On December 2, 2021 Novartis reported that holds an investor event to provide a comprehensive overview of the company’s progress in advancing its industry-leading R&D engine (Press release, Novartis, DEC 2, 2021, View Source [SID1234596404]).

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Vas Narasimhan, CEO of Novartis, said "Novartis has transformed to become a focused medicines company, building depth in our core therapeutic areas and strength across key technology platforms. We expect to continue delivering strong operational performance, with 4%+ CAGR through to 2026*, driven by the momentum of our multi-billion dollar in-market growth drivers. Up to 20 new assets with significant sales potential could be approved by 2026, which will fuel the next phase of growth and address major unmet needs. We are building the foundation for long-term differential growth by investing in advanced technology platforms and data science. Novartis remains disciplined and shareholder focused in its capital allocation priorities, as we continue to deliver on our strategy".

New announcements at R&D Day 2021:

Cosentyx, our largest medicine by sales, showed topline results in moderate to severe hidradenitis suppurativa (HS), a potential new indication. Two Phase 3 studies (SUNRISE and SUNSHINE) met their primary endpoint, with more patients treated with Cosentyx achieving a HS Clinical Response (HiSCR), compared with placebo, at week 16. The safety of Cosentyx in HS was consistent with the therapy’s known safety profile. The trials are ongoing to 52 weeks and are expected to complete in H2 2022. Regulatory filings are planned for 2022.

Novartis presents T-Charge, a next generation CAR-T cell therapy platform, expected to increase CAR-T potency and have important process efficiencies to reduce turnaround time. In first-in-human trials to be presented at ASH (Free ASH Whitepaper) 2021, lead candidates YTB323 and PHE885 showed 75% Complete Response in Diffuse Large B-Cell Lymphoma (DLBCL) at three months and 100% Best Overall Response (BOR) in multiple myeloma, respectively. Novartis is developing T-Charge as the foundational platform for a wave of potentially transformative CAR-T cell therapies.2,3

Phase 3 study starts planned or ongoing across 5 core therapeutic areas include:

Cardio-Renal: Leqvio (CVRR-LDL-C), pelacarsen (CVRR-Lp(a)), iptacopan (C3G; IgAN)
IHD: Cosentyx (HS; GCA; lupus nephritis), ligelizumab (CSU; food allergy; CINDU), ianalumab (Sjögren’s syndrome), remibrutinib (CSU)
Neuroscience: Zolgensma (SMA IT), remibrutinib (MS)
Oncology: Kisqali (HR+/HER2- BC adjuvant), 177Lu-PSMA-617 (mCRPC, pretaxane; mHSPC), canakinumab (adjuvant NSCLC), NIS793 (PDAC), JDQ443 (NSCLC, 2/3L)
Hematology: Iptacopan (aHUS; PNH), Scemblix (CML 1L), sabatolimab (HR-MDS), and YTB323 (2L DLBCL)
(for abbreviations, see below)

Novartis announces a global co-development and co-commercialization agreement with UCB to bring disease-modifying therapies to people living with Parkinson’s Disease. The agreement covers UCB0599, a potential first-in-class, small molecule, alpha-synuclein misfolding inhibitor currently in Phase 2 clinical development. In addition, upon completion of the ongoing Phase 1 program, there is an opt-in to co-develop UCB7853, an anti-alpha-synuclein antibody. Both assets could transform care for 10 million people living with Parkinson’s Disease worldwide given the lack of disease-modifying therapies.4,5

Novartis also provides a comprehensive overview of its mid- and late-stage pipeline assets in five core therapeutic areas, highlighting: Leqvio, pelacarsen, iptacopan, Cosentyx, ligelizumab, remibrutinib, ianalumab, LNA043, branaplam, Zolgensma, Kisqali, 177Lu-PSMA-617, sabatolimab, JDQ443, TNO155, Scemblix and NIS793.

Additionally, Novartis highlights the continued expansion of its pipeline and capabilities in advanced technology platforms that are expected to drive multiple waves of biopharmaceutical innovation. These include: T-Charge, Targeted Protein Degradation, Cell Therapy, Gene Therapy, Radioligand Therapy and xRNA.

On December 2, 2021 Leucid Bio ("Leucid" or the "Company"), a biotech company pioneering next-generation cell therapies for hard-to-treat cancers, reported that it has entered a strategic collaboration with Lonza to utilize Lonza’s Cocoon Platform for the Company’s forthcoming Phase I clinical trial, through to commercial manufacturing (Press release, Lonza, DEC 2, 2021, View Source [SID1234596422]).

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Under the terms of the collaboration, Leucid will utilise Lonza as its preferred manufacturer, aiming to deliver high quality cell therapies quickly and cost-effectively to patients in a decentralized manufacturing model. Leucid is, in turn, one of Lonza’s preferred collaborators on the Cocoon Platform, and both companies will work together to optimise and streamline the manufacturing process for Leucid’s CAR-T therapies. As a preferred collaborator, Leucid will have early access to new Cocoon Platform technologies.

Founded to translate 20 years of pioneering CAR-T research led by Dr John Maher at King’s College London, Leucid has developed a proprietary engine that builds upon Dr Maher’s novel parallel CAR-T model which positions these molecules in a more natural biological configuration. The Company’s technology confers properties on the CART-cells that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies. As a result, this leads to enhanced T-cell potency and persistent long-term response with reduced toxicity.

Artin Moussavi, Chief Executive Officer of Leucid Bio, said: "Following on from our successful Series A financing, we are delighted to be working with Lonza and its Cocoon Platform. This agreement will allow us to accelerate our path to the clinic, treating more patients sooner, potentially at point-of-care, and help to solve the key issues facing CAR-T therapeutics."

John Maher, Chief Scientific Officer of Leucid Bio, added: "This is a fantastic opportunity to collaborate with Lonza, enabling us to develop a state-of-the-art scalable manufacturing process. This will significantly help Leucid to efficiently transition our CAR-T pipeline for maximum patient benefit."

Nicholas Ostrout, Head of Commercial Development within Personalized Medicine at Lonza, commented: "We look forward to working with Leucid to bring its revolutionary, novel cancer immunotherapies to the clinic and patients. Use of the Cocoon Platform, coupled with the array of process development, manufacturing expertise and tools that Lonza brings, will provide a smooth route to commercial approval. By leveraging the Cocoon Platform’s unique capabilities, this collaboration aims to illustrate the promise and feasibility of manufacturing autologous immunotherapies in a decentralized model, into approved routine use."

CAR T-cell therapy is a revolutionary technology in which the patient’s own immune cells are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers, but has not yet been very effective for the treatment of solid tumours.

Leucid’s LEU-011 programme is a NKG2D-targeted CAR T-cell therapy in pre-clinical development for the treatment of solid tumours and haematological malignancies. The NKG2D receptor is an activating immune receptor that triggers cell death upon recognition of human NKG2D ligands expressed on transformed, infected or damaged cells. LEU-011 has potential for the treatment of multiple cancer types as NKG2D ligands are expressed on more than 80% of human tumour cells.

On December 2, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and blood cancers, reported new translational data implicating B cells in the clinical benefit induced by MVP-S treatment in ovarian cancer patients (Press release, IMV, DEC 2, 2021, View Source [SID1234596405]). These data will be showcased at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress, December 8-10, 2021.

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"These data further extend our understanding of MVP-S therapeutic mechanism of action and strongly implicate B cells in the clinical benefit from MVP-S based therapy," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc.

Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA, commented: "Immunotherapies that provoke both a T and B cell response have the potential to provide patients with a new first line therapy for hard-to-treat cancers such as advanced, recurrent ovarian cancer. We are encouraged by the B cell infiltration demonstrated using MVP-S supporting its ability to create a strong immune response in patients who have failed on prior lines of treatment."

Twenty-two women with advanced, recurrent ovarian cancer were enrolled in the DeCidE1 study. In August of this year, IMV announced the completion of the study and shared final top results: Objective Response rates (ORR) of 26.3%, Median Overall Survival of 19.9 months, and a 45% overall survival rate at nearly 2 years. The abstract released today by the ESMO (Free ESMO Whitepaper)-IO congress highlights that:

Enriched B cell infiltration was detected in on-treatment tumor samples, especially in patients who showed tumor reduction; the strongest increase was observed within memory B cells,
The frequency of systemic plasmablasts increased on-study in most of assessed patients and was more pronounced in patients with tumor shrinkage,
Antibodies to all 5 survivin peptides were detected in plasma samples and were more prominent in patients with tumor shrinkage.
These translational data provide new insights into the therapeutic mechanism of action of MVP-S, indicating an important role for B cells in mediating MVP-S induced anti-cancer immunity. The next IMV-sponsored clinical trial in patients with advanced, recurrent ovarian cancer is expected to be initiated in 2022.

The poster will be presented by Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA.

PosterTitle: Translational analyses of the DeCidE phase 2 clinical study in advanced ovarian cancer patients reveal a substantial role for B cells in the clinical benefit derived from maveropepimut-S (MVP-S) treatment
Poster Number: 51P
An e-poster presentation will be available on December 9, 2021, under the Scientific Publications & Posters section on IMV’s website

On December 2, 2021 EOM Pharmaceuticals, Inc. ("EOM"), a privately held, clinical-stage pharmaceutical company, and ImmunoCellular Therapeutics, Ltd. (OTC: IMUC) ("ImmunoCellular") reported that the companies have entered into and closed on a merger agreement pursuant to which the shareholders of EOM are now the majority shareholders of the combined company (Press release, EOM Pharmaceuticals, DEC 2, 2021, View Source [SID1234618848]). The merger will create a public company that will continue EOM’s focus on advancing novel immunomodulatory and retinal disease drug agents to address a range of inflammatory, viral, retinal, and other diseases. ImmunoCellular will be renamed EOM Pharmaceuticals Holdings, Inc. Pending the assignment of a new ticker symbol, EOM Pharmaceuticals’ Common Stock will continue to be quoted on the OTC Markets under the ticker symbol "IMUC." EOM may consider in the future changing the principal listing of the Company Common Stock to a national exchange, assuming it will then meet the relevant listing requirements.

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The combined company’s two pipeline assets are EOM613 and EOM147.

• EOM613 is an investigational peptide-nucleic acid solution believed to have both antiinflammatory and pro-inflammatory broad-spectrum cytokine effects. Patients are currently enrolled in R 1 : RESCUE, a Phase 1/2a open-label clinical study in Brazil evaluating EOM613 treatment in severe hospitalized COVID-19 patients with "cytokine storm" immune responses. EOM expects to announce data from this trial in first quarter 2022. Further clinical development of EOM613 includes planning a Phase 2a multi-center trial for cancer cachexia in the U.S. and initiating exploratory trials for rheumatoid arthritis.

• EOM147 is an investigational, reformulated broad-spectrum aminosterol with a unique intracellular mechanism for the treatment of retinal diseases. EOM147 affects multiple angiogenic growth factors such as VEGF, PdGF, and bFGF. This mechanism of action is uniquely differentiated from other retinal therapies that are only anti-VEGF and administered as an intraocular injection. The novel formulation, administered as an eye drop, represents a potential breakthrough that does not require intraocular injection. Planning is underway for Phase 2 ophthalmic trials for macular edema in patients with diabetic retinopathy and wet age-related macular degeneration (wet-AMD).

EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger said, "EOM’s merger with ImmunoCellular provides the resources necessary to advance our lead program, EOM613, as a potential treatment for COVID-19, as well as support the development of both EOM613 and EOM147. We look 2 forward to advancing our pipeline assets and delivering value to all our stakeholders, including patients, the scientific and medical community, and our stockholders."

"COVID-19 continues to pose a grave threat to millions of people worldwide and to challenge the medical and scientific community as it seeks to understand and treat the underlying causes and symptoms of this devastating disease," said EOM Chief Executive Officer and Director Irach Taraporewala, Ph.D. "We are grateful to the investigators and patients in Brazil who are currently participating in our EOM613 clinical trial and look forward to reporting initial results in early 2022."

"After an extensive review of strategic options for ImmunoCellular, we are pleased to announce the merger with EOM," said Gary S. Titus, ImmunoCellular’s Chairman of the Board. "We believe EOM’s focus on advancing novel immunomodulatory and retinal disease agents addressing unmet medical needs, as well as its experienced management team and board of directors, represent a potentially meaningful opportunity for stockholders in the newly combined company to realize long-term value."

About the Merger Pursuant to the merger agreement, EOM shareholders have exchanged all of their EOM common stock for newly issued shares of ImmunoCellular common and Series C convertible preferred stock. Postmerger, ImmunoCellular’s then-current equity holders will own approximately 3.5% and the former EOM equity holders will own approximately 96.5% percent of ImmunoCellular’s common stock, calculated on a fully diluted basis. Effective with the merger, all existing officers and directors of EOM have assumed their same positions in the new company and all existing officers and directors of ImmunoCellular have resigned. The transaction has been unanimously approved by the board of directors of both companies. EOM Pharmaceuticals Holdings, Inc. will be headquartered in Montvale, NJ. Bridgeway Capital Partners and its affiliates served as exclusive financial advisor to EOM on the transaction.

Management and Organization

The new senior leadership team at EOM Pharmaceuticals Holdings, Inc. includes Chief Executive Officer Irach Taraporewala, Ph.D.; EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger; EOM Co-founder, Chief Scientific Officer and Medical Director Shalom Z. Hirschman, M.D; Wayne I. Danson, Chief Financial Officer and Treasurer; and Scientific Advisor and Chair of the Scientific Advisory Board, Frank L. Douglas, Ph.D., M.D.

On December 2, 2021 GlaxoSmithKline plc and the University of Oxford reported a major five-year collaboration to establish the Oxford-GSK Institute of Molecular and Computational Medicine (Press release, GlaxoSmithKline, DEC 2, 2021, View Source [SID1234596388]). The new Institute, which will be based at the University of Oxford, aims to improve the success and speed of research and development of new medicines, building on insights from human genetics and using advanced technologies such as functional genomics and machine learning.

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Genetic evidence has already been shown to double success rates in clinical studies of new treatments, and the digitisation of human biology has the potential to improve drug discovery by more closely linking genes to patients. The new Institute aims to build on this scientific progress and improve how diseases are understood by drawing on recent advances in pathology, including how to measure changes on a cellular, protein, or tissue level.

Backed by £30 million from GSK, the Institute is intended to pioneer further improvements in how new medicines are discovered and developed. For example, scientists from GSK and Oxford will help prioritise those early R&D programmes most likely to succeed and match them to patients most likely to respond.

The Institute will evaluate and integrate new approaches in genetics, proteomics and digital pathology to understand detailed patterns of disease which vary amongst individuals. The initial focus of research will be on neurological diseases, such as Alzheimer’s and Parkinson’s Disease.

Prime Minister Boris Johnson said: "We saw first-hand during the pandemic how the ingenuity and pioneering spirit of UK scientists and the R&D sector saved thousands of lives, with the rapid development and delivery of medicines and vaccines around the world.

"I am delighted to see that GSK and the University of Oxford are today taking further steps to deepen our understanding of some of the most complex diseases, such as Parkinson’s. Together they will harness the power of scientific collaboration to progress cutting-edge technologies and accelerate drug discovery – helping to cement the UK’s role as a life sciences superpower."

Emma Walmsley, Chief Executive Officer, GSK said: "We are delighted to be joining with the University of Oxford in this new collaboration. By combining the strengths of our two scientific organisations and harnessing advanced technologies, the Oxford-GSK Institute exemplifies the UK’s track-record and continued ambition in life sciences. Together, our aim is to improve drug discovery and development to help bring new and better medicines for patients."

Professor Louise Richardson, Vice-Chancellor of the University of Oxford, said: "On behalf of colleagues across Oxford I would like to say how delighted we are by this new initiative with GSK. The Institute will create a unique partnership with staff from the university’s medical school and GSK working side-by-side to research and develop treatments for some of the most difficult to treat diseases. In addition, the Institute, in keeping with our educational mission, will provide training and build capacity in Britain’s academic and bioscience sectors."

The genetic and genomic revolution of the past decade has amassed vast datasets of promising targets for medicine discovery. These datasets can be combined with functional genomics to provide deep understanding of disease at a molecular level.

By harnessing this understanding, as well as the power of machine learning, the Institute will uncover new indicators and predictors of disease and use them to accelerate the most promising areas for drug discovery. This is particularly important for GSK as it prioritises the large number of genetically informed drug targets generated from its collaborations with organisations, such as 23andMe and UK Biobank. The Institute will also aim to provide new measurements to establish proof of concept for potential medicines earlier in the R&D process, by better identifying the most appropriate patients to enrol in clinical trials, thus accelerating drug development timelines.

GSK and Oxford bring complementary capabilities and expertise into the Institute. GSK has leading capabilities in human genetics and functional genomics, and an in-house artificial intelligence and machine learning function, including its AI hub in central London. The University of Oxford has similar expertise but together they will be using patient, molecular information and state-of-the-art platforms to pinpoint the GSK targets that are most likely to succeed and be developed into safe, effective, disease mechanism-based medicines.

Diseases driven by neuro-immunological mechanisms including Alzheimer’s, Parkinson’s, Multiple Sclerosis (MS), Frontal Temporal Dementia, Amyotrophic Lateral Sclerosis (ALS) and Pain will be within the initial scope of the Institute. GSK has a rich pipeline of genetically informed targets and clinical projects in these areas.

The Institute will recruit a number of new research groups, in addition to drawing upon existing expertise from both GSK and Oxford. Five GSK/Oxford fellowships will be provided for early to mid-career researchers to establish themselves as Principal Investigators researching areas aligned with the Institute’s aims and objectives.

The Institute will have its base in the Nuffield Department of Medicine, and be closely associated with colleagues from across departments, including the University’s Wellcome Centre for Human Genetics and Big Data Institute. GSK and Oxford are in active discussions regarding the nature of the first projects which are anticipated to start in the second half of 2022 and will use the latest laboratory and data science platforms and approaches. A completely new way of collaborating will be established where research teams will have both GSK and University members, including secondments between both institutions.

The Directors of the Institute will be Professor John Todd, Director of the Wellcome Centre for Human Genetics and Dr Tony Wood, SVP, Medicinal Science and Technology at GSK.