Macrophage Pharma Appoints Dr Venkat Reddy as Chief Executive Officer

On June 1, 2021 Macrophage Pharma Limited (‘MPL’), a company focused on the discovery and early stage development of highly novel small molecule therapeutics with the potential to transform outcome in inflammation, autoimmune disease and cancer through regulation of innate immune response, reported that its Chief Scientific Officer (CSO), Dr Venkat Reddy PhD, has been appointed by the Board as Chief Executive Officer (CEO) (Press release, Macrophage Pharma, JUN 1, 2021, View Source [SID1234583301]).

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Commenting on the appointment, Dr Michael Moore, Chairman of Macrophage Pharma, said: "The Board is delighted to have promoted Venkat to CEO. Since joining the Company, Venkat’s influence in combining a strategic biology focus on targets critical for regulated cell death in immune-mediated diseases with the Company’s drug discovery platform based on proprietary Esterase Sensitive Motif (ESM) technology, has been transformative, enhancing the opportunity for commercialisation of our novel small molecule assets for a variety of protein targets and therapeutically unmet diseases."
Dr Venkat Reddy, CEO of Macrophage Pharma, commented: "I am honoured to have been appointed CEO of Macrophage Pharma. The potential of our ESM technology platform to generate novel drugs is compelling as demonstrated by its ability to impact adaptive immunity through selective modulation of myeloid derived innate immune cells. I look forward to continuing my work with Macrophage Pharma’s executive team and Board of Directors to unlock the full therapeutic and commercial potential of the technology across a spectrum of human diseases."

Venkat Reddy has a successful track record and extensive strategic and management experience from senior executive roles in both European and US biotech and pharma, including Glenmark Pharmaceuticals (SVP, Global Head of Translational Sciences), Pfizer (Senior Director, Strategic Alliances and Partnerships, Centers for Therapeutic Innovation), Sanofi (Senior Director, Head, Bio-Innovation France: Global Biotherapeutics) and Novartis (Group leader, GNF). Venkat holds a PhD from the Ludwig-Maximilians Universität München and undertook post-doctoral studies in immunology and oncology at the Scripps Research Institute. He has served Macrophage Pharma as Chief Scientific Officer since January 2020.

AMGEN AND KYOWA KIRIN TO JOINTLY DEVELOP AND COMMERCIALIZE KHK4083, A PHASE 3-READY, POTENTIAL FIRST-IN-CLASS TREATMENT FOR ATOPIC DERMATITIS

On June 1, 2021 Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) reported an agreement to jointly develop and commercialize KHK4083, which is Kyowa Kirin’s potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases. In February, Kyowa Kirin announced positive results from a Phase 2 study of KHK4083 in patients with moderate-to-severe atopic dermatitis, which affects nearly 30 million people in major global markets1.

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Under terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. Additionally, Kyowa Kirin will co-promote KHK4083 with Amgen in the U.S. and have opt-in rights to co-promote KHK4083 in certain other markets outside the U.S., including in Europe and Asia. Amgen will make a $400 million up-front payment to Kyowa Kirin and future contingent milestone payments potentially worth up to an additional $850 million, as well as significant royalty payments on future global sales. Kyowa Kirin and Amgen will share global development costs, except in Japan, and U.S. commercialization costs. Amgen will consolidate sales for KHK4083 in all markets globally, except for Japan. Amgen also will leverage unique data from its deCODE Genetics subsidiary to inform the potential use of KHK4083 in indications beyond atopic dermatitis. The closing of the transaction is conditioned on obtaining any necessary consents and approvals.

"Kyowa Kirin has a long legacy of partnering with other companies to deliver the full value of our scientific discoveries and novel medicines for patients," says Masashi Miyamoto, Ph.D., president and chief executive officer at Kyowa Kirin. "KHK4083 is an important asset in our global pipeline. We know Amgen well, and this alliance will build on the past success and trust we have, bringing additional resources and therapeutic expertise to KHK4083’s development and commercialization, to meet the needs of patients living with atopic dermatitis who seek alternative treatment options."

KHK4083 is an anti-OX40 fully human monoclonal antibody discovered by Kyowa Kirin and engineered with Kyowa Kirin’s patented POTELLIGENT defucosylation technology to enhance its antibody-dependent cellular cytotoxicity (ADCC) activity. KHK4083 has been shown to selectively deplete activated T cells that are critical in the development of atopic dermatitis. Kyowa Kirin antibodies powered by POTELLIGENT technology with ADCC activity are currently marketed in therapeutic areas including Oncology and Asthma. This potent antibody-enhancement platform is also licensed to numerous third parties throughout the biopharmaceutical industry.

"Kyowa Kirin was one of Amgen’s very first collaborators and we are delighted to be joining forces with them once again to advance this promising late-stage asset to treat atopic dermatitis," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We will take advantage of our two decades of experience in inflammatory disease, as well as our industry-leading human genetics capabilities, to help realize the full potential of KHK4083 as quickly as possible."

Amgen is a global leader in treating inflammatory diseases, with a portfolio of marketed medicines that includes Otezla, Enbrel, AMGEVITA (a biosimilar to Humira), and AVSOLA (a biosimilar to Remicade). Amgen’s pipeline of investigational therapies includes tezepelumab (filed for U.S. FDA approval in May 2021 as a potential first-in-class treatment for severe asthma), ABP 654 (a biosimilar to STELARA), and several innovative molecules in Phase 2b development for systemic lupus erythematosus and celiac disease.

"KHK4083 is another example of our world-leading expertise in antibody engineering, applied target selection and optimization. We are proud to be a science-led organization whose research capabilities continue to produce meaningful discoveries, while also taking advantage of open innovation, that offers potential for improving treatment paradigms," said Yoshifumi Torii, Ph.D., executive officer, vice president, Head of Global R&D Division at Kyowa Kirin. "Results from clinical trials for KHK4083, including Phase 2 data, show great promise and we look forward to initiating a late-stage global program with Amgen to deepen our understanding of this asset."

In 1984, Amgen and Kirin Holdings Co., Ltd (former Kirin Brewery Co., Ltd), the parent company of Kyowa Kirin, established a 50-50 joint venture to develop and commercialize EPOGEN (Japanese brand name: ESPO), which, in 1989, became the first Amgen medicine approved in the U.S., and, in 1990, became the first Kirin medicine approved in Japan. Over time, the joint venture expanded to include the development and commercialization of several other medicines, including NEUPOGEN (GRAN in Japan), Neulasta (G-Lasta in Japan), Aranesp (NESP in Japan), and Nplate (Romiplate in Japan). In 2017, the companies announced that the joint venture would become a wholly owned subsidiary of Amgen, with Kyowa Kirin in-licensing certain Amgen medicines in the Asia-Pacific region.

Amgen Webcast Investor Call

Amgen will host a webcast call for the investment community on June 1, 2021, at 8:00 a.m. EST. Peter H. Griffith, executive vice president and chief financial officer, David M. Reese, M.D., executive vice president of Research and Development, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will participate.

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

About the KHK4083 Phase 2 Study

In February 2021, Kyowa Kirin reported that KHK4083 met the primary endpoint in a Phase 2 randomized, double-blind and placebo-controlled clinical study conducted in the U.S., Japan, Canada, and Germany. The study included 274 patients with moderate-to-severe atopic dermatitis, who were not adequately controlled with topical agents. All KHK4083 cohorts achieved superiority to the placebo cohort for the primary endpoint of percent change from baseline in Eczema Area and Severity Index (EASI) at 16 weeks with statistical significance. In addition, there was significant difference in the percentage of patients achieving an EASI-75 (EASI score of 75% or greater improvement from baseline) at 16 weeks and the percentage of patients achieving the Investigator’s Global Assessment (IGA) of 0 or 1 with an improvement of 2 points or more at 16 weeks in all KHK4083 cohorts compared to the placebo cohort. Sustained efficacy of KHK4083 was observed beyond week 16.

Common treatment-emergent adverse events for KHK4083 cohorts were pyrexia, nasopharyngitis, worsening of atopic dermatitis and chills during the first 16 weeks. Pyrexia and chills events were mild to moderate in intensity, most of them were due to injection reaction and observed only after the first administration of the investigational product. There were no events of severe hypersensitivity reactions and no deaths observed in the study.

About Atopic Dermatitis

Atopic dermatitis is a chronic disease in which the immune system becomes disordered and overactive, triggering inflammation that damages the skin barrier. People with atopic dermatitis can get rashes anywhere on the body that can ooze, weep fluid and bleed when scratched, making skin vulnerable to infection. Skin can become dry and discolored, and repeated scratching can cause thickening and hardening of the skin. Atopic dermatitis typically begins in childhood, affecting 15% to 20% of children and 1% to 3% of adults worldwide. The incidence of the disease has increased two- to three-fold since the 1970s. People who have asthma and/or hay fever or who have family members who do, are more likely to develop atopic dermatitis.

About OX40

OX40 is a co-stimulatory molecule that is one of the tumor necrosis factor receptor (TNFR) family members. It plays an important role in maintaining T cell proliferation and survival and in the formation of memory T cells. OX40 is expressed on the surface of effector T cells (CD4 positive) activated by antigens. It has been reported that effector T cells expressing OX40 are present in the lesions of atopic dermatitis.

GSK to showcase scientific advances and progress in oncology at ASCO and EHA

On June 1, 2021 GlaxoSmithKline (GSK) plc reported that it will present new data from key focus areas within its oncology portfolio at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (4-8 June) and the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress (9-17 June) (Press release, GlaxoSmithKline, JUN 1, 2021, View Source [SID1234583299]).

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GSK will showcase innovative approaches to oncology R&D and cutting-edge science at the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings. The company will present new data on its approved therapies, BLENREP (belantamab mafodotin), JEMPERLI (dostarlimab) and ZEJULA (niraparib), as well as its investigational T-cell receptor therapy (TCR-T) letetresgene autoleucel (lete-cel; GSK3377794) for solid tumours.

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "The data we will share at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) demonstrate the continued strengthening of our oncology R&D pipeline in our focus areas of immuno-oncology, cell therapy and synthetic lethality. We are committed to ensuring our three approved medicines – niraparib, belantamab mafodotin and dostarlimab – help as many patients as possible while exploring novel approaches to expand treatment options for the millions of lives impacted by cancer each year."

Continuing GSK’s momentum in immuno-oncology

Dostarlimab, a programmed death receptor-1 (PD-1) blocking antibody, received accelerated approval in the US in April 2021 for certain women with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test who have progressed on or following prior treatment with a platinum-containing regimen. In addition, in April dostarlimab also received a conditional approval in the EU for the treatment of women with dMMR/microsatellite instability-high (MSI-H) endometrial cancer. Data from the registrational GARNET trial of dostarlimab in multiple tumour types will be presented at ASCO (Free ASCO Whitepaper), including an interim combined efficacy and safety analysis of the endometrial and pan-tumour cohorts (ASCO abstract #2564).

Additionally, GSK will present new data regarding the management of adverse events associated with belantamab mafodotin in relapsed/refractory multiple myeloma (ASCO abstract #8033; EHA (Free EHA Whitepaper) abstracts #EP1026 and #PB1698). Belantamab mafodotin is an anti-BCMA (B-cell maturation antigen) treatment that received accelerated and conditional approvals in the US and EU, respectively, for adult patients with relapsed/refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 antibody, a proteasome inhibitor and an immunomodulatory agent.

Updates from GSK’s efforts in synthetic lethality

GSK will share data from combined analysis of three phase III studies in patients with BRCA mutated ovarian cancer, examining the efficacy of niraparib, as well as its safety profile (ASCO abstract #5518). This research adds to the understanding of the use of this poly (ADP-ribose) polymerase (PARP) inhibitor for maintenance treatment in ovarian cancer. GSK remains committed to fully exploring the potential of niraparib, with clinical trials underway evaluating it in ovarian cancer in combination with other therapies and in other solid tumours.

GSK’s latest research in oncology cell therapy

Lete-cel, GSK’s leading cell therapy asset, is a potential first-in-class TCR-T consisting of modified T cells designed to recognise the NY-ESO-1 antigen, which is present across multiple solid tumours, including synovial sarcoma and myxoid/round cell liposarcoma.[1] A presentation of note will include findings from an interim analysis on the safety and efficacy of lete-cel in myxoid/round cell liposarcoma (ASCO abstract #11521). With three programmes currently in clinical development and an emerging pipeline of enhancement technologies and targets, cell therapy in solid tumours is a key pillar of GSK’s broader oncology strategy to help address unmet patient needs.

The complete list of GSK sponsored abstracts accepted by ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) for presentation/ publication from the company’s areas of cancer research is below.

ASCO

Immuno-oncology

Abstract Name

Presenter

Abstract Number

Antitumor activity of dostarlimab in patients with mismatch mutation repair-deficient/microsatellite instability-high tumours: A combined analysis of 2 cohorts in the GARNET study

Berton, D.

#2564

Inducible T-cell co-stimulatory (ICOS) receptor agonist, feladilimab (fela), alone and in combination (combo) with pembrolizumab (P): Results from INDUCE-1 urothelial carcinoma (UC) expansion cohorts (ECs)

Balar, A.

#4519

Evaluation of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in cervical cancer: Data from phase 1 and phase 2 studies

Strauss, J.

#5509

Long-term follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck (SCCHN)

Chul Cho, B.

#6020

Relationship between corneal exam findings, best-corrected visual acuity (BCVA), and ocular symptoms in patients with relapsed or refractory multiple myeloma (RRMM) receiving belantamab mafodotin (belamaf)

Terpos, E.

#8033

Evolution of standard of care therapies used for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A real-world analysis of patient health records from 2016 to 2019

Saba, N.F.

#e18728

Landscape review of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in oncology: Adoption and recent learnings

Regnault, A.

# e18587

Real-world treatment patterns and outcomes of triple-exposed multiple myeloma patients treated in community oncology practices in the United States

Smith, R.

#e18727

Treatment patterns among patients with advanced/recurrent endometrial

cancer in the United States

Maiese, E.M.

#e18693

Synthetic Lethality

Abstract Name

Presenter

Presentation Details

Niraparib efficacy and safety in patients with BRCA mutated (BRCAm) ovarian cancer: Results from three phase 3 niraparib trials

Gonzalez-Martin, A.

#5518

Real-world patterns and predictors of first-line maintenance use among newly diagnosed advanced ovarian cancer: Is there an opportunity for change?

Liu, J.

#e18710

Real-world progression free survival among newly diagnosed advanced ovarian cancer: Does maintenance therapy work?

Liu, J.

#e18707

Tissue distribution and brain penetration of niraparib in tumour bearing mouse models and its clinical relevance

Gada, K.

#e15066

Oncology Cell Therapy

Abstract Name

Presenter

Presentation Details

IGNYTE-ESO: A master protocol to assess safety and activity of letetresgene autoleucel (lete-cel; GSK3377794) in HLA-A*02+ patients with synovial sarcoma or myxoid/round cell liposarcoma (Substudies 1 and 2)

D’Angelo, S.

#TPS11582

Master protocol to assess safety and recommended phase 2 dose of next generation NY-ESO-1–specific TCR T-cells in HLA-A*02 patients with synovial sarcoma or non-small cell lung cancer (Substudies 1 and 2)

Schoenfeld, A.

#TPS2661

Safety and efficacy of letetresgene autoleucel (lete-cel; GSK3377794) in advanced myxoid/round cell liposarcoma (MRCLS) following high lymphodepletion (Cohort 2): Interim analysis

D’Angelo, S.

#11521

Cancer Epigenetics

Abstract Name

Presenter

Presentation Details

Real-world treatment patterns among advanced HR+/HER2- breast cancer patients in the post-CDK4/6 inhibitor era: An analysis of administrative claims data

Boyle, T. A.

#e18695

EHA

Immuno-oncology

Abstract Name

Presenter

Presentation Details

Characterization of ocular adverse events in patients receiving belantamab mafadotin for ≥12 months: post-hoc analysis of DREAMM-2 study in relapsed/refractory multiple myeloma

Lonial, S.

#EP1026

Relationship between corneal exam findings, best-corrected visual acuity (BCVA), and ocular symptoms in patients with relapsed or refractory multiple myeloma (RRMM) receiving belantamab mafodotin (belamaf)

Terpos, E.

#EP1001

DREAMM-5 platform trial: Belantamab mafodotin (belamaf) in combination with five different novel agents in patients with relapsed/refractory multiple myeloma (RRMM)

Richardson, P.

#PB1698

Landscape review of the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Oncology: Adoption and recent learnings

Regnault, A.

#EP1171

Important information for BLENREP in the EU

Indication

BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Refer to the BLENREP Prescribing Information for a full list of adverse events and the complete important safety information.

About Dostarlimab

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[2] In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab (GSK4057190), a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these Products under the Agreement.

Important Information for JEMPERLI in the EU

Indication

JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum‑containing regimen.

Refer to the JEMPERLI Prescribing Information for a full list of adverse events and the complete important safety information in the EU.

About Niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.

Important Information for ZEJULA

Indication

ZEJULA is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Refer to the ZEJULA Prescribing Information for a full list of adverse events and the complete important safety information.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.