On June 30, 2022 Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, reported it has teamed up with Biodesix, Inc. (Colorado, U.S.) (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, to incorporate the results of Biodesix’s Nodify Lung blood-based lung nodule risk assessment testing into Philips Lung Cancer Orchestrator lung cancer patient management system (Press release, Biodesix, JUN 30, 2022, View Source [SID1234616404]). The incorporation of proteomics data, along with the radiologic and patient history data currently used to determine the treatment decisions, can help create diagnostic efficiency for cancer care centers in the management of a growing number of lung nodule cases. Philips Lung Cancer Orchestrator solution is designed to enable health systems to operationalize lung cancer screening and lung nodule management programs at scale.

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!

Lung cancer remains the leading cause of cancer deaths worldwide [1], with current 5-year survival rates after diagnosis typically less than 20% [2]. If detected and treated early, however, research shows 10-year survival rates could increase to more than 90% [3]. Thanks to the adoption of low-dose CT (computer tomography) screening and better management of incidental lung nodule findings, early-stage diagnosis and treatment is now possible, but has resulted in rapidly increasing caseloads. For example, recent changes in U.S. guidelines have nearly doubled the number of people now eligible for lung cancer screening [4].

"By incorporating Biodesix’s Nodify Lung testing, we take another step in leveraging integrated diagnostics from imaging, genomics, and now proteomic results from a simple blood draw to address key moments in the lung cancer patient journey, support care team decision-making, and help health systems learn from their practice patterns," said Louis Culot, General Manager Oncology Informatics and Genomics at Philips. "We expect the inclusion of Biodesix’s ground-breaking technology in Philips Lung Cancer Orchestrator to help drive more confident decisions for the care team, and ultimately benefit patients."

As a next-step after radiologic lung nodule assessment, minimally-invasive biopsy procedures such as endobronchial biopsy (accessing a nodule via the patient’s airways), are already helping early-stage diagnosis. With 62% of biopsies conducted on benign nodules, by detecting the presence of blood-based biomarkers combined with clinical and radiomic factors, Biodesix’s Nodify Lung blood-based proteomic tests help clinicians to reclassify the risk of malignancy to better target resources to those who need them. If a nodule is malignant, the delay in surgical care for cancer patients by four weeks increases the mortality by 6-8% [5].

"We are delighted that our tests are being incorporated into Philips’ vision for end-to-end cancer care management using a multi-diagnostic approach," said Scott Hutton, Chief Executive Officer at Biodesix. "By integrating our Nodify tests in Philips Lung Cancer Orchestrator we hope to make these tests more accessible to physicians and patients and more easily utilized by care teams with the ultimate goal of improving patient care and outcomes."

Philips Lung Cancer Orchestrator is an integrated patient management system for CT lung cancer screening programs and incidental lung nodule findings that keeps track of patients, appointments, diagnostic images, test results, and clinical decisions for every step of a lung cancer patient’s screening and treatment journey. Fitting seamlessly into conventional screening and diagnostic workflows, it coordinates the end-to-end patient journey to create a fully traceable, fully documented timeline of scheduled actions, and aggregates data on tumor staging, radiology, pathology, and biomarker analyses for informed decision-making. The ability to order and receive the results expedites Biodesix’s proteomic testing directly to and from the Lung Cancer Orchestrator at the same time it adds new insights on nodule risk of malignancy to further support the decision-making process.

Lung Cancer Orchestrator is part of Philips’ expanding portfolio of integrated cancer care solutions that seamlessly connect data, technology, operations, and clinical workflows to enable pivotal decision-making. Visit Philips Oncology to learn how Philips combines smart diagnostic and imaging technologies with connected workflows that integrate patient data from disparate systems, to provide solutions that put expert information at clinicians’ fingertips to help expand the quality and reach of personalized cancer care.

On June 30, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a robust preclinical pipeline, reported the completion of Phase 1 dose escalation of INBRX-105, a novel targeted 4-1BB agonist, in combination with Keytruda (Press release, Inhibrx, JUN 30, 2022, View Source [SID1234616421]). It also reported the funding of an additional $60 million from its Loan and Security Agreement, as amended (the "Loan Agreement"), with Oxford Finance, LLC ("Oxford"), to bring its cash balance to approximately $176 million as of June 30, 2022.

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 very encouraged by the results observed in Part 3 and believe the Part 4 expansion cohorts have been designed to demonstrate the potential of INBRX-105," commented Mark Lappe, Inhibrx’s CEO. "The additional debt provided by Oxford provides non-dilutive financing and, we believe, the time needed to mature our programs ahead of various potential strategic options."

Phase 1 Dose Escalation Results for INBRX-105 in Combination with Keytruda
INBRX-105 is a precisely engineered multi-specific therapeutic candidate based on our single domain antibody ("sdAb") platform designed to agonize 4-1BB selectively in the presence of programmed death ligand 1 ("PD-L1"), a protein typically enriched in the tumor microenvironment and lymphoid tissues.

The study is a first-in-human, multicenter, open-label, non-randomized, Phase 1 trial in patients with locally advanced or metastatic solid tumors. This four-part trial is designed to determine the safety profile and identify the maximum tolerated dose and the recommended Phase 2 dose of INBRX-105 administered in combination with Keytruda, a programmed death receptor-1 checkpoint inhibitor. Part 3, dose escalation in combination with Keytruda, has concluded with a total of 30 patients enrolled. Patients were not pre-screened for PD-L1 expression. INBRX-105 in combination with Keytruda was reasonably well-tolerated and we observed durable responses in checkpoint-naïve and relapsed refractory patients. These results informed what we believe to be the optimal dose level for INBRX-105 in combination with Keytruda in Part 4. Additionally, single agent responses have been observed at this same dose level in both checkpoint-naïve and relapsed/refractory patients.

Part 4, dose expansion cohorts of INBRX-105 in combination with Keytruda, initiated enrollment in May 2022. This will include a total of approximately 90 patients in five separate cohorts and we expect to announce initial data from these cohorts in the first half of 2023.

Additional $60 Million in Debt from Oxford
On June 29, 2022, Inhibrx drew two additional term loans from its Loan Agreement with Oxford for an aggregate principal amount of $60.0 million. The two additional term loans were based on the completion of the following:

$30 million upon the receipt of positive topline data from the Phase 1 clinical trial of INBRX-101, our AAT-Fc fusion protein for the treatment of Alpha-1 antitrypsin deficiency, which we released in May 2022; and
$30 million upon initiation of Part 4 of the Phase 1 clinical trial of INBRX-105, our PD-L1x4-1BB tetravalent conditional agonist.
Inhibrx has one additional $30 million tranche available under the Loan Agreement, which will be available to fund upon the initiation of a potential registration-enabling clinical trial of INBRX-101. To date, the aggregate balance of Inhibrx’s outstanding term loans, which mature in January 2027, is $170.0 million. The repayment schedule provides for interest-only payments until March 2025 with a potential 12-month extension.

On June 30, 2022 Blueprint Medicines Corporation (NASDAQ: BPMC) reported strategic financing collaborations with Sixth Street and Royalty Pharma (NASDAQ: RPRX) for up to $1.25 billion, bringing significant non-dilutive, low-cost capital to drive innovation and growth (Press release, Blueprint Medicines, JUN 30, 2022, View Source [SID1234616405]).

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!

These tailored investments by two highly respected life sciences-focused investors capitalize on Blueprint Medicines’ significant accomplishments to date and add strategic financial partners who are aligned with the company’s growth ambitions and confidence in the anticipated commercial opportunity and launch performance of AYVAKIT/AYVAKYT (avapritinib) and GAVRETO (pralsetinib). The financings provide capital to expand and advance the company’s robust and diverse pipeline towards commercialization and to continue pursuing strategic and synergistic business development opportunities.

"This attractive deal puts Blueprint Medicines in a very strong financial position to drive rapid growth while maintaining our path to profitability in the coming years. The combination of our strong cash position, multiple drivers of top-line revenue, and diversity of important pipeline programs uniquely positions us to continue building a leading precision therapy company and bring transformative medicines to patients worldwide," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "Executing this deal with such favorable terms in the current market environment speaks to the quality of the assets, the aligned confidence in the commercial opportunities, and the investment opportunity that Blueprint Medicines represents overall for firms like Sixth Street and Royalty Pharma, with whom we are building long-term strategic relationships."

This multi-component deal is comprised of the following elements:

The agreement with Sixth Street has three parts:
$250 million cash upfront in exchange for future AYVAKIT/AYVAKYT and BLU-263 royalties at a rate of 9.75 percent subject to an annual cap of $900 million in net sales and a cumulative cap of 1.45 times invested capital;
Up to $400 million in a senior secured credit facility, of which Blueprint Medicines will draw $150 million initially with an additional $250 million available in delayed draw tranches at Blueprint Medicines’ election; and
$260 million in a potential credit facility to support buy-side business development opportunities, subject to mutual agreement between Sixth Street and Blueprint Medicines.
The agreement with Royalty Pharma monetizes royalties receivable from GAVRETO net sales by Roche outside of the US, not including Greater China, with $175 million cash paid to Blueprint Medicines upfront and up to $165 million in potential milestone payments based on future sales.
"Blueprint Medicines is an impressive and differentiated biopharmaceutical company, with a proven track record of success in developing and commercializing precision therapies. We are particularly excited about the opportunity for AYVAKIT to meet the substantial need in patients with non-advanced systemic mastocytosis," said Vijay Mohan and Jeff Pootoolal, Partners at Sixth Street. "We believe that investing now, when the company is already in a strong financial position, is the first step toward a long-term relationship that will open the door to further potential opportunities for growth and partnership."

"GAVRETO is an important precision therapy that has been incredibly meaningful for patients with metastatic, RET fusion-positive non-small cell lung cancer who may have otherwise had limited options," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "We are pleased to establish a partnership with the experienced team at Blueprint Medicines to help fuel their execution on the significant commercial and development opportunities they have ahead."

Cowen and Company served as financial advisor and Goodwin Procter LLP served as legal advisor to Blueprint Medicines. Cooley LLP acted as legal advisors to Sixth Street. Gibson Dunn acted as legal advisors to Royalty Pharma.

Investor Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss the collaborations. The conference call may be accessed by dialing 844-200-6205 (domestic) or 929-526-1599 (international), and referring to conference ID 658541. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. For more information, visit AYVAKIT.com. Under the brand name AYVAKYT (avapritinib), this medicine is approved by the European Commission for the treatment of adults with ASM, SM-AHN or MCL, after at least one systemic therapy, and adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation.

AYVAKIT/AYVAKYT is not approved for the treatment of any other indication in the U.S. or Europe.

Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and non-advanced SM. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of moderate to severe indolent SM. The European Commission granted orphan medicinal product designation for AYVAKYT for the treatment of GIST and mastocytosis.

Please click here to see the full U.S. Prescribing Information for AYVAKIT, and click here to see the European Summary of Product Characteristics for AYVAKYT.

About GAVRETO (pralsetinib)

GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of three indications: adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. In addition, GAVRETO is approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy.

GAVRETO is not approved for the treatment of any other indication in the U.S. by the FDA or in China by the NMPA, or for any indication in any other jurisdiction by any other health authority.

GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. In preclinical studies, GAVRETO inhibited RET at lower concentrations than other pharmacologically relevant kinases, including VEGFR2, FGFR2 and JAK2. For more information, visit GAVRETO.com.

Blueprint Medicines and Roche are co-developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-altered NSCLC, various types of thyroid cancer and other solid tumors. The European Medicines Agency validated a marketing authorization application for GAVRETO for the treatment of RET fusion-positive NSCLC. The FDA granted breakthrough therapy designation to GAVRETO for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Please click here to see the full U.S. Prescribing Information for GAVRETO.

On June 30, 2022 Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, reported a collaboration with University of Minnesota (Press release, Inceptor Bio, JUN 30, 2022, View Source [SID1234616422]). The aim of this collaboration is to build a novel induced pluripotent stem cells (iPSC) platform that will accelerate Inceptor Bio’s best-in-class next-generation cell therapies platforms. Under the terms of the agreement, Inceptor Bio will receive an exclusive license to the technology developed under this collaboration.

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!

Inceptor Bio plans to advance multiple cell therapy products into clinical studies incorporating the iPSC platform into its proprietary K62 platform for CAR-M therapy, which increases the phagocytic capabilities of macrophages and supports an M1 anti-tumor phenotype, as well as its novel co-stimulatory domain, M83, for CAR-NK therapies.

"iPSC-derived cell therapies have the potential to enable the next frontier of cell therapies. We are excited to work with Dr. Beau Webber at University of Minnesota and his team to develop this unique platform," said Mike Nicholson, Ph.D., President and Chief Operating Officer at Inceptor Bio.

"The team at University of Minnesota is confident that Inceptor Bio is the right partner for building a differentiated iPSC platform to advance novel cell therapies," said Beau Webber, Ph.D., Assistant Professor in the Department of Pediatrics, Division of Hematology and Oncology. "We are deeply encouraged by Inceptor Bio’s progress in the cell therapy arena, and we look forward to being part of future developments to help cure difficult-to-treat cancers."

"This partnership is an important step in continuing to execute on our strategy of advancing cell therapies to bring a more positive prognosis and quality of life to patients with difficult-to-treat cancers," said Abe Maingi, Vice President, Business Development at Inceptor Bio. "We are thrilled to be able to develop and deliver on the promise of iPSC-derived cell therapies."

On June 30, 2022 Provectus (OTCQB: PVCT) reported that updated data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver (mUM) in its cancers-of-the-liver Phase 1 trial of investigational immunocatalyst PV-10 (NCT00986661) were part of two oral presentations at the 20th Congress of the International Society of Ocular Oncology (ISOO), held June 17-21, 2022 in Leiden, The Netherlands (Press release, Provectus Biopharmaceuticals, JUN 30, 2022, View Source [SID1234616443]).

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!

The first presentation, given by Krysta McVay, Research Nurse, Department of Melanoma Medical Oncology, Division of Cancer Medicine at MD Anderson Cancer Center (MDACC), was entitled "A phase 1 study of percutaneous autolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastases." A copy of her presentation is available on Provectus’ website at: View Source

Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine and Director of the Uveal Melanoma Program at MDACC and Chair, Melanoma Committee, SWOG Cancer Research Network, made the second presentation entitled "Metabolic complete responses (mCR) in metastatic uveal melanoma (mUM) patients treated with image-guided injection of PV-10." A copy of her presentation is available on the Company’s website at: View Source

This ongoing single-center mUM study at MDACC has been led since inception by Dr. Patel. Up to three hepatic mUM tumors can be injected per PV-10 treatment cycle. Response assessments are performed at Day 28, and then every three months. Patients with additional, injectable, visceral hepatic mUM disease may receive additional cycles of PV-10 after Day 28. Eligible patients may also receive standard of care immune checkpoint blockade during and after PV-10 treatment.