(Press release, Galderma, JUL 2, 2014, View Source [SID:1234503692])

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PRECLINICAL MODELS NETWORK TAKING SHAPE

On July 1, 2014 Cancer Research Technology (CRT) reported that it is developing plans to make preclinical models more accessible for translational research across the UK (Press release, Cancer Research Technology, JUL 1, 2014, View Source [SID1234523519]). They’d like to speak to any researchers interested in getting involved or using these models.

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In recent months Hazel Jones, Cancer Research UK’s head of combination therapies, and a team from Cancer Research Technology (CRT) has held a series of meetings and workshops – focused on both PDX and GEMM models – with leading UK researchers in preclinical models to discuss how to make models more accessible for translational research across the UK.

The team has been aiming to identify institutes where the models are currently held, determine the translation capacity of these models and consider ways in which to join up PIs to enable the sharing of models and best practice. Feedback from researchers has indicated that there is a clear need and desire to work more collaboratively in this area.

The CRT team is now in the process of establishing a database of available models across the CRUK research community. Longer term, they are looking to develop a central standardised CRUK repository and network to enable the development and sharing of preclinical models and are currently reviewing funding possibilities, including flexible technical FTE or external support. They are also in talks with the NC3Rs, the UK’s largest funder of research that works to replace, reduce and refine the use of animals in experiments, who has identified preclinical oncology models as a key challenge.

There are further events planned in the coming months including:

Patient Derived Xenograft (PDX) Models: Advantages and Limitations
26th November 2014, London
For more information, or to reserve your place, please click here.

CRT welcomes input from any researchers working in this area – your ideas and opinions will be critical in developing an acceptable and valuable resource. If you are interested in getting involved in this initiative or are looking to access preclinical models, please email: [email protected]

Transcept Pharmaceuticals and Paratek Pharmaceuticals Sign Merger Agreement

On July 1, 2014 Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) and Paratek Pharmaceuticals, Inc., a privately-held biopharmaceutical company, reported that they have entered into a definitive merger agreement under which the stockholders of Paratek will become the majority owners of Transcept and the operations of Transcept and Paratek will be combined (Press release, Paratek Pharmaceuticals, JUL 1, 2014, View Source [SID:1234513488]). As part of the proposed transaction, new investors (including The Baupost Group, Abingworth LLP, and other institutional investors); certain Transcept stockholders (including InterWest Ventures and Roumell Asset Management); and certain Paratek stockholders (including Omega Funds, HBM Healthcare Investments and Aisling Capital) will invest approximately $93 million in the combined organization.

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Glenn Oclassen, Chief Executive Officer and Chairman of the Transcept Board, commented: "Following Transcept’s recent June 3, 2014 special cash dividend of approximately $25.4 million, 2 this transaction with Paratek reflects the continued commitment of Transcept’s Board of Directors and management team to deliver value to Transcept’s stockholders. Under the proposed transaction, Transcept’s stockholders will maintain a meaningful equity ownership stake in Transcept, which will refocus its operations as a late-stage therapeutics company with product candidates we believe possess significant commercial potential. The transaction also provides for our stockholders an additional special cash dividend and the opportunity to realize any upside potential from our INTERMEZZO and TO-2070 assets."

Michael Bigham, Chief Executive Officer and Chairman of the Paratek Board of Directors, commented: "Antibiotic resistance continues to be a growing public health concern worldwide. This transaction provides the financial support necessary for the Phase 3 development of our lead product candidate, Omadacycline, which is an important new once daily, oral and intravenous, broad-spectrum antibiotic for serious community-acquired infections. Omadacycline was designed specifically to address the mechanisms by which bacteria develop resistance to existing antibiotics. The combined organization will have the resources to initiate and complete our planned Phase 3 registration program, as agreed with FDA per Special Protocol Assessments, for both Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-acquired Bacterial Pneumonia (CABP). We will also explore additional potential indications including urinary tract infections (UTI)."

In a joint statement made by Paratek’s lead investors, Richard Lim, Partner at Omega Funds and Matthias Fehr, Partner at HBM Partners, said, "This transaction establishes a well-capitalized public company within which the management of Paratek may progress its late-stage drug pipeline through its pivotal studies. We are excited about the prospects for omadacycline to address the growing need for efficacious, safe and convenient oral and intravenous antibiotic drugs."

About the Transaction

Paratek stockholders will receive newly issued shares of common stock of Transcept in connection with the merger contemplated by the merger agreement. Transcept will issue approximately 167.5 million new shares of its common stock to Paratek stockholders under the exchange ratio formula defined in the merger agreement. Upon the closing of the merger, existing Paratek equity holders are expected to own approximately 37.9 percent of Transcept, the persons investing in Paratek as of immediately prior to the closing of the merger are expected to own approximately 51.7 percent of Transcept, and existing Transcept equity holders are expected to own approximately 10.4 percent of Transcept, each on a fully-diluted basis. The exchange ratio is defined in the merger agreement and is subject to potential adjustments.

The merger agreement also contains further details with respect to a) the cash to be reserved for anticipated merger and holdback expenses of Transcept including patent enforcement expense obligations relating to INTERMEZZO; b) how further payments or royalty payments, if any, that are received relating to the sale of INTERMEZZO and TO-2070 assets will be disbursed 3 to Transcept stockholders of record immediately prior to the Closing; and c) the excess cash that Transcept will distribute via an additional special cash dividend also to such Transcept stockholders of record immediately prior to the Closing.

The executive officers of Transcept will resign from their positions with Transcept upon the closing of the merger, and the executive officers of Paratek will assume their respective positions in Transcept. Paratek Pharmaceuticals, Inc. reported that Michael F. Bigham, Partner at Abingworth LLP, has been appointed as Chairman of the Board of Directors and Chief Executive Officer. In addition, Dr. Evan Loh, Chief Medical Officer (CMO) at Paratek, has been promoted to President and CMO and will continue to serve on the Board of Directors. Following the closing of the merger, the Board of Directors of Transcept is expected to consist of a total of seven members, two of whom will be designated by Transcept prior to the closing of the merger, and five of whom will similarly be designated by Paratek (and which will include the Chief Executive Officer of the combined organization).

The boards of directors of both Transcept and Paratek have unanimously approved the proposed transaction, which is subject to customary closing conditions, including approval by the stockholders of each of Transcept and Paratek. Transcept stockholders holding approximately 43 percent of its outstanding common stock have agreed to vote in favor of the transaction, and a majority of Paratek stockholders, have also agreed to vote in favor of the transaction. Subject to regulatory approvals and customary closing conditions, the transaction is currently expected to close during the second half of 2014.

If the transaction is consummated, Transcept’s name will be changed to Paratek Pharmaceuticals, Inc., and Transcept intends to apply to change its ticker symbol on The NASDAQ Global Market to "PRTK".

Transcept was advised in the transaction by Leerink Partners, LLC and Paratek was advised by Ladenburg Thalmann & Co. Latham & Watkins LLP served as legal counsel to Transcept and Pepper Hamilton LLP served as legal counsel to Paratek. Cooley LLP and Ropes & Gray LLP served as legal counsels to certain investors.

Seragon Pharmaceuticals Announces Acquisition Agreement with Genentech

On July 1, 2014 Seragon Pharmaceuticals whereby Seragon will be acquired for $725 million in cash up front along with $1.0 billion in contingent development milestone payments that could bring the total transaction value to $1.725 billion (Press release, Seragon Pharmaceuticals, JUL 1, 2014, View Source [SID:1234503263]). The acquisition includes Seragon’s entire SERD program, including its most advanced compound, ARN-810, a next generation SERD that is currently being evaluated in a Phase I trial in patients with estrogen receptor positive (ER+) metastatic breast cancer.

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Seragon, founded in August 2013, is an independent venture backed biotech company based in San Diego that was spun out of Aragon Pharmaceuticals, following its acquisition by Johnson & Johnson. Following the spin out, Seragon retained many members of the management and R&D team, including Richard A. Heyman, Ph.D., Chief Executive Officer and co-founder of Aragon and Seragon Pharmaceuticals. The Seragon team focused its attention to develop game changing therapies targeting ER+ breast cancer and other estrogen driven cancers including endometrial and ovarian cancers.

"This acquisition represents an ideal transition between biotech and pharma and may provide an optimal outcome for the SERD program and the breast cancer patient community. The Seragon team has been committed to bringing new therapies to cancer patients and we are excited to have Genentech carry forward these programs. Genentech has repeatedly demonstrated its leadership position the oncology field, and their development and commercial capabilities in the breast cancer area are unparalleled," said Rich Heyman.

In the US alone, there are approximately 229,000 new breast cancer diagnoses and 40,000 deaths/year related to breast cancer. The vast majority of these cancers are dependent on estrogen signaling and women with ER+ breast cancer are treated with 1st generation anti-hormonal therapies such as tamoxifen or the aromatase inhibitors. These therapies are initially effective, but many patients experience disease progression due to acquired resistance. Seragon’s SERDs are next generation therapies that have a dual mechanism of action in that they both bind to the estrogen receptor to antagonize hormone action, and they promote receptor degradation. These SERDs are initially being developed for the treatment of women with late-stage, progressive ER+ metastatic breast cancer, but they also have potential in treating patients with early-stage breast cancer. Furthermore they also may offer an opportunity to be the cornerstone for future combination therapies.

"I would like to sincerely acknowledge Rich and the entire Seragon team for their commitment and dedication in advancing the ground breaking science behind both Seragon and Aragon. In just five years since the founding of Aragon, in The Column Group’s offices, this team has advanced multiple compounds from an early idea to a clinical development program targeting hormone dependent cancers. I would also like to thank Dr. Charles Sawyers for his foundational work helping to elucidate the molecular determinants of resistance for hormone dependent prostate cancer. This is an ideal path, which will hopefully translate to improving the lives of patients," said Peter Svennilson, Founder and Managing Partner of The Column Group and Chairman of both Seragon and former Chairman of Aragon.

The closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is expected to close in the third quarter of 2014.

Wilson Sonsini Goodrich & Rosati served as legal advisor to Seragon Pharmaceuticals in this transaction.

Tolero’s PIM Kinase Inhibitor Demonstrates Promising Activity in Preclinical Models of Urothelial Carcinoma

On June 30, 2014 Tolero Pharmaceuticals reported that recent studies in collaboration with the University of Utah examined the function of PIM kinases in cancer progression and the potential of these kinases to serve as therapeutic targets for treatment (Press release Tolero Pharmaceuticals, JUN 30, 2014, View Source [SID:1234500707]). PIM kinases are upregulated in multiple cancer indications, including lymphoma, leukemia, multiple myeloma, and prostate, gastric, and head and neck cancers. The overexpression of PIM family members often correlates with poor prognosis in tumors.

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This work demonstrates that PIM kinases are overexpressed in urothelial carcinomas taken directly from patients and that targeting the PIM kinases with a novel small-molecule inhibitor (TP-3654) reduces the growth of solid tumor xenografts where the tumorigenicity is mediated by overexpression of PIM-1 or PIM-2, as well as human bladder carcinoma tumors. TP-3654 is poised to enter IND-enabling studies and Phase I clinical testing in solid tumors and hematological malignancies.

"These data support the long-standing effort to target cell survival kinases and may provide patients with new approaches to combat difficult to treat cancers, such as bladder carcinoma. Tolero is advancing TP-3654 to further validate the PIM kinases as therapeutic targets in the clinical setting," said Steven L. Warner, PhD, Vice President of Discovery and Development at Tolero Pharmaceuticals.

Tolero is also evaluating the utility of TP-3654 in skin inflammatory conditions, such as psoriasis.