QB3@953 Facilitates Strategic Alliance between Innovative Start-Up Member and a Sponsor Company

On February 2, 2017 QB3@953, the Bay Area’s premier life science incubator, reported the collaboration between one of its member companies, Telo Therapeutics, and one of its sponsor companies, GlaxoSmithKline (GSK) (Press release, Telo Therapeutics, FEB 2, 2017, View Source [SID1234574485]). Telo Therapeutics is a start-up biotechnology company co-founded by Joe Costello, PhD, UCSF Professor of Neurological Surgery, and Robert Bell, PhD, a former post doc in Dr. Costello’s lab. GSK’s Discovery Partnerships with Academia (DPAc) group recently extended its 2015 collaboration agreement with QB3@953, and has now formed a collaboration with Telo Therapeutics to develop a novel precision medicine with the aim to reverse cancer cell immortality.

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"We’re delighted to collaborate with GSK because of their extensive chemistry resources and drug development expertise," said Dr. Costello.

"This collaboration is a tremendous step forward for Telo, and it will accelerate our development timeline towards patient trials faster than would be possible alone," added Dr. Bell, now CEO of Telo Therapeutics.

"Telo is exactly the type of innovative target concept that we were hoping to see through our collaboration with QB3@953," said Carolyn Buser-Doepner, Head of the GSK DPAc team. "The principal scientists and their innovative, early target concept are an excellent fit for the DPAc model."

Telo first became a member of QB3@953 and then a collaborator with GSK’s DPAc team as well as the recipient of GSK’s "golden ticket" lab bench at QB3@953. The "golden ticket" is provided by QB3@953 to allow sponsor companies to select a promising Bay Area biotech company of their choice to allocate use of state-of-the-art research equipment and lab space granted to partners of QB3@953. As a "golden ticket" company, Telo Therapeutics will have access to GSK’s allocated space and equipment for one year while the two companies work together to perform a series of small molecule screens. If promising drug candidates are identified through this collaboration, a longer multi-year partnership between the parties could be established to advance the drug to the clinic.

"The formation of the collaboration between Telo Therapeutics and GSK is a great example of how QB3@953 serves as a launch pad to pair local researchers possessing great science and entrepreneurial aspirations with partner resources necessary to advance innovative programs within new companies," said Doug Crawford, QB3@953 Managing Director.

TapImmune Completes Scale-Up and GMP Manufacturing of TPIV 200 Vaccine to Supply Additional Phase 2 Clinical Trials

On February 2, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, reported it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, the company’s multi-epitope T-cell vaccine targeting folate receptor alpha (Press release, TapImmune, FEB 2, 2017, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D [SID1234517634]). The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer.

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"The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization."

"Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients," said Dr. John Bonfiglio, President and COO of TapImmune. "The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense."

CytomX Announces the First Patient Treated in Phase 1/2 PROCLAIM-072 Trial

On February 2, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the treatment of the first patient in the PROCLAIM (Probody Clinical Assessment In Man) CX-072 study, a Phase 1/2 clinical trial evaluating CX-072, a PD-L1-targeting Probody therapeutic, as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers (Press release, CytomX Therapeutics, FEB 2, 2017, View Source;p=irol-newsArticle&ID=2241629 [SID1234517635]).

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"Treating the first patient with CX-072 marks a key milestone as we advance our broad pipeline of innovative Probody therapeutics into clinical development within the PROCLAIM program," said Rachel W. Humphrey, M.D., chief medical officer of CytomX Therapeutics. "Advancement of this potentially transformational treatment, derived from our Probody technology platform, would not be possible without the patients who are willing to engage with the scientific community by enrolling in clinical trials. We thank them for their participation."

About the PROCLAIM-072 Trial
The first clinical trial under the international umbrella program PROCLAIM is the open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers. As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.

More information about the trial is available at clinicaltrials.gov.

FY 2016 (Ending March 31, 2017) Third Quarter Financial Results Reference Data

On February 2, 2017 Eisai Co., Ltd. reported financial results for the Nine-Month Period Ended December 31, 2016 (Report, Eisai, FEB 2, 2017, View Source [SID1234517643]).

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Gross profit for the the nine-month periods ended December 2016 was 261.4 billion Yen in comparison to that of 277.2 billion Yen for the the nine-month period ended December 2015.

For Eisai’s detailed sales figures, View Source

Stemline Therapeutics Provides Update on Pivotal BPDCN Trial

On February 2, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported an update on its ongoing pivotal Phase 2 trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), using Stemline’s experimental compound, SL-401. BPDCN at present has no approved treatment (Press release, Stemline Therapeutics, FEB 2, 2017, View Source [SID1234517627]).

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On January 18, the Company received a report that a patient death had occurred. The patient had developed capillary leak syndrome (CLS), a known, sometimes fatal, and well-documented side effect of SL-401. The cause of the patient’s death has not yet been determined. The safety profile for SL-401 includes CLS, and there have been previous deaths reported in patients with CLS in this trial, which have been disclosed in public presentations. That CLS is an expected complication of the administration of SL-401 has also been identified in filings with the Securities and Exchange Commission (SEC) and U.S. Food and Drug Administration (FDA), as well as in the study’s informed consent forms and other information provided to investigators.

As with all study events, the Company has and will continue to report the data to the FDA in accordance with the study protocol and applicable regulations. Stemline plans to provide a clinical and safety update on this cohort when the cohort and data are complete. The pivotal Phase 2 trial with SL-401 in BPDCN is currently ongoing, patient enrollment is ahead of schedule, and patients continue to receive SL-401 in the trial. Our timelines for study completion and BLA submission remain on trac