On May 1, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported further progress in its Phase 1a clinical trial of TTX-MC138 in patients with metastatic cancer (Press release, TransCode Therapeutics, MAY 1, 2025, View Source [SID1234652459]). TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. To date, 13 patients have received at least one dose of TTX-MC138 at 4 separate dose levels ranging from 0.8 mg/kg to 4.8 mg/kg. Two patients have been treated in the expanded enrollment.

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Eight patients remain on study for continued treatment, receiving an additional dose of TTX-MC138 during each 28 day treatment cycle and may remain on study absent any significant safety observations or disease progression. To date, the two patients who have remained on study the longest have received seven doses of TTX-MC138 over the course of approximately seven months and have demonstrated stable disease. No significant safety or dose limiting toxicities have been reported to date in any of the trial’s 13 patients. Ongoing analyses of PK activity from Cohorts 1, 2 and 3 suggest that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode’s Phase 0 clinical trial. Specifically, the preliminary PK data follow a predictable dose-response relationship. Analysis of PD activity from cycle 1 treatments in Cohorts 1 and 2, treated with a dose of 0.8 mg/kg and 1.6 mg/kg respectively, demonstrates miR-10b target engagement at 24 hours post-infusion in 5 out of the 6 patients analyzed to date.

The observed tolerability profile and the available PK/PD results thus far supports advancement of the clinical trial to further evaluate safety and potential anti-tumor activity of TTX-MC138 in the planned dose expansion (Phase 1b) portion of the trial. At the highest dose administered, TTX-MC138 was well tolerated with no significant toxicities noted.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

About the Trial

TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation stage followed by a dose-expansion stage. The primary objective of the dose-escalation stage is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion stage, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase.

Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).

On May 1, 2025 SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for cancer and disorders of the central nervous system (CNS), reported the publication of its research in the journal, Nature Communications, detailing the discovery of PVTX-405, a best-in-class IKZF2 molecular glue degrader (Press release, SK Life Science, MAY 1, 2025, View Source [SID1234652458]).

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"This novel agent represents a significant step toward improved oncology treatments, establishing PVTX-405 as a potent IKZF2 molecular glue degrader that supercharges the body’s immune response against cancer," said Ryan Kruger, Ph.D., Chief Scientific Officer at SK Life Science Labs. "By targeting IKZF2, PVTX-405 dramatically reduces immune suppression, allowing the patient’s own immune system to more effectively fight cancer."

Regulatory T-cells, also known as Tregs, are a major roadblock in cancer treatment, suppressing the immune system and allowing tumors to thrive. IKZF2 is a critical factor in maintaining Tregs stability within the tumor environment. By selectively degrading IKZF2, PVTX-405 weakens Tregs, boosting the activity of tumor-fighting effector T-cells and amplifying the immune response against cancer.

The findings of this research show that PVTX-405 offers superior selectivity, potency and safety over previous IKZF2 molecular glue degraders. It is designed to degrade IKZF2 more efficiently while reducing the risk of unintended immune or blood cell-related toxicities. Most importantly, once-daily oral administration of PVTX-405 demonstrates exceptional anti-tumor efficacy, substantially slowing tumor growth and enhancing the impact of immune checkpoint inhibitors. This combined effect results in greater tumor regression and prolonged survival in preclinical trials.

"These exciting results reinforce our enthusiasm for partnering with biopharma, research institutions, and investors to fast-track the clinical development of this groundbreaking immunotherapy, with the goal of improving and extending the lives of cancer patients," said Dr. Kruger. "This research not only showcases the potential of molecular glue degraders as powerful therapeutic agents but also highlights SK Life Science Labs’ dedication to advancing life-saving treatments."

On May 1, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that management will participate in two upcoming investor conferences (Press release, Sutro Biopharma, MAY 1, 2025, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-to-participate-in-upcoming-investor-conferences-6 [SID1234652454]).

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Conference Details:

The Citizens Life Sciences Conference
Date: May 7-8, 2025
Location: New York, NY

BofA Securities 2025 Health Care Conference
Date: May 13-15, 2025
Location: Las Vegas, NV

Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the event.

On May 1, 2025 Repare Therapeutics Inc. ("Repare") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that it has out-licensed its discovery platforms, including certain platform and program intellectual property, to DCx Biotherapeutics Corporation ("DCx"), a newly-launched Canadian biotechnology company developing next generation precision drug conjugates and supported by Amplitude Ventures (Press release, Repare Therapeutics, MAY 1, 2025, View Source [SID1234652453]). Additionally, DCx will retain certain preclinical research personnel, acquire lease rights to certain laboratory facilities in Montreal and acquire certain laboratory equipment.

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"We have taken careful steps to evaluate all aspects of our business to ensure continued value generation, and this out-licensing agreement with DCx for our discovery platforms enables us to further focus on our clinical portfolio and drive cost reductions while maintaining an economic interest in the platform technologies we have developed." said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "We look forward to reporting initial data from our two ongoing Phase 1 clinical trials in the second half of 2025, and continue to evaluate partnering and strategic alternatives across our portfolio assets."

Under the terms of the out-licensing agreement, Repare will receive upfront and near-term payments totaling $4 million, as well as a 9.99% common equity position in DCx (including certain dilution protection rights) and is eligible to receive potential future out-licensing, clinical and commercial milestone payments, as well as low-single digit tiered sales royalites for the development of certain products by DCx. Additionally, DCx will retain approximately 20 of Repare’s preclinical research employees. Repare has the right to appoint one nominee to the board of directors of DCx. In connection with the transaction, Repare out-licensed its clinically-validated SNIPRx platform and its early discovery-stage SNIPRx-surf and STEP2 platforms, along with other intellectual property. The SNIPRx-surf platform identifies cell surface targets based on gene expression and protein features in tumors or cancer models, including by clinically relevant biomarkers and machine learning algorithm. The STEP2 platform is a chemogenomic discovery platform, which uses CRISPR-enabled genetic screens with small molecule inhibitors to identify clinically relevant genetic lesions that are sensitive to small molecule inhibitors.

On May 1, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30 to June 3 in Chicago, IL (Press release, Regeneron, MAY 1, 2025, View Source [SID1234652452]). Eighteen presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma.

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"Our broad oncology and hematology programs are uniquely designed to investigate regimens that could provide meaningful impact for people living with difficult-to-treat cancers across all stages of the treatment paradigm," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. "Our PD-1 inhibitor Libtayo is the standard of care in advanced cutaneous squamous cell carcinoma, and in clinical trials, our investigational BCMAxCD3 bispecific antibody linvoseltamab has demonstrated a compelling profile in relapsed or refractory multiple myeloma. At ASCO (Free ASCO Whitepaper), our presentations showcase how we are seeking to further transform the treatment of these diseases with updates from two key programs – our Phase 3 trial exploring adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma and early data from investigational combinations of linvoseltamab and different proteasome inhibitors in third-line or higher multiple myeloma."

Notable presentations at ASCO (Free ASCO Whitepaper) on Regeneron’s oncology pipeline include detailed efficacy and safety findings from the Phase 3 C-POST trial evaluating the adjuvant use of the PD-1 inhibitor Libtayo in post-surgical high-risk cutaneous squamous cell carcinoma (CSCC). The results will be presented in an oral session on Saturday, May 31.

In hematology, Regeneron will debut results from two cohorts of the LINKER-MM2 trial, which is exploring combinations of linvoseltamab, Regeneron’s investigational BCMAxCD3 bispecific antibody. These include combinations of linvoseltamab with carfilzomib or bortezomib in relapsed/refractory (R/R) multiple myeloma (MM) after at least two lines of therapy, which will be featured in two rapid oral presentations on Monday, June 2.

In addition, the results of a cooperative group study reporting on the primary analysis of a randomized Phase 2 trial of vidutolimod in combination with an anti-PD-1 versus anti-PD-1 as neoadjuvant therapy in stage 3 resectable melanoma will be presented in an oral session on Tuesday, June 3. Vidutolimod is a toll like receptor 9 antagonist that was acquired by Regeneron in 2022.

The full list of Regeneron presentations at ASCO (Free ASCO Whitepaper) includes:

Medicine Abstract title Abstract and
Session Lead author Presentation
date/time
(all CDT)
Skin Cancer
Libtayo
Phase 3 trial of
adjuvant cemiplimab
(cemi) versus
placebo (pbo) for
high-risk cutaneous
squamous cell
carcinoma (CSCC) #6001

Oral Abstract
Session – Head
and Neck Cancer Danny Rischin Saturday,
May 31

1:15 p.m. –
4:15 p.m.
Libtayo Patient-reported
outcomes (PROs) in
the C-POST trial of
adjuvant cemiplimab
(cemi) vs placebo
(pbo) for high-risk
cutaneous
squamous cell
carcinoma (CSCC) #6065

Poster Session
– Head and
Neck Cancer Annette M. Lim Monday, June
2

9:00 a.m. –
12:00 p.m.
Libtayo CemiplimAb-rwlc
Survivorship and
Epidemiology
(CASE): Interim
results from a
prospective study of
the safety and
effectiveness of
cemiplimab in
patients with
advanced cutaneous
squamous cell
carcinoma (CSCC)
in a real-world
setting #9533

Poster Session
–
Melanoma/Skin
Cancers Soo J. Park Sunday, June
1

9:00 a.m. –
12:00 p.m.
Libtayo A Phase 3
randomized study of
low-dose
intralesional
cemiplimab versus
primary surgery for
patients with early-
stage cutaneous
squamous cell
carcinoma (CLEAR
CSCC) #TPS9612

Poster Session
–
Melanoma/Skin
Cancers Michael Migden Sunday, June
1

9:00 a.m. –
12:00 p.m.
Fianlimab,
Libtayo A randomized phase
2 peri-operative
(neoadjuvant plus
adjuvant) study of
fianlimab (anti–LAG-
3) plus cemiplimab
(anti–PD-1) versus
anti–PD-1 alone in
patients with
resectable stage III
and IV melanoma #TPS9596

Poster Session
–
Melanoma/Skin
Cancers Rodabe N.
Amaria Sunday, June
1

9:00 a.m. –
12:00 p.m.
Libtayo Utilizing EORTC
Item Library to
develop a tailored
patient-reported
outcome measure
(CSCC-NAAP-32) to
evaluate quality of
life in resectable
advanced (RA)
cutaneous
squamous cell
carcinoma (CSCC) #e18014

Publication-
Only Abstract:
Head and Neck
Cancer Neil Gross N/A
Vidutolimod A phase 2
randomized study of
neoadjuvant
pembrolizumab (P)
alone or in
combination with
vidutolimod (V) in
high-risk resectable
melanoma: ECOG-
ACRIN 6194 #LBA9505

Oral Abstract
Session –
Melanoma/Skin
Cancers Ahmad Tarhini Tuesday, June
3

9:45 a.m. –
12:45 p.m.
Multiple Myeloma
Linvoseltamab Linvoseltamab
(LINVO) +
carfilzomib (CFZ) in
patients (pts) with
relapsed/refractory
multiple myeloma
(RRMM): Initial
results from the
LINKER-MM2 trial #7513

Rapid Oral
Abstract Session –
Hematologic
Malignancies—
Plasma Cell
Dyscrasia Salomon Manier Monday, June
2

8:00 a.m. –
9:30 a.m.
Linvoseltamab Linvoseltamab
(LINVO) +
bortezomib (BTZ) in
patients (pts) with
relapsed/refractory
multiple myeloma
(RRMM): First
results from the
LINKER-MM2 trial #7510

Rapid Oral
Abstract
Session –
Hematologic
Malignancies—
Plasma Cell
Dyscrasia Paula
Rodríguez-Otero Monday, June
2

8:00 a.m. –
9:30 a.m.
Linvoseltamab Indirect comparison
of linvoseltamab
versus elranatamab
for triple-class
exposed (TCE)
relapsed/refractory
multiple myeloma
(RRMM) #7531

Poster Session
– Hematologic
Malignancies—
Plasma Cell
Dyscrasia Sundar
Jagannath Sunday, June
1

9:00 a.m. –
12:00 p.m.
Linvoseltamab Second primary
malignancy (SPM) in
patients (pts) with
multiple myeloma
(MM) receiving
chimeric antigen
receptor T-cell (CAR
T) therapy or other
systemic anticancer
therapy (SACT): A
comparative study
using a real-world
database #7519

Poster Session
– Hematologic
Malignancies—
Plasma Cell
Dyscrasia Attaya
Suvannasankha Sunday, June
1

9:00 a.m. –
12:00 p.m.
Linvoseltamab Concordance
between blinded
independent central
review committee
and physician-
assessed
responses: Analyses
based on a real-
world external
control arm in
relapsed/refractory
multiple myeloma
using International
Myeloma Working
Group data #e19521

Publication-
Only Abstract:
Hematologic
Malignancies—
Plasma Cell
Dyscrasia Brian G. Durie N/A
Lung Cancer
REGN7075,
Libtayo A randomized study
of neoadjuvant
REGN7075 +
cemiplimab +
chemotherapy
(chemo) vs
cemiplimab + chemo
in patients (pts) with
resectable non-small
cell lung cancer
(NSCLC) #TPS8116

Poster Session
–Lung
Cancer—Non-
Small Cell
Local-
Regional/Small
Cell/Other
Thoracic
Cancers Ardy Davarifar Saturday,
May 31

1:30 p.m. –
4:30 p.m.
Fianlimab,
Libtayo Phase 2 peri-
operative study of
fianlimab +
cemiplimab +
chemotherapy
versus cemiplimab +
chemotherapy in
resectable early-
stage non-small cell
lung cancer
(NSCLC) #TPS8117

Poster Session
– Lung Cancer
Non-Small Cell
Local-
Regional/Small
Cell/Other
Thoracic
Cancers Ekaterine
Arkania Saturday,
May 31

1:30 p.m. –
4:30 p.m.
Libtayo Evaluation of current
programmed death-
ligand 1 (PD-L1)
testing trends for
metastatic non-small
cell lung cancer
(mNSCLC): Insights
from a large network
of US community
oncology practices #e23294

Publication-
Only Abstract:
Quality
Care/Health
Services
Research Kathleen M.
Aguilar N/A
Libtayo Evaluating the
safety and
effectiveness of
cemiplimab in
combination with
platinum-doublet
chemotherapy by
demographic
characteristics in
first-line treatment of
advanced non-small
cell lung cancer: An
ongoing multi-
database real world
evidence study in
US patients #e20572

Publication-
Only Abstract:
Lung Cancer—
Non-Small Cell
Metastatic Alexi
Archambault N/A
Head and Neck Cancer
Fianlimab,
Libtayo A Phase 2 study of
fianlimab (anti-LAG-
3) plus cemiplimab
(anti-PD-1) versus
cemiplimab plus
placebo in patients
with
recurrent/metastatic
head and neck
squamous cell
carcinoma (HNSCC)
with positive PD-L1
expression #TPS6112

Poster Session
– Head and
Neck Cancer Danny Rischin Monday, June
2

9:00 a.m. –
12:00 p.m.
Lymphoma
Odronextamab Long-term follow-up
of the phase 2 ELM-
2 study:
Odronextamab for
patients (pts) with
relapsed/refractory
(R/R) follicular
lymphoma (FL) #7049

Poster Session –
Hematologic
Malignancies—
Lymphoma and
Chronic
Lymphocytic
Leukemia Deepa
Jagadeesh Sunday, June
1

9:00 a.m. –
12:00 p.m.
Odronextamab Second primary
malignancy in
patients with diffuse
large B-cell
lymphoma (DLBCL)
receiving chimeric
antigen receptor T-
cell (CAR T) therapy
and other systemic
anti-cancer therapy:
A real-world data
analysis #7080

Poster Session
– Hematologic
Malignancies—
Lymphoma and
Chronic
Lymphocytic
Leukemia Matthew
Lunning Sunday, June
1

9:00 a.m. –
12:00 p.m.

The potential uses of Libtayo in adjuvant CSCC, fianlimab, REGN7075, vidutolimod, and the combinations with linvoseltamab described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. Fianlimab, REGN7075 and vidutolimod are not currently approved for use in any indication. Odronextamab is conditionally approved as Ordspono in the European Union for the treatment of R/R follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority. Linvoseltamab is conditionally approved as Lynozyfic in the European Union for the treatment of adult patients with R/R multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority. The U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Applications for linvoseltamab and odronextamab with respective target action dates for FDA decisions of July 10, 2025 and July 30, 2025.