Merck to Hold First-Quarter 2019 Sales and Earnings Conference Call on April 30

On April 2, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its first-quarter 2019 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, April 30 (Press release, Merck & Co, APR 2, 2019, View Source [SID1234534915]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 8493044. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 8493044. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

Advaxis, Inc. Announces Proposed Public Offering of Common Stock

On April 2, 2019 Advaxis, Inc. (Nasdaq: ADXS) (the "Company"), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that it intends to offer and sell in an underwritten public offering shares of its common stock (Press release, Advaxis, APR 2, 2019, View Source [SID1234534931]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

The Company intends to use the net proceeds from this offering to fund its continued research and development initiatives in connection with its product pipeline including, but not limited to, (i) investment in its ADXS-HOT program in both monotherapy and combination therapy and new cancer types; (ii) investment in ongoing clinical research in ADXS-PSA and ADXS-NEO, in combination therapy; and (iii) general corporate purposes.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 30, 2018. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or via email at [email protected]. The offering may be made only by means of a prospectus supplement and the accompanying prospectus. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Combination of first-in-class NBTXR3, radiotherapy, and anti-PD-1 immunotherapy
demonstrate efficacy in treating resistant pre-clinical in vivo models of lung cancer

On April 2, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the ‘‘Company’’) a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported preclinical data from studies currently being conducted under its collaborations with The University of Texas MD Anderson Cancer Center and the Weill Cornell Medical College (Press release, Nanobiotix, APR 2, 2019, View Source [SID1234534950]). These results were presented during two poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, currently taking place in Atlanta, Georgia, USA from March 29 to April 3, 2019.

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This initial pre-clinical set of NBTXR3/radiotherapy/IO combination data provides further insights into the immuneactivation caused by NBTXR3 and strengthens the understanding of the potential systemic effects provided by NBTXR3. Thus, the Company believes it formulates sound rationale to support its clinical development program investigating the combination of NBTXR3, radiotherapy and IO agents.

Enhancement of anti-PD-1 and anti-CTLA4 efficacy by NBTXR3 nanoparticles exposed to radiotherapy Poster #3225 Yun Hu1, Ping Zhang2, Audrey Darmon2, Maria Angelica Cortez1, Sébastien Paris2, James Welsh1 1MD Anderson Cancer Center, Houston, TX; 2Nanobiotix, Paris, France

In both 344SQ_P (sensitive to anti-PD-1 treatment) and 344SQ_R (resistant to anti-PD-1 treatment) lung cancer models, the combination of anti-PD-1 + radiotherapy + NBTXR3 demonstrated both better control of the treated tumor and the distant untreated tumor as well as increased survival when compared to monotherapy. Importantly, it was observed that this combination decreased spontaneous lung metastasis formation in the anti-PD-1 sensitive 344SQ_P model.

For the CT26.WT colon carcinoma model, as previously reported, NBTXR3 activated by radiotherapy generated an abscopal effect. It was observed that administration of anti-CTLA4 monotherapy demonstrated control of both treated and distant untreated tumors, potentially indicating that the CT26.WT was sensitive to a checkpoint inhibitor. The addition of radiotherapy to anti-CTLA4 only improved the tumor control modestly compared to antiCTLA4 alone. In contrast, the combination of anti-CTLA4 + radiotherapy + NBTXR3 in this trial showed the best control of the treated and distant untreated tumors, then any single agent or doublet combination.

NBTXR3 Potentiates Cancer-Cell Intrinsic Interferon beta Response to Radiotherapy Poster #3366 Maria Esperanza Rodriguez-Ruiz1, Karsten A Pilones1, Camille Daviaud1, Jeffrey Kraynak1, Audrey Darmon2, Sébastien Paris2 and Sandra Demaria1 1Department of Radiation Oncology, Weill Cornell Medicine, New York, USA; 2Nanobiotix, Paris, France

Data suggests that NBTXR3 enhances the effectiveness of radiation and improves tumor immunogenicity in murine breast cancer cell lines, via the induction of type-I interferon (IFN-I). In the study, NBTXR3 activated by radiotherapy amplified cancer cell intrinsic IFN-I response and showed a significant improvement in tumor control compared to radiotherapy alone with complete durable regression of tumors.-Ends

About NBTXR3

NBTXR3 is a first-in-class product candidate designed to destroy tumors and metastasis when activated by radiotherapy.

NBTXR3 has a high degree of biocompatibility and requires one single administration before the whole radiotherapy treatment. Nanobiotix believes NBTXR3 has the ability to fit into current worldwide standards of radiation care.

Nanobiotix’s broad clinical program includes seven clinical trials. In June 2018, Nanobiotix established human proof of concept for this first-in-class product candidate in its soft tissue sarcoma (STS) Phase III clinical trial. NBTXR3 is actively being studied in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients who are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results from these clinical studies have been observed from the ongoing Phase I/II trial regarding the local control of tumors.

Nanobiotix is also running an immuno-oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.

The first market authorization process (CE Marking) for the STS indication is ongoing in Europe

Sumitomo Dainippon Pharma Submits an Application of RETHIO for an Additional Indication of Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation for Malignant Lymphoma

On April 2, 2019 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura hereinafter called "Sumitomo Dainippon Pharma") has reported that on March 29 the company applied for a partial change in the marketing approval previously acquired in Japan for RETHIO 100 mg for I.V. infusion (generic name, thiotepa; hereinafter called "RETHIO") (Press release, Sumitomo Dainippon Pharma, FEB 2, 2019, View Source [SID1234605564]). The change applied for this time involves an additional indication of RETHIO for conditioning treatment prior to autologous hematopoietic stem cell transplantation (auto-HSCT) for malignant lymphoma.

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RETHIO is a drug indicated for conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors. Sumitomo Dainippon Pharma obtained the marketing approval for this drug on March 26, 2019 and plans to launch it after NHI drug price listing.

Malignant lymphoma, a hemocytes-derived cancer, is a disease that lymphocytes, a subpopulation of leukocytes (white blood cells), become cancerous. This disease occurs typically in lymphoid tissues, such as lymph nodes, spleens, and tonsils, but it also often develops in other sites. It has been reported that the incidence of malignant lymphoma is around ten in 100,000 persons in Japan annually, the most common hematapostema in Japanese adults. As with conditioning treatment prior to autologous HSCT for pediatric malignant solid tumors, the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs of the Ministry of Health, Labour and Welfare (MHLW) determined similarly high medical need in conditioning treatment prior to auto-HSCT for malignant lymphoma. Thus, Sumitomo Dainippon Pharma conducted Phase 1 trials in Japan and subsequently applied for the additional indication.

Sumitomo Dainippon Pharma believes that, upon approval of its additional indication, this drug will contribute to improved healthcare as a new treatment option for patients indicated for conditioning treatment prior to auto-HSCT for malignant lymphoma, a therapeutic area with high unmet medical need.

About autologous hematopoietic stem cell transplantation (auto-HSCT)
Autologous hematopoietic stem cell transplantation is a therapy that aims to reconstruct hematopoietic capacity via intravenous transfusion of normal hematopoietic stem cells of the patient himself/herself after eradicating intractable cancers by conditioning myeloablative treatment prior to transplantation using maximum levels of anti-cancer drugs or radiation.

About the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs
The Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs is a committee established to promote the development of unapproved or off-label drugs by pharmaceutical companies that are approved for use in Europe and the United States, etc., but not approved in Japan. It is organized under the Ministry of Health, Labour and Welfare of Japan and consists of academic experts in medical and pharmaceutical fields.

Genmab to Present at the H.C. Wainwright & Co. Global Life Sciences Conference

On April 2, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its CEO, Jan van de Winkel, Ph.D., will present a company update at the H.C. Wainwright & Co. Global Life Sciences Conference in London at 11:30 AM BST on April 9, 2019 (12:30 PM CEST) (Press release, Genmab, APR 2, 2019, https://ir.genmab.com/news-releases/news-release-details/genmab-present-hc-wainwright-co-global-life-sciences-conference [SID1234534883]). A webcast of the presentation will be available on Genmab’s website at View Source

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