On February 13, 2019 Achilles Therapeutics ("Achilles"), a biopharmaceutical company developing personalised cancer immunotherapies, reported the approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its Clinical Trial Application (CTA) to conduct a Phase I/II study using clonal neoantigen targeting T cells (cNeT) in patients with metastatic or recurrent melanoma (Press release, Achilles Therapeutics, FEB 13, 2019, View Source [SID1234533294]). The study is expected to enrol the first patient later in 2019.

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"To have received our second CTA approval in as many weeks is highly encouraging," said Dr Iraj Ali, CEO of Achilles Therapeutics. "We look forward to bringing this potentially transformative treatment option into the clinic later this year."

Professor James Larkin, Consultant Medical Oncologist at The Royal Marsden and Reader at the Institute of Cancer Research, said: "The Achilles approach to leveraging the leading science in tumour evolution to tackling solid tumours using cNeT has the potential to change the immune-oncology space and bring life-changing treatment options to patients. We look forward to the start of clinical development."

Achilles is developing personalised T cell therapies for solid tumours targeting clonal neoantigens: protein markers unique to each patient that are present on the surface of all cancer cells. Using its PELEUS bioinformatics platform, Achilles can identify clonal neoantigens from each patient’s unique tumour profile which are present on every cancer cell. Achilles uses its proprietary process to manufacture T cells (cNeT) which exquisitely target a specific set of clonal neoantigens in each patient. Targeting multiple clonal neoantigens that are present on all cancer cells, but not on healthy cells, reduces the risk that new mutations can induce immune evasion and therapeutic resistance, and allows individualised treatments to target and destroy tumours without harming healthy tissue.

On February 13, 2019 Cartherics Pty Ltd ("Cartherics") and panCELLa Inc. ("panCELLa") are pleased to announce their collaboration to research, develop and commercialize products for the treatment of cancer and other debilitating diseases using cell therapy (Press release, Cartherics, FEB 13, 2019, View Source [SID1234553814]). panCELLa will integrate their exclusive FailSafeTM technology into Cartherics’ proprietary homozygous HLA haplotype cells to bring the power of safe cell therapy to a greater number of patients.

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"This technology is an important step to ensure the safety of the next generation of very effective gene-edited stem cell-derived immunotherapies," said Prof. Alan Trounson, CEO Cartherics.

Leveraging the science recently published in "Linking a cell division and a suicide gene to define and improve cell therapy safety" in the November 21st 2018 issue of Nature, panCELLa will maximize the safety level of Cartherics unique therapeutic cancer-killing cells (CAR-T Cells) by building in a molecular kill-switch among the genes of the cells, enabling the efficient elimination of dangerously dividing or rogue cells.

"We anticipate that this partnership will provide for the highest level of cell therapy safety," stated Dr. Andras Nagy, President and CSO of panCELLa. "We are pleased to partner with Cartherics to address the needs of immunotherapy treated cancer patients and to generate a FailSafe cell source for cell therapies in regenerative medicine. It is our mission to provide off-the-shelf universally safe cell therapies for all humankind."

On February 13, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, reported that results of five preclinical study supporting the differentiated profile of AsiDNA, its first-in-class DNA Damage Response (DDR) inhibitor, including insights into the compound’s unique mechanism of action, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held March 29 – April 3, 2019, in Atlanta, GA, USA (Press release, Onxeo, FEB 13, 2019, View Source [SID1234533278]).

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Françoise Bono, PhD, Chief Scientific Officer, commented: "We are thrilled to have had five AsiDNA-related abstracts accepted for presentation at this prestigious meeting of oncology, including 2 abstracts resulting from our long-standing collaboration with Institut Curie, an internationally recognized research institution. The study to be presented notably support the absence of the emergence of resistance to AsiDNA after repeated treatments and the abrogation of acquired resistance to PARP inhibitors when administered in combination with AsiDNA, two properties that make AsiDNA so distinctive and sustain its promising potential for future utilization in clinic. New data also provide valuable insights into the underlying mechanisms supporting these unique outcomes and their potential benefits in oncology. Furthermore, we have identified predictive biomarkers of sensitivity to AsiDNA, a strong advantage to optimize its clinical development and which could, ultimately, open the way to personalized medicine with AsiDNA. Lastly, these results expand the solid preclinical package on AsiDNA, further support the strong rationale for its ongoing development in the clinical setting and confirm its interest and its value in our company portfolio."

Titles of the five abstracts to be presented during poster sessions are:

AsiDNA, a targeted therapy with no acquired resistance
AsiDNA abrogates acquired resistance to PARP inhibitors
Molecular analysis of the mechanism of action of AsiDNA brings new clues on DNA damage response regulation
Development of a biomarker-driven patient selection strategy for AsiDNA treatment (in collaboration with Institut Curie)
AsiDNA, a novel DNA repair inhibitor to sensitize aggressive medulloblastoma subtypes (Institut Curie)
Details on the date, time and location of the sessions during the congress will be provided when available.

On February 13, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that Dr. Amit Kumar, its President and CEO, will be presenting on a panel discussion at Moffitt Cancer Center’s 13th Annual Business of Biotech Conference being held on February 22, 2019 (Press release, Anixa Biosciences, FEB 13, 2019, View Source [SID1234533295]). The panel titled, "Navigating FDA Approvals for Cell Therapy" will focus on regulatory aspects of developing CAR-T and other cell therapies.

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In addition to Dr. Kumar, other participants on the panel will include executives from Atara Biotherapeutics, Inc., Intellia Therapeutics, Inc., and Iovance Biotherapeutics, Inc.

The Business of Biotech Conference is an annual event held by Moffitt Cancer Center that brings together investors and experts from academia and industry interested in learning about the most advanced technologies in cancer research. For those interested in attending, please review the agenda and register here: View Source

Dr. Kumar stated, "I am pleased to be attending and presenting at this conference. Moffitt Cancer Center is one of the top cancer centers in the world and a critical partner for Anixa. I am also pleased to be participating with colleagues from other leading CAR-T and cell therapy companies."

On February 13, 2019 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of "Quality, Affordable Self-care Products", reported that it will release its fourth quarter and calendar year 2018 financial results on Wednesday, February 27, 2019 (Press release, Perrigo Company, FEB 13, 2019, View Source [SID1234533279]). The Company will host a conference call beginning at 4:30 p.m. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 0121144. A taped replay of the call will be available beginning at approximately 7:00 p.m. (EST) Wednesday, February 27, 2019, until midnight March 6, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10128203.