German biotech raises $150M on its way to tackle cancer therapy resistance

CatalYm’s monoclonal antibody visugromab bags $150M

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Today, CatalYm adds its name to the list of biotech companies surpassing $100 million in funding in a single round in 2024 with a $150 million series D joined by investors already involved in the company such as Novartis Venture Fund or Jeito Capital, but also by new investors – Canaan Partners, Bioqube Ventures, Omega Funds, Forbion Growth Fund, and Gilde Healthcare.

CatalYm is a Munich-based biotech company, with a novel approach to tackle cancer resistance through its lead candidate, visugromab. This humanized monoclonal antibody targets the tumor-produced growth differentiation factor-15 (GDF-15), a key factor in immune resistance to cancer therapies. With the new funds, CatalYm plans to expand the late-stage clinical development of visugromab, moving it closer to registration and potential market approval.

This substantial funding, based on the strong Phase 1/2 results of visugromab presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2024, demonstrates the promise of CatalYm’s candidate, but first let’s take a closer look at the landscape of cancer resistance.

CatalYm’s upward trajectory in cancer immunotherapy

CatalYm was founded in 2016 and originated as a spin-off from the Julius-Maximilians-University of Würzburg. Its lead candidate, visugromab, is designed to neutralize GDF-15, thereby enhancing the immune system’s ability to attack cancer cells​​.

Since its inception, CatalYm has secured notable funding across multiple rounds to support its research and development efforts. So far, the company raised approximately $109 million (€100 million) with a series B round in 2020, and a series C round in 2022 of $54.5 million (€50 million) each. Up until now, the German biotech had only attracted European investors. However, that changed today as CatalYm secured new U.S. investors and additional support from existing ones, tripling the amount raised in its previous funding round to nearly $260 million.

While previous rounds were already substantial, how did CatalYm bring new American investors and raise $150 million in a single funding round? The convincing results from visugromab’s phase 1/2 presented at ASCO 2024 definitely played a key role in this success. 

The recent Series D funding of $150 million will be used to expand visugromab’s late-stage clinical development, including randomized phase 2b studies targeting checkpoint-naive and second-line treatment settings for solid tumors. 

Visugromab ASCO presentation: How does the drug work and how promising is it? 

Visugromab is a humanized monoclonal antibody designed to neutralize GDF-15, a protein produced by tumors to create an immunosuppressive environment. GDF-15 acts as a T cell repellent, preventing immune cells from infiltrating the tumor microenvironment. By blocking GDF-15, visugromab aims to restore the immune system’s ability to attack cancer cells effectively.

Visugromab enhances the priming of T cells by dendritic cells and increases tumor cell killing by T cells and NK cells, leading to improved anti-tumor activity​​. Dendritic cells are crucial for the immune response as they present antigens to T cells, initiating their activation or “priming.”

The phase 1/2 trial,  the GDFATHER-1 study, evaluated the safety and efficacy of visugromab in combination with nivolumab, an anti-PD-1 antibody. The trial included patients with advanced-stage, relapsed, or refractory solid tumors, who had exhausted all previous treatment options.  

In the non-small cell lung cancer (NSCLC) and urothelial cancer (UC) cohorts, the objective response rate (ORR) was 14.8% and 21.1% respectively. The duration of response (DoR)  surpassed eleven months for non-squamous NSCLC and ten months for UC, with ongoing responses in several patients. The combination therapy was well-tolerated, with most treatment-emergent adverse events (TEAEs) being mild to moderate. Only a small percentage of patients experienced grade 3 or higher adverse events.

Phil L’huillier, chief executive officer of CatalYm commented on these results. “We saw excellent efficacy up to complete responses in very late-stage solid tumor patients. Importantly, these responses were very durable with long-lasting benefits in most of the patients that responded, which is not common in this patient population. Most patients remain on therapy and the duration of response is currently at approximately fifteen months. What is also striking is that over half of the patients had a better and more durable response than on any of their prior lines of treatments.”

“Additionally, these benefits were observed with an excellent safety profile, which is important in advanced cancer patients. The safety profile not only shows us that visugromab does not add any severe side-effects on top of PD-1 treatment alone, but it can also improve the overall well-being of the patient and reduce other cancer treatment-related weight loss,” L’hullier said.

For the future of cancer treatment, these findings indicate that targeting the tumor microenvironment and its immunosuppressive mechanisms could be a viable strategy for overcoming resistance to current therapies. CatalYm’s ongoing phase 2b development program supported by the $150 million series D round will further explore visugromab’s potential in combination with standard-of-care treatments and in earlier lines of therapy, potentially broadening its application in oncology​​.

Visugromab, a complementary approach in oncology

Visugromab is designated to be administered in complement with PD-1 inhibitors such as the well-established keytruda developed by Merck. The CatalYm drug targeting the GDF-15 pathway is not alone in this competitive landscape as other pathways are good complements to PD-1 inhibitors.

Relatlimab by Bristol-Myers Squibb

Relatlimab, developed by Bristol-Myers Squibb, targets LAG-3 (Lymphocyte-Activation Gene 3), an immune checkpoint receptor on T cells. By blocking LAG-3, relatlimab enhances T cell activity. It is designed to be used in combination with PD-1 inhibitors to provide a dual blockade of immune checkpoints.

Relatlimab, has shown promising results in combination with nivolumab, particularly in melanoma patients. The combination therapy, marketed as Opdualag, was approved by the U.S. Food and Drug Administration (FDA) in March 2022 for the treatment of unresectable or metastatic melanoma in adults and pediatric patients aged 12 years and older.

While relatlimab and visugromab target different pathways, they do compete in the broader sense of combination therapies designed to overcome resistance to PD-1 inhibitors and improve patient outcomes in refractory cancers. 

Other notable pathways enhancing the efficacy of PD-1 inhibitors include TIGIT, IDO, and CTLA-4 pathways.

Moderna and BioNtech cancer vaccines

Moderna’s mRNA-4157 is a personalized cancer vaccine that uses mRNA technology to target neoantigens specific to individual tumors. Neoantigens are proteins arising from tumor-specific mutations. The vaccine is designed to encode these neoantigens, which are then presented by the patient’s cells, priming the immune system to recognize and attack the cancer cells harboring these mutations. When combined with PD-1 inhibitors like Keytruda, the vaccine aims to enhance the overall immune response against tumors by stimulating T cells to target these cancer antigens effectively​.

Early-phase trials have shown promising results in terms of safety and immune response. The combination of mRNA-4157 and Keytruda is currently in phase 2 trials, focusing on melanoma and other cancers​​. Preliminary data suggest that the vaccine, in combination with Keytruda, can generate strong anti-tumor immune responses with an acceptable safety profile​.

BioNtech’s BNT111 is also an mRNA cancer vaccine designed to target multiple tumor-associated antigens (TAAs). Unlike personalized vaccines targeting neoantigens, BNT111 targets TAAs that are commonly expressed across different patients’ tumors. This approach can be used in a broader patient population. The vaccine encodes these antigens, prompting the patient’s immune cells to produce them and stimulate a T cell response against the cancer cells expressing these antigens. Typically, BNT111 is combined with PD-1 inhibitors to enhance efficacy by preventing the tumor cells from evading immune detection​.

BNT111 is currently in phase 2 clinical trials for melanoma and other cancers, showing promise in early-phase studies. Initial data from clinical trials suggest that BNT111, in combination with PD-1 inhibitors, can generate robust immune responses with manageable side effects, paving the way for more extensive studies and potential broader application in cancer immunotherapy​​.

Both vaccines aim to stimulate the immune system by encoding cancer-specific antigens, enhancing T cell responses against tumors. Like visugromab, they are designed to be used in combination with PD-1 inhibitors to enhance the efficacy of immune responses. By neutralizing GDF-15, visugromab reduces immunosuppression, allowing for better infiltration and activity of immune cells within the tumor when combined with PD-1 inhibitors​​.

As visugromab and the mRNA vaccines from Moderna and BioNTech target different aspects of the immune response, they can be considered complementary. Visugromab’s reduction of immunosuppression could enhance the efficacy of vaccines that prime the immune system to target tumor-specific antigens. Visugromab offers a complementary approach to various immunotherapies and could potentially improve outcomes in different cancer types.

Visugromab, on track to make a difference in cancer therapy resistance

“Visugromab offers differentiation from many other anti-cancer therapies because it targets a key immune-related resistance mechanism that has not been addressed so far and it does this while being safe and offering benefit to patients through improvement of quality of life and body weight benefit. GDF-15 is not only a central regulator of immune resistance but also has a metabolic function. For instance, it has been shown to be the main cause of nausea in response to chemotherapy,” explained L’huillier.

A bit over a year ago, AstraZeneca dropped AZD8853, its GDF-15 inhibitor for “strategic portfolio prioritization” according to its 2023 Q1 report, leaving visugromab as the only candidate targeting this pathway.

L’huillier reflected on what was going to be the biggest challenge going forward with the monoclonal antibody. “Visugromab has the potential to offer broad benefits to cancer patients across many solid tumor indications by combining it with multiple modalities. Maximizing this potential for patients and accelerating development with limited resources is a key challenge that requires us to be laser-focused on executing development with pace and precision. We address this by conducting multiple studies in checkpoint naive and refractory patient populations and across multiple indications to ensure we understand where visugromab can provide the most benefit for patients to maximize its potential future development.”

With the convincing phase 1/2 results and today’s $150 million funding round supporting visugromab’s upcoming phase 2 clinical trials, there is ground to be optimistic about CatalYm’s future in cancer therapy resistance.

Explore other topics: CancerFundingGermanyImmunotherapy