On April 23, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has initiated a Phase 1 clinical trial of its first-in-class antibody SRF388, which targets the immunosuppressive cytokine IL-27.

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"IL-27 is an immunosuppressive cytokine that is associated with poor outcomes in certain tumor types. Our first-in-class anti-IL-27 antibody SRF388 strongly inhibits the action of IL-27, a mechanism designed to stimulate the immune system to mount a robust attack against the tumor," said Robert Ross, M.D., chief medical officer of Surface Oncology. "The development of SRF388 is informed by a compelling translational hypothesis which led us to prioritize early assessment in hepatocellular and renal cell carcinoma, both of which are characterized by high levels of circulating EBI3, a subunit of IL-27."

The Phase 1 dose escalation study will enroll patients with advanced solid tumors. Once a recommended Phase 2 dose is reached, the study is designed to expand into cohorts consisting of patients with late-stage renal cell carcinoma and hepatocellular carcinoma. Surface expects to provide an initial clinical update from the dose escalation portion of the study by the end of 2020.

About SRF388
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

On April 23, 2020 GlaxoSmithKline plc (LSE/NYSE:GSK) reported data from an updated analysis of the GARNET trial, which demonstrated that dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based regimen (Press release, GlaxoSmithKline, APR 23, 2020, View Source [SID1234556555]).

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This updated analysis included patients with dMMR endometrial cancer who had measurable disease at baseline and ≥6 months of follow-up by the data cutoff (n=71). Patients received 500 mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression. The primary endpoints were confirmed objective response rate (ORR) and duration of response (DOR), as assessed against RECIST v 1.1 by blinded independent central review. GARNET is the largest dataset evaluating an anti-PD-1 in endometrial cancer.

Treatment with dostarlimab showed an ORR of 42% (95% CI; 31-55) and a disease control rate of 58% (95% CI; 45-69). Overall, 13% of patients had a complete response and 30% of patients had a partial response. At the time of data cutoff, with a median follow up of 11.2 months, the median DOR had not been reached (1.87+ to 19.61+ months).

Dr. Axel Hoos, Senior Vice President and Head Oncology R&D, GSK said: "We are committed to developing medicines for patients who face high unmet medical need. We believe in the clinical potential of dostarlimab for women with advanced or recurrent dMMR endometrial cancer who urgently need additional treatment options for this incurable disease."

Dr. Ana Oaknin, Head of the Gynaecologic Cancer Program at Vall d’Hebron Institute of Oncology, Barcelona, and primary investigator for GARNET said: "There are limited treatment options for women with advanced or recurrent endometrial cancer, and prognosis of these patients is poor. The results observed in the GARNET trial indicate the potential of dostarlimab to offer a new treatment option for women with this challenging disease."

The safety population included all patients with dMMR endometrial cancer who received at least one dose of dostarlimab (n=104). Results showed that dostarlimab was well tolerated with a low discontinuation rate (2%) due to treatment-related adverse events (TRAEs), consistent with the safety profiles of other anti-PD-1 therapies. The most commonly reported TRAEs were asthenia (15%), diarrhea (15%), fatigue (14%), and nausea (13%). No deaths associated with dostarlimab were reported in the study.

Dostarlimab is not currently approved for use anywhere in the world.

About GARNET
The ongoing phase I GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. Part 2B of the study includes five expansion cohorts: dMMR/microsatellite instability-high (MSI-H) endometrial cancer (cohort A1), mismatch repair-proficient endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial cancer (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is still enrolling patients.i,ii

About Dostarlimab
Dostarlimab is an investigational humanized anti-PD-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.iii

In addition to GARNET, dostarlimab is being investigated for women with recurrent or primary advanced endometrial cancer in combination with standard of care (chemotherapy) in the phase III RUBY trial.iv Dostarlimab is also being evaluated in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer.

About Endometrial Cancerv
Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy. Endometrial cancer is the sixth most common cancer in women worldwide.vi

GSK in Oncology
GSK is focused on maximizing 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 utilizing modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On April 23, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the first-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, APR 23, 2020, View Source [SID1234556522]).

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First-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $491.5 million grew 10.8%; organic sales growth was 12.7%.
Reported-diluted EPS of $0.99 increased 36%.
Adjusted-diluted EPS of $1.01 increased 36%.
The Company is maintaining full-year 2020 net sales guidance and is updating full-year 2020 adjusted-diluted EPS guidance to a new range of $3.52 to $3.62, compared to a prior range of $3.45 to $3.55.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"During these unprecedented times, our priorities are focused on the well-being and safety of our team members as well as ensuring the supply of critical, high-quality components and solutions to our customers," said Eric M. Green, President and Chief Executive Officer. "I am extremely pleased that we delivered a strong performance in the first quarter given the challenging environment that the COVID-19 pandemic has had on our customers, our suppliers and our team members. In particular, we continued to deliver strong sales growth in high-value products, as demand trends from our worldwide customer base were similar to trends we saw last year. Additionally, our teams are partnering with a broad range of customers working to support efforts to develop solutions that address the global COVID-19 pandemic such as diagnostics, anti-viral therapeutics and vaccines."

Mr. Green continued, "I am proud with the way our team across the globe is responding during these challenging times. They exemplify our One West philosophy in the way they are supporting our customers, patients and the local communities where our team members live and work."

Proprietary Products Segment
Net sales grew by 9.7% to $373.5 million. Organic sales growth was 11.8% with currency translation decreasing sales growth by 250 basis points. High-value products (components and devices) represented 63% of segment sales and generated double-digit organic sales growth. The segment saw good demand for Westar, Daikyo, NovaPure and FluroTec components as well as for devices such as Daikyo Crystal Zenith syringes and cartridges and our self-injection platforms.

The Biologics market unit had strong double-digit organic sales growth. The Generics market unit had high-single digit organic sales growth, and the Pharma market unit had mid-single digit organic sales growth.

Contract-Manufactured Products Segment
Net sales grew by 14.5% to $118.1 million. Organic sales growth was 15.9% with currency translation decreasing sales growth by 140 basis points. Segment performance was led by sales of components for diagnostic devices as well as drug-injection delivery devices.

Financial Highlights
Operating cash flow was $57.1 million, an increase of 20%. Capital expenditures in the quarter were $32.1 million. Free cash flow (operating cash flow minus capital expenditures) was $25.0 million, an increase of 33%.

During the quarter, the Company repurchased 761,500 shares for $115.5 million at an average share price of $151.65 under its share repurchase program.

Our capital and financial resources, including overall liquidity, remain strong. We believe that cash on hand and cash generated from operations, together with availability under our Credit Facility, will be adequate to address our foreseeable liquidity needs based on our current expectations of our business operations, capital expenditures and scheduled payments of debt obligations.

Full-Year 2020 Financial Guidance

Full-year 2020 net sales guidance continues to be in a range of $1.95 billion to $1.97 billion.
Organic sales growth is expected to be approximately 8%, compared to a prior guidance range of 7% to 8%.
Net sales guidance includes an estimated full-year headwind of $26 million for the full-year 2020 based on current foreign exchange rates, compared to prior guidance of $15 million.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of $3.52 to $3.62, compared to prior guidance range of $3.45 to $3.55.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.07 based on current foreign currency exchange rates, compared to prior guidance of approximately $0.04.
The revised guidance includes a $0.07 EPS impact from first-quarter tax benefits from stock-based compensation.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first-quarter 2020 would provide a positive adjustment to our full-year EPS guidance.
First-Quarter 2020 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 1865786.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, April 30, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 1865786.

On April 23, 2020 Tocagen Inc. (Nasdaq: TOCA), historically a clinical-stage, cancer-selective gene therapy company, reported financial results for the first quarter ended March 31, 2020 (Press release, Tocagen, APR 23, 2020, View Source [SID1234556540]).

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On February 19, 2020, Tocagen announced it had entered into a definitive agreement in which a wholly-owned subsidiary of Tocagen will merge, in an all-stock transaction, with Forte Biosciences Inc., a privately held clinical-stage biopharmaceutical company developing a live biotherapeutic for the treatment of inflammatory skin diseases. Upon stockholder approval, the combined company is expected to operate under the name Forte Biosciences Inc. and trade on the Nasdaq Capital Market under the ticker symbol FBRX. The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the second quarter of 2020, subject to customary conditions, including approval by Tocagen and Forte stockholders.

First Quarter 2020 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the quarter ended March 31, 2020, compared to $12.4 million for the quarter ended March 31, 2019. The decrease of $9.3 million was primarily due to decreases in clinical trial related costs due to wind down activities and a reduction in our workforce.

General and Administrative (G&A) Expenses: G&A expenses were $5.6 million for the quarter ended March 31, 2020, compared to $4.4 million for the quarter ended March 31, 2019. The increase of $1.1 million was primarily due to increased personnel costs, including non-cash stock-based compensation and severance costs in connection with wind down activities and a reduction in our workforce.

Net Loss: Net loss was $10.3 million, or $0.43 per common share (basic and diluted), for the quarter ended March 31, 2020, compared to a net loss of $17.1 million, or $0.74 per common share (basic and diluted), for the quarter ended March 31, 2019. The calculation is based on 23.9 million average common shares outstanding for the first quarter of 2020, compared to 23.0 million average common shares outstanding for the first quarter of 2019.

Cash Position

Cash, cash equivalents and marketable securities were $14.2 million at March 31, 2020 compared to $21.8 million at December 31, 2019.

On April 23, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (nsqNSCLC) (Press release, Innovent Biologics, APR 23, 2020, View Source [SID1234556556]). Tyvyt was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and has been the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL) since November 2019.

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The NDA was based on the pre-specified interim analysis of a randomized, double-blind, Phase 3 clinical trial (ORIENT-11)—Tyvyt (sintilimab injection) or placebo in combination with ALIMTA and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt in combination with ALIMTA and platinum demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with ALIMTA and platinum, which met the pre-defined efficacy criteria. After a median follow up of 8.9 months, the median PFS of the experimental group and the control group assessed by Independent Radiographic Review Committee was 8.9 months and 5.0 months respectively, HR (95%CI) = 0.482 (0.362,0.643), P < 0.00001. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference and journal.

Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of ORIENT-11 study, stated: "Nearly half of Chinese nsqNSCLC patients lack sensitizing EGFR mutation or ALK rearrangement, which makes them do not respond to targeted therapy. ORIENT-11 study has demonstrated a significant delay of disease progression brought by sintilimab in combination with chemotherapy in this patient population."

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The morbidity and mortality of lung cancer both rank first among all types of cancers in China. Despite treatment advances, there remains significant unmet needs for additional effective treatment options for lung cancer patients. The acceptance of NDA by the NMPA represents an important progress in demonstrating the potential value of Tyvyt in lung cancer. We will actively cooperate with the regulatory authority to bring the high quality therapy to more patients with advanced non-squamous NSCLC as soon as possible."

"The intention of Lilly’s strategic cooperation with Innovent is to bring new anti-tumor treatments, developed with global standards, to patients in China. As the success of this partnership, Tyvyt is the only anti-PD-1 monoclonal antibody included in the NRDL for relapsed or refractory classical Hodgkin’s lymphoma," said Dr. Li WANG, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "With the encouraging result of ORIENT-11, Tyvyt may soon expand its indication to lung cancer. In the future, we will strengthen cooperation with Innovent to further explore Tyvyt’s potential in the field of immuno-oncology therapy and how Tyvyt may bring benefits to more patients."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement (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 ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA (pemetrexed) and platinum every 3 weeks for up to 4 cycles, followed by either sintilimab or placebo plus ALIMTA 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 nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, rendering the patients with no chance of radical resection. Meanwhile, even after radical surgery patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China are non-squamous subtype and 50 percent of nsqNSCLC are without sensitizing EGFR mutation or ALK rearrangement. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. Tyvyt is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

Tyvyt (sintilimab injection) is a type of 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 for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.