On May 12, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported positive interim Phase 1 data for its EpCAM PROBODY ADC candidate, CX-2051, in advanced, late-line CRC (Press release, CytomX Therapeutics, MAY 12, 2025, View Source [SID1234652877]). The data are as of an April 7th 2025 data cutoff from the ongoing CTMX-2051-101 Phase 1 study.

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"EpCAM is a high potential and broadly expressed cancer target that has been challenging to drug historically due to expression on normal tissues. We believe we have broken important new ground with our data announced today, which show potential for markedly improved outcomes for CRC patients," said Sean McCarthy, D. Phil, chief executive officer and chairman of CytomX. "CX-2051 is showing impressive, durable anti-tumor activity in late line metastatic CRC, an area of high unmet need and a very difficult tumor to treat. Furthermore, CX-2051 has been generally well tolerated, highlighting the power of CytomX PROBODY masking technology."

Dr. McCarthy added, "Importantly, we believe these results validate EpCAM as an oncology target and unlock a broad development opportunity for CX-2051 in CRC and potentially many other cancer types where EpCAM is expressed. We are excited to rapidly advance CX-2051 for the benefit of CRC patients and to explore the full potential of this novel ADC."

CX-2051 Phase 1a Interim Data Summary in Advanced, Late-line Colorectal Cancer

The CTMX-2051-101 study was initiated in April 2024 with dose escalation proceeding through seven dose levels as of April 2025.
25 advanced metastatic CRC patients were treated with CX-2051 across dose levels 1 through 5 as of the April 7, 2025 data cutoff. CX-2051 was administered on a once every three week schedule (Q3W).
The 2.4 mg/kg and 4.8 mg/kg doses were single patient dose escalation cohorts not anticipated to be therapeutically active.
At the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, 23 patients were treated in total, 18 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff.
Patient Characteristics:

The 25 patients enrolled in the study across dose levels 1 through 5 had previously received a median of 4 prior lines of therapy and all patients had previously been treated with irinotecan. 64% of patients had liver metastases, 64% had KRAS mutations, and 96% were microsatellite stable.
Patients were not preselected based on EpCAM expression levels.
Efficacy Results:
As of the data cutoff, 18 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W.

Overall response rate (ORR):
28% of patients (5/18) achieved confirmed partial RECIST v. 1.1 responses. Overall response rates for currently approved therapies in 3rd line or later CRC are in the low to mid-single digit percentages1.
At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses.
The Disease Control Rate2 was 94% across the three dose groups (17/18).
Durability:
Median progression free survival was 5.8 months as of the data cutoff.
10 of 18 patients remained on study treatment as of the data of cutoff.
Safety Results:
As of the data cutoff, 25 patients were evaluable for safety.

CX-2051 was generally well-tolerated with manageable adverse events, with no observed dose limiting toxicities. Most treatment related adverse events (TRAEs) were Grade 1 or Grade 2 in severity.
The most common reported TRAEs were diarrhea (18 patients, 5 Grade 3), nausea (11 patients, 1 Grade 3), vomiting (8 patients, No Grade 3), fatigue (8 patients, 1 Grade 3), anemia (5 patients, 3 Grade 3), hypokalemia (3 patients, 1 Grade 3), neutrophil count decrease (2 patients, 2 Grade 3) and neutropenia (2 patients, 1 Grade 3). TRAEs included serious adverse events in 5 patients (1 Grade 2, 4 Grade 3). No Grade 4 or 5 TRAEs were observed.
No events of pancreatitis, interstitial lung disease or febrile neutropenia were reported at time of data cutoff.
CX-2051 Phase 1 Dose Expansions Initiated:

Dose expansions have been initiated at doses of 7.2 mg/kg, 8.6 mg/kg and 10 mg/kg Q3W.
A total of 20 patients are expected to be enrolled at each dose level to inform the selection of recommended phase 2 dose.
CX-2051 Anticipated Milestones:

CX-2051 Monotherapy for Advanced Late-Line CRC:
Additional Phase 1 data update by Q1 2026
Planning Phase 2 study initiation in 1H 2026
CX-2051 CRC Combinations:
Potential to initiate CX-2051 combination studies in earlier lines of CRC in 2026
CX-2051 Pan-tumor Potential:
Evaluate non-CRC, EpCAM-expressing tumor indications for potential Phase 1b study initiation in 2026
CytomX Investor Event Information
Additional details will be provided on the Company’s Investor Call on May 12, 2025 at 8 a.m. EST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website for at least 30 days.

About CTMX-2051-101 Study
Additional information about the CTMX-2051-101 study can be found here on clinicaltrials.gov.

About CX-2051 (EpCAM PROBODY ADC)
CX-2051 is an investigational masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM) and armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC, and was discovered in collaboration with ImmunoGen, now part of AbbVie. EpCAM (Epithelial Cell Adhesion Molecule) is a highly expressed but previously undruggable tumor antigen due to expression on normal tissues. CX-2051 is designed to open a therapeutic window for this high potential target and to deliver meaningful anti-cancer activity in solid tumors, including CRC.

On May 12, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapies for unmet medical needs, reported compelling preclinical data for HT-KIT, its proprietary antisense oligonucleotide (ASO) therapeutic designed to target and silence aberrant KIT gene expression—implicated in a variety of rare, treatment-resistant cancers (Press release, Hoth Therapeutics, MAY 12, 2025, View Source [SID1234652893]).

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HT-KIT is engineered to selectively bind to mutant KIT mRNA transcripts and block their translation, thereby preventing the production of the KIT protein, a critical driver of tumor growth in cancers such as gastrointestinal stromal tumors (GIST), systemic mastocytosis, and certain acute leukemias.

Preclinical Milestones:

Over 80% reduction in KIT expression in vitro using cancer cell lines harboring activating KIT mutations.
Significant inhibition of tumor growth in GIST and mast cell tumor animal models following systemic administration of HT-KIT.
No observable off-target toxicity in liver, kidney, or bone marrow, suggesting a favorable safety profile.
"We believe HT-KIT represents a first-in-class approach to treating KIT-mutated cancers at the genetic level, offering hope for patients who have exhausted traditional therapies," said Robb Knie, CEO of Hoth Therapeutics. "The strength of our preclinical data positions HT-KIT as a powerful candidate for precision oncology. We are moving rapidly toward IND submission and are eager to begin human trials.

Current treatment options for KIT-driven cancers often rely on tyrosine kinase inhibitors (TKIs), which may lead to drug resistance or systemic side effects. HT-KIT offers a highly targeted alternative by attacking the disease at the mRNA level—upstream of protein expression—potentially avoiding the resistance mechanisms seen with small-molecule therapies.

Next Steps:

Hoth Therapeutics expects to file an Investigational New Drug (IND) application with the FDA in early 2026, with first-in-human Phase 1 trials planned shortly thereafter. The company is actively engaging regulatory advisors and contract research partners to accelerate clinical development.

About HT-KIT

HT-KIT is a synthetic antisense oligonucleotide developed using proprietary gene-silencing technology licensed exclusively by Hoth. It is designed to inhibit KIT gene expression in tumors where KIT mutations are known oncogenic drivers. Preclinical studies suggest HT-KIT has the potential to overcome resistance seen in patients previously treated with TKIs.

On May 12, 2025 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the first quarter ending March 31, 2025 (Press release, Akoya Biosciences, MAY 12, 2025, View Source [SID1234652860]).

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"Akoya remained focused on operational discipline and innovation in the first quarter of 2025, while successfully increasing our installed base in the face of broader macroeconomic and NIH funding uncertainty. Our technology continues to gain momentum globally, underscored by growing adoption in large-scale population studies as well as an expanding publication footprint across key research areas in high-impact journals," said Brian McKelligon, CEO of Akoya Biosciences. "As we look ahead to combining forces with Quanterix, we are confident in the value-creating opportunities this integration brings—uniting two leaders in proteomics to accelerate the future of precision medicine."

First Quarter 2025 Financial Results

Revenue was $16.6 million in the first quarter of 2025, compared to $18.4 million in the prior year period; a decrease of 9.8%.
Gross margin was 59.3% in the first quarter of 2025, compared to 45.7% in the prior year period.
Operating expenses were $23.3 million for the first quarter of 2025, compared to $30.0 million in the prior year period, an improvement of 22.3%.
Operating loss was $13.4 million for the first quarter of 2025, compared to $21.6 million in the prior year period, an improvement of 37.9%.
Net cash used in operating activities decreased by $13.6 million to $7.2 million in the first quarter of 2025, compared to $20.8 million in the prior year period.
$27.5 million of cash, cash equivalents and marketable securities as of March 31, 2025.

First Quarter 2025 Business Highlights

Akoya and Team SAMBAI announced the selection of PhenoCycler-Fusion as the foundational spatial proteomics platform for a landmark Cancer Grand Challenges-funded study. This large-scale study aims to address cancer inequities through high-plex, high-throughput spatial analysis and will generate data for a first-of-its-kind Biobank and Data Repository.
Akoya and the Singapore Translational Cancer Consortium (STCC) have partnered to deploy the PhenoCode Discovery IO60 panel in the SUPER study, aimed at advancing cancer immunophenotyping in Singapore. The study seeks to identify predictors of PD-1 immunotherapy response in real-world Asian patient populations, bridging cutting-edge spatial proteomics with clinical insights.
At the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (April 25–30, Chicago, IL), Akoya in partnership with Enable Medicine, launched the largest commercially available single-cell spatial proteomics atlas. Akoya also announced the expansion of its Advanced Biopharma Solutions portfolio with a new antibody-drug conjugate (ADC) breast cancer assay and showcased real-world insights from the IO60 panel.
The quarter ended with an instrument installed base of 1,359 (410 PhenoCyclers, 949 PhenoImagers), a year-over-year increase of 12.0% compared to an installed base of 1,213 (354 PhenoCyclers, 859 PhenoImagers) in the prior year period.
The quarter ended with 1,891 total publications citing Akoya’s technology, a year-over-year increase of 44.7% compared to 1,307 total publications in the prior year period.

In light of the pending acquisition by Quanterix Corporation, Akoya will not be hosting an earnings conference call or providing forward-looking guidance at this time.

Important Additional Information

In connection with its proposed acquisition of Akoya (the "Merger"), Quanterix Corporation ("Quanterix") will file with the SEC a post-effective amendment to its previously filed registration statement on Form S-4 (as so amended, the "Registration Statement"), which will contain a preliminary proxy statement of Akoya and a preliminary prospectus of Quanterix (the "Proxy Statement/Prospectus"), and each of Quanterix and Akoya have, and may in the future, file with the SEC other relevant documents regarding the proposed Merger. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT AND THE PROXY STATEMENT/PROSPECTUS CAREFULLY AND IN THEIR ENTIRETY AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC BY QUANTERIX AND AKOYA, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT QUANTERIX, AKOYA AND THE PROPOSED MERGER. A definitive copy of the Proxy Statement/Prospectus will be mailed to Akoya stockholders when that document is final. Investors and security holders will be able to obtain the Registration Statement and the Proxy Statement/Prospectus, as well as other filings containing information about Quanterix and Akoya, free of charge from Quanterix or Akoya or from the SEC’s website when they are filed. The documents filed by Quanterix with the SEC may be obtained free of charge at Quanterix’s website, at www.quanterix.com, or by requesting them by mail at Quanterix Investor Relations, 900 Middlesex Turnpike, Billerica, MA 01821. The documents filed by Akoya with the SEC may be obtained free of charge at Akoya’s website, at www.akoyabio.com, or by requesting them by mail at Akoya Biosciences, Inc., 100 Campus Drive, 6th Floor, Marlborough, MA 01752 ATTN: Chief Legal Officer.

Participants in the Solicitation

Quanterix and Akoya and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Akoya in respect of the proposed Merger. Information about Akoya’s directors and executive officers is available in the Proxy Statement/Prospectus and in Amendment No. 1 to Akoya’s Annual Report on Form 10-K for fiscal year ended December 31, 2024, filed with the SEC on April 28, 2025, and other documents filed by Akoya with the SEC. Other information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the Proxy Statement/Prospectus and other relevant materials to be filed with the SEC regarding the proposed Merger when they become available. Investors should read the definitive Proxy Statement/Prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Quanterix or Akoya as indicated above.

No Offer or Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the Merger, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.

On May 12, 2025 CytomX Therapeutics, Inc. (NASDAQ:CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported the pricing of an underwritten offering of 76,923,076 shares of its common stock at an offering price of $1.30 per share, before underwriting discounts and commissions (Press release, CytomX Therapeutics, MAY 12, 2025, View Source [SID1234652878]). All of the shares are being offered by the Company. The gross proceeds from the offering are expected to be approximately $100 million before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on May 13, 2025, subject to customary closing conditions.

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The Company intends to use the net proceeds from this offering for research and development, general corporate purposes and working capital needs.

The offering was led by Longitude Capital and also included participation from OrbiMed, Venrock Healthcare Capital Partners, Vivo Capital, RTW Investments, and a large investment management firm, among other funds. Jefferies and Piper Sandler are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on August 9, 2024. This offering is being made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A prospectus supplement related to the offering (including the accompanying prospectus) will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement related to the offering and the accompanying prospectus may be obtained, when available, by visiting the SEC’s website or by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in this offering in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

On May 12, 2025 Elpis Biopharmaceuticals, a clinical-stage cell therapy company developing bispecific armored CAR-T therapies for solid tumors, reported that Founder and CEO Yan Chen, MD, PhD, will present new preclinical data on the company’s proprietary multi-mechanism armored CAR-T platform at the PEGS Protein & Antibody Engineering Summit on May 14, 2025, in Boston (Press release, Elpis Biopharmaceuticals, MAY 12, 2025, View Source [SID1234652894]).

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In the presentation, "Multi-Mechanism Armored CAR-T Effectively Overcomes Tumor Microenvironment Resistance and Eradicates Solid Tumors," Dr. Chen will highlight the discovery of Elpis’s multi-mechanism armor by fusing a precision-engineered IL-2 molecule to an anti-PD-L1 antibody, which has the potential to simultaneously overcome multiple resistance mechanisms within the tumor microenvironment (TME). The platform is designed to activate bystander immune cells, selectively target key immune cell types, and orchestrate the immune system for a durable anti-tumor response.

Elpis’s human bispecific armored CAR-T cells have demonstrated potent tumor regression, long persistence, and robust immune modulation across multiple solid tumor models—all at significantly lower doses. These attributes reflect the platform’s potential to improve drugability, safety and support more durable clinical outcomes.

"This is an exciting moment for Elpis," said Dr. Chen. "Our multi-mechanism armor is the result of years of innovation in precision cytokine engineering empowered by mRNA display technology. By addressing both TME resistance with armored cytokine and tumor heterogeneity through bispecific targeting, our platform has the potential to deliver safer, more effective and persistent CAR-T therapies in solid tumors."

Event:

PEGS Summit, Omni Boston Hotel

Session Title:

Multi-Mechanism Armored CAR-T Effectively Overcome Tumor
Microenvironment Resistance and Eradicate Solid Tumors

Session Date:

Wednesday, May 14, 12:30 pm ET

Presenter:

Dr. Yan Chen, Founder and CEO, Elpis Biopharmaceuticals