On April 1, 2019 LabCorp (NYSE: LH) reported that it will release its first quarter of 2019 financial results before the market opens on Tuesday, April 30, 2019, followed by a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, APR 1, 2019, View Source;p=RssLanding&cat=news&id=2392950 [SID1234534812]). Interested parties can access the conference call by dialing 844-634-1444 within the U.S. and Canada, or 1-615-247-0253 internationally, using the passcode 7459328.

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An audio replay of the conference call will be available from 1:00 p.m. EDT on April 30, 2019, until 11:30 a.m. EDT on May 14, 2019, by dialing 855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 7459328.

The earnings release, accompanying financial information, and a real-time webcast of the conference call will be available on the LabCorp Investor Relations website. The webcast will be archived and accessible through April 24, 2020.

On April 1, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing novel cancer immunotherapies, reported that it has received Advanced Therapy Medicinal Product (ATMP) classification for the Company’s lead investigational product candidate, TAVO (DNA plasmid vector expressing IL-12 gene), as a potential treatment for refractory metastatic melanoma from the European Medicines Agency (EMA) (Press release, OncoSec Medical, APR 1, 2019, View Source [SID1234534811]).

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Only innovative investigational product candidates that are based on gene, tissue or cell therapy are qualified for classification as advanced therapy medicinal products. The classification of TAVO as an ATMP is a significant step toward its potential accelerated approval in Europe. The ATMP classification qualifies TAVO to take advantage of a specific EMA regulatory framework designed to facilitate the accelerated review, approval, and access to innovative products in the European market. Further, OncoSec intends to avail itself of the numerous benefits and incentives for medicinal products undergoing clinical testing and marketing approval processes in Europe. Such incentives include fee reductions and exemptions in pre- and post-marketing authorization phases; administrative, procedural and scientific advice and eligibility for funding.

"The ATMP designation confirms TAVO as an innovative gene therapy potentially offering a groundbreaking new opportunity for the treatment of refractory metastatic melanoma," said Robert Ashworth, PhD, Senior Vice President of Regulatory and Quality at OncoSec.

"Similar to TAVO’s existing FDA Fast Track Designation in the United States, the ATMP designation allows OncoSec to take advantage of a specific European regulatory framework designed to facilitate the accelerated review and approval of TAVO in the European market," said Daniel J. O’Connor, OncoSec’s President and CEO. "Obtaining this important designation delivers on one of OncoSec’s key objectives for 2019."

The Committee for Advanced Therapies (CAT) at the EMA is responsible for classifying and assessing the quality, safety and efficacy of products designated as ATMP. The CAT is a multidisciplinary committee of the best available experts in Europe. The main responsibility of the CAT is to prepare a draft opinion on each ATMP application submitted to the EMA before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on granting a marketing authorization for the product. During drug development, CAT also reviews and certifies the acceptability of quality and non-clinical data.

In February 2017, the U.S. Food and Drug Administration (FDA) designated the investigation of OncoSec’s TAVO in combination with KEYTRUDA (pembrolizumab) to stop or cause the regression of the tumor of patients with Stage III/IV melanoma who are progressing on either KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab) treatment as a Fast Track Development Program. Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation is eligible for Accelerated Approval if relevant criteria are met.

On April 1, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the initial results from a Phase Ib study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer (TNBC) (Press release, Hoffmann-La Roche, APR 1, 2019, View Source [SID1234534809]). Combination treatment demonstrated a confirmed objective response rate (ORR) of 73% (95% CI 53-88%), irrespective of tumour biomarker status. The median duration of follow-up was 6.1 months (range 3.1–10.6). Grade ≥3 adverse events occurred in 14 people (54%); the most common all-grade adverse events were diarrhea (88%; grade ≥3 19%) and rash (69%; grade ≥3 27%).

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"We are enthusiastic about the potential of this combination in triple-negative breast cancer, an aggressive type of breast cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "These early results support the contribution of ipatasertib to our combination treatment approach in TNBC and reinforce our vision to develop medicines that may benefit patients with this challenging disease."

Preliminary efficacy data for the first 26 patients (18 paclitaxel, 8 nab-paclitaxel) show confirmed responses in 19/26 patients, giving a confirmed ORR of 73%. Responses were seen irrespective of PD-L1 status (9/11 [82%] PD-L1+; 6/8 [75%] PD-L1–; 4/7 [57%] PD-L1 unknown) or PIK3CA/AKT1/PTEN alteration status (5/7 [71%] Dx+, 9/11 [82%] Dx–; 5/8 [63%] Dx unknown).

Activation of the PI3K/AKT pathway has been implicated in resistance to chemotherapies and hormonal therapies in multiple tumour types and loss of PTEN, a negative regulator of AKT, has emerged as a potential mechanism for resistance to checkpoint inhibitor therapy. By inhibiting the PI3K/AKT pathway, ipatasertib may contribute to reversal of T-cell-mediated immunotherapy resistance. These results and the potential benefit that ipatasertib plus the Tecentriq/taxane combination may bring to patients are encouraging and add to the Roche development program in triple-negative breast cancer following the approval of the Tecentriq combination.

Trial enrolment for the Phase 1b study is ongoing. Later this year, Roche will initiate a pivotal multi-center, randomised, double-blind Phase III study investigating the combination of ipatasertib, atezolizumab and paclitaxel as first-line therapy for locally advanced/metastatic triple-negative breast cancer.

About the study
The Phase Ib study is an open-label, multicentre study evaluating the safety and efficacy of ipatasertib in combination with atezolizumab and paclitaxel or nab-paclitaxel for patients with locally advanced or metastatic triple-negative breast cancer who have not previously received chemotherapy in the advanced setting. Two triplets: ipatasertib in combination with atezolizumab and paclitaxel (Paclitaxel arm) and ipatasertib in combination with atezolizumab and nab-paclitaxel (nab-Paclitaxel arm) are being evaluated for first-line treatment for advanced TNBC. A second cohort, which is enrolling now, will allow collection of tumour biopsies to assess treatment-related biomarker changes in TNBC patients who have progressed after at least one line of chemotherapy in the advanced setting.

About ipatasertib
Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT, which blocks the PI3K/AKT signaling pathway and may prevent cancer cell growth and survival.

Ipatasertib is being studied in tumours that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Pivotal studies are ongoing to evaluate the efficacy and safety of ipatasertib and the opportunity it may provide to address significant unmet needs for patients with these diseases. Ipatasertib has demonstrated clinically meaningful activity in both breast and prostate cancers, with a manageable safety profile.

Ipatasertib was discovered at Genentech in partnership with Array BioPharma Inc.

About Triple-Negative breast cancer
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.[1] TNBC represents 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.[2;3;4] It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.[5] Patients with metastatic TNBC generally experience rapid progression and shorter overall survival (OS) compared to other subtypes of breast cancer.[3]

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in the HER2 -positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-postive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

In the United States Tecentriq in combination with nab-paclitaxel is approved for treatment of PD-L1-positive metastatic triple-negative breast cancer. Roche currently has seven phase III studies in TNBC.

On April 1, 2019 Exicure, Inc. (OTCQB:XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it will present pre-clinical and clinical data for its TLR9 immune system agonist, AST-008, in two poster sessions at the AACR (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia from March 29 – April 03, 2019 (Press release, Exicure, APR 1, 2019, View Source;p=RssLanding&cat=news&id=2392886 [SID1234534808]).

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"On behalf of the Exicure team, we are pleased to announce these two posters which underscore the importance of Exicure’s SNA technology for immune therapy against cancer," said Dr. David Giljohann, Chief Executive Officer of Exicure. "The first poster shows the high potency activation of effector immune cells by our immune system agonist AST-008 after administration of AST-008 to healthy volunteers in a Phase 1 clinical trial. In the second poster, we are pleased to share for the first time, work conducted in collaboration with Celldex Therapeutics showing that Exicure’s TLR9 agonist leads to improved anti-tumor response when combined with CDX-301," said Dr. Giljohann.

The first poster, authored and presented by Exicure scientists, titled: "AST-008, a TLR9 agonist spherical nucleic acid, activated NK cells, T cells, and cytokines in healthy subjects in a Phase 1 clinical trial" demonstrates the utility of Exicure’s proprietary platform technology for targeting TLR9 to upregulate the immune system. Exicure’s drug, AST-008, is now enrolling patients in a Phase 1b/2 trial in patients with advanced solid tumors.

A second poster, to be presented by Celldex scientists, showcases data generated by Celldex Therapeutics, Inc. and Exicure through an ongoing scientific collaboration. The poster, titled: "Preclinical evaluation of the recombinant dendritic cell growth factor CDX-301 (Flt3L), and AST-008, a TLR9 agonist SNA" highlights improved anti-tumor activity after administration of AST-008 in combination with CDX-301.

Details of the posters:

Title: AST-008, a TLR9 agonist spherical nucleic acid, activated NK cells, T cells, and cytokines in healthy subjects in a Phase 1 clinical trial.
Abstract/Poster No: CT044/1
Date of poster presentation: April 01, 2019, 8:00 AM – 12:00 PM ET
Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17

Title: Preclinical evaluation of the recombinant dendritic cell growth factor CDX-301 (Flt3L), and AST-008, a TLR9 agonist SNA
Abstract/Poster No: 3217/27
Date of poster presentation: April 02, 2019, 8:00 AM – 12:00 PM ET
Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23

On April 1, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CEO, Dr. David Giljohann, will give a company presentation on Monday, April 8, 2019 at 11:50 am GMT at the H.C. Wainwright Global Life Sciences Conference (Press release, Exicure, APR 1, 2019, View Source;p=RssLanding&cat=news&id=2392908 [SID1234534807]). The presentation will be made in the Stratton Suite of the Grosvenor House in London.

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A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.