On May 13, 2020 DCprime, the front-runner in the field of relapse vaccines, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for DCP-001, an allogeneic cancer relapse vaccine currently being evaluated in a European Phase II trial in Acute Myeloid Leukaemia (AML) patients who are ineligible for hematopoietic stem cell transplantation (Press release, DCPrime, MAY 13, 2020, View Source [SID1234561870]). The IND provides the possibility for DCprime to expand the ongoing ADVANCE-II trial into the Unites States, where DCP-001 had received orphan drug status in Q4 2019.

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"Following encouraging clinical and preclinical data presented at medical conferences in 2019, 2020 should see the first results emerging from the ADVANCE-II study. The possibility to expand our trial activities into the United States is an important step and follows approvals by different European authorities in The Netherlands, Germany, Norway, Sweden, and recently also Finland," said Jeroen Rovers, MD, PhD, Chief Medical Officer of DCprime. "Although we are currently facing challenging times for clinical studies due to the Covid-19 crisis, DCprime remains committed to expanding its clinical network to support the development of relapse vaccines in AML and other cancer types. Securing the regulatory approval now, allows us to move quickly once the current clinical situation around Covid-19 improves."

The currently active international, multi-center, open-label proof-of-concept study ADVANCE-II is recruiting AML patients in complete remission, but with persistent measurable residual disease (MRD), which is associated with a high relapse rate. The effect of DCP-001 on MRD in combination with immunomonitoring will be used to evaluate the efficacy of DCprime’s relapse vaccination strategy.

Clinical data from a previously concluded Phase I clinical study that was presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2019 demonstrated DCP-001’s potential to prolong relapse-free survival and overall survival in the post-remission setting.

On May 13, 2020 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the first quarter ended March 31, 2020.

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"With the COVID-19 pandemic impacting businesses globally, the first quarter of 2020 was unlike anything we would have anticipated. As work from home restrictions directly impacted our customers and their normal ordering patterns, we felt the immediate impact," said John Lubniewski, President and CEO of HTG. "However, we have managed to take advantage of this time to leverage our teams, improve our processes, and accomplish detailed long-term planning all in preparation of emerging from this period as a stronger company. While we cannot be certain of the ultimate impact of the COVID-19 pandemic on us or our customers, we are optimistic that demand for our products and services will return."

Mr. Lubniewski continued, "Our product development teams have made progress towards the key milestones that we had set for ourselves during the quarter. Our California and Arizona development teams continue to implement our development strategy and we are on track to deliver development milestones. While the pandemic has created some near-term uncertainty, we are very proud of how our employees have faced the challenges – with flexibility and a commitment to ensuring our long-term success. When our customers eventually return to a more normal work environment, we will be prepared to meet demand and for growth in our business."

First Quarter 2020 Financial Highlights:

Total revenue for the first quarter ended March 31, 2020 was $2.2 million, compared with $3.2 million for the same period in 2019. The decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities around the globe. These closures limited the company’s ability to deliver its products to customer facilities and created challenges for customers in preparing and shipping samples to the company for processing.

Product and product-related services revenue was $2.0 million, compared with $2.7 million for the same period in 2019. This decrease in direct revenue primarily reflects a decline in lower margin, subcontracted laboratory services revenue reflected in RUO sample processing revenue when compared with first quarter of 2019 revenue.

Collaborative development services revenue for the quarter ended March 31, 2020 was $0.2 million compared with $0.5 million for the same period in 2019. The decrease in collaborative development services revenue reflects a decrease in activity as partners approached key decision points in current active programs.

Net loss from operations for the first quarter ended March 31, 2020 was $5.4 million, compared with $5.3 million for the first quarter of 2019. Net loss per share was $(0.08) for the first quarter of 2020 compared with $(0.19) for the first quarter of 2019.

Cash, cash equivalents and short-term available-for-sale securities totaled $32.0 million as of March 31, 2020, with current liabilities of approximately $8.4 million and non-current liabilities of $11.6 million. An additional $3.3 million of restricted cash was held in connection with a convertible note that is included in current liabilities as of March 31, 2020.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On May 13, 2020 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming virtual poster presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 29-31, 2020 (Press release, Bio-Path Holdings, MAY 13, 2020, View Source [SID1234558025]).

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Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center, will discuss the Phase 2 study design of BP1001 (liposomal Grb2 antisense), the Company’s lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome.

Details for the virtual poster presentation are as follows:

Date: Friday, May 29, 2020

Presentation Time: 8:00 am Eastern Time

Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract: TPS7561

Poster: 334

Title: A phase II study of BP1001 (liposomal Grb2 antisense oligonucleotide) in patients with hematologic malignancies

On May 13, 2020 OncoSec Medical Incorporated (Nasdaq:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported the European Medicines Agency (EMA) issued an advanced therapy medicinal product (ATMP) certificate for chemistry manufacturing controls (CMC) data covering its lead product candidate, TAVO (interleukin-12 or "IL-12" plasmid), for the treatment of metastatic melanoma (Press release, OncoSec Medical, MAY 13, 2020, View Source [SID1234557968]). Following TAVO’s classification as an ATMP last year, the certification procedure involved a thorough scientific evaluation over several months of CMC data for TAVO by the EMA’s Committee for Advanced Therapies (CAT). The CAT assessment of the TAVO CMC data provides valuable regulatory feedback to help ensure a successful marketing authorization application prior to submission. After a positive opinion from CAT, EMA issued a certificate confirming that the CMC data comply with the standards that apply for evaluating the Marketing Authorization Application (MAA).

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"Certification of TAVO as an ATMP allows us to leverage a specific EU regulatory framework, akin to fast-track in the United States, designed to facilitate the review, approval, and access of TAVO in the EU market," said Robert Ashworth, PhD, Senior Vice President, Regulatory, Quality and CMC at OncoSec. "With the CMC portion of the MAA now reviewed and certified, we are preparing to commence process validation activities for TAVO as we work to bring this innovative immunotherapy to patients with metastatic melanoma who have limited treatment options."

The Committee for Advanced Therapies is the committee at the European Medicines Agency that is responsible for classifying and assessing the quality, safety and efficacy of advanced-therapy medicinal products and following scientific developments in the field. It is a multidisciplinary committee, gathering together some of the best available experts in Europe.

The ATMP designation is a classification for certain medicines for human use that are gene-, cell-, or tissue-based. The main responsibility of the CAT is to prepare a draft opinion on each ATMP application submitted to the European Medicines Agency, 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.

OncoSec has expanded its pivotal KEYNOTE-695 study of TAVO to Europe, laying the foundation for a MAA submission within the EU. The KEYNOTE-695 study is a pivotal, global, open-label trial evaluating TAVO in combination with the checkpoint inhibitor, KEYTRUDA (pembrolizumab) in patients with anti-PD-1 checkpoint resistant metastatic melanoma. TAVO currently has orphan drug designation and fast track status in the United States.

On May 13, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported the acceptance of two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Virtual Annual Meeting, taking place virtually from May 29, 2020 to June 2, 2020 (Press release, Y-mAbs Therapeutics, MAY 13, 2020, View Source [SID1234557967]). The presentations were submitted by Jaume Mora, M.D., Ph.D. from SJD Barcelona Children’s Hospital:

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The role of autologous stem-cell transplantation in high-risk neuroblastoma consolidated by anti-GD2 immunotherapy. Results of 2 consecutive studies in a single referral institution
Naxitamab, a new generation anti-GD2 monoclonal antibody (mAb) for treatment of relapsed/ refractory high-risk neuroblastoma (HR-NB)
Researchers at MSK developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.