On October 20, 2022 AbbVie (NYSE: ABBV) reported the acquisition of DJS Antibodies Ltd ("DJS"), a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs) (Press release, AbbVie, OCT 20, 2022, View Source [SID1234622216]). DJS’s lead program is DJS-002, a potential first-in-class lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently in investigational preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases. IPF is an aggressive, high mortality disease caused by fibrotic scarring in the lungs and remains an area of high unmet medical need.

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"We are excited to bring the innovative science behind DJS-002 and the talented team at DJS to AbbVie," said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. "This acquisition will deliver new capabilities to enhance our current antibody research activities, an opportunity to strengthen our immunology portfolio, and provide a strong foothold for expanded research efforts in the dynamic bioscience hub in Oxford, UK."

DJS’s proprietary HEPTAD platform is a novel approach to antibody discovery with specific capabilities targeting transmembrane protein targets. A key benefit of this acquisition is for AbbVie, through DJS, to access the HEPTAD platform as a complement to its current robust capabilities in biotherapeutics research. DJS will leverage AbbVie’s extensive drug discovery expertise to continue generating antibody therapeutics and novel biology insights against targets like GPCRs, which have previously been intractable to biologics approaches.

"DJS was built on the principles of scientific curiosity and an aspiration to discover clinically meaningful innovative medicines. We’ve been privileged to grow the company within the world-class scientific and entrepreneurial community of Oxford, from an initial concept through to a successful biotech comprising an extremely talented team," said David Llewellyn and Joe Illingworth, co-founders of DJS. "The whole team is incredibly excited to take the next step in this journey with AbbVie as we work together to accelerate the translation of our lead program into the clinic and develop an exciting research center here in the UK."

Under the terms of the agreement, AbbVie will pay DJS shareholders approximately $255 million in cash at closing for the acquisition of DJS. DJS shareholders remain eligible for potential additional payments upon the achievement of certain development milestones related to the success of the DJS-002 program. AbbVie anticipates retaining all current DJS employees and its facility in Oxford.

DJS is backed by founding investors Oxford Science Enterprises and Johnson & Johnson Innovation Ltd., along with LifeArc, Sedgwick Yard and Amgen Ventures.

DJS and its shareholders were advised by Centerview (Financial Advisor). Goodwin Procter LLP (Legal) advised DJS and its shareholders on the transaction, and Cooley LLP (Legal) advised DJS on other corporate matters including providing additional support on the transaction.

On October 20, 2022 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported the United States Patent and Trademark Office has issued a patent covering therapeutic applications of its lead compound, PT-112, as an immuno-modulatory agent, both as a monotherapy and in combination with other immunotherapy approaches (Press release, Promontory Therapeutics, OCT 20, 2022, View Source [SID1234622215]).

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PT-112 has been validated as a highly potent immunogenic cell death (ICD) inducer in peer-reviewed publications in the journals OncoImmunology and Cancers, and in presentations at major research forums including the AACR (Free AACR Whitepaper) and ENA annual conferences. PT-112’s ICD property involves the release of so-called damage associated molecular patterns (DAMPs) that bind with and activate dendritic cells, leading to trafficking of activated T cells to the tumor microenvironment. PT-112 is currently in three Phase 2 clinical trials: for metastatic castration-resistant prostate cancer; thymic epithelial tumors; and in combination with PD-L1 checkpoint inhibition for non-small cell lung cancer.

"As an immunogenic small molecule, PT-112 has the potential to play an important role in overcoming areas of immunotherapy drug resistance, which continues to limit effective treatment options for patients," said Promontory President and Chief Executive Officer Robert Fallon. "This U.S. patent issuance underscores our approach to oncologic small molecule immunotherapies along with our robust clinical pipeline assessing PT-112 alone and in immunotherapy combination."

The patent, titled "Phosphaplatin Compounds as Immuno-Modulatory Agents and Therapeutic Uses Thereof," was issued on Sept. 13, 2022 as U.S. Patent No. 11,439,619 B2.

For more information about Promontory Therapeutics’ clinical pipeline visit www.PromontoryTx.com.

About PT-112

PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and now includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal collaboration with the NCI. The PD-L1 combination Phase 2a study in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients will be presented at the 2022 ESMO (Free ESMO Whitepaper) Immuno-Oncology conference.

On October 20, 2022 Amgen (NASDAQ: AMGN) reported that it has successfully completed its previously announced acquisition of ChemoCentryx, Inc. (NASDAQ: CCXI), a biopharmaceutical company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, for $52 per share in cash, representing aggregate merger consideration of approximately $3.7 billion (Press release, Amgen, OCT 20, 2022, View Source [SID1234622214]).

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"ChemoCentryx enhances Amgen’s leading inflammation and nephrology portfolio and includes TAVNEOS (avacopan), a first-in-class treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), an autoimmune disease for which there remains significant unmet medical need," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We look forward to welcoming the dedicated professionals from ChemoCentryx who share our passion for advancing innovation that makes a difference for patients. Together, we aim to serve more patients affected by serious diseases."

The acquisition includes TAVNEOS, an orally administered selective complement 5a receptor inhibitor that was approved by the U.S. Food and Drug Administration (FDA) in October 2021 as an adjunctive therapy for adults with severe active ANCA-associated vasculitis in addition to standard of care, which generally consists of glucocorticoids and either rituximab or cyclophosphamide immunosuppressant therapy. Beyond its approved ANCA-associated vasculitis indication, TAVNEOS is also being studied in additional inflammatory diseases, including hidradenitis suppurativa (HS), a severe and deforming chronic dermatological condition, and complement 3 glomerulopathy (C3G), a rare genetic kidney disease.

In addition to TAVNEOS, the acquisition adds three early-stage drug candidates that target chemoattractant receptors and other inflammatory diseases and an oral checkpoint for cancer.

On October 20, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, reported that the completed ONCOS-102 phase 1b study in PD-1 CPI resistant advanced melanoma has been published in the prestigious oncology journal Clinical Cancer Research, published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Targovax, OCT 20, 2022, View Source [SID1234622212]).

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PD-1 CPI resistant advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year in the major markets. The diagnosis is associated with a poor prognosis and there are currently no approved treatment options available.

In this phase 1b trial, ONCOS-102 was given intra-tumorally to 21 PD-1 CPI resistant melanoma patients, followed by re-treatment with the PD-1 CPI Keytruda. It is anticipated that local injection of ONCOS-102 will induce an inflammatory immune response in the tumor microenvironment and drive systemic T-cell activation, which in turn can re-sensitize the patient to PD-1 CPI therapy.

As expected, ONCOS-102 generated strong and durable immune activation in the treated patients, which translated into a promising objective response rate (ORR) of 35%. Importantly, the clinical efficacy was associated with continuous replication of ONCOS-102 within the tumor, statistically significant increase in T-cell infiltration, and broad and persistent upregulation of immunological pathways in responding patients.

Dr. Alexander Shoushtari, Memorial Sloan Kettering Cancer Center, New York said: "Checkpoint inhibitors have had a significant impact on the way we treat melanoma; however, a subset of patients still does not respond or become resistant to treatment. Therefore, there is a high medical need for immune activating agents to overcome resistance to checkpoint blockade. Although this was a small study, the 35% ORR and substantial activity in non-injected lesions is promising, particularly as there is a clear correlation with immunological biomarker data. We look forward to continuing to work with Targovax in the upcoming phase 2 trial, which will allow us to validate these findings in a larger patient cohort as well as to test ONCOS-102 in interesting new combinations."

Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, said: "We are very happy that our strong ONCOS-102 results in melanoma have been acknowledged by publication in a high-impact scientific journal. For Targovax, this data set provides an important clinical proof-of-concept and the translational analyses have validated and deepened our understanding of the ONCOS-102 mechanism of action. These findings have allowed us to design a robust phase 2 trial, which will include combination with the second-generation Fc-enhanced CTLA-4 CPI botensilimab. CTLA-4 was strongly up-regulated in response to ONCOS-102 treatment in the phase 1b study, and we believe this combination has the potential to boost response rates up and above 35%, and thereby establish ONCOS-102 as a leading product candidate in PD-1 resistant melanoma."

On October 20, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported a strategic collaboration and license agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second undisclosed novel arenaviral immunotherapy (Press release, Hookipa Pharma, OCT 20, 2022, View Source [SID1234622211]). This represents HOOKIPA’s first oncology licensing collaboration.

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Through the collaboration, HOOKIPA will conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers. Upon the completion of the Phase 1b trial, Roche has the right to assume development responsibility and to commercialize licensed products across multiple indications upon approval. The agreement also includes an option for Roche to license a second arenaviral cancer immunotherapy.

"Roche is an ideal partner, both in terms of development and reaching patients with novel cancer therapeutics. We look forward to working with them to benefit people with KRAS-mutated cancers," said Joern Aldag, Chief Executive Officer at HOOKIPA. "This collaboration validates the potential of our arenavirus platform and accelerates the development pathway to bring new treatments to people with cancer."

"We are excited to collaborate with HOOKIPA in leveraging their arenaviral technology, which has clinically demonstrated the ability to induce potent antigen specific CD8+ T cell responses and represents a promising approach for new cancer immunotherapies," said James Sabry, Global Head of Pharma Partnering at Roche. "This collaboration further strengthens our leadership in oncology, and we are optimistic about advancing this innovative platform to potentially provide more options for people with KRAS-mutated cancers, as well as other potential cancer types."

Under the terms of the agreement, HOOKIPA will receive an upfront payment of $25 million. Roche will have the option to expand the initial collaboration by adding an additional product candidate, whereafter HOOKIPA will receive an additional $15 million payment at option exercise. Including this option payment, HOOKIPA is eligible for research, development and commercialization milestone-based payments for HB-700 and the additional product candidate totaling up to approximately $930 million. Upon commercialization, HOOKIPA is eligible to receive tiered royalties of a high single-digit to mid-teens percentage on the worldwide net sales of HB-700 and the additional product candidate.

About KRAS-mutated cancers
KRAS is a gene that acts as an on/off switch for cell growth. When there is a mutation, or error, in the gene, cells can grow out of control. KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations simultaneously to potentially help more people impacted by these cancers.

About HOOKIPA’s Arenaviral Technology
HOOKIPA’s novel, replicating arenaviral technology has demonstrated the ability to induce potent antigen-specific T cell responses and promising anti-tumor activity in a Phase 1 clinical trial which treated patients with advanced Human Papillomavirus 16-positive head and neck cancers. Preclinical studies have also demonstrated the ability of arenaviral immunotherapies to break self-tolerance and induce potent T cell responses to tumor self-antigens and mutated epitopes, or target parts of a mutated, cancer-causing gene. These findings provide scientific rationale for the HB-700 program.

About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations: (G12D, G12V, G12R, G12C and G13D) and thereby benefits more patients than single mutation inhibitors.