Arvinas Announces Pipeline Programs Targeting Validated and Classically “Undruggable” Disease-Causing Proteins

Rhea-AI Summary

Arvinas, Inc. (Nasdaq: ARVN) announced significant updates to its preclinical pipeline, revealing five new programs targeting oncology, immuno-oncology, and neuroscience. The company aims to enhance its leadership in targeted protein degradation with its PROTAC® Discovery Engine. Key targets include BCL6, KRAS, Myc, HPK1, and mHTT, with plans to file INDs by 2022 and 2023. Clinical trials are ongoing for ARV-110 and ARV-471, with data updates expected in Q4 2020. This expansion underscores Arvinas' commitment to addressing high unmet medical needs in various disease areas.

Positive

• Introduction of five new preclinical programs targeting BCL6, KRAS, Myc, HPK1, and mHTT.
• Ongoing clinical trials for ARV-110 and ARV-471, which focus on significant cancer types.
• Anticipated IND filings for KRAS and BCL6 programs in 2022 and 2023, respectively, indicating potential future revenue streams.

Negative

• The progress of clinical trials and regulatory submissions relies heavily on future outcomes, posing risks to timelines.
• There is uncertainty surrounding the successful execution of Phase 1/2 clinical trials for ARV-110 and ARV-471.

NEW HAVEN, Conn., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced platform updates and disclosed five additional programs from its preclinical pipeline. Arvinas’ portfolio encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience.

“We continue to expand our pipeline and further our leadership position in targeted protein degradation by leveraging the PROTAC® Discovery Engine, our integrated platform that we’ve been advancing since 2013,” said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. “With the programs introduced today, and the important breakthroughs we’ve made over the years – such as achieving oral bioavailability in human patients and successfully penetrating the blood-brain barrier in preclinical studies – we make it clear that we have the ability to rapidly progress Arvinas’ deep pipeline in order to benefit patients in multiple areas of high unmet need.”

“The targets we announced today represent a mix of oncology, immuno-oncology and neuroscience programs,” said Ian Taylor, Ph.D., Chief Scientific Officer of Arvinas. “Our progress with classic ‘undruggable’ targets like KRAS reinforces our commitment to finding solutions for patients and demonstrates the power of Arvinas’ PROTAC® Discovery Engine in generating novel therapies.”

In addition to progressing its platform and preclinical pipeline, Arvinas is testing two PROTAC® protein degraders in human clinical trials: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. Arvinas plans to share updated data for these programs later in the fourth quarter of 2020.

Newly Announced Programs

BCL6 (Oncology)

• B-cell lymphoma 6 protein (BCL6) is a transcriptional repressor implicated in B cell lymphomas and facilitates B cell tolerance of rapid proliferation and somatic gene recombination via repressing cell cycle checkpoints, terminal differentiation, apoptosis, and the DNA damage response. PROTAC®-mediated degradation would address the scaffolding function of BCL6. Arvinas anticipates filing an IND for this program in 2022.
  

KRAS (Oncology)

• Kirsten rat sarcoma (KRAS) is a classic “undruggable” target, due to its lack of deep “pockets,” and is associated with poor prognosis and resistance to standards of care in several tumor types. Arvinas is developing pan-KRAS mutant and mutant-specific KRAS degraders, e.g., G12D and G12V. Arvinas anticipates filing an IND for this program in 2023.
  

Myc (Oncology)

• Myelocytomatosis (Myc) proteins are implicated in up to 70% of all human cancers. Targeting Myc indirectly, such as by inhibiting transcription modulators, has not been successful, but PROTAC®-mediated degradation has the potential to directly target and degrade Myc. This is an Exploratory-stage program.
  

HPK1 (Immuno-oncology)

• Hematopoietic progenitor kinase 1 (HPK1) is a suppressor of T cell activation and targeting HPK1 can enhance anti-tumor immune responses. PROTAC®-mediated degradation has the potential to address the proposed scaffolding component of HPK1’s activity. This is an Exploratory-stage program.
  

mHTT (Neuroscience)

• Huntington’s disease is caused by a mutation in the huntingtin (HTT) gene. PROTAC® degradation has the potential to allow the selective targeting of mutant HTT protein without impacting wild-type HTT protein. This is an Exploratory-stage program.
  

About Arvinas
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, such as statements with respect to our lead product candidates, ARV-110 and ARV-471 and other candidates in our pipeline, and the timing of clinical trials and data from those trials, and our development programs that may lead to our development of additional product candidates, the potential utility of our technology and therapeutic potential of our product candidates and the potential commercialization of any of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the “Risk Factors” sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts for Arvinas

Investors
Will O’Connor, Stern Investor Relations
ir@arvinas.com

Media
Kirsten Owens, Arvinas Communications
kirsten.owens@arvinas.com

FAQ

What are the new programs announced by Arvinas on October 14, 2020?

Arvinas announced five new preclinical programs targeting BCL6, KRAS, Myc, HPK1, and mHTT, focusing on oncology, immuno-oncology, and neuroscience.

When does Arvinas plan to file INDs for its new programs?

Arvinas plans to file INDs for the BCL6 program in 2022 and the KRAS program in 2023.

What clinical trials is Arvinas currently conducting?

Arvinas is conducting clinical trials for two candidates, ARV-110 for metastatic castrate-resistant prostate cancer and ARV-471 for ER+/HER2- breast cancer.

When will Arvinas provide updates on its clinical trial data?

Arvinas plans to share updated data for its clinical trials in the fourth quarter of 2020.

What is the significance of the PROTAC® Discovery Engine for Arvinas?

The PROTAC® Discovery Engine is critical for Arvinas as it enables the development of targeted protein degraders, addressing 'undruggable' targets in cancer and other diseases.