On May 28, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it will present data from the Phase 1/2 study of its proprietary, selective cortisol modulator, relacorilant, in combination with nab-paclitaxel (Abraxane) in patients with solid tumors, at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois (May 31 – June 4) (Press release, Corcept Therapeutics, MAY 28, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-present-data-phase-12-trial-relacorilant [SID1234536593]).

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"Our Phase 1/2 trial of relacorilant in combination with nab-paclitaxel has been productive," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Encouraging results in patients with platinum-resistant ovarian cancer prompted us, after consultation with our investigators, to initiate a 180-patient, controlled Phase 2 trial of relacorilant plus nab-paclitaxel in that indication earlier this year. We look forward to sharing additional data in patients with a variety of solid tumors."

Monday, June 3rd
Relacorilant (RELA) with nab-paclitaxel (NP): Safety and
activity in patients with pancreatic ductal adenocarcinoma
(PDAC) and ovarian cancer (OvCA)

P. Munster; S. Shepard Gastrointestinal (Noncolorectal) Cancer
Poster Board: #235
Time: 8:00 – 11:00 am
Location: Hall A

Selective and nonselective GR antagonists in combination
with chemotherapy in ovarian cancer PDX models

J. Veneris; G. Fleming Gynecologic Cancer
Abstract No: e17039

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, one of the two receptors to which cortisol binds. Relacorilant does not bind to the body’s other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders. Current trials include a 180-patient, controlled Phase 2 trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer and a Phase 3 trial of relacorilant as monotherapy for patients with Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents through 2037. Relacorilant has received orphan designation in the United States for the treatment of both Cushing’s syndrome and pancreatic cancer.

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."