded partnership with Illumina to enable PierianDx genomic reporting solutions for use with AmpliSeqTM for Illumina Focus Panel, AmpliSeqTM for Illumina Myeloid Panel and the TruSight Hereditary Cancer Panel (Press release, PierianDx, DEC 1, 2020, View Source [SID1234572024]). Adding these panels expands the existing relationship between Illumina and PierianDx, which currently covers use of the PierianDx platform to support genomic reporting in key global markets for the TruSight Oncology 500 portfolio.

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Performing a comprehensive NGS test and delivering an accompanying genomic report were once only accomplished via a send-out test to a commercial lab. However, in performing tests as send-outs, healthcare organizations relinquish control over samples, turnaround time, and quality. The PierianDx platform enables healthcare organizations to accelerate their precision medicine programs by empowering them to create accurate, timely, and comprehensive clinical genomic reports in-house.

Illumina’s Senior Vice President and Chief Medical Officer, Dr. Phil Febbo said: "PierianDx has demonstrated its commitment to best-in-class variant reporting solutions. We are excited to expand our partnership to cover the AmpliSeqTM suite of panels which are optimized for clinical cancer research."

PierianDx develops Clinical Genomics Workspace, which consists of intuitive software and a robust clinical Knowledgebase which transforms unstructured variant information into a highly-structured and usable clinical genomic report. In use by academic medical centers, cancer centers, reference laboratories, and healthcare organizations worldwide, it helps users accurately and rapidly classify and interpret variants to produce a physician-ready report.

Lincoln Nadauld, Vice President and Chief of Precision Medicine and Genomics, Intermountain Healthcare explains, "Our partnership with PierianDx has enabled us to advance our precision medicine program by enhancing the classification of variants, accelerating the identification of targeted therapies, and expanding clinical trial opportunities for our patients."