Caladrius Biosciences Licenses Cell Therapy Technology for Ovarian Cancer and Subleases Irvine Facility to AiVita Biomedical

On May 26, 2016 Caladrius Biosciences, Inc. (NASDAQ:CLBS) ("Caladrius" or the "Company"), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, reported that it has licensed to AiVita Biomedical, Inc. ("AiVita") the exclusive global rights to its tumor cell/dendritic cell technology for the treatment of ovarian cancer (Press release, Caladrius Biosciences, MAY 26, 2016, View Source [SID1234528899]). In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Company’s strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.

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The license contributes to AiVita’s intellectual property protection for its next generation immunotherapy targeting cancer stem cells. AiVita intends to begin a Phase II clinical trial to evaluate the efficacy of its novel appoach for ovarian cancer in 2016. To facilitate these clinical objectives, AiVita has also assumed a sublease of the Company’s former Irvine, California facility. This sublease obligation will cover for the remainder of the lease term all cash obligations of Caladrius with respect to the rent and overhead of the Irvine facility.

"Licensing this technology to AiVita is another step forward in streamlining our strategic focus and reducing our operating expenses while monetizing non-core assets through royalty and other milestone-driven transactions," said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. "This agreement adds to the one signed in February 2016 whereby we licensed to AiVita exclusive global rights to our cell-derived dermatological technology for topical skin applications."

OncoResponse Secures Investment from Baxalta

On May 26, 2016 OncoResponse, an immuno-oncology antibody discovery company, reported an investment from Baxalta Incorporated (NYSE: BXLT) (Press release, OncoResponse, MAY 26, 2016, View Source [SID1234522899]). In October 2015, OncoResponse closed a Series A financing co-led by ARCH Venture Partners, Canaan Partners and MD Anderson, with William Marsh Rice University and Alexandria Real Estate Equities also participating . The investment by Baxalta brings the total Series A to $12.5 million and will be used to support OncoResponse’s ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for novel therapeutic development.

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OncoResponse utilizes a validated platform technology to rapidly screen antibodies made by the human immune system and identify those with exceptional reactivity to cancer immunotherapy. The company has an ongoing strategic alliance with the MD Anderson Cancer Center, which provides access to patient samples and oncology and translational medicine expertise including clinical and regulatory input.

"We are pleased to welcome Baxalta to our solid team of investors," said Clifford J. Stocks, CEO of OncoResponse. "Our current partnership with MD Anderson has seen significant progress, and this additional investment reinforces our continued commitment to the identification of rare cancer-fighting antibodies and novel targets that may lead to the development of improved cancer treatments."

"This investment will assist OncoResponse in the advancement of its research programs which seek to develop a deeper understanding of the immune response in patients who have responded exceptionally well to cancer immunotherapy," said Geeta Vemuri, PhD, Managing Venture Partner at Baxalta. "Their innovative approach is in line with Baxalta’s investment strategy to accelerate the development of cuttingedge biotechnologies that address unmet patient needs in hematology, immunology and oncology."

Sunesis Pharmaceuticals Announces Support of First-Ever Acute Myeloid Leukemia Awareness Month in June

On May 25, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported its support for the first-ever Acute Myeloid Leukemia Awareness Month to be held in June. The goal of the campaign, which is being sponsored by CancerCare, is to put a spotlight on the disease, a rare and difficult-to-treat blood cancer that typically affects older adults (Press release, Sunesis, MAY 25, 2016, View Source;p=RssLanding&cat=news&id=2172293 [SID:1234512773]).

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Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and can worsen quickly if left untreated. According to the National Institutes of Health, it is estimated that there will be 19,950 new cases of acute myeloid leukemia in 2016 and an estimated 10,430 people will die from the disease. AML is more common in older adults, who are also the most difficult to treat, with 67 as the median age of diagnosis. While progress in treating leukemia has been made, there has been only one AML treatment approved by the U.S. Food and Drug Administration in the past 30 years (and that drug was subsequently withdrawn from the market).

Patricia J. Goldsmith, CEO of CancerCare, said, "AML Awareness Month will feature in-depth information about AML on the organization’s website, including a video that features NBA broadcaster Craig Sager who is battling the disease, as well as his son, Craig, Jr., who donated his bone marrow twice in an effort to save his father. The website will also offer people living with AML and their caregivers easy-to-use, informative resources to understand their condition. We thank Sunesis Pharmaceuticals for their unrestricted educational grant which has helped to support the development of these resources."

"We are delighted to be supporting CancerCare’s efforts to raise awareness of acute myeloid leukemia," said Daniel Swisher, Chief Executive Officer of Sunesis. "Because it is a rare disease with an older patient population, there has been little attention focused on AML. As a company that is determined to deliver a new treatment option for this disease, we want to support the AML community by helping to provide more education and information for patients and caregivers."

Goldsmith added, "The AML community’s voice has not always been heard because the disease itself is so rare and the mortality rate is so high. We hope to put a spotlight on AML in June and help focus attention on the urgent need these patients and their families have for hope."

Patients and caregivers can find educational resources on AML online at www.cancercare.org; an unrestricted educational grant from Sunesis has helped to support the development of the informational resources on AML which also includes a patient and caregiver workshop webinar to be held on June 17.

About CancerCare

Founded in 1944, CancerCare is the leading national organization providing free, professional support services and information to help people manage the emotional, practical and financial challenges of cancer. Our comprehensive services include counseling and support groups over the phone, online and in-person, educational workshops, publications and financial and co-payment assistance. All CancerCare services are provided by oncology social workers and world-leading cancer experts. Headquartered in New York, NY, CancerCare maintains three additional locations in Norwalk, CT, Ridgewood, NJ and Syosset, NY.

Israeli startup HIL Applied Medical Ltd. acquires US-Based Nanolabz Inc. – en route to developing advanced cancer radiotherapy systems

On May 26, 2016 HIL Applied Medical Ltd. a Jerusalem, Israel medical technology startup reported the acquisition of Nanolabz Inc. – a Reno, Nevada company born out of University of Nevada research and focused on developing and fabricating smart targets for laser-based proton acceleration (Press release, HIL Applied Medical, MAY 25, 2016, View Source [SID:1234512815]). HIL Applied Medical is developing a new class of ultra-compact, high-performance Proton Beam Therapy systems, based on high-intensity lasers and nano-engineered smart targetry.

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"Today’s announcement is important on several levels," Mr. Sagi Brink-Danan, Chief Executive Officer of HIL, said, "The acquisition immediately doubles HIL’s patent portfolio, thus further fortifying our already-strong IP position in our field. It also adds strong, complimentary talent to our team, and provides a strong base for HIL’s US operations. We are looking forward to working together with the NanoLabz and UNR teams towards our joint goal of building the world’s first laser-based cancer proton therapy system."
NanoLabz co-founders Dr. Jesse Adams and Mr. Steven Malekos said they are thrilled to have found a great partner for NanoLabz’ technology with HIL, adding that "we are looking forward to working with HIL’s world-class, committed and capable team on translating cutting-edge technology into products that will benefit cancer patients worldwide."

Co-founder and president of Nanolabz, Mr. Grant Korgan, added: "It’s a joy to see us reach this milestone. It is a testament to hard work and the power of positivity." Mr. Korgan suffered a major spinal cord injury in 2010, and has since become a local and global inspiration, TED-lecturer and sought-after public speaker.

UNR president Dr. Marc Johnson stated that he was pleased to see this milestone, which highlights the institution’s role as an internationally respected, high-impact research university.

What is Proton Therapy: A proton beam is a form of focused radiation used to treat solid tumors. It is superior to traditional radiation therapy (X-Ray, or Photons) in that it reduces damage to surrounding healthy tissue by 2X-6X, thereby reducing toxicities and improving patient survival and quality of life. Proton therapy is used routinely for treating many types of cancer; it is FDA-cleared (510k) and reimbursed by both Federal and private insurers.

Proton Therapy’s Unmet Need: Proton beam therapy can help an estimated 300,000 cancer patients every year in the US – yet last year only 10,000 received it (that’s less than 4%). Protons are arguably the most advanced form of radiation therapy – yet there are only 19 active proton-therapy centers in the US today; compare with over 2,700 traditional (X-Ray) radiation therapy centers. The main barrier to widespread adoption is the large size (football stadium) and high cost ($150-250M) of building and operating a proton therapy center. Single-room solutions are slowly being introduced by some vendors for $30-50M. The key to making protons available to every patient in every midsize hospital is a scalable, add-on, single-room solution for half the current price tag or less. HIL’s technological breakthrough promises to bring about this revolution.

8-K – Current report

On May 25, 2016 Medivation, Inc. (NASDAQ: MDVN) reported that it urged its stockholders to reject Sanofi’s attempt to replace the company’s entire Board of Directors with hand-picked nominees through a proposed consent solicitation, which Medivation believes is a tactic for Sanofi to facilitate its substantially inadequate and opportunistically-timed proposal to acquire Medivation (Filing, 8-K, Medivation, MAY 25, 2016, View Source [SID:1234512818]). Medivation expects to promptly file consent revocation materials with the U.S. Securities and Exchange Commission.

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On April 29, 2016, the Medivation Board unanimously rejected Sanofi’s unsolicited, non-binding proposal to purchase Medivation for $52.50 per share in cash because it substantially undervalues the company, its leading oncology franchise and its innovative, late-stage pipeline. The Medivation Board reached its conclusion about Sanofi’s proposal based on a thorough analysis of the commercial momentum and outlook of the company’s marketed product, XTANDI; its excellent pipeline of prospects; its track record of successful drug development; and its history of delivering superior returns to stockholders.

David Hung, M.D., Founder, President and Chief Executive Officer of Medivation, said, "Medivation’s experienced Board of Directors has been instrumental in overseeing a strategy that has created a leading oncology franchise, delivered consistently strong financial performance, and positioned the company for future growth through its innovative late-stage pipeline. Under the leadership of its Board of Directors, Medivation has achieved great success and rewarded its stockholders with extraordinary results, delivering total stockholder returns of more than 1,440% since 2009. In contrast, Sanofi has no duty to act in the best interests of Medivation or its stockholders. Its proposal to replace our existing directors with its own hand-picked nominees is simply a tactical maneuver to facilitate a transaction that will transfer value that rightly belongs to Medivation stockholders to Sanofi."

Kim Blickenstaff, Chairman of Medivation’s Board of Directors, said, "Sanofi is seeking to take control of our Board in a clear attempt to circumvent objective deliberations over what course of action is in the best interests of all Medivation stockholders. The unattractive economics of Sanofi’s proposal – which the Board has already determined to be substantially inadequate – have not changed. The Medivation Board remains committed to ensuring that our stockholders retain the ability to benefit from the significant value creation potential of our Company."

Evercore and J.P. Morgan are serving as financial advisors to Medivation, and Wachtell, Lipton, Rosen & Katz and Cooley LLP are acting as legal counsel.