On February 7, 2022 Biogen Inc. (Nasdaq: BIIB) and Xbrane Biopharma AB (STO: XBRANE) reported that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA (certolizumab pegol)1 (Press release, Biogen, FEB 7, 2022, View Source [SID1234607852]).

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CIMZIA’s primary indication is for rheumatoid arthritis in adults as well as axial spondylarthrosis, psoriasis and Crohn’s disease. In 2020 global sales of CIMZIA were 1.8 billion Euro2. Under the terms of the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane and will be the Marketing Authorization Holder.

"We aim to bring more biosimilars products to more patients and more geographies and we are excited to bring this additional asset to our Biosimilars pipeline," said Ian Henshaw, Head of Global Biosimilars at Biogen. "This preclinical biosimilar candidate has the potential to add another option for patients living with Rheumatoid Arthritis and other indications."

"Given their vast development and commercialization experience, we are convinced that Biogen is the best possible partner we could have for Xcimzane," said Martin Åmark, CEO of Xbrane Biopharma AB. "Today’s announcement confirms Xbrane’s ambition to become a global biosimilar developer."

Under the terms of the agreement, Biogen will make an upfront payment of $8 million to Xbrane. Should certain development and commercial milestones be achieved, Xbrane will be eligible to receive up to $80 million in potential milestone payments. Xbrane is also eligible to receive tiered royalties. Xbrane will be responsible for the completion of pre-clinical development of Xcimzane and Biogen will be responsible for all remaining development activities and costs required to achieve Marketing Authorization in all territories, including those for clinical development.

About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

On February 7, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy, reported its first Phase 1 clinical study evaluating ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV) (Press release, Immunomic Therapeutics, FEB 7, 2022, View Source [SID1234607792]). The single-center study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and will be led by Drs. Paul Nghiem, Song Park and David Koelle.

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The trial is a Phase 1, open label, First in Humans (FIH) study to evaluate the safety, tolerability and immunogenicity of 4 mg of ITI-3000 in patients with Merkel polyomavirus-positive Merkel cell carcinoma (MCC) patients who have undergone surgery. The study’s primary endpoints include Dose Limiting Toxicities (DLTs), Adverse Events/Serious Adverse Reactions, (AEs/SARs) standard clinical assessments and safety laboratory parameters.

ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform, powered by LAMP, which fuses a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV) with LAMP1. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo. The plasmid DNA vaccine will be administered utilizing PharmaJet’s well established Stratis Needle-free Injection System that precisely targets delivery to the intramuscular tissue layer.

"This therapeutic vaccine trial is the first of its kind in the world and may help address the fact that MCC recurs in 40% of cases after initial treatment, but no adjuvant therapy is approved for these patients," noted Dr. Paul Nghiem, co-lead of the clinical study, and Head of Dermatology at University of Washington.

"This Phase 1 clinical trial of ITI-3000 in MCC is an important milestone, as it expands the reach of our immuno-oncology program beyond our ongoing phase 2 study of ITI-1000 (Umitrelimorgene autodencel) in glioblastoma multiforme, to a second potential indication," stated Dr. William Hearl, Chief Executive Officer of Immunomic Therapeutics, Inc. "Based on the strength of our UNITE platform and strong pre-clinical data generated, to date, we believe ITI-3000 has the potential to address the urgent unmet medical need for therapies to treat this aggressive form of skin cancer."

The majority of MCCs are associated with MCPγV infection, making LT an attractive target for therapeutic cancer vaccines. MCPγV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their proliferation and durability. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Therefore, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPγV-LT may drive robust anti-tumor immune responses.

On February 7, 2022 Varsity Pharmaceuticals (Varsity), a biopharmaceutical company developing small molecule therapies that target treatment resistant cancers, reported that it has secured exclusive rights from Dana-Farber Cancer Institute, a world-leading cancer treatment and research institute, to develop and commercialize Novobiocin, a potential first-in-class DNA polymerase theta inhibitor for the treatment of Homologous Recombination (HR) deficient cancers (Press release, Varsity Pharmaceuticals, FEB 7, 2022, View Source [SID1234607809]).

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Homologous Recombination deficiency is where the body is unable to repair double strand breaks in DNA due to mutations in genes such as BRCA1 and BRCA2. Pol-Theta is an enzyme that can repair double strand breaks that recently emerged as a new cancer specific DNA Damage Response target that compensates for the loss of HR function in HR deficient cancers such as ovarian, breast, pancreatic and prostate cancer. Whilst PARP enzyme inhibitors have seen some success in the treatment of HR deficient cancers, PARP inhibitor drug resistance is emerging as a significant barrier to their effectiveness.

Research led by Prof. Alan D. D’Andrea and published in Nature Cancer (Zhou et al. 2021) demonstrated that Novobiocin, a drug previously used as an antibiotic, is a potent Pol-Theta enzyme inhibitor that can be used alone or in combination with PARP inhibitors to treat HR-deficient tumors, even after they have become resistant to PARP inhibitor therapy.

More than 50% of primary ovarian cancers, 25% of breast cancers, and approximately 5% of pancreatic and prostate cancers are associated with HR deficiency. If development is successful, the Pol-Theta inhibitor Novobiocin could be a new treatment option for more than a 100,000 newly diagnosed cancer patients per year in the US alone. Varsity plans to start the first in-patient clinical studies of Novobiocin in 2022.

Varsity adds Novobiocin to a pipeline of small molecule candidates under development as new therapies for treatment resistant cancers.

On February 7, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that its Chief Executive Officer Nima Farzan will provide a company overview at the 11th Annual SVB Leerink Global Healthcare Conference, being held virtually from February 14-18, 2022 (Press release, Kinnate Biopharma, FEB 7, 2022, View Source [SID1234607793]).

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Event: 11th Annual SVB Leerink Global Healthcare Conference
Location: Virtual
Date: Friday, February 18, 2022
Time: 3:40 PM ET/12:40 PM PT

Members of the Kinnate management team will also host investor meetings during the conference.

A live webcast of the SVB Leerink presentation will be available in the Investors and Media section of the Kinnate website at www.kinnate.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On February 7, 2022 Immagene, a Dutch biotech company developing transformational next-generation precision immuno-oncology treatments, and Selvita (WSE: SLV), one of the largest preclinical contract research organizations in Europe, reported their cooperation on an integrated drug discovery project (Press release, Selvita, FEB 7, 2022, View Source;utm_medium=rss&utm_campaign=immagene-and-selvita-announce-integrated-drug-discovery-cooperation [SID1234607810]).

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Immagene and Selvita have been closely cooperating over the past year on a novel integrated drug discovery project to enhance the clinical benefit of immuno-oncology therapies. In this ongoing effort, Immagene is guiding and tapping into Selvita’s extensive drug discovery capabilities. Selvita is responsible for a broad range of drug discovery activities including medicinal chemistry supported by computational chemistry, in vitro pharmacology, DMPK and recombinant protein production. Immagene and Selvita are now extending their cooperation.

Edyta Jaworska, VP Sales, Drug Discovery Europe and Asia at Selvita Group, comments:
"We are truly delighted with the extension of our close collaboration with Immagene. For Selvita’s team, it is a perfect opportunity to leverage the full scope of our integrated drug discovery capabilities. This project is exceptionally promising in terms of its therapeutic potential and unique chemistry."

Maarten Ligtenberg, PhD, Chief Executive Officer of Immagene, said:
"We are confident that our collaboration with Selvita will help us achieve our aim of generating potent first in class small-molecule immune-oncology assets. The rapid turnaround and effective communication allow for the swift development of our programs. We look forward to a longstanding, joint effort to develop innovative therapeutics."

To date, Selvita has delivered numerous promising compounds for biology and DMPK screening, and the project has entered the lead optimization phase. The ultimate aim of the cooperation is to provide Immagene with a clinical candidate for unmet immuno-oncology needs. The continued collaboration will help accelerate Immagene’s pipeline expansion efforts by leveraging Selvita’s fully integrated R&D platform and unique experience in oncology drug discovery and development.