On May 14, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that new and updated analyses on the ongoing studies of savolitinib, surufatinib, and fruquintinib will be presented at the upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, taking place on May 29-31, 2020 (Press release, Hutchison China MediTech, MAY 14, 2020, https://www.chi-med.com/asco20-virtual-scientific-program/ [SID1234557962]).

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Chi-Med plans to hold a conference call on the following Monday, June 1, to discuss the results.

SAVOLITINIB
Title: Phase II study of savolitinib in patients (pts) with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping
Lead Author: Shun Lu, MD, PhD., Shanghai Chest Hospital, Shanghai Jiao Tong University
Session: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: 9519

Title: SAVOIR: A phase III study of savolitinib versus sunitinib in pts with MET-driven papillary renal cell carcinoma (PRCC)
Lead Author Toni K. Choueiri, MD, Dana-Farber Cancer Institute and Harvard Medical School
Session: Genitourinary Cancer—Kidney and Bladder
Abstract Number: 5002

SURUFATINIB
Title: Efficacy and safety of surufatinib in United States (US) patients (pts) with neuroendocrine tumors (NETs)
Lead Author: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4610

Title: Health-related quality-of-life results from SANET-ep: A phase III study of surufatinib versus placebo for advanced extrapancreatic neuroendocrine tumors
Lead Author Chunmei Bai, MD, Peking Union Medical College Hospital
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4613

FRUQUINTINIB (Publication only)
Title: Early carcinoembryonic antigen (CEA) dynamics to predict fruquintinib efficacy in FRESCO, a 3+ line metastatic colorectal carcinoma (mCRC) phase III trial
Lead Author: Yuxian Bai, Harbin Medical University Cancer Hospital
Abstract Number: e16001

Title: Efficacy and safety of fruquintinib in the treatment of poor patients with metastatic gastrointestinal cancer
Lead Author: Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University
Abstract Number: e16028

About Savolitinib
Savolitinib is an inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.

A New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission. We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET. Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.

Chi-Med currently retains all rights to surufatinib worldwide.

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate, for the treatment of patients with metastatic colorectal cancer ("CRC"). We also intend to initiate a Phase III registration study for CRC in the U.S., Europe and Japan. A Phase III registration study is also ongoing in China for the treatment of patients with gastric cancer, in combination with paclitaxel. Additionally, fruquintinib is in several other proof-of-concept trials in China and the U.S., including in combination with immunotherapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.

On May 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive results from the Phase II CITYSCAPE trial, the first randomised study evaluating the efficacy and safety of tiragolumab plus Tecentriq (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 14, 2020, View Source [SID1234557961]). Tiragolumab is a novel cancer immunotherapy designed to bind to TIGIT, an immune checkpoint protein expressed on immune cells. Both TIGIT and PD-L1 play an important role in immune suppression, and blocking both pathways could enhance anti-tumour activity. The full results will be presented in an oral abstract session (Abstract #9503) at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program organised by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which will be held 29-31 May 2020.

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"We are pleased to share these first randomised anti-TIGIT results, showing that tiragolumab, our novel cancer immunotherapy, has encouraging efficacy and safety in combination with Tecentriq," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "TIGIT, an immune checkpoint protein expressed on immune cells, was identified by our own scientists. By blocking both TIGIT and PD-L1 pathways simultaneously, we hope to deepen patient responses to immunotherapy and widen the circle of people who may benefit."

At the primary analysis, tiragolumab plus Tecentriq met both co-primary endpoints in the intention-to-treat (ITT) population, showing an improvement in the objective response rate (ORR) (31.3% vs 16.2%) and a 43% reduction in the risk of disease worsening or death (progression-free survival; PFS) (median PFS= 5.4 vs 3.6 months; hazard ratio (HR)=0.57, 95% CI: 0.37–0.90) compared with Tecentriq alone.

An exploratory analysis in people with high levels of PD-L1 (TPS ≥50%) showed a clinically meaningful improvement in ORR (55.2% vs 17.2%) and a 67% reduction in the risk of disease worsening or death (median PFS=not reached vs 3.9 months; HR=0.33, 95% CI: 0.15–0.72) with the combination compared with Tecentriq alone.1

The data suggest that the combination of tiragolumab plus Tecentriq was well-tolerated, showing similar rates of all Grade 3 or more all-cause adverse events (AEs) when combining the two immunotherapies compared with Tecentriq alone (41.8% vs 44.1%).

At a six-month follow-up, the improvement in the ORR and PFS in the tiragolumab plus Tecentriq arm persisted in both the ITT and the PD-L1-high populations, and no new safety signals were observed.
As part of Roche’s commitment to explore new immunotherapy options and combinations, the company recently initiated two Phase III clinical trials evaluating tiragolumab plus Tecentriq for people with certain types of lung cancer (SKYSCRAPER-01 and SKYSCRAPER-02). Tiragolumab is also being evaluated in other solid tumours as well as in hematological cancers. Additional Phase 1a/b results in solid tumours will be presented at an upcoming medical meeting.

About CITYSCAPE study 1
CITYSCAPE is a global Phase II, randomised and blinded study evaluating tiragolumab plus Tecentriq compared with Tecentriq alone in 135 patients with first-line PD-L1-positive, locally advanced unresectable or metastatic non-small cell lung cancer. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit. Co-primary endpoints are ORR and PFS. Secondary endpoints include safety and overall survival.

Efficacy results

ITT (TPS≥1%)
N=135 PD-L1-high (TPS≥50%)
N=58 PD-L1-low (TPS1-49%)
N=77
Arms tiragolumab + Tecentriq

(n=67) placebo + Tecentriq
(n=68) tiragolumab + Tecentriq
(n=29) placebo + Tecentriq
(n=29) tiragolumab+ Tecentriq
(n=38) placebo +
Tecentriq
(n=39)
ORR, %
(95% CI) 31.3
(19.5, 43.2) 16.2
(6.7, 25.7) 55.2
(35.3, 75.0) 17.2
(1.8, 32.7) 13.2
(1.15, 25.2) 15.4
(2.8, 28.0)
Odds ratio (95% CI) 2.57
(1.07,6.14)* 5.91
(1.76,19.81)✝ 0.83
(0.23, 3.00)✝
Median PFS (95% CI) 5.4
(4.2, NE) 3.6
(2.7, 4.4) NE
(5.4, NE) 3.9
(2.1, 4.7) 4.1
(1.6, 5.6) 3.6
(1.5, 5.0)
HR (95% CI) 0.57
(0.37,0.90)* 0.33
(0.15, 0.72)✝ 0.85
(0.49, 1.48)✝
*stratified
✝unstratified

At a six-month follow-up, the improvement in ORR (37.3% vs 20.6%) and PFS (median PFS=5.6 month versus 3.9 months) in the tiragolumab plus Tecentriq arm persisted in the ITT population. Results in the PD-L1-high population were also consistent with the first analysis and the median PFS was still not reached.

Safety results

tiragolumab + Tecentriq
n=67 placebo + Tecentriq
n= 68
All Grade 3-5 AEs 41.8% 44.1%
Treatment- related AEs (TRAEs) 80.6% 72%
Grade ≥3 TRAEs 14.9% 19.1%
AEs leading to treatment withdrawal 7.5% 10.3%
About tiragolumab and TIGIT 5
Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells 2 3. By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body’s immune response 4. Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T-cells and enhance NK cell anti-tumour activity 2 6 7.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
View Source

About NSCLC
Lung cancer is the leading cause of cancer death globally 8. Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day 8. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases 9. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope 9.

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On May 13, 2020 DCprime, the front-runner in the field of relapse vaccines, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for DCP-001, an allogeneic cancer relapse vaccine currently being evaluated in a European Phase II trial in Acute Myeloid Leukaemia (AML) patients who are ineligible for hematopoietic stem cell transplantation (Press release, DCPrime, MAY 13, 2020, View Source [SID1234561870]). The IND provides the possibility for DCprime to expand the ongoing ADVANCE-II trial into the Unites States, where DCP-001 had received orphan drug status in Q4 2019.

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"Following encouraging clinical and preclinical data presented at medical conferences in 2019, 2020 should see the first results emerging from the ADVANCE-II study. The possibility to expand our trial activities into the United States is an important step and follows approvals by different European authorities in The Netherlands, Germany, Norway, Sweden, and recently also Finland," said Jeroen Rovers, MD, PhD, Chief Medical Officer of DCprime. "Although we are currently facing challenging times for clinical studies due to the Covid-19 crisis, DCprime remains committed to expanding its clinical network to support the development of relapse vaccines in AML and other cancer types. Securing the regulatory approval now, allows us to move quickly once the current clinical situation around Covid-19 improves."

The currently active international, multi-center, open-label proof-of-concept study ADVANCE-II is recruiting AML patients in complete remission, but with persistent measurable residual disease (MRD), which is associated with a high relapse rate. The effect of DCP-001 on MRD in combination with immunomonitoring will be used to evaluate the efficacy of DCprime’s relapse vaccination strategy.

Clinical data from a previously concluded Phase I clinical study that was presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2019 demonstrated DCP-001’s potential to prolong relapse-free survival and overall survival in the post-remission setting.

On May 13, 2020 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the first quarter ended March 31, 2020.

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"With the COVID-19 pandemic impacting businesses globally, the first quarter of 2020 was unlike anything we would have anticipated. As work from home restrictions directly impacted our customers and their normal ordering patterns, we felt the immediate impact," said John Lubniewski, President and CEO of HTG. "However, we have managed to take advantage of this time to leverage our teams, improve our processes, and accomplish detailed long-term planning all in preparation of emerging from this period as a stronger company. While we cannot be certain of the ultimate impact of the COVID-19 pandemic on us or our customers, we are optimistic that demand for our products and services will return."

Mr. Lubniewski continued, "Our product development teams have made progress towards the key milestones that we had set for ourselves during the quarter. Our California and Arizona development teams continue to implement our development strategy and we are on track to deliver development milestones. While the pandemic has created some near-term uncertainty, we are very proud of how our employees have faced the challenges – with flexibility and a commitment to ensuring our long-term success. When our customers eventually return to a more normal work environment, we will be prepared to meet demand and for growth in our business."

First Quarter 2020 Financial Highlights:

Total revenue for the first quarter ended March 31, 2020 was $2.2 million, compared with $3.2 million for the same period in 2019. The decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities around the globe. These closures limited the company’s ability to deliver its products to customer facilities and created challenges for customers in preparing and shipping samples to the company for processing.

Product and product-related services revenue was $2.0 million, compared with $2.7 million for the same period in 2019. This decrease in direct revenue primarily reflects a decline in lower margin, subcontracted laboratory services revenue reflected in RUO sample processing revenue when compared with first quarter of 2019 revenue.

Collaborative development services revenue for the quarter ended March 31, 2020 was $0.2 million compared with $0.5 million for the same period in 2019. The decrease in collaborative development services revenue reflects a decrease in activity as partners approached key decision points in current active programs.

Net loss from operations for the first quarter ended March 31, 2020 was $5.4 million, compared with $5.3 million for the first quarter of 2019. Net loss per share was $(0.08) for the first quarter of 2020 compared with $(0.19) for the first quarter of 2019.

Cash, cash equivalents and short-term available-for-sale securities totaled $32.0 million as of March 31, 2020, with current liabilities of approximately $8.4 million and non-current liabilities of $11.6 million. An additional $3.3 million of restricted cash was held in connection with a convertible note that is included in current liabilities as of March 31, 2020.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows: