On January 28, 2020 Aflac Incorporated (NYSE: AFL) reported that it will release fourth quarter financial results after the market closes on February 4, 2020 (Press release, Aflac, JAN 28, 2020, View Source [SID1234553631]).

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In conjunction with the earnings release, Aflac Incorporated will webcast a conference call scheduled for 9:00 a.m. (ET) on February 5, 2020. During the teleconference, the company will discuss fourth quarter results and its outlook. The following executives will be available to answer questions: Aflac Incorporated Chairman and Chief Executive Officer Daniel P. Amos; President and Chief Operating Officer of Aflac Incorporated Frederick J. Crawford; Executive Vice President and Chief Financial Officer of Aflac Incorporated Max K. Brodén; President of Aflac International and Chairman and Representative Director of Aflac Life Insurance Japan Charles D. Lake II; President and Representative Director of Aflac Life Insurance Japan Masatoshi Koide; Director, Executive Vice President and Director of Sales and Marketing of Aflac Life Insurance Japan Koji Ariyoshi; President of Aflac U.S. Teresa L. White; Executive Vice President and Global Chief Investment Officer of Aflac Incorporated and President of Aflac Global Investments Eric M. Kirsch; Director, Executive Vice President and Chief Financial Officer of Aflac Life Insurance Japan J. Todd Daniels; Executive Vice President and Chief Distribution Officer Richard L. Williams Jr.; and Senior Vice President; Global Chief Risk Officer and Chief Actuary Albert A. Riggieri.

On January 28, 2020 Kite, a Gilead Company (Nasdaq: GILD), reported that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), has been fully validated and is now under evaluation by the European Medicines Agency (EMA) (Press release, Kite Pharma, JAN 28, 2020, View Source [SID1234553630]).

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The MAA is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19 (median follow-up of 12.3 months). In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando.

"Relapse rates in mantle cell lymphoma remain overwhelmingly high and there is a significant need for new therapies that may improve patients’ prognosis," said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. "The EMA validation of our marketing application brings us closer to delivering on the promise of our industry-leading cell therapy development program, with the hope that we can bring KTE-X19 to appropriate patients in Europe as quickly as possible."

Kite submitted a Biologics License Application (BLA) for KTE-X19 to the U.S. Food and Drug Administration (FDA) on December 11, 2019 for the treatment of adult patients with relapsed or refractory MCL. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA.

KTE-X19 is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with KTE-X19 is available at www.clinicaltrials.gov.

About MCL

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node and typically affects men over the age of 60.

About ZUMA-2

ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy (60 patients) and safety (68 patients) after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate (ORR). ORR in this trial is defined as the combined rate of complete responses and partial responses as assessed by an IRRC.

Secondary endpoints include duration of response, progression-free survival, overall survival, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing.

About KTE-X19

KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

On January 28, 2020 Sengenics, a leading precision medicine focused company, reported that Dr Arif Anwar, CEO of Sengenics, will present a company overview at the 2020 BIO CEO and Investor Conference (Press release, Sengenics, JAN 28, 2020, View Source [SID1234553629]). The presentation will take place at 3:15 PM EST on Monday, February 10, 2020 in the Wilder room at the New York Marriott Marquis.

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Dr Arif Anwar will present an overview of the commercialisation strategy of the company and applications of its patented KREXTM technology for autoimmune and cancer immunotherapy drug response and ADR prediction.

Sengenics is currently co-developing complementary and companion diagnostic tests for several autoimmune and cancer immunotherapy drugs through partnerships with top pharmaceutical companies. The company has commenced the process for obtaining FDA 510(k) approval for several of these tests and plans to launch them in 2020 and 2021.

Sengenics’ management team will also hold meetings with institutional investors and analysts from February 10 – 14 in New York. Accredited investors are invited to request a meeting during the conference through BIO’s One-on-One PartneringTM System.

On January 28, 2020 Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported the Company’s plans for 2020 (Press release, Guided Therapeutics, JAN 28, 2020, View Source [SID1234553628]).

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The Company’s main goals for this year are:

Restart discussions with the FDA and begin work on a small confirmatory study to support the claims of the previously completed pivotal study – The Company has already contacted FDA and informed them to expect the updated protocol for review. The outline for the protocol was previously agreed to during previous meeting between FDA and the Company. FDA also agreed to reduce the criteria for sensitivity of the test, a benchmark that was reached in the completed pivotal study of 2,000 women. Based on these developments, the company intends to discuss with FDA completing the smaller confirmatory study under one of three possible approval scenarios: 1) as part of the normal premarket approval process 2) via the de novo 510(k) route for new technologies or 3) as part of post-marketing studies. The latter two strategies would likely reduce the time to US market launch and would need to be agreed to by FDA.
Start clinical studies for Chinese FDA approval and achieve approval by Q4 2020 – Company intends to fill near term purchase order of 5 devices in Q1 2020 and, once our Chinese distribution partner Shandong Medical Instrumentation Co, Ltd. files with Chinese FDA as a Class 2 device, start to receive payments on larger $2.5 million Purchase Order.
Start taking new orders for Europe and Russia based on final assembly of LuViva at new manufacturing site in Hungary – Contract manufacturer is now ISO 13485 approved to assemble LuViva. New CE Mark with expanded claims has been applied for and expected to be granted in Q1 or Q2 of this year.
Jumpstart sales growth in Middle East and Indonesia – New agreements and subsequent sales with current distributors and addition of new distributor covering a total of 19 countries are expected to generate significant new orders in 2020.
Financial Filings – The Company anticipates releasing Q2 2019 (10Q) financial results later this month and 2019 Q3 (10Q) financial results early in February to catch up with its SEC filings.

On January 28, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that it has demonstrated initial proof-of-concept for its proprietary new class of drug conjugate, TMAC, in a pre-clinical animal model of cancer (Press release, Avacta, JAN 28, 2020, View Source [SID1234553627]). The study showed that AVA04-VbP outperformed Bavencio (Avelumab), a marketed anti-PD-L1 immunotherapy.

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Avacta’s tumour microenvironment activated drug conjugates (TMAC) are a ground-breaking new form of cancer immunotherapy, combining its Affimer biotherapeutics with chemotherapies in a single drug, using a linker (incorporating its proprietary pre|CISION substrate) that is designed to only release the chemotherapy in the tumour microenvironment through the action of an extracellular enzyme called FAPα. This mechanism overcomes the need to target an internalising cancer marker, as with conventional antibody drug conjugates (ADCs), and allows extremely potent chemotherapies to be combined with Affimer immune-checkpoint therapies. Combining pre|CISION technology with the Affimer platform is enabling Avacta to build a pipeline of novel and safe cancer therapies applicable to a broader range of cancer patients, including those who do not respond to existing immunotherapies.

AVA04-VbP combines an Affimer PD-L1 checkpoint inhibitor with an I-DASH chemotherapy warhead, addressing the acute systemic toxicity associated with I-DASH inhibitors by targeting the release of the drug warhead in the tumour microenvironment. The drug warhead induces a highly pro-inflammatory cell death, which in turn stimulates an immune response in the tumour, which is supported by the Affimer PD-L1/PD-1 signalling pathway blockade.

In a mouse syngeneic tumour model study, Avacta has shown that AVA04-VbP outperforms Bavencio; animals treated with AVA04-VbP showed a significant reduction in the rate of tumour growth with respect to those treated with Bavencio. A considerably higher level of the released I-DASH warhead was measured in the tumours compared with very low levels in the blood, indicating that healthy tissues are less exposed to the highly toxic warhead. This tumour targeting is central to the TMAC mechanism of action, and permits the use of the highly potent cancer-killing warheads.