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.

On January 13, 2020 Novocure (NASDAQ: NVCR) reported operating statistics and preliminary, unaudited net revenues and cash balances for the fourth quarter and full year 2019 (Press release, NovoCure, JAN 13, 2020, View Source [SID1234553102]). Novocure plans to discuss these results with investors at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco. Novocure also plans to highlight key clinical and product development programs.

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Fourth quarter and full year 2019 highlights include:

The preliminary, unaudited results described in this press release are estimates only and are subject to revision until the company reports its full, audited financial results for the fourth quarter and full year 2019 on Feb. 27, 2020.

An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

A "prescription received" is a commercial order for Optune or NovoTTF-100L that is received from a physician certified to treat patients for a patient not previously on Optune or NovoTTF-100L. Orders to renew or extend treatment are not included in this total.

"We continued to make substantial progress in 2019 towards becoming a global oncology leader with $351 million in net revenues, representing 42% annual revenue growth, and four advancing phase 3 pivotal trials creating the potential for substantial market expansion over the next five years," said Asaf Danziger, Novocure’s CEO. "Our ongoing focus on product innovation generated 33 new patent applications in 2019 and we ended the year with $326 million cash on hand, an increase of $80 million versus 2018."

"At Novocure, we are working to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy, Tumor Treating Fields," continued William Doyle, Novocure’s Executive Chairman. "Our established commercial business fuels a strong balance sheet and cash position which provides broad flexibility to support a growing body of clinical evidence and deliver meaningful product innovation. We look forward to providing a full company update and discussing our 2019 financial results on our February conference call."

Fourth quarter 2019 operating statistics and preliminary financial highlights

On a preliminary, unaudited basis, for the quarter ended December 31, 2019, net revenues were $99.2 million, representing 42% growth compared to the fourth quarter 2018, and full year 2019 net revenues were $351.3 million, representing 42% growth compared to December 31, 2018.

In the United States, net revenues totaled $65.9 million in the quarter ended December 31, 2019, representing 49% growth compared to the same period in 2018.
In Germany and other EMEA markets, net revenues totaled $25.8 million in the quarter ended December 31, 2019, representing 14% growth compared to the same period in 2018.
In Japan, net revenues totaled $5.6 million in the quarter ended December 31, 2019, representing 95% growth compared to the same period in 2018.
In Greater China, net revenues totaled $1.9 million in the quarter ended December 31, 2019, representing 138% growth compared to the same period in 2018.
There were 2,909 active patients at December 31, 2019, representing 22% growth compared to December 31, 2018, and six percent growth compared to September 30, 2019.

In the United States, there were 1,952 active patients at December 31, 2019, representing 19% growth compared to December 31, 2018.
In Germany and other EMEA markets, there were 765 active patients at December 31, 2019, representing 17% growth compared to December 31, 2018.
In Japan, there were 192 active patients at December 31, 2019, representing 109% growth compared to December 31, 2018.
Additionally, 1,380 prescriptions were received in the quarter ended December 31, 2019, representing five percent growth compared to the same period in 2018, and five percent growth compared to the quarter ended September 30, 2019. In the quarter ended December 31, 2019, 1,079 Optune prescriptions were written for patients with newly diagnosed glioblastoma.

In the United States, 1,002 prescriptions were received in the quarter ended December 31, 2019, representing six percent growth compared to the same period in 2018.
In Germany and other EMEA markets, 285 prescriptions were received in the quarter ended December 31, 2019, representing an 11% decrease compared to the same period in 2018.
In Japan, 93 prescriptions were received in the quarter ended December 31, 2019, representing 79% growth compared to the same period in 2018.
At December 31, 2019, on a preliminary, unaudited basis, Novocure had $177.3 million in cash and cash equivalents and $148.8 million in short-term investments, for a total balance of $326.1 million in cash, cash equivalents and short-term investments. This represents an increase of $80.2 million in cash and investments since September 30, 2019.

Anticipated clinical milestones

Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (H2 2020)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2021)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)
Fourth quarter and full year 2019 financial results conference call

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2019 financial results at 8 a.m. EST on Thursday, February 27, 2020. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1769503.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On January 13, 2020 Oncology Venture A/S ("OV" or the "Company") reported that an update of its ongoing clinical development of the PARP inhibitor, 2X-121, will be presented at an upcoming meeting in Boston on January 28-30th (Press release, Oncology Venture, JAN 13, 2020, View Source [SID1234553101]).

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Oncology Venture, a company developing novel cancer treatments along with its best in class companion diagnostic technology, the Drug Response Predictor (DRP), today announces that an update of the company’s ongoing clinical development of its proprietary PARP inhibitor 2X-121 "Titled: A novel drug specific multigene mRNA biomarker for the PARP/Tankyrase inhibitor 2X-121" has been accepted for poster presentation at the upcoming PARP & DDR Inhibitor Summit taking place in Boston on January 28th-30th, gathering VPs, Heads and Directors of Translational Oncology, Target Discovery, and Early Drug Development companies. The poster includes data from the use of a 2X-121 specific DRP biomarker that the company has developed to enable the selection of patients most likely to respond to the drug.

Title: "A novel drug specific multigene mRNA biomarker for the PARP/Tankyrase inhibitor 2X-121"

Session: Poster Session

Date and Time: January 29th at 3:15 pm Eastern Time

Presenter: Dr. Marie Foegh

"We are delighted to be presenting some of our development data in support of our PARP inhibitor 2X-121 at the upcoming PARP & DDR summit meeting as we expect it will enhance the awareness for our unique compound and the DRP platform." said Steve Carchedi, President and Chief Executive Officer of Oncology Venture. "Our novel multi-targeted approach to hitting both PARP and Tankyrase, we believe will provide an improved clinical impact compared to other PARP inhibitors currently approved and/or under development. We look forward to sharing the data set following its presentation later this month".

The company has chosen to publish this announcement now, even though the company is of the opinion that the contents of this announcement does not constitute information which will impact the company’s share price.

However, in the light of the recent events the company finds that expedited access to this information is relevant in order to provide the highest level of transparency for the members of the general public interested in the news flow from the company.