Travel Vaccine Breaking News

HUTCHMED Limited today announced it entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited to further the global development, commercialization, and manufacture of fruquintinib.

Fruquintinib is orally administered and has the potential to be used across subtypes of metastatic colorectal cancer (“CRC”), regardless of biomarker status.

It is a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2, and -3.

CRC is a type of cancer that starts in either the colon or rectum.

Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. 

HUTCHMED confirmed on January 23, 2023, it will receive up to US$1.13 billion, including US$400 million upfront on closing, as well as potential regulatory, development, and commercial sales milestone payments, plus royalties on net sales.

“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who need additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” commented Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, in a related press release.

Positive results of FRESCO-2, the global Phase III multi-regional clinical trial of fruquintinib in refractory metastatic CRC, were presented at the European Society for Medical Oncology Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival in patients with metastatic CRC and was generally well tolerated.

According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020.

In the U.S., an estimated 155,000 patients were diagnosed with CRC, and there were 54,000 related fatalities.

HUTCHMED stated it would continue to focus on progressing late-stage clinical trials and the commercialization of fruquintinib in mainland China in collaboration with Eli Lilly and Company, where it is approved under the brand name ELUNATE® for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who have previously received anti-vascular endothelial growth factor therapy and/or anti-epidermal growth factor receptor therapy (RAS wild type).

ELUNATE has been included in the China National Reimbursement Drug List since January 2020 and was commercially launched in China in November 2018.

The Pan American Health Organization (PAHO) recently reported that since the initial cholera cases (Vibrio cholerae O1) in the greater Port-au-Prince area in October 2022, the Haitian Ministry of Health has reported a total of 24,232 suspected cases and 483 registered fatalities.

As of January 14, 2023, the Ouest Department, which includes the municipalities of Port-au-Prince, Cité-Soleil, and Carrefour, continues to report the highest number of cases, with 67% (N=10,836) of all suspected cases reported.

During a similar time frame, a total of 19 confirmed cases have been reported in the Dominican Republic (DR), with five of them imported from Haiti. 

In a press release on January 15, 2023, the DR's Ministry of Public Health urged residents not to be alarmed and to remain attentive to the issued reports.

The latest PAHO risk assessment of the Cholera event in La Hispaniola Island (Haiti and the Dominican Republic) assesses the event as very high risk locally, moderate at the regional level, and low at the global level.

The U.S. Centers for Disease Control and Prevention (CDC) stated in 2022, vaccination may be considered for children and adults traveling to areas of active cholera transmission.

As of January 2023, cholera vaccines remain unavailable in the U.S.

Cholera is rare in travelers but can be severe. Certain factors may increase the risk of getting cholera or having severe disease. The CDC says avoiding unsafe food and water and washing your hands can also help prevent cholera.

Furthermore, the U.S. Department of Stated announced in December 2022 do not travel to Haiti due to civil unrest. U.S. citizens should depart Haiti now in light of the current security and health situation and infrastructure challenges.

Furthermore, clinicians should be prepared to treat cholera cases in travelers returning to the U.S. in 2023.

The U.S. Department of State recently updated it's Level 2: Exercise Increased Caution for when visiting the southernmost continent of Antarctica.

As of January 19, 2023, the State Department announced travelers should be aware of environmental hazards posed by extreme and unpredictable weather and limited emergency services.

For travelers to Antarctica, severe low temperatures and high winds are the primary health hazards.

Temperature patterns vary widely because Antarctica is covered in continuous darkness during the winter and constant sunlight during the summer.

The sun's effects in Antarctica can damage the eyes and skin, and protective measures should be taken.

The U.S. Centers for Disease Control and Prevention (CDC) suggests various travel vaccinations, such as measles, before visiting Antarctica.

And if you travel to Antarctica, obtain comprehensive travel, medical, and medical evacuation insurance; see our webpage for more information on insurance providers for overseas coverage, says the State Department.

The U.S. government does not maintain an embassy or consulate in Antarctica.

If you need U.S. consular services when in Antarctica, contact the closest U.S Embassies/Consulates in Argentina, Australia, Chile, New Zealand, and South Africa. 

From outside the U.S., call 1-202-501-4444 to speak with a U.S. representative.

Furthermore, government resources in the Antarctic Region are committed to the Antarctic Program (USAP).

Private expeditions should be self-sufficient and are encouraged to carry adequate insurance coverage against the risk of incurring financial charges or material losses while in the Antarctic.

The National Science Foundation, as manager of the USAP, reserves the right to seek, in accordance with international and domestic law, recovery of all direct and indirect costs of any such emergency search and rescue.

The Antarctic also includes island territories within the Antarctic Convergence, says the National Geographic Society. 

Most of the islands and archipelagos of Lesser Antarctica are volcanic and heavily glaciated.

The islands of the Antarctic region are the South Orkney Islands, South Shetland Islands, South Georgia, and the South Sandwich Islands, all claimed by the United Kingdom.

Peter I Island and Bouvet Island, claimed by Norway.

Heard and McDonald islands, claimed by Australia.

And Scott Island and the Balleny Islands, claimed by New Zealand.

Since the Mpox outbreak began in May 2022, over 1.1 million doses of the Jynneos® vaccine have been administered in the United States (U.S.).

The city of Boston began offering Jynneos vaccinations to healthcare staff on May 24, 2022, followed by New York City (NYC). 

In September 2022, NYC Health began offering second doses of Jynneos to qualifying people.

As of January 17, 2023, 57 U.S. Jurisdictions have offered first and second doses to men and women at no charge.

From an effectiveness perspective, the U.S. Centers for Disease Control and Prevention (CDC) posted data on December 8, 2022, suggesting the effectiveness of a single dose of Jyennos was 87% protective.

Overall, the CDC has confirmed 30,026 Mpox cases and 23 related fatalities, a case-fatality rate of less than 1%.

Demetre Daskalakis, M.D., deputy coordinator of the CDC's pox response efforts in the U.S., recently posted on Twitter, 'Supply is there! We need to keep the drumbeat going for demand even as cases go down.'

'Getting vaccinated for #mpox now means protection in the future! Oh… that means two doses of the vaccine!

Find out where to obtain the Jynneos vaccine at http://mpoxvaxmap.org or your local/state health department.

The Janssen Pharmaceutical Companies of Johnson & Johnson and a consortium of global partners announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen's investigational HIV vaccine regimen.

The study's independent Data and Safety Monitoring Board (DSMB) determined that the regimen was ineffective in preventing HIV infection compared to placebo.

In light of the DSMB's determination, the Mosaico clinical trial was discontinued.

Mosaico began in 2019 and completed vaccinations in October 2022.

The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the U.S.

"We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV," said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC., in a press release on January 18, 2023.

"We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine."

The Mosaico findings align with developments in the Phase 2b “Imbokodo” clinical trial, which tested a similar HIV vaccine regimen in women in sub-Saharan Africa. 

That DSMB determined in August 2021 that the experimental vaccine regimen was also ineffective in protecting against HIV acquisition.

As of January 19, 2023, the U.S. Food and Drug Administration had not approved an HIV vaccine candidate.

Evaxion Biotech A/S recently announced that the U.S. Food and Drug Administration (FDA) determined that the Company may proceed with its Phase 2b clinical trial of EVX-01 targeting malignant melanoma.

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia and in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®. 

The trial was first initiated in Australia with the enrollment of the first patient in September 2022.

In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial.

The Company anticipates a response from the FDA to the Fast Track designation submission in the first quarter of 2023.

“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,” says Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2023.

Moderna, Inc. announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an mRNA vaccine candidate targeting respiratory syncytial virus (RSV) in older adults.

Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease as defined by two or more symptoms.

Based on these results, Moderna stated on January 17, 2023, it intends to submit for regulatory approval for mRNA-1345 in the first half of 2023.

"RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities," commented Abdullah Baqui, a principal investigator for the study sites in Bangladesh and Professor, Department of International Health, Director, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, in a related press release.

"This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas."

A concurrent review of available safety data was also conducted by the DSMB.

mRNA-1345 was well tolerated, with no safety concerns identified. To date, most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.

The overall rate of severe (Grade 3 or greater) solicited systemic adverse reactions was 4.0% for mRNA-1345 and 2.8% for placebo.

The overall rate of Grade 3 or greater solicited local adverse reactions was 3.2% for mRNA-1345 and 1.7% for placebo.

The study is ongoing, and an updated analysis of safety and tolerability will be provided at the time of regulatory submission.