On March 19, 2024 Curium, a world leader in nuclear medicine, reported that in the Netherlands the first commercial dose of PYLCLARI has been sold (Press release, Curium, MAR 19, 2024, View Source [SID1234641260]). PYLCLARI (INN: Piflufolastat (18F) also known as (18 F)-DCFPyL, is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, PET Europe CEO at Curium commented, "We are pleased that with today’s news of first commercial supply in the Netherlands, PYLCLARI is now available to more nuclear medicine physicians and their patients in three European countries – Greece, Italy, and in the Netherlands where the production will be done by our partner BV Cyclotron VU in Amsterdam. With our focus on redefining the experience of cancer through our trusted legacy in nuclear medicine, Curium is proud to be improving the choice of diagnostic modalities available to our customers across Europe – ultimately for the benefit of patients with prostate cancer."

Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union, followed by first commercial doses in Greece in November 2023, and in Italy in February 2024.

On March 19, 2024 Mabwell (688062.SH), an innovative-driven biopharmaceutical company with entire industry chain, reported the clinical study data of the 9MW2821 for patients with cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on March 16, 2024 (Press release, Mabwell Biotech, MAR 19, 2024, View Source;the-first-published-clinical-data-of-nectin-4-targeting-adc-developed-by-mabwell-in-cervical-cancer-demonstrates-its-outstanding-therapeutic-potential-302092792.html [SID1234641277]).

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The data showed good efficacy and safety of 9MW2821 in patients with cervical cancer, which is expected to bring new breakthroughs for the treatment of recurrent or metastatic cervical cancer, meeting a large number of unmet clinical needs.

9MW2821 is the first drug to report clinical data for the indication of cervical cancer among the drugs with the same target in the world.

Report on Study Data of Nectin-4-Targeting Antibody-drug Conjugate (ADC) for the Treatment of Recurrent or Metastatic Cervical Cancer

This phase I/II, multicenter, open-label, clinical study was led by Professor Zhang Jian of Fudan University Shanghai Cancer Center, and Professor Yang Huijuan of Fudan University Shanghai Cancer Center represented the study team to give an in-depth report at the meeting. The study results were highly recognized by experts on site. Further clinical study data are expected to provide more treatment options for patients with recurrent or metastatic cervical cancer.

Clinical Findings

The systemic treatment drug options and efficacy for recurrent or metastatic cervical cancer are relatively limited. The cervical cancer cohort in the phase I/II study of 9MW2821 enrolled patients with Nectin-4-positive recurrent or metastatic cervical cancer who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease. Eligible patients received intravenous 9MW2821 1.25mg/kg on days 1, 8 and 15 of each 28-day cycle until confirmed disease progression, death, intolerable adverse effects or withdrawal from the study.

As of September 25, 2023, in the cervical cancer expansion cohort of the study, the detection rate of Nectin-4 expression was 89.67%, and the rate of Nectin-4 IHC 3+ was 67.82%. A total of 40 patients were enrolled in the study, 57.5% of the patients had previously received platinum-based doublet chemotherapy combined with bevacizumab, and 60% of the patients had previously received platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy.

In terms of efficacy, the overall response rate (ORR) and disease control rate (DCR) of 37 patients evaluable for efficacy were 40.54% and 89.19%, respectively, with one complete response (2.70%) and 14 partial responses (37.84%). Median progression-free survival (PFS), overall survival (OS), and duration of response (DOR) were not reached yet. Among patients with Nectin-4 IHC 3+, the ORR and DCR of 26 patients evaluable for efficacy were 50.00% and 92.31%, respectively. Among patients on or after doublet platinum-containing chemotherapy, the ORR and DCR of 21 patients evaluable for efficacy were 38.10% and 85.71%, respectively.

In terms of safety, treatment-related adverse events (TRAEs) occurred in 92.50% of participants. Grade3-4 TRAEs occurred in 70.00% of participants, with neutropenia (40.00%), rash (17.50%) and gamma-glutamyl transferase increased (12.50%) being the most frequently reported. Nodeaths related to treatment were reported.

The above study results indicate that 9MW2821 has controllable safety and positive efficacy in patients with cervical cancer.

About 9MW2821

9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first product to enter clinical study among the products with the same target developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors.

The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. The phase II clinical study for the indication of esophageal carcinoma will continue enrollment and evaluation, and communication for the initiation of phase III clinical study will be expedited. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma.

About Cervical Cancer

Cervical cancer is the 4th most common neoplasm and the 4th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed.

On March 19, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported fourth quarter and full year 2023 financial results and provided a business update (Press release, Cyclacel, MAR 19, 2024, View Source [SID1234641261]).

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"Following the recently announced precision medicine strategy for oral fadraciclib, our CDK2/9 inhibitor, we have determined the recommended Phase 2 dose (RP2D) and are ready to start proof-of-concept studies," said Spiro Rombotis, President and Chief Executive Officer. "We expect two key data readouts for fadraciclib this year. These include pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of the 065-101 Phase 1/2 study. In addition, we expect to report initial clinical activity from the Phase 2 proof of concept part, evaluating cohorts of patients selected for their mutational profile and/or Phase 1 activity in various solid tumors and lymphoma. At the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2024, independent investigators will present preclinical proof-of-concept data for fadraciclib further demonstrating fadraciclib’s differentiated properties from other next generation CDK inhibitors."

"We have observed CDKN2A/CDKN2B alterations, including loss of function, in multiple, pretreated patients with various cancers, including gynecological, hepatobiliary, lung, and pancreatic, who benefitted from fadraciclib monotherapy. In addition, we have observed clinical activity in patients with T cell lymphoma, said Brian Schwartz, M.D., interim Chief Medical Officer. "We expect to report final Phase 1 results including details on patient genomic profiles at an upcoming medical conference. A precision medicine strategy is also emerging for plogosertib, our PLK1 inhibitor. Preclinical data from independent groups have shown that certain ARID1A- and SMARCA-mutated cancers may benefit from treatment with plogosertib. Before testing this hypothesis in our 140-101 dose escalation study, we plan to switch to a new oral formulation of plogosertib with improved bioavailability. We are excited about the potential precision medicine strategies for both our clinical programs, with initial data from the fadraciclib Phase 2 proof-of-concept study."

Key Highlights for 2024

· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept part of 065-101 study in patients with advanced solid tumors and lymphoma
· Report final data from dose escalation stage from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 open label, proof-of-concept part of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
· Independent investigators to report preclinical proof-of-concept data for fadraciclib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024

Financial Highlights

As of December 31, 2023, pro forma cash and cash equivalents totaled $6.3 million, including $2.9 million of United Kingdom research & development tax credits which were received after the end of the year. Cash and cash equivalents as of December 31, 2023, totaled $3.4 million, compared to $18.4 million as of December 31, 2022. Net cash used in operating activities was $16.1 million for the twelve months ended December 31, 2023 compared to $20.8 million for the same period of 2022. The Company estimates that its available cash, including the United Kingdom research & development tax credit of $2.9 million, will fund currently planned programs into the second quarter of 2024.

Research and development (R&D) expenses were $3.5 million and $19.2 million for the three months and year ended December 31, 2023, as compared to $6.7 million and $20.3 million for the same period in 2022. R&D expenses relating to fadraciclib were $2.7 million and $13.4 million for the three months and year ended December 31, 2023, as compared to $5.3 million and $14.0 million for the same period in 2022 due to decrease in clinical trial costs offset by an increase in manufacturing and other non-clinical expenditures. R&D expenses related to plogosertib were $0.7 million and $5.0 million for the three months and year ended December 31, 2023, as compared to $1.3 million and $5.5 million for the same period in 2022 due to decrease in manufacturing and other non-clinical expenditures.

General and administrative expenses for the three months and year ended December 31, 2023, were $1.9 million and $6.7 million, compared to $2.1 million and $7.4 million for the same period of the previous year due to a decrease in professional fees.

Total other income, net, for the three months and year ended December 31, 2023, were an expense of $0.3 million and expense of $0.1 million, compared to an expense of $0.2 million and income of $1.7 million for the same period of the previous year. The decrease of $1.8 million for the year ended December 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months and year ended December 31, 2023 were $0.4 million and $3.0 million compared to $1.6 million and $4.7 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months and year ended December 31, 2023, was $5.3 million and $22.6 million (including stock based compensation expense of $0.3 million and $1.5 million respectively), compared to $7.4 million and $21.2 million (including stock based compensation expense of $0.3 million and $1.5 million respectively) for the same period in 2022.

On March 19, 2024 Adela, Inc., an innovator in blood testing for minimal residual disease monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 5-10, 2024 from its tissue-agnostic minimal residual disease (MRD) assay (Press release, Adela, MAR 19, 2024, View Source [SID1234641278]). These data demonstrate the feasibility of the assay for cfDNA cancer signal quantification and prognostic prediction in HPV-positive and HPV-negative head & neck cancers following treatment. Data will also be presented on the analytical performance of Adela’s platform.

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In addition, Daniel De Carvalho, Ph.D., Adela’s Chief Scientific Officer, has been selected to serve as Chair of the Plenary Session "Discovery Science in Early Cancer Biology and Interception". Dr. De Carvalho will also present in the session "New Liquid Biopsy Technologies for Detection and Characterization of Cancer".

Adela plans to commercialize its first product, a tissue agnostic test for minimal residual disease (MRD) monitoring, in 2025. The product will be based on Adela’s genome-wide methylome enrichment platform, which utilizes the company’s patented technology, cfMeDIP-seq, originally developed by Dr. De Carvalho at University Health Network’s Princess Margaret Cancer Centre, in collaboration with investigators at Sinai Health System. Adela’s technology efficiently captures extensive, biologically-relevant genomic information to maximize test performance and improve treatment decisions. It can be applied across the entire cancer care continuum and is initially being developed for MRD and multi-cancer early detection.

Presentation Details

Abstract # 2427: The development of a tissue-agnostic genome-wide methylome enrichment MRD assay for applications across the cancer care continuum for head and neck malignancies
Geoffrey Liu1
Mon Apr 8, 2024 9 am-12:30 pm PT
Section 40 Poster Board Number 23

Abstract # 5024: Analytical performance of a genome-wide methylome enrichment platform to detect minimal residual disease from plasma-derived cell-free DNA
Hestia Mellert2
Tues Apr 9, 2024 9am – 12:30pm PT
Section 40 Poster Board Number 11

Discovery Science in Early Cancer Biology and Interception
Dr. Daniel De Carvalho (Chair)
Sat April 6, 2024 4:15 PM PT
Hall GH

New Liquid Biopsy Technologies for Detection and Characterization of Cancer Dr. Daniel De Carvalho
Tues April 9, 2024 12:30 – 2:00 PM PT
Ballroom 20 CD

On March 19, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a Research & Development (R&D) Day focusing on its core AI-Immunology platform (Press release, Evaxion Biotech, MAR 19, 2024, View Source [SID1234641262]). The event will be hosted at our facilities in Hørsholm, Denmark, between 14.00 – 18.00 CET / 9.00 a.m. – 1.00 p.m. EST and can be accessed remotely here.

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The R&D Day features a series of talks providing in-depth insights into Evaxion’s clinically validated AI-Immunology platform for vaccine target discovery, design and development. AI-Immunology consists of a collection of in-house developed AI building blocks that can be intelligently combined into AI prediction models to address complex healthcare issues related to the immune system. With the AI prediction models, PIONEER, ObsERV, EDEN and RAVEN, we can identify clinically relevant vaccine targets within hours.

Christian Kanstrup, CEO of Evaxion, expresses enthusiasm: "We have been looking forward to this exciting day and welcome everyone interested in learning more about our technology and its potential for saving and improving lives. We believe that we hold a truly differentiated position driven by our validated AI-Immunology platform and the multi-disciplinary capability set we have built around it. The potential of AI-Immunology is evidenced by our strong pipeline of vaccine candidates and existing partnerships."

The presentations during the day will, among other things, cover:

The innovative modular architecture of AI-Immunology, where AI building blocks can be combined into AI prediction models, enhancing scalability
Insights into the novel AI-Immunology building block, EvaxMHC, which is used across the platform, significantly enhancing the predictive capabilities
The clinical validation of the predictive capabilities of the PIONEER model showing a statistically significant improvement in progression-free survival in metastatic melanoma patients
The novel tumor target sources, named Endogenous Retroviruses (ERVs), showing high relevance in low tumor mutation burden cancers, allowing for potentially more effective personal cancer vaccines
The EDEN model outperforms reverse vaccinology finding novel targets in hours instead of years. The EDEN designed EVX-B2 vaccine candidate showing stronger protection than a vaccine candidate developed by GSK’s Gonorrhea
RAVEN introduces novel vaccine concepts to enhance the effectiveness of T-cell-based vaccines
The ObsERV model allows for a novel precision vaccine approach toward addressing cancers which cannot be targeted with standard immunotherapies
Following the R&D Day, a replay of the event presentations will be available on our website.

About AI-Immunology 

AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modelling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.