On October 11, 2021 GSK reported proposals for a major new UK-based headquarters and global campus for the new Consumer Healthcare company following separation in 2022, and its long-term plan for the future headquarters of GSK (Press release, GlaxoSmithKline, OCT 11, 2021, View Source [SID1234591097]).

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New Consumer Healthcare company headquarters to be based in Weybridge, UK
The proposals announced today form part of GSK’s ongoing work to prepare for the separation of the Group into two leading UK-based companies next year – new GSK, a global pharmaceuticals and vaccines company with an R&D approach focused on the science of the immune system, human genetics and advanced technologies, and a world leading Consumer Healthcare company with annual sales of more than £10 billion, including nine global power brands holding category leadership positions.

Under the proposals announced today the new Consumer Healthcare company will build a new campus in Weybridge, UK. This campus will house the global headquarters for the new Consumer Healthcare business, including an innovation centre (made up of R&D laboratories and the Consumer Healthcare Shopper Science lab) and the company’s global support function teams based in the UK. It will be home to around 1,400 employees.

The new Consumer Healthcare company will open its new headquarters at the end of 2024, subject to consultation and planning approvals. Whilst the development of the campus is ongoing, and at the point of separation of the two companies – expected in mid-2022 – Consumer Healthcare teams will leave GSK House in Brentford and will move to a temporary headquarters in Weybridge, at a site close to but separate from the company’s existing facilities in the area.

Brian McNamara, CEO Designate, GSK Consumer Healthcare said: "This investment in a new cutting-edge campus in the UK will bring together our first-in-class teams as we drive towards our ambitions as the world’s leading consumer healthcare company. Today’s announcement is an important step as we prepare for separation, marking an exciting new beginning for New Consumer Healthcare."

GSK to move to new UK headquarters after separation
Following separation, GSK will move to a new UK headquarters. The company will identify an appropriate site that meets the needs of the new organisation, with the search based in the same area as GSK’s current headquarters, maintaining access to the UK’s world-leading science and innovation hubs; GSK will provide a further update on its new headquarters in mid-2022, and expects to remain at the company’s current headquarters, at GSK House in Brentford, until at least the end of 2023.

On October 11, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that its CEO, Anker Lundemose, will attend and present at the 8th Annual Solebury Trout Private Company Showcase, co-hosted with BMO, on 14 October 2021 (Press release, Mission Therapeutics, OCT 11, 2021, View Source [SID1234591064]).

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Dr Lundemose will be available for one-to-one meetings and will discuss the Company’s business strategy, technology, discovery platform and development programmes in a 20-minute video presentation at 4.00pm EDT / 9.00pm BST.

As well as these 20-minute video presentations from attending companies, the event’s agenda includes two topical panels and virtual meetings with company executives.

For individuals interested in attending the meeting, please contact the organisers for further information.

On October 11, 2021 Exscientia (Nasdaq: EXAI), the Medical University of Vienna and the CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, reported publication in Cancer Discovery, a journal of the American Association of Cancer Research, of final results from the EXALT-1 trial (Press release, Exscientia, OCT 11, 2021, View Source [SID1234591081]). The study, titled "Functional Precision Medicine Provides Clinical Benefit in Advanced Aggressive Haematological Cancers and Identifies Exceptional Responders," illustrates the potential real-world impact of using Exscientia’s AI-supported precision medicine platform (referred to in the study as single-cell functional precision medicine or scFPM) to propose which therapy would be most effective for late-stage haematological cancer patients based on testing drug responses ex vivo in their own tissue samples. Interim data from the study was previously published in The Lancet Haematology.

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"Precision medicine is the right drug, for the right patient, at the right time. By enabling the robust and accurate assessment of drug effect on viable patient samples at single-cell resolution, we have created a technology that can provide hemato oncologists prediction of a patient’s response prior to deciding on a course of therapy," said Gregory Vladimer, Ph.D., VP of translational research at Exscientia and co-inventor of the platform technology. "While the use of genetics in precision cancer medicine can determine if a target is present, functionally characterizing available drug options on patient cells within a short time window provides evidence for cancer cell sensitivity."

"The EXALT-1 study was the first-ever prospective study of its kind, demonstrating the potential of a functional precision medicine platform to identify the optimal therapy for an individual patient. The results of the trial are clear: patients who were treated using recommendations guided by single-cell drug screenings from real-time biopsies remained progression-free longer as compared to their previous line of therapy," commented Philipp P. Staber, M.D., Ph.D., haematologist oncologist at Medical University Vienna and principal investigator of the study.

The prospective, single-arm, open label EXALT-1 study was a basket trial for patients with a variety of aggressive haematological cancers. The study evaluated a total of 76 patients. Of these, 56 patients were treated according to scFPM and 20 patients received treatment based on physician’s choice. At a median follow-up of 23.9 months, 54% of patients (30/56) demonstrated a clinical benefit of more than 1.3-fold enhanced progression-free survival (PFS) compared to their previous therapy, with 40% of responders (12/30) achieving exceptional responses lasting at least three times longer than expected for their respective disease. The PFS on scFPM-guided treatment was significantly increased (p=0.0093). Of note, 23% of patients (13/56) were progression-free after 12 months after scFPM-guided therapy, compared to only 5% of patients (3/56) on their previous treatment. The objective response rate was 55% for patients treated according to scFPM results.

Giulio Superti-Furga, Scientific Director of the CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences said, "The current study is a wonderful example of how successful collaboration with academic research and innovation, clinical expertise, and pharmatech knowhow can benefit patients and the development of new technologies. This is not personalised medicine inferred from biomarkers, it is really measured. It is based on function."

Exscientia’s precision medicine platform uses AI techniques to conduct single-cell, high content analysis of individual patient tissue samples to generate clinically-relevant insights into which treatments will deliver the most benefit to an individual patient. The underlying technology was developed by Dr. Gregory Vladimer and Prof. Berend Snijder, now at the ETH Zurich, while working in the laboratory of Giulio Superti-Furga at the CeMM Research Center for Molecular Medicine in Austria.

"Exscientia’s patient-first AI strategy aims to bring patients directly into all aspects of new medicine discovery and development, including target discovery, drug optimization and patient selection for clinical trials," said Andrew Hopkins, Ph.D., Founder and Chief Executive Officer of Exscientia. "These results provide strong validation for our strategy to apply AI to modernize drug development, ultimately aiming to bring better drugs, faster, to patients in need."

On October 11, 2021 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the Company’s rusfertide clinical studies, announced on September 17, 2021 (Press release, Protagonist, OCT 11, 2021, View Source [SID1234591098]). Per the FDA, dosing in all clinical studies of rusfertide may be resumed.

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The Company provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, the Company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. The Company is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.

The clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.

"We are extremely pleased that the FDA has acted so quickly in lifting the clinical hold on the rusfertide development program, allowing us to resume patient dosing in our clinical studies," said Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Patient safety continues to be our topmost priority. We believe that the cumulative evidence regarding the safety and clinical risk-benefit of rusfertide is supportive of expedited clinical development. We are actively preparing to initiate the phase 3 registrational study for polycythemia vera in the first quarter of 2022. Protagonist will continue to work closely with the FDA to ensure patient safety with amendments to current and planned future studies with rusfertide. We remain optimistic about the future potential of rusfertide to address unmet medical needs in excessive erythrocytosis and iron overload related diseases like polycythemia vera and hereditary hemochromatosis, respectively."

Conference Call and Webcast Information

A conference call will take place today, October 11, 2021, at 8:00 a.m. ET.

Live audio of the conference call will be simultaneously broadcast over the internet. The call will be available to investors, members of the news media, and the general public.

To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five minutes prior to the call and ask to be joined to the Protagonist Therapeutics call. A live and archived webcast will be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

On October 11, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported the publication in the Annals of Hematology of a paper entitled "Favorable Overall Survival with Imetelstat in Relapsed/Refractory Myelofibrosis Patients Compared with Real World Data," which details statistical analyses comparing data from the Company’s IMbark Phase 2 clinical trial to closely matched Real World Data (RWD) (Press release, Geron, OCT 11, 2021, View Source [SID1234591065]).

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"Across the multiple analyses presented in the publication, the median overall survival for imetelstat-treated patients in our IMbark Phase 2 clinical trial was consistently more than double than the median overall survival for patients treated with best available therapy (BAT) from RWD. For the imetelstat-treated patients, the median overall survival (OS) was approximately 30 months in comparison to approximately 12 months for BAT-treated patients from RWD," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "We are pleased with the publication of this important work as these analyses provide us further confidence in the use of OS as the primary endpoint for our ongoing confirmatory IMpactMF Phase 3 trial."

The paper describes several statistical adjustment methods and multiple sensitivity analyses to improve comparability of the data set from the Company’s IMbark Phase 2 trial and RWD to mimic the effect of a randomized trial. The authors note consistency in the hazard ratios and statistical significance observed across the multiple analyses, which suggests a survival benefit associated with imetelstat treatment of MF patients after ruxolitinib failure. While acknowledging the limitations of RWD analyses, the authors conclude that the results of these analyses warrant further prospective evaluation of imetelstat in a Phase 3 setting with OS as a primary endpoint.

"The RWD used in this paper was collected from patients treated with BAT at the Moffitt Cancer Center after they had discontinued treatment from ruxolitinib, a JAK inhibitor," said Rami Komrokji, M.D., Vice Chair, Department of Malignant Hematology at Moffitt Cancer Center. "There is an urgent and unmet need for treatment options with a novel mechanism of action for MF patients who are relapsed/refractory to JAK inhibitors. The reported favorable OS with imetelstat treatment in this as well as in prior publications in this very poor prognosis MF patient population differentiates imetelstat from other therapeutic agents in development for MF today. We are excited to participate in Geron’s ongoing IMpactMF clinical trial to confirm these data."

The publication is available online at View Source

Ongoing IMpactMF Phase 3 Clinical Trial

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

About Myelofibrosis (MF)

Myelofibrosis, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain.

Approximately 70% of MF patients are classified as having Intermediate-2 or High-risk disease, as defined by the Dynamic International Prognostic Scoring System Plus. There are more than 35,000 patients worldwide and more than 13,000 patients in the U.S. living with Intermediate-2 or High-risk MF. The only drug therapies approved for treating these MF patients are JAK inhibitors. Currently, MF patients who fail or no longer respond to JAK inhibitor treatment have no or limited options, resulting in shortened median overall survival.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent (ESA) and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.