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Preliminary Results From RELIANT Trial of Relacorilant Plus Nab-Paclitaxel in Patients with Metastatic Pancreatic Cancer

On June 22, 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 preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer (Press release, Corcept Therapeutics, JUN 22, 2021, https://ir.corcept.com/news-releases/news-release-details/preliminary-results-reliant-trial-relacorilant-plus-nab [SID1234584221]).

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"RELIANT evaluated relacorilant plus nab-paclitaxel in pancreatic cancer patients who had relapsed following at least two prior lines of therapy, including treatment with nab-paclitaxel in almost all cases," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Two of 31 evaluable patients exhibited tumor shrinkage designated as a partial response, a response rate of six percent, while 15 patients achieved stable disease for at least 12 weeks. The combination was well-tolerated. These data are similar to those of our Phase 1 study.

"Metastatic pancreatic cancer is a dire disease and patients who have relapsed following multiple lines of therapy have no effective treatment options. While our interim analysis suggests that the combination of relacorilant and nab-paclitaxel is active in these patients, the apparent level of benefit does not justify its further study as a treatment for end-stage pancreatic cancer."

"All of the cancers we are studying are aggressively lethal and we will not pursue an approval unless we believe our candidate therapy offers a substantial benefit," added Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Our development program in solid tumors continues to advance. Based on the positive results of our controlled Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, we are very excited to initiate a pivotal trial for that indication in the first quarter of 2022. Our trials of relacorilant plus pembrolizumab in patients with adrenal cancer and of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer continue to enroll. Based on the promising clinical trial results we have observed across our oncology programs, we are evaluating relacorilant as a potential treatment for patients with earlier stages of pancreatic cancer and with other glucocorticoid receptor-expressing tumors."

Trial Design and Preliminary Results

RELIANT is a single-arm, multicenter, open-label, Phase 3 trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer, with a planned enrollment of 80 patients and a planned interim analysis of outcomes in the first 40 patients. Patients received 100 mg of relacorilant every day and 80 mg/m2 nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. RELIANT’s primary endpoint is objective response rate.

At the planned interim analysis, the study had enrolled 43 patients with metastatic pancreatic cancer who had received 2-4 prior lines of therapy (median prior lines of therapy: three), including 40 patients who were previously treated with nab-paclitaxel. As of the database cutoff date of April 15, 2021, there were 31 efficacy-evaluable patients. Two of these patients (six percent) had a partial response (best response based on RECIST v1.1); and 15 patients (48 percent) had stable disease, with two patients (six percent) with stable disease greater than 18 weeks. Safety was consistent with known profiles for relacorilant and nab-paclitaxel.

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer, as well as 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.

Bio-Path Granted Key Mechanism of Action U.S. Patent for BP1003

On June 22, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that the United States Patent and Trademark Office has granted a new patent relating to the Company’s BP1003 program, a novel liposome-incorporated oligodeoxynucleotide inhibitor against Signal Transduction and Activator of Transcription-3 (STAT3). The patent (U.S. Patent No. 11,041,153) is titled "P-Ethoxy Nucleic Acids for STAT3 Inhibition (Press release, Bio-Path Holdings, JUN 22, 2021, View Source [SID1234584220])."

The new patent builds on earlier patents that have been granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drugs. DNAbilize is a proprietary liposomal nanoparticle delivery and antisense technology designed to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion.

"Our growing intellectual property portfolio continues to be a meaningful asset for Bio-Path and the addition of this new patent further strengthens our value as we advance our newest pipeline product, BP1003," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "This mechanistic patent protects our position and underscores the novelty of BP1003’s ability to inhibit STAT3, a protein known to be overly expressed in a number of the most difficult to treat cancers such as pancreatic cancer (PDAC), non-small cell lung cancer (NSLCL) and acute myeloid leukemia (AML), among others. We are looking forward to advancing BP1003’s development in pancreatic cancer, which we expect to begin next year."

About Signal Transducer and Activator of Transcription 3 (STAT3)

STAT3 is aberrantly active in cancer cells. The abilities of tumor cells to proliferate uncontrollably, resist apoptosis, induce vasculature formation, and invade distant organs are well-recognized hallmarks of cancer. STAT3 is a regulator of the genes involved in these cancer processes. More recently, the capability of tumors to evade immune surveillance and avoid destruction by the immune system has also gained significant acceptance in the cancer research field. STAT3, which is a point of convergence for many oncogenic pathways, has emerged as a critical mediator of tumor immune evasion at multiple levels.

Activation of STAT3 has been found in many types of cancers, including NSCLC, AML, and PDAC. Activation of STAT3 correlates with poor clinical outcome, high grade disease and metastasis, and has been linked with resistance to chemotherapy, including gemcitabine, considered a standard-of-care agent for advanced PDAC. Therefore, inhibition of STAT3 in combination with chemotherapy is expected to produce enhanced clinical benefit.

Avid Bioservices to Report Financial Results For Quarter and Fiscal Year Ended April 30, 2021 After Market Close on June 29, 2021

On June 22, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that it will report financial results for the quarter and fiscal year (FY) ended April 30, 2021 on June 29, 2021 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, JUN 22, 2021, View Source [SID1234584219]). Members of Avid’s senior management will discuss financial results for the quarter and FY ended April 30, 2021 and review recent corporate developments.

To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

Arrowhead Pharmaceuticals and Horizon Therapeutics Announce Collaboration to Develop RNAi Therapeutic for Uncontrolled Gout

On June 22, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) and Horizon Therapeutics plc (NASDAQ: HZNP) reported a global collaboration and license agreement for ARO-XDH, a previously undisclosed discovery-stage investigational RNA interference (RNAi) therapeutic being developed by Arrowhead as a potential treatment for people with uncontrolled gout (Press release, Arrowhead Research Corporation, JUN 22, 2021, View Source [SID1234584218]).

Gout is a serious and painful form of arthritis that is caused by excess uric acid in the blood. In the United States, there are more than nine million gout patients and approximately a third of those patients are treated with oral urate-lowering therapies. However, a meaningful portion of treated patients do not respond sufficiently to treatment and therefore continue to experience painful and debilitating gout symptoms. XDH represents a clinically validated target that is the primary source of serum uric acid (sUA). High levels of sUA, if left untreated or undertreated, can potentially lead to serious long-term or even permanent damage to the bones, joints and organs.

Under the terms of the agreement, Arrowhead will conduct all activities through preclinical stages of development of the siRNA therapeutic. Horizon will receive a worldwide exclusive license to the therapeutic and will be wholly responsible for clinical development and commercialization. Arrowhead will receive $40 million as an upfront payment from Horizon and is eligible to receive up to $660 million in potential development, regulatory and commercial milestones, and is further eligible to receive royalties in the low- to mid-teens range on net product sales.

"We believe Horizon’s expertise in the clinical development and commercialization of therapies for gout makes them an ideal partner. We look forward to working closely with Horizon as we

advance this potential new therapy for patients in need," said Christopher Anzalone, Ph.D., Arrowhead’s president and CEO. "This collaboration with Horizon also represents further expansion of our rapidly growing pipeline of investigational RNAi therapeutics that utilize Arrowhead’s proprietary Targeted RNAi Molecule (TRiMTM) platform."

"As a commercial and clinical leader in gout, we understand the disease and its impact, and that there is still a tremendous unmet treatment need," said Tim Walbert, chairman, president and CEO, Horizon. "The collaboration with Arrowhead adds an additional program to our research and development focus to discover and develop new, innovative medicines that continue to improve gout treatment across the continuum of care."

Alchemab Therapeutics Appoints Douglas A. Treco, PhD as Chief Executive Officer

On June 22, 2021 Alchemab Therapeutics, a biotechnology company focused on the discovery and development of naturally-occurring protective antibodies in neurodegeneration and oncology, reported the appointment of Douglas A. Treco, PhD as Chief Executive Officer (Press release, Alchemab Therapeutics, JUN 22, 2021, View Source [SID1234584217]). Dr. Treco will join the Company’s Board of Directors and will be based in Boston, Massachusetts.

"We’re excited that Doug will bring his extensive experience to our leadership team as we seek to grow our highly differentiated platform," said Houman Ashrafian, BM BCh, DPhil, Managing Partner at SV Health Investors and Chairman of Alchemab’s Board of Directors. "Our goal is to develop a world class management team with footprints on both sides of the Atlantic and broaden the Company’s exposure to US investigators, investors, and potential employees."

Most recently, Dr. Treco was Co-Founder, President, and Chief Executive Officer of Ra Pharmaceuticals, Inc., a biotechnology company focused on peptide and small molecule inhibitors of the complement pathway. The company was acquired in April 2020 by UCB S.A. for $2.5 billion.

"Alchemab’s approach of identifying protective antibodies truly changes the game in terms of creating the next major antibody therapeutics company," said Dr. Treco. "We believe this platform gives us a unique ability to develop a robust pipeline of truly innovative neurodegenerative and oncology medicines."

"Doug has a proven track record of building successful life science companies and we’re pleased to team up with him again," said Andrew Levin, MD, PhD, Managing Director at RA Capital. "In addition, Alchemab has tremendous scientific leadership, with Jane Osbourn, PhD FMedSci, OBE, spearheading this novel approach. Together, we’re confident that they will continue to grow Alchemab into a major source of novel drugs to benefit patients."

"We are tremendously grateful to Alchemab’s founding CEO, Alex Leech, who led the Company since its inception and oversaw the Series A financing," noted SV’s Professor Ashrafian. Mr. Leech will return to company creation as a Venture Partner at SV Health Investors.

Previously, Dr. Treco co-founded Transkaryotic Therapies, Inc. (TKT), which was acquired in 2005 by Shire plc. In his position as Senior Vice President of Research and Development, he established and directed TKT’s gene activation and protein production efforts, which led to the approval of Dynepo, Replagal, Elaprase, and Vpriv. Dr. Treco is Chairman of the Board of Directors of Inozyme Pharma and is a member of the Board of Directors of CRISPR Therapeutics AG. He is also a scientific advisor to Lightstone Ventures. From January 2008 to May 2014, Dr. Treco served as an entrepreneur-in-residence with Morgenthaler Ventures and was a visiting scientist in the Department of Molecular Biology at Massachusetts General Hospital and a lecturer in genetics at Harvard Medical School from 2004 to 2007. He received a BA in Biology from the University of Delaware, a PhD in Biochemistry and Molecular Biology from the State University of New York at Stony Brook and performed post-doctoral research at the Salk Institute for Biological Studies and Massachusetts General Hospital.

In April 2021, Alchemab raised $82 million in a Series A financing led by RA Capital and joined by Lightstone Ventures, DHVC, and Data Collective VC Bio. In 2019, Alchemab raised a seed round led by SV Health Investors and the Dementia Discovery Fund. The Company collaborates closely with Illumina, having been part of the first cohort of companies joining the Illumina Accelerator in Cambridge, UK, and recently announced a partnership with AstraZeneca where Alchemab will use its platform to aid in the development of new treatments for prostate cancer.