On September 23, 2019 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in pain management, ophthalmology and oncology, reported that new in vivo data on the efficacy and enhanced tumor accumulation of TLC178 will be presented at the European Society for Medical Oncology Congress (ESMO 2019). ESMO (Free ESMO Whitepaper) 2019 takes place from September 27 to October 1, 2019 in Barcelona, Spain (Press release, Taiwan Liposome Company, SEP 23, 2019, View Source [SID1234539710]). TLC178 is a proprietary NanoX formulation of vinorelbine, an anticancer drug frequently used off-label to treat soft tissue sarcoma.

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Details of the poster presentation (#1722P) are as follows:

Title: In Vivo Efficacy and Enhanced Tumor Accumulation of Liposomal Vinorelbine (TLC178) in Human Sarcoma Xenograft Mouse Models
ID#: 1844
Location: Poster Area (Hall 4), Fira Gran Via
Speaker: Wan-ni Yu, PhD
Date/Time: 12:00pm to 1:00pm CEST, September 28, 2019

The objectives of the studies were 1) to compare the anti-tumor activity of TLC178 to the reference drug in human soft tissue sarcoma xenograft mouse models, and 2) to investigate the pharmacokinetic and the drug distribution of vinorelbine (VNB) from a single intravenous injection of TLC178 or VNB in a tumor-bearing mouse model.

Key findings are as follows:

TLC178 remarkably suppressed fibrosarcoma tumor growth compared with doxorubicin, an approved drug for treatment of sarcomas. TLC178 reached 14% complete regression (CR) and 86% partial regression (PR) while no tumor regression was observed with doxorubicin.

TLC178 showed a better inhibitory effect than both VNB alone and VNB + cyclophosphamide treatments in the rhabdomyosarcoma xenograft model.

TLC178 was well tolerated in all listed studies, as shown by no body weight loss and no lethality, compared to body weight loss and one lethality in doxorubicin-treated mice.

TLC178 showed an improved in vivo systemic pharmacokinetic profile and a five-fold accumulation at the tumor site compared to non-liposomal VNB, which resulted in superior anti-tumor activity.

TLC178 could potentially be used as a single or combination treatment for sarcomas with decreased dosing frequency, reduced toxicity, and enhanced efficacy.

"We are pleased that TLC178 data was selected for presentation at this prestigious conference," said George Yeh, President of TLC. "TLC has long been active in the oncology space, with two oncology products already approved and sold in Asia, and we remain committed to developing medicines with the potential to deliver a better quality of life for patients."

The poster presentation can be accessed under "Publications" in the Pressroom section of TLC’s website at www.tlcbio.com.

About TLC178

TLC178 is TLC’s proprietary NanoX liposomal formulation of vinorelbine, an anticancer drug frequently used off-label to treat soft tissue sarcoma. TLC178 is designed to increase the therapeutic index and reduce side-effects through prolonged circulation time and increased accumulation of vinorelbine in tumor tissues, with the potential to decrease toxicity, improve tolerability, and increase durable response rates. The US Food and Drug Administration (FDA) has granted TLC178 Rare Pediatric Disease Designation in rhabdomyosarcoma, which will qualify TLC178 in this indication for priority review. The FDA and the European Medicines Agency (EMA) have both granted TLC178 Orphan Drug Designation for the treatment of soft tissue sarcoma, which can provide seven and ten years of marketing exclusivity in the US and the EU, respectively.

On September 23, 2019 PharmaMar is a biopharmaceutical company reported that During the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, to be held from September 27th to October 1 st in Barcelona, the recent results of the lurbinectedin trial for the treatment of progressive malignant pleural mesothelioma, carried out by SAKK (Swiss Group for Clinical Cancer Research) in collaboration with PharmaMar (MSE:PHM), will be presented (Press release, PharmaMar, SEP 23, 2019, View Source [SID1234539709]).

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The oral presentation will be entitled "SAKK 17/16: Lurbinectedin as second or third line palliative chemotherapy in pleural malignant mesothelioma (MPM): A multicenter, single-arm Phase II trial". During this conference, the primary results will be shown from a single arm, multicenter, Phase II trial, which has enrolled 42 patients with progressive malignant pleural mesothelioma, which met its primary endpoint of PFS at 12 weeks.

Malignant mesothelioma is a rare tumor, arising from the mesothelial cells of the pleural, peritoneal or pericardial lining, and is often associated with exposure to asbestos, usually with a very poor prognosis at the time of diagnosis, being pleural mesothelioma the most frequent location. There is currently no cure for most malignant mesotheliomas. Therefore, the goal of current cancer treatments (surgery, radiation therapy, and chemotherapy) is to reduce or eliminate symptoms, as well as to prolong progression-free survival (PFS) and/or overall survival (OS). It is estimated that the incidence of this type of cancer may increase in the coming years, after the exposure to asbestos. It usually takes a long time before a malignant mesothelioma forms.

Trabectedin 2 In addition, the data obtained in several clinical studies carried out with trabectedin, evaluating new combinations of trabectedin for the treatment of soft tissue sarcoma, ovarian cancer and different solid tumors will be presented. Among them, data from a multicenter Phase II study of trabectedin in combination with a low dose of radiotherapy conducted by Sarcoma Research Groups in Spain, France and Italy, will be presented.

The studies presented at the ESMO (Free ESMO Whitepaper) 2019 congress are available at: View Source Highlighted studies at ESMO (Free ESMO Whitepaper) 2019 Lurbinectedin  Proffered Paper 2 – Non-metastatic NSCLC and other thoracic malignancies (mesothelioma and thymic carcinoma) Oral presentation-30.09.2019, 10:15-11:45, Pamplona Auditorium (Hall 2) Autor principal: Yannis Metaxas (Chur, Switzerland)  Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors Poster Display session-28.09.2019, 12:00-13:00, Poster Area (Hall 4) Autor principal: Santiago Ponce Yondelis (trabectedin)  Trabectedin with concurrent low-dose of radiation therapy for metastatic soft tissue sarcomas: A phase II trial of Spanish, French and Italian sarcoma groups Poster Discussion – Sarcoma. 28.09.2019, 15:00-16:00, en Malaga Auditorium (Hall 5) Autor principal: J Martin-Broto (Sevilla)  Inhibition of mTOR signaling enhances Trabectedin activity in Soft Tissue Sarcoma Poster Display session. 28.09.2019, 12:00-13:00, Poster Area (Hall 4). Autor principal: David S. Moura, PhD. 3  Randomized Phase II Study of Trabectedin/Olaparib Compared to Physician’s Choice in Subjects with Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies Poster-30.09.2019, 12:00-13:00, en el Hall A3-Poster Area (Hall 4) Autor principal: S Christoph E. Heilig, Germany.  Impact of prior pegylated liposomal doxorubicin (PLD) treatment in recurrent ovarian cancer (ROC): Sub-group analysis from a randomized, open-label study comparing trabectedin (T) and PLD versus PLD alone in ROC (ET743-OVC-3006) Poster-29.09.2019, 12:00-13:00, Poster Area (Hall 4). Autor principal: Bradley J Monk, USA.

Legal warning This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On September 23, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that two posters on clinical studies combining domatinostat and anti-PD-(L)1 checkpoint inhibitor will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held on 27 September to 1 October 2019 in Barcelona, Spain (Press release, 4SC, SEP 23, 2019, View Source [SID1234539707]). The posters will be available on 4SC’s website after the presentation.

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Poster presentations at the ESMO (Free ESMO Whitepaper) Congress 2019

Poster EMERGE: Epigenetic Modulation of the Immune Response in Gastrointestinal cancers (Trial in progress)
Session Poster Display session 2 (ID 211)
Time Sunday, 29 September 2019, 12:00 – 13:00 CEST
Location Poster Area (Hall 4)
Poster Phase Ib/II Study (SENSITIZE) assessing safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical outcome of domatinostat in combination with pembrolizumab in patients with advanced melanoma refractory/non-responding to prior checkpoint inhibitor therapy
Session Poster Display session 3 (ID 212)
Time Monday, 30 September 2019, 12:00 – 13:00 CEST
Location Poster Area (Hall 4)
Related articles
11 July 2019, 4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

8 April 2019, 4SC AG: Domatinostat’s mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

On September 23, 2019 Oncology Venture A/S (Nasdaq First North Growth Market Stockholm: OV.ST) reported that data on the ability of DRP to predict response to 5-FU anti-cancer treatment in late-stage colorectal cancer will be presented at the annual congress of European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Barcelona (Press release, Oncology Venture, SEP 23, 2019, View Source [SID1234539706]).

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Fluorouracil (5-FU) is a central component of the standard of care in colorectal cancer treatment. Unfortunately, not all patients benefit from 5-FU, and individual risk assessment is needed to optimize the therapy for individual patients.

Oncology Venture is developing its first-in-class Drug Response Prediction (DRP) technology by utilizing Artificial Intelligence (AI) proprietary algorithms. It has previously been demonstrated that DRP can predict which patients will benefit from 5-FU when administered after surgery in the adjuvant setting. A new study now shows that the use of DRP can be successfully expanded to patients with late-stage, metastasized colorectal cancer. This by using the biopsy material obtained when the patient was initially diagnosed.

This data is presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual cancer congress in Barcelona September on 27 September – 1 October, 2019 as an abstract with the title "Independent clinical validation of a gene expression profile to predict benefit of 5-FU in metastatic colorectal cancer, and as a poster (please see below).

View Source

Poster Display session 2 (ID 211)
Date: 29.09.2019
Time: 12:00 – 13:00
Location: Poster Area (Hall 4)

For further information, please contact:
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Telephone +45 60 62 93 90

On September 23, 2019 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female-specific oncology products in the precision medicine metastatic breast cancer arena, reported the enrollment and dosing of the first patient into a Phase 2 clinical trial of its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, SEP 23, 2019, View Source [SID1234539705]).

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The open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE, NCT03781063) study will assess the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

"To address this unique population, the landmark ELAINE study of women with advanced metastatic breast cancer is the first of its kind to select all patients for participation prospectively based on ESR1 mutation status," said Paul Plourde, M.D., vice president of clinical oncology development at Sermonix. "A potential targeted therapy for ER+/HER2- breast cancer patients could greatly advance our approach to this complex disease."

Assessment of ESR1 mutations is difficult in patients with advanced disease, as molecular heterogeneity can confound results and tissue biopsies of multiple tumor sites are impractical. To address this challenge, Sermonix partnered with Sysmex Inostics to identify appropriate study participants using the OncoBEAM ESR1 test. The liquid biopsy test has demonstrated proven clinical performance in screening patient plasma for ESR1 mutations.

"The OncoBEAM ESR1 technology allows us to determine if a mutation exists in the binding domain of the tumor’s estrogen receptor gene via a minimally invasive peripheral blood draw," said Dr. Plourde. "We are delighted to collaborate with Sysmex Inostics to quickly and accurately identify appropriate study candidates."

Sermonix’s mission to develop lasofoxifene as a precision medicine for women in great medical need is one important step closer to fruition with the initiation of the ELAINE study, according to Dr. David Portman, Sermonix founder and chief executive officer.

"The dosing of our first patient, which closely follows the completion of our Series A financing, marks a pivotal milestone and truly gratifying moment for Sermonix," said Dr. Portman. "ESR1 mutations are highly prevalent in ER+ metastatic breast cancer and confer a poor prognosis. We are encouraged to be able to offer women the opportunity to participate in the ELAINE study, and for Sermonix to deliver on the promise of demonstrating lasofoxifene’s potential as a novel endocrine treatment option in the fight against this incurable disease."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered at Duke University and Sermonix has exclusive rights to develop and commercialize it in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.