On October 8, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO) reported that it has achieved a milestone under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt, Germany and is entitled to receive a milestone payment (Press release, Sutro Biopharma, OCT 8, 2019, View Source [SID1234540101]). The milestone was achieved upon the designation by Merck KGaA, Darmstadt, Germany of an undisclosed bispecific antibody drug conjugate (ADC) as a clinical development candidate with approval to advance to IND-enabling studies. This candidate was discovered using Sutro’s XpressCF+ drug discovery and manufacturing technology and includes a proprietary linker-warhead also discovered by Sutro. The ADC is based on Merck´s strand-exchange engineered domain (SEED) platform to generate bispecific antibody-like molecules. As part of the agreement, Sutro will manufacture the ADC immediately for the early clinical supply of the candidate and is eligible for further milestones and royalties. Merck KGaA, Darmstadt, Germany will be responsible for drug product, clinical development and commercialization of this clinical development candidate.

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 achievement of this milestone marks our fourth ADC clinical product candidate in three years, further validating our XpressCF+ drug discovery and manufacturing technology which enables iterative optimization through cell-free protein synthesis and site specific conjugation as well as our linker-warhead, all of which are designed to achieve an improved therapeutic window," said Bill Newell, Sutro’s Chief Executive Officer. "We look forward to continuing our collaboration with Merck KGaA, Darmstadt, Germany as we seek to discover the next-generation of oncology therapeutics and transform the lives of cancer patients in urgent need of new therapies."

"We are extremely excited to reach this milestone; the development of a therapeutic candidate that incorporates site-specific homogeneous drug conjugation onto a bispecific antibody for the treatment of solid tumors is another demonstration of the versatility of our technology platform," said Trevor Hallam, PhD, Sutro’s Chief Scientific Officer.

Under the terms of the agreement announced in 2014, Sutro and Merck KGaA, Darmstadt, Germany have collaborated to discover and develop ADCs utilizing Sutro’s cell-free protein synthesis platform, Xpress CF+. Merck KGaA, Darmstadt, Germany will be responsible for drug product, clinical development and commercialization of any resulting products. Sutro is eligible to receive certain pre-commercial milestone payments and tiered royalties ranging from low-to-mid single digit percentages, along with certain additional one-time royalties, on worldwide sales of any commercial products. Further financial details are not being disclosed.

On October 8, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the third quarter 2019 and business progress after the close of market on Tuesday, October 22, 2019 (Press release, Veracyte, OCT 8, 2019, View Source [SID1234540118]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

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 conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

8767084

On October 8, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp) clinical data from the pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) was selected for oral presentation at the 81st Annual Meeting of the Japanese Society of Hematology (JSH), to be held from October 11 – 13, 2019, at the Tokyo International Forum in Tokyo, Japan (Press release, Stemline Therapeutics, OCT 8, 2019, View Source [SID1234540102]).

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!

ELZONRIS (tagraxofusp) is FDA-approved for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and is commercially available in the U.S.

After its delivery, the presentation will be available on the Stemline website (www.stemline.com), under the Scientific Presentations tab.

Details on the presentation are as follows:

Abstract: 30136

Title: Outcomes of Tagraxofusp (SL-401) in Older Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Presenter: Eunice Wang, M.D
Roswell Park Comprehensive Cancer Center

Date: Sunday, October 13th

Time: 3:40 – 4:40 PM JST

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On October 8, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that management will host a conference call on Tuesday, October 29, 2019, at 8:00 a.m. CDT to review first quarter 2020 financial results (Press release, Bio-Techne, OCT 8, 2019, https://investors.bio-techne.com/press-releases/detail/159/bio-techne-to-host-conference-call-on-october-29-2019-to [SID1234540103]).

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!

Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CDT

Date:

October 29, 2019

Dial-in:

1-888-394-8218 or 1-323-701-0225 (for international callers)

Conference ID:

5097333

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by going to:

View Source

The replay will be available from 11:00 a.m. CDT on Tuesday, October 29, 2019, until 11:00 p.m. CST on Friday, November 29, 2019.

On October 8, 2019 Galera Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported final data from its two-year tumor outcomes follow up of patients with locally advanced squamous cell head and neck cancer treated with its lead product candidate, GC4419 (avasopasem manganese) (Press release, Galera Therapeutics, OCT 8, 2019, View Source [SID1234540954]).

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!

GC4419, a highly selective and potent small molecule dismutase mimetic, is being developed to reduce the incidence and severity of radiation-induced severe oral mucositis (SOM), its lead indication. SOM is a common, debilitating complication of radiotherapy in patients with head and neck cancer. There is currently no FDA-approved drug to treat SOM in patients with head and neck cancer.

As part of its Phase 2b clinical trial of GC4419 in patients with locally advanced head and neck cancer, Galera assessed tumor outcomes of the patients over a two-year period following radiotherapy. Patients in the trial received seven weeks of radiation therapy plus cisplatin, and were treated with either 30 mg or 90 mg of GC4419 or placebo by infusion on the days they received their radiation treatment. At both the one-year interim assessment and final two-year mark, tumor outcomes were maintained across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival – in both GC4419 dose groups (30 mg and 90 mg) compared to placebo.

"We are pleased with these data, which demonstrated GC4419, when added to a standard radiotherapy regimen, maintained the efficacy of treatment for head and neck cancer and reduced debilitating radiation-induced oral mucositis," said Mel Sorensen, M.D., President and CEO of Galera Therapeutics. "GC4419 achieved meaningful reductions in the duration, incidence and severity of SOM in the completed Phase 2b trial. These two-year tumor data further reinforce the potential of GC4419 to be a promising treatment to reduce radiation toxicities and complement standard radiotherapy regimens in head and neck cancer."

Full results will be submitted for presentation at a future scientific meeting.

GC4419 is being evaluated in the ongoing pivotal ROMAN Phase 3 trial in patients with head and neck cancer, with topline data anticipated in the first half of 2021. GC4419 is also currently being studied in combination with stereotactic body radiation therapy for its anti-tumor effect in a pilot Phase 1b/2a trial of patients with locally advanced pancreatic cancer.

About GC4419 (Avasopasem Manganese)

Galera’s lead product candidate, GC4419 (avasopasem manganese), is a highly selective and potent small molecule dismutase mimetic that is being developed for the reduction of SOM in patients with head and neck cancer. GC4419 is designed to rapidly convert superoxide to hydrogen peroxide, reducing mucosal damage and thereby the incidence and severity of mucositis. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis, which can limit the anti-tumor efficacy of radiation therapy.

GC4419 is being studied in the Phase 3 ROMAN clinical trial of patients with locally advanced head and neck cancer, its lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis. In Galera’s 223-patient, double blind, randomized, placebo- controlled Phase 2b clinical trial, GC4419 demonstrated the ability to reduce the median duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, and GC4419 was well tolerated in the trial when added to a standard radiotherapy regimen. GC4419 is also currently being studied in combination with SBRT for its anti-tumor effect in a pilot Phase 1b/2a trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration granted Breakthrough Therapy and Fast Track designations to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiotherapy in patients with head and neck cancer.