Terremoto Biosciences Granted FDA Fast Track Designation for TER-2013, an AKT1-Selective Small Molecule Inhibitor for Breast Cancer

On June 3, 2026 Terremoto Biosciences, a biotechnology company developing highly targeted, small molecule medicines, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TER-2013, the Company’s lead AKT1-selective inhibitor, in patients with locally advanced, unresectable or metastatic HR+/HER2- breast cancer harboring one or more AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease.

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Fast Track Designation is intended to facilitate the development and expedite the review of therapies for serious conditions with unmet medical need. The designation allows for more frequent interactions with the FDA regarding development plan, clinical trial design and data requirements to support potential approval. If relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review.

"The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer," said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. "We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers."

TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximizing target engagement within tumor cells. TER-2013 is being evaluated in a Phase 1 clinical trial (NCT-07109726) in patients with solid tumors harboring AKT/​PI3K/​PTEN pathway alterations.

"Our preclinical data demonstrated potent and sustained inhibition of AKT1 while sparing AKT2, AKT3 and other off-target proteins," said James Christensen, Ph.D., President, Head of Research & Development of Terremoto Biosciences. "TER-2013 was designed to selectively target AKT1 with the goal of addressing the limitations of earlier pan-AKT inhibitors. This profile is intended to maximize the coverage of the disease-driving isoform while sparing toxicities linked to AKT2 or other off-target proteins."

The dose-escalation portion of the first-in-human trial has been completed and selection of an optimal dose for POC expansion in patients with cancers harboring AKT/PI3K/PTEN pathway alterations is ongoing. The Company also plans to evaluate expansion opportunities in additional patient populations.

About TER-2013

TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximizing target engagement within tumor cells. In preclinical studies, TER-2013 demonstrated potent and sustained inhibition of AKT1, while sparing AKT2, AKT3 and other off-target proteins at efficacious doses. This selectivity enables robust tumor response and durable anti-tumor activity across multiple xenograft models harboring PIK3CA, AKT1, or PTEN genetic alterations—without AKT2-dependent hyperglycemia, or other toxicities such as rash or diarrhea, observed with earlier pan-AKT inhibitors. TER-2013 is currently being evaluated in a Phase 1 clinical trial (NCT-07109726).

(Press release, Terremoto Biosciences, JUN 3, 2026, View Source [SID1234666424])

Arcus Biosciences Announces Clinical Trial Collaboration and Supply Agreement to Evaluate Casdatifan in Combination with PD‑L1/VEGF‑A Bispecific Immunomodulator to Treat Kidney Cancer

On June 3, 2026 Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, reported a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY, "BMS"). Under the agreement, Arcus will supply casdatifan, the company’s investigational small-molecule HIF-2a inhibitor, to be evaluated as part of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 clinical trial. This trial evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BioNTech and Bristol Myers Squibb, alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC).

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As part of this clinical trial collaboration, casdatifan combinations will be added as two new arms of ROSETTA RCC-208. Each company will retain development and commercial rights to their respective assets, and the agreement is mutually non-exclusive.

"We believe casdatifan can transform the treatment paradigm in kidney cancer, and our development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every patient has the opportunity to benefit from casdatifan across each line of therapy," said Terry Rosen, Ph.D., chief executive officer of Arcus. "HIF-2a inhibition, PD-L1 and VEGF-A blockade are validated mechanisms in the treatment of kidney cancer with a strong biologic rationale for combination. This strategic collaboration with BMS is a top priority for Arcus in order to potentially deliver an additional effective TKI-free option in the first-line setting."

This collaboration is part of Arcus’s holistic development strategy that is intended to provide physicians and patients with: 1) a casdatifan-based and only HIF-2a inhibitor-inclusive TKI-sparing first-line treatment; 2) a casdatifan-based TKI-inclusive first-line regimen; 3) a second-line HIF-2a inhibitor treatment that builds on the second-line standard-of-care TKI, cabozantinib; and 4) a late-line therapy that has been clinically validated to also provide benefit in patients previously treated with a HIF-2a inhibitor-based therapy.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma; ccRCC), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones.

Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.

The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in the:

First-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); and casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing)
Second-line setting with a cohort evaluating casdatifan plus cabozantinib in immunotherapy (IO)-experienced patients (ongoing)
Late-line setting with a cohort evaluating casdatifan plus a TKI in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients (planned)
Arcus is also enrolling patients for PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate a Phase 3 study in first-line metastatic ccRCC by year-end 2026.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally.

About Pumitamig (BNT327/BMS986545)

Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. BioNTech and BMS are currently advancing pumitamig in a broad clinical trial program with more than 20 clinical trials currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications.

About Kidney Cancer

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026. ccRCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for kidney cancer is high; for patients with advanced or late-stage metastatic kidney cancer, however, the five-year survival rate is only 19%. For metastatic kidney cancer, targeted drug therapies are one of the main treatment options.

(Press release, Arcus Biosciences, JUN 3, 2026, View Source [SID1234666423])

Cellares and TScan Therapeutics Announce Agreement to Evaluate Automated Manufacturing of TSC-101 for Patients with Hematologic Malignancies

On June 3, 2026 Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported an agreement to evaluate automated clinical manufacturing of TSC-101, TScan’s lead TCR-T therapy candidate for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), through a comprehensive technical and operational assessment of Cellares’ automated manufacturing and testing platforms.

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TSC-101 is designed to treat residual disease and prevent relapse in patients with AML and MDS undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The therapy candidate uses a gene modification approach to engineer T cells from a healthy donor into a patient-specific cell therapy product. As TScan advances TSC-101 towards a pivotal trial, which is expected to begin in the second quarter of 2026, the Company is evaluating Cellares’ automated manufacturing platform as a scalable and economical path to future commercial demand.

Under the agreement, Cellares will automate the TSC-101 manufacturing and testing processes on the Cell Shuttle, its end-to-end manufacturing platform, and the Cell Q, its automated quality control and release testing system. These closed-system, fully automated workflows are designed to reduce process variability, minimize labor intensity, and enable consistent execution across runs and geographies, delivering the manufacturing economics and reliability that large-scale commercial production requires.

"As we prepare for the initiation of our pivotal study of TSC-101 this quarter, we are increasing our efforts for commercial readiness. Establishing a scalable and cost-efficient manufacturing strategy is a critical component. Cellares’ fully automated Cell Shuttle platform represents a promising approach to automating and scaling cell therapy production, with the potential to reduce manual processes and eliminate capacity constraints," said Ray Lockard, M.B.A., Chief Manufacturing and Quality Officer of TScan Therapeutics. "Through this evaluation, we aim to determine how this technology could strengthen our long-term manufacturing network and support broader patient access, supporting our goal of delivering transformative therapies to patients as efficiently and reliably as possible."

"Patients with AML or MDS who remain at risk of relapse following transplant represent exactly the kind of underserved population that automated manufacturing was designed to reach," said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. "Bringing automation to a late-stage program like TSC-101, with its healthy donor-derived but patient-specific manufacturing model, is the kind of challenge the Cell Shuttle and Cell Q were built for, and we believe it represents the manufacturing economics any developer will need to reach a population of this scale."

The agreement adds TCR-engineered T cell therapies to Cellares’ growing portfolio of automated cell therapy modalities, which includes CAR-T cell therapies, hematopoietic stem cell programs, and autologous progenitor T cell therapies.

(Press release, TScan Therapeutics, JUN 3, 2026, View Source [SID1234666422])

Median Technologies Announces Successful Upsized Capital Increase of € 50 Million

On June 3, 2026 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), developer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a leading provider of AI-based image analyses and central imaging services for oncology clinical trials in the biopharmaceutical industry, reported the success of its upsized capital increase without shareholders’ preferential subscription rights, by way of an issuance of new ordinary shares (the "New Shares"). The New Shares were offered in the framework of (i) a public offering in France and a global placement to certain qualified investors for an amount of €40 million and (ii) an offering reserved to Katarina Martinson AB, Venture S.a.r.l, and Nordica Life (Bermuda) Ltd (the "Guarantors") for an amount of €10 million

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The Offering (as such term is defined below), launched on May 27, 2026, amounted to a total gross proceed of €50 million, including the issuance premium. The initial capital increase of €40 million capital increase was multiple times oversubscribed, demonstrating strong market support. The Offering attracted strong demand from both existing and new institutional investors across Europe, the United States and the United Kingdom, alongside significant participation from retail investors. Given the level of oversubscription recorded, the Reserved Offering to the Guarantors for a maximum amount of € 10 million was fully implemented, bringing the total amount of the transaction to € 50 million.

"On behalf of Median Technologies, I would like to thank all investors—both institutional and retail—for their participation in this capital increase and their confidence in our vision and strategy. This transaction has enabled us to further diversify and strengthen our shareholder base with leading institutional investors from Europe, the United States, and the United Kingdom. We are also grateful for the continued support of Lion Point Capital, which joined Median in 2025, as well as the Guarantors, whose commitment contributed significantly to the success of this transaction," said Fredrik Brag, CEO and Founder of Median Technologies.

"With this financing, Median Technologies believes that it is well positioned to execute its strategic roadmap. The proceeds provide funding visibility into the first half of 2028 and could extend through mid-2029 upon the full exercise of the warrants issued in 2025 and still outstanding," Fredrik Brag added.

"Our priorities are clear: the commercial deployment of eyonis LCS in the United States, its commercial launch in Europe following the expected CE marking in the coming weeks, and the expansion of our eyonis platform into additional cancer indications. We believe early cancer diagnosis is a significant opportunity to improve patient outcomes while helping healthcare systems address the growing burden of cancer. This financing provides the resources to accelerate that mission and create long-term value for patients, healthcare providers, and shareholders alike," concluded Fredrik Brag.

Main Terms of the Offering

Pursuant to the 3rd and 5th resolutions of the general meeting of the shareholders held on October 31, 2025 (the "General Meeting") and the sub-delegation of powers from the Company’s Board of Directors (Conseil d’Administration) held on May 26, 2026, the Chief Executive Officer of the Company decided, on June 3, 2026, to issue 10,000,000 New Shares, excluding the Commission (as such term is defined below) at a price of €5.00 per New Share (i.e. €0.05 nominal value and €4.95 issue premium), representing approximately 31% of the Company’s existing share capital on a non-diluted basis, and corresponding to a capital increase of a total amount of €50,000,000, including issue premium. The price per New Share represents a discount of (i) 2.85% to the volume-weighted average prices (VWAP) of the Company’s shares recorded during the 20 trading sessions preceding May 26, 2026 (inclusive) and (ii) 11.3% to the closing price as of May, 26, 2026.

The New Shares issued in connection with the Offering comprised:

a global offering including (a) a public offering in France, mainly aimed at retail investors (the "Public Offering") and (b) an international offering to qualified investors in certain countries, including (a) in the United States of America, by way of a private placement by the Company to a limited number of "qualified institutional buyers" as defined in Rule 144A under the U.S. Securities Act of 1933, as amended (the "Securities Act"), in reliance on an exemption from the registration requirements of Section 4(a)(2) of the Securities Act, and (b) outside the United States in offshore transactions in accordance with Regulation S under the Securities Act (the "Global Placement", together with the Public Offering, "Global Offering"); and
a share capital increase without shareholders’ preferential subscription rights reserved for a category of persons, for the benefit of Guarantors, in accordance with Article L.225-138 of the French Commercial Code (the "Reserved Offering", together with the "Global Offering", the "Offering",).
As part of the Public Offering: 331,790 New Shares were allocated, representing 3.3 % of the Offering;
In the Global Placement: 7,668,210 New Shares were allocated, representing 76,7 % of the Offering including 4,000,000 New Shares subscribed for and allocated to the Guarantors; and
In the Reserved Offering: 2,000,000 New Shares subscribed for and allocated to the Guarantors, representing 20% of the Offering.
In accordance with the subscription commitments granted to the Company, the Guarantors subscribed in the Global Offering for a total amount of €20,000,000 in the following proportions:

New Shares

Subscribed amount (€)

% of the Global Offering

Katarina Martinson AB

2,666,667

13,333,333

33.3 %

Venture S.a.r.l

933,333

4,666,667

11.7 %

Nordica Life (Bermuda) Ltd

400,000

2,000,000

5.0 %

TOTAL

4,000,000

20,000,000

50 %

In connection with the Reserved Offering, the Guarantors also subscribed, in accordance with the underwriting commitments granted to the Company, for a total amount of €10,000,000 in the following proportions:

New Shares

Subscribed amount (€)

% of the Global Offering

Katarina Martinson AB

1,333,333

6,666,667

16.7 %

Venture S.a.r.l

466,667

2,333,333

5.8 %

Nordica Life (Bermuda) Ltd

200,000

1,000,000

2.5 %

TOTAL

2,000,000

10,000,000

25 %

In consideration for their subscription and underwriting commitments, each Guarantor is in any event entitled to the payment of a fee equal to 8% of the aggregate amount of its subscription and underwriting commitments, i.e. a total aggregate amount of €2,400,000 for the Guarantors, payable by way of set-off of a certain and payable receivable in new shares on the settlement-delivery date of the Offering, representing 480,000 new ordinary shares (the "Commission").

Intended use of the Offering’s net proceeds

The net proceeds from the Offering will be used:

To accelerate commercialization of eyonis LCS in the U.S. and launch in target European countries after CE marking achievement,
To develop eyonis for incremental cancer indications,
For Company’s working capital and general corporate purposes.
The Offering will extend Company’s cash runway until first half-year 2028.

In case of the full exercise of the 12 million warrants issued in July 2025 that are currently outstanding, with an expiration date in January 2028 at an exercise price of €2.39 per share (remaining exercise value of €44.3 million), the cash runway of the Company would be extended to mid-2029.

Settlement of the New Shares

Settlement of the New Shares and their admission to trading on the multilateral trading facility of Euronext Growth Paris are expected to take place on June 5, 2026. The New Shares will be of the same class as, and fungible with, the existing ordinary shares, will carry all rights attached to the existing shares and will be admitted to trading on Euronext Growth Paris under the same ISIN code: FR0011049824 – ALMDT.

Impact of the Offering on the Company’s shareholding structure and shareholders’ equity

Before the Offering, and based on the information made available to the Company, the share capital and number and percentage of voting rights were allocated as follows:

non diluted basis

diluted basis(1)

Number of shares / voting rights

% of share capital and voting rights

Number of shares / voting rights

% of share capital and voting rights

Anne Helen & Fredrik Lungström

5,215,396

13.7 %

11,540,692

17.77 %

Celestial Successor Fund, LP

2,553,312

6.7 %

6,577,343

10.13 %

Matignon Finance

1,625,099

4.3 %

2,586,542

3.98 %

Furui Medical Science Company

1,507,692

3.9 %

1,507,962

2.32 %

Lion Point L P

1,506,024

3.9 %

3,765,060

5.80 %

Canon Inc

961,825

2.5 %

961,825

1.48 %

Free float

24,833,039

65.0 %

38,017,120

58. 53 %

Total

38,202,387

100.00%

64,956,544

100.0%

(1) After acquisition of the free shares granted by the Company and exercise of the stock options and share warrants issued by the Company as of 31 December 2025, corresponding to 26,754,157 shares of the Company.

After the Offering, and based on the information made available to the Company, the share capital and number and percentage of voting rights is allocated as follows:

non diluted basis

diluted basis(1)

Number of shares / voting rights

% of share capital and voting rights

Number of shares / voting rights

% of share capital and voting rights

Anne Helen & Fredrik Lungström

5,215,396

10.7%

11,540,692

15.30%

Celestial Successor fund LP

2,553,312

5.2%

6,577,343

8.72%

Matignon Finance

1,625,099

3.3%

2,586,542

3.43%

Furui Medical Science Company

1,507,692

3.1%

1,507,962

2.00%

Lion Point L P

1,506,024

3.1%

3,765,060

4.99%

Canon Inc

961,825

2.0%

961,825

1.28%

Katarina Martinson AB

4,320,000

8.9%

,4,320,000

5.73%

Venture S.a.r.l

1,512,000

3.1%

1,512,000

2.00%

Nordica Life (Bermuda) Ltd

648,000

1.3%

648,000

0.83%

Free float

28,833,039

59.2%

,42,017,120

55.70%

Total

48,682,387

100.0%

75,436,544

100.00%

(1) After acquisition of the free shares granted by the Company and exercise of the stock options and share warrants issued by the Company as of 31 December 2025, corresponding to 26,754,157 shares of the Company.

For illustrative purposes, the impact of the Offering on the ownership interest of a shareholder holding 1% of the Company’s share capital prior to the Offering and who did not subscribe to it, and on the Company’s shareholders’ equity per share, is as follows, based on the number of shares comprising the Company’s share capital as of the date of this press release, after deduction of treasury shares, and on consolidated shareholders’ equity attributable to the Group as of 31 December 2025:

Share of consolidated shareholders’ equity per share, in euros.

Ownership interest, in %.

Non-diluted basis

Diluted basis(1)

Non-diluted basis

Diluted basis(1)

Before the Offering

-0.920€

0.590€

1%

0.588%

After the Offering (excluding the Commission).

0.308€

1.315 €

0.793%

0.491%

After the Offering (including the Commission).

0.354€

1.203 €

0.785%

0.506%

(1) After acquisition of the free shares granted by the Company and exercise of the stock options and warrants issued by the Company as of 31 December 2025, corresponding to 26,754,157 shares of the Company.

Financial intermediaries

TD Cowen and Stifel Europe Securities SAS acted as Joint Global Coordinators and Joint Placement Agents for the Offering (together, the "Placement Agents"). The Offering was subject to a placement agreement between the Company and the Placement Agents, which was entered into on June 3, 2026 (the "Placement Agreement").

Lock-up and undertakings

The Company has entered into a lock-up undertaking for a period of 90 days following the date of the settlement and delivery of the Offering, subject to certain customary exceptions.

The members of the Company’s Board of Directors and Executive Committee, including the Chief Executive Officer, have undertaken to retain the Company’s shares that they hold for a period of 90 days from the settlement-delivery date of the Offering, subject to certain customary exceptions. Lion Point Capital has also undertaken not to dispose of the shares it holds for a period of 90 days as from the settlement-delivery date of the Offering, subject to certain customary exceptions.

Eligibility of the Offering for PEA / PEA-PME schemes and the regime under Article 150-0 B ter of the French Tax Code, CGI, relating to the reinvestment of capital gains

Shares of Median Technologies are fully eligible for inclusion in share savings plans, or PEA, and PEA-PME accounts, which benefit from the same tax advantages as the standard PEA.

In the event of a contribution of securities to a company controlled by the contributor, the capital gain is placed under tax deferral pursuant to Article 150-0 B ter of the French Tax Code. The sale, within three years, of the contributed securities results in the termination of this tax deferral, unless the Company undertakes to reinvest 60% of the proceeds from the sale in an economic activity within two years of the sale. The sale proceeds may notably be invested in the cash subscription to the initial share capital or to a capital increase of one or more companies that meet the conditions provided for in Article 150-0 B ter of the French Tax Code. In this respect, the Offering constitutes an eligible reinvestment for maintaining the deferral of the capital gain on the contribution, with respect to the nature of the reinvestment.

The other conditions for application of the regime that are independent of the Company, including the reinvestment period and threshold, the holding of the new securities, and other applicable requirements, must also be complied with by the subscriber. Investors who may be eligible for this regime are invited to consult their usual tax adviser in order to assess their personal situation in light of the specific applicable regulations.

Risk factors

The main risk factors relating specifically to the Offering are set out below:

Shareholders not participating in the Offering will see their shareholding in the Company diluted by the issuance of the New Shares, and would see their shareholding diluted by any future capital increases made necessary by the Company’s ongoing openness to fundraising;
The market price of the Company’s shares may fluctuate and fall below the subscription price of the New Shares;
The volatility and liquidity of the Company’s shares may fluctuate significantly;
The other risk factors relating to the Company and its activities set out in the section "P Specific risk factors" of its 2025 annual financial report and of the information document, available on the Company’s website.

(Press release, MEDIAN Technologies, JUN 3, 2026, View Source [SID1234666421])

Verastem Oncology Announces U.S. FDA Fast Track Designation for VS-7375, an Oral and Potential Best-in-Class Investigational KRAS G12D (ON/OFF) Inhibitor for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On June 3, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375, an oral and potential best-in-class investigational selective KRAS G12D (ON/OFF) inhibitor, for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer.

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"Non-small cell lung cancer is the most prevalent lung disease with more than 8,000 patients in the U.S. diagnosed each year with KRAS G12D-mutations. Receiving Fast Track designation for VS-7375 reinforces both the significant unmet need and the potential of VS-7375 to improve outcomes for patients with KRAS G12D-mutated lung cancer," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "We are continuing to accelerate the development of VS-7375 across multiple KRAS G12D-driven tumor types, including pancreatic, non-small cell lung, and colorectal cancers to bring a highly targeted, oral treatment option to patients as quickly as possible."

Non-small cell lung cancer (NSCLC) is the most prevalent type of lung cancer, accounting for approximately 80% to 85% of all cases. The majority of patients with NSCLC are diagnosed with advanced-stage disease, either locally advanced (30% to 35%) or metastatic (50% to 55%), which is inoperable. The KRAS G12D mutation occurs in five percent of NSCLC cases and patients with these mutations are known to have reduced responses to standard therapies and poor prognosis. Currently, no therapies are approved by the FDA specifically targeting KRAS G12D mutations in cancer.

TARGET-D 202 is a Phase 2, open-label, multi-center study to evaluate VS-7375 900 mg oral dose once daily (QD) in patients with advanced NSCLC who have received one to two prior lines of therapy. Based on positive data in pre-clinical intracranial tumor models, the study is also evaluating VS-7375 in NSCLC patients with asymptomatic untreated brain metastases.

In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion and combination clinical trial evaluating VS-7375 in patients with advanced KRAS G12D-mutated solid tumors, including pancreatic, non-small cell lung, and colorectal cancers. Enrollment is ongoing with monotherapy dose escalation progressing from 400 mg through 900 mg once daily (QD) doses without dose-limiting toxicities or major safety concerns observed to date. The study is currently evaluating a 1200 mg QD monotherapy dose and a 900 mg QD cetuximab combination cohort.

In the ongoing TARGET-D 101 study, data reported in March 2026 from 23 patients treated across the 400 mg, 600 mg and 900 mg QD dose levels, with a mean treatment duration of 1.6 months (range 0.7–5.6), showed VS-7375 was generally well tolerated, with no drug-related liver function test abnormalities or Grade >2 neutropenia observed as of the January 30, 2026 data cutoff, and lower reported rates of nausea, vomiting and diarrhea compared with data previously reported in China. Following feedback from the FDA, Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed trials: TARGET-D 201 in metastatic pancreatic ductal adenocarcinoma, TARGET-D 202 in advanced non-small cell lung cancer, and TARGET-D 203 in metastatic colorectal cancer.

About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. The mechanism of action of VS-7375 is unique in that it binds the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state.

In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed, open-label clinical trials: TARGET-D 201 in second-line advanced or metastatic pancreatic ductal carcinoma, TARGET-D 202 in second/third-line advanced or metastatic non-small cell lung cancer, and TARGET-D 203 in metastatic colorectal cancer.

In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal carcinoma who have received at least one prior line of standard systemic therapy.

In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China.

(Press release, Verastem, JUN 3, 2026, View Source [SID1234666420])