On October 27, 2021 GSK reported that strong Q3 sales of £9.1 billion +5% AER, +10% CER Total EPS 23.3p -7% AER, +3% CER; Adjusted EPS 36.6p +3% AER, +10% CER 2021 full year EPS guidance improved (Press release, GlaxoSmithKline, OCT 27, 2021, View Source [SID1234592009])

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Pharmaceuticals £4.4 billion +5% AER, +10% CER with growth in New and Specialty medicines
+24% CER; Respiratory +33% CER; Immuno-inflammation +32% CER ex-COVID-19 solutions; Oncology +34% CER; total HIV +8% CER
Vaccines £2.2 billion +7% AER, +13% CER with Shingrix £502 million +41% CER
COVID-19 solutions sales £209 million; Xevudy £114 million and pandemic adjuvant £94 million
Consumer Healthcare £2.5 billion +3% AER, +8% CER (+10% excluding divestments/brands under review)
Cost discipline supports delivery of EPS growth
Total Group operating margin 21.4%. Total EPS 23.3p -7% AER, +3% CER
Adjusted Group operating margin 31.7%. Adjusted EPS 36.6p +3% AER, +10% CER. This included a contribution to growth from COVID-19 solutions of approximately +5% AER, +5% CER in Q3 (+6% AER,+6% CER in the nine months)
Q3 net cash flow from operations £2.6 billion. Free cash flow £1.2 billion
Continued momentum in R&D delivery and strengthening of pipeline
Additional regulatory indications approved for Nucala in respiratory and Jemperli in cancer
HIV progress with FDA priority review of cabotegravir for prevention of HIV (PDUFA action date 23 Jan 2022) and new collaboration on ultra long-acting integrase inhibitor
Positive Phase III data on daprodustat in anaemia due to chronic kidney disease to be presented at the American Society of Nephrology meeting in Nov 2021
COVID-19 solutions: approval in Japan for Xevudy and ongoing discussions with several governments Phase III start with SK Bioscience for adjuvanted COVID-19 vaccine
World Health Organization recommendation for broad roll-out of RTS,S malaria vaccine for children living in sub-Saharan Africa
Progress on demerger to create new world-leading Consumer Healthcare company in 2022
New UK Corporate Headquarters announced
Announcement expected of Chair Designate in Q4 2021
2021 EPS guidance improved and reconfirm 2022 outlook
Now expect 2021 Adjusted EPS to decline between -2% to -4% at CER excluding COVID-19 solutions, previously mid-to-high single digit decline
Now expect 2021 Adjusted EPS contribution from COVID-19 solutions of 7% to 9% at CER
Expectation for meaningful improvement in revenues and margins in 2022 reconfirmed
2022 outlook excludes any contribution from COVID-19 solutions
Dividend of 19p declared for Q3 2021. Continue to expect 80p/share for 2021

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has delivered another quarter of strong business performance, with double-digit sales growth in Pharmaceuticals and Vaccines, increased momentum in Consumer Healthcare, and continued discipline on costs. This has allowed us to improve our full-year guidance and, alongside the progress in strengthening our R&D pipeline, reinforces our confidence in the outlook for a step-change in growth and performance in 2022 and beyond. We also continue to make excellent progress towards unlocking the value of Consumer Healthcare through a successful demerger in mid-2022."

On October 27, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report third quarter financial results and provide a corporate update on November 3, 2021 (Press release, Corcept Therapeutics, OCT 27, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-third-quarter-financial-results-5 [SID1234592026]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information
To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

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Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 5763926.

A replay will be available through November 10, 2021, at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 5763926.

On October 27, 2021 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that the first patient has been dosed in KZR-261-101, a Phase 1 clinical trial evaluating KZR-261, a novel, broad-spectrum, anti-tumor agent that acts through direct interaction and inhibition of the Sec61 translocon (Press release, Kezar Life Sciences, OCT 27, 2021, View Source [SID1234592052]).

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"Dosing the first patient with KZR-261, the first clinical candidate from our novel protein secretion platform, is an exciting milestone for Kezar as we continue to advance our oncology program and mature into a multi-asset therapeutics company," said John Fowler, Co-Founder and Chief Executive Officer of Kezar Life Sciences. "We believe KZR-261 has a differentiated therapeutic profile which could translate into broad potential across the oncology landscape."

KZR-261-101 is a first-in-human, open-label, multicenter, Phase 1 study of KZR-261 in patients with solid tumor malignancies. The study is being conducted in two parts, dose escalation and dose expansion, and is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, as well as to explore the preliminary anti-tumor activity of KZR-261 in subjects with locally advanced or metastatic disease for whom no therapeutics are currently available. Following safety review of all dose escalation cohorts and determination of the maximum tolerated dose or maximum administered dose, KZR-261 will be evaluated for safety and preliminary efficacy in four tumor-specific cohorts and one all-tumor cohort to determine doses recommended for Phase 2 studies.

Additional information about the KZR-261-101 trial is available via Clinicaltrials.gov (NCT 05047536).

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting the protein secretion pathway. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent, and a Phase 1 trial is underway for the treatment of solid tumor malignancies.

About Inhibition of Protein Secretion

In mammalian cells, the secretion of proteins such as cytokines and growth factors and the expression of cell surface transmembrane proteins such as receptor tyrosine kinases and immune checkpoint molecules involve a process called cotranslational translocation. For most proteins, this process occurs via the Sec61 translocon, a highly conserved multi-subunit protein complex found in the membrane of the endoplasmic reticulum of all cells. Kezar scientists have been researching the protein secretion pathway and ways to drug this important cellular pathway for more than five years and developed novel and robust assays to discover and develop small molecule inhibitors of Sec61. As a result, Kezar has established a broad library of protein secretion inhibitors for potential development across a wide range of diseases.

On October 27, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and NeoCura Bio-Medical Technology Co., Ltd. ("NeoCura"), a leading AI-enabled RNA precision medicine biotech company committed to building a global top RNA innovative drug platform, reported that they have entered into a strategic collaboration agreement to carry out a clinical study in China on the combination therapy of sintilimab from Innovent and individualized neoantigen vaccine NEO_PLIN2101 from NeoCura (Press release, Innovent Biologics, OCT 27, 2021, View Source [SID1234592071]).

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Innovent will collaborate with NeoCura in China to assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination therapy using sintilimab from Innovent and NEO_PLIN2101 from NeoCura in cancer patients, to advance the clinical development of combination immunotherapy for multiple solid tumors, and prepare to submit the Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) in the near future.

Dr. Liu Yongjun, President of Innovent, stated: "We are impressed by NeoCura’s differentiated R&D pipeline and international research team, and we are pleased to enter into this strategic collaboration to explore the clinical value of sintilimab in combination with neoantigen vaccines for solid tumors. Innovent has a robust pipeline with strong capabilities in immunology and cancer biology. Currently, we have five innovative drugs approved and launched in China and will have more than 10 innovative drugs to be launched in the next 2-3 years. Our fully integrated platform has accumulated strong R&D, clinical development and commercialization capabilities and is ideal for partners at home and abroad. We also hope to further explore the new opportunities in expanding indications and enhancing therapeutic efficacy of sintilimab in combination with novel therapies. We look forward to wider and in-depth collaboration between the two parties in the future. "

Dr. Wang Yi, founder of NeoCura, stated: "At present, neoantigen vaccines are a revolutionary emerging therapeutic approach worldwide. NeoCura has been focusing on the R&D of tumor neoantigen vaccines since its establishment, hoping to overcome the challenges of existing immunotherapy in the treatment of solid tumors through the application of new technologies. The collaboration with Innovent will play a synergistic role of personalized neoantigen vaccines and monoclonal antibody drugs and jointly explore the clinical effect of the combination therapy in the treatment of solid tumors, which is expected to improve the objective response rate of cancer immunotherapy and bring new opportunities for cancer combination regimens."

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has one regulatory submission under review in China for sintilimab, for the first line treatment of esophageal squamous cell carcinoma.

Additionally, four clinical studies of sintilimab have met their primary endpoints:

Phase 3 study in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma
Phase 2 study as second-line treatment of esophageal squamous cell carcinoma
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy
Phase 3 study in combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

About NEO_PLIN2101

NEO_PLIN2101 is a personalized neoantigen vaccine developed by NeoCura, which can be custom made according to the unique tumor gene mutation of each patient. Through high-throughput sample sequencing and AI algorithm epitope prediction, high-quality neoantigen fragments that can be efficiently presented by tumor cells and elicit a potent immune response are selected from patient’s tumor sample. The mRNA vaccine encoded corresponding neoantigen is synthesized in vitro, vaccinated into patients to activate tumor-specific T cells to control tumor growth and reduce tumor burden. Compared to conventional approach, NEO_PLIN2101 has stronger specificity and immunogenicity that can induce anti-tumor immune response in cancer patients.

On October 27, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reported the issuance of U.S. Patent No. 11,155,872 for digital polymerase chain reaction (dPCR) technique for molecular detection of solid organ allograft rejection (Press release, Oncocyte, OCT 27, 2021, View Source [SID1234592010]). The new patent strengthens Oncocyte’s intellectual property portfolio in the blood-based monitoring market including the transplant setting, enabling Therasure Transplant Monitor, its donor-derived cell-free DNA (dd-cfDNA) test, access to the $2 billion U.S. transplant market. Therasure Transplant Monitor is a blood-based solid organ transplantation monitoring test that is designed to be used in lieu of a tissue biopsy in kidney, liver and heart transplant patients, minimizing the need for these invasive and costly procedures.

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"Our newest patent will play an important role in strengthening our IP portfolio as we establish a robust pipeline of blood-based monitoring tests to democratize monitoring tests in both the transplant and oncology markets, helping to ensure that patients and their doctors get the right insights at the right time to make the best decisions," said Ron Andrews, President and CEO of Oncocyte. "The issuance of our second U.S. patent, building upon our prior U.S. and EU patents, gives us a protected path to launch an LDT in the U.S. to complement our current efforts in Germany and the EU. Our U.S. LDT is now expected to be validated and ready for CMS submission by the end of the first quarter in 2022 and with the broad LCD coverage for molecular testing of organ rejection from CMS in place, which cited our technology, we believe we will have a solid path to reimbursement."

Mr. Andrews continued, "Our future development beyond the LDT will include partnering with a technology platform and channel partner to initiate a clinical trial effort for a kitted product with an FDA submission planned in the first half of 2023. We believe our strategy to launch as a LDT and move to a kit business in the U.S. and Europe, will allow us a rapid path to market and revenues in 2022, with the ultimate goal of democratizing this new technology. Importantly, this differentiated approach that is more specific, quantitative for longitudinal follow up, cost effective and provides same-day turnaround time of important information for patient management has the potential to improve patient care and accelerate patient access to this essential insight in an estimated $2B U.S. market."

The patent granted delivers Oncocyte the right to exclude others from using the claimed methods in the United States and the European Union (where an earlier patent, EP3004388 was granted), strengthening the broader transplant IP portfolio which also covers methods of absolute quantification of dd-cfDNA through dPCR in both the U.S. and EU (US10,570,443 / EP3201361). Oncocyte is currently validating the Therasure Transplant Monitor in its Nashville CLIA lab and is on track for a lab developed test (LDT) launch in the first half of 2022. The Company is also planning a clinical trial program to support an In Vitro Diagnostic Regulation submission to the U.S. Food and Drug Administration (FDA) in early 2023.

Ekkehard Schütz, M.D., Ph.D., FAACC, Managing Director of Oncocyte GmbH and Head of Blood Based Monitoring Program at Oncocyte, said, "As a biomarker, dd-cfDNA can enable cost-effective, precise surveillance of transplant recipients to decrease premature graft loss resulting in the need for re-transplantation. Quantitative dPCR assays, like Therasure, should be considered the gold standard to monitor this biomarker and give care teams the early information as fast as needed to adjust and optimize a patient’s treatment. On top of the test itself, our IP portfolio together with the newly granted patent also protects its highly precise absolute quantification, which outperforms the standard percentage values for dd-cfDNA. We are thrilled to expand into this market with a proven technology which we believe will enable improved patient care and cost efficiencies across the globe."

To date, over 20 clinical studies and numerous peer reviewed publications have validated the usefulness of dd-cfDNA tests as non-invasive biomarkers to assess rejection, cell death, and under-immunosuppression – all signs that a transplant is or is soon to be rejected. However, the technologies in use differ in effectiveness, accuracy, and speed of turnaround. Data published to date identifies dPCR as the fastest and least-expensive technique as compared to other methods that measure dd-cfDNA, such as next-generation sequencing. With widely published results in high impact medical journals such as PLOS Medicine, American Journal of Transplantation, Transplantation and Clinical Chemistry, Oncocyte’s now-patented Therasure test is the only test on the market of this kind clinically validated for liver transplants, and for kidney and heart transplantation in large clinical cohort studies.