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."

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 Amgen (NASDAQ:AMGN) reported that it will present at the Bank of America Virtual Global Healthcare Conference at 12:35 p.m. ET on Thursday, Sept. 17, 2020 (Press release, Amgen, SEP 14, 2020, View Source [SID1234565120]). Peter H. Griffith, executive vice president and chief financial officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On September 14, 2020 Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") reported that the Company management will present at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (Press release, Intech Pharmaceuticals, SEP 14, 2020, View Source;medtech-summit-301130396.html [SID1234565119]).

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Date: September 21 – 23, 2020

Company Presentation: Monday, September 21, 2020 at 2:30 pm (ET)

Presenter: Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma

Format: Fireside Chat and One-on-One Investor Meetings

Mr. Meckler’s fireside chat will be webcast live and will be accessible through the Events section of Intec Pharma’s website at www.intecpharma.com, where it will also be archived for a period of time.

On September 14, 2020 PANTHERx Rare Pharmacy reported that it has been selected by Blueprint Medicines as a limited distribution partner for new drug GAVRETO (pralsetinib), which was granted ­accelerated approval for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test (Press release, PANTHERx Rare Pharmacy, SEP 14, 2020, View Source [SID1234565118]). Developed by Blueprint Medicines, GAVRETO is a once-daily oral precision therapy designed to selectively and potently target oncogenic RET alterations.

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RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC.

"PANTHERx is honored to be chosen by Blueprint Medicines to deliver this breakthrough oncology therapy to people living with RET fusion-positive metastatic NSCLC," said Dr. Gordon Vanscoy, Chairman and CEO of PANTHERx. "As a partner, we are proud to do our part in advancing rare oncology by providing award-winning white-glove services to this previously underserved patient population as part of our innovative RxARECARE model."

For more information about the symptoms, diagnosis, and treatment of RET fusion-positive NSCLC, please click here.