Gamida Cell reports positive cancer drug trial

The company is preparing for an IPO next year, after recently raising money at a $160 million company value.

A few weeks after Dr. Julian Adams was appointed chairperson and CEO of cancer treatment company Gamida Cell, the company published the results of its Phase I/II clinical trial for its NiCord product. The leading shareholders in the company are Clal Biotechnology Industries Ltd. (TASE: CBI), and Elbit Medical Technologies Ltd. (TASE:EMTC), each of which has an 18% stake. Clal Biotechnology’s market cap is NIS 521 million, and Elbit Medical’s is NIS 262 million.

Although the trial included only 36 patients, it is considered important in this sector, because Gamida is on a fast track for approval by the US Food and Drug Administration (FDA), which significantly reduces the number of trials required in order to reach the market (provided that the trials are successful, of course). Gamida Cell has developed a method for improving the density of stem cells in a blood sample in a way designed to bolster the effectiveness of treatment that utilizes implants of these stem cells. NiCord is a product based on upgrading the density of umbilical blood units designated for implants in the treatment of blood cancer.

Shortening the engraftment time

The principle measure for the trial was how long it took to engraft the cells. The cells in the trial were engrafted within 21 days, while the scientific literature reported twice as much time for engraftment of umbilical blood that did not undergo the treatment. The engraftment time is the same as for bone marrow implants, which is the usual alternative treatment if a donor is found (usually, however, no donor is found).

In the first year following the implant, only 9.8% of the patients suffered from moderate or severe chronic graft vs. host disease (cGvHD) (the figures from medical literature mention 15%), and during 100 days after the implant, 20.2% of the patients experienced grade 2-3 bacterial or grade 3 fungal infections, a figure regarding as compliant with the safety rules.

Gamida Cell is already conducting a Phase III trial of the product, and expects results in 2019. The company wants to hold an IPO in 2018, and hopes that the results from the smaller trial will help it in this task. Several months ago, the company raised $40 million at a company value of $160 million, after money.

In recent days, Gamida Cell also presented results from a number of preclinical trials indicating that the NAM technology it is developing, which makes it possible to enrich blood cells taken from the patient, could be relevant to improving the effectiveness of natural killer cells in immunotherapy for various types of cancer. The company has begun a clinical trial in this area.

Published by Globes [online], Israel Business News – www.globes-online.com – on December 13, 2017