On April 28, 2021 Olatec Therapeutics LLC (Olatec) reported the first publication from its preclinical studies with dapansutrile in selected cancer models (Press release, Olatec Therapeutics, APR 28, 2021, View Source [SID1234578829]). The data in this paper, entitled "Targeting tumor-derived NLRP3 reduces melanoma progression by limiting MDSCs expansion", is published in the Proceedings of the National Academy of Sciences (PNAS). Under leading investigators, including Charles Dinarello MD, Olatec’s CSO, and Mayumi Fujita MD PhD, the data show that blocking NLRP3 with oral dapansutrile resulted in a significant reduction in tumor growth and progression when compared to untreated mice with induced melanoma.

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Cutaneous melanoma is an aggressive malignancy of the skin with a high mortality rate. In melanoma patients, elevated levels of myeloid-derived suppressor cells (MDSCs) are known to correlate with stage, metastasis and poor outcomes in comparison to patients with low levels of these cells. This is due to the fact that MDSCs activation suppresses the immune response to tumor cells, ultimately leading to melanoma expansion and progression. Activation and amplification of MDSCs are largely due to the production of IL‑1β by melanoma cells.

At present, one of the most common treatments for melanoma is immunotherapy, e.g., anti-PD-1 therapy, which stimulates the immune system to kill tumor cells. Despite the significant benefit to and improved prognosis of patients with advanced melanoma treated with anti-PD-1 therapy, a significant proportion of patients fail to respond due to resistance to this treatment.

"Despite breakthrough immunotherapies over the last ten years, melanoma remains a clinical challenge because tumor cells escape from destruction due to upregulated IL‑1β," said Dr. Fujita. "Our studies using a melanoma model in mice show that by reducing IL‑1β with dapansutrile, the immune system returns to its active state with restoration of its antitumor functions. As a result, melanoma tumor growth was reduced in mice. Our data further demonstrate that dapansutrile in combination with immunotherapy restores the host’s antitumor response and results in a greater reduction in the melanoma tumor than either treatment alone."

Dr. Dinarello added, "Targeting NLRP3 with dapansutrile to inhibit IL‑1β represents a new strategy for treating melanoma and other inflammatory tumors, especially to augment response rates to anti-PD-1 antibodies and to overcome resistance to other immunotherapies."

Underscoring the relevance of these ground-breaking preclinical studies, Damaris Skouras, co-Founder and CEO, said, "Based upon the positive data from our preclinical studies in melanoma, Olatec is positioned for a clinical trial to study dapansutrile in combination with a PD-1 inhibitor with the objective of inhibiting melanoma-associated IL‑1β inflammation in order to mitigate immunotherapy resistance and prevent tumor progression."

About Melanoma

In the United States, melanoma has been estimated to be the fifth most common type of new cancer diagnosis in both men and women and the most common cause of skin cancer-related death. Furthermore, among young adults, it is the second most common invasive cancer, and according to the American Academy of Dermatology Association, 1 in every 5 people in the United States suffers from skin cancer. The incidence of melanoma is increasing worldwide with reports estimating the global melanoma therapeutics market to reach over $12 billion by 2025.

About Dapansutrile

Dapansutrile (lab code: OLT1177) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD‑, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL‑1β and IL‑18. NLRP3 is one of the most characterized inflammasome sensors due to its involvement in a wide range of disorders, including sterile inflammation, infections and rare genetic autoimmune syndromes. Dapansutrile is in Phase 2 clinical development and has been well tolerated and shown to improve clinical outcomes in patients with acute gout flare (see The Lancet Rheumatology) and heart failure (see Journal of Cardiovascular Pharmacology). Dapansutrile has also been observed to have antiinflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models including arthritis, asthma, acute myocardial infarction, contact dermatitis, multiple sclerosis, melanoma and breast cancers, spinal cord injury and Alzheimer’s disease.

On April 28, 2021 Pfizer Inc. (NYSE: PFE) reported that it has acquired Amplyx Pharmaceuticals, Inc., a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems (Press release, Pfizer, APR 28, 2021, View Source [SID1234597887]). Amplyx’s lead compound, Fosmanogepix (APX001), is a novel investigational asset under development for the treatment of invasive fungal infections.

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More than 1.5 million cases of invasive fungal infections occur worldwide each year, with mortality rates as high as 30-80% across infection typesi. Fosmanogepix has a novel mechanism of action with the potential to target fungal strains resistant to standard of care therapy. As there are only three classes of antifungal medications currently available, antifungal resistance can severely limit treatment options; a potential new therapeutic class may therefore be of importance for both physicians and patientsii. There has been no novel therapeutic class of antifungal therapies approved by the U.S. Food and Drug Administration (FDA) in nearly 20 years.

"The COVID-19 pandemic has been a stark reminder of the devastating impact of infectious diseases, highlighting the continuous need for new anti-infective therapies to treat both emerging and difficult to treat bacterial, viral and fungal infections," said Angela Lukin, Global President, Pfizer Hospital. "We are deeply committed to helping patients suffering from infectious diseases, continuously seeking opportunities to build our portfolio of anti-infective therapies. We’ve already invested in assets that, if approved, could help address drug-resistant bacterial infections and critical viral infections; with this acquisition, we look forward to progressing the development of a novel anti-fungal as well."

Fosmanogepix is currently in Phase 2 clinical trials evaluating the safety and efficacy of both intravenous (IV) and oral formulations for the treatment of patients with life-threatening invasive fungal infections caused by molds, yeasts and rare molds (e.g., Aspergillus spp, Candida spp including Candida auris, Fusarium spp. and Scedosporium spp). Fosmanogepix has demonstrated broad-spectrum activity in-vitro and has shown wide distribution to various tissues including the brain, lung, kidney and eye. With both IV and oral formulations in development, Fosmanogepix may allow for the transition from IV to oral, thus potentially enabling, for the benefit of patients, the continuation of treatment outside the hospital.

In addition to Fosmanogepix, with this acquisition, Pfizer has secured ownership of Amplyx’s early-stage pipeline that includes potential antiviral (MAU868) and antifungal (APX2039) therapies.

Globally, infectious diseases are responsible for more than 8.4 million deaths annually*iii, accounting for two of the World Health Organization’s top ten causes of death worldwideiv. Infections are caused by different types of pathogens, including bacteria, viruses, fungi and parasites, and can be acquired in the community or in a hospital or healthcare setting.

The acquisition of Amplyx follows an initial equity investment by Pfizer in December 2019 as part of Amplyx’s Series C financing. At that time, Pfizer joined a world class group of biotechnology investors that included 3×5 Partners, Adage Capital Management, Arix Bioscience, BioMed Ventures, Lundbeckfonden Ventures, New Enterprise Associates, Pappas Capital, RiverVest Venture Partners and Sofinnova Investments.

Financial terms of this acquisition were not disclosed.

DLA Piper LLP (US) served as Pfizer Inc.’s legal advisor for the transaction, while Cooley LLP served as Amplyx’s legal advisor and Evercore as its financial advisor.

On April 28, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended March 31, 2021 (Press release, Opko Health, APR 28, 2021, View Source [SID1234578634]).

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Business Highlights

BioReference Laboratories test volume increased 158% compared with the first quarter of 2020. During the first quarter of 2021, BioReference Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR tests and has current capacity to process more than 100,000 PCR tests per day. In addition, during the quarter, BRL performed approximately 200,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.

BRL continues to provide COVID-19 solutions to meet the testing needs of physicians, health systems, long-term care facilities, governments, schools, employers, professional sports leagues and entertainment venues, as well as the general public through relationships with retail pharmacy chains including Rite-Aid and CVS. In April 2021, BRL announced a COVID-19 testing agreement for players and staff, stadium employees and league staff for the 2021 Major League Baseball season and the renewal of a similar agreement for the 2021 Major League Soccer season.

In March 2021, BRL announced expansion of its COVID-19 school testing program to support return to in-person classroom instruction across the country. For two of the nation’s largest school systems, BRL provides testing services to nearly 200 schools every day and has tested nearly 500,000 public school students, teachers and principals.

Topline results reported from first cohort of Phase 2 trial with Rayaldee in patients with stage 5 chronic kidney disease (CKD) on dialysis. Cohort 1 of the Phase 2 clinical trial explored the safety and efficacy of a high-strength formulation of Rayaldee (calcifediol) as a new treatment for secondary hyperparathyroidism (SHPT) in adults with vitamin D insufficiency and stage 5 CKD who require hemodialysis. Topline results from 44 subjects (33 Rayaldee; 11 placebo) demonstrated that the prohormone Rayaldee was well tolerated at a dose of 900 mcg/week, decreased intact parathyroid hormone (iPTH) versus placebo, and was activated to calcitriol (the active hormone) despite the lack of functional kidneys. A full analysis of the data is underway and will be reviewed with both FDA and OPKO’s development partners.
Regulatory submission for somatrogon by Pfizer, OPKO’s commercial partner, accepted by the European Medicines Agency (EMA). In February 2021, the EMA validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone intended to be administered once-weekly to treat pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022. In January 2021, the FDA accepted for filing the initial Biologics License Application for somatrogon with a target Prescription Drug User Fee Act action date in October 2021. Pfizer also submitted a New Drug Application for somatrogon to the Pharmaceuticals and Medical Devices Agency in Japan.

Multiple presentations highlighting somatrogon clinical data were presented at two endocrinology conferences. Data from OPKO’s somatrogon clinical studies were presented virtually at ENDO 2021, the Endocrine Society’s 2021 Annual Meeting held March 20-23, 2021, and at ICE 2021, the 19th International Congress of Endocrinology Annual Meeting held February 24-28, 2021. Utilizing OPKO’s proprietary long-acting technology, somatrogon represents a significant advancement to increase patient adherence and improve quality of life compared with daily injections. Posters and abstracts from the endocrinology conferences can be viewed on the Company’s website in the Investors section. In addition, OPKO will be participating in the 2021 Pediatric Endocrine Society Virtual Annual Meeting to be held today through May 3, 2021.

Phase 2 trial with RAYALDEE in COVID-19 outpatients is 71% enrolled and ongoing at 10 U.S. sites. The trial is a randomized, double-blind, placebo-controlled study and is expected to enroll approximately 160 outpatients, including some with stage 3 or 4 CKD who are at higher risk for developing more severe illness. The qualified outpatients are being randomized one-to-one to four weeks of daily treatment with either RAYALDEE or placebo, and then monitored for another two weeks. Topline data from this trial are expected in the third quarter and, if sufficiently positive, will form the basis for an immediate request to FDA for an Emergency Use Authorization.
First Quarter Financial Results

Consolidated revenues for the first quarter of 2021 were $545.2 million compared with $211.5 million for the comparable period of 2020. Net income for the first quarter of 2021 was $31.1 million, or $0.05 per diluted share, compared with a net loss of $59.1 million, or $0.09 per share, for the comparable period of 2020.

Diagnostics: Revenue from services in the first quarter of 2021 increased to $507.0 million from $170.8 million in the prior-year period, primarily due to COVID-19 testing, partially offset by lower revenue in our base testing business reflecting the negative impact of the COVID-19 pandemic. Total costs and expenses were $439.9 million in the first quarter of 2021 compared with $189.0 million in the first quarter of 2020, resulting in operating income of $67.0 million compared with an operating loss of $18.1 million in the 2020 period. The increase in operating income of $85.1 million reflects the increased demand for COVID-19 PCR testing.

Pharmaceuticals: Revenue from products in the first quarter of 2021 was $33.9 million compared with $31.1 million in the first quarter of 2020, primarily attributable to an increase in sales at OPKO Chile and FineTech, partially offset by a decline in sales of RAYALDEE, which were negatively impacted by the COVID-19 pandemic. Total prescriptions of RAYALDEE for the first quarter of 2021 decreased to approximately 12,300 from approximately 18,300 for the first quarter of 2020. Revenue from the transfer of intellectual property was $4.3 million in the first quarter of 2021 compared with $9.6 million in the first quarter of 2020, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $57.4 million in the first quarter of 2021 compared with $54.8 million in the prior-year period, primarily due to increased sales and an inventory reserve for RAYALDEE. The operating loss was $19.2 million in the first quarter of 2021 compared with $14.1 million in the first quarter of 2020.

Cash and equivalents: Cash, cash equivalents and marketable securities were $89.5 million as of March 31, 2021. In addition, the Company has availability under its present line of credit with JP Morgan of $64.7 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss first quarter financial results and answer questions during a conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, April 28, 2021. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 9993698. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

To access the live call via webcast, please click on the link OPKO 1Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 1Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 9993698.

On April 28, 2021 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancer reported its audited annual consolidated 2020 financial statements (Press release, Theralase, APR 28, 2021, View Source [SID1234578651]).

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Financial Highlights:
For the years ended December 31st:

(1) Other represents (Gain) Loss on foreign exchange, interest accretion on lease liabilities and interest income

Total revenue remained predominantly flat, year over year, and is primarily attributed to the COVID-19 pandemic as most health care practitioners elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.

Cost of sales for the year ended December 31, 2020 was $659,442, which included a one-time write-down of inventory of $131,983, resulting in an adjusted cost of sales of $527,459 or 57% of revenue with an adjusted gross margin of $401,663 or 43% of revenue. In comparison cost of sales for the same period in 2019 was $903,296, which included a one-time provision for inventory of $277,896, resulting in an adjusted cost of sales of $625,400 or 65% revenue with an adjusted gross margin of $338,651 or 35% of revenue. The gross margin increase, as a percentage of sales, year over year, is attributed to a decrease in labour and material costs and a one-time inventory provision of $277,896 in 2019.

The decrease in selling expenses is primarily due to the restructuring of the Canadian and US sales and marketing departments, as a result of the COVID-19 pandemic, resulting in the resignation and/or termination of certain non-essential sales and marketing personnel and significantly reduced travel expenditures.

The decrease in administrative expenses is primarily attributed to decreased spending on general and administrative expenses (40%), director and advisory fees (45%) and administrative salaries (59%) due to the COVID-19 pandemic, resulting in the termination of certain non-essential administrative personnel.

The decrease in research and development expenses for the year ended December 31, 2020 is attributed primarily to the delay in patient enrollment and treatment in the Phase II NMIBC clinical study ("Study II") due to the COVID-19 pandemic. Research and development expenses represented 59% of the Company’s operating expenses and represents investment into the research and development of the Company’s ACT technology

The net loss for the year ended December 31, 2020 was $5,598,540 which included $1,202,017 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2019 of $7,413,914 which included $677,224 of net non-cash expenses. The ACT division represented $4,282,813 of this loss (76%) for the year ended December 31, 2020.

The decrease in net loss is primarily attributed to the following:

Delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.
Decreased salaries due to the COVID-19 pandemic, resulting in the termination of certain non-essential administrative, research and production personnel.
Operational Highlights:

FDA Fast Track. On November 23, 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with TLC-3200, to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with Bacillus Calmette-Guerin ("BCG") – Unresponsive Non- Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), with or without papillary Ta or T1 tumors. FTD can lead to an Accelerated Approval ("AA"), Break Through Designation ("BTD") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.
COVID-19 Pandemic Update. In the ACT division, all Canadian Clinical Study Sites ("CSS") have re-commenced new patient enrollment and treatment in Study II as of September 24, 2020. The CSSs placed themselves on temporary hold due to the COVID-19 between March 20, 2020 to August 12, 2020 and September 24, 2020. In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to reduce expenses by eliminating non-essential personnel and imposing a temporary hiring freeze, to be lifted, subject to the Canadian and United States economies demonstrating recovery from COVID-19.
Clinical study site status and update. The Company has successfully launched five CSSs in Canada and six CSSs in the US that are open for patient enrollment and treatment for a total of 11 CSSs.

To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 18 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 21 patients.
Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 2021.
COVID-19 Research Update. The Company’s PDC technology was proven to be effective in the destruction of Influenza H1N1 and Zika viruses at low nanomolar concentrations. These studies were expanded to include coronavirus Bio Safety Level ("BSL") 2. As a note, COVID-19 is caused by coronavirus (BSL-3), not coronavirus (BSL-2). A new assay was established to measure coronavirus destruction and using this new assay the Theralase PDC technology was able to destroy coronavirus (BSL-2) with drug doses 5 times lower than what was used to kill Influenza H1N1 and Zika viruses. These drug doses demonstrated a 99.995% destruction rate of the BSL-2 coronavirus and are significantly lower than those used by the Company to treat cancers; hence considered safe for human use. Coronaviruses are considered similar in their structure and these new results strongly suggest that Theralase’s PDC will be highly effective against the SARS-CoV-2 (BSL-3) virus responsible for COVID-19.

In April 2021, Theralase executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase’s patented PDC and then light activating it with Theralase’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and commenced in mid-April 2021.
* The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 Coronavirus.

About Study II

Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the US.

Study II has a:

Primary endpoint of efficacy (defined by Complete Response ("CR") at any point in time
Secondary endpoint of duration of CR at 360 days post-initial CR (approximately 450 days post initial Study treatment, assuming CR is achieved at the 90 day assessment)
Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post-initial treatment
The FDA, in its 2018 guidance to industry has stated that, "For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:

Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR."1

On April 28, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that members of management will participate in the following upcoming conferences (Press release, argenx, APR 28, 2021, View Source [SID1234578672]):

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Kempen Life Sciences Conference – 2021 Thematic Virtual Series. Management will participate in investor meetings on Wednesday, May 5, 2021.
BofA Securities Virtual 2021 Healthcare Conference. Fireside chat on Thursday, May 13, 2021 at 8:00 a.m. ET.
Additional information regarding these events will be available on the Company’s website at www.argenx.com.