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Press Release: Helsinn Announces First Patient Dosed in Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

01/12/2021 | 03:30am EDT
 
   Helsinn Announces First Patient Dosed in Phase 1/2 Study of TAS0953/HM06 
in Patients with Advanced Solid Tumors with RET Gene Abnormalities 
 
   Lugano, Switzerland, January 12, 2021 -- Helsinn, a Swiss pharmaceutical 
group focused on building quality cancer care and rare disease products, 
today announces the first patient has been dosed in a Phase 1/2 Study of 
TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene 
Abnormalities. 
 
   TAS0953/HM06 is an investigational oral treatment which inhibits several 
RET abnormalities identified as oncogenic driver alterations in NSCLC, 
papillary and medullary thyroid cancers, and several other tumor types. 
This innovative drug candidate offers several differentiating features 
as compared to other RET inhibitors. 
 
   The study will be initially conducted at sites in US and Japan. 
 
   Helsinn is developing TAS0953/HM06 together with its partner Taiho 
Pharmaceutical Co., Ltd.  In 2017, Helsinn and Taiho signed a global 
co-development and commercialization agreement for TAS0953/HM06. 
 
   Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented: "We are 
very pleased to have dosed the first patient in this Phase 1/2 study 
with TAS0953/HM06.  Based on pre-clinical data generated thus far, 
TAS0953/HM06 has been shown to have several differentiating features in 
comparison to other targeted therapies, and we believe it has therefore 
the potential to offer significant benefits for patients with NSCLC and 
other tumors which harbor RET abnormalities. 
 
   We have had a very collaborative relationship with Taiho to date and are 
looking forward to continuing to work closely with them to advance this 
potential innovative treatment through the clinic." 
 
   Further information on the study can be found at: 
https://www.globenewswire.com/Tracker?data=1kdiqjPF9mDXIxgCH127jv2vxcpMLBjO1DXMTJhShEI8RKfA7f7ajbm1JX2dusa4tPPL1Bf_SoYMalMDzxLHSiKhhDQbgrZhM_edVDOvrrsiEK9ZU09RFGsdY7xb4hVNFhxRqmtudPnwwEa82sTBsba4oQwdrjg8YZ7tWSCC9kjvF_NpZoJWNn-rp_Oe9pzZrjo6WXVKf9THAW8nPUEyQtMcSCUzyOzuweCCyxEO7xKjgMoN6geDY8OnRuwwFNwB 
https://www.clinicaltrials.gov/ct2/show/NCT04683250?term=hm06&draw=2&rank=1. 
 
 
   TAS0953/HM06 is an investigational agent and is not approved for 
commercial use in any country. 
 
   About TAS0953/HM06 
 
   TAS0953/HM06 is an oral RET inhibitor in development for advanced or 
metastatic Non-Small Cell Lung Cancer (NSCLC) and other tumors which 
express RET gene abnormalities. Preclinical data showed several 
differentiating features in comparison to other targeted therapies 
acting on RET abnormalities. 
 
   Taiho and Helsinn signed a co-development and commercialization 
agreement for TAS0953/HM06 in 2017 and will continue to pursue together 
all preclinical, clinical and CMC developments. This alliance also 
includes efforts to reach as many patients as possible around the world 
through their own commercial infrastructures or through valued partners. 
 
   About RET abnormalities in NSCLC and other cancers(1) 
 
   RET kinase abnormalities have been identified as targetable oncogenic 
drivers in NSCLC, papillary and medullary thyroid cancers, and several 
other tumor types. In NSCLC, RET fusions are more common in younger 
patients with no prior history of smoking and in those with 
adenocarcinomas, however the underlying mechanisms remain unknown. 
 
   About the Helsinn Group 
 
   Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has 
been improving the lives of patients, guided by core family values of 
respect, integrity and quality. The Group has an extensive portfolio of 
marketed innovative cancer and rare disease therapies, a robust drug 
development pipeline and ambitions to further accelerate its growth 
through in-licensing and acquisition to address unmet medical needs. 
Helsinn operates a unique integrated licensing business model, achieving 
success with over 80 long-standing partners in 190 countries, who share 
our values. The Group's pharmaceutical business, (Helsinn Healthcare) is 
headquartered in Lugano, Switzerland with operating subsidiaries in the 
U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) 
which market the Group's products directly in these countries. The Group 
has additional operating subsidiaries in Switzerland (Helsinn Advanced 
Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland 
(Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn 
Investment Fund was created to enhance the future of healthcare by 
providing funding and strategic support to innovative companies. 
 
   Helsinn Group plays an active and central role in promoting social 
transformation in favor of people and the environment. Corporate social 
responsibility is at the heart of everything we do which is reinforced 
in the company's strategic plan by a commitment to sustainable growth. 
 
   To learn more about Helsinn Group please visit 
https://www.globenewswire.com/Tracker?data=BwzgGqURoUvk2W8kyNo-5WJPIQ2moeElsPoaA4OG1TLAZ396oMnjL0vPrJXAXrkV856Xz9dF3wEPbpKSDmr-vA== 
www.helsinn.com 
 
   About Taiho Pharmaceutical 
 
   Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an 
R&D-driven specialty pharma focusing on the three fields of oncology, 
allergy and immunology, and urology. Its corporate philosophy takes the 
form of a pledge: "We strive to improve human health and contribute to a 
society enriched by smiles." In the field of oncology in particular, 
Taiho Pharmaceutical is known as a leading company in Japan for 
developing innovative medicines for the treatment of cancer, a 
reputation that is rapidly expanding through their extensive global R&D 
efforts. In areas other than oncology, as well, the company creates and 
markets quality products that effectively treat medical conditions and 
can help improve people's quality of life. Always putting customers 
first, Taiho Pharmaceutical also aims to offer consumer healthcare 
products that support people's efforts to lead fulfilling and rewarding 
lives. For more information about Taiho Pharmaceutical, please visit: 
https://www.globenewswire.com/Tracker?data=1kdiqjPF9mDXIxgCH127jsSe3sS3atx5YYDIy2v0oiMEGRgPkd64esjNXlIdPLU468PavdGVodmu5OcPkMz3AWhYyTjo7l2-A2aLA_XHwA0= 
https://www.taiho.co.jp/en/ 
 
   Helsinn Group Media Contact: 
 
   Paola Bonvicini 
 
   Group Head of Communication 
 
   Lugano, Switzerland 
 
   Tel.: +41 91-985-21-21 
 
   https://www.globenewswire.com/Tracker?data=w4kl1rtw3JjES-XZmkKmLYaALhDquOhxPszr_Ia81TVeYj-nWhVHxNvQtlZ5gHrd4sPeIV3dC-KgH3Nfv6R_tWNz_M7_nmGguuZgqcoD0Dg= 
Info-HHC@helsinn.com 
 
   For more information, please visit 
https://www.globenewswire.com/Tracker?data=BwzgGqURoUvk2W8kyNo-5WAQx9aOErug5Hav2upEnBfa96lRvC90f6cjIug807LiTrre8kyjWNlP68Vg3sq_IQ== 
www.helsinn.com and follow us on 
https://www.globenewswire.com/Tracker?data=WwEaUccjzLwVw8zLK5U8nHcLyzPPw8nDiqG3ZnMFKyefGL5ZyixKE2YhbQculUil30SM_VaDvHi_eP6bfy2_Rw== 
Twitter, 
https://www.globenewswire.com/Tracker?data=L8GW9wxQFCgA4tMjajpTP8JQw-v0izV9hvj89FpB5eKDnFkLrMVNICOrnOYpmZjcXwvq9zoRPgxttrZauNkZBXJ8JviuzwGdekEw_jTJnkI= 
LinkedIn and 
https://www.globenewswire.com/Tracker?data=8r0cuoB7GOjrDEzr8FzLuh6Evm2nQzu4klkr-7_Mq7WNHue49jFG6s_HnnLT_QQUHUvniSmkD1z8H4T7Itw1CA== 
Vimeo 
 
   HELS--0006 
 
   (1) Helsinn and Taiho research and analysis of ASCO 2018; ASCO 2019; 
Cancer Biol Ther 2015; Cell Rep 2017; JCO 2018; Johns Hopkins 2019; Nat 
Med 2012; Nat Rev Clin Oncol 2018; OMIM; Onco Targets Ther 2019 
 
 
 
 

(END) Dow Jones Newswires

January 12, 2021 03:30 ET (08:30 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
HUMAN HEALTH HOLDINGS LIMITED -1.00% 0.99 End-of-day quote.65.00%
OTSUKA CORPORATION -2.07% 5690 End-of-day quote.4.40%
OTSUKA HOLDINGS CO., LTD. -2.76% 4338 End-of-day quote.-1.81%
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