Scribe Therapeutics Expands Collaboration With Biogen to Second Target

On May 2, 2022 Scribe Therapeutics Inc., a molecular engineering company creating the most advanced technologies for CRISPR-based genetic medicine, reported Biogen Inc. (Nasdaq:BIIB) has exercised an option for an additional disease target in gene therapy as part of the companies’ ongoing research collaboration to develop and commercialize CRISPR-based medicines (Press release, Scribe Therapeutics, MAY 2, 2022, View Source [SID1234613280]). The expanded collaboration further validates Scribe’s position as a leading organization driving the development of novel CRISPR-based therapeutics that treat the underlying cause of disease.

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"At Scribe, we continue to push the boundaries of molecular engineering to fulfill the profound promise of CRISPR-based therapeutics and are pleased to have our collaborators at Biogen continue to support and expand our collaboration towards this goal," said Benjamin Oakes, CEO and co-founder of Scribe Therapeutics. "Scribe’s custom-designed CRISPR platforms, molecules, and delivery technologies are overcoming the technical hurdles that challenge many genetic targeting technologies and we are thrilled to continue to drive forward a new era of truly transformative genetic medicines."

In 2020, Scribe announced their research collaboration with Biogen to develop and commercialize CRISPR-based therapies that address an underlying genetic cause of Amyotrophic Lateral Sclerosis (ALS).

NKGen Biotech Announces Three SNK01 Abstracts to be Presented at the 2022 ASCO Annual Meeting

On May 2, 2022 NKGen Biotech Inc., a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that three abstracts with clinical information on its NK cell therapy (SNK01) were accepted for presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago, Illinois (Press release, NKMax America, MAY 2, 2022, View Source [SID1234613279]).

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Details of the presentations are as follows:

Poster Discussion

Title: Interim Analysis of a Phase I Study of SNK01 (Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) and Avelumab in Advanced Refractory Sarcoma

Authors: Sant P. Chawla, Victoria S. Chua, Erlinda Maria Gordon, Ted T. Kim, William Feske, Brenda L. Gibson, Paul Y. Chang, Debra Robinson, Paul Y. Song

Session Type: Poster Discussion

Session Title: Sarcoma

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am; Discussion 11:30 am – 1:00 pm CDT

Poster Presentation

Title: Preliminary Analysis of a Phase I Study of SNK01 (Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) Monotherapy in Patients with Advanced Solid Tumors

Authors: Victoria S. Chua, Sant P. Chawla, Erlinda Maria Gordon, Ted T. Kim, Simranjit Sekhon, William Feske, Lucia Hui, Brenda L. Gibson, Paul Y. Chang, Debra Robinson, Paul Y. Song

Session Type: Poster Presentation

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am CDT

Poster Presentation

Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors

Authors: Anthony B. El-Khoueiry, Paul Y. Song, Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada

Session Type: Poster Presentation

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 am – 11:00 am CDT

Abstracts will be released to the public on Friday, May 26, 2022 at 5:00 pm EDT.

More information on the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting and related posters sessions can be found at www.asco.org

Boston Scientific to Participate in Bank of America Global Healthcare Conference

On May 2, 2022 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in Bank of America’s Global Healthcare Conference on Thursday, May 12 (Press release, Boston Scientific, MAY 2, 2022, View Source [SID1234613275]).

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Dan Brennan, executive vice president and chief financial officer, and Lauren Tengler, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst at approximately 8:00 a.m. PT. A live webcast of the session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com.

The replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Gilead and Dragonfly Announce Strategic Research Collaboration to Develop Natural Killer Cell Engagers in Oncology and Inflammation

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.

Propanc Biopharma Purchases Pharma Grade Raw Materials for PRP Manufacture in Preparation for Phase I First-In-Human Study

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.