On January 29, 2020 DaVita Inc. (NYSE: DVA), reported that it will hold its quarterly conference call to discuss fourth quarter results on Monday, February 10, 2020, at 5:00 p.m. Eastern Time (Press release, DaVita, JAN 29, 2020, View Source [SID1234553674]). The company plans to release its results after market close the same day.

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This call is also being webcast and can be accessed at the DaVita IR web page. You can join this call as follows:

Monday, February 10, 2020
Starting at 5:00 p.m. EST
Dial in number: 877-918-6630
International dial in: 517-308-9042
Webcast: investors.davita.com

When calling in, please provide the operator the password "Earnings" and provide your name and company affiliation. Investors unable to listen to the conference call will be able to access a replay via our website at investors.davita.com. There will be no telephone replay.

On January 29, 2020 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that it has entered into a research collaboration on novel cancer antigens for highly specific immunotherapies with the Université de Montréal (UdeM) and IRICoR, a pan-Canadian drug discovery research commercialization center (Press release, MediGene, JAN 29, 2020, View Source [SID1234553710]). UdeM’s research team, led by Drs. Claude Perreault and Pierre Thibault at the Institute for Research in Immunology and Cancer (IRIC), will provide Medigene with tumor-specific antigens (TSAs) which they discovered using their proprietary platform, as novel targets for various cancer indications, particularly for solid tumors.

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Under the terms of the agreement, Medigene will evaluate a number of proprietary TSA targets provided by UdeM through IRICoR, and will receive an option to exercise an exclusive and worldwide license to develop and commercialize T cell receptors (TCRs) against up to 5 of these novel cancer antigens. Upfront and near-term payments by Medigene to UdeM and IRICoR could potentially reach mid to high single-digit millions over the course of the next five years. Additionally, UdeM and IRICoR are eligible to receive development, regulatory and commercial milestone payments, along with tiered royalties, on a per target basis.

Prof. Dolores Schendel, CEO and CSO of Medigene AG: "The goal of immunotherapies is to fight cancer using the immune system. Medigene’s TCR-based therapies aim to modify the patient’s own T cells so they can specifically recognize and eliminate tumor cells. It is essential that the immune system differentiates precisely between cancer cells and healthy tissue. The research work from UdeM on tumor antigens is fascinating and offers a broad and complementary development opportunity for Medigene’s TCR therapies. These TSAs are uniquely found in tumor cells but are not present in healthy tissue, and are therefore particularly interesting as targets for tailor-made immunotherapies. We believe that this cooperation could expand our portfolio with promising, novel targets that are solely expressed in cancer cells."

Dr. Nadine Beauger, Chief Executive Officer of IRICoR: "IRICoR is delighted to be a part of this new partnership. The foundational funding provided by IRICoR to develop this unique proteogenomic approach led to the unprecedented discovery of human TSAs coded by potentially all genomic regions using high-throughput mass spectrometry. These newly-discovered targets open countless avenues for more targeted cancer treatments for the benefit of patients worldwide."

Dr. Steven Klein, Vice-President, Business Development of IRICoR added: "IRICoR has a strong track record of collaborating with international partners such as Medigene and negotiating the necessary agreements to ensure that these relationships are successful in transforming innovative technologies, such as the TSA platform, into new therapies."

Michel Bouvier, Chief Executive Officer and Principal Investigator, IRIC; Professor, Department of Biochemistry and Molecular Medicine, Université de Montréal: "UdeM and its researchers at IRIC are at the forefront of developing novel therapies for cancers with high unmet medical need. The exciting research of Drs. Perreault and Thibault is a concrete example of how world-class fundamental research carried out at IRIC can be translated into potential new therapies through the financial and business support of IRICoR. We look forward to a very fruitful collaboration between UdeM, IRICoR, and Medigene and to seeing these new T cell-based therapies reach patients who are in need of new therapeutic options."

About UdeM/IRICoR TSAs
A key role of T lymphocytes is to act as extrinsic tumor suppressors and thereby mediate "cancer immunosurveillance". Tumor-specific Antigens (TSAs) can be targeted for T-cell based cancer immunotherapy. TSAs are truly cancer-specific and immunogenic because their presence is induced by cancer-specific somatic mutations. In two murine cancer cell lines and seven human primary tumors, Drs. Perreault and Thibault identified a total of 40 TSAs, about 90% of which derived from allegedly noncoding regions and would have been missed by standard exome-based approaches. Moreover, most of these TSAs derived from nonmutated yet aberrantly expressed transcripts (such as endogenous retroelements) that could be shared by multiple tumor types.

Reference:
Laumont et al. "Noncoding regions are the main source of targetable tumor-specific antigens" Science Translational Medicine 05 Dec 2018:Vol. 10, Issue 470, eaau5516

On January 29, 2020 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on developing curative cell therapies for cancer, reported it has completed Cohort 1 enrollment with no dose-limiting toxiticies (DLT) observed in the ATTCK-34-01 Phase 1 trial evaluating Unum’s novel Antibody-Coupled T cell Receptor investigational therapy, ACTR707, together with trastuzumab for the treatment of patients with HER2+ advanced cancers (Press release, Unum Therapeutics, JAN 29, 2020, View Source [SID1234553640]).

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Patient enrollment—defined as patients who have signed informed consent forms and met all eligibility criteria—is complete with five patients in this first cohort in the ATTCK-34-01 Phase 1 trial, a multicenter, open-label, single-arm, dose-escalation trial. Of the five patients enrolled, three patients received treatment with trastuzumab (1.0 mg/kg weekly) followed by administration of ACTR707 (25 million ACTR707+ T cells) and completed the DLT review period—defined as approximately six weeks post-ACTR707 administration—with no DLTs observed. Two patients enrolled but discontinued from the trial prior to receiving treatment with trastuzumab and ACTR707. In addition to safety and clinical response assessments, data on ACTR707+ T cell expansion and persistence, trastuzumab pharmacokinetics, and post-treatment biopsy analyses are being collected and are expected to inform subsequent dose escalation. Unum continues to plan to submit data from this Cohort for presentation at a scientific conference in 2020. Investigators have begun screening patients for Cohort 2 that includes treatment with trastuzumab (1.0 mg/kg weekly) followed by administration of ACTR707 (50 million ACTR707+ T cells).

"Understanding the significant unmet need in advanced HER2+ malignancies, ACTR707 was engineered to potentially avoid the on-target, off-tumor toxicity that has hindered the development of traditional CAR T cells for solid tumor cancers," said Jessica Sachs, M.D., Chief Medical Officer of Unum Therapeutics. "We are excited to continue this dose-escalation trial, having passed the DLT safety thresholds in this first, low-dose Cohort and we look forward to reporting additional data from multiple dose cohorts during 2020."

Additional details about the ATTCK-34-01 Phase 1 trial can be found here.

About ACTR707 and the ATTCK-34-01 Phase 1 trial for HER2+ solid tumor cancers
ACTR707 is derived from Unum’s novel proprietary Antibody-Coupled T cell Receptor (ACTR) platform. ACTR is designed to develop autologous engineered T-cell therapies that combine the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses. ACTR707 was engineered for properties that potentially optimize its function in solid tumors including increased proliferation, cytokine secretion, and persistence. Preclinical data demonstrate that, unlike traditional trastuzumab-based CAR-T cells that target HER2, ACTR707+ T cells administered with trastuzumab are highly selective for HER2-overexpressing tumor cells and discriminate against cells from normal tissues that express low levels of HER2. In addition, the preclinical activity of ACTR707+ T cells has been shown to be dose-dependent demonstrating control of ACTR707 activity by modulation of trastuzumab concentration.

While some patients with metastatic breast cancer and gastric cancer receive durable benefit from approved HER2-targeted therapies, many are refractory to or relapse from treatment. Additionally, there are other solid tumors that overexpress HER2 for whom existing HER2-targeted therapies are not approved. ACTR707 used in combination with trastuzumab is being developed in this trial to potentially serve patients whose treatment needs are not met by available HER2-targeted therapies.

On January 29, 2020 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 that its partner CSPC Pharmaceutical Group Limited (HKEx: 1093) (CSPC), a leading pharmaceutical company in China, has dosed the first patient in a pivotal Chinese bridging study evaluating COPIKTRA (duvelisib) in patients with relapsed or refractory follicular lymphoma (FL) (Press release, Verastem, JAN 29, 2020, View Source [SID1234553657]). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma in the United States.

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"Building on CSPC’s strong track record of successfully developing and commercializing oncology products in China, we are pleased that this CSPC trial is now underway as they work to provide a new option for patients with follicular lymphoma in China, where there are limited options for this difficult to treat disease," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The first patient dosed in this trial is a critical step in our mission to bring COPIKTRA to patients around the world."

In September of 2018, Verastem Oncology and CSPC entered into an exclusive licensing agreement for CSPC to develop and commercialize Verastem Oncology’s COPIKTRA for the treatment of all oncology indications in China. CSPC’s single-arm, open-label, multi-center pivotal study is designed to evaluate the antitumor activity and safety of duvelisib administered to patients diagnosed with relapsed or refractory follicular lymphoma. This study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 2 DYNAMO study. The results of this study will form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory FL in China.

COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Continued approval in FL may be contingent upon verification and description of clinical benefit in confirmatory trials.

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, in the United States. 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 in the United States 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 in the United States, 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.

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safety 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% (4% fatal) 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% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials.
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.

On January 29, 2020 Geneos Therapeutics reported that its personalized neoantigen-targeting vaccine, GNOS-PV02 (based on its proprietary GT-EPIC platform), will be evaluated in a clinical trial for patients with advanced Hepatocellular Carcinoma (HCC) (Press release, Geneos Therapeutics, JAN 29, 2020, View Source [SID1234553675]). GNOS-PV02 is a tumor-specific DNA plasmid product designed and manufactured for each patient based on the unique tumor variations (neoantigens) identified by sequencing each patient’s tumors. In the trial, GNOS-PV02 will be combined with a DNA plasmid encoded cytokine immunomodulator IL-12 (INO-9012) and standard of care PD-1 checkpoint inhibitor (pembrolizumab).

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This innovative trial is an open-label, non-randomized, exploratory study designed to assess the safety, immunogenicity, and antitumor activity of the combination treatment in advanced HCC patients who have progressed on or are intolerant to first-line treatment with a Tyrosine Kinase Inhibitor (TKI). The primary study goals are to evaluate safety, biomarkers of immune activity, with special emphasis on CD8+ T cell responses, and clinical outcomes.

Geneos has exclusively licensed the DNA Medicines platform, INO-9012 and CELLECTRA device for in vivo delivery of DNA plasmids from Inovio Pharmaceuticals (NASDAQ: INO) for use in the development of personalized cancer treatments. The two DNA based products, GNOS-PV02 and INO-9012, will be administered to cancer patients via intradermal (ID) administration using the CELLECTRA 2000 ID device.

Dr. Niranjan Y. Sardesai, Founder and Chief Executive Officer of Geneos Therapeutics, said "We are excited about this first clinical trial for the Geneos GT-EPIC neoantigen-targeting platform. This trial will seek to demonstrate that Geneos can produce personalized neoantigen-targeting immunotherapies in a clinically meaningful time frame, which drive strong T cell responses (both CD4+ and CD8+) and that these immunotherapies can enhance the efficacy of a PD-1 inhibitor alone. Enabled by our industry leading rapid biopsy to treatment turnaround time and the unique design of this study, the Geneos personalized therapy will be initiated at the same time the patient receives the first dose of the PD-1 inhibitor – we believe this is a critical success factor for neoantigen-based combination trials."

Dr. Mark Yarchoan, Assistant Professor of Oncology at Johns Hopkins and Investigator for the GT-30 advanced HCC study said "Checkpoint inhibitors and other immunotherapies have advanced the cancer treatment field and have had a significant impact on clinical outcomes. However, every patient’s tumor is unique and in order to further improve outcomes, I believe that personalized approaches are critical. I’m excited about this clinical trial utilizing Geneos’ innovative personalized treatment approach in combination with an approved immunotherapy for the treatment of advanced HCC. HCC is one of the fastest growing cancers in the U.S., and a significant unmet need exists to find more efficacious treatments."

HCC accounts for the majority of primary liver cancers. Globally, liver cancers are the fourth most common cause of cancer-related death and rank sixth in terms of annual incidence. The rate of death from liver cancer in the U.S. has increased 43% from 2000 to 2016 and with a 5-year survival rate of 18% for advanced liver cancer, it is the second most deadly tumor behind pancreatic. To date, immunotherapies have shown limited efficacy with two PD-1 inhibitors (pembrolizumab and nivolumab) approved as second line treatments following a tyrosine kinase inhibitor.