On September 15, 2020 Cullinan Oncology, LLC, the German Cancer Research Center and the Eberhard Karls University of Tübingen, Faculty of Medicine (University of Tübingen), Germany, reported the formation of Cullinan Florentine, a company focused on developing a novel FLT3 x CD3 bispecific antibody for the treatment of patients with acute myeloid leukemia (AML) (Press release, Cullinan Oncology, SEP 15, 2020, View Source [SID1234565193]). This antibody has been developed in Tübingen within the German Cancer Consortium (DKTK), whose core center is the German Cancer Research Center (DKFZ) in Heidelberg. Cullinan Florentine has acquired an exclusive license to develop CLN-049 from the University of Tübingen and the DKFZ.

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"We believe the receptor tyrosine kinase FLT3 is among the most attractive targets in AML but is largely untapped as a target for T cell engaging antibodies," stated Jennifer Michaelson, Ph.D., Chief Development Officer, Biologics at Cullinan Oncology. "Given CLN-049’s robust preclinical package and ease of manufacturability, we believe this bispecific antibody has the potential to be a superior treatment option for AML patients. We are looking forward to filing an IND for CLN-049 by year end."

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. AML remains one of the most challenging blood cancers, with high unmet medical need due to low median survival rates in patients. FLT3 is expressed on leukemic cells from the majority of AML patients, including prominent expression on leukemic progenitor cells.

FLT3 is a commercially validated target in AML, yet unlike small molecule inhibitors targeting FLT3, a T cell engaging antibody like CLN-049, which binds to the extracellular domain of FLT3, is agnostic to mutations in the intracellular signaling domain, opening up a broader patient population and avoiding resistance mechanisms. FLT3 has potential advantages over the more commonly selected target antigens for T cell engagers, such as CD33 and CD123, given the low-level expression of FLT3 on normal myeloid cells and hematopoietic stem cells. CLN-049 is therefore predicted to have an improved safety profile.

"We’ve long held the belief that FLT3 is among the most attractive targets in AML," stated Helmut Salih, DKFZ/DKTK Professor and physician at Tübingen University Hospital, and Gundram Jung, Professor at Tübingen University, the originators of the molecule. "And we look forward to advancing CLN-049 into clinical testing with the help of the Cullinan team given their deep domain expertise in the bispecific field."

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."

On September 14, 2020 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported that it has been awarded a National Cancer Institute (NCI) R03 Grant to support its NAV-006 program involving the development of a next-generation rituximab that is refractory to the immuno-suppressive effects of the tumor microenvironment (Press release, Navrogen, SEP 14, 2020, View Source [SID1234565087]).

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Follicular lymphoma (FL) is characterized by proliferation of neoplastic B cells, with 15,000 new cases a year in the USA. CD20 is a protein expressed on malignant FL cells and is the target of the commercially approved monoclonal antibody, rituximab. Rituximab markedly improves progression-free survival and overall survival of FL patients. However, studies have shown that some patients have an immune-suppressed tumor microenvironment that reduces the efficacy of rituximab treatment.

Navrogen has employed its proprietary Humoral Immuno Oncology (HIO) technology to identify the factors reducing rituximab’s therapeutic effects against immuno-suppressed tumors. Navrogen will utilize the NCI grant support (1R03CA241784) to apply its block-removed immunoglobulin technology (BRITE) to create a next-generation rituximab that is refractory to the immuno-suppressive effects of the tumor microenvironment.

"I am delighted by the NCI’s endorsement of the NAV-006 program" said Dr. Luigi Grasso, Ph.D., co-founder and Chief Scientific Officer of Navrogen. "Humoral Immuno Oncology (HIO) is an understudied field and it is encouraging that the scientists in the peer-review panel who reviewed our proposal understood the significance of our discovery and the solutions that we have planned to deploy."

Navrogen will complete the tasks outlined in the awarded grant, and upon successful optimization will seek strategic partners to support later stages of development of the HIO-refractory rituximab.