On September 14, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported the publication of an abstract for an electronic poster to be presented as part of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cardiff Oncology, SEP 14, 2020, View Source [SID1234565103]). The abstract highlights preliminary clinical data from the Company’s ongoing Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated metastatic colorectal cancer.

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The preliminary data published in the abstract continue to show the safety and efficacy of onvansertib, as well as the durability of response, in combination with FOLFIRI and bevacizumab in KRAS-mutated metastatic colorectal cancer patients on their second line of therapy. The data also show that changes in plasma KRAS mutation levels during the first cycle of treatment are predictive of clinical response.

Updated results from the ongoing Phase 1b/2 trial will be presented as part of the abstract’s corresponding electronic poster. Details on the poster presentation are shown below:

Abstract ID: 2969
Presentation number: 436P
Title: Phase 1b/2 Study of the Polo-like kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with FOLFIRI and Bevacizumab for Second Line Treatment of KRAS-Mutated Metastatic Colorectal Cancer
Session Name: Poster Display Session
Presentation Date: September 17, 2020

The electronic poster will be available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 1b/2 Trial of Onvansertib in Metastatic KRAS-mutated Colorectal Cancer

Cardiff Oncology’s ongoing clinical trial is a multi-center, single-arm Phase 1b/2 study assessing the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab in second line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). Trial participants are treated with onvansertib on Days 1-5, and FOLFIRI and bevacizumab on Day 1, of 14-day cycles. Primary outcome measures include safety and tolerability assessments. Secondary outcome measures include preliminary efficacy determined by radiographic scans every 8 weeks and reduction in KRAS mutant allelic burden evaluated by liquid biopsy. The trial is being conducted at the USC Norris Comprehensive Cancer Center and the three Mayo Clinic Cancer Centers. For more information on the trial, please visit View Source

On September 14, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, reported an expansive program to improve care for organ transplant patients with a history of cancer, using the Signatera test for molecular residual disease (MRD) assessment pre- and post-transplant, in combination with the Prospera test for transplant rejection assessment (Press release, Natera, SEP 14, 2020, View Source [SID1234565121]). The goal of the program is to understand how the Signatera and Prospera tests can be used to improve decision making at the complex intersection of organ transplantation and oncology, and respond to the unmet needs within these communities.

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"This research program promises to be a significant advance in personalized care for transplant patients with cancer, or with a history of cancer," said Michael Volk, MD, Division Head, Gastroenterology and Hepatology, Loma Linda University Medical Center. "Not only can it help us better understand these patients’ risk as they undergo evaluation for liver and kidney transplantation, but it will inform the development of guidelines for tailored monitoring and timely treatment, an area in which data is sorely lacking."

A significant number of patients being evaluated for a transplant have a history of cancer, as patients with end-stage renal disease have a 20% higher rate of colorectal cancer than the general population,1 making it difficult for patients to receive a transplant due to the uncertain risk of recurrence. Furthermore, this is exacerbated by the fact that transplant recipients require immune-suppressing medications to avoid rejection, which can increase the risk of new or recurring cancers. There is a large unmet need for more precise, data-driven clinical practice guidelines for the assessment and management of these patients who may be denied life-saving organ transplants based on their history of cancer.

The initial phase of Natera’s program encompasses three study concepts that will be discussed in depth at the virtual TTS 2020 symposium on September 14th, 2020, in a presentation entitled, "The Interface of Solid Organ Transplant and Oncology: A New Paradigm with Cell-Free DNA" featuring Dr. Michael Volk, Division Head, Gastroenterology and Hepatology, Loma Linda University Health, and Dr. Kenar Jhaveri, Associate Chief of Kidney Diseases and Hypertension, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. The main goals are:

Help patients with colorectal cancer to be actively listed for and receive a needed kidney transplant earlier. This will be examined in the Colorectal Neoplasm in Candidates Enlisting for Renal Transplantation study (CONCERT)
Track hepatocellular cancer recurrence post-liver transplant for earlier, faster, and more effective intervention in the observational study of Signatera in Liver Cancer (SIGNAL)
Understand unique organ rejection dynamics in cancer patients through the Prospera in Renal Allograft Recipients with Cancer study (PARC)
"Natera is one of the only molecular diagnostics companies with solutions in both oncology and organ transplant and thus is uniquely positioned to help the medical community improve patient outcomes," said Paul Billings, MD, PhD, Chief Medical Officer and SVP of Medical Affairs at Natera. "This important program gives us the opportunity to leverage the biological and medical synergy between transplant and oncology using highly accurate, non-invasive methods."

For more information or to participate in these studies, please contact us at [email protected].

About Signatera

The Signatera test is a custom-built circulating tumor DNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Prospera

The Prospera test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. Prospera has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. Prospera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On September 14, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR) reported that Chandler D. Robinson, MD, Chief Executive Officer, will present a corporate update at the H.C. Wainwright 22nd Annual Global Investment Conference, Healthcare & Biotech Track (Press release, Monopar Therapeutics, SEP 14, 2020, https://ir.monopartx.com/news/detail/18/monopar-therapeutics-to-present-at-the-h-c-wainwright-22nd-annual-global-investment-conference-on-september-16-2020 [SID1234565086]). The conference will be held virtually.

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Presentation Details:

Date: Wednesday, September 16, 2020

Time: 1:30 PM EDT

Location: Virtual

View Source

For more information, please contact investor relations at [email protected].

On September 14, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed the six-month product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its clinical-trial ready product known as CypCaps (Press release, PharmaCyte Biotech, SEP 14, 2020, View Source [SID1234565105]). This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) for which PharmaCyte submitted an Investigational New Drug application (IND) to the FDA in early September.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed six-month stability study, "Our IND submission is now with the FDA for review, but independent of the IND we are working on our ongoing storage stability study to determine the shelf life of the Cell-in-a-Box encapsulated cell product. It will be kept stored frozen at -80oC throughout the entire duration of the stability study. The six-month time point of the study was recently reached, and we are pleased to report that CypCaps has passed all of the FDA-required tests. With each successful time point reached, this means our final product has proven that it can remain functional when frozen and stored up to that time point.

"This is a continuation of ongoing 24-month stability study to demonstrate the shelf life of our final clinical trial product that the FDA requires for all medicinal products. These six-month data, as well as all future longer-term shelf life analyses, such as the next twelve months post-production shelf life evaluation, will be reported to the FDA but this information does not require PharmaCyte to modify its submitted IND."

ICH guidelines, as well as regulatory agencies around the world, including the FDA, require that shelf life data needs to be determined and provided for any new medicinal product. The functionality of cell-based therapies such as CypCaps, as well as live vaccines etc., are particularly prone to loss of viability, and thus activity, during storage. This necessitates detailed shelf-life determination studies for such products.

A whole range of predefined and agreed tests have been performed on CypCaps that were unfrozen after six months of storage at -80oC. These studies include determinations of the number of cells, cell viability, biological activity of the cells, integrity of the capsules, sterility and pH. It also includes verifying that the labels are still securely adhering to the frozen syringes and are still legible. These tests were performed either by Austrianova (cell count, biological activity of the cells, capsule integrity, label integrity) or by its affiliated subcontractor (sterility, pH measurement).

The recently reported Container Closure Integrity test that demonstrates that the syringes are properly sealed and that the contents of the syringes have not been contaminated is also formally part of the product stability testing. Thus, the CypCaps product passed all of the required tests at this six-month time point.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On September 14, 2020 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported an update on the upcoming special meeting of stockholders (the "Meeting") in response to recent stockholder inquiries regarding the number of meeting adjournments (Press release, Titan Pharmaceuticals, SEP 14, 2020, View Source [SID1234565122]). The sole purpose of the Meeting is to seek approval of a proposal to amend Titan’s certificate of incorporation to increase the number of authorized shares of common stock.

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Without approval of the share increase, the several strategic alternatives management has been exploring with the Company’s bankers will not be possible. The failure to obtain stockholder approval will almost certainly result in the cessation of Titan’s operations and likely a total loss of value to stockholders, given the pledge of all of the Company’s assets as security for its outstanding debt.

The goal of Titan’s Board of Directors is to enable as many stockholders as possible to exercise their right to vote. In contrast to many other types of proposals, the amendment to effect the share increase requires a higher hurdle – the affirmative votes from a majority of the outstanding shares entitled to vote. Since Titan has a large retail stockholder base, this task poses greater challenges than in the past. Importantly, some of the newer, popular brokerage firms do not exercise their permitted discretion to vote shares held in their accounts without explicit direction from the beneficial holder, and companies such as Titan are finding it quite difficult and time consuming to reach individual investors who hold shares in street name.

Prior to each meeting adjournment, the Board examined the voting data and determined, in light of the fact that a substantial majority of votes received to date have been in favor of the proposal, that it would be in the best interest of stockholders to extend the date of the meeting, particularly in light of the stakes involved. As of the close of business on September 11, 2020, approximately 30.7 million shares (28.3% of the record date shares) had not yet been voted. Of those shares that were voted, approximately 72% were in favor of the amendment proposal. The affirmative vote of holders of only 1,251,207 shares (less than 1.5% of the record date shares) are now needed to file the amendment and effect the authorized share increase.

"I and my fellow Board members would like to thank those stockholders who have already voted in favor of the proposal, which if approved should enable the continuation of Titan’s operations by facilitating the raising of capital as well as the pursuit of strategic alternatives," said Titan’s Executive Chairman, Dr. Marc Rubin. "And, to those who have not yet voted, we implore you to do so now."