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.

On April 2, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to clinical trials and precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry" will be presented by Dr. Selin Kurnaz, a lead investigator, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, during the Phase I-III Trials in Progress session on April 2nd, 2019 (Press release, Admera Health, APR 2, 2019, View Source [SID1234537386]).

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The poster (Abstract #CT218), View Source!/6812/presentation/10031 discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We continue active enrollment in this innovative precision oncology and artificial intelligence project, and we are honored and excited to be among the highly selected group of clinical trials to be presented at AACR (Free AACR Whitepaper). Moreover, we are the only company in the market that operationalizes technology – we not only pre-screen patients, we find sites to the patients, eliminate insurance barriers and truly close the last mile in oncology clinical trial enrollment. We clean massive operational inefficiencies and we are making a leap frog in clinical research," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

In addition, today, Massive Bio and Admera Health announced a non-exclusive collaborative agreement as active participants in SYNERGY-AI registry. Under the terms of the agreement, Massive Bio and Admera Health will focus on real world evidence, biomarker data and clinical trial matching in precision oncology studies. In addition, Admera Health also provides genomics and bioinformatics services to customers wishing to conduct research in a CLIA environment.

"By combining the expansive technology and precision oncology capabilities of Massive Bio with Admera Health’s specialization in genomics and bioinformatics, we hope to develop and provide the next wave of molecular-based portfolio of technology innovations and services," stated Jeffrey R. Mitchell, Associate Director of Strategy and Marketing of Admera Health. Mitchell continued, "In addition, given the geographic strengths of our respective companies, there will also be opportunities to expand clinical trials using each other’s proprietary technology around the globe."

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "Massive Bio’s Artificial Intelligence technology platform is extremely well positioned to enable just-in-time clinical trial matching and enrollment, with a targeted therapy and immunotherapy focus, and is proven to accelerate access to innovative therapies, sponsor and CRO efficiency, as well as time to market. We certainly welcome collaborations with all stakeholders in the diagnostics and research space, aiming to close existing gaps in cancer research." Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "With a growing number of successful development applications, it is our goal to continue to promote precision oncology approaches at the point-of-care, and to ease access to clinical trials, while reducing patient and provider burden and overall cancer care costs."

About the Study

The SYNERGY-AI Registry is an international prospective, observational cohort study of adult and pediatric patients with advanced solid and hematological malignancies. Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CT. Machine learning algorithms allow for optimized matching based on CT allocation and availability. Enrollment is ongoing, with a target of ?1,500 patients. Please refer to View Source for details.

On April 2, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing novel cancer immunotherapies, reported its pre-clinical data highlighting its novel anti-tumor product candidate, SPARK, and its improved electroporation generator, "APOLLO," during a poster presentation at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia (Press release, OncoSec Medical, APR 2, 2019, View Source [SID1234534898]).

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The poster, entitled, "Intratumoral electroporation of plasmid IL-12 and CXCL9 with membrane-bound anti-CD3 elicits robust anti-tumor immunity," provides new preclinical data demonstrating robust anti-tumor responses driven by significant enhancements made to OncoSec’s proprietary cancer immunotherapy platform.

"The data presented at AACR (Free AACR Whitepaper) highlight OncoSec’s potentially game-changing approach to drug development. With this data, we show the ability to not only identify the right genes to have anti-cancer effect, but, importantly, that we can deliver those genes directly into tumor cells. We are able to do this with any gene that is identified as having an anti-cancer effect, without having to expose the patient to a systemic therapy, in an expeditious and cost-effective manner. In doing so, these cells convert immunologically cold tumors into inflamed immunogenic lesions, which is fundamental to generating objective responses in both treated and untreated distant tumors," said Daniel J. O’Connor, President and CEO of OncoSec. "Many immunotherapies are stalled for serious toxicity issues associated with treatment, including cytokine release syndrome. In contrast, our clinical studies, in more than 180 patients with several different tumor types, have demonstrated that TAVO has broad clinical activity without the toxicity commonly associated with IL-12. The foundation of our DNA-based immunotherapy relies on electroporation, which bypasses the pitfalls associated with viral vectors or systemic cytokines."

The Company’s research laboratory discovered complimentary anti-tumor immunological pathways related to IL-12 derived from samples of previously treated TAVO patients. These discoveries resulted in the selection of two new genes, CXCL9 and aCD3 (expressing membrane-bound anti-CD3), to further drive a now enhanced version of IL-12, utilizing P2A in place IRES (TAVOPLUS). In parallel, OncoSec’s researchers reengineered the Company’s existing electroporation generator. The new generator, APOLLO, greatly increases DNA-plasmid cellular transfection rates in order to deliver more anti-cancer fighting genes directly into tumor cells. These independent evolutions of both components of OncoSec’s proprietary cancer immunotherapy platform converged in the design of its new product candidate, SPARK.

Highlights of the data presented at AACR (Free AACR Whitepaper) regarding SPARK and APOLLO demonstrate that:

APOLLO, using lower voltage and a longer pulse width, greatly increased DNA-plasmid cellular transfection rates to deliver more anti-cancer fighting genes directory into tumor cells;
TAVOPLUS, OncoSec’s new proprietary IL-12 enhanced DNA-plasmid, which expresses full-length IL-12 via bicistronic expression of both the p35 and p40 subunits, coupled with APOLLO, meaningfully improves anti-cancer responses;
SPARK, OncoSec’s new proprietary product candidate, drives strong anti-tumor immune responses by combining two novel anti-cancer genes, CXCL9 and aCD3, with TAVOPLUS
CXCL9 with TAVOPLUS
Productively modulates immune/tumor microenvironment
Significantly increases antigen-specific CD8+ CTL
Augments abscopal response of TAVOPLUS
aCD3, expressing membrane bound anti-CD3, with TAVOPLUS
Drives polyclonal T cell expansion and antigen-specific killing in vivo
Augments abscopal response when combined with TAVOPLUS
aCD3 complements CXC by strongly increasing cytotoxic anti-cancer tumor inflammation; and
SPARK, when delivered via APOLLO, significantly improves regression of untreated (distant) tumors in a difficult to treat preclinical melanoma model
"The encouraging data presented at AACR (Free AACR Whitepaper) demonstrate the potential of SPARK to integrate three key immunotherapeutic elements, IL-12, CXCL9 and anti-CD3 complimentary, into a single novel, multi-gene expression platform that we believe will have broad applicability across numerous tumor types," said Christopher G. Twitty, Chief Scientific Officer of OncoSec. "Importantly, SPARK builds upon our plasmid-based cancer immunotherapy platform by amplifying the power of intratumoral IL-12 through the sequenced addition of both CXCL9, a critical T cell chemokine and anti-CD3, a membrane-bound strong pan T cell stimulator. We look forward to filing an Investigational New Drug (IND) application for SPARK."

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.

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.