On August 5, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company with a mission to deliver targeted therapies that treat rare forms of cancer, reported its financial and operating results for the second quarter ended June 30, 2021 (Press release, Sierra Oncology, AUG 5, 2021, View Source [SID1234585875]).

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"We are extremely excited by the progress that has been made in the second quarter with the completion of enrollment for our MOMENTUM study," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology. "Importantly, we exceeded our target enrollment for our registration-enabling Phase 3 trial, which supports our hypothesis that physicians want new treatment options for patients suffering from myelofibrosis. We believe the forthcoming data from the MOMENTUM study, when combined with the Phase 3 SIMPLIFY data sets, will provide a robust picture of how momelotinib may help myelofibrosis patients and provide an option for those who are not well served by currently available therapies."

Key Business Highlights

Georgia Erbez and Christy Oliger joined the company’s Board of Directors. Together, they bring over three decades of strategic, financial and commercial experience to Sierra in advance of momelotinib commercialization. Ms. Erbez is presently Chief Financial Officer at Harpoon Therapeutics. Ms. Oliger currently serves on the Board of Directors at Karyopharm Therapeutics and Reata Pharmaceuticals, and most recently was Senior Vice President of the Oncology Business Unit at Genentech.
The Company received an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting suggesting that myelofibrosis patients receiving momelotinib who achieve or maintain transfusion independence at Week 24 have favorable overall survival compared to non-responders, including patients with anemia at baseline. In a separate presentation, transfusion independence was achieved in patients treated with momelotinib irrespective of baseline degree of anemia, platelet count or transfusion status. Combined, these data suggest the goal of achieving transfusion independence should become an important driver of treatment decisions in myelofibrosis.
In June, the company announced the MOMENTUM study—a global, randomized, double-blind, Phase 3 study for intermediate and high-risk myelofibrosis patients previously treated with a JAK inhibitor—had completed enrollment. The study enrolled 195 of a planned 180 patients across 21 countries. Topline data are anticipated in Q1 2022. Assuming MOMENTUM data are positive, Sierra plans to file for regulatory approval of momelotinib with the US Food & Drug Administration (FDA) in mid-2022. The FDA has granted Fast Track designation for momelotinib.
On August 3, the company entered into an agreement with AstraZeneca to in-license AZD5153, a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode. Sierra plans to initiate a Phase 2 study examining momelotinib in combination with AZD5153 for the treatment of myelofibrosis in the first half of 2022.
Second Quarter 2021 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $14.1 million for the three months ended June 30, 2021 compared with $10.2 million for the three months ended June 30, 2020. The increase was due to costs for momelotinib including a $1.3 million increase in clinical trial and development costs and a $0.7 million increase in manufacturing costs. Also attributing to the increase was a $2.0 million increase in personnel-related and allocated overhead costs of which $0.8 million pertained to an increase in non-cash stock-based compensation. Research and development expenses included non-cash stock-based compensation of $1.8 million and $0.9 million for the three months ended June 30, 2021 and 2020, respectively.

Research and development expenses were $28.1 million for the six months ended June 30, 2021, compared with $21.8 million for the six months ended June 30, 2020. The increase was due to costs for momelotinib including a $3.0 million increase in clinical trial and development costs and a $1.4 million increase in third-party manufacturing costs. Also attributing to the increase was a $3.7 million increase in personnel-related and allocated overhead costs of which $2.0 million pertained to an increase in non-cash stock-based compensation. These increases were partially offset by a $1.5 million non-cash charge incurred in 2020 to recognize the change in fair value of an obligation to issue securities to Gilead until the issuance of the securities in January 2020, and a $0.3 million decrease in costs for SRA737. Research and development expenses included non-cash stock-based compensation of $3.4 million and $1.5 million for the six months ended June 30, 2021 and 2020, respectively.

General and administrative expenses were $6.4 million for the three months ended June 30, 2021, compared to $6.3 million for the three months ended June 30, 2020. The increase was due to a $0.4 million increase in professional fees, primarily relating to pre-commercial costs for momelotinib, which was offset by a decrease of $0.2 million in personnel-related and allocated overhead costs. General and administrative expenses included non-cash stock-based compensation of $1.5 million and $2.7 million for the three months ended June 30, 2021 and 2020, respectively.

General and administrative expenses were $12.3 million for the six months ended June 30, 2021, compared to $10.8 million for the six months ended June 30, 2020. The increase was due to a $1.0 million increase in personnel-related and allocated overhead costs and an increase of $0.5 million in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $2.7 million and $3.1 million six months ended June 30, 2021 and 2020, respectively.

Total other expense (income), net was $0.1 million of total other expense, net for the six months ended June 30, 2021, compared to $15.7 million of total other expense, net for the six months ended June 30, 2020. The difference was primarily attributable to a non-cash charge of $16.2 million incurred during the six months ended June 30, 2020 related to the change in fair value of warrant liabilities until the reclassification to equity in January 2020.

For the three months ended June 30, 2021, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $20.6 million compared to a GAAP net loss of $16.5 million for the three months ended June 30, 2020. For the six months ended June 30, 2021 Sierra incurred a GAAP net loss of $40.5 million compared to a GAAP net loss of $48.4 million for the six months ended June 30, 2020. The GAAP net loss for the six months ended June 30, 2020 includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in total other expense (income), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $17.4 million for the three months ended June 30, 2021, compared with a non-GAAP adjusted net loss of $12.8 million for the three months ended June 30, 2020. Non-GAAP adjusted net loss for the three months ended June 30, 2021 and 2020 excludes expenses related to stock-based compensation. For the six months ended June 30, 2021, Sierra incurred a non-GAAP adjusted net loss of $34.4 million compared to a non-GAAP adjusted net loss of $26.1 million for the six months ended June 30, 2020. Non-GAAP adjusted net loss for the six months ended June 30, 2021 excludes expenses related to stock-based compensation. Non-GAAP adjusted net loss for the six months ended June 30, 2020 excludes expenses related to the change in fair value of warrant liabilities, the change in fair value of the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP measure to non-GAAP financial measure.

Cash and cash equivalents totaled $90.7 million as of June 30, 2021, compared to $104.1 million as of December 31, 2020.

As of June 30, 2021, there were 12,358,517 total shares of common stock outstanding and warrants to purchase 11,052,256 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,786,469 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

On August 5, 2021 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported second quarter 2021 financial results and provided a business update (Press release, NextCure, AUG 5, 2021, View Source [SID1234585890]).

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"We have made notable progress across all of our clinical programs including several enhancements to the ongoing NC318 Phase 2 monotherapy trial. Clinical sites can now select for S15+ patients, through screening biopsies in a CLIA certified laboratory. In addition, we have resumed enrolling non-small cell lung cancer (NSCLC) adenocarcinoma patients in the ongoing NC318 monotherapy trial and have revised the NC318 dosing regimen to increase overall drug exposure to NC318," said Michael Richman, NextCure’s president and chief executive officer. "We expect to provide a data update from our ongoing Phase 2 monotherapy trial of NC318, as well as to report Phase 1 data for NC410 by year-end. We have initiated clinical development of our third program, NC762 targeting B7-H4, with anticipated initial Phase 1 data mid-2022."

Business Highlights and Upcoming Milestones

NC318
Clinical Laboratory Improvement Amendments (CLIA) validated assay available for S15+ patient selection to effectively evaluate NC318 activity in patients with S15+ tumors.
Resumed enrollment of a non-small cell lung cancer (NSCLC) adenocarcinoma cohort in the ongoing Phase 2 monotherapy trial.
Revised dosing regimen to 800 mg weekly to increase overall drug exposure.
On track to report Phase 2 monotherapy update in the fourth quarter of 2021.
In the second quarter of 2021, Yale University commenced a Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced NSCLC with anticipated initial data in the first half of 2022.
NC410
Presented trial in progress poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting.
Published preclinical data demonstrating that NC410 promoted T cell mediated anti-tumor immunity, enhanced infiltration and increased localized activity of T cells in the tumor microenvironment.
On track to report initial clinical data in the fourth quarter of 2021.
NC762
Started the Phase 1 portion of a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors.
Initial data anticipated to be available in mid-2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditure requirements into the second half of 2023.

Financial Results for Quarter Ended June 30, 2021

Cash, cash equivalents and marketable securities as of June 30, 2021 were $249.5 million, compared to $283.4 million as of December 31, 2020. The decrease of $33.9 million primarily reflects cash used to fund operations, cash used to purchase fixed assets, and repayments on a term loan.
Research and development expenses were $11.9 million for the quarter ended June 30, 2021, as compared to $11.1 million for the quarter ended June 30, 2020. The increase was driven primarily by clinical-related costs, partially offset by timing of clinical supply costs.
General and administrative expenses were $6.0 million for the quarter ended June 30, 2021, as compared to $4.7 million for the quarter ended June 30, 2020. The increase was driven primarily by personnel-related costs.
Net loss was $18.0 million for the quarter ended June 30, 2021, as compared to $14.5 million for the quarter ended June 30, 2020. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount.
About NC318
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

About NC410
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

About NC762
NC762 is a monoclonal antibody that binds specifically to B7-H4, a protein expressed on multiple tumor types. NextCure believes NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. The company has observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors in mice and believes that NC762 has the potential to treat multiple tumor types. NextCure’s research indicates that NC762 inhibits tumor cell growth independently of immune cell infiltration in the tumor microenvironment.

On August 5, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported financial results for the second quarter of 2021 (Press release, Concert Pharmaceuticals, AUG 5, 2021, View Source [SID1234585905]).

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"Our development priority is to advance CTP-543 through its pivotal trials for alopecia areata in support of a planned early 2023 New Drug Application. We remain on track with our clinical progression of CTP-543, a drug candidate with the potential to address an important unmet medical need and sizeable market opportunity," said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "Alopecia areata is a chronic autoimmune disease with no approved treatment that causes significant emotional and psychological distress in many patients. There’s an enormous need for an FDA-approved treatment, and we’re proud that Concert was one of the first in the industry to act on this important disease by advancing CTP-543, which has the potential to be a best in class treatment."

Recent Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata

Initiated CTP-543 THRIVE-AA2 Phase 3 Trial in May 2021. THRIVE-AA2, the second study in the CTP-543 pivotal program, is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 440 adults with moderate to severe alopecia areata. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. The Company expects to report topline results from the THRIVE-AA2 trial in the second half of 2022.
CTP-543 THRIVE-AA1 Phase 3 Trial Progressing. THRIVE-AA1, the first study in the CTP-543 pivotal program, is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of CTP‑543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adults with moderate to severe alopecia areata. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. The Company expects to report topline results from the THRIVE-AA1 trial in the first half of 2022.
CTP-543 Long-term Data Presented at JAK Inhibitors Drug Development Summit. Data from an ongoing open label, long-term extension study with CTP-543 were presented at the 2nd JAK Inhibitors Drug Development Summit on July 1, 2021. The presentation highlighted that in the extension study, treatment with CTP-543 showed continued maintenance of hair regrowth relative to the hair growth shown in the Company’s previously conducted Phase 2 trials in patients with alopecia areata. Approximately 57% of participants receiving 12 mg of CTP-543 twice-daily following 52 weeks of dosing achieved a clinically-meaningful SALT score of 20 or less. A SALT score ≤ 20 corresponds to 80% or more hair coverage on the scalp. CTP-543 has been generally well tolerated in the extension study, and adverse events are consistent with those reported in the Phase 2 trials.
September is Alopecia Areata Awareness Month. Throughout the month of September, Concert, along with the alopecia areata community, will raise awareness and recognize the importance of alopecia areata, a serious autoimmune disorder that affects approximately 1 million individuals in the U.S. and which often results in poor health-related quality of life as well as high levels of anxiety and depression. Follow our #LightItUpBlue4AlopeciaAreata campaign on Twitter at @ConcertPharma.
Second Quarter 2021 Financial Results

Cash and Investment Position. Cash, cash equivalents and investments as of June 30, 2021 totaled $122.4 million as compared to $130.0 million as of December 31, 2020. Under its current operating plan, the Company expects its cash and cash equivalents to fund the Company into the second quarter of 2022. In May 2021, Vertex purchased the potential future milestones under the companies’ 2017 asset purchase agreement relating to VX-561 for $32.0 million.
Revenues. For the quarter ended June 30, 2021, revenue was $32.0 million, compared to $6.4 million for the same period in 2020. Revenue recognized in 2021 was the result of the $32.0 million of proceeds received from Vertex. Revenue recognized in 2020 was the result of the expiration of licensing options under a previous collaboration with Celgene Corporation.
R&D Expenses. Research and development expenses were $20.2 million for the quarter ended June 30, 2021, compared to $14.8 million for the same period in 2020. The increase in research and development expenses relates primarily to the clinical development program for CTP-543.
G&A Expenses. General and administrative expenses were $5.6 million for the quarter ended June 30, 2021, compared to $4.7 million for the same period in 2020. The increase in general and administrative expenses relates primarily to increased external professional service expenses and non-cash stock-based compensation.
Net Income (Loss). For the quarter ended June 30, 2021, net income applicable to common stockholders was $5.4 million, or $0.16 per share, as compared to net loss applicable to common stockholders of $13.0 million, or $0.41 per share, for the quarter ended June 30, 2020.
Conference Call and Webcast

The Company will host a conference call and webcast today at 8:30 a.m. ET to provide an update on the Company and discuss second quarter financial results. To access the conference call, please dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International) five minutes prior to the start time.

A live webcast of the second quarter financial results may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.

On August 5, 2021 Versant Ventures reported that portfolio company Vividion Therapeutics has been acquired by Bayer AG for $1.5 billion up front and up to $500 million in potential future milestone payments (Press release, Versant Ventures, AUG 5, 2021, View Source [SID1234585938]). This acquisition represents one of the largest transactions for a preclinical-stage biotechnology company.

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Versant’s Series A investment in Vividion builds on a successful track record of San Diego-based start-ups including Amira Pharmaceuticals, Quanticel Pharmaceuticals, Jecure Therapeutics, Crinetics Pharmaceuticals and multiple spinouts launched from the firm’s San Diego-based Inception Therapeutics Discovery Engine.

"San Diego possesses a world-class academic community for discovery research and access to high-quality entrepreneurs for company creation," said Thomas Woiwode, Ph.D., managing director at Versant and a Vividion board member. "The result is a tremendous environment for venture capital investment."

"The field of chemical proteomics is uniquely positioned to translate modern scientific discoveries in human biology into first-in-class therapeutics for patients suffering from cancer and other debilitating diseases," said Benjamin Cravatt, Ph.D., Gilula Chair of Chemical Biology at the Scripps Research Institute and a co-founder of Vividion.

Vividion represents one of several Versant portfolio companies focused on developing better cancer therapies through discovery platforms for previously intractable drug targets. Since the firm’s initial investment in Vividion in 2017, Versant has launched four other start-ups in this field. Monte Rosa Therapeutics recently completed a successful IPO. Other Versant-created companies in the field include Stablix Therapeutics and two stealth companies, all launched within the past 12 months.

On August 5, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company (NYSE: LLY) reported new and updated data from the ORIENT-11 study demonstrating a sustained survival benefit of sintilimab in combination with pemetrexed and platinum chemotherapy in the first-line treatment of patients with nonsquamous non-small cell lung cancer (Press release, Innovent Biologics, AUG 5, 2021, View Source [SID1234586030]). In addition, biomarker results from the trial provide important insights for patients with high major histocompatibility complex (MHC) class-II expression. These findings were published today in the Journal of Thoracic Oncology. (https://www.sciencedirect.com/science/article/pii/S1556086421023303)

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In August 2020, interim analysis data from ORIENT-11 were released in an oral presentation at the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium. These interim data were simultaneously published online by the Journal of Thoracic Oncology.

ORIENT-11 is a randomized, double-blind Phase 3 clinical trial evaluating sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for locally advanced or metastatic nonsquamous NSCLC without sensitizing EGFR mutations or ALK rearrangements. The Journal of Thoracic Oncology manuscript discloses, as of January 15, 2021, with a median follow-up of 22.9 months, the median overall survival (OS) of patients receiving the sintilimab combination was not yet reached. The sintilimab combination demonstrated a sustainable OS benefit (HR=0.60, 95% CI: 0.45-0.79; p=0.0003), and the median OS for those receiving the placebo combination was 16.8 months.

Whole transcriptome sequencing of baseline tumor samples was performed to probe the predictive and correlative biomarkers, showing that high or medium immune cell infiltration was strongly associated with improved progression-free survival (PFS) in the sintilimab combination group. In particular, high MHC class-II presentation pathway expression was significantly correlated with prolonged PFS (HR=0.32, 95% CI: 0.19-0.54; p<0.0001) and OS (HR=0.36, 95% CI: 0.20-0.64; p=0.0005) in the sintilimab combination group.

Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of ORIENT-11 and the corresponding author of the manuscript, stated, "Sintilimab in combination with pemetrexed and platinum chemotherapy demonstrated a sustainable survival benefit after long-term follow-up in the ORIENT-11 study. These data showed that this sintilimab combination should be further evaluated as front-line therapy for patients with previously untreated, locally advanced or metastatic nonsquamous non-small cell lung cancer without EGFR or ALK genomic tumor aberrations."

Dr. Wei Xu, Vice President of Translational Medicine of Innovent and co- corresponding author of the manuscript, stated, "Immunotherapy based on PD-1 and PD-L1 antibodies has revolutionized clinical practice of treating non-small cell lung cancer. However, the precise patient population who will benefit from immunotherapy-chemotherapy combination treatment is still unclear. We explored the gene expression profile in the tumor microenvironment and found that the infiltration of antigen-presenting cells and high expression of the MHC-II antigen presentation pathway correlated with improved outcomes in patients who received the sintilimab-pemetrexed-platinum chemotherapy combination. This finding contributes to a better understanding of the mechanism of action of the immunotherapy-chemotherapy combination which could help inform selection of suitable patients for future sintilimab studies. Publication of this study in the Journal of Thoracic Oncology is a recognition of the important work by this research team and we will continue to explore new areas in immuno-oncology, with the goal of identifying additional novel approaches to treat cancer in clinical practice."

Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "We’re excited to see that the results of ORIENT-11 show sintilimab in combination with pemetrexed and platinum chemotherapy can bring an overall survival benefit to patients with nonsquamous non-small cell lung cancer in the first-line treatment setting. Also, research of the tumor microenvironment is helping scientists find suitable biomarkers as potential targets for cancer treatment. These ORIENT-11 biomarker results published in the Journal of Thoracic Oncology will help us further understand the mechanism of action of this immunotherapy-based combination in order to identify patients who are more likely to respond to treatment."

About the ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating the efficacy and safety of sintilimab or placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (nsqNSCLC) without sensitizing EGFR mutations or ALK rearrangements (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in the ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab injection or placebo plus pemetrexed maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About Lung Cancer

Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year. In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype. Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.

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 nonsquamous 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 a regulatory submission under review in China for sintilimab for the second-line treatment of squamous non-small cell lung cancer.

Innovent also has two clinical studies of sintilimab that have met their primary endpoints:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma
The second-line treatment of esophageal squamous cell carcinoma
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 nonsquamous 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.