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Cleveland Clinic Launches First-of-its Kind Preventive Breast Cancer Vaccine Study

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#October 30, 2021 – Cleveland Clinic researchers have opened a novel study for a vaccine aimed at eventually preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.

This phase I trial is designed to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer and to characterize and optimize the body’s immune response. The U.S. Food and Drug Administration recently approved an investigational new drug application for the vaccine, which permits Cleveland Clinic and partner Anixa Biosciences, Inc. (ANIX:NASDAQ) to start the study.

“We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” said G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study. “Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments.”

There is a great need for improved treatments for triple-negative breast cancer, which does not have biological characteristics that typically respond to hormonal or targeted therapies. Despite representing only about 12-15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, Ph.D., the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute. “The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.” Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences, Inc. He will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and also holds personal equity in the company.

The investigational vaccine targets a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in the majority of triple-negative breast cancers. Activating the immune system against this “retired” protein provides pre-emptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response that allows the immune system to mount a response against emerging tumors to prevent them from growing.

The study is based on pre-clinical research led by Dr. Tuohy that showed that activating the immune system against the α-lactalbumin protein was safe and effective in preventing breast tumors in mice. The research also found that a single vaccination could prevent breast tumors from occurring in mouse models, while also inhibiting the growth of already existing breast tumors. The research, originally published in Nature Medicine, was funded in part by philanthropic gifts from more than 20,000 people over the last 12 years.

Funded by the U.S. Department of Defense, the new study at Cleveland Clinic will include 18 to 24 patients who have completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence. During the course of the study, participants will receive three vaccinations, each two weeks apart and will be closely monitored for side effects and immune response. The study is estimated to be completed in September 2022.

Researchers anticipate that a subsequent trial will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. Typically, those women carry mutations in either the BRCA1 or BRCA2 gene and are therefore at risk of developing triple-negative breast cancer or have high familial risk for any form of breast cancer.

“This vaccine strategy has the potential to be applied to other tumor types,” added Dr. Tuohy. “Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had.”

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Grand Bahama celebrates the nation’s 52nd Anniversary

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By Shakara Trott
Bahamas Information Services

 

GRAND BAHAMA, The Bahamas –  From Tin Tubs to Jacuzzis.  From Kerosene Lamps to Chandeliers.  From Hand Pumps to Running Water.

As the nation reflects on its journey, these nostalgic comparisons remind Bahamians of just how far we’ve come.  On the eve of July 10th, the Grand Independence Central Lawn was transformed into a vibrant hub of celebration as scores of Bahamians, families, dignitaries, and special guests gathered to commemorate the country’s 52nd Anniversary of Independence.

The evening featured a cultural showcase brimming with national pride—from lively food trucks to breathtaking fireworks—bringing the community together in a unified celebration of heritage, resilience, and hope for the future.

Dignitaries made a grand entrance, chauffeured onto the grounds in red-carpet, Vogue-style fashion, and introduced by the evening’s Master of Ceremonies, Wilbert Stubbs.

The festivities began with an ecumenical service led by the Grand Bahama Christian Council.  Bishop Barry Morris and Bishop John C. Wallace opened with a call to worship and invocation, followed by an uplifting session of praise led by Calvary Temple’s worship team.

In a stirring keynote address, Archdeacon Earl Hepburn reflected on the spiritual foundation of the Bahamian journey. “No matter how much effort is put in, if God is not at the center, the foundation will falter,” he said, reminding attendees that the nation’s progress must always be rooted in faith.

As the evening progressed, the atmosphere shifted to high-energy entertainment with performances by DECISION, Top Tier Band, RYCON, Sharade, The Bmes, Bahamas Dance Theatre Troupe, Wilfred Solomon, Nishie L.S., DMAC, and KB—offering a rich tapestry of Bahamian culture in music and dance.

Minister for Grand Bahama, the Hon. Ginger Moxey, carried out the traditional Inspection of the Guard, setting the stage for the ceremonial highlight of the evening.

Finally, just prior to midnight, and as Independence Day, July 10, rolled in, the Royal Bahamas Defence Force and Royal Bahamas Police Force raised the National Flag, and sounds of the National Anthem filled the air.

With fireworks lighting up the sky, The Bahamas proudly turned 52—marking more than half a century of independence, growth, and national pride.

PHOTO CAPTION: Independence Park was abuzz with excitement as the nation celebrated its 52nd anniversary.  The event drew hundreds of attendees who came to mark this significant milestone in the country’s history.  Minister for Grand Bahama, the Hon. Ginger Moxey is pictured as she greeted uniformed branch officers, dignitaries, and members of the community at the celebration.

(BIS Photos/Andrew Miller)

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Bahamas News

STATEMENT BY THE MINISTER FOR GRAND BAHAMA ON GRAND BAHAMA POWER OUTAGES

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FREEPORT, Grand Bahama – The Ministry for Grand Bahama is aware of the power outages impacting residents and businesses and has brought the Grand Bahama Power Company (GBPC) to the table to ensure a speedy resolution.

The Government has received a full briefing on the situation and are advised that the problem relates to the damage of the GBPC Peel Street Station, as a result of a lightning strike.

At this moment, we understand that Unit 33 that was undergoing corrective maintenance is now online, and all customers have successfully been restored.  In addition, the Government is working with GBPC on   proposed temporary technical assistance over the next several weeks.

We fully acknowledge the deep frustration and inconvenience this has caused residents and businesses and will continue to work with the relevant stakeholders on behalf of the people of Grand Bahama.

Photo Caption: The Minister for Grand Bahama Hon. Ginger Moxey, M.P., meets with GBPC Chief Operating Officer Nikita Mullings and Energy Transformation Lead Neilsen Beneby to discuss reliable power restoration plans for Grand Bahama.

Also pictured is Permanent Secretary at the Ministry for Grand Bahama Joel Lewis, Under Secretary Carol Roache and First Assistant Secretary Arnald Cooper

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Bahamas News

Bahamas conducts grand 52nd Independence Anniversary celebrations despite turbulent weather

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By Lindsay Thompson
Bahamas Information Services

 

NASSAU, The Bahamas — Severe weather conditions forced the much-anticipated Independence Anniversary Celebration to take on a different format from the usual exciting lineup, on the evening of July 9.

The planned traditional Ecumenical Service and the Cultural Show set for that evening at 8:00pm were impacted by turbulent weather, and organizers pivoted to meet the nation’s expectations.

Gratefully, as the rain cleared and time progressed to just past midnight, July 10 — Independence Day — the Aquamarine, Gold and Black National Flag was raised under a calm sky, with events unfolding serenely to usher in 52 years of Independence before scores of Bahamians who assembled at historic Clifford Park.

Just hours prior, the Department of Meteorology had issued a “Severe Weather Warning” for several islands including New Providence, cautioning residents against localized flooding, strong gusty winds and tornadic activity, and to remain indoors until the passage of the storm.

Out of an abundance of caution, The National Independence Secretariat, acting on the weather warning and in consultation with the relevant agencies, made adjustments to the Independence Calendar for that evening.

As a result, the Cultural Show would be held on a date to be announced.

The Bahamas Christian Council held its traditional Ecumenical Service at Bahamas Harvest Church on J.F. Kennedy Drive, which was broadcast live on ZNS at 9:00pm.

The Flag Raising Ceremony proceeded as usual at Clifford Park, where The Bahamas had become an independent nation in 1973, on July 10.

A number of clergymen participated in the Ecumenical Service, and choirs rendered melodious and spirited gospel songs – all with a common message imbued with this year’s theme: “Together We Rise.”  In attendance were high-level Government officials, and members of The Opposition.

Pastor Mario Moxey of Bahamas Harvest Church implored Bahamians to not look at the theme as merely a slogan, but instead as a call for renewed hope for our Bahamaland.

In delivering the Independence sermon, Apostle Delton Fernander, president of the Bahamas Christian Council, said that independence came about by many, who believed in the cause.  He said though much has been accomplished, there is still more to do.

Tying the line from The Pledge, ‘One People, United in Love and Service,’ to the theme, “Together We Rise”, he stated, “these words instruct us to address many of the ills facing the nation.  In this vein, he called for unity as a means to achieving this.

At Clifford Park, and the Flag Raising Ceremony: Her Excellency, the Most Honourable Dame Cynthia A. Pratt, Governor General of the Commonwealth of The Bahamas, carried out the customary Inspection of the Guard despite the soggy conditions of the grounds.

Witnessing the historic events were the Hon. Philip Davis, Prime Minister and Minister of Finance; the Hon. Chester Cooper; Deputy Prime Minister and Minister of Tourism, Investments and Aviation; The Hon. Mr. Chief Justice Sir Ian Winder; Members of the Opposition, Cabinet Ministers, high level officials, guests, and spectators.

At midnight, with the Flag hoisted in the air by officers of the Royal Bahamas Defence Force and Royal Bahamas Police Force, the playing of the National Anthem by the parade band, and fireworks, The Bahamas became 52-years-old as an independent nation.

Following on — at 1:00am was ‘The People’s Rush’ by the various Junkanoo groups, which thrilled the crowds on Bay Street.

Independence Day will also be commemorated with the traditional State Reception at Government House, and a Family Fun Day at Clifford Park.

(BIS Photos/Patrick Hanna)

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