Scientia raises $50M to develop guidewires and microcatheters for stroke, cancer treatment

On May 27, 2021 Scientia Vascular may focus largely on producing medical devices of tiny proportions, reported that certainly doesn’t carry over to its latest wave of financing (Press release, Scientia Vascular, MAY 27, 2021, View Source [SID1234583261]).

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 Salt Lake City-based company, which develops not only a suite of microcatheters and guidewires but also the manufacturing technology it takes to produce them, has received $50 million in growth equity to support and expand that development.

The funding came solely from Vivo Capital, a global healthcare investment firm that has backed biotech and medtech companies through its multiple nine-figure venture funds, including, most recently, Esco Lifesciences’ $200 million series A.

The $50 million in growth capital will help speed up global sales and marketing efforts for Scientia’s existing products while also supporting new product development in the neurovascular stroke, peripheral vascular and interventional oncology markets.

RELATED: Surmodics gets FDA nod for Telemark microcatheter

Currently, Scientia’s product portfolio includes a handful of guidewires and microcatheters that, since their 2018 commercial launch, have been used primarily in neurovascular surgeries and specifically in stroke treatment.

Among these are the Plato line of microcatheters—including the Plato 17 model, which was cleared (PDF) by the FDA just last month—and the trio of Aristotle flexible guidewires. Additionally, last August, the company received FDA clearance for and began rolling out its Zoom Wire collection of guidewires, which are designed to lead catheters into the body during intensive, time-critical vascular operations, such as during ischemic or hemorrhagic stroke.

At the time of the Zoom Wire’s launch, John Lippert, Scientia’s founder and CEO, said in a statement that the company had plans to introduce an even wider line of guidewires and microcatheters under the Zoom umbrella in 2021.

Beyond designing and developing its range of neurovascular devices, Scientia also does all of its own manufacturing. To that end, the company has invented patented micromachining and microfabrication technologies to achieve high levels of stability and flexibility in its guidewires and catheters. Scientia has also automated much of this proprietary manufacturing process to ensure consistency in the quality of its products.

RELATED: FDA approves wireless brace that uses brainwaves to improve hand function in stroke patients

The realm of microcatheters and guidewires has long been dominated by medtech giants like Stryker and Boston Scientific, both of which boast a broad range of products for interventional vascular operations.

More recently, smaller startups have begun to challenge these behemoths with innovative takes on the products, whether through new manufacturing processes like Scientia’s or entirely new technology. In the latter category are companies like Sensome, which is developing sensor-equipped guidewires that use machine learning algorithms to analyze the tissue they come in contact with during stroke treatment.

UK Pharma Group Vectura Agrees $1.4 Billion Takeover by Carlyle

On May 27, 2021 Vectura Group, a British pharmaceutical company focused on inhaled medicines, reported had agreed a 958 million pound ($1.36 billion) takeover by global investment firm The Carlyle Group (Press release, Carlyle Group, MAY 27, 2021, View Source [SID1234583254]).

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!

Shareholders will receive 136 pence in cash plus a dividend of 19 pence for each share under the terms of the offer, representing a 32% premium on the ex-dividend closing price of the stock on Tuesday, Vectura said.

Vectura’s Chairman Bruno Angelici said the company had made strong progress since embarking on a strategy in 2019 to become a leading inhalation-focused CDMO, or contract development and manufacturing organisation.

He said that while the board remained confident in the fundamentals of the group and its strategy, the "attractive offer" secured future value for shareholders in cash today.

Vectura has 13 key inhaled and 11 non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development.

Its partners include Novartis, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork.

Oncorus Announces Nomination of its First IV-Administered Synthetic Viral RNA (vRNA)
Immunotherapy Product Candidates, ONCR-021 and ONCR-788

On May 27, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported the nomination of its first Synthetic viral RNA (vRNA) immunotherapy clinical candidates, ONCR-021 and ONCR-788 (Press release, Oncorus, MAY 27, 2021, View Source [SID1234583253]). Oncorus’ pioneering intravenous (IV)-administered approach involves encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in a lipid nanoparticle (or LNP), creating a Synthetic vRNA immunotherapy. ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes for a modified version of the Seneca Valley Virus (SVV). Both CVA21 and SVV have extensive clinical experience and favorable safety profiles when administered IV. Oncorus’ novel Synthetic vRNA approach holds the potential for IV-administration and avoids the challenge of neutralizing antibodies seen in previous approaches with IV-administered OVs. Oncorus plans to investigate its novel Synthetic vRNA immunotherapies in multiple histologies including cancers of the lung both as monotherapy and in combination with immune checkpoint inhibitors and other cancer treatments.

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!

"There has been a notable rise in the development and approval of RNA-based vaccines, most prominently for COVID-19, and therapeutics for certain rare diseases. To date, however, there are no approved RNA-based cancer therapies. Simultaneously, the therapeutic benefit of viral immunotherapy

has been limited to intratumoral (iTu) administration, restricting broader applications of this modality. In addition, past investigational programs that utilized IV-administered natural OVs faced the challenge of neutralizing antibodies which likely hinders the clinical efficacy of later doses. Our proprietary Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and OV-based modalities and, in doing so, holds the potential to create a new pillar in cancer therapy," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO of Oncorus.

LNP-encapsulated IV-administered vRNA to create a "living immunostimulatory drug"

Developing IV-administered RNA medicines for cancer requires addressing two primary technological hurdles: first, getting adequate concentrations of the RNA-based drug candidate to all tumor cells, and second, limiting exposure to normal tissue throughout the body.

OVs, through rapid, self-amplification of their genomes in permissive cells and their ability to infect nearby cancer cells, are a potential answer to the challenge of the suboptimal LNP delivery of cargo RNA to tumor cells. In addition, OVs are selected or engineered to replicate more robustly in cells with deficiencies in antiviral responses, as is the case for cancer cells. OVs’ selectivity for tumors ensures that their genomes, when delivered by LNP, are minimally or not at all replicating in healthy tissues, thus potentially providing a large therapeutic window for Oncorus’ Synthetic vRNA immunotherapy candidates. Furthermore, the immunogenic cell death triggered by OVs, and the release of tumor antigens in an inflamed tumor microenvironment, are expected to broadly stimulate the immune system in its fight against cancer.

"Taken together, the oncolytic and immunogenic properties of OVs, combined with the broad tissue distribution enabled by IV-administered LNPs and the tumor selective self-amplification afforded by vRNA, opens the door to the successful application of IV-administered RNA medicines in cancer," explained Dr. Ashburn. "This approach holds the promise of improving outcomes for patients across multiple types of cancer, in particular those with cancers of the lung."

Christophe Quéva, Ph.D., Oncorus’ Chief Scientific Officer, said, "We are proud of our team’s work to advance both our oncolytic Herpes Simplex Virus and Synthetic Viral RNA Immunotherapy Platforms. With this dual-platform strategy, we are building a versatile pipeline of iTu-administered and IV-administered viral immunotherapy product candidates that will potentially enable the treatment of a broad range of cancer settings. We continue to advance our lead oHSV candidate, ONCR-177, through Phase 1 study, and we are working diligently to progress our lead synthetic candidates, ONCR-021 and ONCR-788, into the clinic."

ONCR-021 and ONCR-788 Clinical Development and In-House GMP Manufacturing

Oncorus plans to file an investigational new drug (IND) application for ONCR-021 in the first half of 2023 to enable clinical development for non-small cell lung cancer and other cancers such as hepatocellular carcinoma, clear cell renal cell carcinoma and melanoma, both as a single agent and in combination with immune checkpoint inhibitors. Following the IND filing for ONCR-021, Oncorus plans to file an IND for ONCR-788 to enable its development in small cell lung cancer, neuroendocrine prostate and other neuroendocrine cancers, both as a single agent and in combination with immune checkpoint inhibitors and other cancer treatments. In the process of developing ONCR-021 and ONCR-788, Oncorus also developed and optimized a proprietary LNP platform for delivery of large nucleic acids, with efficient

endosomal escape. Oncorus will manufacture ONCR-021 and ONCR-788 at its 88,000 square foot state-of-the-art process development and Good Manufacturing Practices (GMP) manufacturing facility in Andover, Mass. With the site buildout underway, Oncorus plans to initiate process development activities at the facility in the second half of 2021 and anticipates this facility will be operational for GMP manufacturing in first half of 2023.

Link here to a white paper on Oncorus’ Synthetic vRNA Immunotherapy Platform and lead candidates.

Upcoming Synthetic vRNA Immunotherapy-Focused Investor Event

Oncorus will host a virtual investor event on Monday, June 21, 2021 from 1:00 pm to 3:30 pm ET to discuss details surrounding these Synthetic vRNA programs, including preclinical data supporting the ONCR-021 and ONCR-788 candidate nominations and planned clinical studies. Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute, will be a featured speaker. For more information or to RSVP for the event, please contact Josh Rauch at [email protected].

BioMarin to Participate in Two Upcoming Virtual Investor Conferences

On May 27, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual conferences (Press release, BioMarin, MAY 27, 2021, View Source [SID1234583249]). An audio webcast of the presentations will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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!


Photocure to Present at Two Upcoming Investor Conferences in June

On May 27, 2021 Photocure ASA (OSE: PHO), The Bladder Cancer Company, reported that President and Chief Executive Officer, Daniel Schneider and Chief Financial Officer, Erik Dahl are scheduled to present corporate overviews at two upcoming institutional investor conferences in June (Press release, PhotoCure, MAY 27, 2021, View Source [SID1234583248]).

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!

Details for the two presentations are as follows:

The MicroCap Rodeo 2021 Summer Solstice – Best Ideas from the Buyside: June 1-4, 2021. Photocure will present on Tuesday June 1 at 3:00pm CET / 9:00am ET. Management will be available for virtual 1-1 meetings with investors attending the virtual conference.
Access to the live event/webcast is available by clicking here: www.webcaster4.com/Webcast/Page/2134/41489

The MicroCap Rodeo’s third edition is a virtual conference this year focused on investors in the United States. It brings together the top 35 "best ideas from the buy side". Qualified institutional investors recommended each of the 35 companies represented as one of their "best ideas". For more information: microcaprodeo.com.

Handelsbanken Nordic Mid/Small Cap Seminar 2021: June 2-3, 2021. Photocure will present on Wednesday, June 2 at 4:15pm CET / 10:15am ET. Management will be available for virtual 1-1 meetings with investors.
Handelsbanken Capital Markets’ 12th consecutive Nordic Mid/Small Cap Seminar is a two-day intensive event featuring senior leadership speakers from an array of Nordic Mid/Small Cap companies. All presentations will be digital and presenting companies will host meetings with institutional investors signed up for the conference.