On January 11, 2017 CureVac, a clinical-stage biopharmaceutical company pioneering the field of mRNA-based technology, reported an update of its clinical progress at the 35th Annual J.P. Morgan Healthcare Conference in San Francisco(Press release, CureVac, JAN 11, 2017, View Source [SID1234518820]).

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Interim Results of Phase I First-in-Human Clinical Trial with CV7201, an RNActive Rabies Vaccine
CureVac’s first-in-human phase I clinical trial with an mRNA-based rabies vaccine was designed to evaluate CV7201 in healthy volunteers without pre-existing immunity against the rabies virus. CV7201 encodes for the G protein of the rabies virus. To date, the vaccine appears well tolerated and no safety concerns were identified. In one cohort of 21 subjects vaccinated at the lowest dose of 80 µg with a needle-free device, virus neutralizing antibodies (VNTs) were detected in all subjects and in 17 (81%) exceeded the threshold considered protective by the WHO (0,5 IU/ml). The complete data set will be published after completion of a long-term safety valuation.
Regarding CV7201, CureVac is developing an optimized vaccine, which shows good efficacy when injected intramuscularly with a conventional needle. The company is planning to bring this vaccine into clinical testing in 2017.

Topline Result of Phase IIb Clinical Trial with CV9104, an RNActive Prostate Cancer Vaccine
CureVac’s double-blinded and placebo controlled phase IIb clinical trial with CV9104 was designed to evaluate the investigational mRNA-based cancer vaccine in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. CV9104 is composed of six protamine-formulated mRNAs, encoding individually for self-antigens that are overexpressed in prostate cancer patients.
CV9104 failed to meet the primary endpoint of improving overall survival. Progression-free survival was similar in both arms of the clinical trial. No safety concerns were identified confirming the favorable safety results of previous trials with RNActive cancer vaccines. CureVac is continuing to evaluate the data and plans to present the full set of data at an upcoming medical conference.

Clinical Results to Point Way Forward to Medical Innovation
Ingmar Hoerr, Ph.D., co-founder and CEO of CureVac, stated: "We received encouraging data from the first ever clinical trial of a prophylactic RNActive mRNA vaccine in immune-naïve healthy volunteers indicating our vaccine is able to effectively prime immune responses against a viral antigen. These results affirm the prior preclinical proof of concept data for our vaccine format and pave the way for us to advance more potent prophylactic vaccine formulations into the clinic. Regarding our CV9104 program, we now recognize that this therapeutic vaccine fails to induce a survival benefit as a monotherapy in patients with metastatic prostate cancer receiving standard of care therapies. However, we see the path forward for our RNActive cancer immunotherapy in combination with checkpoint inhibitors."
Dr. Hoerr continued, "Having administered our RNA technologies to more than 450 human subjects and having conducted eight different clinical studies, we are confident that it can be administered safely, and based on data generated in our clinical program in rabies, we now have clear evidence that our RNActive technology induces effective immune responses in humans. As the pioneer in the mRNA field, we look forward to advancing our mRNA development and applying uniquely designed mRNA-based drugs in oncology, prophylactic vaccines and molecular therapies as CureVac strives to have the first mRNA-based product on the market for people suffering from high and unmet medical needs."

About CV7201 Phase I Clinical Trial in Rabies
The study is designed to evaluate the safety and immunogenicity of CV7201 according to (1) dose level (2) route of injection and (3) injection schedule. Rabies-specific binding and neutralizing titers will be evaluated across different injection routes using an injection schedule of 0-7-28 and 0-28-56. The trial started in 2013 and is still ongoing. To date, more than 100 subjects have been enrolled in Germany and safety follow-up is ongoing.

More details can be found here.

About CV9104 Phase IIb Clinical Trial in Prostate Cancer
The phase IIb with CV9104 was a double-blind, placebo controlled trial with 197 chemo-naïve, asymptomatic or minimally symptomatic patients with metastatic, castrate-resistant prostate cancer randomized to CV9104 or placebo. The trial which was conducted in eight European countries started in 2012 and recruitment was completed in December 2013. The primary endpoint of the study was overall survival and key secondary endpoints were progression-free survival and change of quality of life.

On January 11, 2017 Maverick Therapeutics Inc., an MPM Capital portfolio company, and Takeda Pharmaceutical Company Limited (TSE:4502) reported that they have entered a collaboration to develop Maverick’s T-cell engagement platform created specifically to improve the utility of T-cell redirection therapy for the treatment of cancer (Press release, Takeda, JAN 11, 2017, View Source [SID1234517353]). The $125 million of funding includes an upfront option, equity and research and development funding payments, and provides Takeda the exclusive right to purchase Maverick after five years for an undisclosed sum. Maverick was founded in 2016.

"We believe that this collaboration validates Maverick’s approach to T-cell engagement in the tumor microenvironment which we believe will allow us to address previously intractable oncology targets," said Jeanmarie Guenot, Ph.D., Maverick’s co-founder. "Importantly, this strong collaboration should allow us to move rapidly to the clinic and address unmet needs in cancer immunotherapy."

"We see significant potential in Maverick to develop unique, small and customizable T-cell engagement therapeutics," said Phil Rowlands, Interim Head, Oncology Therapeutic Area Unit, Takeda. "Collaborations are critical to helping us advance our aspiration of curing cancer. Working together with Maverick will enable us to leverage a potentially groundbreaking biologics platform to support Takeda’s goal of developing innovative, targeted therapies to treat people with cancer."

MPM’s BioVentures 2014 and the UBS Oncology Impact Fund, managed by MPM Capital, join Takeda in a $23 million Series B Financing as a key element of the financing package. Takeda will add a director to Maverick’s Board. The management team of Maverick will be led by President and Chief Scientific Officer Hans-Peter Gerber, Ph.D., formerly of Pfizer.

Takeda signed agreements with Maverick Therapeutics through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc.

On January 11, 2017 Takara Bio Inc. (Takara Bio), reported that it has submitted the Clinical Trial Notification for regenerative medicines to PMDA (Pharmaceuticals and Medical Devices Agency), Japanese regulatory agency, to conduct phase I/II clinical trial for gene therapy using CD19 Chimeric Antigen Receptor (CAR) (Development code: TBI-1501) targeting relapsed and refractory acute lymphoblastic leukemia (ALL) in Japan (Press release, Takara Bio, JAN 10, 2017, View Source [SID1234517405]). In the clinical trial, CAR which recognizes CD19, a protein expressing on the surface of malignant lymphocyte, is transferred ex-vivo to lymphocytes of patients with adult ALL, and the gene-modified lymphocytes are infused back to the patients. The patients will be monitored for safety and efficacy. The Takara Bio’s method of gene transduction and T-cell expansion using RetroNectin, and Takara Bio’s original retroviral vectors for transduction of CD19-CAR will be used during the cell processing for the clinical trial. After the clearance, the protocol will be reviewed by each IRB (Institutional Review Board) and the study will be initiated. Takara Bio aims to commercialize the CD19-CAR gene therapy in the fiscal year 2020, by obtaining an early approval utilizing the conditional and term-limited approval system for regenerative medicines under The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical devices.

【Overview of the Clinical Trial】
Study name Multicenter Phase I/II Clinical Trial of TBI-1501 for elapsed and refractory CD19-positive B-cell Acute Lymphoblastic Leukemia
Condition Patients with elapsed and refractory CD19-positive B-cell Acute Lymphoblastic Leukemia
Main Endpoint Phase I Clinical trial
1) Safety
2) TBI-1501 Persistency
Phase II Clinical trial
1) Efficacy
Estimated Enrollment 21 (maximum 24)
Duration Mar 2017 – Mar 2020
Site Jichi Medical University and others, total 6 sites

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On January 10, 2017 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH), a world leading life sciences company, and the Mount Sinai Health System (Mount Sinai), one of the largest health systems in metropolitan New York City, reported that they have entered into a definitive agreement for LabCorp to acquire assets of Mount Sinai’s Clinical Outreach Laboratories (Press release, LabCorp, JAN 10, 2017, View Source;p=irol-newsArticle&ID=2236528 [SID1234518885]). When the transaction is complete, LabCorp will be available to provide comprehensive laboratory services to physicians and patients that currently use Mount Sinai’s outreach laboratory.

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"LabCorp has successfully provided comprehensive health system solutions for over three decades," said David P. King, chairman and chief executive officer of LabCorp. "This transaction, giving us the opportunity to serve an anchor health system in the critical New York metro market, provides us even broader opportunity to improve health and lives through the delivery of world class diagnostics."

Mount Sinai will continue to provide laboratory testing for patients registered at its hospitals and ambulatory facilities as inpatients or outpatients, as well as laboratory testing services for physicians in their professional practices in the areas of anatomic pathology, molecular pathology and genetics. LabCorp will offer clinical pathology testing, including cytology and cytology-related molecular testing. Seven patient service centers currently operated by Mount Sinai will be added to LabCorp’s existing network of 120 patient service centers in the metropolitan New York City area. The parties are also vigorously exploring opportunities to collaborate on projects involving companion diagnostics, clinical trials and medical education.

"LabCorp was selected for its depth and breadth of services and track record of high quality," said Carlos Cordon-Cardo, M.D., Ph.D., Irene Heinz Given and John LaPorte Given professor and chairman, Department of Pathology, Mount Sinai Health System. "Their unparalleled reputation and success ensures our patients will continue to have access to high-quality, high-value and convenient testing services."

"Customers and patients will quickly see the advantages of our differentiators," said William B. Haas, senior vice president and co-leader of LabCorp Diagnostics. "Only LabCorp can offer access to clinical trials and research through Covance Drug Development, enhanced IT and data analytics, standardized testing platforms and broad patient access."

"We are confident this transaction will provide great benefits for our patients and physicians and allow Mount Sinai to continue to invest in our core strategic programs," said Donald Scanlon, chief financial officer and chief of corporate services, Mount Sinai Health System. "LabCorp’s proven track record of service excellence, breadth of diagnostic capabilities, and cost-efficiency will benefit our community now and in years to come."

The transaction, which has already received clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, is expected to close in the first quarter of 2017. Other terms of the transaction were not disclosed.

Citi acted as exclusive advisor to the Mount Sinai Health System in connection with the clinical outreach assets sold in this transaction.

On January 10, 2017 Integra LifeSciences Holdings Corporation (Nasdaq:IART), a global leader in medical technology, reported that it has signed a definitive agreement to acquire Derma Sciences Inc. (Nasdaq:DSCI) for a price of $7.00 per share of Derma Sciences common stock in cash (Press release, Integra LifeSciences, JAN 10, 2017, View Source [SID1234517585]).

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"Derma Sciences’ amniotic tissue-based platform technology further broadens Integra’s regenerative technology capabilities and builds upon our 3×3 wound care strategy," said Peter Arduini, Integra’s president and chief executive officer. "The addition of a complementary portfolio of wound care products, including an amniotic product with reimbursement in the wound care channel, allows us to further drive scale in the advanced wound care market."

Under the agreement, Integra will commence a tender offer to purchase all of the outstanding shares of Derma Sciences common stock for $7.00 per share in cash. Integra will also offer to purchase the outstanding shares of Derma Sciences preferred stock for an amount equal to its liquidation preference per share. The tender offer will be followed by a merger of Derma Sciences with a newly formed subsidiary of Integra. The companies expect to complete the transaction at the end of the first quarter of 2017, subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of outstanding shares of Derma Sciences common stock and preferred stock. Integra expects to use its existing credit facility to finance the transaction.

BofA Merrill Lynch acted as exclusive financial advisor and Latham & Watkins LLP acted as legal advisor to Integra.

Preliminary Fourth Quarter and Full Year 2016 Financial Results

Integra is also announcing today that it expects its fourth quarter 2016 total revenue to be approximately $256 million, resulting in full-year 2016 revenue of approximately $992 million, at the low end of the previously provided guidance range. Integra expects to report fourth-quarter 2016 organic revenue growth, which excludes the impact of foreign currency changes and revenue from discontinued and acquired products, of approximately 7.0%, and full-year 2016 organic growth of approximately 9.0%.

The Company expects fourth-quarter 2016 GAAP and adjusted diluted earnings per share to be at or above the mid-point of the prior guidance range of $0.32 to $0.35 and $0.50 to $0.53 post-stock split, respectively. This implies full-year 2016 GAAP and adjusted diluted earnings per share at or above the mid-point of the range of $0.91 to $0.94 and $1.73 to $1.77 post-stock split, respectively. At this point during our year-end close activities, the Company is not able to provide a breakdown of the components of the non-GAAP adjustments, but preliminarily estimates these to total $0.82 per share for the full year 2016.

Operating cash flow, excluding approximately $43 million of accreted interest payment associated with the 2016 Convertible Notes that matured in December 2016, and free cash flow were strong. The Company expects to be slightly above the high end of the previous guidance range for both metrics, above $145 million operating cash flow and above $105 million for free cash flow. The difference between operating cash flow and free cash flow is a preliminary estimate of $40 million for capital expenditures.

2017 Financial Guidance

The Company is also providing preliminary 2017 revenue and adjusted earnings per share guidance for 2017. Integra expects full-year 2017 organic revenue growth to be between 7% and 8.5%. This implies a revenue range of approximately $1.05 billion to $1.07 billion, inclusive of an unfavorable impact from foreign currency of approximately one percent at current exchange rates.

Full-year 2017 earnings per share are expected to grow low double digits, exclusive of the unfavorable impact expected from foreign currency. The Company expects full-year 2017 adjusted earnings per share to be in the range of $1.91 to $1.97, taking into account a two cent negative impact from foreign currency. The Company is still in the process of reconciling estimates for full-year 2017 GAAP EPS projections and will provide this information and other additional information when full 2016 financial results are reported on February 22, 2017.

This preliminary 2017 guidance does not include the acquisition of Derma Sciences, Inc., which has not closed. Assuming a closing date at the end of the first quarter of 2017, Integra expects the acquisition to add approximately $65 million in revenue and to be dilutive to adjusted earnings per share by approximately three cents during 2017. The acquisition is expected to turn accretive to adjusted earnings in 2018, and to reach our return on invested capital hurdle by the end of the third year.