On March 19, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2019, and provided a corporate update (Press release, VBL Therapeutics, MAR 19, 2020, View Source [SID1234555698]).

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"We are excited to advance our clinical program for VB-111 in ovarian cancer towards an important interim analysis, while collaborating with the National Cancer Institute and top US neuro-oncology centers in externally-sponsored studies of VB-111 for colon cancer and recurrent GBM," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients as planned and we expect the readout from an important interim analysis by the end of the first quarter. VBL made significant advancement during 2019 on all fronts. We now look forward to 2020 as a potential turn around year for the company, with three parallel clinical trials for VB-111 and upcoming results from our MOSPD2 programs for inflammation and oncology."

Amos Ron, Chief Financial Officer of VBL Therapeutics stated, "We had more than $37 million in cash, cash equivalents and restricted bank deposits at December 31, 2019. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements into the third quarter of 2021."

Fourth Quarter and Key Corporate Highlights:

VB-111 program in ovarian cancer – The OVAL Phase 3 potential-registration study of VB-111 in ovarian cancer continues as planned towards the important interim analysis in 1Q 2020. This analysis will focus on CA-125 response rate, which will be analyzed according to GCIG strict criteria in 60 evaluable patients. The data will help to inform whether the positive outcome observed with VB-111 in the Phase 2 study in ovarian cancer is being replicated in the OVAL Phase 3 trial.
Results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data demonstrated a median overall survival (OS) of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm (p=0.03). 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone.
VB-111 for colon cancer – In February 2020, we announced the launch of a Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer, under a Cooperative Research and Development Agreement (CRADA) between VBL and the U.S. National Cancer Institute (NCI). NCI will serve as the IND sponsor for this study (ClinicalTrials.gov Identifier: NCT04166383).
VB-111 program in recurrent glioblastoma (rGBM) – VBL announced the publication of clinical data from the Phase 2 and GLOBE Phase 3 studies of VB-111 in rGBM in two manuscripts published in December 2019 in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology.
Study results attribute the contradictory outcomes between the Phase 2 and Phase 3 trials to the lack of VB-111 monotherapy priming in the GLOBE Phase 3 study, providing clinical, mechanistic and radiographic support for this hypothesis.
With the understanding that study regimen may be a key factor for VB-111 activity in rGBM, a new study, under U.S. IND sponsorship by Dana-Farber Cancer Institute, in collaboration with a group of leading U.S. neuro-oncology investigators, will assess neo-adjuvant and adjuvant treatment with VB-111 in rGBM patients undergoing a second surgery. Launch of this study is expected in the first half of 2020.
VB-111 GMP Facility – VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, was certified by the European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). The facility has also been certified by the Israeli Ministry of Health as being in compliance with the Israeli law and regulations of GMP. These important steps are expected to support future commercialization of VB-111, if approved.
MOSPD2 bi-specific mAbs for cancer – We are developing bi-specific antibodies designed to kill tumor cells, based on MOSPD2 as a novel target whose expression is induced in multiple tumors. We previously presented preclinical proof-of-concept for this approach using a BiTE antibody, and are currently advancing our lead bi-specific antibody candidate towards an IND filing. New data from this program were accepted for presentation in a late breaking abstract session at the 2020 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
MOSPD2 mAb program for inflammation – VBL continues to advance the development of lead MOSPD2 antibodies for immune-inflammatory indications, with potential for MS, RA and NASH. The Company signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development. A pre-IND submission for VB-601 is expected in 2Q 2020. New data on MOSPD2 as a target for inflammatory digestive disorders were accepted for presentation at EASL’s annual International Liver Congress, ILC 2020, and Digestive Disease Week (DDW) conferences later this year. Our abstract for DDW was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.
Lecinoxoids platform – VBL executed a strategic exclusive option to license agreement with one of the world-leading European animal health companies for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment. Upon exercise of the license option, VBL expects to receive additional milestones and royalties, which have the potential to exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Fiscal Year Ended December 31, 2019 Financial Results:

Cash Position: At December 31, 2019, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit of $37.0 million and working capital of $29.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into 3Q 2021.
Revenues: Revenues related to VBL’s collaboration in Japan and with an animal health company amounted to $0.6 million in the year ended December 31, 2019.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2019, were approximately $15.5 million, compared to approximately $15.9 million in the same period in 2018.
G&A Expenses: General, administrative and marketing expenses for the year ended December 31, 2019, were $4.9 million, compared to $5.6 million for the same period in 2018.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2019, of $19.5 million, or ($0.54) per share, compared to a net loss of $20.4 million, or ($0.62) per share, in the year ended December 31, 2018.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

Conference Call:
Thursday, March 19th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13699636
Webcast: View Source

On March 19, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) (Press release, Soligenix, MAR 19, 2020, View Source [SID1234555697]). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.

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"This is an important outcome for patients suffering from CTCL. SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease," stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study. "The treatment showed a statistically significant improvement after just 6 weeks of treatment. This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment. In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies."

"On behalf of everyone at Soligenix, I would like to extend my sincere appreciation to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are extremely pleased with the results, which demonstrate successful treatment with SGX301 and reinforces its potential to be an important new treatment for early stage CTCL. We will now look to move as quickly as possible to complete a full analysis of the data for publication, as well as begin preparations for a robust discussion with the FDA regarding this important dataset."

Dr. Schaber continued, "With approximately $7.6M in cash, not including the anticipated sale of our New Jersey net operating loss carryovers and United Kingdom tax incentive receivable of approximately $1.0M or our non-dilutive government funding, we will evaluate the potential need for a larger capital raise only after top-line results from our Phase 3 study in oral mucositis. This will afford us the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the New Drug Application submission to FDA. These results support our long-standing belief that SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."

Conference Call Thursday, March 19 at 8:30 AM Eastern Time

The Company will share trial results on Thursday, March 19, 2020 during an investor conference call. Investors may submit questions electronically at: [email protected] at least 15 minutes prior to the scheduled start of the call.

U.S. toll free: 1-866-652-5200

International: 1-412-317-6060

Please request to be entered into the Soligenix call.

A transcript of the conference call will be archived for 30 days following the event.

The Phase 3 FLASH trial enrolled 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 subjects received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04). SGX301 treatment in the first cycle was safe and well tolerated. In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment. Of note, preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Further independent review of lesion photographs may be conducted to provide for a more uniform confirmation of response. Results from Cycle 2 are expected to be announced in June 2020.

In the third (optional) treatment cycle (Cycle 3), all subjects could receive SGX301 treatment of all their lesions. Of note, the majority of patients enrolled have elected to continue with this optional cycle of the study. Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. Results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment will be further announced as the final patients continue to complete their designated visits.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial targeted to enroll 160 evaluable subjects. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, 116 subjects received SGX301 and 50 subjects received placebo treatment of their index lesions. In the second cycle, all subjects received SGX301 treatment of their index lesions and in the third cycle all subjects could receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint was assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score for three index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Assessment of the primary endpoint revealed that 16% patients receiving SGX301 responded (i.e., had ≥ 50% reduction in index lesion size) while only 4% receiving placebo responded (p=0.04). Preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment.

Other secondary measures assessed are treatment response (including duration), degree of improvement, time to relapse and safety, and will be available as the subsequent cycles and follow-up visits are completed for all subjects.

Overall safety of SGX301 is a critical attribute of this treatment and will continue to be monitored throughout the additional treatment cycles and the 6-month follow-up period. SGX301’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. SGX301 potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

On March 19, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that it will report its fourth quarter and year-end 2019 financial results on Thursday, March 26, 2020 (Press release, IGM Biosciences, MAR 19, 2020, View Source [SID1234555696]).

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In connection with the earnings release, IGM’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 26, 2020, to discuss the Company’s financial results and provide a corporate update.

Conference ID: 2991398
Domestic Dial-in Number: (866) 649-1996
International Dial-in Number: (409) 217-8769
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.igmbio.com.

On March 19, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported its financial results and corporate update for the fourth quarter and full year 2019 (Press release, Hookipa Pharma, MAR 19, 2020, View Source [SID1234555695]).

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"In 2019, HOOKIPA achieved its development progress and financial goals," commented Joern Aldag, HOOKIPA’s Chief Executive Officer. "We dosed our first patient in HB-201, our first immuno-oncology clinical trial in Human Papillomavirus-positive cancers, continued enrolling our Cytomegalovirus prophylaxis trial HB-101, progressed our collaboration with Gilead for HBV and HIV, and executed our Series D and IPO early in the year to fund our clinical trials beyond proof of concept. Well prepared for an important, data-rich year 2020, we now have to assume that the coronavirus pandemic will very likely affect how we will operate in order to fully execute our 2020 strategic plan in order to remain on track for our previously announced clinical milestones. Focusing first on our people and then on business continuity, we have instituted a work from home policy for those who do not need the company infrastructure for their work. We maintain our labs for business critical projects and stay in close connection with manufacturers and clinical trial sites. Our people are remarkable in doing everything under our control to deliver in the context of this situation."

R&D Pipeline Update and Clinical Progress

HB-101, lead product candidate in infectious diseases
HOOKIPA’s VaxWave-based prophylactic Cytomegalovirus (CMV) vaccine candidate, HB- 101, continues to enroll patients in a Phase 2 randomized, double-blinded clinical trial in CMV-negative patients awaiting kidney transplantation from CMV-positive donors. Based on HB-101’s tolerability profile in the target patient population dosed to date and to gain further insights that will inform the Phase 3 trial design, the Company added a new cohort of CMV-positive recipients awaiting kidney transplantation from CMV-positive or -negative donors to the trial protocol in early 2020. HOOKIPA expects to report safety and immunogenicity data in the first half of 2020 from approximately one-third of the total 150 patients to be enrolled, including placebo recipients. The immunogenicity data set will contain both CMV-specific antibody (gB) and CMV-specific CD8+ T cell responses. Preliminary efficacy data is on track to follow late in the second half of 2020.

HB-201 and HB-202, programs for the treatment of Human Papillomavirus-positive cancers
HB-201 and HB-202, HOOKIPA’s TheraT-based lead oncology product candidates, are in development for the treatment of Human Papillomavirus serotype 16-positive (HPV16+) cancers. HOOKIPA dosed the first patient in an open label, dose escalating Phase 1/2 clinical trial for HB-201 in December 2019, HOOKIPA’s first clinical trial in immuno-oncology. The Company expects preliminary results in late 2020 or early 2021. HOOKIPA’s second planned Phase 1/2 clinical trial will assess the safety and efficacy of the combination of HB‑201 and HB‑202 in HPV16+ cancers, with or without an approved checkpoint inhibitor. HOOKIPA remains on track to file the HB‑202 Initial New Drug submission with the U.S. Food and Drug Administration in the first half 2020. The planned HB-202/201 clinical trial is an open label, dose escalation Phase 1/2 trial with the primary endpoint to evaluate safety and tolerability. That trial is expected to commence later in 2020.

Strategic Collaborations

Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
During 2019, HOOKIPA received $6.0 million in milestone payments from Gilead for the delivery of research vectors and advancing the programs closer to clinical trials. Based on preclinical data generated to date, Gilead committed to preparations to advance the HBV and HIV vectors toward development, with the HBV development decision triggering a milestone payment of $4.0 million, which the Company received in early 2020. To enable the development activities and expanded research programs, Gilead agreed to reserve manufacturing capacity and increase reimbursement budgeted for the Company’s expanded resources allocated to the Gilead collaboration.

Fourth Quarter and Full Year 2019 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of December 31, 2019 was $113.6 million compared to $48.6 million as of December 31, 2018. The increase was primarily attributable to $37.3 million in net proceeds received from the issuance of shares of Series D convertible preferred stock in February 2019, and $74.6 million in net proceeds received from HOOKIPA’s initial public offering in April 2019, offset by cash used in operating and investing activities. On April 23, 2019, HOOKIPA completed an initial public offering of its common stock by issuing 6.0 million shares of its common stock, at $14.00 per share.

Revenue was $3.6 million for the three months ended December 31, 2019, and $11.9 million for the full year ended December 31, 2019 compared to $5.1 million for the three months ended December 31, 2018 and $7.6 million for the full year ended December 31, 2018. Revenue was driven by the recognition of milestone payments and partial recognition of the upfront payment as well as cost reimbursements received under the Collaboration Agreement with Gilead.

Research and Development Expenses: HOOKIPA’s research and development expenses were $11.2 million for the three months ended December 31, 2019, and $46.3 million for the full year ended December 31, 2019 compared to $4.6 million for the three months ended December 31, 2018 and $22.0 million for the full year ended December 31, 2018.

The primary drivers of the increase for 2019 were an increase in direct research and development expenses by $19.9 million, and an increase in personnel expenses by $3.1 million. Direct research and development expenses increased primarily due to the costs for conducting a Phase 2 clinical trial for the Company’s HB-101 program the preparation costs of clinical trials for HOOKIPA’s HB-201 and HB‑202 programs, expansion of earlier stage programs and costs in connection with securing manufacturing capacity for production of clinical trial material. In addition, costs related to HOOKIPA’s collaboration with Gilead contributed to the increase in direct expenses.

General and Administrative Expenses: General and administrative expenses were $5.7 million for the three months ended December 31, 2019, and $16.7 million for the full year ended December 31, 2019, compared to $2.7 million for the three months ended December 31, 2018 and $6.8 million for the full year ended December 31, 2018. The increase was mainly due to the growth in personnel related expenses, an increase in professional and consulting fees as well as costs associated with ongoing business activities and costs to operate as a public company.

Net Loss: HOOKIPA’s net loss was $10.2 million for the three months ended December 31, 2019 and $43.0 million for the full year ended December 31, 2019, compared to a net loss of $1.9 million for the three months ended December 31, 2018 and $16.2 million for the full year ended December 31, 2018. This increase was due to an increase in research and development expenses, mainly driven by the progression of HOOKIPA’s oncology programs, and an increase in general and administrative expenses following HOOKIPA’s IPO.

Conference Call

To access the live conference call, please dial +1 631 510 7495 (from the US) or +44 207 192 8000 (international) and refer to conference ID 1769733. A live audio webcast of the event will also be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On March 19, 2020 GT Biopharma, Inc. (OTCQB:GTBP)(GTBP.PA) a biotherapeutics company focused on developing innovative therapeutic treatments in oncology and infectious diseases based on its proprietary NK cell engager TriKE platform reported that it had successfully completed dosing of the first patient in a Phase I/II clinical trial of GTB-3550 for the treatment of relapsed/refractory acute myeloid leukemia (AML) (Press release, GT Biopharma, MAR 19, 2020, View Source [SID1234555694]).

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All patients enrolled in the open label clinical trial receive a single course of GTB-3550 given as four, 24-hour consecutive continuous infusions, for three consecutive weeks. The first patient with advanced relapsed/refractory AML who enrolled in the clinical trial was treated at a dose of 5µg/kg/day with GTB-3550. There were no observed adverse or serious adverse events recorded during the course of therapy, and the patient achieved stable disease as measured by AML blast count. We observed an increase in the patient’s total NK cell population that we believe is attributable to the IL-15 component of the TriKE molecule. and with no appreciable increase of any hyper-active T-cell populations, which otherwise results in cytokine storm or other T-cell associated toxicities.

GTB-3550 is a tri-specific recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The NK cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their cytotoxic activity.

Acute myeloid leukemia is a heterogeneous hematologic stem cell malignancy in adults with incidence rate of 3% to 5% per 100,000 people. The median age at the time of diagnosis is 65 to 69 years. AML is an aggressive cancer that is fatal on the absence of treatment. The five-year expected overall survival rate for AML is 27.4 percent, according to the National Cancer Institute (NCI).

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "we are pleased to see these results in our first patient who is being administered GTB-3550." Mr. Cataldo further commented, "we remain optimistic that GTB-3550 will demonstrate therapeutic benefit in patients who have relapsed/refractory AML and other hematologic malignancies that are at an advanced stage." Mr. Cataldo added, "we believe the robustness of the TriKE platform will enable the development of therapeutics for the treatment of other cancers and certain infectious diseases, such as HIV and coronavirus infections."