On September 9, 2021 Pieris Pharmaceuticals, Inc., a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that members of the management team will participate in the following upcoming investor conferences (Press release, Pieris Pharmaceuticals, SEP 9, 2021, View Source [SID1234587485]).

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!

H.C. Wainwright 23rd Annual Global Investment Conference
Monday, September 13, 2021 at 7:00 AM EDT. A webcast of the Company’s presentation will be available at this link.

Cantor Global Healthcare Conference
Thursday, September 30, 2021 at 12:00 PM EDT. A webcast of the Company’s presentation will be available at this link.

On September 9, 2021 Viewpoint Molecular Targeting, Inc., a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence a Phase I imaging study of VMT–NET for imaging of neuroendocrine tumors (NETs) (Press release, Viewpoint Molecular Targeting, SEP 9, 2021, https://viewpointmt.com/viewpoint-molecular-targetingtm-receives-fda-clearance-of-investigational-new-drug-application-for-phase-1-imaging-study-for-vmt-a-net-for-neuroendocrine-tumors/ [SID1234587507]). The Phase I imaging study is an investigator-initiated study that will be conducted at the University of Iowa Hospitals and Clinics.

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 Phase I imaging study will evaluate [203Pb]VMT–NET as an agent for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors. The images obtained will inform future therapeutic trials of [212Pb]VMT–NET alpha-particle therapy for this tumor type. In parallel to this investigator initiated imaging trial, the Company plans to move forward with a Phase I/IIa therapy study of VMT–NET for the treatment of neuroendocrine tumors.

"We are incredibly pleased that our second product has received IND clearance from the FDA, allowing our collaborators at the University of Iowa to proceed with another first-in-human Phase I imaging study. We continue to be encouraged by the preclinical results demonstrated to date, that show the promise of treating this disease with targeted alpha-particle therapy. With this milestone now achieved, Viewpoint together with the team at the University of Iowa is excited to progress toward enrollment and provisional results in our imaging study over the remainder of this year," commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting.

Preclinical data seen to-date provides strong evidence that the VMT–NET image-guided approach can be an effective therapy with a promising toxicity profile. Supported by over $4 million in the form of Small Business Innovation Research grants and R01 academic research grants from the NCI to advance this treatment, VMT–NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

On September 9, 2021 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 results from its 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer will be featured in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, Corcept Therapeutics, SEP 9, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-announces-presentation-positive-results-randomized [SID1234587543]). The congress will take place from September 16 – 21, 2021.

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!

"We are extremely excited by the potential of relacorilant to treat women with recurrent platinum-resistant ovarian cancer," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As we announced when we released our preliminary results, delaying disease progression without increasing side effect burden was a tremendous benefit to the women in this trial. In the first quarter of next year, we plan to initiate a pivotal Phase 3 trial to confirm these positive results."

Presentation Title: Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: A 3-arm, randomized, open-label, phase II study

Speaker: Dr. Domenica Lorusso, Gynecologic Oncology Unit Fondazione Policlinico Universitario Gemelli IRCCS

Presentation Number: 721O

Session: Gynecological Cancers Proffered Paper Session

Presentation Date/Time: Friday, September 17, 2021 at 13:40 – 13:50 CEST | Channel 3

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and castration-resistant prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.

On September 9, 2021 Greenwich LifeSciences, Inc., a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, provided updates on recent and upcoming developments (Press release, Greenwich LifeSciences, SEP 9, 2021, View Source [SID1234587472]).

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!

As of the close of markets on September 8, 2021, Greenwich LifeSciences has the highest listed share price return of all 307 biotech IPOs tracked since February 2019 based on the Company’s share price increase of approximately 763% from its IPO offering price (Source: BioPharmCatalyst with data from IPOScoop).

CEO Snehal Patel commented, "We look forward to celebrating the upcoming first year anniversary of our IPO. In addition, we are pleased that H. C. Wainwright initiated analyst coverage of the Company on September 1, 2021 with a price target of $78 per share, consistent with the $75 price target from our first covering analyst. Another important milestone is our addition to the Russell 2000, which placed more of our public float in the hands of long-term investors."

"The analyst coverage, participation in investor conferences, and addition to the Russell 2000 will continue to support our outreach to institutional investors and our transition to investment banking partners that focus on M&A, licensing, and long-term biotech institutional investors. We want to thank Aegis Capital and their investors for their support during our first year as a public company and for their continued support as we expand our investment banking team and investor base."

Mr. Patel added, "We are grateful to our loyal shareholders and breast cancer patients who continue to reach out to us offering encouragement and support. In the near future, the Company plans to announce updates on the manufacturing of GP2 and initiation of the upcoming Phase III clinical trial, as well as the publication of additional data from the Phase IIb clinical trial."

About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On September 9, 2021 Precision BioSciences, Inc., a clinical-stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, and iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, reported a license and collaboration agreement under which iECURE plans to advance Precision’s PBGENE-PCSK9 candidate into Phase I studies and gain access to Precision’s PCSK9-directed ARCUS nuclease to develop additional gene editing therapies for genetic diseases, initially targeting liver diseases (Press release, Precision Biosciences, SEP 9, 2021, View Source [SID1234587486]).

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!

This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, iECURE plans to file a clinical trial application as early as 2022 to advance the PBGENE-PCSK9 clinical candidate through Phase 1 clinical studies for the treatment of familial hypercholesterolemia (FH). Precision will retain rights to PBGENE-PCSK9, including all products developed for genetic indications with increased risk of severe cardiovascular events such as FH. In return, Precision has granted iECURE a license to use its PCSK9-directed ARCUS nuclease to insert genes into the well-characterized PCSK9 locus to develop treatments for four other pre-specified rare genetic diseases. Precision will receive an equity stake in iECURE and is eligible to receive milestone and royalty payments on sales of iECURE products developed with ARCUS.

"We are excited to continue working with Jim Wilson under this new in vivo gene editing license and collaboration agreement with iECURE, as iECURE looks to rapidly advance our PBGENE-PCSK9 candidate, file for a clinical trial application in 2022, and use our PCSK9-directed ARCUS nuclease, and its knock-in capabilities, to pursue new treatments for rare genetic diseases," said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. "Through this collaboration we expect to gain important clinical validation for in vivo gene editing with ARCUS, while retaining rights to this PCSK9-directed nuclease, which we believe offers a safe harbor locus for DNA gene editing knock-in without deleterious effects when the PCSK9 gene is disrupted."

"We founded iECURE with the aim of focusing on genetic diseases with significant unmet need that we could target in a mutation-agnostic manner. After evaluating different gene editing technologies and platforms, we believe gene editing with ARCUS, including use of the uniquely designed ARCUS nuclease as a gene insertion tool targeting the PCSK9 gene will help us rapidly advance several candidates to the clinic with the potential to deliver on the promise of highly efficient, specific, and safe gene insertion," said Joe Truitt, Chief Executive Officer of iECURE. "We are excited to partner with Precision on this key pillar of our gene editing strategy, to advance this work for rare genetic diseases."

James M. Wilson, M.D., Ph.D., Chief Scientific Advisor of iECURE and Professor in the Departments of Medicine and Pediatrics, Perelman School of Medicine, University of Pennsylvania, Director, Gene Therapy Program, will present new non-human primate data demonstrating ARCUS-mediated gene addition today, September 9, 2021 during the Precision BioSciences gene editing R&D event. Dr. Wilson and his team have demonstrated in non-human primates that it is possible to use ARCUS to insert new genes stably into the PCSK9 locus, which could be used as a potential approach for treating multiple genetic diseases with a single therapeutic strategy.

About ARCUS

ARCUS is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock in), remove (knockout), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision’s platform and products are protected by a comprehensive portfolio including more than 80 patents to date.