On August 17, 2021 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported two presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, to be held from September 16-21, 2021 (Press release, Carrick Therapeutics, AUG 17, 2021, View Source [SID1234586690]). An e-poster will be available from 07:30 BST (02:30am ET) on September 16, 2021, and a mini-oral presentation from 17:10 BST (12:10pm ET) on September 18, 2021.

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!

Poster and oral presentation details are as follows:

Poster Presentation Title: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+ BC)
Presenting Author: Sacha Howell, The Christie NHS Foundation Trust Manchester, UK
Abstract number: 1346 (265P)

Oral Presentation Title: First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies
Presenting Author: Matthew G. Krebs, The Christie NHS Foundation Trust & University of Manchester, UK
Abstract number: 943 (230MO)

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. It is currently being evaluated in Phase 2a studies targeting CDK4/6 inhibitor resistant second-line HR+, HER2- metastatic breast cancer, in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer and in combination with chemotherapy for the treatment of locally advanced or metastatic TNBC.

On August 17, 2021 Navrogen Inc. ("Navrogen"), a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and Tavotek Biotherapeutics ("Tavotek"), a biotech company focusing on novel multi-specific antibodies in immuno-oncology and autoimmune diseases, reported that they have entered into a strategic collaboration to identify and develop experimental monoclonal antibodies (mAbs) for the treatment of various cancer indications (Press release, Navrogen, AUG 17, 2021, View Source [SID1234586689]).

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!

Under the agreement, Navrogen and Tavotek will collaborate on the development of future Tavotek oncology assets while utilizing Navrogen’s proprietary screening technology to identify mAb leads that are susceptible to Humoral Immuno-Oncology (HIO) factors. HIO is a process by which tumors produce factors that suppress a patient’s humoral immune response against malignant tissues as well as diminish therapeutic response of immune-mediated anti-cancer therapies. Working with Navrogen’s HIO platform technologies and its expertise in patient tumor screening methods, the teams will identify and/or engineer HIO-refractory antibodies that are effective across a wide range of HIO-positive cancers leading to innovative treatment options for patients with limited therapeutic options.

On August 17, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has entered into an agreement with New Horizon Health Limited (6606.HK) on the sale of certain non-essential biological samples. Gross proceeds from the sale are USD 6.7 million from which Epigenomics receives USD 4.7 million at closing and the remainder is payable within 90 days based upon the Company providing verification of sample integrity and documentation. The Company is retaining all necessary samples for the on-going development of Epi proColon Next-Gen and other R&D activities. As a result of the sale, the Company is updating its current full year 2021 revenue and earnings guidance to approximately EUR 6.0 million of revenue and EUR -3.0 million to EUR -4.0 million of EBITDA before share-based payment expenses. Cash consumption in 2021 is expected to be between EUR 3.5 million and EUR 4.5 million.

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!

On August 17, 2021 Incyte (Nasdaq:INCY) reported that it will present at the Morgan Stanley 19th Annual Global Healthcare Conference (Virtual) on Monday, September 13, 2021 at 11:45 a.m. ET (Press release, Incyte, AUG 17, 2021, View Source [SID1234586683]).

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!

The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

On August 17, 2021 Shorla Pharma (‘Shorla’), a specialty pharmaceutical company, and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support the launch and commercialization of Shorla’s oncology portfolio (Press release, EVERSANA, AUG 17, 2021, View Source [SID1234586682]). The new partnership will initially focus on SH-111, an oncology drug designed to treat T-cell leukemia, currently pending U.S. FDA approval.

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!

Under the terms of the agreement, Shorla maintains ownership of SH-111 as well as all financial, legal, regulatory, and manufacturing responsibilities for the product. EVERSANA receives the exclusive right to support all commercialization activities for SH-111 in partnership with Shorla.

"With the recent opening of our Cambridge, MA office, we are excited to announce EVERSANA’s commercial support to bring SH-111 to patients with T-cell leukemia. This partnership will provide us with a fully integrated commercial organization to support the launch of SH-111," said Sharon Cunningham, CEO, Shorla Pharma. "New therapies for women and children are often overlooked or in short supply. Our goal is to bring to market products that represent a new standard of treatment for these patients."

In March, Shorla filed its application for SH-111 with the FDA and looks forward to expedited review and anticipates approval to bring this much needed product to market later this year. SH-111 is designed to treat T-cell leukemia, an aggressive blood and bone marrow cancer which progresses quickly. While most leukemias present in older people, T-cell leukemia is most common among children, with the current treatment often in shortage.

"Knowing that so many young patients and families eagerly await this much-needed treatment, EVERSANA stands ready to immediately deploy our commercialization expertise and infrastructure in the United States," said Jim Lang, CEO, EVERSANA. "This partnership will support Shorla’s oncology innovations with our oncology commercialization expertise to ensure a successful launch and access to long-awaited treatment for patients."

Future EVERSANA services may include patient services, health economic research, market access, commercial deployment solutions, channel management, pharmacovigilance compliance and other services as the teams require.