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.

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On May 28, 2019 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a biotechnology company focused on designing, developing and commercializing innovative immunotherapies and proprietary medical approaches to stimulate and guide an anti-tumor immune response for the treatment of cancer, reported the closing of its previously announced underwritten public offering (Press release, OncoSec Medical, MAY 28, 2019, View Source [SID1234536594]). The gross proceeds from the offering were approximately $11 million, before deducting underwriting discounts and commissions and estimated offering expenses paid by OncoSec.

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Alliance Global Partners acted as lead book-running manager for the offering. Maxim Group LLC acted as co-manager and Roth Capital Partners, LLC and ThinkEquity, a division of Fordham Financial Management, Inc., acted as financial advisors for this offering.

With the closing of this transaction, OncoSec’s current pro forma unaudited cash, cash equivalents and investment balance exceed $30 million. The proceeds from this offering are expected to fund OncoSec’s clinical research and development activities, to provide working capital and to support general corporate purposes for at least the next 12 months.

The Company also announced the termination of its at-the-market (ATM) agreement with Cantor Fitzgerald and its existing equity facility with Aspire Capital.

The offering was made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities Exchange Commission (SEC) on August 9, 2016 and declared effective by the SEC on August 25, 2016. The final prospectus supplement for the offering is available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected].

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]).

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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]

On May 28, 2019 Synaffix B.V., a Dutch biotechnology company focused on the advancement of its clinical-stage antibody-drug conjugate (ADC) technology for the development of best-in-class ADCs, reported that ADC Therapeutics has triggered a third target-specific license under its existing Commercial License Agreement dated October 2016 (Press release, Synaffix, MAY 28, 2019, View Source [SID1234536595]).

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This license provides ADC Therapeutics with the rights to Synaffix’s proprietary GlycoConnect site-specific antibody-drug conjugation and HydraSpace polar spacer technologies to develop and commercialize a third product candidate against a specific target.

Under the terms of the agreement, Synaffix is eligible to receive upfront, milestone and royalty payments on a per-target basis. Further financial details were not disclosed.

Peter van de Sande, CEO of Synaffix said:

"We are very pleased with our collaboration, the rapid progress made by ADC Therapeutics and the successive expansion to date. This third target-specific license taken out by ADC Therapeutics provides further validation of our ADC technology. Since we reached our license agreement, Synaffix’s GlycoConnect and HydraSpace technologies have continued to demonstrate their ability to generate exceptional ADC product candidates in terms of therapeutic index."

"2019 has been a tremendous year so far for Synaffix. The first ADC Therapeutics product candidate generated using our technology reached the clinic in January 2019 and we have signed additional commercial license agreements with other partners – Mersana Therapeutics, USA and Shanghai Miracogen, China. We look forward to continuing our close collaboration with our license partners, enabling their best-in-class ADCs and expanding our list of collaborations further."

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]).

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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.