Faeth Therapeutics

Today, Faeth Therapeutics announced its acquisition by Sensei Bio, alongside a concurrent private financing to advance PIKTOR through key clinical milestones, including topline data from an ongoing Phase 2 trial in second-line advanced endometrial cancer, as well as the initiation of a Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year-end 2026 As Faeth co-founder and CEO Anand Parikh explains, in the PI3K pathway, the field has repeatedly faced the same constraint. Single-node inhibitors force a tradeoff between efficacy and tolerability. PIKTOR is an oral, first-in-class inhibitor designed to target PI3K-alpha and mTORC1 and 2 simultaneously. The goal is more complete pathway suppression with improved tolerability. In our Phase 1b, we observed complete responses in endometrial cancer patients who had received multiple prior lines of therapy. The entire Faeth team is excited to join Sensei to help ensure this important intervention reaches the patients who need new options most. More details in the press release linked in the comments section. 

In a new STAT op-ed, Faeth Therapeutics co-founder Sid Mukherjee makes the case that metabolism belongs alongside drugs as part of cancer treatment, not as background advice, but as a targeted, measurable intervention. Tumors adapt by rewiring how they use glucose, amino acids, and lipids. When a therapy blocks one pathway, cancer cells often find another fuel source. Generic dietary guidance cannot address this, and in some cases can undermine treatment. What matters is the interaction between a specific tumor, a specific drug, and the patient’s physiology. The op-ed describes a model of tumor-informed metabolism, where nutrition is scripted to complement pharmacology. Diets are paired with defined treatment windows, calibrated to biomarkers, and adjusted to avoid weight loss or metabolic harm. This approach is being developed at Faeth Therapeutics with the aim of integrating food into care with the same rigor applied to drugs. The argument is measured and practical. If metabolism contributes to resistance, then addressing it is not optional. It is part of making therapies work as intended. Read more: https://lnkd.in/gWqp3bFw

We’re proud to announce that Faeth Therapeutics has been named “BioPharma Startup of the Year” by the BioTech Breakthrough Awards. The honor recognizes Faeth’s progress in advancing metabolic oncology through rigorous science, clinical innovation, and a commitment to patients. From our Phase 1b data at ESMO - European Society for Medical Oncology to the advancement of PIKTOR into Phase 2, this award reflects the momentum our team has built and the growing recognition of metabolism as a powerful new pillar in cancer treatment. Thank you to our scientists, clinicians, investors, and partners who share our vision for transforming how cancer is understood and treated. https://lnkd.in/e-JnpyyY

Lei Lei Wu writes in her exclusive for Endpoints News, Faeth has raised $25 million to accelerate a Phase 2 trial of a combination of serabelisib and sapanisertib in #endometrialcancer, conducted in partnership with the The GOG Foundation, Inc. The trial builds on our central thesis that metabolism and nutrition shape cancer behavior and patient outcomes. In a Phase 1 trial, Faeth reported that 7 out of 15 patients with #ovariancancer, #breastcancer or endometrial cancer responded to treatment with a combination and chemotherapy. 3 endometrial cancer patients saw all signs of their cancer disappear. Using its Phase 2 data, there’s the potential for Faeth to get accelerated approval. Anand Parikh, Faeth CEO and co-founder, said: “People underestimated the incidence and prevalence of these diseases. Even when we were talking to people about gynecologic cancers two years ago, and they would say, ‘Well, if it’s not breast, prostate, lung or colorectal, I’m not interested.’ … But now that attitude is shifting. If I can get 35% of ovarian cancer patients, and that’s a $10 billion acquisition, maybe I should be looking more deeply at gynecological cancers.” Additionally, the momentum at ESMO - European Society for Medical Oncology highlighted how much progress is possible in gynecologic oncology. With new data, growing investor confidence, and a deeper scientific foundation, the field is no longer being underestimated. Read more about the new funding and data presented at #ESMO25: https://lnkd.in/gdwS6fTu

Faeth has announced a new $25 million raise led by S2G Investments, bringing total funding to $92 million, to advance PIKTOR and expand its MetabOS platform. Returning investors include Khosla Ventures, Future Ventures, Digitalis Ventures, KdT Ventures and Cantos, plus new investors B Capital Group, Avicella Capital and THO SeedFund. For women with advanced #endometrialcancer, options have long been limited. Faeth is changing with our PIKTOR regimen, combining selective multi-node inhibition of the PI3K/AKT/mTOR pathway with metabolic control, which achieved an 80% overall response rate and a median progression-free survival of 11 months in a phase 1b study. Building on that success, the Gynecological Oncology Group Foundation has launched a randomized phase 2 trial now enrolling patients. As Faeth’s data and support grow, so does the case for metabolism as a new frontier in oncology, where targeting how tumors consume may deliver more durable control. Anand Parikh, Faeth CEO and co-founder, said: "We've achieved the optimal balance in PI3K pathway inhibition, comprehensive enough to prevent resistance, selective enough to avoid immunosuppression. The 80% response rate, 11-month progression-free survival, initiation of a trial by the GOG Foundation, and recognition as a late-breaking oral presentation at #ESMO25 show that Faeth is executing as a clinical-stage company positioned to expand across the solid tumors where PI3K alterations drive disease." Please read more in today’s press release: https://lnkd.in/gM3svcJn

For women with platinum-resistant ovarian cancer, treatment often means a cycle of short-lived responses and hard choices. At ESMO - European Society for Medical Oncology, we shared data that could begin to shift that pattern. Results from the randomized Phase 2 DICE trial show that adding oral sapanisertib (TAK228) to weekly paclitaxel reduced the risk of disease progression by 34% and extended mean progression-free survival by 45% compared to paclitaxel alone. The trial met its prespecified hazard ratio target and primary endpoint, supporting advancement to Phase 3. Jon Krell MD, Ovarian Cancer Action Research Centre, Imperial College London, the study's lead investigator, said, "Platinum-resistant ovarian cancer remains one of the toughest conditions we face, with women often cycling through treatments that only briefly hold the disease at bay temporarily. The DICE trial shows that adding an oral targeted agent to weekly paclitaxel can slow progression without added high-grade toxicity, a finding that clearly warrants a phase 3 trial." Faeth CEO and co-founder Anand Parikh said, "These results reinforce our belief that targeting the metabolism of cancer cells can improve the impact of existing therapies. On the strength of DICE, we see sapanisertib plus paclitaxel as phase 3-ready in ovarian cancer, alongside our ongoing phase 2 in endometrial cancer and planned phase 1b/2 in breast cancer." These findings suggest that a targeted approach to cancer metabolism can meaningfully extend benefit without added high-grade toxicity. For patients and clinicians facing limited options, this signals a possible new path forward in ovarian cancer care. Read more on the DICE Trial results in the press release: https://lnkd.in/gkhNVvwh #ESMO2025

We’ve expanded our pipeline into rare metabolic diseases, engaging in development of a small-molecule drug designed to address both the genetic drivers and metabolic processes underlying these conditions, while reducing toxicities linked to existing therapies. In preclinical studies, our development candidate has matched the survival benefit of current options while avoiding neurocognitive side effects. This program builds on our founding mission: to use metabolism as a therapeutic lever across serious diseases. From cancer regimens to now rare disease applications, our AI-driven MetabOS platform is opening new paths to treatments that address what has been overlooked: how disordered metabolism shapes human health. Read more via Catherine Shaffer’s story in Precision Medicine Online. https://lnkd.in/dMGC62R5 And in the comments, you can see our corresponding press release.

We are honored that Phase 2 data from the DICE trial will be presented as a late-breaking oral session at the 2025 ESMO - European Society for Medical Oncology (ESMO) Congress in Berlin.  Dr. Jon Krell of Imperial College London will share results demonstrating whether sapanisertib, also part of Faeth’s lead multi-node PIKTOR program, could improve the treatment of ovarian cancer when added to paclitaxel. We are hopeful that if positive this will mark a step forward in expanding possibilities for ovarian cancer patients who urgently need more options. 📍 Oral session: Gynaecological cancers 🗓 Sunday, October 19, 2025, 11:01 am CEST 📌 Cologne Auditorium, CityCube A #ESMO2025 https://lnkd.in/g2GE_kMn

Congratulations to Dr. Daniel Wahl, DO, FACEP and his team at the University of Michigan for their outstanding work on the metabolism of Gliomas, recently published in Nature Magazine! Dan and his team studied the metabolic transformation that #glioblastomas undergo in exquisite detail. That included tracing metabolite fate in human patients, identifying the rewiring of glucose metabolism that confers increased reliance on exogenous serine supply. The researchers showed that nutritional serine deprivation significantly increased the efficacy of chemoradiation. Approximately half of all patients with cancer receive radiotherapy, so making it more effective is a huge opportunity to improve lives – especially for glioblastomas, which have a five-year survival rate below 10%. The research is also consistent with our own previous findings in other cancers. We published a paper in 2022 (linked below) showing that breast, colorectal, and pancreatic cancer cells also appear susceptible to this kind of sensitization, through serine and glycine restriction. Faeth is now testing it in a trial for radiosensitization in locally advanced rectal cancer. Supporting evidence continues to grow behind Faeth’s thesis, as demonstrated in our lead program targeting metabolism in patients with advanced endometrial cancer. That Phase 2 trial is now enrolling. https://lnkd.in/gp_aiiJY

Cancer research has long treated precision nutrition as background noise rather than a potential tool. That assumption is now breaking down. The Weill Cancer Hub West, launched with continued support from Joan and Sandy Weill and their Family Foundation, will unite experts from the UCSF Helen Diller Family Comprehensive Cancer Center and the Stanford Cancer Institute. A key pillar of the new hub will be Project FEAST, dedicated to answering how precision nutrition shapes the response to cancer treatment. Earlier this year, the Weills established the Weill Cancer Hub East with a similar emphasis on metabolism and nutrition in cancer immunotherapy. Together, the two hubs represent a growing recognition across oncology that food is not incidental but mechanistic. This shift echoes the thesis on which Faeth was founded in 2019: metabolism is not confined to so-called “metabolic diseases.” It cuts across oncology, where nutrient pathways can be exploited as therapeutic targets. We look forward to seeing what the Weill Hubs uncover in advancing precision nutrition over the coming years.