On April 3, 2018 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), and Allogene Therapeutics, Inc. (Allogene), a biotechnology company focused on the rapid advancement of allogeneic CAR T therapies targeting blood cancers and solid tumors, reported that Allogene intends to assume from Pfizer the global strategic collaboration to develop "off-the-shelf" CAR T immunotherapies for oncology (Press release, Cellectis, APR 3, 2018, View Source [SID1234525157]). This agreement was initially formed with Cellectis in June 2014.

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Earlier today, Allogene and Pfizer announced that the two companies have entered into an asset contribution agreement for Pfizer’s allogeneic CAR T-cell therapy portfolio, which includes 16 preclinical assets and UCART19. Subject to certain closing conditions, Allogene will assume the strategic collaboration and license agreement with Cellectis, with exclusive rights to develop and commercialize previously defined allogeneic UCART programs directed at select targets. Cellectis will remain eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets and tiered royalties in the high single digits on net sales of any products that are commercialized by Allogene under the agreement. This new alliance, with Allogene’s dedicated team, is expected to lead to a strong acceleration of CAR T therapies.

Allogene, co-founded and led by former executives of Kite Pharma, is well-positioned to catalyze the next revolution in cell therapy with its leaders’ unrivaled experience in the clinical development of autologous CAR T therapy. Arie Belldegrun M.D., FACS, Founder and former Chairman, President and Chief Executive Officer of Kite, will serve as Executive Chairman of Allogene, and David Chang, M.D., Ph.D., former Executive Vice President, Research and Development and Chief Medical Officer of Kite, will serve as President and Chief Executive Officer of Allogene.

Cellectis’ CAR T platform provides a proprietary, allogeneic approach that uses engineered T-cells from a healthy donor for use in multiple patients. This is distinct from autologous approaches that use a patient’s own T-cells to target tumor cells.

"Allogeneic represents the next transformative step in medicine, as it will potentially allow patients all over the world to quickly receive these potentially life-saving therapies in the most efficient and cost-effective way possible. The last four years of partnership with Pfizer have been very rewarding and productive. Pfizer was among the early adopters of the allogeneic approach, seeing that gene-edited CART programs are the future of immunotherapy to treat cancer. We sincerely thank everyone involved in this collaboration, from the top management to the scientists, for their foresight and their belief in our common portfolio," said Dr. André Choulika, Ph.D., Cellectis’ Chairman & Chief Executive Officer. "We strongly believe Allogene, together with Cellectis, will from the best possible team to continue this collaboration. Our expertise in allogeneic CART and gene-editing combined with the leadership of Drs. Arie Belldegrun and David Chang and their exemplary track record and execution in cell therapy paves the way for the future in off-the-shelf products enhanced by gene editing."

"We have built mutual trust and respect over the years in the CAR T industry and this collaboration will be the starting point for a long-term partnership," said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene. "Our mission at Allogene is to catalyze the next revolution in cancer treatment through the development of allogeneic CAR T therapies directed at blood cancers as well as solid tumors. We believe this collaboration fuels our mission and we look forward to partnering with Cellectis to accelerate the development of allogeneic cell therapies."

On April 3, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the full year ended December 31, 2017 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, APR 3, 2018, View Source [SID1234525156]).

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"During 2017 we made meaningful progress advancing both our clinical and corporate objectives, which has positioned us for continued growth throughout 2018 and beyond," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path. "As we move into 2018, we expect to implement the protocol amendments to our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia, to prepare for a Phase 1 clinical trial of BP1002 in lymphoma, to begin enrollment of a Phase 1 clinical trial of prexigebersen in solid tumors potentially by year-end, and to start a series of IND-enabling studies for BP1003 in pancreatic cancer. We continue to have confidence in the performance and potential of our DNAbilize platform technology to produce exciting drug candidates to help patients with high unmet medical need."

Recent Corporate Highlights

·Reported Pre-Specified Interim Results from Phase 2 Study of Prexigebersen in Combination with LDAC to Treat AML. Of the 17 evaluable patients, four patients achieved complete responses, one patient achieved a leukemia free, one patient had significantly reduced bone marrow blasts and three patients achieved stable disease. In total, 47% of the evaluable patients showed some form of response to the combination treatment, including four patients with complete remission (23%) and four patients with stable disease.

·Published Data in The Lancet Haematology. In March 2018, the Company announced that data from its Phase 1/1b study of prexigebersen (BP1001) as a treatment for hematological malignancies was published in The Lancet Haematology in an article titled, "Liposomal Grb2 antisense oligodeoxynucleotide (BP1001) in patients with refractory or relapsed haematological malignancies: a single-centre, open-label, dose-escalation, phase 1/1b trial."

·Announced Third Drug Candidate, BP1003, for Treatment of Pancreatic Cancer. In November 2017, Bio-Path announced its third drug candidate, BP1003, entered into preclinical development for the treatment of pancreatic cancer. BP1003 targets the Stat3 protein and is currently being studied in patient-derived tumor models. Previous ex vivo tumor studies have shown BP1003 to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments. Bio-Path expects to initiate IND-enabling studies for BP1003 in 2018.

Upcoming Events

·Presentation at the 2018 AACR (Free AACR Whitepaper) Annual Meeting. Bio-Path will present preclinical animal model data at the upcoming AACR (Free AACR Whitepaper) Annual Meeting on Wednesday, April 18, 2018, at the Experimental and Molecular Therapeutics Session, Section 36, from 8:00 a.m. – 12:00 p.m. ET in Chicago. The abstract (#5786) is titled: "Grabbing GRB2: The use of liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies."

Financial Results for the Full Year Ended December 31, 2017

The Company reported a net loss attributable to common stockholders of $8.1 million, or $0.80 per share, for the year ended December 31, 2017, compared to a net loss attributable to common stockholders of $6.8 million, or $0.73 per share, for the year ended December 31, 2016. The increase was primarily due to the deemed dividend related to the warrant conversion in 2017. The per share amounts above have been adjusted to give effect to the 1-for-10 reverse stock split that occurred on February 8, 2018.

Research and development expenses were $5.5 million for both the years ended December 31, 2017 and December 31, 2016.

General and administrative expenses for the year ended December 31, 2017 increased to $3.5 million, compared to $3.0 million for the year ended December 31, 2016. The increase was primarily due to increased legal and audit fees.

As of December 31, 2017, the Company had cash of $6.0 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the year ended December 31, 2017 was $8.0 million compared to $8.1 million for the comparable period in 2016. Net cash used in investing activities for the year ended December 31, 2017 was $0.5 million. Net cash provided by financing activities for the year ended December 31, 2017 was $5.1 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full year 2017 financial results and to provide a general update on the Company. To access the conference call please dial 844-815-4963 (domestic) or 210-229-8838 (international) and refer to the conference ID number 5195559. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On April 3, 2018 AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) reported that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting (Press release, AstraZeneca, APR 3, 2018, View Source [SID1234525155]).

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This is the first regulatory submission for a poly ADP-ribose polymerase (PARP) inhibitor in breast cancer in Europe. If approved, the identification of a patient’s BRCA status could become a critical step in the management of their disease alongside current consideration of their hormone receptor and HER2 status. The MAA includes data from the randomised, open-label, Phase III OlympiAD trial, which investigated Lynparza versus chemotherapy (physician’s choice of capecitabine, eribulin or vinorelbine). In the trial, Lynparza significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression or death by 42% (HR 0.58; 95% CI 0.43-0.80; P=0.0009 median 7.0 vs. 4.2 months).

In January 2018, Lynparza was approved by the US Food and Drug Administration for use in the treatment of BRCA-mutated HER2-negative metastatic breast cancer, becoming the first PARP inhibitor to be approved beyond ovarian cancer. Lynparza is available in nearly 60 countries and has been used to treat more than 20,000 patients. AstraZeneca and MSD are working together to bring Lynparza to more patients across multiple cancers.

On April 3, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, and Gregory K. Chow, Senior Vice President and Chief Financial Officer, will participate at the H.C. Wainwright Annual Global Life Sciences Conference in Monte Carlo, Monaco on Monday, April 9, 2018 at 11:30 a.m. CEST (Press release, Aptose Biosciences, APR 3, 2018, View Source [SID1234525154]):

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Time: 11:30 a.m. CEST
Date: Monday, April 9, 2018
Location: Le Meridien Beach Plaza Hotel, Monte Carlo, Monaco
Live webcast: View Source
The audio webcasts can also be accessed through the Aptose website at www.aptose.com and will be archived shortly after the live event and available for 90 days.

On April 3, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported that it will present new data on Arginase 1 Deficiency patients at the 2018 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics (ACMG) in Charlotte, North Carolina on Thursday, April 12 (Press release, Aeglea BioTherapeutics, APR 3, 2018, View Source [SID1234525152]). The new data will include additional clinical insights on short-term treatment with repeat doses of pegzilarginase, including baseline standardized assessments of neuromotor function. The Company will conduct a clinical update conference call at 8:30 a.m. ET on April 12.

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Title: Weekly Pegzilarginase Produces Marked and Sustained Reductions in Guanidino Compounds in Adults with Arginase 1 Deficiency: Early Phase 1/2 Results

Presenting Author: Roberto Zori, M.D., University of Florida, Gainesville, FL

Poster Number: 803

Presentation Date and Time: Thursday, April 12, 10:00 a.m. to 11:30 a.m. ET

An electronic version of the presentation will be available for download from the Presentations & Events section of the Company’s investor relations website beginning on the day of the their presentation at the 2018 ACMG Annual Clinical Genetics Meeting.

Conference Call & Webcast Details
Aeglea will hold a clinical update conference call on Thursday, April 12, 2018 at 8:30 a.m. ET. To access the live conference call via phone, please dial 1-877-709-8155 (toll free) within the United States, or 1-201-689-8881 internationally. A replay of the call will be available through April 19, 2018 by dialing 1-877-660-6853 within the United States or 1-201-612-7415 internationally. The conference ID is 13678293.

To access the live and archived webcast of the presentation, please visit the Presentations & Events section of the Aeglea BioTherapeutics investor relations website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

About Pegzilarginase (AEB1102) in Arginase 1 Deficiency
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a debilitating urea cycle disorder caused by deficiency of a key arginine metabolizing enzyme that leads to severe and progressive hyperargininemia-related neurological abnormalities, hyperammonemia and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. The Company’s Phase 1 data demonstrated that pegzilarginase reduced blood arginine levels into the normal range, supporting its mechanism of action.