BONE TISSUE GROWN OUTSIDE THE BODY TRANSPLANTED INTO ARM

The success of this experimental treatment may lead humanity to a new era in which it will be possible to achieve full recovery in most cases.

For the first time in the world, live human bone tissue that was grown outside the body has been successfully transplanted into a person’s arm, thanks to a still-experimental procedure developed by an Israeli company.

Because of the importance of the announcement, the Tel Aviv Stock Exchange halted fixed trade in the company’s stock for 15 minutes; sales resumed at 10:05 a.m., when its price rose by 13%.

The transplant was carried out by injection at Afula’s Emek Medical Center, as part of a clinical trial of the BioGroup Bonus company.

Dr. Shai Mertzky, CEO of BioGroup Bonus, noted that “transplantation of human bone tissue into a patient who has suffered a major critical deficiency in the bone of his arm sets a new standard of hope for rapid healing in a wide variety of cases. This was the only solution for the patient when nothing else helped.

“The success of this experimental treatment may lead humanity to a new era in which it will be possible to achieve full recovery in most cases,” he said.

BioGroup is a Haifa-based biotech company specializing in tissue engineering and developing a unique technology for the implantation of human bone grafts for transplantation in humans.

The live implant of human bone was produced in the company’s production laboratory in Haifa, under sterile and controlled conditions. It simulated the conditions required for bone production in the human body within two weeks after a fat tissue sample was taken from the patient.

The first patient is an Israeli man in his 40s who, as a result of a serious car accident several years ago, suffered significant bone loss in his arm. Before this transplant, the patient had undergone several operations in which the missing bone could not be replaced, and the possibility of cutting off part of his forearm had been considered.

Israeli system id’s the gene mutations driving your cancer

NovellusDx analyzes each patient’s genome sequence to deliver actionable intelligence to oncologists, helping them choose the right cancer therapy.

Inside the NovellusDx lab in the Jerusalem Bio-Park, a team of 35 biologists, engineers, mathematicians and physicians recreates the genetic maps of real human individuals with cancer.

It’s not a research project but a personalized medical tool.

The NovellusDx team analyzes the cancer-driving mutations in each patient’s DNA to deliver actionable intelligence to oncologists, helping them choose the right cancer therapy for each and every one.

NovellusDx CEO Haim Gil-Ad explains that although genomic sequencing already is starting to be performed for cancer patients and is likely to become standard, sequencing can reveal tens or even hundreds of mutations but cannot annotate the exact eight to 12 driver mutations that are actually enabling the tumor to grow.

The Israeli company is filling this gap in knowledge.

“Every patient is different,” Gil-Ad tells ISRAEL21c. “Two 35-year-old women with breast cancer, living in the same place and having similar physical features, will have totally different oncogenic maps.”

NovellusDx uses genomic data sent to its lab by email – no actual patient samples are needed – to recreate the individual’s genetic map on a unique biochip.

The company’s proprietary technology measures the activity of signaling pathways to assess the oncogenic action of known and unknown mutations and their response to cancer drugs. It also provides a hierarchy of driver mutations and mutation “cross-talk.”

Projects with major cancer centers

Founded in 2011 and in operation since May 2012, NovellusDx is working with oncologists in about 20 prominent cancer medical centers, mainly in the United States, including MD Anderson in Texas, Memorial Sloan-Kettering in New York and Massachusetts General.

“If the oncologist has a dilemma of which mutation to target first, NovellusDx can find the right target and you can try different types of drugs on a single mutation to see which gives the best results,” says Dr. Nir Peled, medical adviser for NovellusDx and head of the Thoracic Cancer Unit and the Center for Precision Cancer Care at the Davidoff Cancer Center of Rabin Medical Center in Petah Tikva.

“The platform annotates known and unknown mutations, prioritizes between different genes and classifies the effect of different drugs for the same target. I’m not aware of any other specific platform with the ability to do this in one place in a certified lab within a week,” says Peled, who also heads the Thoracic Oncology Assembly of the European Respiratory Society.

“I am using the platform under a clinical study, and it may support some decisions,” he tells ISRAEL21c.

Sample web page that is part of a dynamic physician report of his patient’s oncogenic map. Image courtesy of NovellusDx

The company also has several projects ongoing with diagnostics and biopharma companies. The NovellusDx solution helps them identify expanded subgroups of cancer patients who are likely to respond to existing therapies, stratify patients to enable more focused and efficient trials and isolate new mutations to target.

“We have also established an exciting collaboration with the Institute Curie’s SHIVA trial, where we demonstrated our ability to clinically predict response,” says Gil-Ad, referring to the French research institute’s groundbreaking personalized medicine project to genetically map hundreds of patients’ malignant tumors.

A paper on this collaboration is soon to be published in a scientific journal.

Scaling up

In its current facility on the campus of Hadassah Ein-Kerem Medical Center, NovellusDx can perform 6,000 tests per year, each taking less than two weeks.

The company is starting a new financing round to boost its commercialization and build facilities in the United States, Europe and Asia. Its previous $16.5 million funding round in 2015 was led by OrbiMed, Pontifax, Intercure and several institutional investors.

“Our major issue now is scaling up,” says Gil-Ad, who retired from the Ministry of Defense 12 years ago.

Gil-Ad tells ISRAEL21c that his defense background was unexpectedly relevant to his current work.

“Both the life-sciences and defense industries demand a ‘system of systems’ approach and are highly regulated, which gives some advantages over competitors. And in both areas you save lives,” he points out.

The scientist who had the idea behind NovellusDx’s core technology first approached Gil-Ad because he thought it would be useful for the air force.

Instead, Gil-Ad saw a more global potential. “I saw there was an unmet need in cancer and I built the company around the technology