Markets React Well to Atossa Genetics (ATOS) Announcing FDA Approval For “Expanded Access”

Atossa Genetics Inc., (NasdaqCM; ATOS) is a Seattle-based clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. ATOS announced on Monday that the FDA has approved an “expanded access” of Atossa’s proprietary oral Endoxifen in the preoperative setting in a U.S. patient awaiting surgery for breast cancer. Under the FDA Expanded Access IND program, the use of Atossa’s proprietary Endoxifen is restricted to this patient only.

The markets reacted positively to this news on Monday as ATOS shot up over 50% and hit a high of $1.85 while trading north of 16.8 million shares or approximately $28-30 million dollars of trading before closing at $1.38.

Note that Atossa is currently conducting a Phase 2 study of its oral Endoxifen in Australia in the “window of opportunity” between diagnosis of breast cancer and surgery.  Steven C. Quay, Ph.D., MD, President and CEO stated. “Once a patient is diagnosed with breast cancer, there is a window of time, typically a few weeks, before surgery is performed. Our goal with this study is to show that our proprietary oral Endoxifen can modify the cancer activity in ER+ breast cancer during this ‘window of opportunity.’ Because our Phase 1 study indicated that our oral Endoxifen reaches therapeutic levels within 8 hours and therapeutic steady-state levels in only seven days, we are optimistic we can achieve a valuable treatment effect.”

The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with ER+ and HER2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa’s proprietary oral Endoxifen for at least 21 days from the time of diagnosis up to the day of surgery. Provided tumor activity reduction is demonstrated in at least two patients, an additional 17 patients will be enrolled for a total of 25. The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67, which is a marker of cellular proliferation. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored. The Phase 2 study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.

Steven C. Quay, Ph.D., MD, President and CEO commented further, “A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic therapy is typically an aromatase inhibitor and a drug for ovarian suppression. The patient’s physician was reluctant to use this preoperative therapy as it typically induces menopause and can have other potentially serious side effects. We worked with the physician to apply to the FDA to provide “expanded access” (formerly known as compassionate use) to this patient under an Investigational New Drug (IND) application. We are very pleased to report that the FDA approved this single-patient study, and the patient is currently receiving our proprietary oral Endoxifen preoperatively. This is the same clinical setting as our Phase 2 ‘window of opportunity’ study of preoperative systemic oral Endoxifen in breast cancer patients which is open for enrollment in Australia.”

Note that expanded access, sometimes called “compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access may be appropriate when all the following apply: patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition; there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; patient enrollment in a clinical trial is not possible; potential patient benefit justifies the potential risks of treatment; providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication. Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects. For more information, see the FDA website: FDA Expanded Use Website

If you found this story interesting you should consider following Atossa Genetics (Nasdaq: ATOS)  please see Atossa the dedicated coverage page at Vista Partners to learn more.

Atossa Genetics Announces FDA Approval of Endoxifen for “Expanded Access” as Preoperative Systemic Endocrine Therapy for a U.S. Breast Cancer Patient

Steven C. Quay, Ph.D., MD, President and CEO commented, “A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic..

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Pfizer Will Raise US Drug Prices in January

Pfizer (PFE)  is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products.

Pfizer has announced its plan to increase U.S. prices on 41 of its medicines this January. The company had pulled back its original prices hikes this summer at the urging of President Trump. This increase would affect about 10 percent of Pfizer’s medicines.

The increase of the medicine prices is not expected to increase the company’s revenue because insurance rebates and pharmacy benefit managers are expected to offset the price hikes. Pfizer is leaving it in the hands of insurers and PBMs to make the cost of drugs more affordable.

It is not known whether other drug companies will follow Pfizer’s lead. Roche, Merck & Co, and Novartis all pledged to not raise their U.S. prices before the end of the year, just as Pfizer had.

To learn more about Pfizer (PFE) and to track its progress please visit the Vista Partners Pfizer Coverage Page.

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Pfizer to raise US drug prices in January after previously backing down

Pfizer Inc said on Friday that it plans to hike U.S. prices on 41 of its medicines in January, after walking back its previous planned price increases this summer under pressure from President Donald Trump. Pfizer said it would raise the list price of most of the drugs by 5 percent, while prices..

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Clinical-stage Biopharmaceutical Company Atossa Announces Q3 Financial & Clinical Program Progress Update

Seattle based Atossa Genetics Inc., (NasdaqCM: ATOS) is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.

Atossa Genetics Inc. (ATOS) today announced third quarter ended September 30, 2018, financial results and provided an update on recent company developments.

Steven C. Quay, Ph.D., MD, President, and CEO commented, “We continue to make great progress with our clinical programs. We successfully achieved all objectives in our Phase 1 study of topical Endoxifen in men and are looking forward to advancing that program into a Phase 2 study to address gynecomastia in men being treated for prostate cancer. We also completed enrollment in the Phase 2 study of our topical Endoxifen to treat mammographic breast density.”

Recent Corporate Developments

Atossa’s important recent developments include the following:

  • October 2018 – Completed enrollment in Phase 2 study of topical Endoxifen to treat mammographic breast density.
  • September 2018 – Reported that all objectives were achieved in our Phase 1 study of topical Endoxifen in men.
  • August 2018 – Contracted with a US-based additional manufacturer of Endoxifen.
  • July 2018 – Announced intraductal microcatheter immunoOncology pre-clinical program.
  • June 2018 – Appointed two additional prominent industry executives from Pfizer and the Belgium-based Flemish Institute of Biotechnology to the strategic advisory board.

Q3 2018 Financial Results

For the three and nine months ended September 30, 2018, and 2017, they had no revenue and no associated cost of revenue.

  • Total operating expenses were approximately $3.3 million and $9.3 million for the three and nine months ended September 30, 2018, respectively, consisting of research and development (R&D) expenses of approximately $1.4 million and $3.4 million, respectively, and general and administrative (G&A) expenses of approximately $1.9 million and $6.0 million, respectively.
  • Total operating expenses were approximately $2.1 million and $5.7 million for the three and nine months ended September 30, 2017, respectively, consisting of R&D expenses of $0.7 million and $2.1 million, respectively, and G&A expense of approximately $1.3 million and $3.5 million, respectively.
  • Total operating expenses for the three and nine months ended September 30, 2018, as compared to the same periods of 2017 increased approximately $1.3 million, or 61%, and increased $3.7 million, or 65%, respectively.
  • As of September 30, 2018, the Company had cash and cash equivalents and restricted cash of $13.0 million and the current market cap is $7.09 million with ATOS stock closing at $1.29/share today up 7.5%.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress please visit the Vista Partners Atossa Genetics’, Coverage Page.

Atossa Genetics Announces Third Quarter 2018 Financial Results And Provides Company Update

SEATTLE, Nov. 13, 2018 — Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast…

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Fate Therapeutics Announces Encouraging Dose-Escalation Clinical Data of FATE-NK100

San Diego-based Fate Therapeutics (Nasdaq: FATE) is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders.

Fate recently announced new clinical data for FATE-NK100, an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy, and provided a regulatory update on the development of FT500, a universal, off-the-shelf NK cell product candidate derived from a master induced pluripotent stem cell (iPSC) line, on November 10, 2018.

Twenty heavily pre-treated subjects, each presenting with progressive disease at the time of enrollment, have been treated with FATE-NK100 in the dose-escalation phases of three Phase 1 clinical trials. As of an October 22, 2018 data cutoff, one-month follow-up data were available on fourteen subjects1, with clinical benefit indicated in seven of these fourteen subjects:

In the DIMENSION study for the treatment of advanced solid tumors (n=5 in the monotherapy regimen; n=1 in the monoclonal antibody combination regimen1), one subject at the second dose level (1-3×107 cells per kg) and two subjects at the third dose level (3-10×107 cells per kg) treated with a single intravenous infusion of FATE-NK100 in the monotherapy regimen had stable disease at one month. These two subjects at the third dose level were each subsequently treated with a second dose of FATE-NK100 and remain on study (3.1 and 5.0 months, respectively) with ongoing disease control. The study is currently enrolling at the third dose level in the monotherapy regimen, at the second dose level in the cetuximab combination regimen (1-3×107 cells per kg) and at the run-in dose level in the trastuzumab combination regimen (1×106 cells per kg).
In the APOLLO study for the treatment of recurrent ovarian cancer (n=4), one subject treated with a single intraperitoneal infusion of FATE-NK100 at the second dose level (1-3×107 cells per kg) had stable disease at one month. The subject was subsequently treated with a second dose of FATE-NK100 and maintained disease control for 6.2 months. The study is currently enrolling at the third dose level (3-10×107 cells per kg).
In the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia (n=4), all three subjects treated with a single intravenous infusion of FATE-NK100 at the second dose level (1-3×107 cells/kg) showed complete clearance of leukemic blasts in the bone marrow and achieved a morphologic leukemia-free state at Day 14 following treatment. Each of these three subjects received a single dose of FATE-NK100 only, and the anti-leukemic response in each of these subjects was transient. The study is currently enrolling at the second dose level.
No dose-limiting toxicities related to FATE-NK100 were reported. One serious adverse event related to FATE-NK100 was reported (Grade 3: abdominal pain) in the APOLLO study.

Sarah Cooley, M.D., Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the lead investigator of the VOYAGE study stated, “The safety and clinical benefit observed with a single infusion of FATE-NK100 as a monotherapy in heavily pre-treated cancer patients, including in refractory AML patients that have high leukemic blast burden in the marrow and in advanced solid tumor patients with progressive disease, are encouraging. We are particularly excited that a repeat dose of FATE-NK100 was well-tolerated and showed persistence. Importantly, all three subjects re-treated with a second dose have demonstrated disease control. These data provide compelling proof-of-concept for FATE-NK100 and support earlier intervention with NK cell therapy using a multi-dose treatment cycle.”

In addition, the Company announced that adventitious agents testing of the master iPSC bank for the clinical production of FT500, a universal, off-the-shelf NK cell product candidate, has been completed. The FT500 master iPSC bank was found to be free of adventitious agents as determined by in vivo and in vitro testing. The Company has submitted these results to the U.S. Food and Drug Administration (FDA) in furtherance of the agency’s review of the Company’s FT500 Investigational New Drug (IND) application. Upon allowance by the FDA of the FT500 IND, the Company plans to initiate Phase 1 clinical testing of FT500 as a monotherapy and in combination with checkpoint inhibitor therapy for the treatment of advanced solid tumors. This first-in-human study is expected to evaluate the safety and tolerability of multiple doses of FT500 in multiple dosing cycles.

An updated presentation on the Company’s NK cell cancer immunotherapy franchise can be found under “Events & Presentations” in the Investors and Media section of the Company’s website at www.fatetherapeutics.com.

Fate Therapeutics Announces Encouraging Dose-Escalation Clinical Data of FATE-NK100 and Provides Regulatory Update on Landmark IND Application for FT500

SAN DIEGO, Nov. 11, 2018 (GLOBE NEWSWIRE) —  Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced new clinical data for FATE-NK100, an investigational, first-in-class..

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CAR-T Pioneer Dr. Grupp Joins Paris Headquartered Cellectis (CLLS)’s CAB

Cellectis S.A. (Euronext Growth: ALCLS; Nasdaq: CLLS), founded in 1999 and headquartered in Paris, France, is a clinical stage biotechnological company, develops and sells immuno-oncology products based on gene-edited T-cells that express chimeric antigen receptors to target and eradicate cancer in France. The company operates through two segments, Therapeutics, and Plants. Its lead product candidate is UCART19, an allogeneic T-cell product candidate for the treatment of CD19 expressing hematologic malignancies, which develop in acute lymphoblastic leukemia (ALL). The company’s products also comprise UCART123 for acute myeloid leukemia indications and blastic plasmacytoid dendritic cell neoplasm; UCARTCS1 for multiple myeloma (MM) indications; UCART22 for ALL; and UCART38 for T-ALL. In addition, it focuses on applying its gene-editing technologies to develop a new generation of plant products in the field of agricultural biotechnology. The company has strategic alliances with Pfizer Inc (PFE); Les Laboratoires Servier SAS; The University of Texas MD Anderson Cancer Center to research and develop novel cellular immunotherapies for patients suffering from various liquid tumors; and Cornell University to accelerate the development of a targeted immunotherapy for patients with acute myeloid leukemia, as well as a partnership agreement with the Wyss Institute for Biologically Inspired Engineering at Harvard University.

Cellectis recently announced that Stephan A. Grupp, MD, Ph.D., a leading pediatric oncologist at Children’s Hospital of Philadelphia and Chief of the Section of Cellular Therapy and Transplant at the Children’s Hospital of Philadelphia (CHOP) joined the Company’s Clinical Advisory Board (CAB).

Dr. Grupp, MD, Ph.D. stated, “Over the course of my career, I have devoted a great deal of attention to both autologous and allogeneic cellular therapies for pediatric cancer patients, and I believe universal CAR-T products can change the paradigm of cancer treatment and address urgent unmet medical needs. I have great hopes that allogeneic CAR-T therapy can open up treatment options for patients who don’t have enough T-cells to undergo an autologous CAR-T therapy, or who live in regions where the technology is not available. My mission throughout my career has been to change the standard of care for pediatric patients who are battling difficult cancers, so joining Cellectis’ CAB presents a unique opportunity to strategically guide and advance the development of these lifesaving therapies.”

Dr. Grupp is a world-renowned pediatric oncologist and cancer researcher who initiated the first pediatric CAR T-cell trial for acute lymphoblastic leukemia at CHOP in 2012. He also delivered CAR T-cell therapy to the first pediatric patient in the world, paving the way for the clinical development of engineered T-cell therapies. Dr. Grupp then led the first multicenter global study of Kymriah®, which became the first CAR-T therapy to receive approval by the U.S. Food and Drug Administration (FDA).  Dr. Grupp is Chief of the Cell Therapy and Transplant Section, Director of the Cancer Immunotherapy Program, Director of Translational Research for the Center for Childhood Cancer Research and Medical Director of the Stem Cell Laboratory at CHOP, as well as an attending physician in the Cancer Center at CHOP, where he has worked for more than two decades. Dr. Grupp completed a pediatric residency at Boston Children’s Hospital, and a pediatric hematology/oncology fellowship at Dana-Farber Cancer Institute and Children’s Hospital. He also completed a research fellowship in immunology at Brigham and Women’s Hospital. Dr. Grupp has published numerous papers on various therapies for the treatment of children with cancers, including CAR T-cell therapies, and has been honored by numerous prestigious organizations for his work, including the American Society of Pediatric Hematology / Oncology and American Pediatric Society.

Dr. André Choulika, Cellectis CEO stated, “Dr. Grupp is one of the true pioneers that have marked the history of CAR T-cell therapies whose decades of work and distinction as a true visionary will continue to shape and inform the future of these transformative therapies in the service of pediatric patients suffering from cancer. His experience in pediatric oncology and groundbreaking work in CAR-T therapy will be an enormous asset for Cellectis’ CAB, and his firm belief in Cellectis’ unique approach lends additional credence to our innovative work developing allogeneic CAR-T therapies.”

Shares of CLLS closed today’s trading at $26.63 up 4.88%

CAR-T Pioneer Dr. Stephan A. Grupp to Join Cellectis Clinical Advisory Board | Cellectis

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Fate Therapeutics Reports Q3 2018 Financial Results & Highlights

Fate Therapeutics (Nasdaq: FATE), headquartered in San Diego, CA, is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders.

Today, Fate reported business highlights and financial results for the third quarter ended September 30, 2018.

Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics stated, “We continue to see strong momentum in the enrollment of our Phase 2 PROTECT study of ProTmune, and an encouraging set of initial clinical data for FATE-NK100 is emerging across the dose-escalation phases of three Phase 1 clinical trials. In addition, we are poised to achieve a significant milestone for Fate Therapeutics as well as the entire cell therapy field, as we continue working with the FDA on the allowance of our landmark IND application for FT500, a first-of-kind, off-the-shelf NK cell product derived from a clonal master iPSC line. At ASH, we plan to share preclinical data across our entire pipeline of off-the-shelf NK cell and CAR T-cell product candidates that demonstrate the unique value in using clonal engineered master iPSC lines as a renewable source for manufacture and delivery of cell-based cancer immunotherapies.”

Fate reported the following regarding its clinical programs:

Exceeded 50% Enrollment in Phase 2 PROTECT Study of ProTmune™.The randomized, controlled and double-blinded Phase 2 PROTECT study of ProTmune is over 50% enrolled. The clinical trial is intended to enroll a total of 60 adult subjects with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Subjects are being randomized, in a 1:1 ratio, to receive either ProTmune or a conventional matched unrelated donor hematopoietic cell graft. New clinical data from the seven subjects receiving ProTmune in the Phase 1 PROTECT study, including data on key secondary endpoints assessing disease-free survival and freedom from chronic graft-versus-host disease (GvHD), cancer relapse, and death at one-year following HCT, will be featured at the 2018 American Society of Hematology (ASH) Annual Meeting in a poster presentation.

20th Subject Treated across Three Phase 1 Studies of FATE-NK100.The twentieth subject has been treated with FATE-NK100, the Company’s first-in-class, donor-derived adaptive memory NK cell cancer immunotherapy, across the dose-escalation phases of three Phase 1 clinical trials. At the Society for Immunotherapy of Cancer (SITC) Annual Meeting, the Company plans to hold an investor event and share new clinical data of FATE-NK100, including safety, persistence and anti-tumor activity, in advanced hematologic malignancies and solid tumors. An oral presentation at the 2018 ASH Annual Meeting will describe a next-generation, GMP-compliant protocol, established by Dr. Karl-Johan Malmberg under the Company’s research collaboration with Oslo University Hospital, that enables robust ex vivo expansion of adaptive memory NK cells having a homogeneous expression of a single inhibitory killer cell immunoglobulin-like receptor (KIR).
Universal Off-the-Shelf Cancer Immunotherapy Preclinical Pipeline

Submitted First-of-Kind IND Application to FDA for FT500. In July, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FT500, a universal, off-the-shelf NK cell product derived from a clonal master induced pluripotent stem cell (iPSC) line. In response to a request by the FDA, the Company is conducting additional adventitious agents testing of the master iPSC bank used for the production of FT500, and intends to submit these test results to the FDA during the fourth quarter of 2018. Upon FDA allowance of the IND, the Company expects to begin clinical investigation of FT500 in combination with FDA-approved checkpoint inhibitors in subjects with advanced solid tumors.

Achieved IND-Enabling Milestone under FT516 CIRM Grant. In September, the Company received a $1.1 million milestone payment under its California Institute for Regenerative Medicine (CIRM) award for the preclinical development of FT516, a universal, off-the-shelf NK cell product candidate derived from a clonal master iPSC line engineered to uniformly express a high-affinity, non-cleavable CD16 Fc receptor. Since CD16 binds to the Fc region of tumor-targeted antibodies, FT516 can be combined with FDA-approved monoclonal antibody therapy to target a broad spectrum of tumor-associated antigens. The Company expects to submit an IND application to the FDA by the end of 2018 for first-in-human clinical investigation of FT516 in combination with CD20 antibody rituximab and with SLAMF7 antibody elotuzumab.
Five Presentations covering iPSC Product Platform Scheduled for ASH. Two oral presentations, including new preclinical data of FT500 in combination with checkpoint inhibitors and initial preclinical data of engineered iPSC-derived NK cells in combination with target-cell specific engagers, were accepted for presentation at the ASH Annual Meeting. Additionally, three poster presentations on other product candidates emerging from the Company’s iPSC product platform, including the Company’s first iPSC-derived chimeric antigen receptor (CAR) T-cell (FT819) and CAR NK cell (FT519) product candidates, are scheduled for presentation.
Corporate Highlights

Entered into iPSC-derived CAR T-cell Collaboration with ONO Pharmaceutical.In September 2018, the Company entered into a Collaboration and Option Agreement with Ono Pharmaceutical Co. Ltd. for the joint development and commercialization of two off-the-shelf, iPSC-derived CAR T-cell product candidates. Fate Therapeutics is entitled to receive up to $70 million during the preclinical option stage of the collaboration. In addition, in connection with the development and commercialization of the product candidates, the Company is eligible to receive up to $1.2 billion in aggregate milestone payments, plus tiered royalties on net sales by Ono.
Extended iPSC Technology Leadership Position to include CRISPR-based Cell Reprogramming. In September, the Company exclusively licensed intellectual property from the J. David Gladstone Institutes that covers the generation of iPSCs using CRISPR-mediated gene activation. This new approach uses CRISPR to induce pluripotency by directly targeting a specific location of the genome and activating endogenous gene expression, and does not rely on established methods of cellular reprogramming that require the transduction of multiple transcription factors.
Completed $144 Million Common Stock Offering. In September, the Company closed an underwritten public offering of 10,648,149 shares of its common stock at a public offering price of $13.50 per share.
Third Quarter 2018 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of September 30, 2018, were $211.2 million compared to $100.9 million as of December 31, 2017. The increase was primarily driven by $134.9 million in net cash proceeds received by the Company from its September 2018 public offering of common stock. These proceeds were offset by the Company’s use of cash to fund operating activities.

Total Revenue: Revenue was $1.0 million for the third quarter of 2018 as well as for the same period in 2017. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.

R&D Expenses: Research and development expenses were $13.6 million for the third quarter of 2018, compared to $8.6 million for the same period in 2017. In the third quarter of 2018, the Company incurred a one-time $1.4 million expense associated with the in-license of intellectual property from the J. David Gladstone Institutes covering the use of CRISPR for cellular reprogramming and iPSC generation. The remaining increase in R&D expenses was primarily attributable to an increase in expenses associated with the clinical development of FATE-NK100 and with the preclinical development of the Company’s iPSC-derived product candidates, including regulatory and manufacturing activities to support the submission of its FT500 IND application, and in employee compensation associated with growth in headcount.

G&A Expenses: General and administrative expenses were $4.1 million for the third quarter of 2018, compared to $2.8 million for the same period in 2017. The increase in G&A expenses was primarily attributable to an increase in advisory fees, including audit and legal fees, and in employee compensation.

Shares Outstanding: Common shares outstanding were 64.5 million as of September 30, 2018, and 52.6 million as of December 31, 2017. Preferred shares outstanding as of September 30, 2018, and December 31, 2017, were 2.8 million, each of which is convertible into five shares of common stock. All preferred shares outstanding are from the Company’s sale and issuance of non-voting Class A convertible preferred stock to Redmile Group, LLC in November 2016.

The Company conducted a conference call today, Thursday, November 1, 2018, at 5:00 p.m. ET to review financial and operating results for the quarter ended September 30, 2018.  The archived webcast is available on the Company’s website: www.fatetherapeutics.com.

Shares of FATE closed today’s trading at $13.61/share up 9.23%.

If you found this story interesting you should consider reading about Seattle-based Atossa Genetics (Nasdaq: ATOS) which is is a clinical-stage drug company developing novel, proprietary therapeutics and delivery methods for breast cancer and other breast conditions. To learn more please see the dedicated coverage page at Vista Partners.

Fate Therapeutics Reports Third Quarter 2018 Financial Results and Highlights Operational Progress

Twenty Subjects Treated across Three Phase 1 Studies of FATE-NK100 Entered into Off-the-Shelf, iPSC-derived CAR-T Cell Collaboration with ONO Pharmaceutical Completed…

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Novartis Purchases Endocyte for $2.1 Billion

Novartis, a Swiss pharmaceutical giant, recently purchased the West Lafayette, Indiana-based company Endocyte. The $2.1 billion acquisition will be a large addition to Novartis’s cancer treatment portfolio.

Endocyte is currently conducting clinical trials for radiopharmaceuticals that have the potential to be used to treat metastatic castration-resistant prostate cancer in men.

Novartis Oncology CEO Liz Barrett stated, “Today’s announcement about the proposed acquisition of Endocyte builds on our growing capability in radiopharmaceuticals, which is expected to be an increasingly important treatment option for patients and a key growth driver for our business.”

The deal is expected to close in the first half of 2019.

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Novartis Is Paying $2.1 Billion for Endocyte, a Company That’s Developing a New Prostate Cancer Treatment

Novartis Is Paying $2.1 Billion for Endocyte, a Company That’s Developing a New Prostate Cancer Treatment..

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Immunotherapy-Chemo Treatment for Breast Cancer Shows Positive Results

New research that studied the effects of a joint immunotherapy and chemo treatment for women battling advanced triple-negative breast cancer has shown positive results. 
 
The study tested the effects of a treatment consisting of Tecentriq, a drug called a checkpoint inhibitor, plus chemo versus treatment with chemo by itself. 
 
902 women were involved in the study and the results show that women who received treatment with Tecentriq and chemo went an average of two additional months without their cancer worsening.
 
While the results are modest, and the cost versus rewards are debatable, they do provide at least a promising start to research into this new treatment method. 
 
While the treatment did not appear to improve survival rates for patients, it did increase the average length of time lived from 15 months for women given only chemo to 25 months for women given chemo plus the new drug.

 

Side effects from the treatment do provide a serious concern, as serious side effects were more prevalent among the women undergoing the immunotherapy-chemo treatment and nearly two times as many dropped treatment due to the side effects when compared to those undergoing chemo alone.

The cost of the treatment is significant; Tencentriq for a month costs $12,500 while the chemo used in the study had a price tag $3,000 per dose plus additional doctors fees.

While the success of the study was small, the research it provided will doubtlessly be useful going forward. Dr. Jennifer Litton, from the MD Anderson Cancer Center, remained optimistic: “We’re really hopeful that we can identify a group of women who can get a much bigger and longer response.”

If you found this story interesting you should consider reading about Seattle-based Atossa Genetics (Nasdaq: ATOS) which is is a clinical-stage drug company developing novel, proprietary therapeutics and delivery methods for breast cancer and other breast conditions. To learn more please see the dedicated coverage page at Vista Partners.

Immunotherapy scores a first win against some breast cancers

For the first time, one of the new immunotherapy drugs has shown promise against breast cancer in a large study that combined it with chemotherapy to treat an aggressive form of the disease. But the benefit for most women was small, raising questions about whether the treatment is worth its high cost and side effects. Results were discussed Saturday at a cancer conference in Munich and published by the New England Journal of Medicine. ..

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Spotlight On Breast Cancer Awareness Month

October, while often associated with pumpkin spice, scary movies, and jack-o-lanterns, is also Breast Cancer Awareness Month – a time when pink ribbons abound and the effort to spread awareness about breast cancer is particularly heightened. Increasing breast cancer awareness is critical to continuing the current research on the latest developments in treatment.

Prevalence

Breast cancer accounts for the second most cancer-related deaths among women, second only to skin cancer. By the end of 2018, it is predicted that 266,000 women will be diagnosed with it. As of 2015, 3.4 million women were dealing with this disease.

Prevention and Detection

Despite its prevalence, there are steps you can take to lower the risk of developing breast cancer.  Some habits can help reduce this risk such as exercising, maintaining a healthy weight, and refraining from smoking and excessive drinking. Detecting breast cancer in its early stages is important, and breast mammography has become an indispensable tool. While recommendations vary, experts agree that regular screening is key to stopping breast cancer early. Doctors suggest women start screening between the ages of 40 and 50 and continue to do this either annually or biennially.

A new tool in cancer detection, tomosynthesis, became available in 2011 and has had better detection than traditional mammography with fewer false alarms. Additionally, ultrasounds can be useful for detecting cancer in women with dense breast tissue.

Treatment

There are several possible treatment plans for patients diagnosed with breast cancer. One of these, called a lumpectomy, includes the surgical removal of cancer in addition to a post-operation radiation therapy plan. While a lumpectomy removes only a small portion of the breast tissue, for patients with more advanced stages of cancer, a mastectomy may be required in which the whole breast is removed. Other treatments include hormone therapy which can be used for cancers that have either estrogen receptors or progesterone receptors. Around 2/3 of cancers have one of these receptors or a receptor called HER2 which allows for treatment with hormone therapy or other medications. Cancers that lack all of the receptors mentioned above are termed “triple-negative” and are usually more aggressive and require more intense treatments, like chemotherapy.
Not only in October, but throughout the year, the medical community continues to search for better and more effective treatment options for breast cancer. Today, more than ever before, doctors are prepared to help patients diagnosed with breast cancer by using the best tools and research available.
If you found this story interesting you should consider reading about Seattle-based Atossa Genetics (Nasdaq: ATOS) which is is a clinical-stage drug company developing novel, proprietary therapeutics and delivery methods for breast cancer and other breast conditions. To learn more please see the dedicated coverage page at Vista Partners.

Breast Cancer Awareness Month: What to know about new breast cancer research

Here’s what to know about the latest developments in breast cancer research…

abcnews.go.com

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Atossa Confirms Completion of Enrollment of Phase 2 Study of Proprietary Topical Endoxifen in Women with MBD

As many as approximately 10 million women in the United States have high mammographic breast density (“MBD”), for which there is no FDA-approved treatment. MBD increases the risk of developing breast cancer.  According to an article on  Imaging Technology News, in 1976, John Wolfe proposed a four-tiered classification of mammographic breast parenchymal patterns, after he had noticed a strong association between parenchymal pattern and breast cancer risk. The more complex (and generally denser) the parenchyma, the higher the risk of subsequent breast cancer. His top category had a breast cancer risk that was 31 times higher than that of his bottom category. Although subsequent analysis concluded that this quoted risk was vastly overstated, experts still considered the density-cancer connection to be valid. In the early 1990s, researchers studying breast density (rather than parenchymal patterns) found that density itself was a predictor of breast cancer risk. This was the basis for the American College of Radiology’s decision to incorporate a four-tiered breast composition rating as part of its Breast Imaging Reporting and Data System (BI-RADS).

Today, Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced that it has completed enrollment in its Phase 2 study of Atossa’s proprietary Topical Endoxifen in women with mammographic breast density or MBD. Although oral tamoxifen is approved to prevent new or recurrent estrogen-receptor positive early-stage breast cancer and to treat metastatic breast cancer patients, it is rarely used in women who have not developed breast cancer who have an increased risk of developing breast cancer. Tamoxifen can have side effects that are difficult to tolerate and it has the risk of more serious side effects such as blood clots and strokes.

This double-blinded, placebo-controlled Phase 2 study is being conducted at Stockholm South General Hospital in Sweden. The study is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. “We are very pleased with the speed at which the study has fully enrolled 90 participants in under 6 weeks,” commented Dr. Hall. “This fast enrollment is a testament to the hard work and superlative service of my dedicated staff and the positive experience patients have had with this novel topical drug,” continued Dr. Hall.

The primary endpoint of the study is to determine if daily Topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants were randomized to one of three groups (one placebo group and two groups of different strengths of Topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future a Phase 3 study.

Steve Quay, MD, Ph.D., CEO and President of Atossa, commented, “We are thrilled with Dr. Hall’s and his team’s work on our lead Endoxifen program and the rapid progress at his clinic. Quick enrollment in clinical trials can be a good indicator that there is a strong demand for a therapy in an underserved market.”

 

 

 

 

 

 

Summary of Atossa’s Clinical Pipeline

Atossa has two development programs: Endoxifen (topical and oral forms) and a program for the targeted delivery of drugs and immunotherapies via its proprietary intraductal microcatheters to treat early breast cancer.

Atossa’s Endoxifen program consists of clinical studies to address the three segments of the Breast Cancer Continuum as well as gynecomastia, and include:

  1. Phase 2 study to determine if Oral Endoxifen reduces tumor activity in early stage breast cancer patients in the “window of opportunity” between the diagnosis of breast cancer and surgery (now open for enrollment in Australia)
  2. Phase 2 study to determine if Topical Endoxifen reduces MBD (enrollment completed in Sweden) A completed Phase 1 study of Topical Endoxifen in men that supports further development in men with gynecomastia induced by androgen deprivation therapy
  3. Phase 2 study of Topical Endoxifen to treat gynecomastia in men being treated with androgen deprivation therapy for prostate cancer (retaining CRO in Q4 2018)
  4. Phase 2 study of Oral Endoxifen for patients who are not benefiting from (meaning they are “refractory”) Tamoxifen (retaining CRO in Q4 2018)Atossa’s Proprietary Topical Endoxifen

Atossa is developing its proprietary Topical Endoxifen to treat or prevent breast health conditions in both men and women. For women, the proprietary Topical Endoxifen is being developed to treat MBD. Legislation that has been recently enacted in over 30 states requires that women be notified if they have MBD and those notifications typically state that women with MBD have a higher risk of developing breast cancer, and that mammography may not be as effective in detecting breast cancer because the MBD can “mask” the detection of cancers.

For men, Atossa is developing Topical Endoxifen to prevent a condition called gynecomastia, for which there is no FDA-approved pharmaceutical. Gynecomastia is male breast enlargement and accompanying pain, which according to the Mayo Clinic affects 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer, anti-anxiety medications, cancer treatments (chemotherapy), and some heart medications. Subject to further clinical studies and regulatory approval, Topical Endoxifen could fill a significant unmet medical need in reducing gynecomastia in men taking androgen deprivation therapy to treat prostate cancer.

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Atossa Genetics Completes Enrollment in Phase 2 Study of Topical Endoxifen in Women with Mammographic Breast Density

Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, has completed enrollment in its Phase 2 study of Atossa’s proprietary Topical Endoxifen in women with mammographic breast density..

finance.yahoo.com

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