Ayala Pharmaceuticals Raises $30 Million in Series B Financing

On May 28, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically defined, reported the successful completion of a $30 million Series B financing (Press release, Ayala Pharmaceuticals, MAY 28, 2019, View Source [SID1234536611]).

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 investment was led by Novartis with participation from SBI JI Innovation Fund and all existing investors, including Israel Biotech Fund, aMoon and Harel Insurance & Finance Group. The new capital will fuel Ayala’s plans to advance the clinical development of lead product candidate AL101, a pan-Notch inhibitor that is currently being evaluated for adenoid cystic carcinoma (ACC). The company intends to advance the phase 2 study in ACC and initiate a phase 2 clinical trial in triple negative breast cancer (TNBC).

"The strategic investment by Novartis coupled with the continued support from our investors in this round underscores the potential for both AL101 and AL102, pan-Notch inhibitors being investigated in patient populations with high unmet needs," said Roni Mamluk, Ph.D., Chief Executive Officer at Ayala Pharmaceuticals. "With this funding we are well positioned to complete the ongoing phase 2 study of AL101 in ACC and begin a phase 2 study with AL101 as a targeted therapy for patients living with TNBC bearing Notch activating mutations/fusions."

Ayala Pharmaceuticals is broadly developing its product candidates, AL101 and AL102, best-in-class gamma secretase inhibitors, with studies underway in solid tumors (AL101) and in hematologic malignancies (AL102) and in collaboration with Novartis in multiple myeloma.

The U.S. Food and Drug Administration’s Office of Orphan Products Development recently granted Orphan Drug Designation to AL101 for the potential treatment of ACC.

About AL101
AL101 is a gamma secretase inhibitor developed as a Notch inhibitor for oncology indications. Notch signaling pathway plays an important role in tumorigenesis in several solid and hematological malignancies. Upon ligand binding of the Notch receptor, an important step in the activation of Notch receptors is cleavage by gamma secretase, which frees the Notch intracellular signaling domain.

AL101 is currently in Phase 2 for adenoid cystic carcinoma patients with tumor bearing Notch activating mutations (ACCURACY). For additional information about the AL101 ACCURACY clinical trial, please go to www.clinicaltrials.gov. Interested patients and physicians can contact Medical Affairs at Ayala Pharmaceuticals for more information at: [email protected] or call +1-857-444-0553.

Lunit to Present Findings on the Predictive Power of AI Biomarker for Lung Cancer Immunotherapy at ASCO 2019

On May 28, 2019 Lunit reported an abstract presentation of its AI precision medicine research portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019, held May 31 – June 4 in Chicago (Press release, Lunit, MAY 28, 2019, View Source [SID1234536610]).

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 accepted abstract highlights the feasibility of AI-based biomarker in metastatic non-small cell lung cancer, based on the H&E analysis that predicts response to immune checkpoint inhibitors (ICI).

The abstract will be presented at ASCO (Free ASCO Whitepaper) poster sessions on Sunday, June 2. Lunit will also be hosting a booth exhibition during ASCO (Free ASCO Whitepaper), at booth #19129.

The study evaluated the predictive value of AI versus PD-L1, the main biomarker for ICI, in terms of both its comparative predictive value as well as additive predictive value. According to the research, within PD-L1(+) patient group, the treatment response and progression-free survival (PFS) significantly differed depending on the AI score. The same results were obtained within the PD-L1(-) group.

After reclassifying PD-L1(-) patient group based on the AI score, 52% of patients with high AI score had, in fact, shown response to ICI. These patients had three times longer PFS compared to the patients who had a low AI score. Similar outcomes were found among the PD-L1(+) patient group. Classified with AI profiling, 63% of low AI score patients were non-responsive to ICI. These patients had six times shorter PFS compared to high AI score patients.

Additionally, in an AI analysis independent of PD-L1, the team was able to identify more patients that showed response to ICI. Among PD-L1(+) patient group, 49% of the patients were responsive to ICI, whereas 65% of patients within high AI score patient group showed response.

"With our advanced deep-learning technology, we seek to push the boundary of precision medicine and navigate for opportunities that transcend current practices," said Brandon Suh, CEO of Lunit. "We look forward to accelerating our research and development in AI biomarkers for cancer treatment and outcome prediction through various research partnerships."

Full ASCO (Free ASCO Whitepaper) abstract: View Source

ASCO Poster Session Abstract by Lunit:
#9094 Deep learning-based predictive biomarker for immune checkpoint inhibitor response in metastatic non-small cell lung cancer
Poster Session: Lung Cancer – Non-Small Cell Metastatic (Board #417)
Sunday, June 2, 2019, 8:00am to 11:00am, Hall A

Contacts
Media Contact
Lunit
Jussarang Lee, Communications Manager
+82-10-4884-0827
[email protected]

Pacira BioSciences to Present at the Jefferies 2019 Healthcare Conference

On May 28, 2019 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will participate in an analyst-led fireside chat at the Jefferies 2019 Healthcare Conference at 10:00 AM ET on Tuesday, June 4, 2019 (Press release, Pacira Pharmaceuticals, MAY 28, 2019, View Source [SID1234536609]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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!


Onconova Therapeutics Announces Presentations At Three Upcoming Conferences

On May 28, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it will be presenting at three upcoming conferences (Press release, Onconova, MAY 28, 2019, View Source [SID1234536608]):

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!

Acute Leukemia Forum China May 31 – Shanghai
Presentation: Fri, May 31 Steven Fruchtman, MD, President & CEO

BIO International Forum, Philadelphia June 3-6 – Philadelphia, PA
Presentation: Tues, June 4 3:15p EDT Steven Fruchtman, President & CEO
Webcast: http://www.veracast.com/webcasts/bio/internationalconvention2019/74119246905.cfm
Avi Oler, VP Corporate Development, will also attend and be available to meet with interested parties

9th Annual LD Micro Invitational June 4-5 – Bel Air, CA
Presentation: Tues, June 4 8:20a PDT Mark Guerin, CFO

Zymeworks to Present at Jefferies 2019 Global Healthcare Conference

On May 28, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Jefferies 2019 Global Healthcare Conference taking place June 4-7, 2019 in New York, NY (Press release, Zymeworks, MAY 28, 2019, View Source [SID1234536607]).

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 Company’s presentation will be Friday, June 7, 2019 at 12:30 p.m. ET.

Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.