On August 1, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that through a priority review process, the South Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s New Drug Application (NDA) for the Orphan Drug-designated first-in-class oral inhibitor of XPO1, selinexor (XPOVIO), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (penta-refractory); and as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment (Press release, Antengene, AUG 1, 2021, View Source [SID1234585496]).

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Introduction of a practice-changing therapy for MM and DLBCL patients

Most patients with MM eventually suffer from relapse or become refractory diseases. For patients who have failed in one therapy, diffuse large B-cell lymphoma (DLBCL) has poor prognosis and the chance of cure or long-term disease-free survival declined every time getting worse after treatment. At present, there is no cure for rrMM and rrDLBCL and it is in dire need for safer and more effective therapies.

In October 2020, selinexor was granted an Orphan Drug Designation (ODD) in South Korea, where the term "Orphan Drug" is defined by the MFDS as therapies used to treat diseases affecting 20,000 or fewer patients and therapies used to treat diseases for which no appropriate therapy has been developed, or therapies that have demonstrated significant improvement in safety and/or efficacy compared to existing treatments.

A new mechanism of action with a broad therapeutic window

Selinexor’s novel mechanism of action (MoA) which is based on the selective inhibition of the nuclear export protein XPO1, is different from that of all currently approved therapies. The drug can be combined with various therapies to deliver improved treatment outcomes in these diseases. To date, five selinexor-based regimens have been added to the National Comprehensive Cancer Network (NCCN) Guidelines.

In addition, a number of international multicenter clinical trials in respect of selinexor are jointly carried out in places such as North America, Europe, Australia, Asia. These include the study of XPORT-DLBCL-030 in international multicenter clinical trials in combination with R-GDP for the treatment of rrDLBCL, and the study of SIENDO in international multicenter clinical trials of monotherapy of endometrial neoplasms.

Minyoung Kim, General Manager of Antengene, commented: "We are very encouraged by the MFDS’ approval of selinexor. I am confident that this oral selective inhibitor of nuclear export protein, with its practice-changing therapeutic utility, will improve the quality of life of patients with rrMM and rrDLBCL in South Korea, and bring renewed hope to this patient population."

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.

On August 1 2021 Evotec SE (Frankfurt Stock Exchange; EVT, MDAX/TecDAX, ISIN: DE0005664809, WKN 566480) reported that it confidentially submitted a Registration Statement on Form F-1 ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") for a proposed offering and sale in the United States of shares of Evotec represented by American Depositary Shares ("ADSs") (Press release, Evotec, AUG 1, 2021, View Source;announcements/ad-hoc-releases/p/evotec-se-announces-confidential-submission-of-draft-registration-statement-on-form-f-1-with-the-us-securities-and-exchange-commission-for-a-proposed-offering-of-american-depositary-shares-6080 [SID1234585507]). The Registration Statement has not yet become effective and the final number of ADSs to be offered and their price have not yet been determined.

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Evotec’s shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment. Evotec will seek a secondary listing of the ADSs on the Nasdaq Global Select Market in the United States under the ticker symbol "EVO". The new shares underlying the ADSs will be issued from Evotec’s authorized capital. The first day of trading of the ADSs is expected to occur during the second half of 2021, however, this timing remains subject to change.

The ADSs referred to in this announcement are to be offered only by means of a registration statement on Form F-1 approved by the SEC. In accordance with applicable capital markets requirements, Evotec will announce when the registration statement has been approved by the SEC, including further details, such as final number and price of ADS.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations, or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the U.S. Securities Act of 1933, as amended ("Securities Act"), and other applicable securities laws. This announcement is being issued in accordance with Rule 135 under the Securities Act and other applicable securities laws. This public disclosure of inside information does not constitute a prospectus.

On July 30, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported financial results for the first quarter of fiscal year 2021 (period ended June 30, 2021). Based on the solid first-quarter results, the Company also confirmed its fiscal year 2021 management guidance and forecast. Fiscal year 2021 remains a year of inflection with Takeda positioned for topline acceleration and continued pipeline progress, including critical regulatory submissions, potential approvals and additional new molecular entities (NMEs) advancing in pivotal studies.

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Costa Saroukos, Chief Financial Officer, commented:
"With the Shire integration behind us and continued transformation over the last two years, we’ve pivoted towards accelerating topline growth and investing in R&D to fuel our highly innovative pipeline. Takeda’s first-quarter results demonstrate the continued strength of our 14 global brands and, with the business momentum from this strong start to our fiscal year, we remain on track towards our full-year management guidance."

"FY2021 is an inflection year for our pipeline as we ramp up strategic R&D investments and the pipeline starts to deliver. We anticipate having five to six Wave 1 pipeline regulatory submissions by the end of this fiscal year, with the potential for five approvals by end of H1 FY2022. The resilience of Takeda’s business model is a testament to our unwavering commitment to serving patients, our people and the planet. We are focused on discovering and delivering life-transforming treatments to people around the world to create and maximize long-term value for society."

FINANCIAL AND BUSINESS HIGHLIGHTS

Results for Q1 FY2021 Ended June 30, 2021

(a) Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
(b) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
(c) Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as non-recurring items, purchase accounting effects and transaction related costs.
(d) Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, intangible assets and investments, and any other cash that is not available to Takeda’s immediate or general business use, and including proceeds from sales of property, plant, sales and redemption of investments and businesses, net of cash and cash equivalents divested.
View Source

Reported Revenue increased +18.4% to 949.6 billion yen ($8.6B); Underlying Core Revenue increased +3.8% vs. FY2020 Q1, driven by the 14 global brands

Takeda’s 14 global brands, with an aggregate reported revenue of 335.6 billion yen ($3.0B), posted year-over-year underlying revenue growth of +6.8% despite quarterly phasing headwinds for TAKHZYRO and IG. Takeda’s 5 key business areas with 708.0 billion yen ($6.4B) in reported revenue represented 87% of core revenues1.
GI with 210.5 billion yen ($1.9B) in reported revenue, with underlying revenue growth of +8% spearheaded by gut-selective ENTYVIO.
Rare Diseases with 155.5 billion yen ($1.4 B) in reported revenue declining -3% on an underlying basis, with HAE growth impacted by phasing, but remains in line with the current plan.
Plasma Derived Therapy (PDT) Immunology with 107.2 billion yen ($1.0B) in reported revenue declining -2% on an underlying basis, impacted by quarterly phasing of Immunoglobulin products, with full-year outlook unchanged.
Oncology with 121.4 billion yen ($1.1B) in reported revenue, with underlying revenue growth +9% driven by indication expansion across the portfolio.
Neuroscience with 113.4 billion yen ($1.0B) in reported revenue, with underlying revenue growth +3% driven by strong rebound of Vyvanse following impact of COVID-19 in the prior year.
————————
1 Percentage of sales are based on Core revenue; adjusted to remove JPY 133.0B from sale of Japan diabetes portfolio recorded in revenue

Reported Operating Profit increased 48.6% Underlying Core Operating Profit Margin was 30.5% for Q1

Reported operating profit increased 48.6% to 248.6 billion yen ($2.2B) compared to FY2020 Q1, driven by a gain on the sale of the diabetes portfolio in Japan, lower purchase price accounting expenses and lower integration costs. These items more than offset a decrease in other operating income due to a one-time gain recorded in FY2020 Q1.
Underlying core operating profit for the current period declined -2.1% reflecting an increase in R&D investment and is expected to recover to "mid-single digit" growth for the full year.
Continued progress in debt pre-payment with approximately 242.9 billion yen toward $2.2 billion paid in FY2021 Q1.
Achieved several critical pipeline milestones to date in FY2021

Moderna’s COVID-19 Vaccine, approved in Japan for adults in May and expanded age indication to adolescents 12+ years old in July, with distribution underway.
Mobocertinib (TAK-788) filing under review in US, China, and other countries.
Maribavir’s (TAK-620) filing and acceptance in the US and EU, with FDA granting priority review.
Orexin (TAK-994) granted Breakthrough Therapy designation by the FDA for Narcolepsy Type 1.
TAK-999 granted Breakthrough Therapy designation by the FDA for AATD2 Liver Disease
Collaboration with Frazier Healthcare Partners to launch HilleVax, Inc., a biopharmaceutical company to develop and commercialize TAK-214, Takeda’s norovirus vaccine candidate.
————————
2 AATD = Alpha-1 antitrypsin deficiency

Important recognition in Q1

Two of Takeda’s facilities in Japan and Ireland were recognized by the International Society for Pharmaceutical Engineering (ISPE) with the 2021 Facility Of the Year Awards for the use of digital and innovative technologies to enhance manufacturing capabilities.
FY2021 Guidance

On track towards full-year FY2021 guidance (Unchanged from May 2021)

Key assumptions in FY2021 forecast

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of its 14 global brands, and accelerated realization of cost synergies, while continuing to invest in R&D.

FY2021 guidance reflects the following key assumptions, including (1) Takeda expects at least one 505(b)2 competitor for subcutaneous VELCADE to launch in the U.S. around mid FY2021; (2) Takeda does not expect to restart sales of Natpara in the U.S. market in FY2021; and (3) FY2021 guidance does not include the impact of any potential further divestitures beyond what has already been disclosed by Takeda.

To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19). Based on currently available information, Takeda believes that its financial results for FY2021 will not be materially affected by COVID-19 and, accordingly, Takeda’s FY2021 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2021, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in an additional impact on Takeda’s business, results of operations or financial condition, as well as result in significant deviations from Takeda’s FY2021 forecast.

For more details on Takeda’s Q1 FY2021 results and other financial information, please visit: View Source

More information on Takeda’s Environmental, Social and Governance (ESG) approach and values-based corporate governance can be found in the 2021 Annual Integrated Report for FY2020, which ended March 31, 2021. This report can be accessed on Takeda’s website at: View Source

On July 30, 2021 Van Andel Institute reported that The mutations that give rise to melanoma result from a chemical conversion in DNA fueled by sunlight — not just a DNA copying error as previously believed, report a study by Van Andel Institute scientists published today in Science Advances (Press release, Van Andel Institute, JUL 30, 2021, View Source;utm_medium=rss&utm_campaign=pfeifer-melanoma-mutations [SID1234585461]).

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The findings upend long-held beliefs about the mechanisms underlying the disease, reinforce the importance of prevention efforts and offer a path forward for investigating the origins of other cancer types.

Gerd Pfeifer, Ph.D.

"Cancers result from DNA mutations that allow defective cells to survive and invade other tissues. However, in most cases, the source of these mutations is not clear, which complicates development of therapies and prevention methods," said Gerd Pfeifer, Ph.D., a VAI professor and the study’s corresponding author. "In melanoma, we’ve now shown that damage from sunlight primes the DNA by creating ‘premutations’ that then give way to full mutations during DNA replication."

Melanoma is a serious type of skin cancer that begins in pigment-producing skin cells. Although less common than other types of skin cancer, melanoma is more likely to spread and invade other tissues, which significantly reduces patient survival. Previous large-scale sequencing studies have shown that melanoma has the most DNA mutations of any cancer. Like other skin cancers, melanoma is linked to sun exposure, specifically a type of radiation called UVB. Exposure to UVB damages skin cells as well as the DNA within cells.

Most cancers are thought to begin when DNA damage directly causes a mutation that is then copied into subsequent generations of cells during normal cellular replication. In the case of melanoma, however, Pfeifer and his team found a different mechanism that produces disease-causing mutations — the introduction of a chemical base not normally found in DNA that makes it prone to mutation.

DNA comprises four chemical bases that exist in pairs— adenine (A) and thymine (T), and cytosine (C) and guanine (G). Different sequences of these pairs encode all of the instructions for life. In melanoma, the problem occurs when UVB radiation from the sun hits certain sequences of bases — CC, TT, TC and CT — causing them to chemically link together and become unstable. The resulting instability causes a chemical change to cytosine that transforms it into uracil, a chemical base found in the messenger molecule RNA but not in DNA. This change, called a "premutation," primes the DNA to mutate during normal cell replication, thereby causing alterations that underlie melanoma.

These mutations may not cause disease right away; instead, they may lay dormant for years. They also can accumulate as time goes on and a person’s lifetime exposure to sunlight increases, resulting in a tough-to-treat cancer that evades many therapeutic options.

"Safe sun practices are very important. In our study, 10–15 minutes of exposure to UVB light was equivalent to what a person would experience at high noon, and was sufficient to cause premutations," Pfeifer said. "While our cells have built-in safeguards to repair DNA damage, this process occasionally lets something slip by. Protecting the skin is generally the best bet when it comes to melanoma prevention."

The findings were made possible using a method developed by Pfeifer’s lab called Circle Damage Sequencing, which allows scientists to "break" DNA at each point where damage occurs. They then coax the DNA into circles, which are replicated thousands of times using a technology called PCR. Once they have enough DNA, they use next-generation sequencing to identify which DNA bases are present at the breaks. Going forward, Pfeifer and colleagues plan to use this powerful technique to investigate other types of DNA damage in different kinds of cancer.

Other authors include Seung-Gi Jin, Ph.D., Dean Pettinga, Jennifer Johnson and Peipei Li, Ph.D., of VAI.

Research reported in this publication was supported by Van Andel Institute and the National Cancer Institute of the National Institutes of Health under award no. R21CA228089 (Pfeifer). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

On July 30, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company") reported it has completed the second tranche of its institutional placement (Placement), details of which were announced to the market on June 21, 2021 (Press release, Immutep, JUL 30, 2021, View Source [SID1234585533]). The second tranche of the Placement comprises the issue of 88,970,717 new ordinary fully paid shares in the Company (Tranche 2 Shares) at an issue price of A$0.52 per Tranche 2 Share to raise approximately A$46.3 million. The issue of these shares was as approved by the Company’s shareholders at its Extraordinary General Meeting held on July 26, 2021.

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Net proceeds from the now completed A$60 million two-tranche Placement and the recently completed Share Purchase Plan (SPP) which raised A$7.2 million (details of which were announced to ASX on July 21, 2021) bring the total funds raised under the Placement and SPP to approximately A$67.2 million. These funds will be used to support Immutep’s ongoing and planned immuno-oncology clinical development programs, its pre-clinical program in autoimmune disease and for general working capital purposes.

The Tranche 2 Shares were issued today and will commence trading on ASX on Monday, August 2, 2021.