On July 28, 2020 Taiho Pharmaceutical Co., Ltd. reported the launch of its anticancer agent LONSURFⓇ (brand name in Japan, trifluridine/tipiracil (FTD/TPI), development code TAS-102) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, in addition, might be treated or not able to be treated by an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy (Press release, Taiho, JUL 28, 2020, View Source [SID1234562403]).

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Lonsurf was approved in China in August 2019 based on the results of the Phase III TERRA study on patients with refractory mCRC in Asia (China, South Korea, and Thailand). The study met the primary efficacy endpoint of statistically prolonging overall survival (OS) in patients with unresectable advanced or recurrent colorectal cancer. The drug appeared to be generally well tolerated and its toxicities were consistent with what has been previously reported.

With this launch in China, Taiho Pharmaceutical expects that Lonsurf will make a broader contribution to patients and medical institutions as a new treatment option for patients with colorectal cancer.

About the TERRA study
The TERRA study was a randomized, double-blind, placebo-controlled Phase III comparison study evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The study enrolled 406 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory or intolerant those chemotherapies. The study was conducted in China, South Korea, and Thailand. Patients were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the TERRA study was improvement in OS versus placebo. The study was conducted under the leadership of principal researchers in China, South Korea, and Thailand. Results from TERRA study were presented at ESMO (Free ESMO Whitepaper) 2016 Congress and e-published in the Journal of Clinical Oncology in 2017*1.

About Colorectal Cancer
The number of patients with colorectal cancer in China is on the rise. It is the fifth most common cancer cause of death in China after lung cancer, gastric cancer, hepatic cancer, and esophageal cancer. It has been reported that around 250,000 people died of colorectal cancer in China in 2018.*2

About Lonsurf
Lonsurf is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing Lonsurf for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. Since receiving FDA approval in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, has been marketing Lonsurf in the United States for mCRC refractory to prior therapy.

Taiho Pharmaceutical and Servier*3 have an exclusive license agreement for the co-development and commercialization of Lonsurf in Europe and other countries outside of the United States, Canada, Mexico, and Asia. In parts of Asia outside of Japan, Lonsurf is being marketed in Taiwan and South Korea, among others, to expand the indication of the drug.

As of July 2020, Lonsurf has been approved as a treatment for advanced mCRC in 88 countries and regions worldwide. Lonsurf has been approved as a treatment for metastatic gastric cancer in the United States in February 2019, in Japan in August 2019 and in EU in September 2019, and as of July 2020, it is approved in more than 40 countries and regions worldwide.

*1 Xu, J., Kim T., Shen L., et al. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Patients With Previously Treated Metastatic Colorectal Cancer: The TERRA Study, Journal of Clinical Oncology, 2018; 36(4): 350-358.

*2 WHO International Agency for Research on Cancer. CANCER TODAY. Colorectal cancer: Estimated number of deaths in 2018, China, both sexes, all age

View Source;mode=cancer&mode_population=who&population=900&populations=160&key=asr&sex=0&cancer=39&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=5&group_cancer=1&include_nmsc=1&include_nmsc_other=1#collapse-group-0-3

(Accessed July 3, 2020)

*3 Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). More information: www.servier.com/en/.

On July 27, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release second quarter 2020 financial results on Thursday, August 6, 2020, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update (Press release, Athenex, JUL 27, 2020, View Source [SID1234573875]).

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13706637. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

On July 27, 2020 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that interim results from the ongoing Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harbouring Notch activating mutations will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, being held September 19-September 21, 2020 (Press release, Ayala Pharmaceuticals, JUL 27, 2020, View Source [SID1234563989]).

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Oral presentation information is as follows:

Title: ACCURACY a Phase 2 trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut)
Session Title: Mini Oral Presentation
Session Date and Time: September 18, 2020, 03:55 CEST
Presentation Number: 919MO
Presenter: Renata Ferrarotto, MD, MD Anderson Cancer Center

The presentation will be available to registrants of the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 at 03:55 CEST on September 18, 2020. The presentation will be archived under "Events and Presentations" in the Investors section of Ayala’s website at ir.ayalapharma.com.

On July 27, 2020 Immodulon, the immuno-oncology company, reported an expansion to its ongoing collaboration with Professor van Eijck and his team at the Erasmus University Medical Center Rotterdam ("Erasmus MC") (Press release, Immodulon Therapeutics, JUL 27, 2020, View Source [SID1234562740]). A phase I/II, open label study is being planned in patients with limited metastatic pancreatic cancer ("MEPANC -1") . The trial is designed to evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy of metastases in the liver and lung in patients with limited metastatic pancreatic cancer. This follows the successful recruitment of 20 patients in a separate phase I/II study combining IMM-101 with stereotactic radiotherapy in locally advanced pancreatic cancer ("LAPC-2"). The MEPANC -1 study design will be submitted to the local Erasmus MC Medical Ethics Review Committee and the national Central Committee on Research Involving Human Subjects(CCMO) and, should it be approved, recruitment is expected to begin by the end of 2020.

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Professor Casper H J van Eijck, hepatobiliary surgeon and Professor in surgery, commented:
"We look forward to starting this new original study which has not been performed before in patients with limited metastatic pancreatic cancer. Since the recruitment in the LAPC-2 study is highly successful, we expect to include patients from all Dutch Pancreatic Cancer Group hospitals within the allocated time frame. We are pleased that Immodulon is providing us with the IMM-101 study drug again and their support and hope that combining IMM-101’s positive effects on the immune system in combination with radiotherapy will lead potentially to a major step forward in the search of new and effective treatments for pancreatic cancer."

Dr. Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are pleased with the progress of our collaboration with Professor van Eijck and his team at this Centre of Excellence for pancreatic cancer at Erasmus MC. The MEPANC -1 study, testing our lead drug candidate, IMM-101, in limited metastatic pancreatic cancer, is designed to complement the ongoing LAPC-2 study. We look forward to the potential initiation of the MEPANC -1 study before the end of 2020, pending approval from local and national regulatory authorities. Pancreatic cancer is a devasting disease and remains exceedingly challenging to treat effectively, despite the advances in other cancer treatments."

On July 27, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported that it has raised £0.75 million (before expenses) pursuant to a Broker Option following the completion of the UK Placing (Press release, Midatech Pharma, JUL 27, 2020, View Source [SID1234562695]). The result of the UK Placing of 18,518,518 Placing Shares at an Issue Price of £0.27 per share was announced earlier today. The UK Placing was significantly oversubscribed and brings new UK institutions into the Company’s shareholder base.

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The Company granted an option to Turner Pope under the Placing Agreement to enable them to deal with additional demand under the UK Placing in the event that requests to participate in the UK Placing from qualifying investors were received during the period from the time of the announcement of the UK Placing to 8.00 a.m. on 27 July 2020 up to a maximum of £0.75 million. Turner Pope has exercised the Broker Option to the maximum extent in respect of 2,777,777 Broker Option Shares at the same price as the UK Placing.

Accordingly, the total number of New Ordinary Shares to be issued by the Company pursuant to the UK Placing and the Broker Option is 21,296,295. The aggregate gross proceeds of the UK Placing and the Broker Option is £5.75 million. Aggregate proceeds, net of expenses, are expected to be £5.28 million.

Application for Admission to trading on AIM

Subject to all conditions being met, application will be been made for 21,296,295 New Ordinary Shares to be admitted to trading on AIM. It is expected that settlement of the Placing Shares and the Broker Option Shares and Admission will take place at 8.00 a.m. on or about 3 August 2020 and that dealings in the Placing Shares and, if applicable, the Broker Option Shares will commence at that time.

When issued the New Ordinary Shares will be fully paid and will rank pari passu in all respects with the existing Ordinary Shares.

Total Voting Rights

The Company’s issued share capital following the issue of equity noted above, will comprise 60,548,852 ordinary shares of 0.1p each with voting rights. The Company does not hold any shares in treasury. This figure of 60,548,852 may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA’s Disclosure and Transparency Rules.

Capitalised terms used in this announcement have the meanings given to them in the announcement of the UK Placing earlier today.

Commenting, Stephen Stamp, Midatech CEO and CFO, said: "I am delighted with the result of the UK Placing and welcome on board our new shareholders. The oversubscription of the UK Placing followed by full take-up of the Broker Option is a massive vote of confidence in our new strategy and the progress we have made since we started our strategic review in April."