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Salarius Pharmaceuticals Reports Business Highlights and Second Quarter 2020 Financial Results

On August 12, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting cancers caused by dysregulated gene expression, reported its corporate and financial results for the second quarter ended June 30, 2020 (Press release, Salarius Pharmaceuticals, AUG 12, 2020, View Source [SID1234563509]).

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Financial Highlights:

$6.2 million gross proceeds in underwritten public offering closed August 3, 2020
Three-month period ended June 30, 2020 net loss per common share – basic and diluted – of $0.13, compared to $0.30 for the same period ended June 30, 2019
Total cash and cash equivalents of $7.2 million as of June 30, 2020
o Up to $9.10 million remains available under the Cancer Prevention and Research Institute of Texas (CPRIT) Contract, subject to meeting certain requirements or approvals
Recent Business and Corporate Highlights:

Ewing sarcoma clinical trial expanded to include Ewing-related sarcomas supported by clinical observations including observation of seclidemstat activity in a patient with refractory Ewing sarcoma
Ewing sarcoma phase 1/2 clinical trial and advanced solid tumor (AST) phase 1/2 clinical trial continue to enroll patients during COVID-19
Salarius presented seclidemstat data to Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee (ODAC)
European Patent Office (EPO) issued Patent EP2744330 for seclidemstat
"The second quarter of 2020 and recent weeks have proven to be a period of substantial progress for Salarius, highlighted by several events that we believe affirm the company’s growth strategy and demonstrate the value of seclidemstat as a potential treatment for Ewing sarcoma and other cancers," said David Arthur, President and CEO of Salarius. "These highlights included a new EU patent for seclidemstat, our data presentation at ODAC and the ongoing progress of our clinical trials in advanced solid tumors and Ewing sarcoma; the latter of which is now being expanded to include Ewing-related sarcomas where seclidemstat has potential to demonstrate activity."

Mr. Arthur concluded, "Patient enrollment in our clinical trials for seclidemstat in Ewing sarcoma and advanced solid tumors continue and we expect to reach important development milestones this year and in 2021. These milestones support our ultimate goal to maximize the potential of seclidemstat and bring hope to patients and their families fighting rare, pediatric and other cancers. To that end, we believe Salarius remains well-capitalized including up to $9.1 million in non-dilutive funding that remains available from the CPRIT award."

Three-Month Financial Results:

For the three-month period ended June 30, 2020, Salarius’ reported net loss was $1.8 million, or $0.13 per basic and diluted share, compared to a net loss of $0.9 million, or $0.30 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended June 30, 2020 increased by $1.0 million compared to the loss before other income for the same time span last year, which was primarily due to an increase of $0.6 million in research and development expenses resulting from increased clinical trial expenses and drug manufacturing costs. Salarius also reported a net increase of $0.7 million in general and administrative costs resulting from Salarius’ transformation into a public company and increased personnel expenses during the current quarter.

As of June 30, 2020, total cash, cash equivalents and restricted cash were $7.2 million, compared to $3.7 million at year-end 2019. Increases in cash balances result from the Company’s public offering of stock in the first quarter 2020.

$6.2 Million Underwritten Public Offering

On August 3, 2020, Salarius completed an underwritten public offering with total gross proceeds of approximately $6.2 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering to fund the expansion of the Ewing sarcoma clinical trial and ongoing company operations.

Ewing Sarcoma Clinical Trial Expanded

On July 29, 2020, Salarius announced the expansion of its ongoing Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas. Sarcomas of interest include myxoid liposarcoma, desmoplastic round cell tumors and other sarcomas that harbor similar FET family gene rearrangements to Ewing sarcoma, i.e. Ewing-related sarcomas.

These Ewing-related sarcomas were chosen based on their underlying biology as well as preclinical data and early clinical observations involving seclidemstat that suggest the drug may demonstrate activity and may have applicability in several sarcomas that share key characteristics of Ewing sarcoma.

The planned amendment to the ongoing trial will allow up to 30 patients with Ewing-related sarcomas to enroll in the trial’s upcoming dose-expansion phase, which is in addition to the 20 Ewing sarcoma patients also planned to be treated in the dose-expansion phase.

Conference Call Information:

Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, August 12, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the second quarter 2020. Interested participants and investors may access the conference call by dialing either:

(833) 423-0481 (U.S.)
(918) 922-2375 (international)
Conference ID:9367616
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on August 12, 2020.

NGM Bio Provides Business Highlights and Reports Second Quarter 2020 Financial Results

On August 12, 2020 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the period ending June 30, 2020 (Press release, NGM Biopharmaceuticals, AUG 12, 2020, View Source [SID1234563508]).

"We continue to progress across our clinical-stage programs spanning liver, retinal and metabolic diseases as well as cancer, despite the ongoing challenges presented by the COVID-19 pandemic, thanks to the dedication and tireless efforts of our team, and the ongoing support and commitment from our clinical collaborators," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We’re thrilled to have achieved our most recent clinical milestone, the advancement of NGM621 into Phase 2 development for the treatment of patients with GA. GA is a highly prevalent and progressive retinal degenerative disease that can have a devastating, irreversible impact on patients’ vision and quality of life. Based on NGM621’s novel profile as a complement C3 inhibitory monoclonal antibody, we believe it has the potential to be an important treatment option for this significantly underserved patient population. It is gratifying to now have two programs in Phase 2 clinical development in two distinct therapeutic areas, both for the treatment of serious unmet needs."

Dr. Woodhouse further commented, "Within the diverse NASH development landscape, we are pleased with the impressive and highly consistent clinical performance of aldafermin to date, with robust, placebo-controlled data demonstrating statistically significant dual activity in reversing fibrosis and resolving NASH. Our Phase 2b ALPINE 2/3 and ALPINE 4 clinical studies remain on track, and we are hard at work on Phase 3 readiness in anticipation of an ALPINE 2/3 topline data readout in the first half of next year."

Key Second Quarter and Recent Highlights

Liver and metabolic disease

Continued enrollment in Phase 2b ALPINE 2/3 study of aldafermin in NASH. NGM has continued enrollment in the Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with biopsy-confirmed NASH and stage 2 or 3 (F2-F3) liver fibrosis. The 24-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. Enrollment activities have increased since our first quarter update, and we reiterate our expectation of announcing topline data from the study in the first half of 2021.

Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in NASH patients with compensated cirrhosis. NGM has continued enrollment in the Phase 2b ALPINE 4 study of aldafermin in patients with biopsy-confirmed compensated NASH cirrhosis (F4). The 48-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.

Data from 24-week double‑blind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients published in Gastroenterology. Comprehensive findings and analysis from the 24-week Cohort 4 reported by NGM in February 2020 were published this month in the journal Gastroenterology. The 24-week double-blind, randomized, placebo-controlled Phase 2 clinical study demonstrated statistically significant dual activity in reversing fibrosis and resolving NASH. In the study, aldafermin continued to demonstrate a favorable tolerability profile. Cohort 4 was the final reported cohort from NGM’s adaptive Phase 2 clinical study of aldafermin in NASH, and the results observed in Cohort 4 were consistent with data from the three previous cohorts.

Continued enrollment in Phase 1 study of NGM395 in overweight and obese healthy adults. NGM has continued to enroll patients in a Phase 1 single ascending dose clinical study evaluating the safety, tolerability and pharmacokinetics of NGM395, a long-acting growth differentiation factor 15 (GDF15) analog, in overweight and obese but otherwise healthy adults.

Completed Phase 1 study of NGM217 in adults with autoimmune diabetes. We recently completed a Phase 1 study of NGM217, an antibody binding an undisclosed target, which assessed the safety, tolerability and pharmacokinetics of NGM217 in adults with autoimmune diabetes. The study demonstrated that NGM217 was well tolerated. However, as NGM continues to advance multiple clinical‑stage programs and anticipates advancing earlier-stage discovery programs into clinical development, the company has decided to suspend activities related to NGM217 to concentrate its resources on the development of other product candidates.
Retinal disease

Initiated Phase 2 CATALINA study of NGM621 in patients with GA. As announced in July 2020, NGM initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal injections (IVT) of NGM621 in patients with GA secondary to age-related macular degeneration (AMD). Dysregulated activation of the complement system, a key component of the immune system, has been implicated in the onset and progression of GA. NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit activity of complement C3 with the treatment goal of reducing disease progression in patients with GA, and with the potential for extended every eight week dosing without PEGylation. Designed as a Phase 3-enabling study, the Phase 2 CATALINA study is expected to enroll 240 patients diagnosed with GA in one or both eyes.

NGM also successfully completed a first-in-human open-label Phase 1 study in which treatment with single- and multiple-dose IVT injections of NGM621 in patients with GA was well tolerated, supporting advancement to the Phase 2 CATALINA study. NGM plans to present the data from the Phase 1 study at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting from November 13-15, 2020. In addition, NGM presented NGM621 preclinical findings at The Association for Research in Vision and Ophthalmology Annual Meeting, held virtually in June 2020. The presentations are available on NGM’s website.
Cancer

Continued enrollment in Phase 1a/1b study of NGM120 in patients with cancer anorexia/cachexia syndrome (CACS) and cancer. NGM continues to enroll patients in a Phase 1a/1b clinical study to evaluate NGM120, a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL), and inhibits GDF15 signaling, for the potential treatment of CACS and cancer. CACS is the uncontrolled wasting of both skeletal muscle and fat that is a common co-morbidity of cancer and is associated with shortened survival in cancer patients.
Corporate

Expanded leadership with key management team and board appointments. NGM announced the appointment of a new executive team member, Siobhan Nolan Mangini, as Chief Financial Officer effective July 13, 2020 and announced the appointment of Carole Ho, M.D. to its Board of Directors. Dr. Ho currently serves as Chief Medical Officer and Head of Development at Denali Therapeutics.
Merck Collaboration

Merck has a one-time option to license NGM pipeline programs, other than NGM’s wholly-owned programs aldafermin and NGM395, following human proof-of-concept trials under the terms of the companies’ ongoing strategic collaboration. Upon exercising any such option, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. In January 2019, Merck exercised its first option under the collaboration to license NGM313, also referred to as MK‑3655.

Second Quarter Financial Results

For the quarter ended June 30, 2020, NGM reported a net loss of $25.6 million compared to a net loss of $7.7 million for the corresponding period in 2019.

Related party revenue from our collaboration with Merck for the quarter ended June 30, 2020 was $19.8 million compared to $25.3 million for the corresponding period in 2019. The decrease in related party revenue was primarily attributable to the completion of all remaining obligations associated with the upfront payment at the conclusion of the initial five-year term of the Merck collaboration.

Research and development expenses for the quarter ended June 30, 2020 were $38.5 million compared to $28.8 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in external research and development expenses associated with the advancement of NGM’s growing pipeline, primarily expenses related to our aldafermin, NGM621 and NGM395 programs, and personnel-related expenses driven by increased headcount.

General and administrative expenses for the quarter ended June 30, 2020 were $6.8 million compared to $6.2 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount and legal expenses to support our operations as a public company.

Cash, cash equivalents and short-term marketable securities were $312.1 million as of June 30, 2020, compared to $344.5 million as of December 31, 2019.

Brickell Biotech Reports Second Quarter 2020 Financial Results and Provides Corporate Update

On August 12, 2020 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Vical, AUG 12, 2020, View Source [SID1234563507]).

"We announced several milestones during the first half of 2020 that strengthened our ability to execute our strategy to develop sofpironium bromide as a treatment for primary axillary hyperhidrosis in the U.S. and in Japan. Most notable are the successful completion of our U.S. Phase 3 long-term safety study, the positive Phase 3 pivotal study results in Japan for sofpironium bromide presented in June by our Japanese development partner, Kaken Pharmaceutical Co., Ltd. ("Kaken"), and an equity financing for net proceeds of $18.7 million," commented Robert Brown, Chief Executive Officer of Brickell. "These important achievements position us well to move towards the anticipated initiation of our U.S. Phase 3 pivotal program in the fourth quarter of 2020. We continue to be excited by the prospects of sofpironium bromide as a potential best-in-class treatment for primary axillary hyperhidrosis and look forward to keeping our shareholders updated on our R&D progress."

Business and Recent Developments

In July 2020, Brickell completed the analysis of its 12-month Phase 3 open-label long-term safety study, in 300 subjects 9 years and older with primary axillary hyperhidrosis, sofpironium bromide gel, 5% and 15%. The study results confirmed that sofpironium bromide gel, at both concentrations, was safe and generally well tolerated, which was consistent with the earlier Phase 2 clinical trial results. No treatment-related serious adverse events were observed. Brickell expects to release additional details at an upcoming scientific forum.

In June 2020, Brickell announced positive Phase 3 pivotal study results in Japan from Kaken. All primary and secondary efficacy endpoints of the study were achieved and sofpironium bromide was safe and generally well tolerated. The study evaluated a total of 281 Japanese patients randomized 1:1 to apply sofpironium bromide gel, 5% (SB) or vehicle gel (placebo) to the axillae (i.e., underarm) for 42 days. These study results were presented as part of the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Virtual Meeting Experience.

In January 2020, Kaken announced submission of a new drug application in Japan requesting approval to manufacture and market sofpironium bromide gel, 5% for primary axillary hyperhidrosis based on the positive Phase 3 data.

In June 2020, Brickell completed an equity offering resulting in net proceeds of approximately $18.7 million. The Company anticipates using the proceeds from the offering for research and development, including clinical trials, working capital, and general corporate purposes.
Upcoming Milestones

Plan to initiate the U.S. Phase 3 pivotal program for sofpironium bromide gel, 15% in the fourth quarter of 2020. The planned program will be comprised of two pivotal Phase 3 trials to evaluate approximately 350 subjects per trial with primary axillary hyperhidrosis in the U.S. The first Phase 3 study is expected to begin in the fourth quarter of 2020.

Expect Kaken to receive regulatory decision for sofpironium bromide gel, 5% in Japan, as early as the fourth quarter of 2020. Under the agreement with Kaken, Brickell is entitled to receive commercial milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide in Japan.
Financial Results

The Company reported cash and cash equivalents and marketable securities of $21.6 million as of June 30, 2020 compared to $11.7 million as of December 31, 2019. In addition, Brickell has prepaid $4.6 million to third-party clinical research organizations in anticipation of commencing Phase 3 pivotal clinical trials of sofpironium bromide in the U.S. later this year.

Revenue was $0.6 million for the second quarter of 2020 compared to $2.6 million for the second quarter of 2019. Revenue in both periods was driven by research and development activities related to the agreement with Kaken pursuant to which Kaken provided research and development funding to Brickell. The decrease in revenue recognized was attributable to Brickell’s Phase 3 long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were ongoing in 2019 but were concluded or winding down by the end of the first quarter of 2020. Conducting these studies is the basis for revenue recognition for a $15.6 million research and development payment received from Kaken in the second quarter of 2018.

Research and development expenses were $2.7 million for the second quarter of 2020 compared to $4.2 million for the second quarter of 2019. This decrease was primarily due to reduced clinical and other related regulatory and administrative costs of the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were concluded or winding down by the end of the first quarter of 2020. Expenses in the second quarter of 2020 included $1.5 million in paid or accrued milestone payments to the licensor of sofpironium bromide. Research and development expenses are expected to increase following the initiation of the Phase 3 program for sofpironium bromide.

General and administrative expenses were $3.0 million for the second quarter of 2020 compared to $1.3 million for the second quarter of 2019. This increase was primarily due to higher costs of $0.9 million for professional-related fees related to capital-raising activities and additional expenses incurred for operating as a public company, $0.6 million for stock and other compensation expense, and $0.3 million for directors’ and officers’ liability insurance fees due to becoming a public company.

Total other income, net was $7.0 thousand for the second quarter of 2020 compared to total other expense, net of $0.7 million for the second quarter of 2019. The change was primarily due to a decrease of $0.7 million in interest expense related to the issuance of convertible promissory notes in 2019 and principal borrowings provided by a loan agreement with a former lender.

Brickell’s net loss was $5.1 million for the second quarter of 2020 compared to $3.7 million for the second quarter of 2019.

Conference Call and Webcast Information

Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13706625. A live webcast of the conference call can be accessed through the "Investors" tab on the Brickell Biotech website at View Source A replay will be available on this website shortly after conclusion of the event for 90 days.

About Sofpironium Bromide

Sofpironium bromide is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. Sofpironium bromide is not approved for use in any country at this time.

About Hyperhidrosis

Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, and more than 16 million people, or 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States or 10 million individuals and an estimated 45% of patients with hyperhidrosis in Japan or 7.2 million individuals1,2. Additional information can be found on the International Hyperhidrosis Society website: View Source

Genmab Announces Financial Results for the First Half of 2020

On August 12, 2020 Genmab reported that Interim Report for the First Half of 2020 (Press release, Genmab, AUG 12, 2020, View Source [SID1234563506])

Highlights

·Genmab and AbbVie enter into broad oncology collaboration; USD 750 million upfront payment with total potential milestone and opt-in payments of up to USD 3.15 billion
·Very favorable topline results announced from Phase 2 clinical trial of tisotumab vedotin in recurrent or metastatic cervical cancer
·Subcutaneous formulation of DARZALEX (daratumumab), known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., approved in U.S. and Europe for certain multiple myeloma indications
·Positive topline results in Phase 3 ANDROMEDA study of daratumumab in light-chain (AL) amyloidosis
·DARZALEX net sales increased approximately 31% compared to the first half of 2019 to USD 1,838 million, resulting in royalty income of DKK 1,652 million for the first half of 2020

"At Genmab our core purpose is to improve the lives of patients by creating differentiated antibody medicines. Despite the unprecedented challenges created by the global coronavirus pandemic, the motivation provided by this core purpose, along with our passion for innovation and determination to be the best at what we do have driven our company to transformational success during the first half of 2020. From our broad collaboration with AbbVie to the impressive results from the tisotumab vedotin innovaTV 204 study, the second quarter of 2020 has further strengthened Genmab’s position as a world-class innovation powerhouse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2020

Revenue was DKK 6,343 million in the first half of 2020 compared to DKK 1,365 million in the first half of 2019. The increase of DKK 4,978 million, or 365%, was primarily driven by the upfront payment from AbbVie and higher DARZALEX royalties.
Net sales of DARZALEX by Janssen were USD 1,838 million in the first half of 2020 compared to USD 1,403 million in the first half of 2019, an increase of USD 435 million, or 31%.
Operating expenses were DKK 1,775 million in the first half of 2020 compared to DKK 1,254 million in the first half of 2019. The increase of DKK 521 million, or 42%, was driven by the advancement of epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD-L1x4-1BB, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 4,568 million in the first half of 2020 compared to DKK 111 million in the first half of 2019. The increase of DKK 4,457 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook

Genmab is improving its 2020 financial guidance published on June 10, 2020 due to increased royalty income related to the sales of TEPEZZA.

MDKK Revised Previous
Guidance Guidance
Revenue 9,100 – 9,700 9,100 – 9,500
Operating expenses (3,850) – (3,950) (3,850) – (3,950)
Operating income 5,200 – 5,800 5,200 – 5,600

Conference Call

Genmab will hold a conference call in English to discuss the results for the first half of 2020 today, Wednesday, August 12, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial +1 646 741 3167 (U.S. participants) or +44 2071 928338 (international participants) and provide conference code 5658476.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Helix BioPharma Corp. and Moffitt Cancer Center Extend Immunotherapy Collaboration

On August 12, 2020O Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), is a clinicalstage biopharmaceutical company developing unique therapies in the field of immuno-oncology for the prevention and treatment of cancer based on its proprietary technological platform DOS47, reported that it has extended its collaboration agreement with Moffitt Cancer Center ("Moffitt") for an additional year (Press release, Helix BioPharma, AUG 12, 2020, View Source [SID1234563505]).

To date, Helix and Moffitt have developed a new pancreatic adenocarcinoma mouse model suitable for testing the Company’s lead clinical compound L-DOS47 alone or in combination with immunotherapies. Preliminary data includes how L-DOS47 may work with immunotherapy were shown in American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2019. In addition, in September 2019, at the World Molecular Imaging Conference, the Company and Moffitt jointly presented a poster presentation on the pharmacodynamics of targeted urease and checkpoint blockade using Chemical Exchange Saturation Transfer ("CEST") and 31P-magnetic resonance spectroscopy ("31P-MRS"). The imaging technique is currently being used in the Company’s U.S. clinical study in advanced stage pancreatic patients.

In this next stage, the Company together with Moffit, intends to build on these early successes and provide additional preclinical support in using L-DOS47 with immunotherapies as clinical support.

"I look forward to expanding the use of L-DOS47 in combination with immunotherapy for future clinical application", said Dr. Heman Chao, Helix’s Chief Executive Officer