Cancer Vaccine Breaking News

Cancer vaccine breaking news brought to you by Vax Before Cancer.

Jan 27, 2022 • 4:46 pm CST
Cleveland Clinic

The U.S. Food and Drug Administration (FDA) approved a novel drug on January 25, 2022, to treat certain patients with metastatic uveal melanoma, a rare cancer of the eye.

The FDA approved KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. 

Bahija Jallal, CEO of Immunocore, said in a press release issued on January 26, 2022, "Every year in the U.S., hundreds of people are diagnosed with mUM who, until now, had no approved treatment options."

Uveal melanoma is a rare and aggressive form of melanoma that affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease.

"KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease, and we are focused on making KIMMTRAK available as quickly as possible."

"We're also proud to have developed the world's first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need," added Dr. Jallal.

This FDA review used the Real-Time Oncology Review pilot program, which streamlined data submission before filing the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA's assessment.

This application had been granted priority review, breakthrough designation, and orphan drug designation.

The company is ready to commercialize KIMMTRAK and expects to make the product commercially available in the U.S. within weeks.

Jan 27, 2022 • 2:03 pm CST

The Scottish Medicines Consortium (SMC) announced on January 17, 2022, advice on new medicines for use in conditions including advanced breast cancer and non-small cell lung cancer.

Trastuzumab deruxtecan (Enhertu) was accepted to treat patients with advanced HER2-positive breast cancer, subject to ongoing evaluation and future reassessment once further information is available.

Trastuzumab deruxtecan is used to treat patients who have already received two or more HER2-targeted treatments for their advanced cancer. Trastuzumab deruxtecan offers the potential to control the disease and its symptoms and may slow disease progression, which could lead to more prolonged overall survival.

Secondarily, Tucatinib (Tukysa) was also accepted through PACE to treat adult patients with advanced HER2-positive breast cancer.

It is combined with other medicines to treat patients who have already received two or more HER2-targeted treatments for their advanced cancer. Tucatinib is expected to allow patients more time before cancer progresses.

And Osimertinib (Tagrisso) was accepted through PACE for the treatment of non-small cell lung cancer (NSCLC) in patients whose cancer cells have changes (mutations) in a gene responsible for making a protein called EGFR.

Cancer cells with this kind of mutation are described as EGFR positive, and around 10% of patients with NSCLC have these cancer cells.

Osimertinib is used for the initial treatment of these patients where the cancer is advanced (has spread to tissues near the lung or other parts of the body) and provides a treatment option that could increase survival and may have fewer side effects.

The committee was unable to accept nivolumab (Opdivo) when used with another medicine, ipilimumab, and chemotherapy, to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body.

Nivolumab was not recommended as the company’s evidence was not strong enough to satisfy the committee that it offers value for money to NHS Scotland compared to the current treatment option.

SMC chairman Mark MacGregor stated in a press release, “The committee is pleased to be able to accept these medicines for use by NHS Scotland.”

“We were unable to accept nivolumab as the evidence provided by the company was not strong enough to satisfy the committee of its cost-effectiveness.”

Healthcare Improvement Scotland, the national healthcare improvement organization for Scotland, reviews new medicines that have received a license from the Medicines and Healthcare products Regulatory Agency. It also reviews new formulations and new ways to use established medicines. 

Jan 27, 2022 • 1:40 pm CST

China-based Dizal Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration ("FDA") had granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Breakthrough Therapy designation is a process designed by the FDA, China CDE, and other regulatory agencies to expedite the development and review of drugs that are intended to treat a serious condition.

DZD9008 is a rationally designed selective, irreversible, novel EGFR inhibitor.

In global Phase 1/2 studies, it has demonstrated promising antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. Its confirmed ORR is 45.5% at 200 mg and 41.9% at 300 mg (data cut-off by July 30, 2021).

It also shows efficacy among patients with brain metastasis or previously treated by Amivantamab. In addition, it was well tolerated with a manageable AE profile.

Dizal is conducting Phase 2 pivotal clinical trials in China, U.S., EU, Japan, Australia, South Korea, and other regions.

"Lung cancer patients with exon20 insertion mutations need better treatment. Sunvozertinib was specifically designed with high selectivity for inhibiting mutated EGFR, which causes cancers. Available clinical evidence shows that Sunvozertinib has the potential to provide the patients with a new and much improved targeted therapy," commented Dr. Xiaolin Zhang, CEO at Dizal, in a press release dated January 28, 2022.

Dizal Pharmaceutical is a global, science-oriented biotech company located in Shanghai dedicated to discovering, developing, and commercializing innovative medicines. 

Jan 26, 2022 • 11:00 am CST

Cancer Research UK announced on January 24, 2022, it intends to invest £100 million over five years into Cancer Research UK Centres in Cambridge, City of London, Convergence Science, Manchester, Newcastle, Oxford, and Scotland.

'The seven funded Centres are central to our ambition to beat cancer, providing a key link between laboratory research and patient-focused studies,' commented Michelle Mitchell, CEO, Cancer Research UK.

'We award Centre status to locations that perform the highest quality cancer research.'

'Our funding supports essential research infrastructure including technical staff, equipment, pump-priming grants, and training, to further develop the breadth and depth of research at each of these Centres.'

'Our Centres bring together a network of research teams from local universities, NHS hospitals, and other research organizations.'

'They seek to understand the impact and efficacy of treatments to initiate new research ideas and programs, translating cutting-edge discoveries from the laboratory into direct benefits for patients.'

'Standards were particularly high, in part, because our investment of £100 million is a reduction of around a third compared to the last funding round in 2017.'

'While the COVID-19 pandemic has required us to reshape our research model and make tough decisions about the research we fund, this investment continues to provide vital infrastructure for the bench to bedside research, as well as creating opportunities for the next generation of scientists.'

Jan 26, 2022 • 10:20 am CST

British Columbia-based Defence Therapeutics Inc. today announced the development of AccuVAC-PT009, a new protein-based human papillomavirus (HPV) vaccine, leading to a humoral response bypassing Merck's Gardasil 9 immunogenicity in animals.

Vaccination against HPV is recommended to prevent new infections and associated diseases, including cancers, says the WHO. 

The Defence research and development team designed and engineered an HPV vaccine (a mix of the same 9 HPV-derived L1 proteins used in Gardasil 9) and compared its immunogenicity to a group of Gardasil 9-immunized animals.

Compared to Gardasil 9, AccuVAC-PT009 triggers an impressive 27- and 36-fold increase in antibody titer at 4- and 6-weeks post-immunization, respectively.

"We are extremely proud to demonstrate again how ACCUM can be exploited and applied to significantly improve any protein-based vaccine. Not only can this vaccine have a tremendous impact on improving the immunogenicity of the commercialized Gardasil-9, but it can, in addition, lower the dosing regimen (at least by 10-fold) yet triggering a similar or more potent humoral response," stated Sebastien Plouffe, the CEO of Defence, in a press release issued on January 26, 2022.

Although its initial intent is to develop its AccuVAC-PT009 HPV vaccine candidate or even add other subtypes currently not covered by the Gardasil 9 vaccine, Defence is actively looking to establish partnerships to bring forward its vaccine portfolio.

Defence Therapeutics is a publicly-traded biotechnology company located in Vancouver, BC, working on engineering the next-generation vaccines and ADC products using its proprietary platform.

Jan 25, 2022 • 6:52 am CST

Sweden-based RhoVac AB announced that the Canadian Intellectual Property Office had issued a "Notice of Allowance," which means that it intends to grant RhoVac's patent application for the RV001 (onilcamotide) cancer vaccine.

The Canadian patent will provide RhoVac's onilcamotide vaccine with broad protection in a key market and significantly strengthen the company's patent portfolio.

The patent covers RhoVac's onilcamotide cancer vaccine, possible variants of the vaccine, and the use of such vaccines in the treatment or prevention of metastatic cancer where RhoC is expressed.

The patent term will then extend to December 2028, potentially longer

The company has previously been granted patents relating to onilcamotide in the USA, Europe, and Japan.

CEO Anders Månsson commented in a press release issued on January 24, 2022, "This patent, when granted, will give product protection for our vaccine, along with additional protection for its use in the treatment and prevention of metastatic cancer [where RhoC is expressed], and in combination therapies."

RhoVac's drug candidate, RV001, is an immuno-oncologic drug presented to the immune system as an antigen, stimulating T-cells to identify and destroy cells that carry this protein, i.e., metastatic or metastatic potential cells.

Historically, "cancer vaccines" have shown inadequate efficacy in treating solid tumors, which have various mechanisms for evading and excluding the immune system.

However, RV001 is not designed to deal with solid tumors.

It targets only metastatic cancer cells and metastases in early formation. This makes a big difference in terms of the ability of the immune system to be effective. 

RhoVac was established as a private company in Denmark in 2007 and is currently listed on Spotlight, Sweden, a Multilateral Trading Facility.

Jan 24, 2022 • 11:35 am CST

Florida-based AIM ImmunoTech Inc. today announced the publication of positive data from a Phase 1/2 clinical study of intraperitoneal chemo-immunotherapy in advanced, recurrent ovarian cancer. The chemokine-modulating IP chemo-immunotherapy combination was demonstrated to be well-tolerated and associated with interferon-stimulated gene changes that favor cytotoxic T lymphocytes chemoattraction and function.

"These results represent an important extension of prior studies using human tumor explants that showed Ampligen's potentially important role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio," stated David Strayer, MD, Chief Medical Officer, Chief Scientific Officer of the Company, and Board Certified in Medical Oncology, in a press release issued on January 24, 2022.

"This current study shows that similar findings are seen combining Ampligen with chemokine-targeting and chemo-immunotherapy in patients being treated for recurrent ovarian cancer."

"The importance of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion of 'cold' tumors into 'hot' tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression."

"This, of course, creates the potential for a positive survival advantage,"

A phase 2 clinical study will be conducted to evaluate the immunologic and clinical efficacy of tumor loaded αDC1 vaccine in conjunction with the cisplatin/chemokine modulatory combination regimen.

The Phase 1/2 study being conducted by the University of Pittsburgh School of Medicine is designed to evaluate the immunologic and potential clinical effectiveness of intensive loco-regional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced-stage ovarian cancer (III-IV) at primary neoadjuvant setting. AIM ImmunoTech provided rintatolimod (Ampligen®, a dsRNA acting as TLR3 agonist) for the Phase 1/2 study.

The manuscript titled, "Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity1" was published in the American Association for Cancer Research publication, Clinical Cancer Research, on January 19, 2022.

The U.S. CDC says 'ovarian cancer is the second most common gynecologic cancer in the United States. Ovarian cancer causes more deaths than any other cancer of the female reproductive system.

And the U.S. Cancer Statistics Data Visualizations Tool makes it easy to explore the latest cancer data from United States Cancer Statistics. 

AIM ImmunoTech Inc. is an immuno-pharma company located in Ocala, FL, focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Jan 24, 2022 • 7:18 am CST

Israel-based BioLineRx Ltd. today announced the completed enrollment of the Phase 1/2a study of its innovative intratumoral cancer vaccine candidate, AGI-134.

This clinical study is designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors.

The AGI-134 multicenter, open-label study results, which recruited a total of 38 patients in the UK, Spain, and Israel, are anticipated in the first half of 2022.

Philip Serlin, CEO of BioLineRx, stated in a press release issued on January 24, 2022, "AGI-134 is our second clinical-stage oncology asset, has a unique mode of action, applicable to all injectable tumor types."

"In preclinical models, AGI-134 led to regression of primary tumors, prevented the growth of secondary tumors via an abscopal effect, and triggered a vaccine effect that we believe may prevent the development of metastases."

"This clinical study aims to confirm the proposed mechanism of action and safety profile of AGI-134 in humans, based on which we also plan to explore potential combinations as part of its future clinical development program."

BioLineRx Ltd. is a late clinical-stage biopharmaceutical company located in Tel Aviv focused on oncology.

Jan 24, 2022 • 5:17 am CST

Taiwan-based OBI Pharma today announced that the first patients had been enrolled in both of the Phase 2 studies of OBI-999, an antibody-drug conjugate (ADC) cancer therapy targeting Globo H, and OBI-3424, a prodrug targeting the enzyme aldo-keto reductase 1C3 (AKR1C3).

OBI anticipates completing the enrollment of both Phase 2 studies in the second half of 2023.

OBI's Chairman and CEO, Michael Chang, Ph.D., commented in a press release issued on January 24, 2022, "OBI Pharma strives to develop novel therapeutics for cancer patients worldwide."

"Based upon the impressive Phase 1 safety study and preclinical data of OBI-999 and OBI-3424, we are excited to commence our Phase 2 efficacy and safety study in patients with high Globo H or AKR1C3 antigen expression in solid tumors."

"We would like to thank the commitment of our international investigators to bring these 1st-in-class cancer therapeutic products to potential patients in our ongoing study."

The Phase 2 cohort expansion part of the OBI-999-001 entitled "A Phase 1/2, Open-Label, Dose-Escalation, and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors" has now begun enrollment in medical centers in the U.S. and Taiwan.

The Phase 2 part of the study will enroll Globo H expressing patients with pancreatic, colorectal, and other high Globo H expression solid tumors in more than ten medical centers in the United States and Taiwan.

The Phase 2 cohort expansion part of the OBI-3424-001 ( Identifier: NCT03592264) entitled "A Phase 1/2 Study of OBI-3424 in Subjects with Advanced Solid Tumors" has also begun enrollment.

This study will enroll AKR1C3 expressing patients with pancreatic and other high AKR1C3 expressing solid tumors in select oncology medical centers in the United States.

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers.

OBI-999 uses a Globo H antibody to target high Globo H expression cancer cells.

By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells.

In preclinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung, and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses.

And in the human Phase 1 study, OBI-999 was well-tolerated and achieved a favorable safety margin which warrants further clinical development.

Furthermore, OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3) and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme.

This selective activation mode distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in several treatment-resistant and difficult-to-treat cancers, including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL).

In addition, AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, thus offering the possibility for a streamlined clinical development strategy.

OBI-3424 is currently in a Phase 2 trial in medical centers in the U.S.

OBI Pharma, Inc. is a Taipei, TW, located biopharmaceutical company founded in 2002 with subsidiaries in the U.S., China, Hong Kong, and Australia.

Jan 21, 2022 • 1:03 pm CST

Researchers at Mayo Clinic Cancer Center in Jacksonville, Florida, have found that patients with cancer who receive chemotherapy may mount an inadequate immune response to COVID-19 vaccination. On December 12, 2021, this study's findings were published in Mayo Clinic Proceedings: Innovation, Quality & Outcomes.

A substantial proportion of cancer patients with hematologic and solid malignancies on chemotherapies and CDK4/6i had poor humoral responses after mRNA vaccination.

"It is important for patients with cancer who are receiving chemotherapy to receive a COVID-19 vaccine," says Saranya Chumsri, M.D., a Mayo Clinic hematologist and oncologist, and author of the paper.

Dr. Chumsri said in a press release issued on January 20, 2022, "this advice also applies to patients with cancer who are taking a CDK 4/6 inhibitors."

"These inhibitors are a newer class of medicines used to treat hormone-receptor-positive and HER2-negative breast cancers."

Dr. Chumsri anticipates having additional data later in 2022 regarding broader immune responses to COVID-19 vaccinations, including cellular and antibody responses in patients receiving chemotherapy and targeted therapies with booster vaccinations.

Jan 21, 2022 • 11:00 am CST

The peer-reviewed Journal of Obstetrics and Gynaecology Research published an Original Article on January 19, 2022, that reported women who drank caffeinated coffee had a lower risk of endometrial cancer (EC).

A total of 24 studies on coffee intake were included in the meta-analysis, with 9,833 incident cases and 699,234 subjects.

The pooled Risk Reduction (RR) of endometrial cancer for the highest versus the lowest categories of coffee intake was 0.71 (95% CI: 0.65–0.77; I2 = 14%, p for heterogeneity = 0.26).

By study design, the pooled RRs were 0.68 (95% CI: 0.56–0.83) for case–control studies and 0.70 (95% CI: 0.63–0.77) for cohort studies.

The pooled RRs were 0.74 in Europe, 0.71 in U.S. / Canada, and 0.40 in Japan for different regions.

By additional subgroup analysis, a stronger inverse association was shown in caffeinated coffee drinkers (RR 0.66, 95% CI: 0.52–0.83), individuals with the higher body mass index (RR 0.65, 95% CI: 0.54–0.79), never smokers (RR 0.68, 95% CI: 0.56–0.84), ever smokers (RR 0.56, 95% CI: 0.45–0.70), and those who never used hormone replacement therapy (RR 0.88, 95% CI: 0.79–0.98).

Furthermore, the consumption of filtered or boiled coffee showed no significant association.

In conclusion, these researchers stated 'Increased coffee intake is associated with a reduced risk of EC. says 'endometrial cancer is a disease in which malignant (cancer) cells form in the endometrium tissues. And obesity and having metabolic syndrome may increase the risk of endometrial cancer.

Jan 20, 2022 • 3:01 pm CST

The Annals of Internal Medicine published the results from a peer-reviewed systematic review on January 18, 2022, that identified 19 studies addressing the use of follow-up colonoscopy to assess the presence of colonic neoplasia after an episode of presumed acute left-sided colonic diverticulitis.

Clinicians and patients face several decisions in planning appropriate evaluation and management after acute left-sided colonic diverticulitis.

The American College of Physicians (ACP) developed this guideline to provide clinical recommendations on the role of colonoscopy for diagnostic evaluation of colorectal cancer (CRC) after a presumed diagnosis of acute left-sided colonic diverticulitis and on the role of pharmacologic, nonpharmacologic, and elective surgical interventions to prevent recurrence after initial treatment of acute complicated and uncomplicated left-sided colonic diverticulitis. 

Important outcomes, including colonoscopy complications or failed or incomplete colonoscopy, were rarely reported in primary studies.

High-certainty evidence showed that very few had complications among 1,253 patients in five observational studies, such as bleeding or perforation (0.2% [CI, 0.04% to 0.64%]).

High-certainty evidence from observational studies showed that 3.7% (CI, 2.7% to 4.9%) of patients with acute left-sided colonic diverticulitis undergoing colonoscopy six weeks to 1 year after hospital discharge had a failed or incomplete colonoscopy.

The target audience for this ACP guideline is all clinicians, and the target patient population is adults with recent episodes of acute left-sided colonic diverticulitis.

Jan 20, 2022 • 1:02 pm CST

China-based CStone Pharmaceuticals today announced on January 19, 2022, that a phase 3 clinical study of sugemalimab for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) met the overall survival (OS) endpoint.

This study's results demonstrated that sugemalimab combined with chemotherapy showed statistically significant and clinically meaningful OS improvement in patients.

Based on the previously reported impressive progression-free survival (PFS) data, the National Medical Products Administration of China approved sugemalimab in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC in December 2021.

In addition, sugemalimab is being investigated in several ongoing clinical trials, including one Phase 2 registrational study for lymphoma and four Phase 3 registrational studies in stage IV NSCLC, stage III NSCLC, gastric cancer, and esophageal cancer, respectively.

Professor Caicun Zhou, Principal Investigator of the GEMSTONE-302 registrational clinical study of sugemalimab and Director of the Department of Oncology, Shanghai Pulmonary Hospital, Tongji University, said in a press release, "Globally, the mortality of lung cancer ranks first among all malignant tumors. The goal of first-line treatment for advanced lung cancer is to maximally prolong survival benefits for patients and to delay disease progression."

"The prespecified OS analysis data further confirmed that sugemalimab combined with chemotherapy provided durable survival benefits to patients."

"Sugemalimab has the potential to reshape the first-line treatment landscape of advanced NSCLC and could become the preferred immune-oncology therapy for the treatment of advanced NSCLC."

The anti-PD-L1 monoclonal antibody (mAbs) sugemalimab was discovered by CStone using OmniRat® transgenic animal platform, which allows the creation of fully human antibodies in one step.

As a result, Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 mAbs, allowing a reduced risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

CStone recently formed a strategic collaboration agreement with New York-based Pfizer Inc., including the development and commercialization of sugemalimab in mainland China and a framework to bring additional Oncology medicines to the greater China market.

Established in 2015, CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide.

Jan 20, 2022 • 5:49 am CST

Hong Kong-based HUTCHMED today announced it had initiated a Phase I trial in China of HMPL-653, an investigational novel, highly selective, and potent colony-stimulating factor 1 receptor (“CSF-1R”) inhibitor.

The first patient received their first dose on January 18, 2022.

Currently, no CSF-1R inhibitor has been approved in China. However, there is a high unmet need for an effective and safe treatment for these patients.

The Phase I trial is a multicenter, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HMPL-653 in treating patients with advanced or metastatic solid tumors and tenosynovial giant cell tumors (“TGCT”).

HMPL-653 is an investigational novel, highly selective, and potent CSF-1R inhibitor designed to target malignant driven tumors as a monotherapy or in combination with other drugs.

CSF-1R is usually expressed on the surface of macrophages and can promote growth and differentiation of macrophages after binding with its ligand, CSF-1.

Several previous studies have shown that blocking the CSF-1R signaling pathway could effectively modulate the tumor microenvironment, relieve tumor immunosuppression, and synergize with other anti-cancer therapies such as immune checkpoint inhibitors to achieve tumor inhibition.

TGCT is a rare soft tissue tumor caused by abnormal proliferation and inflammation of giant cells, monocytes, and inflammatory cells. 

The incidence of TGCT is approximately between 1.8 and 50 per 1 million people.

The expression of CSF-1 mainly characterizes these tumors.

Surgery is the standard treatment for TGCT patients. However, among patients with diffuse or recurrent/refractory TGCT, tumors are wrapped in peripheral organs such as bone, tendon, ligament, and joint, making removal by surgery difficult.

The recurrence rate of diffuse-type cases is estimated to be 21% to 50%.

HUTCHMED currently retains all rights to HMPL-653 worldwide.

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage biopharmaceutical company with operations in Florham Park, New Jersey.

Jan 19, 2022 • 9:11 am CST

The JAMA Network published an Orginal Investigation on January 18, 2022 that found that U.S. Preventive Services Task Force guideline-concordant cervical cancer screening rates decreased between 2005 and 2019, before the COVID-19 pandemic.

The most common reason for not receiving cervical cancer screening was 'not knowing cancer screening was needed.'

Among women in the older age cohort, those responding they 'did not' receive screening was because they did not have a recommendation from healthcare practitioners more than doubled in 2019, from 5.5% to 12%.

In this cross-sectional study of 20,557 women eligible for cervical cancer screening in the U.S., the proportion of women without up-to-date screening significantly increased from 14.4% in 2005 to 23.0% in 2019 among all sociodemographic groups.

The study's findings also revealed that barriers to screening significantly varied by sociodemographic factors, suggesting cultural adaptation of interventions will be an essential factor in the success of efforts to increase cervical cancer screening uptake.

Along with increasing HPV vaccine coverage, improving cervical cancer screening rates represents an essential strategy for national campaigns to eliminate cervical cancer as a public health concern.

Campaigns addressing patient knowledge and practitioner communication may help to improve cervical cancer screening rates, and cultural adaptation of interventions is needed to reduce existing disparities.

Corresponding Author: Ryan Suk, Ph.D., MS, Department of Management, Policy, and Community Health, University of Texas Health Science Center at Houston School of Public Health ([email protected]). No industry conflicts of interest were disclosed.