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.

On May 13, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will present new data on its lead partnered asset, monalizumab, at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program being held May 29-31, 2020 (Press release, Innate Pharma, MAY 13, 2020, View Source [SID1234557963]). The presentation will highlight a Phase II expansion cohort investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated"). Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

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"We are pleased to present additional data on the combination of monalizumab and cetuximab in head and neck cancer at this year’s ASCO (Free ASCO Whitepaper) Virtual Scientific Program. These data further strengthen the encouraging response rates previously reported in our head and neck clinical trial program," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "While the study was not randomized, numerically, these data compare favorably with historical data reported for cetuximab alone or for immuno-oncology (IO) single agent in recurrent or metastatic head and neck cancer after one line of previous systemic therapy."

The poster discussion presentation (#177, abstract #6516), entitled "Combination of Monalizumab and Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer Previously Treated with Platinum-based Chemotherapy and PD-(L)1 Inhibitors," will be available on demand beginning at 8 a.m. ET on Friday, May 29 under the Head and Neck Cancer track.

Key Highlights from Phase II Expansion Study Cohort 2 ("IO-pretreated")
As of March 2020, 40 platinum and IO-pretreated patients achieved an overall response rate (ORR) of 20%, which confirms the activity previously reported in the post-hoc analysis in the IO-pretreated subgroup in cohort 1 (ORR = 17%, n=18). Responses were observed in platinum-sensitive (3/21) and platinum-resistant patients (5/19), as well as in IO-sensitive (3/17) and IO-resistant patients (5/23), in patients exposed to IO as last previous therapy (5/34) and IO as earlier treatment (3/6).

The combination of monalizumab and cetuximab demonstrated a manageable safety profile, supporting continued investigation. No adverse events led to treatment discontinuation. Seventeen patients (42%) experienced grade 3-4 adverse events. Only one patient (2%) experienced a grade 3-4 adverse event considered related to monalizumab: peripheral sensory neuropathy and asthenia. No treatment-related deaths were reported.

"The additional findings from this Phase II study are encouraging and validate the overall response rates previously observed with the combination of monalizumab and cetuximab for the treatment of recurrent or metastatic head and neck cancer, a malignancy with poor prognosis where novel, effective and tolerable therapies continue to be needed for this patient population," said Dr. Roger B. Cohen, Professor of Medicine at the Hospital of the University of Pennsylvania. "The dual-targeting action exhibited by the combination of this NKG2A monoclonal antibody, monalizumab, when paired with cetuximab has the potential to provide greater antitumor activity than cetuximab alone, the current standard of care. We look forward to further studies evaluating this novel combination."

As previously disclosed, the start of the Phase III trial of monalizumab in combination with cetuximab in IO-pretreated patients suffering from R/M SCCHN, which will be conducted by AstraZeneca (LSE/STO/NYSE: AZN), is expected in 2020.

About the Monalizumab Phase II Trial
This trial is an open-label, Phase Ib/II study testing monalizumab in combination with cetuximab in patients with R/M SCCHN. The Phase II portion of the trial is comprised of three expansion cohorts:

Expansion Cohort 1, which enrolled 40 patients, evaluated the combination of monalizumab and cetuximab in patients with R/M SCCHN who had been previously treated with chemotherapy alone or chemotherapy followed by checkpoint inhibitors.
Expansion Cohort 2, which enrolled 40 patients and is evaluating the combination of monalizumab and cetuximab in patients with R/M SCCHN who have received a maximum of two prior systemic regimens in the R/M setting and with prior exposure to a platinum and a PD-(L)1 inhibitor (who we refer to as IO-pretreated patients).
Expansion Cohort 3, which is expected to enroll up to 40 patients, began recruiting in April 2019 and is evaluating the combination of monalizumab, cetuximab and durvalumab in IO-naïve patients with R/M SCCHN.
The primary endpoint for the Phase II portion of the trial is objective response rate. Secondary endpoints for the Phase II portion of the trial include duration of response, progression-free survival and overall survival.

In expansion cohort 1, the combination of monalizumab and cetuximab demonstrated a manageable safety profile and a response rate of 27.5% (36% and 17% in IO-naïve and IO-pretreated patients, respectively). Data were presented at the ESMO (Free ESMO Whitepaper) 2019 Congress. Expansion cohorts 2 and 3 are currently ongoing.

About Monalizumab:
Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing Phase II development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

About Cetuximab:
Cetuximab is an anti-EGFR monoclonal antibody. NK cells mediate cetuximab-induced antibody dependent cellular cytotoxicity (ADCC) against SCCHN. Genetic and preclinical experiments suggest that ADCC can be enhanced by NK-stimulators.

The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6% overall response rate, a median time to progression of 2.3 months and a median overall survival of 5.8 months (Vermorken et al, JCO 2007).