VAXIMM to Participate at Upcoming Industry Events

On January 30, 2020 VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the Company will participate in several industry events in the coming months (Press release, Vaximm, JAN 30, 2020, View Source [SID1234553685]). Company representatives will be available for networking and one-on-one meetings at the following conferences:

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BIO CEO & Investor Conference
February 10-11, 2020
New York, NY, USA
VAXIMM representatives will be available for one-on-one meetings during the conference. To schedule a meeting, please use the event partnering system or contact [email protected].

13th SACHS Annual European Life Science CEO Forum
February 19-20, 2020
Zurich, Switzerland
Dr. Heinz Lubenau, CEO, will give a corporate presentation on February 19th at 2:15 pm CET and participate in the panel, "Oncology Advanced Therapies & Diagnostics," taking place on the same day at 4:30 pm. The Company will also host one-on-one meetings at this event. To request a meeting with VAXIMM, please sign up through the event’s meeting system.

14th Annual International Partnering Conference BIO-Europe Spring
March 23-25, 2020
Paris, France
VAXIMM plans to give a corporate presentation and host one-on-one meetings at this event. To request a meeting, please sign up through the event’s partneringONE meeting system.

30th MedTech Investing Europe Conference
March 31-April 1, 2020
Lausanne, Switzerland
VAXIMM representatives will be available for one-on-one meetings during the conference. Dr. Heinz Lubenau also plans to give a corporate presentation. To schedule a meeting, please contact [email protected].

Karolinska Development’s portfolio company Aprea Therapeutics receives FDA Breakthrough Therapy Designation

On January 30, 2020 Karolinska Development (Nasdaq Stockholm: KDEV) reported that its portfolio company Aprea Therapeutics has been granted Breakthrough Therapy Designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) with a TP53 mutation (Press release, Aprea, JAN 30, 2020, https://www.karolinskadevelopment.com/en/press-releases?page=/en/pressreleases/karolinska-development%2527s-portfolio-company-aprea-therapeutics-receives-fda-breakthrough-therapy-designation-1769167 [SID1234553684]). A Breakthrough Therapy Designation facilitates expedited development and regulatory review of a drug candidate.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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APR-246 is a small molecular drug candidate that binds, refolds and stabilizes mutant p53, occurring in approximately 50% of all human tumors. A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has previously received Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, acute myeloid leukemia (AML) and ovarian cancer.

"This is yet another success for Aprea Therapeutics, and we look forward to following the continued development of its potentially ground-breaking cancer therapy", says Viktor Drvota, CEO, Karolinska Development AB, in response to the announcement.

MDS represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to directly contribute to disease progression and a poor overall prognosis.

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

Sysmex and RIKEN Innovation Sign a Comprehensive Collaborative Agreement

On January 30, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and RIKEN Innovation Co., Ltd. (HQ: Saitama, Japan; President and CEO: Yoshihiro Aburatani) reported that they have signed a partnership agreement to use the research results from National Research and Development Institute RIKEN (HQ: Saitama, Japan; President: Hiroshi Matsumoto) to jointly create new businesses and return benefits to society (Press release, Sysmex, JAN 30, 2020, View Source [SID1234553683]).

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Through this agreement, the companies aim to apply advanced and broad-ranging research results from RIKEN, a comprehensive research institution for the natural sciences. The objective is to create high-value testing and diagnostic technologies to resolve global medical issues and contribute to the realization of personalized medicine.

The healthcare issues faced by individual countries have grown more diverse in recent years, due to aging populations and the expansion of preventive medicine in developed countries, and the establishment of healthcare infrastructures in emerging markets. With IT and other technological innovations making industries increasingly borderless, it is important to respond to increasingly diverse healthcare needs, proactively collaborate with companies and research institutions that go beyond their industry boundaries, and conduct R&D activities leading to efficient and effective innovation and the creation of new business opportunities.

Sysmex has established an open innovation lab at Technopark (Nishi-ku, Kobe) to pursue collaboration with researchers in Japan and overseas. The Company is pursuing numerous joint research projects at global R&D centers and through its network of Group companies, centering on the development of new diagnostic applications. In these ways, Sysmex aims to acquire unique diagnostic technologies through open innovation with medical and research institutions in Japan and overseas.

As a wholly owned subsidiary of RIKEN, RIKEN Innovation is tasked with promoting collaboration between industry and academia that will quickly return value to society based on RIKEN’s research results. As Japan’s key comprehensive research institution for the natural sciences, RIKEN is involved in a broad range of research fields. By promoting the joint creation of businesses, RIKEN Innovation will leverage research results from diverse researchers engaged in fundamental and applied research. As a result, RIKEN Innovation aims to work together on a variety of measures that will help resolve issues faced by companies and society.

Sysmex and RIKEN Innovation have entered into a partnership agreement in the aim of leveraging RIKEN’s cross-disciplinary research results and Sysmex’s R&D knowhow related to diagnostic technologies to create new diagnostic technologies and new businesses that can be rolled out globally.

Based on this partnership agreement, the two companies will collaborate in searching for needs with a view to creating new diagnostic technologies, outlining diagnostic technology development themes, and building an R&D structure. The companies will pursue open innovation aimed at creating new businesses.

Going forward, by providing diagnostic technologies created under this agreement, Sysmex, RIKEN Innovation and RIKEN aim to create treatment opportunities for patients with diseases that have no established diagnostic methods and contribute to medical economy through more efficient healthcare.

Evotec and Bayer advance further programme into Phase I clinical development

On January 30, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that its partner Bayer AG has decided to advance a further programme from the endometriosis multi-target alliance into clinical Phase I development (Press release, Evotec, JAN 30, 2020, View Source;announcements/press-releases/p/evotec-and-bayer-advance-further-programme-into-phase-i-clinical-development-5905 [SID1234553682]). Evotec will receive a milestone payment of € 2 m upon first dosing in the Phase I clinical trial and may be eligible for further significant clinical and sales milestones as well as royalties depending on the future progress during clinical development and potential commercialisation of a drug in the future.

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The companies entered into their endometriosis multi-target discovery alliance in October 2012 with the aim to discover three clinical candidates. So far, the alliance generated six pre-clinical candidates, of which a fourth has now progressed into Phase I. Bayer advanced the first programme into a Phase II trial in refractory chronic cough in 2018. The Phase II study yielded positive results which met all of the targeted endpoints. For more information about this Bayer/Evotec alliance also see "White Paper on Bayer/Evotec Alliance".

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are very pleased that the excellent collaboration between Bayer and Evotec has now officially surpassed the ambitious initial target by delivering a fourth clinical drug candidate. The candidates we have identified and developed together are performing extremely well and hold great potential, most likely also beyond the initially surveyed indications."

Chugai Announces 2019 Full Year Results and Forecasts for 2020

On January 30, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the fiscal year ended December 31, 2019 and forecasts for the fiscal year ending December 31, 2020 (Press release, Chugai, JAN 30, 2020, View Source [SID1234553681]).

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"In 2019, the initial year of our mid-term business plan IBI 21, Chugai posted strong results with record high revenues and profits for the third consecutive year mainly driven by the successful global rollout of Hemlibra. Another milestone in 2019 was the completion of global regulatory filings for satralizumab, a drug candidate we expect as our next growth driver. Reflecting our favorable results and expected growth in the future, we significantly raised the three-year Core EPS target in IBI 21 to a challenging goal of "around 30%*". We also revised our dividend policy with a 45%* payout ratio to Core EPS on average in order to maintain a stable dividend and secure a financial base to support investment for innovation. In 2020, we will continue striving to realize advanced and sustainable patient-centric healthcare" said Tatsuro Kosaka, Chugai’s President and CEO.

*Amount excludes effect of the stock split. Ordinary share will be split with July 1, 2020 as the effective date.

Chugai reported record high revenues, operating profit and net income for the third consecutive years (Core-basis). Revenues increased by 18.4% from the previous year due to increases both in sales and royalty and other operating income. Sales increased by a double-digit percentage driven by the contribution of new products and mainstay products including the hemophilia A treatment Hemlibra, the immune checkpoint inhibitor Tecentriq, and the treatment for HER-2 positive breast cancer Perjeta and strong exports. The significant increase in royalties and other operating income was mainly due to Hemlibra-related income. Operating profit increased by 72.6% due to a better cost to sales ratio as the proportion of in-house products increased in the total product mix.

Reflecting the favorable results and based on our dividend policy, year-end dividends for the fiscal year 2019 are planned to be ¥92 per share including special dividends of ¥44. As a result, total dividends for the fiscal year will be ¥140 per share, and the Core dividend payout ratio is 47.4% on a five-year average basis (45.8% on a single fiscal year basis).

The Company also made good progress in research and development. In-house antibody projects have achieved major milestones including the global filings of satralizumab and the breakthrough therapy designation by the U.S. Food and Drug Administration for nemolizumab. The label extension of Tecentriq was achieved with two additional indications. In the area of personalized healthcare for cancer, Chugai launched FoundationOne CDx Cancer Genomic Profile aiming to promote cancer genome medicine in Japan. Building the base for future growth, the company started construction of the new core research laboratory Chugai Life Science Park Yokohama, and the new manufacturing building for active pharmaceutical ingredients of middle molecule pharmaceuticals, the next modality to follow antibodies, for clinical studies.

In 2020, the Company expects revenues and profits to mark a record high for the fourth consecutive year. Revenues, Core operating profit, and Core net income are all forecasted to increase by 7.8%, 22.3%, and 19.9%, respectively. Domestic sales are expected to decrease mainly due to the revision of the national health insurance reimbursement price and impact from biosimilars and generics, however, overseas sales are expected to increase. The increase in royalties and other operating income is driven by Hemlibra-related income. In research and development, the first clinical study for a switch antibody utilizing Chugai’s proprietary antibody engineering technology is planned to start in 2020. A global phase III study of a recycling antibody crovalimab (development code: SKY59) for the treatment of paroxysmal nocturnal hemoglobinuria is also planned to initiate this year.

Chugai expects the annual dividends per share of ¥150 with the Core dividend payout ratio of 45.0% on a five-year average basis (41.0% in a single fiscal year basis)*.

*Amount excludes effect of the stock split. Ordinary share will be split three-for-one, with July 1, 2020 as the effective date. After taking into account of the stock split, Chugai expects interim dividends payment of ¥75 (prior to the stock split) and year-end dividends payment of ¥25 (after the stock split).

In light of the favorable results for 2019 and expected business expansion over the coming years, Chugai upgraded its target of the three-year compound annual growth rate in Core EPS from "a high single-digit rate" to "around 30%", both assuming a constant exchange rate and excluding effect of the stock split.

Chugai decided to revise its dividend policy by changing the target dividend payout ratio in comparison with Core EPS from "50% on average" to "45% on average" excluding the effect of the stock split. The Company maintains the objective of continuing a stable dividend considering the strategic funding needs and earnings prospects. On the other hand, it is required to secure a financial base solid enough to support flexible and focused strategic investment in order to take bold challenges for innovation amid the rapid development of life science and digital technologies. In light of investment opportunities in the future and financing plans, Chugai decided to revise its dividend policy to continue providing stable dividend payments.