The American Society of Clinical Oncology (ASCO) meeting concluded on June 4, 2024. During the five-day event, thousands of biotech developers demonstrated their research and development capabilities, marking it as a key event in the biotech calendar. This year's ASCO served as a stage for prominent cancer developers, and we've compiled a list of the top gainers and losers based on stock price analysis at the year's most significant oncology conference.

Top Gainers

Summit Therapeutics emerged as an unexpected winner at ASCO 2024

The relatively little-known Miami-based biotech company saw its stock more than double in value after its lead asset, ivonescimab, outperformed Merck's blockbuster cancer therapy, KEYTRUDA, in the Phase III HARMONi-A trial for lung cancer. Following this success, Summit Therapeutics accepted an unsolicited offer from an institutional investor to purchase 22.22 million shares at USD 9 each, resulting in a 13.4% increase in premarket trade. The company received approximately USD 200 million in gross proceeds, which will be used to advance the clinical development of ivonescimab, as well as for working capital and general corporate purposes. Additionally, Summit Therapeutics expanded the license territories for ivonescimab in a deal with Akeso for USD 500 million upfront, now covering Latin America, the Middle East, and Africa.

Agenus’ significant stock up based on R/R MSS-CRC data readout

Agenus' stocks also saw a significant rise following a novel analysis from the Phase Ib trial of botensilimab combined with balstilimab in relapsed/refractory microsatellite stable colorectal cancer without active liver metastases (NLM). The overall response rates (ORR) across different NLM sites ranged from 18-33%, and disease control rates (DCR) ranged from 67-82%. Overall survival (OS) remained consistent, ranging from 20.7 months to not reached (NR). After failing to get its anti-PD-1 monoclonal antibody, balstilimab approved for cervical cancer in 2021, Agenus is attempting another FDA submission, with a combination therapy and in a different indication. The company plans to submit a biologics license application (BLA) to the FDA for potential accelerated approval by the end of 2024, with a subsequent submission to the European Medicines Agency.

Affimed's stock surged based on early lung cancer data for AFM24, a CD16A-based NK cell engager targeting EGFR. 

Data presented at ASCO indicated that AFM24 might enhance the efficacy of TECENTRIQ (atezolizumab) on a cross-trial basis and could offer a new strategy to overcome resistance to existing therapies. In a study involving 17 EGFR wild-type (EGFRwt) NSCLC patients who had failed chemotherapy and PD-1/PD-L1 inhibitors, the combination of AFM24 and TECENTRIQ achieved 4 objective responses, with 3 of these responses ongoing for more than 7 months, and a progression-free survival (PFS) of 5.9 months. Additionally, objective responses were observed in 4 of 13 response-evaluable EGFR mutant (EGFRmut) NSCLC patients, confirming the activity of AFM24 and atezolizumab in heavily pretreated NSCLC patients. Shortly before announcing these results, Affimed received fast-track designation from the FDA for its drug candidate AFM24 in combination with atezolizumab for the treatment of EGFR wild-type NSCLC.

Shares of Precigen spike post positive data of its Gene therapy

Shares of Precigen increased following positive data of its PRGN-2012 AdenoVerse gene therapy in treating recurrent respiratory papillomatosis suggesting the product is approvable. Precigen reported that a pivotal Phase I/II study met its primary safety and efficacy endpoints, with 51% of the 35 patients achieving a complete response, requiring no surgeries after treatment with PRGN-2012. The company plans to begin submitting a rolling biologics license application to the FDA for PRGN-2012 under an accelerated approval pathway in the second half of 2024, with an expected launch in 2025.

IN8bio's stock surged based on encouraging preliminary clinical data for INB-200 in Glioblastoma

The data showed that 92% of evaluable patients treated with INB-200, along with concomitant temozolomide, exceeded a median PFS of 7 months, with a median follow-up of 11.7 months. The survival data, coupled with radiographic improvements, indicate positive treatment effects and highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a promising first-in-class therapy for patients with newly diagnosed glioblastoma. As more supportive data emerges from the INB-200 trial, attention is now shifting to the INB-400 trial, which has commenced and will also evaluate DRI gamma-delta T cells in glioblastoma patients.

Top Losers

Verastem’s avutometinib disappoints in pancreatic cancer patients

In 2020, Verastem acquired avutometinib, a dual RAF/MEK inhibitor previously known as CKI27, from Roche's Chugai unit for USD 3 million. Before a significant announcement at ASCO, there was optimism that data from this project would bolster Verastem's position. However, Verastem's stock dropped significantly following the release of new clinical trial data on avutometinib for its metastatic pancreatic cancer treatment. Initial interim safety and efficacy results from the ongoing RAMP 205 Phase I/II clinical trial, which is evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer, showed that 83% (5 out of 6) of patients in cohort 1 achieved a confirmed partial response. However, a high rate of serious adverse events was reported, with 12 patients experiencing 19 treatment-emergent serious adverse events (SAEs), and 11 patients experiencing grade ≥3 SAEs. Two patients discontinued treatment due to treatment-emergent adverse events. On the other hand, the potential for FDA accelerated approval of avutometinib plus defactinib is planned for 2025 for the treatment of recurrent low-grade serous ovarian carcinoma.

Sensei Biotherapeutics shares plunged post release of dose escalation data from Phase I/II study of SNS-101 for the treatment of solid tumors.

Company assessed SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor LIBTAYO in patients with advanced tumors who had primary or acquired resistance to PD-1 therapy. As of the April 30, 2024 data cutoff, SNS-101 demonstrated preliminary evidence of promising clinical activity across multiple tumor types. One microsatellite stable (MSS) endometrial cancer patient had a confirmed partial response with a 59% decrease in tumor size and remained in the study for over 30 weeks. One MSS colorectal cancer patient remained in the study for 18 weeks with a 27% reduction in tumor size. One pembrolizumab-resistant renal cell carcinoma patient stayed in the study for 12 weeks with an 18% reduction in tumor size. One pembrolizumab-resistant human papillomavirus (HPV) + head and neck cancer patient remained in the study for 12 weeks with a 17% reduction in tumor size. The majority of adverse events (AEs) were Grade 1 or 2 in severity. Two patients experienced Grade 1 cytokine release syndrome (CRS), one in monotherapy and one in combination therapy, both at the highest dose of SNS-101.

ALX Oncology’s stock also fell after results of CD47 blocker were announced 

ALX Oncology’s primary focus is the CD47 blocker evorpacept, which has shown promising results when combined with other therapies for various cancers. Two abstracts featuring evorpacept were presented at ASCO 2024. The first abstract reported results from the dose escalation Phase Ia study of evorpacept combined with enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma. The data cut from the ASCO poster presentation revealed an unconfirmed ORR of 59% (n = 22) with evorpacept plus enfortumab vedotin, compared to an ORR benchmark of 41% for enfortumab vedotin as a single agent in locally advanced or metastatic urothelial carcinoma. The second abstract detailed a Phase II trial sponsored by the University of Colorado Cancer Center, evaluating evorpacept in combination with cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer. While initial activity was observed, the criteria to terminate study accrual were met at the dose levels evaluated.

Although evorpacept has shown positive early data in several indications, the long-term outlook remains uncertain. The target has experienced significant hype over the past few years, reminiscent of Gilead's development of the monoclonal antibody magrolimab to target CD47 in various blood cancers, which ultimately faced a series of high-profile failures and the program's shutdown. Evorpacept differs from magrolimab in that it is a fusion protein incorporating the binding domain of the CD47 receptor SIRP-alpha, rather than a monoclonal antibody's binding domain. ALX Oncology has already terminated the evorpacept program in myelodysplastic syndromes (MDS) and leukemia.

Caribou Biosciences' stocks tumbled post CAR-T data readout

Following the release of disappointing Phase I data from its ANTLER study for the company’s CAR-T cell therapy CB-010, along with a significant change in commercial strategy for this allogeneic CAR-T cell therapy. Data presented at ASCO reported a median PFS of 14.4 months in ANTLER patients with partial HLA matching (≥4 alleles). Caribou Biosciences has changed its strategy and is now focusing on human leukocyte antigen (HLA) matching between donor cells and patients to improve persistence. The company plans to enroll approximately 20 additional second-line large B-cell lymphoma (2L LBCL) patients in the ANTLER study to confirm that partial HLA matching improves patient outcomes, with initial data expected in the first half of 2025. Caribou expects to initiate a pivotal trial for CB-010 in the second half of 2025, pending confirmation of improved outcomes in a partially HLA-matched cohort.

Adlai Nortye’s stock also dipped after the preliminary data of AN0025 in combination with definitive chemoradiotherapy in patients with unresectable locally advanced or locally recurrent esophageal cancer were announced.