FDA Clears VIP152 IND for Richter Syndrome, CLL

 

According to a recent news release, the FDA cleared an Investigational New Drug (IND) application for VIP152, a potential therapeutic option for patients with Richter syndrome and relapsed/refractory chronic lymphocytic leukemia (CLL). The treatment, developed by recently formed biopharmaceutical and life sciences company Vincerx Pharma Inc. (“Vincerx”), is intravenously administered. Now that the IND has been cleared, Vincerx may move forward with a Phase 1b dose escalation trial to determine the ideal dose for patient use.

VIP152

According to the Vincerx website, VIP152 is a PTEFb/CDK9 inhibitor which:

inhibits PTEFb phosphorylation of RNA polymerase II (RNAPII), thereby preventing transcription elongation and blocking expression of genes that drive cancer.

Outside of Richter syndrome and CLL, VIP152 is also being explored as a potential option for patients with non-Hodgkin’s lymphoma (NHL), solid tumors, and acute myeloid leukemia (AML). In preclinical studies, VIP152 showed the ability to significantly inhibit CDK9 and help maintain sustained responses in tumor suppression.

Now, the VIP152 NDA is FDA-cleared. According to the FDA:

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement.

The IND is the vehicle through which sponsors (in this case, Vincerx) can provide the drug to clinical trials. However, since Vincerx has received their IND, the company may now launch the Phase 1b study. In the first part of the study, previously treated patients with CLL may enroll. Patients should have had poor responses to at least 2 or more other treatments, including either venetoclax or a Bruton tyrosine kinase inhibitor (BTKi).

During the study’s second phase, 20 patients with CLL will enroll. In the expansion cohort, another 20 patients with CLL will enroll. But in the case of the expansion cohort, these patients’ CLL has moved to diffuse large B cell lymphoma (DLBCL). Much like the first phase of the study, enrolled patients must have treatment-averse cancer.

Richter Syndrome

Also known as Richter’s transformation, Richter syndrome is a rare complication in patients with chronic lymphocytic leukemia (CLL). Altogether, an estimated 2-10% of patients with CLL will develop Richter syndrome. Ultimately, this causes CLL to transform into a more aggressive form of cancer, such as DLBCL. While doctors are not sure what causes Richter syndrome to occur, many believe it is caused by some sort of underlying genetic basis. Symptoms and characteristics include:

  • Unintended weight loss
  • Night sweats
  • Sudden lymph node expansion/swelling
    • Note: This may also lead to swelling in the areas where the lymph nodes are located, such as the groin, neck, or abdomen.
  • Dizziness
  • Fatigue
  • Shortness of breath and/or difficulty breathing
  • Easy bruising and bleeding
  • Spleen enlargement
  • Abdominal pain
  • Thrombocytopenia (low platelet count)
  • Fever
  • Heart palpitations

Learn more about Richter syndrome here.

Chronic Lymphocytic Leukemia (CLL)

In chronic lymphocytic leukemia (CLL), a blood and bone marrow cancer, DNA mutations in blood-producing cells cause blood cells to create abnormal and ineffective white blood cells called lymphocytes. Normally, lymphocytes play a role in immune health. But when too many abnormal lymphocytes accumulate, they crowd healthy cells out of the bone marrow. Ultimately, this causes a variety of health-related issues. In adults, CLL is the second most common form of leukemia. Symptoms, which often occur at later stages, include:

  • Fever
  • Fatigue
  • Unintended weight loss
  • Spleen enlargement
  • Easy bruising and bleeding
  • Petechiae under the skin
  • Abdominal pain
  • Enlarged, but painless, lymph nodes
  • Night sweats
  • Frequent infections
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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