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Positive Survival Data from Phase 2 Lung Cancer Trial Accepted for Presentation at 2020 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 14, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported that it has been selected to deliver a poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, to be held virtually during May 29 – 31, 2020 (Press release, Heat Biologics, MAY 14, 2020, View Source [SID1234558030]). The ASCO (Free ASCO Whitepaper) Annual Meeting is the largest international conference to showcase the latest advancement in oncology. The abstracts published in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time on May 13, 2020 on the ASCO (Free ASCO Whitepaper) meeting website at: View Source

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HS-110 is currently in Phase 2 trial in combination with Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients’ immune system against multiple tumor antigens to elicit a robust pan-antigen T-cell attack against tumor cells. Heat completed enrollment in this trial in July 2019.

The abstract provides an update on the efficacy data of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC. The median overall survival (OS) was 28.7 months with a median follow up of 15.7 months. This study is ongoing and 21 of the 47 patients enrolled (45%) were still alive as of this datacut. Additional subset analysis will also be presented. HS-110 has a good safety profile in over 200 patients and combination of HS-110 and nivolumab appears to be safe and well-tolerated.

Exploratory biomarker analysis on cancer testis antigens (CTAs) was performed using patients’ tumor tissue at baseline. In this evaluation, improved overall survival (OS) was observed in patients whose tumors have 8 or more overlapping CTAs with the 39 CTAs overexpressed by HS-110. In addition, overexpression of zinc finger protein 492 (ZNF492) was associated with greater OS. ZNF492 is a transcription factor that is expressed in multiple cancers.

Details of Heat Biologics’ ASCO (Free ASCO Whitepaper) poster presentation:

Abstract Title: Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab

Session: Lung Cancer – Non-Small Cell Metastatic
Abstract #: 9546
Poster#: 312
Date: Friday, May 29, 2020, 8am Eastern Time

Following the presentation, a copy of the poster will be available on Heat Biologics’ website at: View Source

Reference:

The Human Protein Atlas – ZNF492: View Source

Halozyme To Receive $15 Million Milestone Payment From Janssen

On May 14, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the company will receive a $15 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies (Press release, Halozyme, MAY 14, 2020, View Source [SID1234558029]). The milestone payment is associated with the first commercial sale in the United States of Janssen’s DARZALEX FASPROTM (daratumumab and hyaluronidase – fihj) utilizing ENHANZE, which was recently approved by the U.S. Food and Drug Administration.

Corcept Therapeutics to Present Data at the American Society of Clinical Oncology Annual Meeting

On May 14, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it will present novel immuno-oncology data from the selective cortisol receptor modulator relacorilant at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Corcept Therapeutics, MAY 14, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-present-data-american-society-clinical [SID1234558028]). This year’s annual meeting will be held in a virtual format from Friday, May 29 through Sunday, May 31, 2020. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

"Patients with adrenal cancer often have tumors that produce cortisol, which may limit the efficacy of immune checkpoint inhibitors," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Our hypothesis is that administering a selective cortisol modulator in combination with an immunotherapeutic agent such as pembrolizumab will treat the symptoms of hypercortisolism and help pembrolizumab achieve its maximum effect.1 The data presented in this abstract have informed the design of our Phase 1b trial in which 20-patients with metastatic or unresectable adrenal tumors that produce cortisol will receive our selective cortisol modulator relacorilant in addition to pembrolizumab."

Impact of relacorilant, a selective glucocorticoid receptor antagonist,
on the immunosuppressive effects of endogenous cortisol (abstract no. 3091)

Session Title: Developmental Therapeutics – Immunotherapy
Session Type: Poster session
Location: Virtual meeting
Presentation Available Online: May 29 to November 20, 2020 (meeting registration required)
About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. 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, including Cushing’s syndrome and advanced adrenal, ovarian and pancreatic cancer. 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.

Cellectar Granted Composition of Matter and Use Patent in Europe for CLR 131

On May 14, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the European Patent Office has granted patent number EP 2440253 titled "Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging and Detection of Cancer Stem Cells (Press release, Cellectar Biosciences, MAY 14, 2020, View Source [SID1234558027])." The patent provides composition of matter and use protection for the treatment and/or diagnosis of cancer and cancer stem cells for the company’s Phase 2 lead asset CLR 131 and the proprietary PLE analogs combined with I-125 (CLR 125).

"Few drugs have shown the capacity to target and effectively treat highly resistant cancer stem cells. We believe CLR 131’s demonstrated ability to kill both conventional cancer cells as well as difficult-to-treat cancer stem cells is a unique treatment benefit of this drug", stated Jim Caruso CEO & president of Cellectar Biosciences. "Importantly, this patent provides additional long-term protection for our lead compound CLR 131 in the second largest global market and represents an important expansion of our intellectual property protections for our portfolio of targeted oncology product candidates."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ concentration within tumor cells to be increased while reducing the concentration in normal tissue, which may enhance drug potency while reducing adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens which can be modified or removed by tumor cells resulting in resistance to the treatment. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types or classes of molecules that can be selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in r/r multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

Boston Scientific Prices $1.7 Billion of Senior Notes

On May 14, 2020 Boston Scientific Corporation (NYSE: BSX) reported the pricing of a public offering of $1.7 billion aggregate principal amount of its senior notes under the company’s shelf registration statement (Press release, Boston Scientific, MAY 14, 2020, View Source [SID1234558026]). The public offering consists of $500.0 million in aggregate principal amount of 1.900% notes due 2025 and $1.2 billion in aggregate principal amount of 2.650% notes due 2030.

Boston Scientific expects to receive the net offering proceeds upon closing on May 18, 2020, subject to customary closing conditions. The company intends to use the net proceeds from this offering to (i) refinance $450.0 million of borrowings under its revolving credit facility and a portion of its pre-payable bank debt, including $750.0 million under its $1.0 billion term loan credit facility maturing in February 2021 and $500.0 million under its $1.25 billion term loan credit facility maturing in April 2021 and (ii) pay related fees, expenses and premiums.

Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification under the securities laws of any such state or jurisdiction. The offering is being made by means of a prospectus and related preliminary prospectus supplement only, copies of which or information concerning this offering may be obtained by contacting the joint book-running managers: Barclays Capital Inc., toll-free at (888) 603-5847; Citigroup Global Markets Inc., toll-free at (800) 831-9146, J.P. Morgan Securities LLC, toll-free at (212) 834-4533, or Wells Fargo Securities, LLC, toll-free at (800) 645-3751.