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.

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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.

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]).

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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.

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]).

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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.

On August 16, 2019 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it was selected to be a specialty pharmacy network partner for Celgene’s new product Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis (MF) (Press release, Onco360, AUG 16, 2019, View Source [SID1234538820]).

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"Onco360 is privileged to be selected as a specialty pharmacy provider for Inrebic patients," said Paul Jardina, President and CEO, Onco360. "The recent approval of Inrebic provides another treatment option for patients with newly-diagnosed MF while providing a novel treatment option for MF patients who have experienced failure with ruxolitinib as a result of lack of tolerance or response. As a provider of Inrebic treatment, Onco360 will utilize its expertise in the delivery of clinical oncology and hematology programs through its high-touch patient support model designed for the highly specialized needs of MF patients and their physicians."

MF is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells. Bone marrow is gradually replaced with fibrous scar tissue, which limits the ability of the bone marrow to make red blood cells. The disorder can lead to anemia, weakness, fatigue and swelling of the spleen and liver, among other symptoms. Myelofibrosis is classified as a myeloproliferative neoplasm, a group of rare blood cancers that derive from blood-forming stem cells. In the U.S., myelofibrosis occurs in 1.5 of every 100,000 people each year. Both men and women are affected, and while the disease can affect people of all ages, the median age at diagnosis ranges from 60 to 67 years. On average, MF patients survive five to six years following their initial diagnosis. In the absence of treatment, up to 12% of MF patients will progress and develop Acute Myeloid Leukemia (AML).

Inrebic obtained FDA approval as a result of the randomized, Phase III JAKARTA trial which demonstrated that Inrebic administration resulted in significantly improved MF-associated symptom burden (40% vs. 9%) and significantly improved spleen response rates (37% vs. 1%) compared to a placebo.

Inrebic is manufactured by Celgene and was approved by the U.S. FDA on August 16, 2019. For full prescribing information, visit INREBIC.com

On August 16, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported the acceptance of an oral late breaking presentation providing updated melflufen data from the Phase 2 pivotal OP-106 HORIZON study as well as two poster presentations at the 17th International Myeloma Workshop (IMW) meeting (September 12-15, Boston, Massachusetts, USA) (Press release, Oncopeptides, AUG 16, 2019, View Source [SID1234538822]).

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Melflufen is a lipophilic peptide-conjugated alkylator belonging to a novel class of Peptidase Enhanced Cytotoxics (PEnC) and is presently being evaluated in a broad global clinical development program.

Comment from CEO Jakob Lindberg
"We are looking forward to the upcoming IMW meeting. IMW is an important myeloma-specific meeting held every two years. Professor Paul G. Richardson will be presenting data from the phase 2 HORIZON study at the oral late breaking session on melflufen’s activity in patients with relapsed-refractory multiple myeloma (RRMM) and extra medullary disease (EMD). At the European Hematology Association (EHA) (Free EHA Whitepaper) in June, interim data were presented suggesting that melflufen may be the first drug to exhibit meaningful activity in this difficult to treat EMD patient population. To our knowledge, HORIZON represents the largest clinical trial cohort of EMD patients to date and there is a clear unmet medical need in this rapidly growing patient population" said Jakob Lindberg, CEO Oncopeptides. "Melflufen, in combination with dexamethasone, demonstrates encouraging activity in advanced RRMM patients with EMD. Response rates appear higher than observed in prior studies and this could be linked to melflufen’s unique mechanism of action. These results are encouraging, and we continue to monitor this patient group in ongoing and future clinical trials".

Upcoming presentations at IMW
The HORIZON data will be presented as an oral presentation by Professor Paul G. Richardson, in the plenary session "Late Breaking Abstracts" on Sunday, September 15 at 08.30 AM (ET) (14.30 CET) under the title: Activity of Melflufen in RRMM Patients with Extramedullary Disease in the Phase 2 HORIZON Study (OP-106) – Promising Results in a High-Risk Population.

The first poster presentation will be held during Poster Session I, Multiple Myeloma Genomics – Friday, September 13 at 6.30 – 8.00 PM (ET) (Saturaday, September 14 at 00.30 – 02.00 CET) under the title: Aminopeptidase gene expression in myeloma.

The second poster presentation will be held during Poster Session II, Treatment of Previously Treated Myeloma – Saturday, September 14 at 12.30 – 2.00 PM (ET) (18.30 – 20.00 CET) under the title: Quality of life treatment for relapsed/refractory multiple myeloma, a systematic review.

Paul G. Richardson, MD, is Professor of Medicine at Harvard Medical School and Clinical Program Leader, Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute in Boston, Massachusetts, USA.

About the OP-106 HORIZON study
Patient recruitment in the pivotal HORIZON study is ongoing. The goal is to include 150 patients in the study with the last patient included during Q3 2019. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). Interim data were presented at the EHA (Free EHA Whitepaper) meeting in June based on a data cut-off dated May 6th 2019 with 121 patients treated, out of which 108 patients had recivied two or more cycles of treatment.

Oncopeptides has initiated preparations for submitting a New Drug Application (NDA) for accelerated approval of melflufen in the US based on the available HORIZON data. The detailed plan for the filing process is still under development, but Oncopeptides currently targets to submit the application to FDA during the first quarter of 2020. This could then lead to the first melflufen market approval in the US in 2020.

More information can be found at: View Source;rank=2

About Melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.