On May 2, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and Dragonfly Therapeutics reported a collaboration designed to advance a number of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications (Press release, Gilead Sciences, MAY 2, 2022, View Source [SID1234613274]). NK cell engagers represent a novel mechanism with the potential to address a broad range of cancers, including potential for activity in checkpoint resistant and refractory tumors, as well as other disease areas such as inflammation. Under the agreement, Gilead will receive an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001. The agreement also grants Gilead options, after the completion of certain preclinical activities, to license exclusive, worldwide rights to develop and commercialize additional NK cell engager programs using the Dragonfly Tri-specific NK Engager (TriNKET) platform. TriNKETs are activators of the innate and adaptive immune systems, recruiting NK and cytotoxic T cells into the tumor microenvironment.

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DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells. The target of DF7001 is 5T4, a protein expressed on cancer cells and stromal cells that support tumor growth associated with poor prognosis in several cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer, and head and neck squamous cell carcinomas (HNSCC). DF7001 has the potential to trigger the killing of 5T4+ expressing cells, including tumor cells, cancer-associated fibroblasts and cancer stem cells. The program is on track for filing an Investigational New Drug (IND) application in the first half of 2023.

"We are excited to partner with Dragonfly as we expand our pipeline with innovative NK cell engager programs. Using our scientific framework to focus our efforts, we are growing our portfolio with assets that have complementary MOAs and strong scientific rationale for combination opportunities," said Flavius Martin, MD, Executive Vice President, Research at Gilead. "We look forward to working with the Dragonfly team to explore novel NK engager treatments across diverse therapeutic areas to address some of the greatest gaps in care for cancer and inflammatory diseases."

"Gilead’s investment in Dragonfly, and specifically in DF7001, reinforces the value of our TriNKET platform and the differentiated and sustainable approach focused on people with cancer and inflammatory diseases," said Bill Haney, Co-Founder and Chief Executive Officer of Dragonfly. "Gilead has a well-established track record in development and commercialization and is a well-matched partner for our scientific expertise and platform. We look forward to working with the Gilead team to advance new treatment options where there is a high unmet need."

Terms of the Agreement

Under the terms of the agreement, Gilead will make a $300 million upfront payment to Dragonfly. In addition, Dragonfly is eligible to receive potential opt-in payments and performance-based development, regulatory and commercial milestone payments. Dragonfly will also be eligible to receive royalties of up to 20% on worldwide net sales.

The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

DF7001 is an investigational product candidate; it is not approved by any regulatory agency for any use and has not been proven safe or efficacious.

On May 2, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that pharma grade raw materials were purchased for the manufacture of PRP in preparation for the Phase I First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors (Press release, Propanc, MAY 2, 2022, View Source [SID1234613273]). Approximately 0.5kg of trypsinogen and 2.4kg of chymtrypsinogen was procured initially, with a second half of the same batch quantities to be purchased towards the middle of this year. The total amount of raw materials purchased is expected to be sufficient for the early-stage clinical development plan for PRP, which is administered by intravenous (I.V.) injection, once weekly. The first FIH study is planned for treatment of up to 30 to 40 patients with advanced solid tumors. This will be followed by up to two 60 patient Phase II studies in patients suffering from pancreatic and ovarian tumors.

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The initial pharmaceutical grade raw materials have been purchased from the Company’s preferred supplier, through a collaborative arrangement with an active pharmaceutical ingredient (API) sourcing agent, with specific expertise in the industrial use of enzymes. Through extensive research and development activities with a selected contract manufacturing organization (CMO) and contract research organizations (CRO’s) predominantly in the EU over several years, the Company has now developed a proprietary purification method and manufacturing process to produce PRP in sufficient commercial quantities for scale up and to Good Manufacturing Process (GMP) standard, with the goal of international regulatory approval of PRP, administered by I.V. injection.

"We are entering a significant development phase for PRP, as we advance towards a FIH study for the treatment and prevention of metastatic cancer from solid tumors," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our intellectually intensive work to produce a pharmaceutical preparation of PRP to GMP standard, administered by I.V. injection, is a world first, and we remain steadfast in our belief that PRP has the potential to be a long-term therapeutic option for patients, where metastatic cancer remains the main cause of patient death, free from the side effects usually associated with standard treatment options. In the context of this current global environment, such approaches are urgently needed."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung liver, uterine and skin cancers.

On May 2, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that Astrego Diagnostics AB (HQ: Uppsala, Sweden; CEO: Ove Öhman) has become a wholly-owned subsidiary through the acquisition of outstanding shares and that the company name has changed to Sysmex Astrego AB (Press release, Sysmex, MAY 2, 2022, View Source [SID1234613265]). Going forward, in addition to accelerating the clinical application of rapid antimicrobial susceptibility testing1 for urinary tract infections,2 the companies aim to contribute to solving the problem of antimicrobial resistance (AMR)3 and other issues related with healthcare.

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Urinary tract infections are infectious diseases with a high rate of incidence and are said to affect 150 million people globally4. Making a proper diagnosis and using an effective antimicrobial in a timely manner is of crucial importance in the treatment of bacterial infections. For this purpose, in addition to clinical findings, bacterial identification tests5 and antimicrobial susceptibility tests are required; however, such testing can require several days in the current situation, making it difficult to prescribing antimicrobials based on test results at the first consultation. As a result, the appearance of antimicrobial-resistant bacteria due to improper antimicrobial use has become a problem. This is not limited to urinary tract infections. As a factor in the development of drug-resistant bacteria, the improper use of antimicrobials is becoming a global issue. If measures against AMR are not taken, in 2050, it is estimated that annual worldwide deaths due to drug-resistant bacteria will exceed 10 million6, more than those due to cancer. At the World Health Assembly held in May 2015, the Global Action Plan on Antimicrobial Resistance was adopted and initiatives toward countermeasures have been gathering speed, particularly among developed countries.

Astrego’s unique and proprietary microfluidic technology (View Source) involves forming microchannels at the micrometer to nanometer level, capturing individual bacteria from among the multiple bacteria present in a fluid and the bacteria are then cultured unidirectionally within these tiny channels, which achieves a rapid antimicrobial susceptibility test result. Astrego has been developing a rapid antimicrobial susceptibility test for urine samples. With the aim of commercializing Astrego’s rapid antimicrobial susceptibility test, Sysmex acquired 24.99% of Astrego’s shares in 2020. The companies have been conducting joint product development activities and on March 23, 2022, completed a self-declaration and CE-marking according to Directive 98/79/EC on in vitro diagnostic medical devices.

In May 2022, Sysmex acquired outstanding shares in Astrego to strengthen synergies between the companies and accelerate clinical application of the rapid antimicrobial susceptibility test. With the acquisition, Astrego became a wholly-owned subsidiary of Sysmex, and the company name changed to Sysmex Astrego AB.� In addition to working on the further development of diagnostic technologies, the two companies will contribute to solving medical issues through such endeavors as measures to reduce the occurrence of antimicrobial resistance and promote the proper stewardship of antimicrobial drugs to improve patient QOL and efficiency in medical care.

Overview of Astrego Company name: Sysmex Astrego AB Location: Uppsala, Sweden Representative: Mikael Olsson Capital: 76,476 Swedish Krona Capital supplied by: Sysmex Corporation Employees: 38 Line of business: Development of in vitro diagnostic products related to drug susceptibility References January 29, 2020 press release entitled "Sysmex Invests in Astrego Diagnostics with a View to Developing New Urinalysis Solutions for the Primary Care Business" View Source November 4, 2021 story entitled "What Is Antimicrobial Resistance (AMR)?-Tackling Global Threats and Aiming to Create a Sustainable Society-" View Source

Terminology

1 Antimicrobial susceptibility test: A test to determine the efficacy of various antimicrobial drugs against pathogenic bacteria detected in a sample.
2 Urinary tract infections: The urinary tract runs between the kidneys and the urethral opening. Inflammations due to the incursion of bacteria into the urinary tract are known as urinary tract infections. Such infections can lead to bladder inflammation and pyelonephritis (inflammation of the kidneys).
3 Antimicrobial resistance (AMR): This phenomenon occurs when living organisms develop a resistance to a drug, whose efficacy is reduced or nullified as a result. Bacteria that have developed microbial resistance are known as antimicrobial-resistant bacteria.
4 "Antimicrobial resistance among uropathogens that cause community-acquired urinary tract infections in women: a nationwide analysis." Clinical Infectious Diseases. 2001;33(1):89–94. doi: 10.1086/320880.
5 Identification test: A test to determine the name of bacteria that are the source of an infectious disease � detected in a sample.
6 "Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations." The Review on Antimicrobial Resistance, Chaired by Jim O’ Neill.

Sysmex’s materiality
Sysmex has identified "Resolution of medical issues through products and services" as one of the issues that we prioritize (materiality) as we work to develop and supply products with high clinical value. Leveraging our proprietary technology and the global network that we have cultivated thus far, we con