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Cardiff Oncology Advances Colorectal Cancer Treatment

BIOTECH: ‘New Mechanism’ Discovered, Pfizer Partners on Clinical Trial

Cardiff Oncology is reaping the rewards of an exciting scientific discovery tied to its lead drug candidate for colorectal cancer.

The company’s stock is up 40% since the end of July and this fall Pfizer Ignite will execute a clinical trial for the colorectal cancer treatment.

Cardiff announced its partnership with Pfizer Ignite – a new end-to-end service for biotech companies – on Aug. 7. The news follows the release of extremely positive data from a Phase  1b/2 second-line clinical trial of Cardiff’s oral drug onvansertib used in conjunction with current standard of care drugs FOLFIRI and Avastin® in patients with KRAS-mutated metastatic colorectal cancer (mCRC) whose cancer has progressed after first-line treatment.

Mark Erlander, Ph.D.
CEO
Cardiff Oncology

“What we’re showing here is that we have really unexpected response rates for these patients,” said Cardiff Oncology CEO Mark Erlander, Ph.D., adding that 73% of patients treated with onvansertib added to the existing standard of care responded to treatment. “What that means is that the tumor shrunk considerably.”

In addition to the 73% response rate – three times the existing care rate of around 25% – the drug also kept working in patients for a median of around 15 months, up from the current standard of six to eight months.

“Triple the response rate, double the longevity of the effectiveness of the treatment – that’s really what got us excited,” Erlander said.

A New Discovery

Because of the exciting data, Cardiff scientists started looking closer at why the results were so significant.

“What we learned from a six-month process is we identified a new mechanism of how our drug works,” Erlander said. “This drug attacks the Achilles heel of cancer and how cancer cells grow – it attacks the lynch pin of the survival path of tumor cells; onvansertib hits a very central node in that pathway.”

Following the discovery of onvansertib’s new mechanism in preventing tumor cells from dividing and multiplying, Cardiff had what Erlander described as “a terrific meeting” with FDA where the regulatory agency suggested the company consider changing the clinical development path from a second-line drug treatment to the first line “to have a much bigger impact on patients.”

“That’s a huge and exciting recommendation by the FDA,” he added.

Cardiff then proposed and came to agreement with the FDA to conduct two consecutive first-line clinical trials of onvansertib with the goal of an accelerated approval followed by a formal approval.

Pfizer Relationship Expanded

Jamie Levine
CFO
Cardiff Oncology

With an accelerated approval plan green-lighted by FDA, Cardiff was in a good position to expand its relationship with Pfizer. The pharma giant invested $15 million into the company in 2021 and also placed Adam Schayowitz, Ph.D., Pfizer Global Product Development vice president and medicine team group lead for breast cancer, colorectal cancer and melanoma on Cardiff’s scientific advisory board.

“They have watched our data develop over time as a result of that investment,” said Cardiff Oncology CFO Jamie Levine, adding Pfizer made the equity investment in Cardiff because they found the company’s science “strategically interesting.”

That strategic interest led Schayowitz to recommend Cardiff utilize Pfizer Ignite to run the new first-line trial of onvansertib.

Adam Schayowitz, Ph.D.
VP & Development Head, Breast Cancer, Colorectal Cancer & Melanoma
Pfizer Global Product Development

“We believe onvansertib, by inhibiting PLK1, has the potential to play a meaningful role in the treatment of several types of cancer, including the lead program in RAS-mutated mCRC,” said Dr. Schayowitz. “We believe that by combining Pfizer’s clinical development capabilities and expertise, with onvansertib’s promising novel clinical findings, we have an opportunity to accelerate the advancement of this program for the benefit of the many patients in the RAS-mutated mCRC setting.”

Cardiff estimates that there are 48,000 new patients in the U.S. annually in the first-line RAS-mutated mCRC setting for whom there are no ongoing clinical trials and no new treatments approved in the past 20 years.

Erlander said the results of onvansertib’s clinical trials are promising for the “huge unmet need” in mCRC’s large patient population.

“It’s all about clinical data and what are you doing to help have a positive effect on patients’ lives,” he said. “That’s the focus in biotech and certainly the focus here at Cardiff Oncology.”

Positive Market Reaction

News of the accelerated approval pathway for onvansertib and Pfizer Ignite’s involvement in the clinical trials, investors sent Cardiff Oncology (NASDAQ: CRDF) shares up a few notches. At the end of July, CDRF was trading at around $1.40. On Aug. 7 when the announcement was made, CRDF went from $1.57 to $2.18 and has since been trading steady at around $2 a share.

Cardiff Oncology, Inc.

Founded: 2017
CEO: Mark Erlander, Ph.D.
Headquarters: San Diego, Sorrento Valley
Business: oncology biotech
Stock: CRDF (NASDAQ)
Financials: Cash position on  June 30, 2023  was  $89.4 million.
Employees: 30
Website: www.cardiffoncology.com
Notable: In addition to the mCRC program, Cardiff Oncology also has programs in pancreatic and breast cancer.

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