On Target Completes OTL38 Phase 2 Clinical Trial in Lung Cancer

On August 19, 2019 On Target Laboratories, Inc., a privately held biotechnology company that is developing tumor-targeted fluorescent imaging agents to improve cancer surgery, reported that it has completed its Phase 2, multi-center, open-label clinical trial for OTL38 in the detection of lung cancer nodules in lung cancer patients during surgery (Press release, On Target Laboratories, AUG 19, 2019, https://www.prnewswire.com/news-releases/on-target-completes-otl38-phase-2-clinical-trial-in-lung-cancer-300903646.html [SID1234538872]). Top-line data from the trial are expected to be reported in the first half of 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2 study assessed the efficacy, safety and tolerability of OTL38 used intraoperatively in patients with suspected lung cancer. OTL38 is an imaging agent consisting of a folate receptor targeting ligand linked to a highly fluorescent near-infrared dye, which specifically targets folate receptors overexpressed in multiple cancers, including non-small cell lung cancers. For more information on the trial refer to www.clinicaltrials.gov, using the NCT identifier NCT02872701.

"Completing the OTL38 Phase 2 trial in lung cancer is a major milestone for On Target Laboratories," said Chris Barys, newly appointed CEO of On Target Laboratories, who recently succeeded outgoing CEO Martin Low. "The completion of this study propels us one step closer to FDA approval and commercialization which will bring a much-needed advancement in imaging for patients undergoing image-guided surgery for lung cancer."

About OTL38

OTL38, which is being evaluated in clinical trials in ovarian cancer and lung cancer, is a novel compound consisting of a folate receptor targeting ligand, linked to a near-infrared dye which specifically targets folate receptors overexpressed in multiple cancer types.

Abstract on CStone’s CS1001-101 trial accepted for poster presentation at ESMO 2019 Annual Congress

On August 19, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that an abstract on the company’s ongoing CS1001-101 Phase Ib clinical study has been accepted for poster presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress (Press release, CStone Pharmaceauticals, AUG 19, 2019, View Source [SID1234538871]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone, and one of the company’s three backbone immunotherapy assets. CS1001 is currently being evaluated in a number of clinical trials in China, including one multi-arm Phase I study, two registrational Phase II studies, and three Phase III clinical studies.

CS1001-101 is a Phase Ia/Ib open-label, multiple-dose, dose-escalation and expansion study assessing the safety, tolerability, pharmacokinetics and anti-tumor efficacy of CS1001 in patients with advanced solid tumors or lymphomas. The study has already completed its dose-escalations. According to data released at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting, as of the data cut-off of November 30, 2018, 7 of the 29 enrolled patients showed partial response, with an overall response rate (ORR) of 24% (6 patients are still on treatment). This data demonstrates CS1001’s durable anti-tumor activities in a variety of solid tumors and lymphomas.

The updated data to be presented at the ESMO (Free ESMO Whitepaper) 2019 Annual Congress includes the safety data from the CS1001 Phase Ia/Ib study, and efficacy data of CS1001 in gastric cancer, esophageal cancer, MSI-H cancer and cholangiocarcinoma from the Phase Ib study. It is worth mentioning that, based on previously released data, CS1001 has shown good overall safety and tolerability, and durable anti-tumor activities across different tumor types.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during the Phase Ia stage of the study.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S. In China, its clinical program includes one multi-arm Phase Ib study, two pivotal Phase II studies, and three Phase III studies for several tumor types.

WuXi AppTec Reports First Half 2019 Interim Results

On August 19, 2019 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 2359.HK), a platform that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients, reported its financial results for the six months ended June 30, 2019 ("Reporting Period") (Press release, WuXi AppTec, AUG 19, 2019, View Source [SID1234538870]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This document serves purely as a summary and is not intended to provide a complete representation of the relevant matters. For further information, please refer to the 2019 interim report and relevant announcements published on the websites of the Shanghai Stock Exchange (www.sse.com.cn) and the Stock Exchange of Hong Kong (www.hkexnews.hk), and the designated media for dissemination of the relevant information. Investors are advised to exercise caution and be aware of the investment risks in dealing in the shares of the Company.

All financials disclosed in this press release are prepared based on International Financial Reporting Standards (or "IFRSs").

First Half 2019 Financial Highlights

Accelerated revenue growth of 33.7% year-over-year to RMB 5,894 million which was broad-based across all our business segments. During the Reporting Period, we added nearly 600 new customers and our active customers during this period exceeded 3,600. By fully leveraging the strength of our integrated end-to-end R&D services platform, we were able to create further synergies across all our business segments as we continued to adhere to our "Follow the Project" and "Follow the Molecule" strategies.
Gross profit grew 30.0% year-over-year to RMB 2,284 million. Gross profit margin was 38.7%[3]
Adjusted non-IFRS net profit attributable to owners of the Company grew 32.0% year-over-year to RMB 1,179 million.
Net profit attributable to owners of the Company was lower 16.9% year-over-year to RMB 1,057 million, due to a RMB 55 million loss from changes in fair value of our investment portfolio, versus a RMB 432 million gain in the same period last year.
Adjusted non-IFRS EPS increased by 9.1% versus the same period last year while diluted EPS was down 31.2%.[4]
First Half 2019 Operational Highlights

We acquired nearly 600 new customers, and our active customer count reached more than 3,600. We attracted and enabled numerous innovative biotech companies on our platform. We focused on and increased customer conversion, creating further synergies across all our business segments.
In small molecule drug discovery services, we continued to assist global customers develop pre-clinical candidate molecules and patent applications, with multiple research papers published in leading scientific journals. Our DNA-Encoded library ("DEL") now contains 90 billion compounds, enabling a growing number of customers globally to discover innovative small molecule drugs.
In our success-based drug discovery unit, we filed INDs for 10 new-chemical-entities for domestic customers with the China National Medical Products Administration (the "NMPA") and obtained 11 clinical trial authorizations ("CTAs"). As of June 30, 2019, we have cumulatively submitted 65 new-chemical-entity IND filings with the NMPA for our customers and obtained 45 CTAs.
In our laboratory testing services, we fully leveraged our platform, combining our technical experience, program management and regulatory expertise to prepare and facilitate submissions of our customers’ IND packages (the WuXi IND program or "WIND"). For the first time, we also helped our customers obtain clinical trial approval from the FDA under eCTD format.
Our small molecule CDMO/CMO pipeline has grown to more than 800 active projects, including 11 under China’s MAH pilot program. Furthermore, 40 projects are in Phase III clinical trials and 16 are already in commercial manufacturing.
Our cell and gene therapies CDMO business provided services for 30 clinical stage projects, including 21 projects in Phase I and 9 projects in Phase II/III.
We continued to build our global clinical research capabilities. Since our acquisition of Research Point Global, we are now providing multi-regional clinical development services to multiple customers. In May 2019, we also acquired Pharmapace, Inc., a clinical research services company with significant expertise in providing high quality biometrics services, allowing us to further diversify our global clinical trial service offering.
In April 2019, we appointed Dr. Frederick H. Hausheer as our Chief Medical Officer. With his decades of extensive clinical experience in both the US and China, Dr. Hausheer is already having a big impact on the design of our customers’ medical and clinical development programs. His skills enable us to provide a seamless integration of drug development projects from preclinical translational R&D into first-in-human studies along with Phase I-IV clinical development plans for our customers.
We hired Dr. Zhigang Chen as our Chief Digital Officer. As digital technology within the healthcare field becomes an increasingly important asset, Dr. Chen will put the infrastructure in place for WuXi AppTec to capitalize on the copious information synergies within our platform.
During the Reporting Period, we also continued to enhance our capacities and capabilities across all segments and facilities. Our newly built Qidong research and development center began operation. Three of our Laboratory Testing Division’s facilities – Drug Safety Testing, Bioanalytical Services and Medical Device Testing – completed regulatory inspections by the FDA, OECD, and CNAS, all with excellent results. Our cell and gene therapies CDMO/CMO facility in Wuxi city began operation, providing services to customers in China. Our small molecule CDMO/CMO STA’s new drug product manufacturing facility in Shanghai passed its first GMP inspection by the European MPA and, in July 2019, STA’s ASU facility in Shanghai and API process R&D and manufacturing facility in Changzhou, successfully passed two inspections by the FDA, with no Form 483 issued.
Management Comment

Mr. Edward Hu, Co-CEO of WuXi AppTec, said, "We achieved accelerated growth in the first half of 2019 across all of our businesses. Our revenue grew 33.7% to RMB 5,894 million and our adjusted non-IFRS net profit attributable to owners of the Company grew 32.0% to RMB 1,179 million. Both revenue and adjusted net profit growth rate accelerated compared with growth rate from the same period last year. In addition, we increased our focus on customer conversion, enabling further synergies across all our business segments."

Mr. Edward Hu further commented, "Our China-based laboratory services segment expanded its global and domestic customer base, improved customer penetration, and maintained a steady revenue growth rate of 23.7% to RMB 2,989 million. Our small molecule CDMO/CMO services portfolio increased from 650+ molecules at the end of 2018 to over 800 molecules as of June 30, 2019, and revenue grew 42.0%. US-based laboratory services revenue growth increased 30.0%, compared to a drop of 1.9%, in the same period last year. This was primarily due to cell and gene therapies CDMO services progressing more projects to later stage. Likewise, our medical device testing business returned to more historical levels of growth. Clinical research services was our fastest growing segment. Revenue grew 104.2%, driven by strong development of the domestic new drug clinical trial market, and contribution from acquired clinical CRO business."

Dr. Ge Li, Chairman and CEO of WuXi AppTec, concluded, "While achieving strong revenue growth, we continued to invest in new capacity and capabilities, including talent, laboratories, manufacturing facilities and technologies. Our integrated platform enables more entrepreneurs, scientists, and doctors around the world to participate in innovation to bring the best and newest medicines to those patients in need."

2019 Interim Results

Revenue increased 33.7% year-over-year to RMB 5,894 million.
– China-based laboratory services realized revenue of RMB 2,989 million, representing a year-over-year growth of 23.7%. We have one of the largest and most experienced small molecule drug R&D organizations globally, along with a comprehensive testing platform.
– CDMO/CMO services realized revenue of RMB 1,718 million, representing a year-over-year growth of 42.0%. The Follow-the-Molecule" strategy continues to perform very well. We establish close, cooperative relationships with our customers during the pre-clinical and early clinical development stage, and are then able to advance these projects into later clinical and commercialization stages if the molecules succeed in clinical development.
– U.S.-based laboratory services realized revenue of RMB 710 million, representing year-over-year growth of 30.0%. For cell and gene therapies CDMO services, we acquired more customers and more projects progressed to late stage, allowing revenue growth to accelerate. For medical device testing services, we actively developed new customers and capitalized on incremental demand resulting from the European Union Medical Device Regulation change.
– Clinical research and other CRO services realized revenue of RMB 472 million, representing year-over-year growth of 104.2%. Growth was mainly driven by continued rapid development of the domestic new drug clinical trial market, and acquired US clinical CRO business contributed RMB 84 million for the six months ended June 30, 2019. Excluding the effect of acquisition, the revenue of our clinical research and other CRO services grew 67.7%.
Gross profit increased 30.0% year-over-year to RMB 2,284 million. Gross profit margin was 38.7%, slightly lower than 39.8% in the six months ended June 30, 2018.[5]
– China-based laboratory services realized gross profit of RMB 1,301 million, representing year-over-year growth of 20.0%. Gross profit margin was 43.5%, lower by 1.34 percentage points[6], due to an increase in share-based compensation expenses and project mix.
– CDMO/CMO services realized gross profit of RMB 698 million, representing a year-over-year growth of 42.7%, in line with revenue growth. Gross profit margin was 40.6%[7], the same as last year. |
– U.S.-based laboratory services realized gross profit of RMB 191 million, representing year-over-year growth of 52.3%. Gross profit margin was 26.9%, up 3.93 percentage points[8], because of new customer acquisition and higher utilization rate of cell therapy manufacturing facilities.
– Clinical research and other CRO services realized gross profit of RMB 92 million, representing year-over-year growth of 65.5%. Gross profit margin was 19.4%, down 4.54 percentage points,[9] mainly due to the effect of pass-through revenue and amortization cost of intangible assets associated with M&A.
Net profit attributable to owners of the Company decreased 16.9% year-over-year to RMB 1,057 million, mainly due to a RMB 55 million loss in fair value of our investment portfolio, compared with a RMB 432 million gain in the same period last year. Excluding the impact of changes in fair value of our investment portfolio, the net profit attributable to owners of the Company in the current period increased by 32.4% compared with the same period last year.
2019 Interim Non-IFRS Results

2019 interim non-IFRS net profit attributable to owners of the Company decreased 10.7% year-over-year to RMB 1,213 million. This adjusts for share-based compensation expenses, listing expenses, foreign exchange-related effects and amortization of intangible assets acquired in business combinations.
2019 Interim Adjusted Non-IFRS Results

Excluding realized/unrealized gains or losses from our venture investments and realized/unrealized gains or losses from our joint ventures, 2019 interim adjusted non-IFRS net profit attributable to owners of the Company increased 32.0% year-over-year to RMB 1,179 million.

Immunicom Hosts Oncology Clinical Leaders at the 1st Annual Global Immunopheresis™ Clinical Conference in Krakow, Poland

On August 19, 2019 Immunicom, Inc., a medical technology company reported that it has been awarded FDA Breakthrough Device Designation for its non-pharmaceutical solution for treating stage IV metastatic cancer, hosted its 1st Annual Global Immunopheresis Clinical Conference which began on July 31st (Press release, Immunicom, AUG 19, 2019, View Source [SID1234538869]). This event provided a forum for oncology clinical leaders to meet, discuss and learn about Immunicom’s novel, cutting-edge immunotherapy − Immunopheresis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference was a collaborative event involving Immunicom’s global partners and focused on therapeutic apheresis as a viable clinical approach in oncology that potentially represents a less-costly innovation than currently-available therapies with the promise to enhance patient care and quality of life.

"Immunicom was extremely pleased to host such accomplished clinicians and thought leaders to our 1st Annual Global Immunopheresis Clinical Conference. Clearly, their collective interest in and enthusiasm for this potentially transformational therapy fueled the robust discussions that took place throughout the conference," said Amir Jafri, founder and CEO of Immunicom.

Immunicom plans to expand this conference series and other discussion opportunities in the future to include more participants and foster the exploration of new treatment boundaries in oncology. For more information about the event, please refer to the conference website.

ViewRay Announces Results of the First Prospective Clinical Trial on MR-guided Radiation Treatment for Prostate Cancer Without Implanted Markers

On August 19, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported the acceptance of publication by the International Journal of Radiation Oncology, Biology and Physics of the first prospective clinical trial of MR-guided radiation therapy (MRgRT) in patients with localized prostate cancer (Press release, ViewRay, AUG 19, 2019, View Source [SID1234538868]). This robust study of clinician and patient reported outcomes demonstrated zero CTCAE v4 grade 3 or higher gastrointestinal (GI) and genitourinary (GU) toxicity and even lower incidence of grade 2 toxicity than investigators hypothesized. It is also one of the first prospective clinical trials to study SBRT in a mix of intermediate- and high-risk prostate cancer patients, a challenging patient population to treat. The journal is the official scientific journal of the American Society for Radiation Oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Researchers from Amsterdam University Medical Center enrolled 101 patients with intermediate- or high-risk prostate cancer in a prospective phase II clinical trial. All patients received MRgRT in five fractions of 7.25 Gy to the target volume using on-table adaptive techniques. The trial did not use implanted markers or tissue spacers because treatments were delivered under MR-guidance, thereby eliminating an invasive procedure, potentially associated complications, and implantation costs.

Results at three months showed that no early CTCAE v4.0 grade 3 GU or GI toxicity was observed, and the maximum cumulative grade 2 early GU and GI toxicity measured by any symptom at any study time point was 23.8% (study hypothesis 40%) and 5.0% (study hypothesis 15%). These results were obtained in a complex clinical cohort (59.4% high-risk patients) and are comparable to what would be typically observed in lower-risk populations, pointing to the potential benefits of MR-guided SBRT in this higher risk group. Additionally, the low incidence of early GI toxicity, despite the inclusion of the base of the seminal vesicles in 96 percent of patients, illustrates the benefit of MR-guidance and on-table adaptive re-planning. This technology facilitates smaller treatment margins while minimizing damage to surrounding tissue and critical structures, such as urethra, rectum, and bladder. The publication noted that incontinence was uncommon, reported by 4% of patients at the end of MRgRT and decreasing over time.

"SBRT offers significant promise in the treatment of prostate cancer. Our clinical trial takes that a step further in showcasing its value in patients with intermediate- and high-risk disease, with a focus on evaluating associated toxicities and quality of life outcomes," said principal investigator Anna Bruynzeel, M.D., Ph.D., Radiation Oncologist at Amsterdam UMC. "We see a lower incidence of GI and GU toxicity with MR-guidance as compared to similar SBRT prostate cancer studies. The results reinforce the value of MRIdian’s real-time on-table adaptive treatment with automatic beam gating for prostate patients."

"This promising data in the treatment of prostate cancer with SBRT, enabled by the unique combination of MRIdian’s ability to see, shape, and strike, is notable for patients and physicians," said Scott Drake, President and CEO. "MRIdian is providing physicians the confidence and tools they need to deliver ablative radiation doses both precisely and accurately while sparing sensitive structures near the target, in order to achieve better patient outcomes. We are pleased to add this prospective trial to our clinical data compendium and thank the team at Amsterdam UMC for their work to improve the lives of cancer patients."

The article in press can be viewed at View Source(19)33640-5/fulltext.

About the Study
Article in Press in the International Journal of Radiation Oncology, titled: "A prospective single-arm phase II study of stereotactic magnetic-resonance-guided adaptive radiotherapy for prostate cancer: Early toxicity results", authored by Anna M.E. Bruynzeel, MD, PhD, Shyama U. Tetar, MD, Swie S. Oei, MD, Suresh Senan, MRCP, FRCR, PhD, Cornelis J.A. Haasbeek, MD, PhD, Femke O.B. Spoelstra, MD, PhD, Anna H.M. Piet, MD, Philip Meijnen, MD, PhD, Marjolein A.B. Bakker van der Jagt, MD, Tamara Fraikin, Berend J. Slotman, MD, PhD, Reindert J.A. van Moorselaar, MD PhD, and Frank J. Lagerwaard, MD, PhD. According to the study, "The maximum cumulative grade ≥2 early GU and GI toxicity measured by any symptom at any study time point was 23.8% and 5.0%, respectively. No early grade 3 GI toxicity was observed. Early grade 3 GU toxicity was 0% and 5.9% according to the CTCAE and RTOG and scoring systems, respectively, as a result of different grading of radiation-cystitis. The low incidence of early GI toxicity was confirmed by patient-reported outcome data. GU grade ≥2 toxicity peaked to 19.8% at the end of MRgRT, followed by a return to the baseline average score at three months follow-up."