1stOncology™: Cancer Intelligence Service – Page 10005 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Study Reveals Compelling Data for a New Nanoparticle-based Immuno-Therapeutic to Treat Cancer

On February 10, 2021 OncoNano Medicine, Inc. reported that a research paper titled "Prolonged activation of innate immune pathways by a polyvalent STING agonist" published in Nature Biomedical Engineering shows that a pH-sensitive nanoparticle-based drug developed by Dr. Jinming Gao and team at the University of Texas Southwestern Medical Center (UTSW) could boost the body’s innate immune pathways in the treatment of multiple cancers with a unique mechanism of activating the STimulator of INterferon Genes (STING) (Press release, OncoNano Medicine, FEB 10, 2021, View Source [SID1234574870]). OncoNano licensed this technology from UTSW for further development as part of the company’s proprietary pH-activated micelle platform, and Dr. Gao, a co-founder of OncoNano, currently also serves as a consultant for the company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We are excited about the study published by our colleagues at UTSW demonstrating that the STING activating polymeric micelle can be selectively triggered in the endosomes and enter the cytoplasm of phagocytic cells to achieve robust antitumor immunity," said Marty Driscoll, CEO at OncoNano Medicine, Inc. "The novel polymer component can bind uniquely to the STING target and produce longer activation of this critical innate immune pathway. Our development candidate, ONM-501, utilizes the STING activating pH-sensitive micelle technology encapsulated with an endogenous high affinity ligand to produce a dual and prolonged activation of STING."

The STING pathway plays a crucial role in mediating the body’s innate immune system. The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonist compounds. ONM-501 micelles enable targeted and efficient delivery of the endogenous ligand and the STING activating polymer to the phagocytic cells in tumors where they are released by low pH-induced micelle dissociation. Preclinical studies have shown that both the polymer and the endogenous ligand payload of ONM-501 bind to and activate the STING protein in the cell in a synergistic manner, enabling activation for up to 48 hours. The polymers bind to a non-competitive STING surface site distinct from the conventional cyclic dinucleotide-binding pocket, and also induce condensation of STING proteins via polyvalent interactions. Preclinical studies showed that ONM‑501 used in combination with a checkpoint inhibitor produces an immune response effective in treating multiple cancer types.

OncoNano Medicine, Inc. is developing ONM-501 as a potential immuno-therapeutic treatment for multiple cancers. Development of the core technology of ONM-501, the STING activating polymer, has been partially funded by a grant from the Cancer Prevention and Research Institute of Texas.

Personal Genome Diagnostics Announces Close of $103 Million Series C Financing

On February 10, 2021 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported the close of a $103 million Series C financing (Press release, Personal Genome Diagnostics, FEB 10, 2021, View Source [SID1234574869]). The financing was led by Cowen Healthcare Investments and joined by new and existing investors including Northpond Ventures, Vensana Capital, Rock Springs Capital, Kern Capital, Sands Capital, PFM Health Sciences, Windham Ventures, New Enterprise Associates, Innovatus Capital Partners, Catalio Capital Management, and others. Concurrent with the financing, Kevin Raidy, Managing Partner of Cowen Healthcare Investments, and Lily Li, Principal with Northpond Ventures, have joined the PGDx Board of Directors.

PGDx intends to use the proceeds of the financing to expand the company’s tissue-based and liquid biopsy portfolio and its global commercial footprint to support growth. The added commercial and operational infrastructure will enable broader access to and adoption of PGDx’s elio oncology products, while supporting the expansion of the company’s pharma and biotechnology partnerships to identify novel cancer biomarker targets and accelerate biomarker-driven therapy development.

"We are grateful to receive such enthusiastic support from new and existing investors of this caliber, and are pleased that each of them shares our vision of a future where all patients have access to their genomic information to better inform their treatment decisions," said Megan Bailey, PGDx Chief Executive Officer. "As an organization, we remain committed to enabling the highest quality personalized molecular diagnostics performed locally, from academic medical centers to community hospitals in the United States and in countries around the world. With this funding, we are confident PGDx will be able to maintain a leading position in the field of decentralized tumor profiling, a cornerstone of the future of precision oncology."

Today’s financing announcement follows several successful regulatory and commercial milestones in the past year. PGDx gained significant commercial momentum in 2020, achieving FDA clearance in April for PGDx elio tissue complete, the industry’s first and only diagnostic kit for comprehensive genomic profiling that is cleared for use by any laboratory in the country. The company also secured positive Medicare coverage decisions and signed several notable strategic partnership agreements.

"PGDx’s vision of enabling access to precision medicine for millions more patients, and their demonstrated ability to execute commercially gives us a great deal of confidence in the company’s future," said Kevin Raidy, Managing Partner at Cowen Healthcare Investments. "The PGDx elio platform represents the first-of-its-kind, FDA-cleared kit that enables labs to perform comprehensive tumor profiling on-site. Meeting the significant market and patient need for this with the only regulated option represents a sizable opportunity to drive growth, build shareholder value, and improve outcomes for cancer patients globally. We are thrilled to partner with PGDx in advancing decentralized NGS testing, changing the standard of care in oncology."

Illumina to Webcast Upcoming Investor Conference Presentations

On February 10, 2021 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conferences and invited investors to participate via webcast (Press release, Illumina, FEB 10, 2021, View Source [SID1234574867]).

SVB Leerink Annual Global Healthcare Conference on Thursday, February 25, 2021
Fireside Chat at 12:00pm Pacific Time / 3:00pm Eastern Time

Cowen Annual Health Care Conference on Tuesday, March 2, 2021
Fireside Chat at 9:50am Pacific Time / 12:50pm Eastern Time

The live webcasts can be accessed under the Investor Info section of the "company" tab at www.illumina.com. Replays will be posted on Illumina’s website as soon as possible after the event and will be available for at least 30 days following.

Day One Announces $130 Million Series B Financing to Accelerate New Targeted Cancer Treatments for Children

On February 10, 2021 Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company focused on accelerating new, promising targeted therapies for children and adults with cancer, reported a $130 million Series B financing from leading life sciences investors (Press release, Day One, FEB 10, 2021, View Source [SID1234574866]). The financing was led by RA Capital Management with participation from additional new investors Boxer Capital, BVF Partners L.P., Franklin Templeton, Janus Henderson Investors, Perceptive Advisors, funds and accounts advised by T. Rowe Price Associates, Inc., and Viking Global Investors. Existing investors Canaan, Access Biotechnology, and Atlas Venture also participated.

Day One is a purpose-built company passionately committed to advancing important new cancer treatments for patients of all ages, with a focus on children. Proceeds from the Series B financing will allow Day One to accelerate and expand its search and evaluation capabilities, support drug development efforts and continue advancing commercial launch plans for the Company’s lead program, DAY101. With the completion of the Series B financing, Day One has raised more than $190 million from leading life science investors since the Company initiated operations in late 2019.

DAY101 is designed as a first-in-class, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor. The Company has initiated the pivotal Phase 2 FIREFLY-1 study with DAY101 in pediatric low-grade glioma (pLGG), which is the most common form of childhood brain cancer and has no approved therapies. In addition, Day One plans to initiate an adult solid tumor study to further evaluate DAY101 in patients with RAF-altered tumors for which there are no currently approved therapies. DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients with low-grade glioma harboring an activating RAF alteration who have progressed after one or more prior systemic therapies.

"Day One was founded to solve a critical unmet need: Children are being left behind during a cancer treatment revolution," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We have made significant and rapid progress since our recent inception, including initiating our first sites for the pivotal FIREFLY-1 study, which has the potential to make DAY101 the first approved targeted therapy for pediatric low-grade glioma, the receipt of FDA Breakthrough Therapy designation for DAY101, and the continued build-out of our senior leadership team. The completion of this financing will enable us to accelerate and expand our efforts even further. We are thrilled to have the support of this exceptional group of investors, are pleased to welcome Derek to our Board, and look forward to the next chapter of growth for Day One."

In association with the financing, Derek DiRocco, Ph.D., Partner of RA Capital Management, joined the Day One board of directors.

"Day One is a unique and inspiring company," said Dr. DiRocco. "I am excited to be part of the mission to develop new targeted therapies for children with cancer with a sense of urgency. What Day One has accomplished in a short time is extremely impressive, and I look forward to contributing to Day One’s future growth and success as the Company executes on its late-stage clinical development activities, the commercial launch planning for DAY101 and other corporate objectives."

About DAY101
DAY101 is designed as a first-in-class, oral, highly-selective pan-RAF kinase inhibitor to target a key enzyme in the MAPK signaling pathway. Studies have shown DAY101 has high brain distribution and exposure in comparison to other MAPK pathway inhibitors, thus potentially benefiting patients with primary brain tumors or brain metastases of solid tumors. DAY101 is a type II RAF inhibitor that selectively inhibits both monomeric and dimeric RAF kinase.

Over 250 patients have received DAY101 in clinical trials thus far. Early studies have demonstrated evidence of anti-tumor activity in adult and pediatric populations with specific genetic alterations in the RAS/MAPK pathway. In November 2020, Day One announced preliminary results from PNOC014, an ongoing Phase 1 Pacific Pediatric Neuro-Oncology Consortium (PNOC) network study with DAY101 sponsored by the Dana-Farber Cancer Institute, in patients under 18 years of age with relapsed low-grade glioma. Preliminary results demonstrated that of the eight patients in the study with RAF fusions, two patients achieved a complete response by Response Assessment for Neuro-Oncology (RANO), three had a partial response, two achieved prolonged stable disease, and one experienced progressive disease. DAY101 also demonstrated a tolerable safety profile.

DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients with an advanced low-grade glioma harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. DAY101 has also received Orphan Drug designation from the FDA for the treatment of malignant glioma.

The Company has initiated the pivotal Phase 2 FIREFLY-1 study with DAY101 in pediatric patients with recurrent or progressive low-grade glioma with a known activating BRAF alteration. In addition, Day One plans to initiate an adult solid tumor study to further evaluate DAY101 in patients with RAF-altered tumors for which there are no currently approved therapies.

PureTech Founded Entity Vor Biopharma Closes Over $200M Initial Public Offering

On February 10, 2021 PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported to note that its Founded Entity, Vor Biopharma (Nasdaq: VOR), announced the closing of its previously announced initial public offering of 9,828,017 shares of its common stock, plus an additional 1,474,202 shares sold pursuant to the full option exercised by the underwriters, at a price to the public of $18.00 per share (Press release, PureTech Health, FEB 10, 2021, View Source [SID1234574864]). The aggregate gross proceeds to Vor from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by Vor, were approximately $203.4 million. The shares began trading on the Nasdaq Global Market on Friday, February 5, 2021 under the ticker symbol "VOR".