Orthofix Medical Inc. and SeaSpine Holdings Corporation announced the successful completion of their previously announced merger of equals following the approval of each company’s stockholders at respective special meetings of stockholders held today. Of votes cast, 99% of SeaSpine common shares were voted in approval of the merger, and 98% of Orthofix common shares were voted in approval of the merger.

The merger will officially become effective as of 12:01 a.m. Eastern Standard Time on January 5, 2023, at which time, under the terms of the merger, a wholly-owned subsidiary of Orthofix will merge with and into SeaSpine, with SeaSpine continuing as the surviving company and a wholly-owned subsidiary of Orthofix. SeaSpine shares will cease trading on the Nasdaq Global Select Market at 8:00 p.m. Eastern Standard Time today, and holders of SeaSpine common stock will receive 0.4163 shares of Orthofix common stock for each share of SeaSpine common stock owned. Orthofix, as the corporate parent entity in the combined company structure, will continue to trade on NASDAQ under the symbol “OFIX.” The combined company will be renamed at a later date and until then will continue to be known as Orthofix Medical Inc.

The combined Orthofix is a leading global spine and orthopedics company with a complementary portfolio of biologics, innovative spinal hardware solutions, market-leading bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. The Company has approximately 1,600 employees, products distributed in 68 countries world-wide, and a global R&D, commercial and manufacturing footprint.

“The completion of this merger catalyzes our ambition to be an industry leader in spine and orthopedics,” said Keith Valentine, President and CEO of Orthofix effective as of the closing. “I’m privileged to lead this talented team and excited for all of the opportunities that lie ahead. Together we are stronger and better positioned to deliver innovative, quality-driven solutions for surgeons in their work to improve patients’ lives.”

Jon Serbousek, Executive Chairman of the combined company’s Board of Directors, said, “With broad, differentiated technologies, extensive commercial reach and a strong financial profile, we expect our combined company to drive meaningful market share gains, sustainable growth and value creation. We look forward to setting new standards of innovation and delivering on the many benefits we expect to provide for our shareholders, surgeons and employees.”

A technique created by Karolinska Institutet researchers should be able to forecast whether a breast cancer patient will benefit from a specific treatment or not. According to a study that was published in PNAS, the cell-based approach has been tried on patients and has shown encouraging outcomes.

There are currently few options for anticipating which breast cancer patients will respond best to various treatments. With the use of this technology, it is possible to forecast how patients will react to specific medicines, reducing the risk of unneeded side effects and lowering expenditures. They find that the concept works, but larger confirmatory investigations are required, says professor at the Department of Oncology-Pathology, Karolinska Institutet, and corresponding author of the study, Johan Hartman.

The therapy of breast cancer at the moment includes a wide range of drugs. However, because the illness is so complicated, not all people benefit from the same medications. Through, for instance, DNA sequencing, it is possible to learn a little bit about the type of treatment that will be most beneficial for a patient. Better approaches are therefore required to forecast how patients will react to therapy because it is frequently impossible to say whether a medication will benefit a specific patient or not.

The technique created by KI researchers is based on extracting and growing not only tumour cells but also so-called supportive cells from breast cancer patients. The sensitivity of the grown cells to the various concentrations of the cancer treatments is next examined.

Tumor-like cell models derived from patients

In the current study, the researchers demonstrate that this form of cell-based tumour model can be created from breast tumours and that the cell models are relevantly comparable to the patients’ primary tumours, including biologically and in terms of many protein markers.

The biopsies of 98 patients who had undergone surgery for breast cancer were used to produce the tumour models. They underwent testing with more than 35 breast cancer medications, both those in use and those in development. The researchers could then see that, in some cases, the tumour models were sensitive to the drugs that were in the process of being developed and that the drug responsiveness the tumour models showcased was very much in line with current information concerning treatment options based on patient tumour types.

The researchers then looked at how well the technique could predict treatment outcomes. At Södersjukhuset in Stockholm, a validation study was conducted on 15 breast cancer patients who had undergone treatment prior to surgery, or neoadjuvant treatment.

The researchers developed tumour models for each patient using biopsies taken before surgery and subjected the models to the same medications as the patients. The models’ pharmacological sensitivity was then contrasted with the way patients responded to treatment.

High precision

The findings demonstrate that the therapeutic responses suggested by the tumour model and those that the patient subsequently displayed were largely consistent. In contrast, four of the four patients who were treated and evaluated for anti-HER2 monoclonal antibody medications demonstrated consistency. For instance, the model predicted the therapeutic efficacy of the chemotherapy agent epirubicin with 90% accuracy.

The researchers point out that tiny tumours, which are sometimes thought to be difficult to collect without endangering diagnostics, can also be used to generate cell models, and that the tests can be completed quite quickly.

This procedure can be used in routine clinical practise since, in the majority of situations, one can do personalised drug testing and receive the results in less than ten days. However, it can also be applied to research and drug development, according to the study’s first author, Xinsong Chen, a research specialist at the Karolinska Institutet’s Department of Oncology-Pathology.

The technology will then be tested on a wider sample of patients, and its potential to be combined with other molecular techniques will be looked at in order to improve therapy response prediction and research resistance mechanisms.

The Swedish Breast Cancer Association,The Swedish Cancer Society, Region Stockholm, the research funds at Radiumhemmet, as well as the Swedish Research Council all contributed to the study’s funding.

The NHS has released encouraging statistics regarding cancer rates in the UK to kick off the new year. Over the past year, more patients than ever before the pandemic received essential NHS cancer treatments. Furthermore, the number of people who received life-saving NHS cancer checks increased, with over 2.8 million people seen, up by almost one-fifth from the same period prior to the pandemic (2.35 million in 2018–19). Over 10,000 checks are performed daily, with about 6% of them leading to a cancer diagnosis.

NHS staff have been functioning extraordinarily hard over the past year to recover from the pandemic, said Dame Cally Palmer, National Cancer Director for NHS England. It is because of their campaigning efforts and early diagnosis drives, as well as the fortitude of people like Dame Deborah James inspiring people to come forward, that they have seen and treated record numbers of people.

Investing in cancer awareness programmes that save lives

More people were welcomed and urged to come forward for checks as a result of the NHS’s first-ever doubling of investment in cancer awareness initiatives. Due to this, the NHS saw and treated a greater variety of patients. According to the data, 100,000 people last year had cancer diagnoses at stages one or two, when treatment is simpler (2021–2022).

According to Health and Social Care Secretary Steve Barclay, a record number of people underwent critical cancer treatment in the past year, up by more than 8,000 from the same period prior to the epidemic.

The NHS is investing in initiatives to promote awareness of symptoms and encourage people to come forward with concerns, as well as giving more cancer screenings than ever before and detecting record numbers of cancers at an early stage.

Providing community cancer patients with NHS care

Early cancer detection is essential for enhancing health outcomes and giving patients access to the best NHS cancer care. Since all GP teams have immediate access to life-saving testing for patients, waiting times are shorter, and thousands of patients can receive diagnoses or the all-clear faster. In addition, high street pharmacies will get funding to identify cancer symptoms, and pharmacist training will begin in January 2022.

The NHS has also quadrupled the number of community lung truck locations, resulting in the monthly MOT of over 30,000 people’s lungs, which can save their lives. As a result, almost 1,300 persons received early lung cancer diagnoses, with more than 77% receiving a stage one or stage two diagnosis.

The Institute of Cancer Research’s Chief Executive Officer, Professor Kristian Helin, stated that when cancer is detected early, therapy is frequently more effective, and the chances of a full recovery are significantly higher. This is why the likelihood of survival might significantly increase with an earlier cancer diagnosis. It is good to note that a record number of individuals underwent cancer therapy in the previous year and that a significant fraction of them were identified at an early stage when the illness is more amenable to treatment.

It is critical to motivate people to seek care if they exhibit symptoms. The Man Van, a mobile health clinic that offers free health screenings for men to promote timely detection of prostate cancer as well as other urological malignancies, was recently introduced by the ICR in collaboration with our hospital partner, The Royal Marsden.

This is one method they can innovate to make sure more malignancies are caught early.

Atezolizumab (Tecentriq), a therapy for advanced alveolar soft tissue sarcoma (ASPS), has received FDA approval for the first time for adults and children two years of age and older who have ASPS that has migrated to other regions of the body or cannot be removed surgically.

Atezolizumab (Tecentriq), which is an anti-PD-L1 immune checkpoint inhibitor, has been authorised for use in young patients with ASPS for the first time. Tyrosine kinase inhibitors (TAKs), among other emerging targeted therapies, do not have long-lasting efficacy, according to the National Institutes of Health (NIH). Therefore, the immunotherapy drug’s clearance is good news because it will make atezolizumab available to a significant number of the 80 Americans who are diagnosed with ASPS each year.

Phase II atezolizumab trial following FDA approval

According to the NIH, the FDA’s approval is based on findings from the largest ASPS study to date, a non-randomized Phase II trial.

49 patients with metastatic ASPS who were two years of age or older were enrolled in the Phase II trial. According to their doctor’s opinion, patients responded to the therapy, with some level of tumour shrinking in about one-third of them after receiving an injection of atezolizumab every 21 days. The majority of the other patients had stable illnesses. Patients with advanced alveolar soft-tissue sarcoma were offered the option to quit treatment after 2 years and take a break from it for up to 2 years while being closely monitored. No patient who stopped receiving treatment experienced progress during that time.

41% of individuals in the research experienced serious side effects, including anaemia, diarrhoea, rash, disorientation, hyperglycemia, and discomfort in the extremities. However, no participants left the trial as a result of adverse consequences.

Potential of the immune checkpoint inhibitor anti-PD-L1

Dr. James H. Doroshow, director of the National Cancer Institute’s Division of Cancer Treatment and Diagnosis, said, their capacity to bring patients in from all over the world was a crucial aspect of their ability to undertake the study.

The research’s principal investigator, Dr. Alice Chen of the Developmental Therapeutics Clinic in NCI’s DCTD, who oversaw the study of patients with advanced alveolar soft tissue sarcoma, said that this approval signifies a triumph for uncommon diseases, which are understudied in clinical trials. It is extremely significant that this approval for a rare condition was granted and that it will have an effect on the lives of such young people. Atezolizumab, according to the NIH, works by enhancing the immune system’s capacity to combat cancer. Atezolizumab has been authorised by the FDA for the treatment of individuals with a variety of cancers, including lung cancer, melanoma, and liver cancer.

The Phase II study’s findings are currently being readied for publication. For individuals with ASPS, research teams are pursuing more studies using atezolizumab, including the administration of the medication in conjunction with additional treatments.