Cancer Vaccine Breaking News

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

Apr 13, 2021 • 2:21 pm CDT

China-based LintonPharm Co., Ltd. announced that the National Medical Products Administration had authorized the company to proceed with a Phase 1/2 clinical trial evaluating the safety and efficacy of catumaxomab in patients with Non-Muscle-Invasive Bladder Cancer whose tumors have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure.

This is LintonPharm’s second clinical program evaluating catumaxomab. In July 2020, the company announced the authorization of a Phase 3 trial in advanced gastric cancer which screened its first patient in October 2020.

Recently, Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase 1 trial with catumaxomab in NMIBC patients in Germany (NCT04819399) and reported an excellent safety profile, which supports the conduct of the Phase 1/2 trial in China.

“Regulatory clearance to move forward with our clinical program evaluating catumaxomab in bladder cancer is another significant milestone for LintonPharm and supports our goal of exploring the potential for this targeted therapy in a broad range of cancers,” commented Robert Li, Ph.D., DABT, Co-founder and CEO of LintonPharm, in a press release. 

“Patients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function. New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients.”

Bladder cancer is the 10th most common cancer worldwide. In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period.

NMIBC is a cancer found in the tissue that lines the inner surface of the bladder and accounts for approximately 75 percent of all bladder cancer.

Transurethral resection of bladder tumor (TURBT) is the current standard of treatment for NMIBC. Relapse is common after TURBT (up to 70 percent at five years) and as a result, patients often undergo multiple surgical procedures over a longer period. 

Intravesical BCG is commonly used as an adjuvant treatment after TURBT. However, a large number of patients experience tumor recurrence, which is referred to as BCG failure. Radical cystectomy (RC) is usually recommended after BCG failure, but many physicians and patients refrain from RC in favor of preserving bladder function.

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites.

This bispecific antibody binds to a transmembrane glycoprotein on the tumor cell--the epithelial cell adhesion molecule (EpCAM)--and CD3 on the T cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.

Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer.

LintonPharm Co., Ltd. is a clinical-stage, research-oriented biopharmaceutical company committed to developing innovative T cell engaging bispecific antibodies with the goal of turning malignant cancers into manageable and possibly curable diseases.

Apr 12, 2021 • 2:22 pm CDT

Austria-based HOOKIPA Pharma Inc. announced on April 10, 2021, positive preliminary Phase 1 immunogenicity data for its immunotherapy candidates to treat advanced HPV16+ cancers.

The data demonstrated a robust increase in HPV16+-specific T cells, including up to 8% of circulating CD8+ T cells, after one dose of HB-201 or HB-202. And early data on HB-201 monotherapy show an increase in interferon-gamma and other immune stimulatory cytokines after a single dose, highlighting immune system activation.

Furthermore, late-breaking data presented at the AACR Annual Meeting reinforced promising anti-tumor activity reported in 2020 and underscore the potential of HOOKIPA’s novel arenavirus platform to deliver transformational cancer therapies.

“Treatment options are limited for people with metastatic HPV16+ cancers, and the likelihood for long-term survival is low,” stated Dmitriy Zamarin, M.D., Ph.D., Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center and co-investigator in this study, in a press release.

“We don’t often see this robust and high-quality immune response, particularly in antigen-specific CD8+ T cells, from a single dose and without any combination therapy. I’m excited to see how these early immunogenicity data may translate to clinical outcomes in the future.”

The company stated 'these preliminary immunogenicity data reinforce the promising anti-tumor activity reported from this trial in December 2020 and are consistent with recently published preclinical data, which showed that intravenous HB-201 administration induced single-digit percentage of antigen-specific CD8+ T cells, while alternating administration of HB-201 and HB-202 induced a potent CD8+ T cell response, exceeding 50% of the circulating T cell pool.'

As the HB-201/HB-202 clinical trial is ongoing, HOOKIPA indicated it expects to present additional translational and clinical data at upcoming medical conferences in 2021.

HOOKIPA Pharma Inc. (HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform reprograms the body’s immune system.

Apr 8, 2021 • 2:56 pm CDT

California-based Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001).

Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.

Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse.

“A metastatic TNBC diagnosis is frightening. As an aggressive and difficult-to-treat disease, it’s a significant advance to have an FDA-approved treatment option with a proven survival benefit for patients with metastatic disease that continues to progress,” commented Ricki Fairley, Founder, and CEO of Touch, the Black Breast Cancer Alliance, in a press statement.

“For far too long, people with metastatic TNBC had very few treatment options. Today’s news continues the progress of bringing more options to treat this devastating disease.”

TNBC is an aggressive type of breast cancer, accounting for approximately 15% of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is more prevalent in African American and Hispanic women

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Mar 31, 2021 • 10:44 am CDT

North Carolina-based Istari Oncology, Inc. announced that the first patient was dosed in the LUMINOS-102 phase 2 clinical trial, which will assess the safety and efficacy of PVSRIPO alone or in combination with a programmed death receptor-1/ligand 1 (PD-1/L1) inhibitor in patients with melanoma who are resistant to these checkpoint therapies.

PVSRIPO is a novel viral immunotherapy that activates the innate and adaptive immune system to stimulate the production of a functional, systemic anticancer CD8+ T cell response.

“Anti-PD-1/L1 therapies have been a major advancement in melanoma treatment, however, many patients develop resistance or never respond in the first place,” said Matt Stober, President, and CEO at Istari Oncology, in a related press statement.

“We are very optimistic about the prospects for the phase 2 trial. PVSRIPO monotherapy has already shown clinical activity in this population, and its mechanism is synergistic with anti-PD-1/L1 therapies, so we believe the combination may provide even more benefit.”

Following positive phase 1 results, the phase 2 trial will further explore PVSRIPO’s impact on this population of patients in severe need of additional therapeutic options.

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Mar 28, 2021 • 10:01 am CDT

A new study published in the journal Nature on March 25, 2021, reveals promising results of phase 1 clinical trial testing of a novel brain cancer vaccine that's designed to assist a patient's immune system respond to certain brain tumors.

Diffuse gliomas are a type of brain cancer that is difficult to treat and can spread well across the brain, making it extremely difficult to eliminate through conventional surgery.

The published data suggest that the IDH1 peptide vaccine stimulated a critical immune response that slows tumor progression.

The NOA-16 study included 36 patients and met its primary endpoints by demonstrating the safety and immunogenicity of IDH1-vaccine in patients with newly diagnosed WHO grade 3 and 4 IDH1(R132H)+ astrocytomas without further positive prognostic factors.

Immunogenicity, irrespective of HLA type, and the high rate of PsPD warrant further clinical investigation of IDH1-vac. Patients who did not mount an IDH1-vac induced immune response showed reduced efficacy of the vaccine and disease progression within two years.

Targeting a shared clonal driver mutation in newly diagnosed patients overcomes these limitations6. It may provide a basis for future trials that target MHCII-restricted clonal shared and personalized neoepitopes in cancer immunotherapy.

Currently, a larger Phase 2 clinical trial is being planned, said these researchers.

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Mar 28, 2021 • 9:45 am CDT

The U.S. Food and Drug Administration (FDA) announced the approval of Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.

Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.

“The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement issued on March 27, 2021.

“While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual’s age and the stage of the condition at the time of diagnosis. Today’s approval provides a new treatment option for patients who have this uncommon type of cancer.” 

Multiple myeloma is an uncommon type of blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in many bones of the body. This disease keeps the bone marrow from making enough healthy blood cells, resulting in low blood counts, says the FDA.

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Mar 25, 2021 • 6:29 am CDT

New York-based Pfizer Inc. announced today real-world evidence (RWE) demonstrating that first-line therapy with IBRANCE® (palbociclib) in combination with letrozole was associated with improved real-world progression-free survival (rwPFS) and overall survival (OS) in women with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (mBC) compared with letrozole alone.

This analysis showed the two-year OS rate was 78.3% in the IBRANCE group and 68.0% with letrozole. The rwPFS and OS benefits were generally consistent across all subgroups, including younger patients (18-50 years of age) and site or extent of metastases.

IBRANCE is an oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression.

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research.

Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development, stated in a press release, “With more than six years of patient experience, a positive benefit-risk profile, strong clinical data, and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”

Since the U.S. Food and Drug Administration's initial approval more than six years ago, IBRANCE has been prescribed to more than 380,000 patients across more than 100 countries.

Pfizer Oncology is committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood, and lung cancers, as well as melanoma.

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Mar 24, 2021 • 8:56 am CDT

New Jersey-based Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, an anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

KEYTRUDA works by increasing the body’s immune system's ability to help detect and fight tumor cells, says Merck.

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% and reduced disease progression or death by 35% versus FU and cisplatin alone.

The ORR, an additional efficacy outcome measure, was 45% for patients who received KEYTRUDA plus FU and cisplatin and 29% for those who received FU and cisplatin alone.

Dr. Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center, stated in a press release, “Today’s approval of this indication for KEYTRUDA introduces a new option, which has shown a superior survival benefit compared to FU and cisplatin alone, for newly diagnosed patients with locally advanced or metastatic esophageal or GEJ carcinoma that is not amenable to surgical resection or definitive chemoradiation, regardless of PD-L1 expression status and tumor histology.”

Esophageal cancer begins in the inner layer (mucosa) of the esophagus and grows outward. Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. In the U.S., about 67% of newly diagnosed esophageal cancer cases were adenocarcinoma, and 33% were squamous cell carcinoma. It is estimated there will be approximately 19,260 new cases of esophageal cancer diagnosed and about 15,530 deaths resulting from the disease in the U.S. in 2021.

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives.

Mar 22, 2021 • 3:44 pm CDT

The journal PLOS published a cost-effectiveness analysis on March 11, 2021, using models that are part of the Cancer Intervention and Surveillance Modeling Network (CISNET) to evaluate the cost-effectiveness of extending HPV vaccination in females and males up to ages 30, 35, 40, or 45 years.

This study found HPV vaccination of women and men aged 30 to 45 years provides limited health benefits at the population level, at a substantial cost (HPV vaccine prices).

This sensitivity analysis revealed that assumptions about cervical screening compliance, vaccine costs, and the natural history of noncervical HPV-related cancers could have major impacts on the vaccination strategies' estimated cost-effectiveness.

However, even with the most extreme assumptions, both models almost universally found that the cost-effectiveness of HPV vaccination for adults aged 30 to 45 years was greater than $200,000 per QALY.

'Where possible, we erred in the direction of making assumptions that were favorable to increasing the age of vaccination, including assuming no delay between the reduction in HPV infections from vaccination and the reduction in genital warts,' concluded these researchers.

A nonavalent human papillomavirus vaccine (Gardasil 9) has been licensed for women and men up to age 45 years in the USA. 

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Mar 13, 2021 • 10:47 am CST

California-based Anixa Biosciences, Inc. announced that the European Patent Office has issued and published the first European patent for its novel ovarian cancer vaccine technology. 

The patent is titled "Ovarian Cancer Vaccines," and the inventors are Drs. Vincent K. Tuohy, Suparna Mazumder, and Justin M. Johnson, all of Cleveland Clinic. This technology was developed at Cleveland Clinic, and Anixa is the worldwide licensee.

"The ovarian cancer vaccine targets a protein (the Extracellular Domain of the Anti-Mullerian Hormone Receptor 2, AMHR2-ED) that is expressed only in the ovaries and only in pre-menopausal women.  After menopause, the target protein disappears and is only seen again when ovarian cancer cells arise.  Our vaccine targets the AMHR2-ED and trains the immune system to destroy these cancer cells as they arise," commented Dr. Vincent Tuohy of the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute in a press release issued on March 12, 2021.

"We are looking forward to our continued alliance with Anixa Biosciences to develop this technology further."

Anixa is a publicly-traded biotechnology company developing several programs addressing cancer and infectious disease.

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Mar 10, 2021 • 11:02 am CST

To update its 2013 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the accuracy of screening for lung cancer with low-dose computed tomography (LDCT) and on the benefits and harms of screening for lung cancer, reported a study published by the JAMA on March 9, 2021.

The USPSTF announced it now recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

Furthermore, screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.

The USPSTF concluded with moderate certainty that annual screening for lung cancer with LDCT has a moderate net benefit in persons at high risk of lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking.

Lung cancer is the second most common cancer and the leading cause of cancer death in the US. In 2020, an estimated 228 820 persons were diagnosed with lung cancer, and 135 720 persons died of the disease.1

The most important risk factor for lung cancer is smoking.2,3 Smoking is estimated to account for about 90% of all lung cancer cases, with a relative risk of lung cancer approximately 20-fold higher in smokers than in nonsmokers.3 Increasing age is also a risk factor for lung cancer. The median age of diagnosis of lung cancer is 70 years.

Lung cancer has a generally poor prognosis, with an overall 5-year survival rate of 20.5%. However, early-stage lung cancer has a better prognosis and is more amenable to treatment.

Mar 5, 2021 • 6:40 am CST

On International human papillomavirus (HPV) Awareness Day, Tennessee-based St. Jude Children's Research Hospital announced the HPV Cancer Prevention Program's launch. With an investment of $12 million, St. Jude is launching outreach programs to reduce HPV-related cancer deaths by increasing vaccination rates locally, nationally, and eventually, globally.

Heather Brandt, Ph.D., leads the St. Jude HPV Cancer Prevention Program.

"Since 2006, we have had a safe, effective, and durable vaccine to prevent six types of HPV-related cancers in men and women," Brandt stated in a press release.

"However, rates of this cancer-prevention vaccination remain low, especially in areas of the Southeastern and Mid-Southern United States where HPV-related cancer rates are high. We also know there are vast differences in uptake among some populations, so there is an urgent need to address these inequities."

"Far too few have taken advantage of this cancer prevention tool, and I look forward to joining forces with other partners to improve vaccination rates."

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Mar 4, 2021 • 2:55 pm CST

The National Comprehensive Cancer Network (NCCN) recently released preliminary guidelines for COVID-19 vaccination in patients with cancer.

The new Recommendations of the NCCN COVID-19 Vaccination Advisory Committee state:

  • Patients with cancer should be prioritized for vaccination (CDC priority group 1b/c) and immunized when vaccination is available to them.
  • Immunization is recommended for all patients receiving active therapy, understanding that there are limited safety and efficacy data in these patients.
  • Reasons for delay of vaccines are similar to those that impede delivery to the general public (eg, recent exposure to COVID-19), and there are also cancer-specific factors.
  • Vaccination should be delayed for at least 3 months following hematopoietic cell transplantation or engineered cellular therapy (eg, chimeric antigen receptor [CAR] T cells) to maximize vaccine efficacy.

The NCCN says 'vaccination prioritization is challenging to develop when considering the diverse population of patients with varied comorbidities, demographic and social factors known to increase risk of COVID-19 acquisition, morbidity, and/or mortality. Decisions must be made in accordance with state and local vaccine guidance on allocation.'

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Mar 2, 2021 • 4:04 pm CST

California-based NGM Biopharmaceuticals, Inc. announced it had dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients with metastatic pancreatic cancer.

NGM120 is an antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling.

This placebo-controlled study will evaluate the effect of NGM120 on both cancer and cancer-related cachexia.

Cachexia is the uncontrolled wasting of both skeletal muscle and fat linked to many cancers. It is estimated to affect 60% to 80% of advanced cancer patients and to be responsible for approximately 30% of all cancer deaths. 

This proof-of-concept expansion represents a pre-planned progression of an ongoing Phase 1a/1b dose-finding clinical trial NGM is conducting in patients with select advanced solid tumors and metastatic pancreatic cancer.

“We are pleased to advance NGM120 into a placebo-controlled, Phase 1b expansion in patients with metastatic pancreatic cancer. Patients with this aggressive disease are in particularly dire need of therapeutic solutions to fight their disease and enhance their quality of life,” commented Alex DePaoli, M.D., SVP, Chief Translational Officer at NGM, in a press release.

“Our approach of targeting the GDF15 receptor, GFRAL, gives NGM120 a novel profile in the GDF15 inhibition space and enables us to evaluate NGM120 as a potential treatment for both cancer-related cachexia and underlying cancer.”

NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on a scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases, and oncology. 

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Mar 1, 2021 • 9:34 am CST

France-based Transgene and BioInvent International AB announced that the first patient in a Phase I/IIa clinical trial of the novel dual mechanism-of-action oncolytic Vaccinia virus BT-001 had been enrolled at Institut Bergonié, located in Bordeaux, France.

By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. Also, delivering the anti-CTLA4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity.

Consequently, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA4 antibody will be greatly improved.

Hedi Ben Brahim, Chairman, and CEO of Transgene, stated in a press release, “This first Invir.IO™ based oncolytic virus entering the clinic has been shown to induce long-lasting antitumor immune responses and abscopal effects in several preclinical tumor models; in these experiments, the activity of BT001 was further enhanced through combination with an anti-PD-1 antibody treatment. It has a unique mode of action, and the outstanding results so far indicate it could make a significant difference to cancer patients.”

Transgene (Euronext: TNG) is a publicly-traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.

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