Tag: Cellectis (CLLS)

Immunotherapy and some other results from ESMO 2018

Immunotherapy and some other results from ESMO 2018

IMMUNOTHERAPY  The Checkpoint Inhibitors The most revered news was the discovery of the checkpoint proteins on the surface of the immune system cells. The checkpoint proteins’ natural job is to put a break on the immune system cells to prevent them from attacking people’s own body cells. An immune attack on host cells can lead to disabling and life-threatening autoimmune diseases. Long before the scientists …
Following the Stars. Less Science and More Logic

Following the Stars. Less Science and More Logic

Prohost Letter #424 Following the Stars Less Science and More Logic We reiterate that while a human star is born every once in a while on Earth, several stars born daily in research labs may be designated every other day by the FDA and other health regulatory agencies around the world. These agencies call these potential stars’ breakthrough drugs, but not all the molecules designated …
Victims of fear and misunderstanding

Victims of fear and misunderstanding

ProhostLetter #423 TOMORROW’S THERAPEUTICS TODAY For a more or less fair evaluation of biotechnology and pharmaceutical firms, analysts currently rely for their assessment on criteria that include quarterly financial results, products’ sales revenues, and year over year growth of each and every marketed therapeutic. When it comes to clinical-stage firms, the logic implies that these criteria cannot be relied on for evaluation, as most of …
Stories about research, clinical trials results and an FDA ruling

Stories about research, clinical trials results and an FDA ruling

The Week in Review #26 IN THE BIOTECH WORLD - RESEARCH - IMPROVING CRISPR GENE EDITING The problem cited with gene editing is that the editing may stay switched on after it succeeded in reaching its goals. To prevent further unwarranted mutations, scientists from the Bath and Cardiff University have invented a switch that aims at controlling protein expression in cultured cells and mouse embryos with the …
AveXis Drug’s Data for Spinal Muscular Atrophy Highlights Gene Therapy

AveXis Drug’s Data for Spinal Muscular Atrophy Highlights Gene Therapy

The Week in Review #21 Part 2 THE  MARKET (2) - Our remarks in the past Week in Review included our confidence that the attempts by negative investors to drive the market crazy will not deprive the market from its innate capability to sense and react to the authentic factors it usually reacts to . . . This content is for paid subscribers. Please click here to …
Yes, the Biotech Evolution is Speeding. See Also: Allogene Therapeutics, Pfizer and Cellectis

Yes, the Biotech Evolution is Speeding. See Also: Allogene Therapeutics, Pfizer and Cellectis

THE BIOTECH EVOLUTION: AN UNPARALLELED SPEED The Tremendous Regret Investors Will Feel If They Sell the Best of the Best Biotechnology Firms Only Because the Market Is Weird   Even if one is scared and feels he should sell shares, he must be wise enough to select those stocks whose prices are closer to reaching the targets he estimated as representing their fair values. Biotech investors who lend their ears to …
Highlighting Gene Editing Firms

Highlighting Gene Editing Firms

The Week in Review #19 Targeting the Root-­Cause of Diseases - Investing in the Future is Currently the Best Way - Stopping aberrant genes from causing diseases has taken time to move from wishful thinking to reality. Through trial and error, various different approaches have been tested over the years, including attempts at genetic engineering... &nbsp . . . This content is for paid subscribers. …
Private Lessons and More

Private Lessons and More

Prohost Letter #417 Private Lessons - These lessons are overdue and we had to do this homework before we go into further evaluations of our picks and introduction of new companies as we promised in the past issue. We believe that the Prohost readers, the fans and the critics should know how and why we pick our biotech stocks . . . This content is …
Cellectis: Offering Proof of Concept is What Led to the Stock Rally

Cellectis: Offering Proof of Concept is What Led to the Stock Rally

UCART19 UCART19 is one of the Cellectis’ (CLLS) lead allogeneic anti-CD19 CAR T-cell products. The word allogeneic is important as it makes the difference between Cellectis’ CAR T products and the two approved chimeric antigen receptor (CAR T) products and some of the investigational CAR T immuno-oncology products. Except for Cellectis’ and a few other  biotechs including  Celyad’s (CYAD)  products all other CAR T treatments are non-allogeneic (autologous) treatments. Being allogeneic, Cellectis’ products …
Gilead’s New Acquisition: An Important Step Forward Toward Building a Superior Cancer Franchise

Gilead’s New Acquisition: An Important Step Forward Toward Building a Superior Cancer Franchise

Gilead Sciences (GILD) has unsurprisingly agreed to acquire Cell Design Labs in a structured buy out valued for up to $567 million, including the shares of Cell Design Labs held by Kite, the CAR T firm that Gilead has recently acquired. Brian Atwood, President and CEO of Cell Design Labs, Inc., said, “Bringing our robust technology platforms under the Gilead umbrella, with its outstanding research …
The Week in Review #11

The Week in Review #11

The Week in Review #11 A New Era - Faster than the speed of light, the management of diseases is shifting from fast improvement to a total gigantic unprecedented change. Some of the conquering approaches towards providing long-­lasting cures look as if the outcome of magic rather than mere science . . . This content is for paid subscribers. Please click here to subscribe or here to log …
The FDA New Guidelines to Speed the Approval of Gene Therapy. See Also: The Gene Editing Effect

The FDA New Guidelines to Speed the Approval of Gene Therapy. See Also: The Gene Editing Effect

Important news has come from the FDA, which issued new guidelines to speed the introduction of treatments with human cells and tissues, including gene therapy. Cracking down on rogue clinics offering dangerous or unproven versions of gene therapy or stem cell therapy is also included in the report. Scott Gottlieb, the commissioner of the FDA stated that regenerative medicine and other important gene therapy treatments …
Cellectis Allogeneic “Off-the-Shelf” CAR T Candidate is Back in Clinical Trial

Cellectis Allogeneic “Off-the-Shelf” CAR T Candidate is Back in Clinical Trial

A couple of days ago, Cellectis (CLLS), which uses its own proprietary gene editing technology known as “transcription activator-like effector nuclease (TALEN®)” in developing immunotherapies, received the following good news: The FDA has lifted the clinical hold, which the Agency has put on Phase 1 trials of Cellectis’ UCART123 product candidate.       The Story In February 2017, Cellectis received an Investigational New Drug (IND) approval …
Gilead’s CAR T Drug, Yescarta, is Approved for NHL Resisting Previous Treatments

Gilead’s CAR T Drug, Yescarta, is Approved for NHL Resisting Previous Treatments

As expected by those who welcome good news from publicly-traded firms, the Food and Drug Administration (FDA) has given the green light to a second CART immuno-oncology product with the trade name Yescarta.  This drug, which has been developed by Kite Pharma is now belonging to Gilead Sciences (GILD) together with the rest of Kite’s CAR T wealthy pipeline after Gilead acquired Kite less than …
New Breakthrough Immuno-Oncology Products

New Breakthrough Immuno-Oncology Products

The Week in Review #7 A lot more happened in the past week regarding improving the treatment of cancer and of other devastating diseases. This issue contains discoveries that aim at improving breakthrough immuno-­oncology treatment outcomes. Here are some of the breakthrough technologies and treatments that might improve, by-­far, the management of cancer . . . This content is for paid subscribers. Please click here to …
Circumventing Cellectis’ UCART123 Severe Adverse Effects

Circumventing Cellectis’ UCART123 Severe Adverse Effects

In the news, the FDA has placed a clinical hold on two phase 1 trials of Cellectis’ (CLLS) off- the-shelf product UCART123 after the death of a 78-year old patient. Cellectis is working with the FDA towards finding ways that help mitigate the risks expected to have caused the fatality. We experienced deaths with other CAR T products with the cytokine release syndrome on the …
Bluebird Flies Sky-High with Its CAR-T Wings

Bluebird Flies Sky-High with Its CAR-T Wings

AT ASCO CAR-T Was Created to Stay BlueBird Bio CAR-T Results Bluebird Bio (BLUE) presentation was well received at ASCO after the firm stated results demonstrating that all the 15 evaluable patients in the clinical trial of its chimeric antigen receptor T cell (CAR-T) drug “bb2121 responded to treatment. Data were convincing demonstrating 89% of the patients observed their tumors shrink with 27% seeing their …
CAR-T Great News and About the Biotech Sector in General

CAR-T Great News and About the Biotech Sector in General

It is obvious that the CAR-T approach to cancer treatment is here to stay and to change the way cancer has been managed for decades. Attempts to improve the novel elegant procedure safety profile and efficacy on solid cancers are being pursued by academia as well as by biotechnology and pharmaceutical companies. Kite Pharma’s (KITE) CAR-T therapy axicabtagene ciloleucel is an investigational therapy in which …