On March 20, 2024 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has initiated the dose expansion portion of the Phase II CLINCH study of ATG-022 (Claudin 18.2 antibody-drug conjugate[ADC]) in China and Australia (Press release, Antengene, MAR 20, 2024, View Source [SID1234641301]). Prior to this, the CLINCH trial has already produced promising preliminary clinical results with partial response (PR) and compete response (CR).

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The CLINCH trial, consists of a dose escalation portion and a dose expansion portion, is a multi-center, open-label Phase I/II study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022.

The dose expansion portion of the study will enroll patients with gastric cancer or other solid tumors. In May 2023, the U.S. Food and Drug Administration (FDA) consecutively granted two Orphan Drug Designations (ODDs) to ATG-022 for the treatment of pancreatic cancer and gastric cancer, separately.

Dr. Amily Zhang, Antengene’s Chief Medical Officer, said, "We are excited that the dose expansion portion of the Phase II study of ATG-022 in China and Australia. The Phase I/II CLINCH trial is supported by strong preclinical data and has already made encouraging early observations with one PR and CR in two patients with metastatic gastric cancer. With the trial entering its next critical phase, we will continue working closely with regulators and investigators to fully explore the clinical potential of ATG-022."

About ATG-022

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 is often overexpressed in various primary malignant tumors including gastric, esophageal, cholangiocarcinoma and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (2022 AACR (Free AACR Whitepaper)), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacy demonstrated in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

On March 20, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT886 for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma (Press release, Phanes Therapeutics, MAR 20, 2024, View Source [SID1234641300]). PT886 was also granted orphan drug designation for the treatment of pancreatic cancer by the FDA in 2022.

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PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47, is being developed for the treatment of patients with gastric, gastroesophageal junction and pancreatic adenocarcinomas. PT886 was assembled using Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair.

Pancreatic cancer is an aggressive form of cancer characterized by high mortality rates and significant morbidities. For patients who present with metastasis at the time of diagnosis, the 5-year survival rate is only 3%. Projections for 2024 estimate that approximately 51,000 Americans will die of pancreatic cancer this year and by 2030, is projected to exceed breast, prostate, and colorectal malignancies as the leading cause of cancer-related deaths in the US.

"PT886 has the potential to be a transformative treatment option for patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma, for which current standard of care is insufficient," said Ming Wang, Founder and CEO of Phanes Therapeutics. "PT886 is a product of Phanes’ ingenious innovation in creative design of both novel therapeutic approaches and practical technologies."

The multi-center Phase I clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.

On March 20, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAR 20, 2024, View Source [SID1234641299]).

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Chief Executive Officer John Valliant, Ph.D., commented, "We entered 2024 with strong momentum focused on execution to advance our pipeline of targeted alpha therapies, and we are pleased to recently have achieved several critical milestones. For our lead program, FPI-2265, we expect to initiate the Phase 2 portion of the registrational program in metastatic castration-resistant prostate cancer (mCRPC) in the second quarter of this year. Acknowledging the substantial and expanding market for patients in the post-PLUVICTO setting we believe FPI-2265, which is positioned to be the first actinium-based PSMA targeted radiopharmaceutical to market, will effectively address a crucial unmet need for patients with progressive disease. We look forward to presenting data from the TATCIST trial at AACR (Free AACR Whitepaper) in April.

Dr. Valliant continued, "We also continue to advance our other clinical-stage programs, including the ongoing Phase 1 study of FPI-1434, which has demonstrated a promising safety profile and early evidence of antitumor activity. We expect to provide an update on this program around mid-year 2024. Underpinning our platform, which has produced a robust pipeline of targeted alpha therapies, is our state-of-the-art GMP manufacturing facility now operational and producing clinical doses of FPI-2265. With a strong balance sheet and secured actinium supply, we are well positioned to execute on our commitment of bringing this next generation of radiopharmaceuticals to patients in need."

Corporate Update

On March 19, 2024, Fusion announced the Company has entered into a definitive agreement to be acquired by AstraZeneca. Under the terms of the agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion’s outstanding shares pursuant to a plan of arrangement for a price of $21.00 per share in cash at closing plus a non-transferable contingent value right (CVR) of $3.00 per share in cash payable upon the achievement of a specified regulatory milestone.

The upfront cash portion of the consideration represents a transaction value of approximately $2 billion, a 97% premium to Fusion’s closing market price of $10.64 on March 18, 2024. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $2.4 billion, a 126% premium to Fusion’s closing market price on March 18, 2024. As part of the transaction, AstraZeneca will acquire the cash, cash equivalents and short-term investments on Fusion’s balance sheet, which totaled $234 million as of December 31, 2023.

The transaction is expected to close in the second quarter of 2024, subject to customary closing conditions, including the approval of Fusion shareholders and regulatory clearances.

Portfolio Update

FPI-2265: A 225Ac based radiopharmaceutical targeting prostate specific membrane antigen (PSMA) for the treatment of patients with mCRPC.

In January 2024, the Company announced alignment with the FDA on its Phase 2/3 protocol for FPI-2265 in patients with mCRPC with progressive disease who have previously been treated with a 177Lu-based PSMA radiotherapy. The development plan includes a Phase 2 dose optimization lead-in, which aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every eight weeks, expected to be initiated in the second quarter of 2024. This Phase 2 portion is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the FDA, a Phase 3 global registrational trial in approximately 550 patients is expected to begin in 2025.
The TATCIST trial, which began as an investigator sponsored study, is designed to evaluate FPI-2265 in patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceutical therapy, completed target enrollment of 25-30 patients. The Company announced that interim data will be presented at the upcoming 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.
The Company is also pursuing the opportunity to potentially move this therapeutic candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the first half of this year.
FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R).

In January 2024, Fusion announced encouraging early findings from Cohort 2 in the cold/hot dosing arm of the ongoing Phase 1, multi-center, open-label clinical trial. The trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression. Evidence of anti-tumor activity was observed in a heavily pre-treated patient with Ewing sarcoma after a single dose and a second patient receiving four cycles of therapy demonstrated stable disease as best response.
The Company plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024.
FPI-2059: Targeting neurotensin receptor 1 (NTSR1).

Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors. Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment.

FPI-2068: A bispecific IgG-based targeted alpha therapy (TAT) targeting EGFR-cMET.

FPI-2068 is currently being evaluated in a Phase 1 study and is being jointly developed with AstraZeneca under the companies’ multi-asset collaboration agreement. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The investigational new drug (IND) application has been cleared and Fusion is currently activating clinical trial sites.
Other Recent Updates

In January 2024, Fusion announced it had completed validation of its state-of-the-art GMP manufacturing facility and produced the first clinical dose of a TAT. The facility, which has clinical and commercial scale manufacturing capacity, is designed to support the Company’s growing pipeline of TATs and is expected to be capable of producing more than 100,000 doses per year.
In February 2024, Fusion announced that it has entered into a licensing agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre (together, the "Licensors"). The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T ("FPI-2265") for the treatment of prostate specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties’ dispute related to an inter partes review ("IPR") of the patent which was instituted in August 2023 by the United States Patent and Trademark Board.
Fourth Quarter 2023 Financial Results

Cash and Investments: As of December 31, 2023, Fusion held cash, cash equivalents and investments of $247.3 million, compared to cash, cash equivalents and investments of $186.6 million as of December 31, 2022. Fusion expects its existing cash, cash equivalents and investments as of December 31, 2023, together with net proceeds from sales of common shares under the Company’s at-the-market equity offering program received in January and February 2024 and net proceeds of $14.9 million from a draw down under the Company’s existing debt facility in January 2024, will be sufficient to fund operations into the fourth quarter of 2025.
R&D Expenses: Research and development expenses for the fourth quarter of 2023 were $20.6 million, compared to $17.6 million for the same period in 2022. The increase was primarily due to increased manufacturing-related expenditures, as well as increased personnel-related costs.
G&A Expenses: General and administrative expenses for the fourth quarter of 2023 were $7.6 million, compared to $6.9 million for the same period in 2022. The increase was primarily due to increased consulting and personnel-related costs.
Net Loss: For the fourth quarter of 2023, Fusion reported a net loss of $28.2 million, or $0.39 per share, compared with a net loss of $24.6 million, or $0.55 per share, for the same period in 2022.
Upcoming Presentations

Fusion will present data in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in San Diego, CA, April 5-10, 2024.

Title: Preliminary efficacy and safety results from the (TACIST) trial: A PSMA-directed targeted alpha therapy with FPI-2265 (225Ac-PSMA-I&T) for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Session: Phase II Clinical Trials 1
Date and Time: Tuesday April 9, 2024 9:00 AM – 12:30 PM PT
Location: Poster Section 49
Abstract Number: CT224

On March 20, 2024 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates (Press release, OmniAb, MAR 20, 2024, View Source [SID1234641298]).

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"2023 was a year of significant expansion of OmniAb’s partnership base and pipeline programs as we continued to execute against our plan, while key partner programs made significant progress despite last year’s sector-related headwinds. Partners exceeded our expectations regarding the number of new programs entering the clinic, with a total of six new entrants last year," said Matt Foehr, Chief Executive Officer of OmniAb. "In addition, we successfully launched two new technologies and expanded our business development function, now with a presence in the U.S., EU and Asia Pacific. We look forward to meaningful advancements in 2024 and in the coming years, as we are now staffed and resourced to efficiently leverage the future growth of the business."

Fourth Quarter 2023 Financial Results

Revenue for the fourth quarter of 2023 was $4.8 million, compared with $35.3 million for the same period in 2022, with the decrease primarily due to the recognition of a $25.0 million milestone payment in the prior-year period related to the first commercial sale of TECVAYLI (teclistamab) in the U.S. and lower service revenue as a result of the completion of discovery work on certain ion channel programs.

Research and development expense was $14.8 million for the fourth quarter of 2023, compared with $12.9 million for the same period in 2022, with the increase primarily due to higher personnel costs. General and administrative expense was $7.9 million for the fourth quarter of 2023, compared with $10.2 million for the same period in 2022, with the decrease primarily due to one-time expenses related to the spin-off of OmniAb into a separate public company in the prior-year period partially offset by increases in personnel costs.

Net loss for the fourth quarter of 2023 was $14.1 million, or $0.14 per diluted share, compared with net income of $6.8 million, or $0.07 per share, for the same period in 2022.

Full Year 2023 Financial Results

Revenue for 2023 was $34.2 million, compared with $59.1 million for 2022, with the decrease primarily due to the recognition of TECVAYLI milestones of $10.0 million in 2023 compared with $25.0 million in 2022. Service revenue was lower primarily related to the completion of work on certain ion channel programs and an adjustment related to the extension of one of our programs with GSK, partially offset by the recognition of a portion of a research progression milestone.

Research and development expense for 2023 was $56.5 million, compared with $48.4 million for 2022, with the increase primarily due to headcount and facility costs. General and administrative expense for 2023 was $33.3 million, compared with $24.9 million for 2022, with the increase primarily due to higher personnel costs and expenses related to being an independent publicly traded company.

Net loss for 2023 was $50.6 million, or $0.51 per share, compared with a net loss of $22.3 million, or $0.26 per share, for 2022. Cash provided by operating activities was $2.3 million for 2023.

As of December 31, 2023, OmniAb had cash, cash equivalents and short-term investments of $87.0 million.

2024 Financial Guidance

OmniAb expects operating expense in 2024 to be approximately the same as in 2023, and is now staffed and resourced to leverage the future growth of the business.

OmniAb expects its cash use in 2024 to be relatively similar to its cash used in 2023, excluding the $35 million TECVAYLI milestone payment received in 2023. Given the expected progression of the existing partnered pipeline, OmniAb expects its cash use in 2025 to be substantially lower than in 2024. OmniAb’s current cash balance and cash from operations are expected to provide sufficient capital to fund operations for the foreseeable future.

Fourth Quarter 2023 and Recent Business Highlights

The Company signed 10 new licenses in 2023, including three in the fourth quarter, with Enable Life Sciences, Mirador Therapeutics, and a global pharma company. In addition, six new OmniAb-derived antibodies entered the clinic in 2023. As of December 31, 2023, the company had 77 active partners and 325 active programs, including 32 OmniAb-derived programs in clinical development, or being commercialized.

OmniAb launched two new technologies during 2023 including OmniDeep and, during the fourth quarter, OmnidAb . OmniDeep is a suite of in silico tools for therapeutic discovery and optimization that are woven throughout OmniAb’s various technologies and capabilities. These tools include structural modeling, molecular dynamics simulations, large multi-species antibody databases, artificial intelligence, machine learning, deep learning models and more. OmniDeep facilitates rapid identification of candidates with the right affinity, specificity and developability profiles intended to make drug development more effective and efficient. The OmnidAb transgenic chicken novel host system builds upon the success of the Company’s OmniChicken legacy by expressing an optimized single-domain human framework that can generate modular building blocks well suited to support a variety of therapeutic modalities. OmnidAb antibodies target distinct epitopes and have favorable developability profiles with high expression levels in mammalian cells. Compared with traditional antibodies, sdAbs produced by OmnidAb chickens have a compact format that opens new opportunities and broad clinical applications.

Fourth quarter 2023 and recent partner highlights include the following:

Batoclimab

Immunovant reported positive initial results for batoclimab in Graves’ disease (GD). The company announced that results from the initial cohort of patients in an ongoing 24-week Phase 2 clinical trial meaningfully exceeded a 50% response rates.
Immunovant also reported that global Phase 3 clinical trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) are progressing and on track for topline data in the second half of 2024 (MG) and the first half of 2025 (TED). Initial period 1 data from the Phase 2b clinical trial of batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) are expected in the second or third quarter of 2024.
IMVT-1402

Immunovant announced initial data from the 600 mg multiple-ascending-dose cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults. The results show that four subcutaneously administered doses of 600 mg produced a mean IgG reduction similar to high-dose batoclimab, but with minimal changes in albumin and LDL-C similar to those in placebo, confirming the potential of IMVT-1402 as a best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor.
In addition, Immunovant announced plans to initiate four to five potentially registrational programs for IMVT-1402 over the next fiscal year. The company also plans on initiating trials in 10 indications for IMVT-1402 over the next two fiscal years.
Acasunlimab (formerly GEN1046)

Genmab expects to announce additional acasunlimab (GEN1046: PD-L1 x 4-1BB) Phase 2 data in second-line non-small cell lung cancer (NSCLC) in the first half of 2024.
In addition, Genmab plans to initiate a Phase 3 study of acasunlimab in a second-line NSCLC indication in 2024.
JNJ-79635322

Johnson & Johnson presented preclinical data for JNJ-79635322, a trispecific antibody comprised of an anti-CD3 binding domain, an anti-BCMA binding domain and an anti-GPRC5D binding domain, concluding that it is a potential first-in-class trispecific antibody with the ability to deplete dual- and single-target expressing multiple myeloma clones in preclinical studies in vitro and in vivo. A Phase 1 dose-escalating study of JNJ-79635322 in myeloma patients is ongoing.
Zimberelimab

Arcus and Gilead have reprioritized the joint domvanalimab + zimberelimab development program to focus on advancing, and potentially accelerating, the Phase 3 studies of STAR-121 (lung cancer) and STAR-221 (gastrointestinal cancer), which are both expected to be fully enrolled by year-end 2024. The companies also plan to initiate STAR-131, a new registrational Phase 3 lung cancer study that includes the domvanalimab + zimberelimab regimen.
Arcus presented preliminary data from the dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680 + NP/Gem + zimberelimab in metastatic pancreatic cancer. The results included a 41% objective response rate observed to-date across the first four cohorts in the Phase 1 dose-escalation portion of ARC-8, comparing favorably to the current standard of care.
Sugemalimab

CStone announced the National Medical Products Administration of China (NMPA) has approved the supplemental BLA for sugemalimab (Cejemly) in combination with fluorouracil and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Sugemalimab becomes the world’s first anti-PD-L1 monoclonal antibody approved for this indication in the first-line setting.
OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter. The inclusion became effective as of December 18, 2023.

Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (888) 259-6850 using the conference ID 72611636. Slides, as well as the live and replay webcast of the call, are available at View Source

On March 20, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAR 20, 2024, View Source [SID1234641294]).

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As of December 31, 2023, NuCana had cash and cash equivalents of £17.2 million compared to £17.8 million as of September 30, 2023 and £41.9 million as of December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2023, as compared to a net loss of £15.2 million for the quarter ended December 31, 2022. Net loss for the year ended December 31, 2023 was £27.6 million, compared to a net loss of £32.0 million for the year ended December 31, 2022. Basic and diluted loss per share was £0.14 for the quarter and £0.53 for the year ended December 31, 2023, as compared to £0.29 per share for the comparable quarter and £0.61 for the year ended December 31, 2022.

"In 2023, we announced data that demonstrated encouraging signals of efficacy and favorable safety profiles for our ProTides, NUC-3373 and NUC-7738," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Working towards our mission of improving treatment outcomes for patients with cancer by developing more effective and safer medicines, we look forward to providing important data readouts across our pipeline in 2024."

Mr. Griffith continued: "Our development programs for both NUC-3373 and NUC-7738 are progressing well. NUC-3373, our ProTide transformation of 5-FU, is being evaluated in three ongoing clinical studies. Our randomized Phase 2 study is comparing NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI + bev) with the standard of care, 5-FU in combination with irinotecan, leucovorin and bevacizumab (FOLFIRI + bev) for the second-line treatment of patients with advanced colorectal cancer. We have now fully recruited all 171 patients to the study and we remain on track to announce data from this study in 2024. Additionally, we are completing our Phase 1b/2 study of NUFIRI + bev and NUFOX + bev in patients with metastatic colorectal cancer. We recently presented data from this study demonstrating that NUFIRI + bev and NUFOX + bev showed a favorable safety profile and encouraging signs of efficacy, including tumor volume reductions. In addition, several patients achieved a longer progression-free survival (PFS) on NUC-3373-based regimens as compared to the PFS achieved in their first-line treatment with 5-FU-based therapy. Lastly, we remain on track to announce data in 2024 from our Phase 1b/2 study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer."

Mr. Griffith continued: "Moving to NUC-7738, we recently presented data from the Phase 2 part of the Phase 1/2 study of NUC-7738 in combination with pembrolizumab in patients with melanoma. These data showed tumor volume reductions and prolonged time on treatment and indicated that NUC-7738 may potentiate the activity of anti-PD-1 agents in patients who were refractory to, or progressed on, prior immunotherapy, including anti-PD-1 therapy. We look forward to sharing additional updates from this study in 2024."

Mr. Griffith concluded, "With a cash runway that is expected to extend into 2025, we look forward to providing a number of important data updates in the coming year as we continue to advance our pipeline of ProTides."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)
In 2024, NuCana expects to:

Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bev compared to the standard of care FOLFIRI + bev for the second-line treatment of patients with advanced colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev for the second-line treatment of patients with advanced colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In 2024, NuCana expects to:

Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma.