On November 26, 2019 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported that the company has closed on its joint venture agreement with HealthBanks Biotech (USA) Inc., a leading stem cell bank network (Press release, Thermogenesis, NOV 26, 2019, View Source [SID1234551744]). The joint venture, called ImmuneCyte Life Sciences, Inc. ("ImmuneCyte"), has been formed in order to commercialize ThermoGenesis’ proprietary cell processing platform, CAR-TXpress, for use in immune cell banking as well as for cell-based contract development and manufacturing services (CMO/CDMO).

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Under the terms of the previously announced joint venture agreement, ImmuneCyte will initially be owned 80% by HealthBanks Biotech and 20% by ThermoGenesis. In addition to contributing to ImmuneCyte exclusive rights to use ThermoGenesis’ proprietary cell processing technology for the immune cell banking business and non-exclusive rights for other cell-based contract development and manufacturing services, ThermoGenesis has contributed its clinical development assets to ImmuneCyte, divesting these programs in order to focus exclusively on the device business. ImmuneCyte, which is expected to be operational by the end of the fourth quarter of 2019, will be among the first immune cell banks in the U.S. and offer customers the ability to preserve younger, healthier and uncontaminated immune cells for future potential use in dendritic and chimeric antigen receptor (CAR-T) cell therapies, in a GMP compliant processing environment.

"The closing of this joint venture represents an important step in our quest to become a preferred cell processing and manufacturing solution provider in the cell and gene therapy field," said Dr. Chris Xu, Chairman and Chief Executive Officer of ThermoGenesis. "Immunotherapy remains one of the fastest growing research areas with over 800 clinical trials now underway in CAR-T therapy alone. The challenges in developing these therapies are well known, including high manufacturing costs and low patient accessibility. Our CAR-TXpress platform addresses these issues with the ability to increase cell processing efficiency significantly versus traditional, labor-intensive methods. As important, by providing the ability to bank younger, healthier immune cells, ImmuneCyte will help ensure the future benefit of cell and gene therapy to everyone in need."

On November 26, 2019 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, reported that the European Commission has granted Ivozall an European Marketing Authorisation (MA) (Press release, ORPHELIA Pharma, NOV 26, 2019, View Source [SID1234551678]).

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Ivozall is a solution for infusion containing 1 mg/ml of clofarabine and is supplied in 20 ml-vials. Clofarabine is an essential medicine for the treatment of relapsed or refractory Acute Lymphoblastic Leukaemia (ALL) in children. Ivozall will be the first generic form of clofarabine to be authorised under the European centralized procedure.

« This approval is a significant milestone for ORPHELIA Pharma as Ivozall is the first medicine in a series of oncology products we plan to launch. We believe it addresses important pediatric needs and will meaningfully improve children’s care », comments Jeremy Bastid, Chief Development Officer. « We will now focus on launching Ivozall throughout Europe and building relationships with distribution partners to bring Ivozall to patients with ALL ».

« This MA will allow the company to strengthen its product portfolio with this first oncology medicine in which we have great expectations » says Hugues Bienaymé, Founder and General Manager. « We anticipate to make Ivozall available to hospital centres treating ALL patients in some countries from March 2020. Other countries will be handled by ORPHELIA’s distributors, to be selected in the course of 2020 ».

About Acute Lymphoblastic Leukaemia

ALL is a cancer associated with the uncontrolled proliferation of lymphoblasts that invade the bone marrow. The disease progresses rapidly and aggressively and requires immediate treatment. ALL is a rare disease, with around 7,000 people diagnosed each year in Europe. The majority of ALL cases occurs in children. Although rare, ALL is the most common type of childhood cancer. Clofarabine is indicated for the treatment of ALL in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.

On November 26, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN; the "Company" or "Applied DNA") reported that LineaRx, Inc., the Company’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, has signed a definitive agreement with Tyme Technologies, Inc. to supply the Company’s Vita-AssayTM invasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer (the "Agreement") (Press release, Applied DNA Sciences, NOV 26, 2019, View Source [SID1234551695]).

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Under the terms of the Agreement, TYME has the option to purchase from the Company up to 3,000 Vita-Assay kits and associated iCTC analytical and storage services over the course of treatment of up to 250 patients. The potential value of the Agreement is the largest contract to-date for LineaRx, and the largest in the development history of the iCTC assay.

The Company and TYME have previously announced a study demonstrating correlation between the number of iCTCs in a patient’s blood and their disease status, as observed in TYME’s SM-88 Phase II trial for recurrent prostate cancer. The study demonstrated that SM-88 had very encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone was important. The study also showed that reduction of CTCs, an important prognostic indicator, may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88 and other non-hormonal agents.

"We continue to commercialize our Vita-Assay functional iCTC capture assay and iCTC identification technologies, which we recently acquired in August of this year," said Dr. James Hayward, President, Chairman and CEO of Applied DNA. "We are excited to work with TYME to support their important pivotal stage trial for pancreatic cancer and, together with TYME, to potentially compile additional evidence of iCTC-count correlation with cancer disease status and therapeutic efficacy."

Dr. Giuseppe Del Priore, Chief Medical Officer of TYME, stated: "We are impressed by the distinguishing character of the iCTC assay developed by LineaRx; they have a functional assay which directly mimics the behavior of metastatic cells in the body, by capturing iCTCs after they invade a cellular adhesion matrix directly from fresh blood. These live metastatic cells can be counted and characterized by the unique biomarkers from LineaRx. iCTCs can be cultured and analyzed by the latest genomic methods."

Dr. Hayward concluded: "Our contract with TYME, and other recent collaborations not yet announced, will, we believe, help advance our understanding of the metastatic process and the underlying genomic changes that accompany late-stage cancers. We believe that an oral cancer treatment like SM-88 may be used as a monotherapy or in combination therapy across multiple cancers and potentially provide an opportunity to also intervene with genetic immunotherapeutic approaches that may one day be delivered via linear DNA."

On November 26, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that members of Exelixis’ management team will provide an overview of the company at the following investor conferences in December (Press release, Exelixis, NOV 26, 2019, View Source [SID1234551728]):

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Evercore ISI 2nd Annual HealthCONx: Exelixis is scheduled to present at 8:45 AM EST / 5:45 AM PST on Tuesday, December 3, 2019 in Boston.
Piper Jaffray 31st Annual Healthcare Conference: Exelixis is scheduled to present at 10:00 AM EST / 7:00 AM PST on Tuesday, December 3, 2019 in New York.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

On November 26, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported participation in an analyst-led fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 3:00 p.m. Eastern Time in New York, NY (Press release, Alpine Immune Sciences, NOV 26, 2019, View Source [SID1234551679]).

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A live webcast of the fireside chat will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.