On October 29, 2021 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies worldwide in the pharmaceutical, biotech and medical device industries to advance discoveries and deliver groundbreaking treatments to patients, reported its financial results for the third quarter and nine months ended September 30, 2021 ("Reporting Period") (Press release, WuXi AppTec, OCT 29, 2021, View Source [SID1234592204]).

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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 2021 third quarter 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 (IFRS), in currency of RMB.

The 2021 Third-Quarter Report of the Company has not been audited.

[1] To better reflect the operation results and key performance, we adjusted the scope of Non-IFRS, and the comparative financial figures for the comparable periods have been adjusted to reflect this change.

[2] Third quarter 2021 and 2020, we had a fully-diluted weighted average share count of 2,949,275,618 and 2,821,245,946 ordinary shares, respectively.

Third-Quarter 2021 Financial Highlights

Revenue grew 30.6% year-over-year to RMB5,985 million. This strong revenue growth was mainly attributable to the Company’s continued focus on leveraging its unique integrated end-to-end platform to achieve synergy and strong growth across our business segments:

WuXi Chemistry revenue grew 33.3% to RMB3,651 million, adjusted non-IFRS gross profit grew 28.7% to RMB1,503 million, gross profit margin at 41.2%.
WuXi Testing revenue grew 37.4% to RMB1,227 million, adjusted non-IFRS gross profit grew 18.6% to RMB397 million, gross profit margin at 32.3%.
WuXi Biology revenue grew 22.4% to RMB504 million, adjusted non-IFRS gross profit grew 52.2% to RMB256 million, gross profit margin at 50.8%.
WuXi ATU revenue grew 14.7% to RMB283 million, adjusted non-IFRS gross profit declined 57.3% to RMB17 million, gross profit margin at 6.0%. ATU China revenue grew 223% YoY.
WuXi DDSU revenue grew 10.5% to RMB311 million, adjusted non-IFRS gross profit declined 15.2% to RMB118 million, gross profit margin at 38.0%.
Segment

Revenue

YoY

Adjusted
Non-IFRS
Gross Profit

YoY

Adjusted
Non-IFRS
Gross Profit
Margin

WuXi
Chemistry

3,651.40

33.3%

1,503.32

28.7%

41.2%

WuXi Testing

1,227.27

37.4%

396.68

18.6%

32.3%

WuXi Biology

504.10

22.4%

256.15

52.2%

50.8%

WuXi ATU

282.52

14.7%

17.07

-57.3%

6.0%

WuXi DDSU

311.05

10.5%

118.33

-15.2%

38.0%

Unit: RMB million

Third-Quarter 2021 Key Financials

IFRS gross profit increased 24.7% year-over-year to RMB2,200 million. Gross profit margin was 36.8%.[3]
Adjusted Non-IFRS gross profit increased 23.5% year-over-year to RMB2,295 million. Adjusted Non-IFRS gross margin was 38.3%.
EBITDA increased 47.2% year-over-year to RMB1,523 million.
Adjusted EBITDA increased 42.1% year-over-year to RMB2,012 million.
Net profit attributable to owners of the Company increased 36.2% year-over-year to RMB887 million. The strong net profit growth is mainly attributable to robust revenue growth and continuous improvements to the Company’s operating efficiencies.
Adjusted non-IFRS net profit attributable to owners of the Company increased 37.8% year-over-year to RMB1,358 million.
Diluted EPS increased 30.4% year-over-year to RMB0.30, while adjusted diluted non-IFRS EPS increased by 39.4% year-over-year to RMB0.46.

[3] If prepared under Accounting Standard for Business Enterprises of PRC, the gross profit grew 24.9% year-over-year to RMB2,213 million. Gross profit margin was 37.0%.

Year-to-Date 2021 Financial Highlights

Revenue grew 39.8% year-over-year to RMB16,521 million. The strong revenue growth was mainly attributable to the Company’s continued focus on leveraging its unique integrated end-to-end platform to achieve synergy and strong growth across our business segments:

WuXi Chemistry revenue grew 47.5% to RMB10,077 million, adjusted non-IFRS gross profit grew 44.7% to RMB4,238 million, gross profit margin at 42.1%.
WuXi Testing revenue grew 43.9% to RMB3,335 million, adjusted non-IFRS gross profit grew 51.4% to RMB1,132 million, gross profit margin at 33.9%.
WuXi Biology revenue grew 33.2% to RMB1,424 million, adjusted non-IFRS gross profit grew 26.6% to RMB596 million, gross profit margin at 41.8%.
WuXi ATU revenue declined 5.2% to RMB736 million, adjusted non-IFRS gross profit declined 89.7% to RMB14 million, gross profit margin at 1.9%. ATU China revenue grew 187% YoY.
WuXi DDSU revenue grew 16.4% to RMB932 million, adjusted non-IFRS gross profit declined 0.6% to RMB412 million, gross profit margin at 44.2%.
Segment

Revenue

YoY

Adjusted
Non-IFRS
Gross Profit

YoY

Adjusted
Non-IFRS
Gross Profit
Margin

WuXi
Chemistry

10,077.19

47.5%

4,237.64

44.7%

42.1%

WuXi Testing

3,334.51

43.9%

1,131.53

51.4%

33.9%

WuXi Biology

1,424.33

33.2%

596.05

26.6%

41.8%

WuXi ATU

735.93

-5.2%

13.67

-89.7%

1.9%

WuXi DDSU

931.80

16.4%

411.76

-0.6%

44.2%

Unit: RMB million

Year-to-Date 2021 Key Financials

IFRS gross profit increased 37.5% year-over-year to RMB6,084 million. Gross profit margin was 36.8%.[4]
Adjusted Non-IFRS gross profit increased 36.0% year-over-year to RMB6,397 million. Adjusted Non-IFRS gross margin was 38.7%.
EBITDA increased 50.3% year-over-year to RMB5,466 million.
Adjusted EBITDA increased 49.2% year-over-year to RMB5,660 million.
Net profit attributable to owners of the Company increased 50.4% year-over-year to RMB3,562 million. The strong net profit growth is mainly attributable to robust revenue growth and continuous improvements to the Company’s operating efficiencies.
Adjusted non-IFRS net profit attributable to owners of the Company increased 55.7% year-over-year to RMB3,806 million.
Diluted EPS increased 42.4% year-over-year to RMB1.21, while adjusted diluted non-IFRS EPS increased by 49.4% year-over-year to RMB1.30.
[4] If prepared under Accounting Standard for Business Enterprises of PRC, the gross profit grew 37.6% year-over-year to RMB6,111 million. Gross profit margin was 37.0%.

Year-to-Date 2021 Business Highlights

During the first nine months of 2021, demand for our services was strong and we continued to grow our customer base to more than 5,640 active accounts by adding over 1,300 new customers. We continued to optimize cross-platform synergies to better serve our customers worldwide, strengthening our unique competitive advantage as a fully integrated CRDMO (Contract Research Development and Manufacturing Organization) and a one-stop service provider for our clients’ discovery, development and manufacturing service needs.
– Revenue from US grew 38% to RMB9,011 million, revenue from Europe grew 33% to RMB2,255 million, revenue from China grew 45% to RMB4,038 million, and revenue from others grew 53% to RMB1,216 million.
– We continued to expand our customer base and retain existing clients. During the Reporting Period, revenue from existing clients grew 30% to RMB15,337 million and new clients contributed RMB1,184 million in revenue.
– During the Reporting Period, revenue from top 20 global pharmaceutical companies grew 21%, up to RMB4,699 million in revenue; revenue attributable to all other customers grew 49% to RMB11,823 million.
– Our unique positioning across the pharmaceutical development value chain drove our "follow-the-customer", "follow-the-molecule" strategy and enhanced synergies across our business segments. Customers using services from more than one of our business units contributed RMB14,190 million in revenue, growing 40% year-over-year.
WuXi Chemistry: CRDMO integrated business model drives strong growth
– Revenue of WuXi Chemistry grew 47.5% to RMB10,077 million, adjusted non-IFRS gross profit grew 44.7% to RMB4,238 million, with gross margin at 42.1%. During the Reporting Period:
– Revenue of small molecule discovery services grew 42.3% to RMB4,443 million.

i. We have a world-leading small molecule research team that delivered approximately 200,000 custom synthesized compounds to our clients from January to September 2021. Through our small molecule discovery service, we enable our customers to accelerate their R&D while generating opportunities for our downstream business units. Executing our strategies of "follow the customer" and "follow the molecule," we establish trusted partnership with our customers, which supports continued clinical and commercial projects and opportunities for the company. The small molecule discovery service laid a solid foundation to support the rapid and sustainable growth of our CRDMO business.
ii. We continue executing our "long-tail" strategy and the "long-tail" customers demonstrated outperforming growth. During the Reporting Period, revenue from "long-tail" customers in our small molecule discovery service grew 68%, with its percentage of revenue contribution continuously rising.

– Revenue of our small molecule CDMO service grew 51.9% to RMB5,634 million.

i. During the Reporting Period, the Company added 526 new molecules to our project funnel, including 9 commercial projects and 31 projects from "win-the-molecule," with a total of 1,548 molecules, including 37 in commercial stage, 47 in phase III stage, 235 in phase II stage and 1,229 in phase I and pre-clinical stage.
ii. New modalities CDMO business is gaining strong momentum. During the reporting period, oligo & peptide clients and molecules grew 96% and 97% respectively versus the end of 2020.

– On August 3, 2021, WuXi STA, a subsidiary of the Company, completed the acquisition of a drug product manufacturing facility in Couvet, Switzerland ("Couvet site") from Bristol Myers Squibb. The Company has consolidated its contribution starting from July. The Couvet site is a state-of-the-art manufacturing facility with commercial-scale production capacity for capsule and tablet dosage forms.

– On Sep 24, 2021, WuXi STA announced its decision to build a new state-of-the-art pharmaceutical clinical and commercial manufacturing complex in Middletown, Delaware. The new facility will feature space for testing laboratories, manufacture active pharmaceutical ingredients (APIs), and manufacture and package solid dosage pharmaceutical products and sterile products. The site responds to the growing industry and local customer demand for manufacturing innovative new medicines.
WuXi Testing: strengthening synergies between preclinical and clinical testing services
– Revenue of WuXi Testing grew 43.9% to RMB3,335 million, adjusted non-IFRS gross profit grew 51.4% to RMB1,132 million, with gross margin at 33.9%. During the Reporting Period:
– Revenue of lab testing services grew 41.9% year-over-year to RMB2,133 million. Lab testing services revenue excluding medical devices testing grew 58% YoY.

i. The Company provides a full range of laboratory testing services to our customers, including DMPK, toxicology, and bioanalysis for drug developing testing as well as medical device testing. We leveraged our integrated WuXi AppTec Investigational New Drug (IND) program (WIND) to generate preclinical data and prepare global regulatory submissions of IND packages, expediting the IND application process for many of our customers worldwide. 123 WIND service packages were signed during the Reporting Period and the average revenue per WIND package ranges from USD1.1 million to 1.5 million.
ii. Toxicology services achieved strong revenue growth of 72% year-over-year. We maintain and reinforce our industry leading position in China for drug safety evaluation services.
iii. The Company formed a cross-functional team between laboratory testing departments and clinical CRO department to approach our customers when their projects are close to IND stage. We believe this business realignment will further strengthen the funnel flow from pre-clinical testing to clinical testing, creating synergy across our integrated testing platform.

– Revenue of clinical CRO & SMO grew 47.4% year-over-year to RMB1,201 million.

i. For clinical CRO, the Company provided services to more than 200 projects for our clients, enabling our customers to obtain 14 IND approvals and file 5 BLA/NDA applications. During the Reporting Period, biometrics revenue grew quickly.
ii. For SMO (site management organization), the Company keeps expanding quickly. Our SMO maintained its leadership position in China with around 4,500 staff in 153 cities, providing services for hundreds of clinical trials across about 1,000 hospitals. Team size increased 42% year-over-year, implying continued strong market demand for our SMO services.
iii. In the first nine months of 2021, SMO supported 16 new drug approvals versus 17 drugs approvals in the full year of 2020.
WuXi Biology: leading innovation in new modalities
– Revenue of WuXi Biology grew 33.2% to RMB1,424 million, adjusted non-IFRS gross profit grew 26.6% to RMB596 million, with gross margin at 41.8%. – The Company has the largest discovery biology enabling platform with over 2,000 experienced scientists. We provide comprehensive biology services and solutions, with a strong track record of enabling the delivery of hits, leads and PCCs (Preclinical Candidates).
– The Company has a leading DNA Encoded Library (DEL). As of September 30, 2021, our DEL had more than 90 billion compounds, 6,000 proprietary scaffolds and 35,000 building blocks.
– Through comprehensive integration of our DEL, protein production, and structure-based drug design (SBDD) capabilities, we have established a competitive Target-to-Hit platform to enable our customers’ innovative R&D of small molecule drugs.
– The Company continues to build new biology capabilities related to new modalities, including oligo, cancer vaccine, PROTAC, vector platform, novel drug delivery vehicles, etc. During the Reporting Period, revenue from new modalities and large molecules in WuXi Biology grew 56%, and its revenue contribution rose to 13.3% by the end of third quarter 2021, from 10.4% by end of 2020, implying that new modalities related biology service has become an increasingly important growth driver.
WuXi ATU: CTDMO integrated business model drives future growth
– Revenue of WuXi ATU declined 5.2% to RMB736 million. Driven by strong demand for plasmids and lenti-viral vectors manufacturing, ATU China saw strong performance with revenue growth of 223% in the third quarter and 187% in the first nine months of 2021, which partially offset the decline in ATU US.
– During the Reporting Period, the Company focused on improving our CTDMO integrated enabling platform and provided testing services for 326 projects, and provided development and manufacturing services for 45 pre-clinical and Phase I projects, 6 Phase II projects, and 10 Phase III projects.
– Our Shanghai Lin-gang site opened on October 18, 2021. It is the fourth site for WuXi ATU globally providing testing, process development and manufacturing services to global clients.
WuXi DDSU: enabling domestic customer innovation
– Revenue of WuXi DDSU grew 16.4% to RMB932 million, adjusted non-IFRS gross profit declined 0.6% to RMB412 million, implying gross margin at 44.2%.
– During the Reporting Period, our success-based drug discovery service unit filed INDs for 16 drug candidates and obtained 12 CTAs for domestic customers. As of September 30, 2021, we have cumulatively submitted 136 new chemical entity IND filings with the NMPA and obtained 103 CTAs, with 1 project in NDA pending stage, 1 project in Phase III clinical trial, 14 projects in Phase II clinical trials, and 73 projects in Phase I clinical trials. Upon the products’ successful launch to the market by our customers, we will begin receiving royalty income.
– Among the 136 projects that IND were filed or currently in clinical stage, over 70% of them rank top 3 in China in terms of the drug development progress among same-class drug candidates.
Continuous Improvements in ESG Management and Performance

As a global corporate citizen, we are continuing to improve our ESG management and performance and the implementation of our sustainability strategy. We strictly comply with the highest ethical standards, while continuously refining our standards and sustainability policies across all business operations. In order to accomplish this, we conducted Business Code of Conduct trainings for all employees. We also carried out the annual Supplier Business Code of Conduct training and ESG audit trainings for all of our key suppliers to ensure the implementation of the high ESG requirements and standards across our supply chain management.

In September 2021, Morgan Stanley Capital International ("MSCI") upgraded our MSCI ESG Rating to AA. This new rating reflects our commitment to incorporating environmental and social responsibilities into the company’s business strategies and operations.

We remain committed to "doing the right thing and doing it right," and will focus on delivering on our commitments to our customers, employees, investors, communities and the environment to operate in a sustainable way both today and in the future.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "As part of our commitment to serving our customers better, we have completed changes to the organization of our business segments in the third quarter 2021. We have integrated our capabilities to form three new business divisions – WuXi Chemistry, WuXi Biology, and WuXi Testing – which now possess the end-to-end capabilities needed to provide integrated services to customers. Along with WuXi ATU and WuXi DDSU, we now have five integrated platforms."

"Dr. Minzhang Chen leads the WuXi Chemistry segment, which now encompasses all chemistry services, including research, development and commercial manufacturing under one roof. This is our new business model that we have named CRDMO (Contract Research, Development and Manufacturing Organization). Executing our strategy of ‘follow-the-molecule,’ we believe it will provide more integrated service offerings to our customers, spanning from discovery and process development to commercial manufacturing, which will in turn enhance funnel flow and realize synergies across our end-to-end platform. WuXi Chemistry performed very well in the first nine months of 2021, with revenue growth of 47.5% YoY."

"Dr. Steve Yang leads our WuXi Testing and WuXi Biology segments. WuXi Testing now integrates our drug development testing services (DMPK, Toxicology, Bioanalytical) and clinical trial services (clinical CRO and SMO) to provide customers with seamless experience to accelerate project and pipeline progression. WuXi Biology provides a full spectrum of discovery biology enabling service and collaborates with WuXi Chemistry to support integrated small molecule drug discovery. WuXi Testing and WuXi Biology both performed well in the first nine months of 2021, with revenue growth of 44.1% and 33.2% respectively."

Dr. Ge Li concluded, "In the third quarter of 2021, we began to experience apparent results of our business segment realignment come to bear in the form of enhanced synergies, increased cross-selling, and deeper customer penetration. The power of our unique and differentiated CRDMO and CTDMO end-to-end business models lay the foundation for reliable and continued long-term growth. Concurrently, the fundamentals of our business and its future outlook both remain very strong. Looking ahead, we will further increase investment in our R&D services in both capacity and capabilities, particularly in new modalities. We are confident that this will better enable our customers to bring innovative medicines to patients in need – realizing our vision that ‘every drug can be made and every disease can be treated."

On October 29, 2021 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"), a highly differentiated, multi-product, commercial-stage medical technology company, reported that it hosted a virtual investor event with several hundred participants on October 26, 2021 (Press release, PAVmed, OCT 29, 2021, View Source [SID1234592202]). The event, Veris Heath: Bringing Digital Health to Cancer Care, focused on PAVmed’s digital health subsidiary Veris Health ("Veris").

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"When I first heard about Veris Health I was impressed by their big vision to make a measurable impact on cancer care"

The event recording and presentation deck are now available for viewing.

The panelists provided a comprehensive overview of Veris’ disruptive technology, vision, business model, and strategy. They discussed how PAVmed’s entry into the digital health sector fits within its broader long-term growth strategy and how Veris seeks to utilize the first intelligent implantable vascular access port with biologic sensors to facilitate and optimize cancer care through remote patient monitoring and data analytics. Panelists included:

Lishan

Aklog, MD

PAVmed Chairman & Chief Executive Officer

Veris Executive Chairman

James D.

Mitchell, MD

PAVmed VP, Digital Health

Veris Chief Medical Officer

Sumit

Shah, MD, MPH

Veris Medical Advisory Board Member

Director of Clinical Innovation & Digital Health, Division of Oncology, Stanford Cancer Institute, Stanford Health Care

Clinical Assistant Professor, Medicine-Oncology, Member, Stanford University School of Medicine

Timothy E.

Baxter

PAVmed Board of Directors

Former President & CEO of Samsung Electronics North America

Sunny

Webb

PAVmed VP, Data & Analytics

Veris Chief Technology Officer

The event concluded with a moderated question and answer session, which provided the attendees the opportunity to interact with the panelists.

Veris, a majority-owned subsidiary of PAVmed, acquired Oncodisc Inc., a digital health company with groundbreaking tools to improve personalized cancer care in May 2021. Veris is developing a remote cancer care platform that integrates an intelligent implantable vascular access port with physiologic sensing, software with symptom reporting and telehealth functions, as well as advanced data analytics. Veris’ groundbreaking vascular access port contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in cancer patients undergoing treatment. Wireless communication to the patient’s smartphone and Veris’ cloud-based digital healthcare platform will deliver actionable real time data to patients and physicians efficiently and effectively. Veris is targeting FDA 510(k) clearance of the intelligent implantable vascular access port and launch of the remote digital healthcare platform for H2-2022.

"We have about 20% of the U.S. economy, which is what healthcare represents, finally leveraging digital tools that have been long available in other sectors," said Lishan Aklog, MD, PAVmed’s Chairman and Chief Executive Officer and Veris’ Executive Chairman. "The Veris technology…offers data-driven risk management tools for precision oncology, and incorporates additional prospects for substantial value-creation through data monetization and biotherapeutic clinical trial support."

James Mitchell, MD, PAVmed’s VP, Digital Health and Veris’ Chief Medical Officer noted, "today’s aggressive outpatient cancer treatments, including immunotherapy and chemotherapy, leave patients unmonitored and at risk of serious, avoidable complications, leading to high rates of hospitalization, poor patient quality of life, and increasing health system costs. Every year in the United States there are about 1.5 million unplanned hospital admissions in cancer patients…[which] cost up to $70,000 per patient on average. We also know through cancer research that 19-50% of these hospitalizations are potentially preventable with appropriate timely outpatient interventions."

"If we look at other solutions…there is no solution that really checks all the boxes—providing the uninterrupted data needed for true patient care, that tucks easily into the existing workflow, leverages existing reimbursement, and really takes advantage of telemedicine technology," said Dr. Mitchell.

"When I first heard about Veris Health I was impressed by their big vision to make a measurable impact on cancer care," said Sunny Webb, PAVmed’s VP, Data & Analytics and Veris’ Chief Technology Officer. "Like many of you, I have had people close to me that have battled cancer…Applying data science to cancer care is a world changer for future generations. Treatment has come a long way in recent years, but we can do better. I’m certain that Veris has the right approach…to build an integrated digital health care platform that will help millions of cancer patients and their oncologists."

"Veris is fundamentally a healthcare-oriented tech platform that uses smart devices," said Timothy E. Baxter, a member of PAVmed’s Board of Directors and former President & CEO of Samsung Electronics North America. "[In the tech sector] we are moving from…what some might call ‘dumb’ products to now ‘smart’ devices and ‘smart’ solutions…The growth we have seen is quite remarkable…driven by a host of new technologies…it’s AI, it’s big data, it’s cloud, it’s 5G, IoT, VR/AR…When you combine these new technologies with relevant data…we are now creating new possibilities and disrupting old."

Recently, Veris entered into a global program relationship with Microsoft, and engaged with leading full-service Silicon Valley-based full-stack software development firm Loka Inc. to build its remote digital healthcare platform.

On October 29, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported its Marketing Authorization Application (MAA) for ZYNLONTA, a CD19-targeted ADC for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), has been validated by the European Medicines Agency (EMA) (Press release, ADC Therapeutics, OCT 29, 2021, View Source [SID1234592201]). Validation of the application enables the evaluation process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) to begin.

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"We continue to gain momentum with the U.S. ZYNLONTA launch, and we are pleased to be making progress in Europe with the submission and validation of our MAA," said Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics. "This is a significant step forward in our commitment to making ZYNLONTA available to as many patients as may benefit."

In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA as the first and only CD19-targeted ADC as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. In September 2021, the European Commission granted Orphan Drug Designation to ZYNLONTA for the treatment of DLBCL.

The MAA is supported by data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. The trial enrolled patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplants and CAR-T therapy prior to their treatment with ZYNLONTA.

Results from LOTIS-2 demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months. At the most recent data cut-off for patients enrolled in the trial, the median duration of response (mDoR) was 13.4 months. In a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common (≥10%) grade ≥3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On October 28, 2021 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported it was ranked one of the global biopharmaceutical industry’s top employers honored by Science and Science Careers’ 2021 Top Employers Survey for the seventh consecutive year (Press release, Moderna Therapeutics, OCT 28, 2021, View Source [SID1234592200]). Moderna was ranked 7th on the list this year and was recognized for its commitment to innovative leadership, respect for employees and easily adapting to change.

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"We are honored to be one of only a few pharmaceutical and biotech companies around the world that has ranked as a top 20 employer in Science’s survey for the last seven years in a row, which is for most of our history. This recognition is a humbling reminder of our employees’ dedication and relentless pursuit of our collective mission," said Stéphane Bancel, Chief Executive Officer of Moderna. "Since our founding, we have obsessed about doing groundbreaking, cutting-edge science to bring a new class of medicines to the world. These investments in science over the past 10 years prepared us to chase the SARS-CoV-2 virus when it emerged. And, that scientific passion enabled us to bring a vaccine against COVID-19 to hundreds of millions of people around the world – one that real-world evidence has shown to have sustainably high, durable efficacy. We built the company as a platform company and because mRNA is an information molecule, we believe this is just the beginning."

Over the past year, Moderna’s COVID-19 response efforts created hundreds of jobs, increasing its employee numbers from 800 in 2019 to more than 1,800 employees by June 2021. The Company is making several investments to support this growth. Moderna recently announced an expansion of the Moderna Technology Center in Norwood, including more than doubling of space to transform the facility from a production and lab space to an industrial technology center. The expansion also includes an increase in Moderna’s technical development capacity and preclinical production capability. The Company also announced that it is investing in a new Moderna Science Center, a purpose-built space to support the Company’s next chapter of discovery.

Moderna has continued to prioritize employee well-being, even as new COVID-19 variants and other pipeline advancements drove urgency of innovation across the organization. The Company is committed to maintaining an inclusive culture and instituted a Conscious Inclusion diversity training series, hosted learning opportunities and celebrations to encourage dialogue through diversity-related events and doubled the number of its Employee Resource Groups, from three to six, with two more in the early stages of forming. At its annual R&D Day, Moderna unveiled plans to reinvigorate employee training and development programs, with a particular focus on AI Academy, as well as outlined how it has prioritized accelerating digital investments over the past year to better support employee collaboration and co-invention.

"Over the past ten years, we brought together the curious, the bold and the visionaries to advance mRNA science for society and create a COVID-19 vaccine," said Tracey Franklin, Chief Human Resources Officer. "Together, we demonstrated that when you put humans in the right environment and allow them to be who they are, they will achieve incredible things."

The annual survey’s findings are based on more than 7,200 completed surveys from readers of Science and other survey invitees. Survey respondents came from North America (64%), Europe (19%), and Asia/Pacific Rim (11%); 95% worked in biotechnology, biopharmaceutical, and pharmaceutical companies. The responses were analyzed by The Brighton Consulting Group, which used a mathematical process to determine the driving characteristics of a top employer and to assign a unique score to rate each company’s employer reputation.

For the complete feature along with individual company rankings, please visit: View Source

On October 29, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present multiple posters on its lead program, ST101, at the 28th Prostate Cancer Foundation (PCF) Annual Scientific Retreat, being held virtually October 28- 29th, 2021 and November 4-5, 2021, and the 18th International Congress of the Society for Melanoma Research, being held virtually October 28-31, 2021 (Press release, Sapience Therapeutics, OCT 29, 2021, View Source [SID1234592199]).

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Presentation details for the posters are as follows:

Society for Melanoma Research

Presentation Title: Efficacy, safety, PK and PD data from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ, in patients with advanced and metastatic solid tumors
Date/Time: October 28, 2021 from 3:00 PM-4:30 PM ET

Presentation Title: C/EBPβ antagonist peptide, ST101, as a novel therapeutic for melanoma
Date/Time: October 28, 2021 from 3:00 PM-4:30 PM ET
PCF Annual Scientific Retreat

Presentation Title: Efficacy, safety, pharmacokinetic and pharmacodynamic data from phase 1 dose-escalation of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ, in patients with castration-resistant prostate cancer
Date/Time: November 4, 2021 from 1:00 PM-2:30 PM PT

Presentation Title: Cell-penetrating peptide antagonist of CCAAT/enhancer binding protein β displays potent anti-prostate cancer activity
Date/Time: October 29, 2021 from 12:30 PM-2:00 PM ET
About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation for the treatment of glioma by the European Commission.