On December 9, 2021 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported a series of events in December 2021 that will highlight various aspects of its DARPin cancer therapeutic portfolio (Press release, Molecular Partners, DEC 9, 2021, View Source [SID1234596685]). These events include a presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) Congress, focused on the clinical-stage fibroblast activation protein (FAP)-targeted CD40 activator candidate, MP0317; a presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, focused on MP0533, the company’s acute myeloid leukemia (AML) candidate, designed to simultaneously engage CD3 on T cells and target three tumor associated antigens (TAAs); and a comprehensive review of the company’s cancer portfolio and its research & development strategy at a virtual Oncology Day to be held at 8:30 am ET on December 15, 2021.

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"Our growing understanding of cancer biology enables us to expand and enhance our oncology portfolio. We carefully analyze clinical results of antibodies, their targets, and the underlying biology, with a focus on near misses. We then apply our DARPin technology to overcome these problems to offer solutions to patients in need," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Data shared this month will show how our current cancer therapeutic portfolio addresses difficult targets and modes of action. At our Oncology Day, we will discuss further extensions of our platform in cancer as part of our corporate strategy to build out our offering in areas where the unique DARPin protein drug class can make a meaningful impact for patients."

Details of the events follow:

ESMO Immuno-Oncology (onsite and online congress), Geneva, Switzerland; December 8-11, 2021
At ESMO (Free ESMO Whitepaper)-IO, Molecular Partners will focus on MP0317, which targets both fibroblast activation protein (FAP) and the immunostimulatory protein CD40 to enable tumor-localized immune activation in solid tumors. Through this mechanism, MP0317 is designed to activate immune cells specifically within the tumor microenvironment, potentially delivering greater efficacy with fewer side effects compared to other CD40-targeting agents. MP0317 is the second DARPin immuno-oncology therapeutic candidate to enter clinical trials. Its Phase 1 first-in-human clinical study design includes collection of a wide array of biomarkers to support the establishment of combination therapies in specific indications.

A poster reviewing the MP0317 Phase 1 study will be on display throughout the conference.
A presentation on MP0317 will be presented on December 10:
Title: The development of MP0317 FAP X CD40 agonist DARPin
Educational Session: Emerging Immunotherapy platforms: From bispecifics to cell transfer therapy
Date: Friday, December 10
Time: 5:00-6:30 pm ET
Location: Virtual / Hall C
63rd ASH (Free ASH Whitepaper) Annual Meeting & Exposition, Atlanta, Georgia, U.S.; December 11-14, 2021
At ASH (Free ASH Whitepaper), Molecular Partners will focus on MP0533, its DARPin candidate for acute myeloid leukemia (AML). MP0533 is designed to target AML cells, especially leukemic stem cells (LSCs), via the three tumor-associated antigens CD33, CD70 and CD123, and bind CD3 on T cells to induce tumor cell killing. MP0533 preferentially targets AML cells via an avidity dependent mechanism which increases the candidate’s total binding strength when two or more antigens are bound. This leads to T-cell mediated killing of these malignant cells upon CD3 engagement, while healthy cells, which express only one of these targets or none, are left unharmed.

In previously reported preclinical work, Molecular Partner’s AML program has demonstrated the potential to improve upon the therapeutic window of CD3-activated T cell engagers through reducing dose-limiting toxicity via its unique avidity-driven targeting mechanism. The research at ASH (Free ASH Whitepaper) will review prior work from the program and share new ex vivo and in vivo studies supporting MP0533’s anti-tumor activity and enhanced therapeutic window, relative to another CD3-activating molecule. More specifically, we will show that MP0533 is able to induce the killing of AML patients’ malignant cells by the patients’ own T cells, demonstrating that AML patients could respond to MP0533 despite a potentially weaker T cell response. We will further demonstrate that such an efficacy may be achieved without impacting the safety profile of MP0533, as demonstrated by specific killing of LSCs while preserving healthy hematopoietic stem cells. Clinical development of MP0533 is expected to initiate in 2022.

A poster reviewing the preclinical development of MP0533 will be displayed on December 11 accompanied by an oral presentation.
Title: Avidity-Engineered CD3 Engaging DARPin Targeting Three Tumor Associated Antigens Induce Strong and Specific T Cell Dependent Killing of AML Cells with Potential for Improved Safety
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I
Date: Saturday, December 11, 2021
Time: 5:30 PM – 7:30 PM ET
Location: Virtual / Georgia World Congress Center, Hall B5

Molecular Partners Virtual Oncology Day (online only), 8:30 am ET, December 15. Register here.
Molecular Partners will host a virtual session with its management team focused on cancer portfolio and strategy, including MP0310, MP0317, MP0533 and additional research programs. After a brief corporate review, the session will explore the underlying biology, candidate design and preclinical data supporting each oncology or immuno-oncology program, as well as the underlying development strategy and new opportunities for the portfolio. Molecular Partners management will be joined by leading AML experts Professors Ochsenbein and Riether from the University of Bern.

Relevant materials from the above events will be shared via Molecular Partners’ website investor portal at investors.molecularpartners.com.

On December 9, 2021 Investigators from US Oncology Research, The US Oncology Network (The Network), and OntadaTM reported that it will share results from more than 30 studies exploring areas such as diffuse large B cell lymphoma, non-Hodgkin lymphoma, multiple myeloma and hematological adverse event management in the community oncology setting at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, US Oncology, DEC 9, 2021, View Source [SID1234596681]). The ASH (Free ASH Whitepaper) Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will take place in Atlanta, Georgia and virtually from Dec. 11-14, 2021.

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"We are making tremendous strides in caring for a wide array of hematological malignancies, including hard-to-treat blood cancers, and have much more to offer patients than in years past. However, there is still need for advances," said Robert L. Coleman, MD, FACOG, FACS, chief scientific officer, US Oncology Research. "We are excited about presenting our latest findings and coming back together with the community as we continue to learn, collaborate and innovate towards improved patient outcomes."

In a late-breaking abstract session on Tuesday, Dec. 14 from 9:00 am to 10:30 am ET, results will be presented from "The POLARIX Study: Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma."

"Approximately 40 percent of patients with newly diagnosed diffuse large B-cell lymphoma are not cured with the current standard of care regimen known as R-CHOP," said study co-author John Burke, MD, a hematologist with Rocky Mountain Cancer Centers, a practice in The Network. "In the Phase 3 POLARIX study, we compared a combination of the CD79b-targeting antibody–drug conjugate, polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin and prednisone, or pola-R-CHP, with R-CHOP. The results of the POLARIX study may have significant implications for the way we treat diffuse large B-cell lymphoma in the front-line setting in the future and look forward to the findings being shared at the ASH (Free ASH Whitepaper) Meeting."

Additionally, Dr. Burke will present an abstract titled, "Efficacy and Safety of Umbralisib, Ublituximab (U2), and U2 Plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)," in an oral presentation Sunday, Dec. 12 at 5:30 pm.

"Patients with relapsed or refractory DLBCL generally have a poor prognosis, particularly if they are not candidates for autologous stem cell transplantation or experience relapse following approved CAR-T therapies. In the UNITY-NHL study, we systematically explored the efficacy and tolerability of the PI3K-d/CK1-e inhibitor, umbralisib, alone, and in combination with the glycoengineered anti-CD20 monoclonal antibody ublituximab, followed by a cohort treated with umbralisib, ublituximab and bendamustine," said lead author Dr. Burke. "We found that the triplet regimen was effective and well tolerated in patients with relapse or refractory DLBCL who were unsuitable for transplant or who had relapsed following transplant."

In an oral abstract session on Monday, Dec. 13 at 4:45 pm, results will be presented from the study, "Completed Induction Phase Analysis of Magnify: Phase 3b Study of Lenalidomide + Rituximab (R2) Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma."

"Unfortunately, people with relapsed indolent non-Hodgkin lymphoma have limited standard treatment options," said study co-author David Andorsky, MD, hematologist with Rocky Mountain Cancer Centers. "Therefore, our analysis from the induction phase of the Phase 3b MAGNIFY trial which provides additional evidence that lenalidomide combined with rituximab is active with a tolerable safety profile in a wide range of patients with relapsed or refractory disease is encouraging."

Jerome Goldschmidt, MD, oncologist at Blue Ridge Cancer Care, a practice in The Network, will present results during a poster presentation titled, "Understanding Hematological Adverse Event Management through Health Care Resource Utilization, Costs, and Treatment Patterns of Patients with Extensive-Stage Small Cell Lung Cancer Treated in the Community Oncology Setting," on Saturday, Dec. 11 from 5:30 pm to 7:30 pm. Dr. Goldschmidt, lead author of the abstract, worked with Ontada researchers on this retrospective, observational study. Ontada is an oncology real-world data and evidence, clinical education and provider technology business dedicated to improving the lives of cancer patients.

"Our study found that there is significant burden of myelosuppressive hematological adverse events among extensive stage small cell lung cancer patients in the community oncology setting. Notably, patients with grade ≥3 hematological adverse events appear to have more dose reductions, treatment delays and healthcare service utilizations than those without," said Dr. Goldschmidt. "Future research should strive to understand the full scope of hematologic adverse event management and define the role therapies that protect bone marrow from these adverse events can play in reducing this burden."

Robert Rifkin, MD, medical director of biosimilars for McKesson, associate chair of hematology research and myeloma disease lead for The US Oncology Network, and hematologist with Rocky Mountain Cancer Centers, co-authored an analysis of outcomes among people with triple-class refractory multiple myeloma titled, "Real-World Treatment Patterns and Clinical, Economic, and Humanistic Burden in Triple-Class Refractory Multiple Myeloma: Analysis of the Connect Multiple Myeloma (MM) Disease Registry." The oral presentation will take place on Saturday, Dec. 11 at 10:00 am.

"Treatment resistance remains a challenge for most multiple myeloma patients and their outcomes and health-related quality of life worsens with each line of therapy. Patients who are refractory to immunomodulatory drugs, proteasome inhibitors and anti-CD38 antibodies, or triple-class refractory, have an especially bleak prognosis and high disease burden," said Dr. Rifkin. "Data presented from the ongoing prospective Connect MM Disease Registry confirm that people with triple-class refractory multiple myeloma experience poor survival, substantial hospitalizations and a clinically meaningful decline in health-related quality of life and suggest that novel tolerable and efficacious therapeutic agents are urgently needed to address the burden of illness in triple-refractory multiple myeloma."

The full schedule of affiliated data presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or [email protected] or Edie DeVine at 209.814.9564 or [email protected].

On December 9, 2021 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) reported that the Hart-Scott-Rodino (HSR) antitrust waiting period had expired and that the parties closed the exclusive worldwide collaboration and license agreement between Syndax and Incyte to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody (Press release, Syndax, DEC 9, 2021, View Source [SID1234596680]).

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In connection with closing, Incyte paid Syndax the $117 million upfront initial license fee, and Syndax closed on Incyte’s $35 million equity investment in the company.

Additional information about the collaboration can be found in the press release announcements dated September 27, 2021, as well as in Syndax’s Form 8-K filed with the Securities and Exchange Commission (SEC) on September 27, 2021.

About Axatilimab

Axatilimab is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages along with their monocyte precursors, which has been shown to play a key role in the fibrotic disease process underlying diseases, such as chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary fibrosis (IPF). Axatilimab data has demonstrated deep, durable responses and multi-organ clinical benefit in patients with cGVHD refractory to multiple therapeutic agents, and is currently being evaluated in the global pivotal Phase 2 AGAVE-201 trial in patients with cGVHD. Axatilimab was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD and IPF. Axatilimab is being developed under an exclusive worldwide license from UCB entered into between Syndax and UCB in 2016.

On December 9, 2021 SUNY Upstate reported that Selected as one of just 30 recipients from a field of 1400 applicants nationally, the Upstate Foundation was awarded a $25,000 grant from AstraZeneca’s inaugural ACT on Health Equity: Community Solutions Challenge for the Upstate Cancer Center’s She Matters program (Press release, SUNY Upstate, DEC 9, 2021, View Source [SID1234596679]).

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This award stems from AstraZeneca’s commitment to advance health equity through collaboration with non-profit organizations positively impacting the health of underserved populations through regional and local community-based programming.

She Matters is a peer-to-peer community outreach program of the Upstate Cancer Center to reduce breast cancer disparities in low income, primarily Black and Latinx women living in public housing in Syracuse. Working in partnership with the Syracuse Housing Authority, residents are recruited to serve as community health workers (CHWs). CHWs receive training and ongoing support from the Upstate Cancer Center while working as peer health advocates. CHWs provide breast health education, offer support from navigation to screening mammography, and improve access to necessary diagnostic and treatment services. The goal is to eliminate health care barriers, change behavior and make annual breast cancer screening a priority.

Since its establishment in 2014, She Matters has reached over 3,500 women of all ages and facilitated screening in over 650 women ages 40 and above, the majority of whom are low-income, women of color who experience lapses in routine health care services. At the same time, She Matters serves as a work readiness, skill development opportunity for women who serve as CHWs.

The grant will be used to expand She Matters into additional Syracuse Housing Authority residential communities to increase access to breast cancer education, screening and navigation services.

"We are so pleased that AstraZeneca recognizes the value of the She Matters program and the important work that the team does in the community to get underserved women screened for breast cancer," explained Linda Veit, assistant vice president of community relations and interim chief of staff at Upstate. "Due to this grant, we will be able to expand the program into other public housing communities in Central New York, educate more women on screening and find more breast cancers earlier, when treatment can be most effective."

"It’s exciting to receive this funding from AstraZeneca," said Eileen Pezzi, Upstate vice president for development. "To be selected from such a large field of applicants is a testament to the importance of the work Upstate carries out every day in our community."

According to the American Cancer Society, breast cancer is the most common cancer among American women and the second leading cause of cancer death. Black women are more likely than all other women to die from breast cancer. Their tumors are often found at a later, more advanced stage when there are fewer treatment options. In order to improve health and well-being in underserved communities, especially women of color, it is critical that outreach is provided to those most at risk of early death.

About AstraZeneca’s ACT on Health Equity: Community Solutions Challenge

Through its ACT on Health Equity: Community Solutions Challenge, AstraZeneca has awarded 30 nonprofit organizations across the country support for programs focused on community health and well-being and youth STEM education and career readiness. The organizations awarded represent a variety of innovative programs providing a wide range of services that support underserved communities to improve health outcomes. Click here for a complete list of programs awarded.

On December 9, 2021 SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that interim results from the highest-dose cohort of its ongoing Phase 1/2 clinical trial of lead Antigen Presenting Cell (APC) therapy candidate targeting Human Papillomavirus positive (HPV16+) solid tumors at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress (Press release, SQZ Biotech, DEC 9, 2021, View Source [SID1234596677]). Of the five patients in this cohort evaluable for efficacy, one checkpoint refractory head-and-neck cancer patient showed a radiographic response and symptomatic improvement. The target lesion demonstrated a complete response at both radiographic assessments. At the most recent assessment, the major oropharyngeal lesion demonstrated continued improvement upon physical examination; however, a new dermal lesion was detected. The investigational therapy was well-tolerated, and no dose-limiting toxicities were observed as of October 8, 2021.

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"The combined radiographic response and symptomatic improvement observed in this patient and the strong correlation with histological data demonstrated the investigational therapy’s intended cellular vaccine mechanism at work," said study first author and presenter Jong Chul Park, MD, Medical Oncologist and Investigator, Massachusetts General Hospital Cancer Center. "This heavily treated patient with significant tumor burden in the neck had marked increases in CD8 T cell tumor infiltration which correlated with clinical improvement, including the ability to swallow more easily. SQZ-PBMC-HPV showed favorable safety data and was generally well tolerated in this patient and across all patients in the highest-dose cohort."

"While our clinical study is ongoing, we believe that this is a ‘Kitty-Hawk moment’ for the SQZ APC cell therapy platform," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "Our goal has been to develop a new generation of cell therapies – one that could potentially enable significant and broad patient impact by unlocking historically challenging biology while remaining practical and accessible. We believe this patient’s journey is consistent with the trial’s practical and rapid approach. We manufactured a cell therapy in under a day, administered it with mild treatment-related adverse events, and generated clinical benefit by marshalling the power of endogenous killer T cells. We are very excited for the advancement of this program into combination therapy and the broader future potential of SQZ cell therapy candidates."

Responder Patient Characteristics & Treatment Journey

The patient in the highest-dose cohort who achieved a complete response in the target lesion (patient 17) was a 52-year-old male diagnosed over three-and-a-half years prior to first dose with a locally advanced squamous cell carcinoma of the tonsil, a part of the oropharynx. He initially had chemo-radiation treatment but developed recurrence in the throat and the chest almost two years prior. At trial entry, patient 17 had received six prior lines of therapy, including two combination approaches with the checkpoint inhibitor pembrolizumab.

Patient 17 did not require pre-conditioning. Following a single leukapheresis session, his investigational therapy was manufactured in 18 hours and produced 7 doses.

Clinical Results

Patient 17 had marked improvement of the target lesion on physical examination and reported that his ability to swallow had substantially improved
Patient 17 experienced two low grade treatment related adverse events, i.e., grade 1 flushing and grade 1 fatigue
As of October 20, 2021, he received all seven doses of SQZ-PBMC-HPV and the investigational therapy was well tolerated
Radiographic Response

Patient 17’s main lesion was a large, diffuse, non-measurable oropharyngeal lesion
The target tumor lesion selected for response assessment was a mediastinal lymph node measuring 17.1mm in diameter, which decreased at second assessment below 10.0mm resulting in a complete response of the target lesion according to RECIST 1.1
At the second on treatment tumor assessment, despite continuing improvement of the target lesion and patient symptoms, a new dermal lesion was found in the previously irradiated region
Histologic Assays

At day 28 on treatment, patient 17’s matched tumor biopsy samples from the main oropharyngeal lesion showed an 8-fold increase in CD8 T cell tumor infiltration and a conversion of the tumor phenotype from desert to inflamed
PD-L1 expression, an additional maker of tumor inflammation, increased from 2 percent at baseline to 100 percent in the matched tumor biopsies
An RNA in situ hybridization (ISH) assay used for the detection of E6 and E7 expression demonstrated a dramatic reduction in the number of cells with high E6 and E7 antigen expression. E6 and E7 are the two antigens targeted by the SQZ APC cell therapy candidates
Highest Dose Monotherapy Cohort Interim Safety and Manufacturing Findings as of October 8, 2021

There were no observed treatment-related serious or severe (grade 3 or greater) adverse events in the highest-dose cohort
The investigational therapy was generally well-tolerated, and no dose-limiting toxicities were observed
All patient batches were produced in less than 24 hours and yielded multiple cryopreserved doses
Clinical Trial Progress

The combination stage of SQZ-PBMC-HPV-101 trial with checkpoint inhibitors (CPI) is now enrolling. The company believes the increase in PD-L1 expression observed in the patient 17 data suggests potential synergy with a CPI combinatory approach
The highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
Today’s ESMO (Free ESMO Whitepaper)-IO presentation can be found on the Events & Presentations section of the company’s website.

Conference Call
The company will host a conference call and webcast today at 8:00 a.m. ET to discuss the ESMO (Free ESMO Whitepaper)-IO presentation. Participants can join via webcast link or by dialing 1-877-805-7920 (domestic) or 1-629-228-0702 (international) five minutes prior to the start of the call. An archived webcast will be accessible for 90 days after the event.

SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.