Three Cancer Drug Programs Advanced This Week and Nobody Noticed

Three Cancer Drug Programs Advanced This Week and Nobody Noticed

MAIA Biotechnology got FDA clearance to open US enrollment for its Phase 2 lung cancer trial on June 3. ADC Therapeutics released Phase 3 data confirming ZYNLONTA extends progression-free survival in lymphoma the same day. Verastem got an FDA Fast Track for its KRAS G12D inhibitor in lung cancer the day after. Three different companies, three different mechanisms, three different stages. All of them worth knowing about.

MAIA Biotechnology Receives FDA Clearance for Phase 2 NSCLC US Enrollment

On June 2, MAIA Biotechnology’s CEO and a director bought shares on the open market. On June 3, the company announced the FDA had cleared an amended investigational new drug application enabling US enrollment in the Phase 2 THIO-101 trial expansion.

MAIA’s lead candidate is ateganosine (a novel cancer drug that works through two mechanisms simultaneously. It targets telomeres to destabilize cancer cell DNA while also triggering an immune response against the tumor). THIO-101 is testing ateganosine in combination with a checkpoint inhibitor in patients with advanced third-line non-small cell lung cancer. Patients who have already tried two other lines of therapy.

The IND amendment also updates the manufacturing protocols, which the FDA cleared alongside the enrollment expansion. The trial is running across 44 clinical sites in six countries. Up to five US sites are planned for 2026. Eight patients in THIO-101 have shown overall survival beyond two years, meaningful in a patient population where survival beyond 12 months is often considered a win.

MAIA also has a pivotal Phase 3 trial, THIO-104, enrolling up to 300 patients in the same indication. The Phase 3 was presented at the ASCO 2026 Annual Meeting on June 1, one day before the insider purchases and two days before the FDA clearance. The Fast Track designation was granted by the FDA in July 2025. The stock gained 5.93% on June 3. Filings on SEC EDGAR.

ADC Therapeutics Phase 3 LOTIS-5 Confirms ZYNLONTA Extends Survival in Lymphoma

Also June 3. ADC Therapeutics (NYSE: ADCT) released topline data from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA plus rituximab in relapsed or refractory diffuse large B-cell lymphoma (DLBCL, the most common type of aggressive lymphoma). The trial met its primary endpoint. ZYNLONTA plus rituximab reduced the risk of disease progression or death by 27% compared to the control arm of gemcitabine and oxaliplatin plus rituximab (R-GemOx), with a hazard ratio of 0.73 and a p-value of 0.008. Median progression-free survival was 6.1 months versus 4.7 months.

Overall survival showed no detrimental effect. The combination did not shorten lives even where it did not extend them. Complete response rates were higher and lasted longer in the ZYNLONTA arm. The safety picture is worth reading carefully. Overall adverse event rates were similar between the two arms, but serious adverse events and Grade 5 events: (events resulting in death), were more frequent with ZYNLONTA plus rituximab, particularly in patients aged 75 and older. Any physician or patient considering this combination in older patients should review the full safety data in the press release.

ADC Therapeutics has scheduled a pre-supplemental biologics license application meeting with the FDA for August 2026 and is targeting an sBLA submission in Q4 2026. ZYNLONTA is already approved in the US for third-line DLBCL. This trial is designed to extend its use into an earlier line of therapy. ADC Therapeutics is a Switzerland-based company listed on the NYSE. Filings on SEC EDGAR.

Verastem Oncology Gets FDA Fast Track for Oral KRAS G12D Lung Cancer Inhibitor

On June 4, Verastem Oncology (Nasdaq: VSTM) announced the FDA granted Fast Track designation for VS-7375 in KRAS G12D-mutated advanced non-small cell lung cancer. VS-7375 is described as an oral, potential best-in-class KRAS G12D ON/OFF inhibitor, meaning it blocks the mutant protein in both its active and inactive states.

KRAS G12D (a specific mutation in a gene called KRAS that locks a protein in an active state, driving uncontrolled tumor growth. Present in roughly 4% of all NSCLC cases and historically difficult to target with drugs) has been one of the most sought-after targets in oncology for decades. Sotorasib and adagrasib address the G12C variant. The G12D variant is different and has had fewer options. Verastem previously held Fast Track for VS-7375 in pancreatic cancer, where KRAS G12D is far more prevalent. The NSCLC designation expands the potential addressable population.

The Phase 1 TARGET-D 101 trial is ongoing with early data updates expected in the first half of 2026. A Phase 2 registration-directed trial has already been initiated. VS-7375 was licensed from GenFleet Therapeutics, which is developing it in China as GFH375. Verastem holds the rights outside GenFleet’s markets. Filings on SEC EDGAR.

TransCode Therapeutics Completes Phase 1a With No Dose-Limiting Toxicities

TransCode Therapeutics (Nasdaq: RNAZ). We covered TransCode’s Phase 2a trial initiation last week. On June 3, the company released the complete Phase 1a dataset. No dose-limiting toxicities across any of the four dose cohorts. Nine of 14 evaluable patients achieved stable disease lasting six months or more. Three patients are still on trial at 21, 16, and 14 cycles respectively. One metastatic thyroid cancer patient has shown a dramatic decline in thyroglobulin levels, a tumor marker, and has had stable disease for 12 months. The recommended Phase 2 dose was confirmed at 4.8mg/kg. Market cap approximately $5 million at the time of publication.

Upcoming Catalysts: MAIA, ADC Therapeutics, Verastem and TransCode

MAIA THIO-101 US enrollment: watch for any announcement of the first US patient enrolled. That milestone converts FDA clearance into an operational reality and signals the US clinical network is activated.

ADC Therapeutics pre-sBLA meeting: scheduled August 2026. Any readout from that FDA interaction will signal how the agency views the LOTIS-5 data and what, if anything, needs to be addressed before formal submission.

Verastem TARGET-D 101 early data: the company has guided for early Phase 1 data updates in H1 2026. That window closes at the end of June. Any data presentation at a medical conference or investor event is the next near-term catalyst.

TransCode Phase 2a enrollment: the trial in ctDNA-positive colorectal cancer has been initiated. First enrollment update and any interim signal from the Phase 2a will be the next meaningful disclosure from a company with a $5 million market cap and a funded runway into late 2027.

Sources

Editorial Disclosure

This roundup is based entirely on publicly available information including press releases, regulatory filings, and clinical trial disclosures. Securities discussed include MAIA Biotechnology, Inc. (NYSE American: MAIA), ADC Therapeutics SA (NYSE: ADCT), Verastem Oncology, Inc. (Nasdaq: VSTM), and TransCode Therapeutics, Inc. (Nasdaq: RNAZ). aktiego.com has not received any compensation from any company mentioned, their management, investor relations representatives, or any third party. No staff member or principal of aktiego.com holds a position in any security mentioned at the time of publication. All press release dates verified from primary sources: MAIA via GlobeNewswire June 3, 2026 09:45 ET; ADC Therapeutics via PRNewswire June 3, 2026; Verastem via Business Wire June 4, 2026; TransCode via PRNewswire and SEC EDGAR 8-K June 3, 2026. TransCode Therapeutics is included in the follow-up section as a continuation of coverage initiated the week of May 25-31, 2026 when Phase 2a trial initiation was reported. All drugs referenced are investigational and not FDA approved for the indications discussed except ZYNLONTA, which is already FDA approved for third-line r/r DLBCL; the LOTIS-5 data is for a supplemental indication not yet approved. MAIA’s ateganosine, Verastem’s VS-7375, and TransCode’s TTX-MC138 are investigational; their safety and efficacy have not been established. The safety signal for ZYNLONTA plus rituximab in patients aged 75 and older, including higher rates of Grade 5 adverse events, is disclosed in the article body. MAIA insider share purchases were disclosed on June 2, 2026 in a separate GlobeNewswire press release. TransCode Therapeutics had a market capitalization of approximately $5 million at the time of publication and is burning through cash; readers should review the most recent SEC filings for liquidity details. These are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.

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