On January 9, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported that it has received Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA in Australia (Press release, Imugene, JAN 9, 2023, View Source [SID1234626003]).

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Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of VAXINIA required to commence human clinical trials in Australia.

The Australian component of the Phase I trial will be conducted under Australia’s Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities. The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital located in Eastwood, South Australia. Additional clinical sites will be opened in Australia, as have already been in the US following a Food and Drug Administration (FDA) investigational new drug (IND) approval 12 months ago.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources.

The primary aim of the Phase 1 trial is to determine safety and an optimal biological dose of VAXINIA (CF33-hNIS) as a monotherapy and later in combination with immune checkpoint inhibitors. Efficacy, tolerability and immune response will also be measured.

The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models1.

Imugene MD & CEO Leslie Chong said "The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of advanced solid tumour cancers. Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential. In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of VAXINIA and the oncolytic virotherapy platform for Australians inflicted with cancer."

On January 8, 2023 Debiopharm, a privately-owned, Swiss-based, biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today secured an option to enter an exclusive licensing deal with SunRock Biopharma (www.sunrockbiopharma.com), a Galician company supported by the regional government, Xunta de Galicia, through Xes Galicia (Press release, SunRock Biopharma, JAN 8, 2023, View Source [SID1234647327]). SunRock is devoted to the development of sophisticated, bispecific antibodies against highly invasive tumors with an urgent clinical need in oncology and will benefit from Debiopharm’s Multilink technology to produce an enhanced HER3-EGFR bispecific antibody-drug conjugate (ADC). This option agreement prolongs the existing partnership that was initiated in September of this year allowing Debiopharm to further develop HER2/HER3 targeting antibodies.

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"At Debiopharm, we are actively scouting for opportunities to apply our proprietary linker technology, Multilink, in a way that complements the licensed antibodies. MultilinkTM has been engineered to produce ADC with high drug to antibody ratio and excellent stability in circulation, to avoid premature drug release, and to increase treatment specificity and effectiveness," commented Frederic Levy, Chief Scientific Officer of Debiopharm.

Over the past five years, ADCs have gained enormous momentum and become standard-of-care for the treatment of many cancers. The success of this therapeutic class is mainly linked to the possibility of chemically conjugating cytotoxic payloads onto antibodies, thereby combining the targeted specificity of antibodies with the lethality of cytotoxic payloads while minimizing damage to healthy tissue.

"We are thrilled to enhance our partnership with Debiopharm. This collaboration enables us to merge our innovative expertise in bispecific antibodies with Debiopharm’s cutting-edge Multilink technology. Together, we’re paving new paths to address highly aggressive cancers with critical clinical needs. It’s a significant step in our quest to deliver more effective, targeted therapies to patients," commented Laureano Simón, CEO of SunRock Biopharma.

About Multilink

Multilink is a new cleavable linker platform suited for multidrug attachment and compatible with any conjugation technology to produce ADCs with high DAR (drug-to-antibody ratio). This unique and innovative technology allows the loading of multiple payloads on an antibody for an enhanced therapeutic effect. This highly efficient and well-tolerated linker platform is available for use by other specialty biotech or pharmaceutical companies to generate proprietary, clinical-stage ADCs.

On January 8, 2023 EVQLV and Libera Bio reported a collaboration agreement to jointly develop and deliver new antibodies to high-value intracellular cancer targets (Press release, Libera Bio, JAN 8, 2023, View Source [SID1234626615]).

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Multiple pathways inside tumor cells, such as the MAPK pathway or the "hedgehog pathway," may create the conditions for tumors to develop, grow and evade the immune system. Disrupting the signals in these pathways in one or multiple points may slow down the growth of the tumors and inhibit their proliferation. Small molecules have been successfully developed to this goal, but they may present a significant level of toxicity and a lack of specificity. Engineering antibodies to force them inside tumor cells has also been attempted but is a complex process, wrought with failure.

Libera Bio’s Multifunctional Polymeric Nanocapsules (MPN Technology) offer an elegant way to deliver antibodies inside tumor cells. The relevant antibodies are encapsulated in nanocapsules made of natural polymers of approx. 1/10,000th of a millimeter in diameter. The nanocapsules protect antibodies or other biologics from degradation. Actively or passively targeted, the MPNs deliver these biologics to intracellular targets. A second active ingredient may be co-encapsulated in the MPN and delivered simultaneously to the cytosol.

Whole antibodies, close to their natural form, can be delivered in this manner. EVQLV has developed a proprietary, AI-based system to optimize the design of such antibodies. EVQLV will computationally generate and rapidly screen a large set of diverse antibody candidates against a prioritized list of intracellular targets.

EVQLV and Libera Bio will jointly develop novel antibodies and their MPN delivery, with the goal of offering them to larger pharma companies to conduct late-stage development and commercialization.

"Combining computational antibody design with Libera’s novel intracellular delivery technology allows us to push beyond the current limitations of antibodies, opening an array of innovations for patients." said Andrew Satz, Co-founder and CEO of EVQLV. "We are thrilled to work alongside the expert team at Libera Bio and continue our mission of accelerating the speed that healing reaches those in need."

"There are many intracellular targets that have been elusive so far to conventional treatments and that specifically designed antibodies may address efficiently. We are delighted to work with EVQLV that brings strong molecular biology background and state-of-the-art technology to design such novel antibodies. We are looking forward to creating new options for cancer patients with unmet needs", added Olivier Jarry, Co-Founder and CEO of Libera Bio.

On January 8, 2023 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported its new clinical data from the Phase 1b/2 trial of Nana-val in patients with EBV+ R/M NPC and other EBV+ solid tumors and outlined its key 2023 clinical objectives (Press release, Viracta Therapeutics, JAN 8, 2023, View Source [SID1234626117]).

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"We begin 2023 with important new data from our advanced EBV-positive solid tumor trial. A partial response at this point in the dose escalation phase is highly encouraging, particularly given the safety data to-date and the lack of dose-limiting toxicities in the first three dose levels. We are now enrolling patients into the trial’s fourth dose level, with a further update expected after the completion of the dose escalation portion of the study," said Mark Rothera, President and Chief Executive Officer of Viracta. "Combined with our Phase 1b/2 results in lymphoma, these early data in recurrent or metastatic nasopharyngeal carcinoma support our ambition to develop Nana-val as a tumor-agnostic therapy for EBV-associated cancers, particularly in indications of high unmet medical need. Seeing our first clinical response outside of lymphoma gives us confidence as we work toward our 2023 objectives in solid tumors, which include establishing a recommended Phase 2 dose and exploring Nana-val in additional EBV-positive solid tumor indications. We believe our team, clinical strategy and strong balance sheet leave us well positioned to advance Nana-val’s development through multiple milestones in both the lymphoma and solid tumor settings in 2023 and beyond."

New Phase 1b data on Nana-val in patients with EBV+ R/M NPC

One PR and one disease progression were reported in evaluable patients in the third dose level
Preliminary safety data from the first three dose levels was previously presented at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) in December 2022, showing Nana-val was well-tolerated with no dose limiting toxicities
Enrollment in the fourth dose level is ongoing
Key 2023 Clinical Objectives

Nana-val in patients with EBV+ R/R lymphoma

Pivotal NAVAL-1 study open for enrollment at more than 60 sites globally; the study footprint is expected to expand further in 2023
Anticipate providing an update on NAVAL-1’s first lymphoma subtype that may advance from Stage 1 to Stage 2 in the first half of 2023
Expect to provide additional updates from other lymphoma subtype(s) throughout 2023
Nana-val in patients with advanced EBV+ solid tumors

Anticipate completion of the Phase 1b dose escalation portion of the trial and selection of the recommended Phase 2 dose (RP2D) in 2023
Anticipate initiating the Phase 2 randomized expansion portion of the trial, designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with EBV+ R/M NPC, in the second half of 2023
Anticipate initiating the exploratory Phase 1b cohort designed to evaluate Nana-val at the RP2D in other EBV+ solid tumors in the second half of 2023

Cash Position and Anticipated Runway

Viracta strengthened its balance sheet by exercising its option to draw the $20 million tranche from its non-dilutive $50 million credit facility with Silicon Valley Bank (SVB) and Oxford Finance LLC (Oxford). Viracta intends to use this additional capital to support Nana-val’s development in EBV+ R/M NPC and to explore its potential in other advanced EBV+ solid tumor indications. As a result, Viracta ended 2022 with over $90 million in cash, cash equivalents, and investments, and has an anticipated cash runway into late 2024.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

On January 8, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported preliminary financial and operational highlights for the fourth quarter and fiscal year ended December 31, 2022 (Press release, NanoString Technologies, JAN 9, 2023, View Source [SID1234626086]).

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"NanoString continued to build on our strong spatial biology franchise in 2022, capturing a record 105+ new system orders in the fourth quarter, bringing growth in spatial biology system orders to 50% for the full year," said Brad Gray, President and CEO of NanoString. "We shipped our first CosMx systems to customers in December, and our CosMx order backlog of approximately $40 million at year end provides the foundation for revenue growth in 2023."
Q4 and 2022 Highlights

Spatial Biology

•Secured customer orders for more than 105 spatial biology systems in Q4, including approximately 80 for CosMx Spatial Molecular Imagers (SMI) and over 25 for GeoMx Digital Spatial Profilers (DSP), an increase of 50% as compared to 2021 for both the fourth quarter and full year 2022
•CosMx SMI highlighted on the cover of the December 2022 issue of Nature Biotechnology, demonstrating high-resolution, single cell imaging of RNA and protein
•CosMx SMI featured in the January 2023 issue of National Geographic. Researchers at Wake Forest used CosMx to perform high-resolution imaging of brain tissue in their ongoing Alzheimer’s research. They were able to discover rare senescence cells that contribute to neurodegeneration
•Total peer-reviewed publications featuring our spatial biology platforms were approximately 195 as of December 2022, representing an increase of approximately 105 publications in the last 12 months
•NanoString was named the Gold Sponsor for 2023 Advances in Genome Biology and Technology (AGBT) meeting, where we will host a workshop on February 7, 2023 highlighting advances in our spatial biology platforms and showcasing research conducted by our collaborators and customers
nCounter
•Concluded 2022 with an nCounter installed base of approximately 1,120 systems, an increase of approximately 7% as compared to 2021
•Total peer-reviewed publications featuring nCounter were approximately 6,520 as of December 2022, representing an increase of approximately 1,320 publications in the last 12 months
Preliminary Financial Results
•For the fourth quarter of 2022, product and service revenue is expected to be over $34 million, within our guidance range of $33 to $35 million
•For the full year 2022, product and service revenue is expected to be approximately $127 million, within our guidance range of $125 to $127 million
•As of December 31, 2022, cash, cash equivalents and short-term investments is expected to total more than $195 million

These preliminary results are based on management’s initial analysis of operations for the quarter and year ended December 31, 2022 and are subject to further internal review and audit by the company’s external auditors.