On November 17, 2025 Nerviano Medical Sciences (NMS), a clinical-stage biopharmaceutical company focused on oncology innovation, reported that its subsidiary, Nerviano Medical Sciences (Shanghai) Co., Ltd. (NMS China), has officially joined the Roche Accelerator.

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NMS China is part of the Roche Accelerator since October 2025. The Roche Accelerator is Roche’s first in-house accelerator globally, representing Roche’s long-term commitment to Shanghai and China. The Roche Accelerator aims to catalyze and empower scientists and entrepreneurs to accelerate breakthrough innovation into next-generation therapeutics.

Joining the Roche Accelerator marks a new milestone for NMS China, reinforcing the company’s mission to bring differentiated cancer therapies to patients through scientific excellence and global partnerships.

Entrectinib, a precision oncology therapy approved for the treatment of NTRK and ROS1 fusion-positive cancers, originated from NMS and was out-licensed to Ignyta, subsequently acquired by Roche. This success story exemplifies NMS’s commitment to advancing transformative therapies from discovery to global reach.

"We are delighted to see Nerviano Medical Sciences join the Roche Accelerator," said Hugues Dolgos, Pharm.D, CEO of NMS Group and NMS Srl. "By bringing together Roche’s global innovation ecosystem and NMS’s deep oncology expertise, we aim to accelerate the translation of breakthrough science into impactful therapies for patients in China and around the world."

"Becoming part of Roche Accelerator is a significant step for NMS China," said Li Dadong, Ph.D., CEO of NMS China. "This partnership provides us with an invaluable environment to collaborate, innovate, and accelerate the development of our precision oncology programs."

NMS will continue to expand its research and development in oncology, focusing on targeted therapies, antibody–drug conjugates (ADCs), and mechanism-driven approaches to cancer treatment.

(Press release, Nerviano Medical Sciences, NOV 17, 2025, View Source [SID1234660023])

On November 17, 2025 Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners’ clinical development, reported its Next-Generation LNP advancements, a suite of novel and enhanced technologies that expand the range of diseases treatable with mRNA-LNP medicines, at the 13th International mRNA Health Conference in Berlin. Also at the conference, the company highlighted additional preclinical data on its LNP formulations’ applicability in cancer vaccines, potency, and safety.

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"Commercial validation of our technology has provided both an important milestone of success and the impetus for continued advancement," said Dr. Thomas Madden, CEO of Acuitas Therapeutics. "Our research, presented at the mRNA Health Conference, is focused on two key goals: expanding the application of our technology into new therapeutic areas and enhancing the potency and safety of the platform itself, with novel LNP formulations and various improvement strategies. Underpinning both is our commitment to improving the translatability of preclinical data, which is essential for accelerating the journey of mRNA and personalized therapies from the laboratory bench to the clinic."

Next-Generation LNP for mRNA-based Therapeutics

At the conference, Acuitas’ Chief Scientific Officer, Dr. Ying Tam, showcased the company’s Next-Generation LNP advancements, a comprehensive approach that uses multiple technologies and strategies to improve all aspects of LNP utility and applicability – from potency, safety, extrahepatic targeting, to manufacturing.

The advancements were featured in an oral presentation titled "Next-Generation Lipid Nanoparticles for Clinical Development of mRNA-based Therapeutics." The presentation detailed Acuitas’ efforts in advancing mRNA-LNP beyond current clinical standards and broadening the range of diseases these therapies can treat. Key highlights of the presentation include:

Novel LNP candidates engineered for significantly improved potency, as high as a four-fold increase for some cases, in gene editing and vaccine applications.
Optimized lipid structures reduced liver exposure, leading to increased tolerability, lowered liver enzymes, while preserving therapeutic activity in mice.
DARPin-conjugated LNP candidates that achieved highly targeted delivery to immune cells (T-lymphocytes), with a long-circulating format further enhancing uptake efficiency and expression levels.
Mucous penetrant mRNA-LNP candidates capable of extrahepatic delivery to airway epithelial cells in cystic fibrosis lung models, enabling effective gene editing compared to control LNP.
An alternative LNP manufacturing approach, called pre-formed vesicles (PFV), with equivalent potency to standard benchmark manufacturing methods, offered significant improvements in cost, storage, distribution, and flexibility of LNP manufacturing, especially for personalized mRNA-LNP therapies.
Additional Posters Presented

In addition to its lead presentation, Acuitas also showcased three posters that elucidated the mechanics of LNP delivery and assessed its existing slate of lipids, as well as explored novel options for future formulations.

Applying Clinically Approved ALC-315 in Cancer Vaccines

Acuitas’ ALC-315 ionizable lipid — used in the Pfizer-BioNTech COVID-19 vaccine (COMIRNATY) — was assessed for its cancer vaccine development potential. The research directly compared Acuitas’ LNP to lipoplexes and evaluated modified mRNA against the unmodified mRNA predominantly used in current cancer vaccine trials. Key highlights of this data include:

Using LNP comprised of ALC-315, unmodified RNA induced a stronger antigen-specific CD8 T-cell response compared to a nucleoside-modified mRNA incorporating N1methylpseudouridine-encoding OVA payload as a model tumour antigen, while maintaining strong immunogenicity at one-tenth of the initially tested dose.
Using LNP comprised of ALC-315, mRNA delivered intramuscularly induced equal or superior cellular and humoral immunity compared to intravenously (IV) administered mRNA lipoplexes – an alternative mRNA cancer vaccine format in clinical development – despite mRNA lipoplexes being administered at four-fold higher doses and with more boosts.
Several potent novel proprietary lipids were identified that achieved equivalent cellular responses to ALC-315. Further assessment will be conducted to compare potency and activity using syngeneic neoantigen models.
Novel Lipids with Improved Activity for Prophylactic Vaccine Development

Acuitas identified and validated six novel lipids that induce higher virus-specific immunogenicity compared to ALC-315. Key findings related to these novel lipids include:

The six novel lipid candidates induced equivalent neutralizing antibody titres at a five-fold lower dose than ALC-315.
The lipid candidates demonstrated favorable reactogenicity profiles comparable to ALC-315, while eliciting stronger cellular- and B-cell responses.
Innate immune responses induced by LNP correlated with their reactogenicity, but not with adaptive and innate immune responses.
Several lipid candidates achieved higher in vivo expression in secondary lymphoid organs and reduced liver expression compared to ALC-315.
Impact of Body Weight and Medications on mRNA-LNP Safety in Monkeys

As the industry continues using larger nonhuman primates in translational work, Acuitas sought to understand how body weight, premedications (steroid, H1 and H2 blockers), and concomitant medications (meloxicam) impact LNP activity and tolerability. The study was conducted in monkeys using an IV-administered mRNA-LNP encoding human IgG. Key highlights of this data include:

LNP tolerability is reduced in larger monkeys (>6 kg).
Premedications helped reduce the elevation of liver transaminases.
Premedications improved tolerability but reduced the level of IgG mRNA expression.
Platelet count decreases were greatest in large monkeys and monkeys given meloxicam.
More information on posters presented at the mRNA Health Conference and Vaccine R&D Conference can be found here.

(Press release, Acuitas Therapeutics, NOV 17, 2025, View Source [SID1234660039])

On November 17, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, reported the closing of its previously announced private placement in public equity ("PIPE"). The PIPE was led by Ikarian Capital, Squadron Capital Management, Affinity Healthcare Fund, LP, and Exome Asset Management, with participation from other healthcare focused funds, for total gross proceeds of approximately $21.5 million.

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NextCure sold and issued an aggregate of 708,428 shares of common stock ("Common Stock") at the market purchase price of $8.52 per share, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 1,815,049 shares of Common Stock at a purchase price of $8.519 per Pre-Funded Warrant (each with a nominal exercise price of $0.001 per share for exercise of the warrant) in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act").

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

NextCure intends to use the net proceeds from the offering for general working capital needs, extending the company’s cash runway into the first half of 2027, which is beyond the planned first half of 2026, proof of concept data readouts of its two antibody drug conjugate (ADC) programs, SIM0505 (CDH6 ADC) and LNCB74 (B7-H4 ADC).

The securities sold in the private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. In connection with the private placement, NextCure and the investors entered into a registration rights agreement pursuant to which NextCure will file a registration statement (the "Resale Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the securities sold in the private placement. Any offering of the securities sold in the private placement under the Resale Registration Statement will only be made by means of a prospectus.

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

(Press release, NextCure, NOV 17, 2025, View Source [SID1234660024])

On November 17, 2025 CorriXR Therapeutics, Inc., an oncology-focused biotherapeutics company pioneering a novel gene editing platform to overcome drug resistance in solid tumors, reported the publication of a manuscript in Molecular Therapy Oncology detailing results from a preclinical study evaluating CRISPR-directed gene editing for the treatment of squamous cell lung carcinoma (LUSC). The study was conducted in collaboration with scientists at ChristianaCare’s Gene Editing Institute (GEI).

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"This foundational work strengthens CorriXR’s strategy of disrupting cancer cell survival pathways to restore sensitivity to standard therapies," said Eric B. Kmiec, Ph.D., Founder and Chief Executive Officer of CorriXR Therapeutics and Executive Director of GEI. "These findings build on more than a decade of GEI research into NRF2, a master regulator of cellular stress responses and known driver of treatment resistance. We are encouraged by the consistency of results across in vitro human lung cancer models and our in vivo studies and are actively pursuing IND-enabling work to bring this promising approach to patients."

Key findings from the study include:

Restoration of chemosensitivity: Editing 20-40% of LUSC cells to disrupt NRF2 was sufficient to resensitize tumors to chemotherapy, resulting in significant reductions in tumor growth.
Reduced cancer-driving signals: Edited tumors reduced NRF2 expression and downregulation of its downstream markers, demonstrating effective pathway disruption.
No off-target editing above background: Unintended edits remained below 0.2% supporting the specificity and safety of the gene editing approach.
Strong translational potential: The lipid nanoparticle (LNP) delivery system achieved robust editing in both engineered and patient-derived tumor models, reinforcing the feasibility of advancing towards clinical development.
"Treatment resistance remains one of the greatest challenges in oncology, and these data demonstrate that targeting NRF2 can meaningfully resensitize tumors with minimal off-target effects," said Kelly Banas, Ph.D., lead author of the study and Associate Director of Research at GEI. "This approach has the potential to lower chemotherapy doses, reduce toxicity and help patients remain healthier throughout treatment." Kmiec added, "Instead of creating entirely new drugs, we are using gene editing to make existing ones effective again."

The study also highlights that the biology of NRF2 driven resistance extends beyond lung cancer. "While this work focused on LUSC, NRF2 overactivation drives treatment resistance across multiple solid tumors, including head and neck squamous cell carcinoma (HNSCC)," said Kmiec. "These data indicate that CRISPR-enabled targeting of NRF2 may disrupt the tumor microenvironment and address a shared mechanism of therapeutic failure."

LUSC is an aggressive form of non-small cell lung cancer (NSCLC), representing 20-30% of lung cancer cases and affecting an estimated 190,000 people annually in the U.S. Chemotherapy remains a cornerstone of care, but many patients develop resistance, leaving limited options beyond dose escalation, which increases toxicity and typically worsens quality of life. NRF2 overactivation is a well-established driver of this resistance across multiple solid tumors, including HNSCC, esophageal and liver cancers – representing a significant unmet medical need.

These findings provide a compelling foundation to advance CorriXR’s lead program for HNSCC, as well as the Company’s LUSC program, into clinical development. CorriXR and GEI are now independently validating results at commercial CROs, conducting the required safety and regulatory studies to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for approval of human trials, and are exploring partnerships to accelerate clinical translation.

The full publication: Functional characterization of tumor-specific CRISPR-directed gene editing as a combinatorial therapy for the treatment of solid tumors – ScienceDirect is available online in Molecular Therapy Oncology.

(Press release, CorriXR Therapeutics, NOV 17, 2025, View Source [SID1234660040])

On November 17, 2025 Nuvalent, Inc. (the "Company") reported positive topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor ("TKI") pre-treated patients with advanced ALK-positive non-small cell lung cancer ("NSCLC") from the global ALKOVE-1 Phase 1/2 clinical trial. Additionally, the Company shared the first report of preliminary data from the Phase 2 exploratory cohort for TKI-naïve patients with advanced ALK-positive NSCLC from the ALKOVE-1 study.

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Summary of Topline Pivotal Data

Neladalkib is being evaluated in ALKOVE-1, a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The recommended Phase 2 dose ("RP2D") for neladalkib of 150 mg once daily ("QD") was determined during the Phase 1 dose-escalation portion of the trial. The global, single-arm, multi-cohort, open-label Phase 2 portion is designed to evaluate neladalkib at the RP2D with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors other than NSCLC, and for adolescent patients with ALK-positive NSCLC.

In this topline pivotal dataset for the TKI pre-treated ALK-positive NSCLC population, data are pooled across Phase 1 and 2 and reported for the primary objective of objective response rate (ORR, RECIST 1.1) by blinded independent central review ("BICR"). Key secondary objectives include duration of response ("DOR"), intracranial ORR ("IC-ORR"), and safety.

As of the data cut-off date of August 29, 2025, 781 patients with ALK-positive solid tumors had received neladalkib at any starting dose across the Phase 1 and Phase 2 portions of the ALKOVE-1 clinical trial. Of these, 656 patients with advanced ALK-positive NSCLC were treated with neladalkib at the RP2D.

Efficacy Analysis in TKI Pre-treated Advanced ALK-positive NSCLC

The pivotal primary analysis population consisted of 253 TKI pre-treated patients with advanced ALK-positive NSCLC with measurable disease by BICR who received neladalkib at the RP2D by September 30, 2024, with DOR follow-up of at least 6 months available for nearly all responders.

The pivotal primary analysis population was distinct from the ALK TKI pre-treated populations that have been reported for the currently available ALK TKIs:

•
Patients received a median of 3 prior lines of therapy (range, 1 – 11) and 51% had received prior chemotherapy.

•
78% of patients had received 2 or more prior ALK TKIs ± prior chemotherapy, of which 91% had received prior lorlatinib. No approved therapies have demonstrated activity after lorlatinib.

•
19% of patients had a secondary ALK G1202R resistance mutation, and 17% had a compound ALK resistance mutation, which are key drivers of disease progression.

•
40% of patients had active CNS disease by BICR at baseline.

Of the overall TKI pre-treated population, 25% (63/253) of patients were lorlatinib-naïve. Within this subpopulation:

•
25% received prior chemotherapy.

•
100% had received ≥ 1 prior 2G ALK TKI ± prior chemotherapy, of which 70% received prior alectinib only. No patients received crizotinib as their only ALK TKI.

•
19% of patients had a secondary ALK G1202R mutation.

•
35% had active CNS disease by BICR at baseline.

Activity was observed across subsets of TKI pre-treated patients, and durability of response was assessed as the probability of patients remaining in response for at least 6, 12, and 18 months by Kaplan-Meier estimate (Table 1).

Table 1. Any prior ALK TKI
± chemotherapy a
TKI Pre-treated,

Lorlatinib-naïve b

n

253 63
ORR, % (n/N)

(95% CI)

31% (79/253) c, d

(26, 37)

46% (29/63) e

(33, 59)

% DOR ≥ 6 months f

(95% CI)

76%

(64, 84)

89%

(69, 96)

% DOR ≥ 12 months f

(95% CI)

64%

(51, 75)

80%

(58, 91)

% DOR ≥ 18 months f

(95% CI)

53%

(34, 68)

60%

(19, 85)

G1202R mutation g

n

47 12
ORR, % (n/N)

(95% CI)

68% (32/47) h, i

(53, 81)

83% (10/12)

(52, 98)

% DOR ≥ 6 months f

(95% CI)

84%

(65, 93)

90%

(47, 99)

% DOR ≥ 12 months f

(95% CI)

80%

(61, 91)

77%

(34, 94)

% DOR ≥ 18 months f

(95% CI)

70%

(42, 86)

77%

(34, 94)

Measurable CNS lesions

n

92 j 24 k
IC-ORR, % (n/N)

(95% CI)

32% (29/92) l, m

(22, 42)

63% (15/24) l

(41, 81)

IC-CR, % (n/N)

13% (12/92) n 21% (5/24) n
% IC-DOR ≥ 6 months f

(95% CI)

81%

(59, 91)

92%

(57, 99)

% IC-DOR ≥ 12 months f

(95% CI)

71%

(48, 85)

92%

(57, 99)

% IC-DOR ≥ 18 months f

(95% CI)

71%

(48, 85)

92%

(57, 99)

a Median DOR ("mDOR") not reached with median follow-up of 11.3 months.

b mDOR not reached.

c Includes 2 unconfirmed partial responses ("uPRs").

d Includes responses in patients previously treated with lorlatinib (ORR = 26% [50/190 including 2 uPRs] with mDOR = 17.6 months [95% CI: 6.9, NE]).

e For patients receiving only 1 prior 2nd generation ALK TKI (alectinib [n = 44] or brigatinib [n = 2]) ± chemotherapy, ORR was 48% (22/46) with mDOR not reached, and DOR ≥ 12 and 18 months of 74% (95% CI: 48, 88).

f Estimated for responders by Kaplan-Meier analysis.

g ALK G1202R mutation identified in local or central testing of blood ("ctDNA") or tissue. Patients may have had other mutations in addition to ALK G1202R.

h Includes responses in patients with compound ALK mutations (≥2 ALK mutations, cis allelic configuration not determined in all cases) after ≥ 2 prior ALK TKIs (ORR = 58% [25/43, including 1 uPR] with DOR ≥ 12 months of 69% [95% CI: 45, 84]) and in patients with ALK resistance mutations other than G1202R, including C1156Y, I1171N, I1171T, F1174C, F1174L, V1180L, L1196M, L1198F, D1203N, E1210K, and G1269A.

i Includes 1 uPR.

j For intracranial ("IC") responders, the emerging IC-mDOR was 21.6 months (95% CI: 10.1, NE) and continues to mature.

k For IC-responders, the emerging IC-mDOR was 21.6 months (95% CI: 21.6, NE) and continues to mature.

l Includes 2 IC-uPRs.

m IC responses were also observed in lorlatinib-experienced patients with measurable CNS lesions at baseline (IC-ORR = 21%, 14/68) with IC-mDOR not reached, IC-DOR ≥ 6 months of 71% (95% CI: 41, 88), and IC-DOR ≥ 12 and 18 months of 55% (95% CI: 26, 77).

n Includes 1 IC-uCR with prior confirmed IC-PR.

Preliminary Data from Exploratory Cohort for TKI-Naïve Patients with Advanced ALK-positive NSCLC

Encouraging preliminary data were available for 44 TKI-naïve patients with advanced ALK-positive NSCLC and measurable disease by BICR. These patients were treated with neladalkib at RP2D in an exploratory cohort of ALKOVE-1, with data cut-off of August 29, 2025. Patients may have received up to one prior line of chemotherapy.

The preliminary ORR was 86% (38/44; 2 uPRs) and a CR rate of 9% (4/44; 1 uCR with prior confirmed PR) was observed. DOR ranged from 1.7+ to 14.8+ months with DOR ≥ 6 and 12 months of 91% (95% CI: 70, 98) and only two progression events among responders. In 9 patients with measurable intracranial lesions, the IC-ORR was 78% (7/9) and the intracranial CR rate was 44% (4/9; 1 IC-uCR with prior confirmed IC-PR). The IC-DOR ranged from 3.1+ to 7.0+ months with no CNS progression among responders.

Global enrollment of TKI-naïve patients is ongoing in ALKAZAR, the Company’s Phase 3 randomized controlled trial of neladalkib versus alectinib.

Safety Analyses in Advanced ALK-positive NSCLC

Neladalkib demonstrated a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design.

In the 656 patients with advanced ALK-positive NSCLC treated at RP2D as of the data cut-off date, the median duration of exposure was 6.0 months (range, 0.1, 28.4). The most frequent treatment-emergent adverse events ("TEAEs") occurring in ≥ 15% of patients were alanine aminotransferase increased (47%), aspartate aminotransferase increased (44%), constipation (28%), dysgeusia (23%), peripheral edema (18%), cough and nausea (16% each).

The most common TEAE of transaminase elevations were generally observed to be asymptomatic lab abnormalities that were low-grade, transient, and reversible with dose interruptions or reductions. Preliminary data suggest increased incidence in less heavily pre-treated patients. Enhanced monitoring for transaminase elevations and prompt dose interventions have been implemented in the protocol for the ALKAZAR Phase 3 randomized, controlled trial.

Across the 656 patients treated in ALKOVE-1 at RP2D, dose reductions due to TEAEs occurred in 17% of patients and 5% of patients discontinued treatment due to TEAEs.

The Company plans to discuss the topline pivotal data for TKI pre-treated ALK-positive NSCLC with the U.S. Food and Drug Administration (the "FDA") at a pre-New Drug Application ("NDA") meeting. Additionally, the Company plans to present detailed study results at a future medical meeting.

(Press release, Nuvalent, NOV 17, 2025, View Source [SID1234660025])