AmpliPhi Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AmpliPhi Biosciences, 2017, NOV 14, 2017, View Source [SID1234522079]).

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On November 14, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells, reported that the Company has launched its AWE Program or Actinium Warhead Enabling Program (Press release, Actinium Pharmaceuticals, NOV 14, 2017, View Source [SID1234522039]).

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The AWE Program is designed to provide biopharmaceutical companies with access to the Company’s proprietary AWE technology platform in order to allow development of actinium-225 enabled conjugates wherein targeting agents are labeled with the alpha particle emitting radioisotope, actinium-225. Utilizing the AWE Technology Platform, the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. can potentially be improved via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents, provide an opportunity to extend intellectual property protection by the creation of "Biobetters" or improved versions of the approved agent. Actinium is currently conducting a Phase 2 clinical trial for its drug candidate Actimab-A and a Phase 1 clinical trial for its drug candidate Actimab-M, both of which are fruits of the AWE Technology Platform and are comprised of actinium-225 labeled to an antibody that targets the antigen CD33 in patients with acute myeloid leukemia and multiple myeloma, respectively.

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Recently, Actinium announced that it successfully labeled the anti-CD38 monoclonal antibody daratumumab, a blockbuster therapy for patients with multiple myeloma, with actinium-225. Stability and target engagement was similar between the unlabeled and actinium-225 labeled antibody, demonstrating that the Company’s AWE Technology can successfully label a CD38 targeting agent without disrupting binding. In-vitro experiments with both the labeled and unlabeled antibody were performed in the same cell lines that initially established daratumumab’s proof of concept. In each CD-38 expressing cell line, improved cell killing was observed with the actinium-225 enabled daratumumab. The previous maximum reported cell killing was 62% with the naked daratumumab. However, at 1/10 of that antibody concentration the cell killing was 97% with the actinium-225 enabled daratumumab. Additionally, the cell-killing effect demonstrated both a time and concentration dependency. Importantly, specificity is demonstrated as no cell killing was observed when a cell line that does not express the target CD38 was treated with the actinium-225 labeled daratumumab. Data from this study were accepted as an abstract for poster presentation at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting Annual which can be viewed in the following link: View Source

Sandesh Seth, Actinium’s Chairman and CEO said, "The element actinium-225 is tremendously potent yet highly specific given its short path length, making it the ideal warhead for oncology indications when labeled to monoclonal antibodies. Through the development of our drug candidates, we have gained significant expertise and know-how in the application of actinium-225 and we look forward to providing our proprietary technology and highly specialized know how and supply chain capabilities to potential partners via our AWE Program. This expertise is evidenced by the recent results showing that actinium-225 increased the cell killing power of the blockbuster multiple myeloma antibody therapy daratumumab at 10-fold lower antibody concentration in Daudi cells. We are currently utilizing our technology toward generating potential "Biobetters" of selected commercial targeting agents and believe that our technology can be applied to a significant number of antibodies, peptides, Fab fragments or other targeting moieties. We look forward to working in collaboration via the AWE Program with biopharmaceutical companies that would like to increase the efficacy of their commercial or development stage antibodies to improve patient outcomes and also to better manage the lifecycle of their commercial antibodies."

About Our Actinium Warhead Enabling Technology Platform

The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Despite this superior cell killing power, actinium-225 when delivered in a targeted manner is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of radioimmunoconjugates, management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of "Biobetters" or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating Biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at [email protected].

On November 14, 2017 Ligand Presents Analyst Day Presentation (Presentation, Ligand, NOV 14, 2017, View Source [SID1234522066]).

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On November 14, 2017 Pieris Pharmaceuticals, Inc presents Investor Presentation (Presentation, Pieris Pharmaceuticals, NOV 14, 2017, View Source [SID1234522036]).

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On November 14, 2017 Molecular Templates, Inc. (Nasdaq:MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the third quarter of 2017 (Press release, Molecular Templates, NOV 14, 2017, View Source [SID1234522067]). As of September 30, 2017, cash and cash equivalents totaled $68.2 million.

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"The completion of our merger with Threshold Pharmaceuticals as well as the $60M in financings in the third quarter mark a significant milestone for Molecular Templates," said Molecular Templates’ Chief Executive Officer and Chief Scientific Officer, Eric Poma, Ph.D. "The merger and financings put us in a strong position to continue to execute on the development of our lead program, MT-3724, in aggressive lymphomas as well as make strides toward the clinic in 2018 with our next generation of ETBs currently in preclinical development. Additionally, we are excited about our ongoing research collaboration with Takeda Pharmaceuticals as we look to expand the application of our ETB technology."

Company Highlights and Upcoming Milestones

Corporate
On August 1, 2017, we successfully completed the reverse merger with Threshold Pharmaceuticals, Inc. (previously Nasdaq ticker: THLD) and concurrently changed the Company’s name to Molecular Templates, Inc. (new Nasdaq ticker: MTEM).

On August 1, 2017, we closed an equity financing for $40 million; as well as a private placement of $20 million to Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd.

MT-3724
On October 24, 2017, we announced the identification of the maximum tolerated dose (MTD) for MT-3724 and the initiation of and first patient dosed in an expansion cohort, as part of the second portion of the ongoing Phase I study focused on relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients. The expansion cohort is expected to better define the overall response rate to MT-3724 in heavily pre-treated DLBCL patients. Initial results of this expansion cohort are expected to be announced in 1H18.

Molecular anticipates initiating a Phase II monotherapy study in relapsed and refractory DLBCL patients in 2018.
Takeda Collaboration

Expanded Takeda collaboration in June 2017 with Multi-Target Research and Licensing Collaboration Agreement to develop next-generation oncology therapies, including stock purchase.

MT-4019
Continued development of MT-4019, an ETB candidate that is designed to target CD38-expressing myeloma cancer cells.

Plan to submit an IND application to the FDA in mid-2018 to initiate a Phase I clinical trial in the United States.
Research

Several other ETB candidates in pre-clinical development targeting both solid and hematological cancers where the differentiated mechanism of action innate to ETBs, ribosome inactivation, could play a significant role in treating cancer.

Financial Results
The net loss attributable to common shareholders for the third quarter was $(11.1) million, or $(0.62) per basic and diluted share. This is compared to a net loss attributable to common shareholders for the same period in 2016, of $(3.6) million, or $(11.89) per basic and diluted share. As of September 30, 2017, cash and cash equivalents totaled $68.2 million, which includes $11.2 million received from the merger with Threshold Pharmaceuticals in August 2017 and the receipt of $60 million for two financings that closed on the same day.
Revenues for the third quarter of 2017 were $0.6 million, compared to no revenues during the same period in 2016. Revenues for the third quarter of 2017 related to research and development revenues from our collaboration with Takeda.

Total research and development (R&D) expenses for the third quarter of 2017 were $2.5 million, compared with $2.3 million for the same period in 2016. The $0.2 million increase in R&D expenses in the third quarter of 2017, compared with the same period in 2016, was primarily due to severance benefits related to the merger with Threshold.

Total general and administrative (G&A) expenses for the third quarter of 2017 were $4.0 million, compared with $0.8 million for the same period in 2016. The $3.2 million increase in G&A expenses in the third quarter of 2017, compared with the same period in 2016, was primarily due to costs associated with the Merger and being a publicly traded company.

Revenues for the nine months ended September 30, 2017 were $2.6 million, compared to $1.5 million for the same period in 2016. Revenues for the nine months ended September 30, 2017 were primarily comprised of research and development revenues from our collaboration with Takeda. Revenues for the same period in 2016 comprised of grant revenue from the Cancer Prevention & Research Institute of Texas ("CPRIT").

Total R&D expenses for the nine months ended September 30, 2017 were $4.8 million, compared to $7.2 million for the same period in 2016. The $2.4 million decrease in R&D expenses for the nine months ended September 30, 2017, compared the same period in 2016, was primarily due to decreased spending for outsourced preclinical costs.
Total G&A expenses for the nine months ended September 30, 2017 were $8.2 million, compared to $2.6 million for the same period in 2016. The $5.6 million increase in G&A spending for the nine months ended September 30, 2017, compared to the same period in 2016, was primarily due to costs associated with the Merger and being a publicly traded company.

The net loss attributable to common shareholders for the nine months ended September 30, 2017 was $(17.2) million, or $(2.75) per basic and diluted share, compared to a net loss attributable to common shareholders of $(9.6) million or $(32.01) per basic and diluted share, for the same period in 2016.