Patients

At H3, patients are our inspiration, purpose and partners in our research and development; all of our efforts focus on both giving hope and working to make a positive difference in our patients’ lives. Clinical programs assess patients’ personal disease characteristics, then leverage rigorous biology and chemistry with continually updated medical feedback to identify the right patient populations who may benefit from our investigational medicines. By involving patients, their caregivers and health care providers in our research, H3 aims to bring clinically meaningful products to market faster and more efficiently.

Diseases We Study

Breast Cancer (ER+, HER2-)

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There are many types of breast cancer and ways to describe them. At H3 the breast cancer studies focus on patients with estrogen receptor alpha (ER-alpha) positive, human epidermal growth factor receptor 2 (HER-2)-negative breast cancer. Both ER-alpha and HER-2 are proteins that may be expressed on breast cancer cells. In patients who are ER-alpha positive/HER-2 negative, tumor tissue may express either a normal or mutated version of the ER-alpha protein without the overexpression of HER-2 protein.1,2 Clinical trials underway at H3 are testing a targeted oral drug, H3B-6545, a selective estrogen receptor covalent antagonist (SERCA). Administered alone or in combination with other cancer therapies, H3B-6545 is in a new class of endocrine therapies designed to inactivate estrogen receptors, thereby targeting breast cancer caused by normal or mutated version of ER-alpha protein.1

Hepatocellular Carcinoma

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Livers cancers are the fourth most common cause of cancer death worldwide. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer with increasing incidence worldwide; in selected countries, a 35% increase is predicted from 2005 to 2030, resulting in over 459,000 new cases annually.3 HCC most often occurs in people with chronic liver diseases such as cirrhosis caused by hepatitis B or C infection or alcohol abuse. Therapy typically is multi-pronged, depending on factors such as tumor stage, liver function, or other medical conditions.4 H3’s HCC study is testing a targeted oral drug, H3B-6527. H3B-6527 inhibits aberrant fibroblast growth factor receptor 4 (FGFR4) pathway activation, identified as a potentially key genetic driver of both tumor development and dependency in a subset of patients with advanced HCC.5

AML/Myelodysplastic Syndrome

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Hematologic malignancies are cancers that affect the body’s blood and lymph system.6 The cancer may begin in blood-forming tissue such as bone marrow or in the cells of the immune system.7,8 H3’s MDS, AML, and CMML leukemia study is testing a targeted oral drug, H3B-8800. H3B-8800 is being investigated as a potential treatment for patients with hematological malignancies through targeting core RNA splicing machinery,6 specifically modulating wild-type and mutant SF3b1 complexes.

Bladder Cancer

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Bladder cancer is the tenth most common cancer worldwide, occurring in men more frequently than women and usually affecting older adults.9 Causes can include smoking or other tobacco use, exposure to chemicals, past radiation exposure, or parasitic infections.10 At H3 the current bladder cancer study is focused on non-muscle invasive bladder cancer (NMIBC), which is a cancer found in the cells that line the inside of the bladder. An investigational intra-vesical therapy, E7766, aims to activate and mobilize the body’s own immune system to fight invading cancer cells.11 Among patients who qualify are those who fail the current first line therapy, Bacillus Calmette-Guerin (BCG).

All agents are investigational. The diseases highlighted are chosen based on ongoing clinical trials and each agent’s proposed site of action and suggested biologic activity. This is not meant to convey conclusions of safety or effectiveness towards these diseases prior to any regulatory approval from a health authority. There is no guarantee that any of these agents will successfully complete clinical development or be available commercially.

Clinical Trials

This information is from the ClinicalTrials.gov website and is current as of May 12, 2020. For questions or to request more information, please contact the H3 clinical team directly at clinicaltrials@H3Biomedicine.com

Trial of H3B-6545, in Women with Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Additional details and information on how to connect with a study center can be found here.

  • Program: H3B-6545
  • Disease: Breast Cancer
  • Status: Active, not recruiting
  • Phase: 1/2
A Study of H3B-6545 in Combination with Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

Additional details and information on how to connect with a study center can be found here.

  • Program: H3B-6545
  • Disease: Breast Cancer
  • Status: Not yet recruiting
  • Phase: 1
A Phase 1 Study to Evaluate H3B-8800 in Participants with Myelodysplastic Syndrome, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

Additional details and information on how to connect with a study center can be found here.

  • Program: H3B-8800
  • Disease: Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML)
  • Status: Active, not recruiting
  • Phase: 1
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants with Advanced Hepatocellular Carcinoma

Additional details and information on how to connect with a study center can be found here.

  • Program: H3B-6527
  • Disease: Advanced Hepatocellular Carcinoma
  • Status: Recruiting
  • Phase: 1
Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants with Advanced Solid Tumors or Lymphomas

Additional details and information on how to connect with a study center can be found here.

  • Program: E7766
  • Disease: Lymphoma, Advanced Solid Tumors
  • Status: Recruiting
  • Phase: 1
Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Additional details and information on how to connect with a study center can be found here.

  • Program: E7766
  • Disease: Urinary Bladder Neoplasms
  • Status: Not yet recruiting
  • Phase: 1

Patient Resources

The following is a collection of organizations that offer information about certain cancers and clinical trials for patients, families, their caregivers and healthcare providers. Visit these resources for more information about treatment, research, clinical trials and other tools.

Investigational Medication

H3 Biomedicine also supports expanded access to investigational products where there is preliminary scientific evidence to support the use of a product for an indication when it is logistically feasible and when permitted by applicable law.

Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. The intent of an expanded access program is to provide patients with access to investigational medication for serious diseases or conditions where there is no comparable or satisfactory alternative therapy available. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.

H3 Biomedicine will consider a number of factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines when reviewing requests for expanded access.

All individual requests will be evaluated in a fair, unbiased manner, and we anticipate acknowledging receipt of requests sent to clinicaltrials@h3biomedicine.com within five (5) business days.

At this time, H3 Biomedicine believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. If you have additional questions, please speak with your physician or contact clinicaltrials@h3biomedine.com.

Consistent with the 21st Century Cures Act, H3 Biomedicine is publicly disclosing their policy on making investigational drugs available for expanded access and may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.

References

  1. Waks AG, Winer EP. Breast cancer treatment: A review. JAMA 2019 Jan; 321(3): 288 – 300.
  2. Harbeck N, Gnant M. Breast cancer. Lancet 2017 Mar; 389(10074): 1134 – 1150.
  3. Valery P, Laversanne M, Clark P, Petrick J, McGlynn K, Bray F. Projections of primary liver cancer to 2030 in 30 countries worldwide. Hepatology. 2018 February; 67(2): 600-611.El Jabbour T,
  4. El Jabbour T, Lagana SM, Lee H. Update on hepatocellular carcinoma: Pathologists’ review. World J Gastroenterol 2019 Apr; 25(14): 1653-1665.
  5. 5McGlynn KA, Petrick JL, El-Serag HB. Epidemiology of hepatocellular carcinoma. Hepatology 2020 Apr. doi: 10.1002/hep.31288. [Epub ahead of print].
  6. Patnaik, M.M., Tefferi, A. Chronic Myelomonocytic leukemia: 2020 update on diagnosis, risk stratification and management. Am J Hematol 2020; 95(1):97-115.
  7. Coltro G, Patnaik MM. Chronic Myelomonocytic leukemia: Insights into biology, prognostic factors, and treatment. Curr Oncol Rep 2019; 21(11): 101.
  8. Emadi A, Karp JE. Acute Leukemia: An Illustrated Guide to Diagnosis and Treatment. Demos Medical Publishing; 2017.
  9. Cooley LF, McLaughlin KA, Meeks JJ. Genomic and therapeutic landscape of non-muscle-invasive bladder cancer. Urol Clin North Am. 2020 Feb; 47(1): 35 – 46.
  10. Malats N, Real FX. Epidemiology of bladder cancer. Hematol Oncol Clin North Am. 2015 Apr; 29(2): 177 – 89.
  11. Golla V, Lenis AT, Faiena I, Chamie K. Intravesical therapy for non-muscle invasive bladder cancer – Current and future options in the age of Bacillus Calmette-Guerin shortage. Rev Urol. 2019; 21(4): 145-153.

Curious about our clinical trials?

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