On August 28, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported that the FDA has accepted the company’s IND filing for AGEN1223, a milestone in its partnership with Gilead Sciences, Inc (Press release, Agenus, AUG 28, 2019, View Source [SID1234539051]). This milestone triggers a cash payment of $7.5M.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This announcement represents the third milestone delivered in our collaboration with Gilead this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1223 is a first-in-class bispecific designed to selectively deplete immune-suppressing cells (regulatory T cells) from the tumor microenvironment while boosting cancer-fighting effector T cells and sparing important peripheral regulatory T cells – an important mechanism not addressed with current therapies."

The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received $150 million in upfront cash payment and equity investment and is eligible for approximately $1.7 billion in future fees and milestones.

AGEN1223 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.

On August 27, 2019 CERENIS Therapeutics reported following the Extraordinary General Meeting of 21 June 2019, the shareholders of CERENIS Therapeutics approved the proposal for a new company name, which is now ABIONYX Pharma (Press release, ABIONYX Pharma, AUG 27, 2019, View Source [SID1234639900]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Beginning on 29 August 2019, the name, ISIN code and symbol/mnemonic of the share listed on Euronext Paris will be as follows:
– Share name: ABIONYX Pharma (replacing CERENIS Therapeutics)
– ISIN code of the share: FR0012616852 (unchanged)
– Stock symbol / Mnemonic code of the action: ABNX (replacing CEREN).

ABIONYX Pharma is a new generation biotech company that seeks to leverage a rich portfolio of clinical and preclinical programs inherited from the assets of CERENIS Therapeutics, to focus on the discovery and development of innovative therapies.

On August 27, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported that a late-breaking abstract detailing results from a phase 2 study of varlitinib in patients with advanced or metastatic biliary tract cancer in China has been accepted for oral presentation at the upcoming 2019 Chinese Society of Clinical Oncology (CSCO) in Xiamen, China on 19 September 2019 (Press release, ASLAN Pharmaceuticals, AUG 27, 2019, FilingView Source [SID1234539052]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, said: "Our study of varlitinib is the largest clinical trial conducted to date on biliary tract cancer patients in China and we are pleased to see the data we have generated welcomed as an important insight into the treatment of BTC by a prestigious academic group like CSCO."

The abstract titled: "JADETREE*: A phase 2A, single arm, multicenter, study of the panHER inhibitor varlitinib plus capecitabine in Chinese patients with advanced or metastatic biliary tract cancer (BTC)", will be presented in an oral session by Dr. Weijia Fang, Associated Chief Physician , M.D., Department of Medical Oncology, Zhejiang University.

Varlitinib is a highly potent pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. At CSCO, new data will be presented from ASLAN’s phase 2A, single arm, multicenter study of varlitinib plus capecitabine in unselected Chinese patients with second line BTC. Patients with advanced or metastatic BTC who failed on prior first line gemcitabine containing regimens were given varlitinib (300 mg twice daily in a 21-day cycle) plus capecitabine (1,000mg/m2 twice daily for 2 weeks followed by a 7-day rest period).

Presentation date: Thursday, 19 September 2019
Presentation time: 3:30pm – 3:40pm CST

*JADETREE: Joint Assessment of Drug Efficacy of Pan-Her inhibition using Varlitinib in second line BTC in China

Ends

Media and IR contacts
Emma Thompson
Spurwing Communications
Tel: +65 6571 2021

Email: [email protected]

Robert Uhl
Westwicke Partners
Tel: +1 858 356 5932

Email: [email protected]

About varlitinib (ASLAN001)

Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumours, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumour growth. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.

On August 27, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases, reported that the Company will present a corporate overview at two investor conferences in September (Press release, RedHill Biopharma, AUG 27, 2019, View Source [SID1234539045]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

H.C. Wainwright Annual Healthcare Conference
Date: Monday, September 9, 2019
Time: 11:40 a.m. EDT
Speaker: Dror Ben-Asher, Chief Executive Officer
Location: Lotte New York Palace Hotel, NY

Ladenburg Thalmann 2019 Healthcare Conference
Date: Tuesday, September 24, 2019
Time: 1 p.m. EDT
Speaker: Guy Goldberg, Chief Business Officer
Location: Sofitel Hotel, NY

A copy of the presentations will be available on the Company’s website and may be viewed at: View Source

On August 27, 2019 Adaptimmune Therapeutics plc, Philadelphia, PA, and Oxfordshire, UK (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Noile-Immune Biotech, Inc., Tokyo, Japan, a biotechnology company focusing on the development of innovative cancer immunotherapies, reported that they will co-develop next-generation SPEAR T-cell products, incorporating Noile-Immune’s PRIME (proliferation inducing and migration enhancing) technology, based upon co-expression of IL-7 and CCL19 (Press release, Adaptimmune, AUG 27, 2019, View Source [SID1234539042]). The PRIME technology, which is already being investigated for augmentation of CAR-T cell activity, will be investigated with Adaptimmune’s SPEAR T-cells, as part of Adaptimmune’s next-generation programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We recently started our Phase 2 trial in sarcoma called SPEARHEAD-1 as well as the SURPASS trial, our first next-generation product clinical trial. We will continue to develop enhanced products with the aim of increasing the efficacy and durability of anti-tumor responses," said Karen Miller, Adaptimmune’s Senior Vice President of Pipeline Research. "This agreement with Noile-Immune will enable us to generate next-generation SPEAR T-cells secreting both IL-7 and CCL19, which may improve proliferation and trafficking of not only our engineered SPEAR T-cells, but also the patient’s own T-cells into solid tumors. This increased T-cell proliferation and trafficking may enhance anti-tumor activity for cancer patients."

"We are very pleased to step into co-development of next-generation T-cell products with Adaptimmune," said Hidenobu Ishizaki, M.D., Ph.D., President & CEO of Noile-Immune. "This agreement is another example of our collaborations to apply PRIME technology, which was invented by Dr. Koji Tamada, our scientific founder, to highly innovative cell therapies, and to work with top external scientific and clinical teams. This technology may establish more effective cancer treatments that address the needs of patients."

Under the terms of the agreement, Noile-Immune and Adaptimmune will collaborate on preclinical development of next-generation SPEAR T-cells directed to a limited number of T-cell targets incorporating Noile-Immune’s PRIME technology. Adaptimmune will have exclusive rights to develop and commercialize resulting products on a worldwide basis. Adaptimmune will make an upfront cash payment and milestone payments to Noile-Immune of up to $312M across all programs. Noile-Immune is also entitled to receive mid-single digit royalties on net sales of resulting products. The companies plan to gain regulatory approval for human testing of the first target program by 2021.