On January 13, 2020 Human Longevity, Inc., an innovator in providing data-driven health intelligence and precision health to physicians and patients reported that the Oncology Division was sold to NeoGenomics (NASDAQ NEO) for $37 Million (Press release, Human Longevity, JAN 13, 2020, View Source [SID1234553107]). The financing, a cash transaction, closed on Friday, January 10, 2020.

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David Karow, MD, PhD, President and Chief Innovation Officer of Human Longevity, Inc., said, "The sale of this division allows us to focus entirely on longevity and extending the healthy, high-performance human lifespan. Additionally, it will provide the firm with additional working capital, along with the recent Series A2 round of financing, to grow domestically and internationally."

On January 13, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that its Chief Executive Officer and President, Alan H. Auerbach, will be presenting at the 38th Annual J.P. Morgan Healthcare Conference at 12:00 p.m. PST on Wednesday, January 15, 2020 (Press release, Puma Biotechnology, JAN 13, 2020, View Source [SID1234553106]). Mr. Auerbach will be providing a corporate update that will include, among other things, the company’s preliminary estimate that it sold approximately 4,900 bottles of NERLYNX in the United States in the fourth quarter of 2019. This preliminary estimate is subject to completion of the Company’s customary closing and review procedures and could change based on that process. The slides to be discussed during the presentation are currently available on the Investors section of Puma’s website at View Source A live webcast of the presentation will also be available on January 15, 2020, at www.pumabiotechnology.com.

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On January 13, 2020 TriSalusTM Life Sciences ("TriSalus"), a company committed to transforming outcomes for patients with solid tumors, reported the launch of its TriNav Infusion System ("TriNav") (Press release, TriSalus Life Sciences, JAN 13, 2020, View Source [SID1234553105]). Powered by its proprietary Pressure-Enabled Drug DeliveryTM (PEDD) approach with SmartValveTM technology, TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumors, including hepatocellular carcinoma (HCC) and liver metastases.2,3

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The TriNav System can provide interventional radiologists intravascular tumor access with improved trackability, compatibility with standard angiographic catheters and workflow comparable to standard interventions.4

The tumor microenvironment creates pressure barriers that limit flow into solid tumors.5,6 PEDD with SmartValve creates a high-pressure gradient that improves delivery and penetration of therapy into tumors.7,8 The porous expandable SmartValve is designed to allow antegrade flow and leverages blood flow to carry the dose deep into the solid tumor.1,7 SmartValve enables therapy delivery to the intended target while minimizing non-target delivery that has been shown to damage healthy tissue.2,9

In a clinical study, PEDD with SmartValve demonstrated the ability to overcome tumor infusion barriers and significantly improve response rates in HCC.2 Outcomes from a retrospective, single-center study of patients with solitary HCC tumors who underwent treatment utilizing either PEDD or standard end-hole microcatheters, showed 100% Objective Response (OR) with PEDD versus 76.5% with standard end-hole microcatheters (p=0.019).2* Additionally, after first treatment, Pathological Response (PR) as shown by tumor necrosis percentage was significantly greater with PEDD (88.8%) vs. standard end-hole microcatheters (33.8%), (p=0.026).2* Improving response rates could potentially help more patients meet transplant criteria, lead to successful downstaging, bridging, and post-transplant survival.10

"Tumor-directed delivery of therapeutics is an exciting opportunity to help improve outcomes across a wider range of procedures by overcoming intratumoral pressure that can prevent drugs from adequately penetrating the tumor," said Mary Szela, President and CEO of TriSalus. "The new TriNav Infusion System utilizes SmartValve, a first-in-kind, proprietary technology that has been shown to modulate pressure and flow with the goal for improved therapeutic delivery and deeper penetration into the tumor while helping to protect healthy tissue."1-3,7,8

Acknowledging its unique technology for therapeutic delivery, the Centers for Medicare and Medicaid Services (CMS) granted TriNav transitional pass-through payment as part of the 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS-1717-FC), effective January 1, 2020.12

This supplemental payment is intended to "facilitate access for [Medicare] beneficiaries to the advantages of new and innovative devices"13. The TriNav Infusion System met the required criteria to receive transitional pass-through status, including the demonstration of substantial clinical improvement, with the CMS saying it believes there is no existing pass-through payment category for this device because its SmartValve technology offers a unique mechanism for therapy delivery to selected sites in the peripheral vascular system, including solid tumors in the liver.12

*Study design: A retrospective, single-center study included 88 treatment-naive patients with solitary HCC tumors <6.5 cm who underwent treatment utilizing either PEDD (n = 18) or standard end-hole (EH) microcatheters (n = 70). Explant liver assessment of pathological response after first treatment: PEDD n=4; EH n=12.

About the TriNav Infusion System
The TriNav Infusion System is a 0.021-inch lumen microcatheter with SmartValve self-expanding tip. SmartValve supports pressure generation, which enables delivery of therapeutic agents to select sites in the peripheral vascular system, including solid tumors in the liver.2,3,8,14

The TriNav SmartValve has demonstrated the potential to overcome intratumoral pressure in solid tumors to improve distribution and penetration of therapy during arterial embolization procedures per clinical studies performed to date. 2,3,14

Intended Use: The TriNav Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.15

Contraindications: TriNav is not intended for use in the vasculature of the central nervous system (including the neurovasculature) or central circulatory system (including the coronary vasculature).15

On January 13, 2020 Pear Therapeutics, Inc. the leader in Prescription Digital Therapeutics (PDTs), reported that it has entered into an agreement with Apricity Health, LLC to develop up to two product candidates for precision management of patients undergoing cancer treatment (Press release, Pear Therapeutics, JAN 13, 2020, View Source [SID1234553104]). Apricity, a pioneer in leveraging technology and analytics to address the expertise gap in real-world medicine, is developing its first product candidate, ApricityRx, to enable intelligent monitoring and precision management of patients receiving immune checkpoint therapies. As part of the agreement, Pear will have the option to license two oncology PDTs arising out of this combined effort.

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IO is transforming cancer care, but there remains a major unmet need in maximizing its real-world effectiveness and minimizing associated toxicities. Founded by world renowned physician scientists in cancer and immuno-oncology, with an august advisory board of clinical experts led by Nobel Laureate Dr. James Allison, Apricity’s mission is to deliver clinical expertise with digital technology at the point of care to help practicing oncologists and nurses better manage IO-related toxicities in patients receiving IO therapies.

"Dr. Allison, an inventor of immune checkpoint therapy, has shown us that targeting the immune system can potentially cure cancer patients. Our team of expert advisors has over a decade of experience treating patients on IO therapies and managing their toxicities to help them stay on treatment with better outcomes," said Lynda Chin, M.D., President and CEO of Apricity Health. "We now need to share our expertise with real world practitioners so more patients can benefit from these revolutionary new medicines. We believe our synergistic collaboration with Pear will help us get there faster."

"By combining Pear’s platform and infrastructure with Apricity’s clinical expertise and analytics, we believe we can enhance the effectiveness of cancer treatment for patients," said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. "PDTs like ApricityRx may have the potential to directly improve efficacy when prescribed in combination with IO medications."

On January 13, 2020 Phoenix Biotechnology’s (PBI) (www.phoenixbiotechnology.com) reported that New research findings presented in November at the Italian Cancer Society’s 61st annual meeting in Naples, Italy confirm the ability of drug PBI-05204 to act synergistically with coadministration of temozolamide and radiotherapy to kill Glioblastoma Multiforme (GBM) in mice with orthotopically implanted human GBM cells Italian Cancer Society’s 61st annual meeting in Naples, Italy. These data are currently being prepared for publication.

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The new research results are the latest in a series of evidence in support of PBI-05204, PBI’s lead anticancer drug derived from Nerium oleander, as a potential treatment for GBM, according to Robert A. Newman, Ph.D., Phoenix Biotechnology’s President and Chief Science Officer. The American Brain Tumor Association reports that GBM kills more than 16,000 people each year in this country. Both Senator John McCain and Senator Edward Kennedy died from complications of GBM.

The Italian research, conducted through the University of L’Aquila, shows an ability of PBI-05204 to synergistically interact with standard of care chemotherapy (temozolamide) and radiotherapy in extending the life of mice with human GBM, according to Dr. Claudio Festuccia, the lead investigator of the project.

GBM is the most common glial brain tumor and results in extremely low patient survival. A better understanding of GBM biology has recently shown some of the important reasons why current new drugs fail to produce major tumor responses, Newman said.

These include, for example, inabilities of a drug (1) to gain access to malignant tissue across the blood barrier, (2) to selectively target only malignant cells, (3) to eliminate GBM stem cells, (4) to induce the synthesis of brain derived neurotrophic factor (BDNF) recently shown to be important for a meaningful GBM response and (5) to interact in a synergistic manner with currently used standard of care therapeutic strategies, he said. In addition to these criteria, an ideal drug would also be orally bioavailable.

"Recent data from research with PBI-05204, a modified supercritical extract of Nerium oleander, has shown that it can meet each of these challenges," Newman said. "Data from Phoenix Biotechnology as well as Duke University have shown the facile ability of oleandrin, an important API within PBI-05204, to cross the blood brain barrier following oral administration to mice."1-3

"Once in the brain, PBI-05204 induces the synthesis of brain derived neurotrophic factor (BDNF), something which very few other drugs have been able to do," he said.4 "PBI’s lead drug also represents targeted delivery against malignant cells through their selective expression of a particular subunit of Na, K-ATPase."5-6

"Very recent and exciting research which is also being prepared for publication has shown that PBI-05204 is very potent in elimination of human GBM stem cells, possibly eliminating the recurrence of tumor after therapy," Newman continued, noting that other scientific investigators from Istanbul, Turkey and Pozzilli, Italy have suggested that oleandrin represents a new approach to brain cancer therapy.7-8

PBI-05204 is the only patented drug containing oleandrin that has been through Phase I and Phase II clinical cancer trials in the United States.