Personalis to Participate in the 17th Annual Morgan Stanley Global Healthcare Conference

On August 26, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the company will participate at the upcoming 17th Annual Morgan Stanley Global Healthcare Conference being held from September 9-11, 2019 in New York, NY (Press release, Personalis, AUG 26, 2019, View Source [SID1234538977]).

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Personalis is scheduled to participate in a fireside chat with analysts and investors on Wednesday, September 11, 2019 at 1:00 p.m. Eastern Time. A live, listen-only webcast of the presentation may be accessed by visiting investors.personalis.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the Company’s website for 180 days following the presentation.

ADC Therapeutics and Freenome Enter Biomarker Development Collaboration

On August 26, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), and Freenome, a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw, reported that they have entered a biomarker development collaboration in which ADC Therapeutics will use Freenome’s platform to identify patients who are most likely to respond to treatment with ADCT-402 (loncastuximab tesirine) (Press release, ADC Therapeutics, AUG 26, 2019, View Source [SID1234538976]). ADC Therapeutics is currently evaluating ADCT-402 in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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Freenome’s platform will characterize tumor heterogeneity and systemic immune response to identify signatures from blood of DLBCL patients participating in ADC Therapeutics’ pivotal Phase II clinical trial. The multiomics approach will allow ADC Therapeutics to consider a broad range of DNA, RNA and protein markers in developing a biomarker signature.

"Our partnership with ADC Therapeutics validates our unique multiomics platform and its potential to help biopharmaceutical companies develop innovative cancer therapies for patients in need," said Gabe Otte, Chief Executive Officer of Freenome. "Our platform can help biopharma partners refine biomarker development and potentially de-risk and accelerate drug development by characterizing patients likely to respond to therapy. In addition, given that ADCT-402 is targeting a hematological malignancy, this partnership highlights the potential of our platform to provide tumor and immune signatures for hematological cancers in addition to solid tumors. Combined with the ongoing development of our early cancer screening test, we are moving closer to our goal of helping physicians and patients navigate precision health by identifying cancer at its earliest stages when treatments can be most effective."

"We are excited to leverage Freenome’s unique platform to potentially enhance our identification and understanding of the patients who are most likely to benefit from treatment with ADCT-402, which has been demonstrating significant single-agent clinical activity in a broad population of patients with relapsed or refractory diffuse large B-cell lymphoma in our pivotal Phase II clinical trial," said Patrick van Berkel, Senior Vice President of Research and Development at ADC Therapeutics. "This partnership adds to our ongoing biomarker research efforts, which we believe will be advantageous as we continue to advance the clinical development of ADCT-402."

Financial terms of the collaboration were not disclosed.

About Freenome’s Multiomics Platform

Freenome’s multiomics platform detects key biological signals from a routine blood draw. The platform integrates assays for cell-free DNA, methylation, and proteins with advanced computational biology and machine learning techniques to identify additive signatures that improve the accuracy for early cancer detection given the molecular subtypes of cancer are heterogeneous in nature. This strategy incorporates a multidimensional view of both tumor- and immune-derived signatures that enables the early detection of cancer, instead of relying only on tumor-derived markers, which may miss the early signs of cancer. Freenome’s first cancer test is for the screening of colorectal cancer, the second deadliest form of cancer in the U.S. When identified early, colorectal cancer has a 90 percent five-year relative survival rate compared to 14 percent when detected at a more advanced stage according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program.

Lineage Cell Therapeutics Announces Issuance of U.S. Patent for System for Generating Immunogenic Dendritic Cells

On August 26, 2019 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,344,262, for a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs) (Press release, Lineage Cell Therapeutics, AUG 26, 2019, View Source [SID1234538975]). The claimed system and cell populations involve culturing cells in a serum-free medium utilizing factors including bone morphogenetic protein-4 (BMP-4), granulocyte macrophage-colony stimulating factor (GM-CSF), stem cell factor (SCF) and vascular endothelial growth factor (VEGF) to generate hESC-derived mature dendritic cells.

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"The issuance of this patent is important because the allowed claims support our differentiation process for the production of VAC2, our allogeneic, or "off-the-shelf" cancer immunotherapy program, currently being tested in a Phase I clinical trial in subjects with non-small cell lung cancer," stated Brian M. Culley, Chief Executive Officer of Lineage. "VAC2 is produced from pluripotent cell technology to generate a population of mature dendritic cells, which are utilized because of their potent antigen presenting ability which instructs the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. VAC2 is specifically designed to stimulate a patient’s immune response to a tumor antigen commonly expressed in cancerous cells but rarely found in normal adult cells. We are fortunate that the VAC2 trial is being fully-funded and conducted by Cancer Research UK, the world’s largest independent cancer research charity. Patient enrollment will continue throughout 2019 and we expect to have immunogenicity data on the initial set of patients later this year."

Audentes Therapeutics to Participate in Upcoming Investor Conferences

On August 26, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported that it will participate in the following investor conferences in September (Press release, Audentes Therapeutics, AUG 26, 2019, View Source [SID1234538974]):

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Citi’s 14th Annual Biotech Conference
Matthew R. Patterson, Chariman and Chief Executive Officer
Format: 1×1 Investor Meetings
Wednesday, September 4, 2019 – Thursday, September 5, 2019
Boston, Massachusetts

Morgan Stanley 17th Annual Global Healthcare Conference
Natalie Holles, President and Chief Operating Officer
Format: Fireside Chat
Monday, September 9, 2019, at 11:05 am ET
New York, New York

To access the live webcast of the Morgan Stanley fireside chat, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. Following the conference, a replay of the live webcast will be available on the Audentes website for approximately 30 days.

Trovagene Presents Positive Clinical Data from Ongoing Phase 2 Study of Onvansertib in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

On August 26, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis), for the treatment of various cancers including prostate, colorectal and leukemia, reported the presentation of positive clinical data from its ongoing Phase 2 clinical trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone, an androgen-receptor signaling (ARS) inhibitor, in metastatic Castration-Resistant Prostate Cancer (mCRPC), at the 20th Asia-Pacific Prostate Cancer Conference in Melbourne, Australia (Press release, Trovagene, AUG 26, 2019, View Source [SID1234538973]). These data demonstrate the efficacy of onvansertib in patients showing resistance to the ARS inhibitor, Zytiga (Johnson & Johnson), including those with the highly-aggressive and difficult-to-treat androgen receptor variant 7 (AR-V7) tumor.

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"We have discovered that adding onvansertib to daily ARS inhibitor therapy changes the trajectory of resistance in patients harboring AR-V7, as demonstrated by the immediate decrease in serum PSA levels in patients showing initial signs of resistance to Zytiga," said Mark Erlander, PhD, Chief Scientific Officer of Trovagene. "The inhibition of the PLK1 enzyme by onvansertib appears to enhance the efficacy of Zytiga by repressing the ARS pathway, which is consistent with preclinical data."

In the ongoing Phase 2 clinical trial of onvansertib, a first-in-class, oral and highly-selective PLK1 inhibitor, patients are being tested with a simple blood test to assess whether they are positive for AR-V7. In all four patients who tested positive for AR-V7, thus far, an immediate decrease in their serum PSA levels was observed. To-date, two of these patients have achieved the primary efficacy endpoint of disease control. Importantly, while on Zytiga alone the PSA level for one of the AR-V7 positive patients had a greater than five-fold rise in the two months prior to enrollment and treatment in the trial. Once onvansertib was added to Zytiga, the patient’s PSA level stopped rising and immediately decreased; the patient remains on treatment.

Additionally, since presenting early data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April, a second arm (Arm B) with a two-week dosing schedule and 50% greater drug exposure to onvansertib over the treatment course, was added to the trial. Preliminary efficacy with PSA stabilization or reduction was observed in the initial three patients enrolled, suggesting that a shorter dosing schedule may maximize response to treatment. Importantly, no unexpected, off-target toxicities have been reported in patients treated to-date.

mCRPC is an incurable and lethal cancer. Nearly all patients with prostate cancer will progress to castration resistance, indicated by increasing serum PSA levels despite castrate levels of testosterone and progress to metastases. 10% to 20% of prostate cancers progress to castration resistant prostate cancer (CRPC) within 5 years of diagnosis, and 84% of newly diagnosed CRPC have metastases. The median survival of patients following diagnosis of castration resistance ranges between 15 and 36 months. The standard-of-care first-line treatment are ARS inhibitors, Zytiga (Johnson & Johnson) or Xtandi (Pfizer); however, resistance to these drugs typically develops within 9 to 15 months of initiating treatment. Additionally, up to 30% of patients have the highly-aggressive and ARS-resistant AR-V7. These patients have a shorter progression-free survival (PFS), overall survival (OS) and a poor prognosis. Current treatment for these patients is limited to toxic chemotherapy and there are no effective targeted therapies available.

About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has an ongoing Phase 2 clinical trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga. The trial was accepted by the NLM and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03414034.

Trovagene has an ongoing Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation. The trial was accepted by the NLM and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03829410. The trial is being conducted at three prestigious cancer centers: USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic.

Trovagene has an ongoing Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML that was accepted by the National Library of Medicine (NLM) and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03303339. Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.