On May 14, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported its financial results and corporate update for the first quarter ended March 31, 2020 (Press release, Hookipa Pharma, MAY 14, 2020, View Source [SID1234558006]).

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"The current unusually challenging times are impacting our industry significantly. HOOKIPA continues to progress well in areas which are under our control," commented Joern Aldag, HOOKIPA’s Chief Executive Officer. "The HOOKIPA team is continuing to activate sites for our oncology candidate HB-201 and patients are accruing. We expect to submit the combined HB-202/201 IND to the U.S. Food and Drug Administration in the first half of 2020, as previously forecasted. For HB-101, although enrollment of kidney transplant patients is currently hampered by the impact of COVID-19, we expect to report preliminary safety and immunogenicity data in July 2020 and efficacy data by the end of 2020, roughly at the same time we expect to report preliminary safety and efficacy for HB-201. With approximately $105 million in cash and cash equivalents, we believe that we are well funded beyond multiple clinical data points across our programs. In addition, I am particularly proud of the remarkable contribution of the HOOKIPA team voluntarily accepting a significant reduction of their fixed salaries and thereby extending our cash runway."

R&D Pipeline Update and Clinical Progress

HB-101, lead product candidate in infectious diseases
HOOKIPA’s VaxWave-based prophylactic Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized, double‑blinded Phase 2 clinical trial in patients awaiting kidney transplantation who are at risk for CMV-associated complications post-transplant. Due to the COVID-19 pandemic, nearly all ongoing Phase 2 trial sites have suspended patient enrollment, and it remains unclear when kidney organ transplants will resume at any of the trial sites.

By the end of July 2020, HOOKIPA expects to report safety data (on approximately one-third of the total 150 patients to be enrolled) as well as immunogenicity data (on approximately one-quarter of the total patients to be enrolled). The immunogenicity data will focus on CMV-neutralizing antibody responses. Analyses of cellular immune responses, including CD8+ T cells, have been limited to date due to the complexities of sample collection, transport, and analysis. HOOKIPA reiterates its guidance to deliver preliminary efficacy data by the end of 2020. Due to the COVID-19-impacted accrual, the timing of study completion will be delayed.

HB-201 and HB-202, programs for the treatment of Human Papillomavirus-positive cancers
HOOKIPA’s lead oncology product candidates, HB‑201 and HB‑202, are in development for the treatment of Human Papillomavirus‑positive (HPV+) cancers. In December 2019, HOOKIPA initiated the Phase 1/2 clinical trial for HB-201 and expects preliminary results in late 2020 or early 2021. The open label, dose escalating Phase 1/2 clinical trial is evaluating HB-201 in HPV16+ cancers, alone and in combination with an approved checkpoint inhibitor. HOOKIPA plans to enroll 100 patients in total with 20 patients in each dose escalation and expansion group, respectively. Enrollment of the first group of patients receiving the intravenously administered first dose level has been completed and the trial is accruing patients at the next higher dose level.

HOOKIPA remains on track to file the HB‑202/201 Initial New Drug (IND) submission with the U.S. Food and Drug Administration in the first half of 2020. The planned clinical trial combining HB-202 with HB-201, also in patients with HPV16+ cancers, is an open label, dose escalation Phase 1/2 trial with the primary endpoint to evaluate safety and tolerability. That trial is expected to commence later in 2020.

Strategic Collaborations

Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
During 2019, HOOKIPA received $6.0 million in milestone payments from Gilead for the delivery of research vectors and for advancing the programs towards clinical trials. Based on preclinical data generated to date, Gilead committed to preparations to advance the HBV and HIV vectors toward development, with the HBV development decision triggering a milestone payment of $4.0 million, which the Company received in early 2020. To enable the development activities and expanded research programs, Gilead agreed to reserve manufacturing capacity and increase reimbursement budgeted for the Company’s expanded resources allocated to the Gilead collaboration.

Other
At HOOKIPA’s New York City headquarters, all employees will continue to work from home and are fully operational. The Austrian government has removed some of the previously mandated COVID-19 restrictions that it put in place during March 2020, and this has allowed HOOKIPA’s Austrian site to ramp up its activities. The Company plans to increase its lab capacity to the extent safe and reasonable, and at the same time encourages all employees who can reasonably work from home to continue to do so.

First Quarter 2020 Financial Results

Cash Position:

HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2020 was $104.9 million compared to $113.6 million as of December 31, 2019. The decrease was primarily attributable to cash used in operating activities.

Revenue was $3.7 million for the three months ended March 31, 2020 compared to $2.2 million for the three months ended March 31, 2019. Revenue was driven by the recognition of milestone payments and partial recognition of the upfront payment as well as cost reimbursements received under the Collaboration Agreement with Gilead.

Research and Development Expenses:

HOOKIPA’s research and development expenses were $11.5 million for the three months ended March 31, 2020 compared to $10.2 million for the three months ended March 31, 2019.

The primary drivers of this increase were $1.3 million higher personnel expenses along with a general increase in internal research and development expenses, partially offset by an overall decrease in direct research and development expenses by $0.6 million. The latter reduction was a consequence of reduced activity around our earlier stage programs; in addition, preparation costs of clinical trials for our HB-201 and HB-202 programs were lower than in the same period last year. This decrease was partially offset by an increase in the direct costs related to our collaboration with Gilead due to an acceleration program and a modest increase in direct expenses for the HB-101 Phase 2 trial.

General and Administrative Expenses: General and administrative expenses amounted to $4.6 million for the three months ended March 31, 2020 compared to $2.7 million for the three months ended March 31, 2019. The increase was mainly due to personnel related expenses, an increase in professional and consulting fees, as well as costs related to being a public company, such as premiums for directors and officers liability insurance.

Net Loss: HOOKIPA’s net loss was $10.9 million for the three months ended March 31, 2020 compared to a net loss of $9.3 million for the three months ended March 31, 2019. This increase was driven by higher research and development expenses, in particular for HOOKIPA’s oncology programs, and an increase in general and administrative expenses following HOOKIPA’s IPO.

On May 14, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, VBL Therapeutics, MAY 14, 2020, View Source [SID1234558005]).

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"We reached an important milestone in our development of VB-111 in ovarian cancer with the recent positive outcome of the interim analysis of the ongoing Phase 3 OVAL study, which demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "A second planned interim analysis which will assess overall survival in the two treatment arms, is expected in the third quarter this year. We are pleased to be making progress also in our MOSPD2 antibody programs. We recently presented promising new data in NASH and colitis models in a Poster of Distinction at Digestive Disease Week, and also published a peer review manuscript on the potential of MOSPD2 antibodies to treat multiple sclerosis (MS). New data on our MOSPD2 bi-specific antibodies will be presented in a late breaking session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in June. Based on these positive developments, we successfully raised additional $18.1 million in gross proceeds, in spite of the COVID-19 pandemic complexities. Our current cash position is expected to fund our operations into the third quarter of 2022."

First Quarter and Key Corporate Highlights:

VB-111:

●The independent Data Safety Monitoring Committee (DSMC) reviewed un-blinded data from the ongoing OVAL study in ovarian cancer and determined that the study has met the interim pre-specified criterion, of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification.
●The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.
●The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in Phase 2, which enrolled similar population of patients with platinum-resistant ovarian cancer. The results will be presented at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.
●The OVAL interim analysis results were discussed by Dr. Bradley J. Monk of Arizona Oncology on a KOL call hosted by the Company on March 26.
●NanoCarrier Co., Ltd., the Japanese licensee for VB-111, announced its intention to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan.
●The Israel Innovation Authority (IIA) awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS) (approximately $0.9 million) to fund development of VB-111.
●The planned studies of VB-111 in metastatic colorectal cancer and GBM are expected to start patient recruitment as soon as the COVID-19 situation allows.
MOSPD2:

●Published a new peer review manuscript demonstrating the potential of MOSPD2 antibodies for multiple sclerosis (MS).
○VBL’s data offer a differentiated approach to potential treatment of relapsing as well as progressive MS disease
●New preclinical data on MOSPD2 antibodies for treatment of NASH and colitis were presented at Digestive Disease Week (DDW).
○Data demonstrate the potential of VBL’s proprietary MOSPD2 mAbs for chronic inflammatory indications, via a novel and distinct mechanism targeting monocyte migration
○The study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction
VB-201:

●A milestone event was reached under VBL’s collaborative agreement with a world-leading European animal health company, evaluating use of VB-201 for veterinary applications.
Quarter Ended March 31, 2020 Financial Results:

●Cash Position: At March 31, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $31.6 million and working capital of $24.6 million. VBL expects that its cash and cash equivalents and short-term bank deposits with the addition approximately $16.7 million from the net proceeds of the Registered Direct Offerings of which we have announced on May 7, 2020 and on May 11, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.
●Revenues: Revenues for the three-month period ended March 31, 2020 were $366 thousand, compared to $219 thousand in the same period of 2019.
●R&D Expenses: Research and development expenses, net, after government grants, in the three-month period ended March 31, 2020, were $4.8 million, compared to $3.3 million in the same period in 2019.
●G&A Expenses: General, administrative and marketing expenses for the three-month period ended March 31, 2020, were $1.2 million, compared to the $1.3 million in the same period in 2019.
●Comprehensive Loss: VBL reported a net loss for three-month period ended March 31, 2020 of $5.4 million, or ($0.15) per diluted share, compared to a net loss of $4.2 million, or ($0.12) per diluted share, in the same period of 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.

Conference Call:

Thursday May 14th @ 8:30amET

From the US: 877-407-9208
International: 201-493-6784
Israel: 1 809 406 247
Conference ID: 13703295
Webcast: View Source

On May 14, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Mike Nally, executive vice president and chief marketing officer, is scheduled to participate in a fireside chat at the UBS Virtual Global Healthcare Conference on May 18, 2020, at 11:40 a.m. EDT (Press release, Merck & Co, MAY 14, 2020, View Source [SID1234558004]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On May 14, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health reported financial results for the first quarter 2020 (Press release, Kaleido Biosciences, MAY 14, 2020, View Source [SID1234558003]).

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"The COVID-19 pandemic is having an unprecedented impact on the global healthcare system. We continue to adapt our work to prioritize the safety of our employees, as well as patients and clinical staff as study sites limit certain activities in light of the ongoing pandemic," said Alison Lawton, Kaleido’s President and Chief Executive Officer. "We are fortunate that our product platform and efficient development model provide Kaleido flexibility in responding to the current situation. We have rapidly initiated new clinical programs aimed at addressing the unmet need for outpatients with mild-to-moderate COVID-19 disease and are further exploring the potential of MMTs in immune-mediated and inflammatory diseases in ulcerative colitis. We anticipate data readouts from these and other programs starting in Q4 2020 and throughout 2021."

Pipeline Update

COVID-19 Program and KB109

As announced separately today, Kaleido has initiated a clinical program evaluating KB109 when added to Supportive Self-Care for outpatients with mild-to-moderate COVID-19 disease. The program aims to enroll a total of approximately 400 patients in two non-IND controlled clinical studies. Top-line data from the larger, multi-center study are expected in Q4 2020.

COVID-19 infection has been associated with activation of an inappropriate inflammatory cascade, which in some patients can cause an abnormally aggressive immune response that can lead to pneumonia and respiratory failure. Scientific evidence indicates that metabolites such as short chain fatty acids (SCFAs) produced by the microbiome through fermentation of glycans, are modulators of the immune response and therefore could potentially play a role in limiting this inflammatory cascade. KB109 is Generally Recognized as Safe (GRAS) and was selected for evaluation in these COVID-19 clinical studies based on its demonstrated ability to increase production of SCFAs as well as to promote commensal bacteria and reduce pathogenic bacteria ex vivo.

Due to prioritization of KB109 in COVID-19 and anticipated delays due to the pandemic, Kaleido has elected to pause the VITORA clinical study in patients colonized with multidrug-resistant pathogens. The Company is evaluating next steps for its pathogens program, including evaluating KB109 in a patient population at high-risk of infections such as Hematopoietic Stem Cell Transplantation (HSCT) recipients.
Immune-mediated and Inflammatory Diseases Programs

In addition to exploring immune pathways involved in respiratory viral infections with the COVID-19 program, Kaleido is expanding its efforts to understand the potential of MMTs in addressing immune-mediated and inflammatory diseases, including:
Initiating a clinical study later this year evaluating a new MMT candidate, KB295, in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Top-line results are expected in mid-2021.
In its immuno-oncology program, selecting clinical ready, lead MMT candidates that improve therapeutic responses in advanced preclinical models in Q4 2020.
Identifying lead MMTs from preclinical studies in validated models of immune-mediated diseases in the first half of 2021.
Metabolic and Liver Diseases Programs

KB195 is being evaluated in a Phase 2 clinical trial (UNLOCKED) in patients with urea cycle disorders who are inadequately controlled on standard of care. Given limitations on patient visits and the impact on new enrollment due to COVID-19, the Company now anticipates the availability of top-line data will be delayed into the second half of 2021.
Kaleido has received IND clearance and CTA approvals in nine countries, activated more than 20 sites and recently submitted a protocol amendment that expands the eligibility age to adolescents as young as 12 and adults up to age 70 (previously between 18 and 65), which will help facilitate enrollment.

In the hepatic encephalopathy program, Kaleido is ready to initiate the next clinical study evaluating KB174 in patients with the disease. Study initiation is dependent on partnering the program and resolution of COVID-19 impact at trial sites.

Preclinical work for the cardiometabolic and liver diseases program remains on track for results in Q4 2020.
Key Anticipated 2020 Milestones

Abstracts featuring clinical and ex vivo data from KB174 have been accepted for poster presentations during The Digital International Liver Congress (EASL 2020), rescheduled for August 27-29, 2020. Two of these abstracts were accepted for presentation and published to the online portal for Digestive Disease Week, which was cancelled due to the COVID-19 pandemic.

Top-line data from clinical study of KB109 in patients with mild-to-moderate COVID-19 disease expected in Q4 2020.

Data from preclinical programs in immuno-oncology and cardiometabolic and liver diseases expected in Q4 2020.
First Quarter 2020 Financial Results

For the first quarter 2020, Kaleido reported a net loss of $19.6 million, or $0.64 per common share, compared to $20.2 million, or $1.56 per common share, for the first quarter 2019. The 2020 first quarter net loss includes non-cash stock-based compensation expenses of $2.7 million, as compared to $2.5 million in the first quarter of 2019.

Research and development (R&D) expenses were $13.1 million for the three months ended March 31, 2020, compared to $15.2 million for the three months ended March 31, 2019. The decrease in R&D expense was primarily driven by decreased external manufacturing and research costs.

General and administrative (G&A) expenses were $5.9 million for the first quarter 2020, compared to $5.4 million for the first quarter of 2019. The first quarter 2020 increase in G&A, as compared to the first quarter of 2019, was primarily due to increased facility-related expenses.

As of March 31, 2020, the Company reported cash and cash equivalents of $53.8 million. Kaleido continues to manage its operating expenses in-line with its pipeline priorities and, as a result, has extended its cash runway further into the first quarter of 2021.

Conference Call and Webcast Information

Kaleido will host a conference call and webcast today, May 14, 2020, at 8:30 a.m. ET to discuss these pipeline updates. To access the live conference call, please dial (833) 423-0448 (domestic) or (956) 394-3566 (international) and reference conference ID 4182326. The live webcast can be accessed in the Investors & Media section of Kaleido’s website at: View Source Due to current high volume accessing virtual events, participants are encouraged to connect at least 15 minutes prior to the call to ensure a timely connection or to utilize the webcast link for listen-only access. An archived webcast will be made available on Kaleido’s website shortly after the event and accessible for 90 days.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

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, View Source [SID1234558002]).

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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

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.