On November 11, 2024 NuCana plc (NASDAQ: NCNA) reported that initial data from the ongoing Phase 1b/2 modular study (NuTide:303) investigating NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors (Module 1) and in combination with docetaxel for patients with lung cancer (Module 2) have been published in MedRxiv, the preprint server for Health Sciences (Press release, Nucana, NOV 11, 2024, View Source [SID1234648580]).

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Module 1 included 12 patients with a variety of solid tumors who had exhausted all other treatment options. The majority of patients (n=9) had received prior PD-(L)1 based therapy. Encouraging signals of anti-cancer activity were observed with confirmed Partial Responses in 2 patients and Stable Disease in a further four patients, resulting in an objective response rate of 22% and a disease control rate of 67% in the efficacy evaluable population. The combination of NUC-3373 plus pembrolizumab was generally well tolerated.

Module 1 Selected Case Studies: NUC-3373 plus pembrolizumab in patients with advanced solid tumors

72-year-old patient with urothelial bladder cancer (Lynch syndrome) who had previously received gemcitabine plus cisplatin followed by the PD-L1 inhibitor atezolizumab (achieved a Partial Response and remained on therapy for 23 months). Following treatment with NUC-3373 plus pembrolizumab, the patient achieved 100% reduction in the target lesion (considered a confirmed Partial Response due to the presence of non-target lesions) and remains on treatment for over 10 months.
75-year-old patient with BRAF mutant metastatic cutaneous melanoma who had previously received pembrolizumab (best response of Progressive Disease within 5 months) followed by dabrafenib plus trametinib (discontinued trametinib after 1 month due to toxicity and achieved Stable Disease before progressing after seven years on dabrafenib). Following treatment with NUC-3373 plus pembrolizumab, this patient achieved a confirmed Partial Response with an 81% reduction in the target lesion and remains on treatment for over 12 months.
Module 2 included 4 patients with non-small cell lung cancer (NSCLC) or pleural mesothelioma who had disease progression on, or were unable to tolerate, prior chemotherapy-containing regimens. Docetaxel is the current standard of care for NSCLC patients without targetable alterations who progress on PD-(L)1 inhibitor-based therapy, however, it is associated with modest clinical benefit (median PFS of 3-4 months) and substantial toxicity. Following treatment of the first 4 patients in this module, enrollment was put on hold due to toxicity challenges with docetaxel. Despite this, 2 patients achieved prolonged Stable Disease. Protocol modifications to include the use of a different taxane in this combination are currently being considered.

Module 2 Selected Case Studies: NUC-3373 plus docetaxel in patients with lung cancer

60-year-old patient with pleural mesothelioma who had previously received carboplatin plus pemetrexed (progressed within 4 months), the PD-1 inhibitor nivolumab (progressed within 4 months), and carboplatin plus pemetrexed (progressed within 1 month). Following treatment with NUC-3373 plus docetaxel, the patient achieved Stable Disease for more than 13 months (ongoing).
77-year-old patient with squamous NSCLC who had previously received carboplatin plus paclitaxel plus pembrolizumab (Stable Disease for 2 months) followed by maintenance pembrolizumab (progressed within 21 months). Following treatment with NUC-3373 plus docetaxel, the patient achieved Stable Disease for 7 months.
Full details can be found in the publication: Link

Professor David Harrison, NuCana’s Head of Translational Medicine, stated: "We previously presented data on NUC-3373’s ability to elicit the release of Damage Associated Molecular Patterns (DAMPs), promote an anti-tumor immune response, and potentiate the activity of PD-1 inhibitors in human cancer cell lines. These data led us to investigate the combination of NUC-3373 plus pembrolizumab so we are very excited to observe these encouraging clinical findings in PD-(L)1 inhibitor experienced patients."

Professor Harrison continued: "We have also demonstrated that NUC-3373 is a very potent thymidylate synthase inhibitor and causes DNA damage, leading us to hypothesize that NUC-3373 may be an attractive alternative to pemetrexed in patients with NSCLC and mesothelioma. Observing that NUC-3373 in combination with docetaxel is stabilizing disease in these hard-to-treat patient populations provides further evidence supporting this hypothesis."

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: "We are very excited that these NUC-3373 combinations have been observed to provide a meaningful clinical benefit to patients who had exhausted all other treatment options. We recently presented encouraging efficacy and safety data at ESMO (Free ESMO Whitepaper) on NUC-7738 plus pembrolizumab in patients with metastatic melanoma who were refractory or resistant to PD-1 inhibitors. We are pleased to have two Phase 2 product candidates in our portfolio, each with a distinct mechanism of action, that can potentiate PD-1 inhibitors in PD-(L)1 resistant patients. We look forward to sharing additional data from the NuTide:303 study and our clinical development plans for both NUC-3373 and NUC-7738 in the near future."

On November 11, 2024 23andMe Holding Co. (Nasdaq: ME) (the "Company" or "23andMe"), a leading human genetics and preventive health company, reported a business restructuring to streamline operations and reduce costs (Press release, 23andMe, NOV 11, 2024, View Source [SID1234651087]). In addition, 23andMe is discontinuing further development of all its therapeutics programs, while evaluating strategic alternatives for its clinical and preclinical assets.

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The Company is reducing its overall headcount by over 200 employees, representing approximately 40% of the workforce. The business restructuring is expected to substantially reduce operating expenses and result in annualized cost savings of more than $35 million. The Company expects to incur up to $12 million in costs and expenses primarily related to one-time severance, transition and termination-related costs.

"We are taking these difficult but necessary actions as we restructure 23andMe and focus on the long-term success of our core consumer business and research partnerships," said Anne Wojcicki, 23andMe’s CEO, Co-Founder, and Chair of the Board. "I want to thank our team for their hard work and dedication to our mission. We are fully committed to supporting the employees impacted by this transition."

Strategic Alternatives Process for Therapeutics Programs

In parallel with the discontinuation of its therapeutics division, the Company is actively exploring all strategic options for a limited time to maximize the value of its therapeutics programs, including licensing agreements, asset sales or other transactions. 23andMe intends to wind-down its ongoing clinical trials as quickly as practical, while the strategic alternatives process is ongoing.

"We continue to believe in the promise shown by our clinical and preclinical stage pipeline and will continue to pursue strategic opportunities to continue their development. We remain deeply grateful to the patients, investigators and study staff for their participation in our clinical trials," said Wojcicki.

The Company’s therapeutic programs include 23ME-00610 (a Phase 1/2a therapeutic antibody that is designed to restore the immune system’s ability to kill cancer cells by blocking the immune checkpoint CD200R1), 23ME-01473 (a Phase 1 therapeutic antibody that targets ULBP6, which can be expressed and secreted by tumor cells to suppress immune activity), and other preclinical immunology and inflammation programs. 23ME-00610 has demonstrated early monotherapy responses, potential patient selection biomarkers, and combination potential for patients across multiple difficult-to-treat solid tumors and 23ME-01473 has yielded promising preclinical data with a novel NK-cell-activating mechanism.

There can be no assurance that the strategic alternatives process for the therapeutics assets will result in any course of action and there is no definitive timeline for completion.

About 23ME-00610 (Phase 1/2a)
23ME-00610 is a monoclonal antibody that binds to CD200R1 to prevent the interaction of CD200R1 with CD200. Using the world’s largest proprietary database of health and genetic information, 23andMe identified genetic variants of CD200R1, CD200, and DOK2, the downstream signaling protein, associated with higher risks of immune disease and lower risks of cancer, pinpointing CD200R1 as a promising immuno-oncology target.

23ME-00610 has demonstrated preliminary evidence of clinical benefit as monotherapy, including partial responses by RECIST criteria in patients with neuroendocrine tumors and clear-cell renal-cell carcinomas in the Phase 1/2a clinical trial. Additional preclinical data and recent literature validate the CD200-CD200R1 pathway as a potential oncology target for reversing immune tolerance, as a monotherapy or in combination (e.g., with anti-PD-1, anti-VEGF, CAR-T cell therapies). Higher tumor expression of CD200 and human genetics correlated with increased clinical benefit, suggesting potential value as patient selection biomarkers.

23ME-00610 has shown favorable pharmacokinetics (PK) for dosing once every three weeks, expected on-target pharmacologic activity, and a promising safety and tolerability profile suggesting amenability to combination therapies.

About 23ME-01473 (Phase 1)
23ME-01473 targets ULBP6 to restore anti-tumor immunity through NK and T cells. ULBPs are stress-induced ligands found on the surface of cancer cells that bind to their receptor, NKG2D, on NK and T cells. Cancers escape immune cell recognition by shedding decoy ULBP ligands from their cell surface. ULBP6 has the highest binding affinity to NKG2D, potentially 30 times higher than MICA.

Blocking the binding of soluble ULBP6 to NKG2D through ‘1473 may restore immune cell recognition and killing of cancer cells. ‘1473 is also Fc-effector enhanced, which further enables NK cells to induce cell death of ULBP6-expressing cancer cells.

ULBP6 was identified as a potential cancer drug target using the 23andMe immuno-oncology (I/O) genetic signature, an approach developed by 23andMe to identify evidence for genetic variants that increase immune function while decreasing cancer risk. Using genetic data, 23andMe can identify immune-related genes that are expected to have an impact on cancer biology. Specifically, germline genetics can reveal which of the immune-related genes harbor genetic variants that also alter an individual’s predisposition for developing cancer.

On November 11, 2024 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported that data from the pivotal, Phase 2b ReNeu trial of mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), were published online in the Journal of Clinical Oncology (JCO) (Press release, SpringWorks Therapeutics, NOV 11, 2024, View Source [SID1234648076]). Data from ReNeu, which is a multi-center, single arm trial, were previously presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The JCO e-publication can be accessed at the following link: View Source

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"Plexiform neurofibromas can cause extreme pain, disfigurement, compression of internal organs, and impaired physical function. There is a substantial unmet need for a highly effective and well tolerated systemic therapy for these patients," said Christopher Moertel, M.D., Medical Director, Pediatric Neuro-Oncology and Neurofibromatosis Programs and Kenneth and Betty Jayne Dahlberg Professor of Pediatrics, University of Minnesota and lead author of the JCO publication. "The deep tumor volume reductions and significant improvements in pain and other quality of life measures that we saw in the ReNeu trial, as well as having a formulation option for young children or those who have difficulty swallowing, underscore the potential for mirdametinib to be a valuable new treatment option for adults and children with NF1-PN."

As of the data cutoff of September 20, 2023, the ReNeu trial met its primary endpoint of confirmed objective response rate (ORR), as assessed by blinded independent central review. During the 24-cycle treatment phase (approximately 22 months), the ORR was 41% (95% CI, 29 to 55; n=24/58) in adults and 52% (95% CI, 38 to 65; n=29/56) in children receiving mirdametinib treatment. An efficacy analysis that also included patients who achieved a confirmed objective response after 24 cycles of mirdametinib treatment resulted in an ORR of 45% in adults (n=26/58) and 54% in pediatric (n=30/56) patients. Of the patients who achieved a confirmed objective response during the treatment phase, 96% of adults and 100% of children had durable responses at the time of data cut-off, with 75% of adults and 76% of children having met or exceeded 12 months in response. The median time to onset of confirmed response was 7.8 months (range: 4 to 19) in adults and 7.9 months (range: 4.1 to 18.8) in children. The median duration of treatment at data cutoff was 21.8 months (range: 0.4 to 45.6) in adults and 22 months (range: 1.6 to 40.0) in children, and the median duration of response had not been reached in either cohort.

Tumor volume reductions were deep and durable during the course of the study. The median best percentage change in target PN volume was –41% (range: –90 to 13%) in adults and –42% (range:–91 to 48%) in children. Among those with a confirmed objective response, 62% of adults and 52% of children achieved a best percent reduction in target tumor volume from baseline of >50%. From baseline to Cycle 13, both cohorts reported significant and clinically meaningful improvement in patient- or parent proxy-reported secondary endpoint outcome measures of worst tumor pain severity, pain interference, and health-related quality of life that began early and were sustained during treatment. These improvements began early and were generally sustained at the majority of timepoints over the course of the study. In addition, through an exploratory analysis, the tablet for oral suspension formulation of mirdametinib demonstrated high acceptability by patients and caregivers, providing a dosing option for patients with swallowing difficulties such as young children and adults with tumors in the head and neck region.

Mirdametinib was generally well tolerated in the ReNeu trial, with the majority of adverse events (AEs) being Grade 1 or 2. The most commonly reported treatment-related adverse events (TRAEs) occurring in >20% of adults were dermatitis acneiform (78%), diarrhea (48%), nausea (36%), vomiting (28%) and fatigue (21%). The most commonly reported TRAEs occurring in >20% of children were dermatitis acneiform (43%), diarrhea (38%), paronychia (30%; infection of the tissue adjacent to a fingernail or toenail), nausea (21%), ejection fraction decreased (20%), and increased blood creatine phosphokinase (20%). Among all study participants, 22% of adults and 9% of children discontinued treatment due to AEs.

"ReNeu is the largest multicenter trial conducted to date in patients with NF1-PN and we are very pleased that the JCO publication will serve as an important resource to further disseminate the robust efficacy and safety data of mirdametinib to the broader scientific and clinical community," said Jim Cassidy, M.D., Ph.D., Chief Medical Officer, SpringWorks Therapeutics. "We look forward to continuing to work with the FDA and EMA as they review our applications and are excited by the opportunity to make a meaningful impact on this underserved patient community."

About the ReNeu Trial

ReNeu (NCT03962543) is an ongoing, multi-center, open-label, single arm, Phase 2b trial evaluating the efficacy, safety, and tolerability of mirdametinib in patients ≥2 years of age with an inoperable NF1-associated PN causing significant morbidity. The trial enrolled 114 patients to receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily) without regard to food. Mirdametinib was administered orally in a 3-week on, 1-week off dosing schedule as either a capsule or tablet for oral suspension. The primary endpoint is confirmed objective response rate assessed by proportion of patients with a ≥20% reduction in target tumor volume on consecutive scans during the 24 cycle treatment phase, as measured by MRI and assessed by blinded independent central review. Secondary endpoints include safety and tolerability, duration of response, and changes in patient reported outcomes from baseline to Cycle 13. The treatment phase of the trial is complete, and results were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Patients who completed the treatment phase were eligible to continue receiving treatment in the optional long-term follow up portion of the study, which is ongoing.

About NF1-PN

Neurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from mutations in the NF1 gene, which encodes for neurofibromin, a key suppressor of the MAPK pathway.1,2 NF1 is the most common form of neurofibromatosis, with an estimated global birth incidence of approximately 1 in 2,500 individuals, and approximately 100,000 patients living with NF1 in the United States.3, The clinical course of NF1 is heterogeneous and manifests in a variety of symptoms across numerous organ systems, including abnormal pigmentation, skeletal deformities, tumor growth and neurological complications, such as cognitive impairment.5 Patients with NF1 have an 8 to 15-year mean reduction in their life expectancy compared to the general population.4

NF1 patients have approximately a 30-50% lifetime risk of developing plexiform neurofibromas, or PN, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment; in rare cases, NF1-PN may be fatal.6,7 NF1-PNs are most often diagnosed in the first two decades of life.6 These tumors can be aggressive and are associated with clinically significant morbidities; typically, they grow more rapidly during childhood.8,9

Surgical removal of these tumors is challenging due to the infiltrative tumor growth pattern along nerves and can lead to permanent nerve damage and disfigurement.10 MEK inhibitors have emerged as a validated class of treatment for NF1-PN.11

About Mirdametinib

Mirdametinib is a potent, oral, CNS-penetrant, allosteric small molecule MEK inhibitor in development as a monotherapy treatment for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) and low-grade glioma (LGG), and as a combination therapy for the treatment of several subsets of biomarker-defined metastatic solid tumors. Mirdametinib is an investigational drug for which safety and efficacy have not been established.

Mirdametinib is designed to inhibit MEK1 and MEK2, which occupy pivotal positions in the MAPK pathway. The MAPK pathway is a key signaling network that regulates cell growth and survival and plays a central role in multiple cancers and rare diseases when genetically altered.

The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mirdametinib in adults and children with NF1-PN. The NDA was granted Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2025. The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for mirdametinib for the treatment of adult and pediatric patients with NF1-PN.

In addition, the FDA and the European Commission previously granted Orphan Drug designation for mirdametinib for the treatment of NF1. The FDA has also granted Fast Track designation for the treatment of patients ≥ 2 years of age with NF1-PN that are progressing or causing significant morbidity and Rare Pediatric Disease designation for the treatment of NF1.

On November 11, 2024 Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported an interim data readout of the Phase 1/2a studies of Radspherin for the treatment of peritoneal carcinomatoses (Press release, Oncoinvent, NOV 11, 2024, View Source [SID1234648093]). The studies were closed for recruitment at the end of 2023, and patients are currently in long-term follow-up. The readout confirmed the previously published results on efficacy and adds further confidence in the ongoing randomized controlled Phase 2 clinical trial for Radspherin in patients with ovarian cancer.

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In the first interim readout from the Phase 1 study in ovarian cancer, only 1 patient out of the 10 receiving the selected dose (10%) had peritoneal recurrence at the 12-month interim readout, compared to an expected recurrence rate of 25% in similar populations [1-3]. Correspondingly, in the second intermediate readout of the colorectal cancer study, only 3 of 20 patients (15%) receiving the selected dose of 7 MBq had peritoneal recurrence after the full 18 months follow-up period. With current standard therapy, the expected peritoneal recurrence rate is approximately 50% after 18 months [4]. 36 patients with colorectal cancer have received the selected dose, with results from the final 16 patients still pending full follow-up.

"We are excited to announce the interim results of our Phase1/2a studies of Radspherin, confirming a positive efficacy signal and demonstrating Radspherin’s ability to enable local control in the peritoneum, thus ensuring patients remain in remission after surgery," said Oystein Soug, Chief Executive Officer of Oncoinvent. "These positive results increase confidence in the further development of Radspherin as an effective treatment option for patients suffering from peritoneal carcinomatoses, a condition that is notoriously difficult to treat effectively with systemic therapy."

"Patients with ovarian cancer often have peritoneal carcinomatoses already at diagnosis, giving them higher recurrence rate and worse prognosis – so an effective treatment targeted specifically at these carcinomatoses could reduce recurrence and prolong survival," says Yun Wang, MD PhD, Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo University Hospital, principal investigator in the RAD-18-001 study.

About Radspherin

Radspherin is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of billions of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin is investigated in ongoing clinical studies to treat peritoneal carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.

About the RAD-18-001 and RAD-18-002 study

Two early phase studies with Radspherin in patients with peritoneal carcinomatoses have completed recruitment at the end of 2023 with 68 patients treated. One study in patients with peritoneal carcinomatoses from platinum sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma (RAD-18-001, n=21, phase 1) scheduled for secondary cytoreduction, and one in patients with peritoneal carcinomatoses from colorectal cancer (RAD-18-002, n=47, phase 1/2a) scheduled for cytoreduction and HIPEC. The two studies were designed to evaluate the dose, safety and tolerability, dosimetry, and signal of efficacy of Radspherin.

On November 11, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported the dosing of the first patient in the intratumoural (IT) combination arm of its Phase 1 onCARlytics (CF33-CD19) clinical trial (Press release, Imugene, NOV 11, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0b72d5aa-3410-e210-9537-71ef3b912378/onCARlytics_Trial_Doses_First_Patient_in_IT_Combination_Arm.pdf [SID1234648060]). This development is part of the OASIS trial, which is designed to assess the safety and efficacy of Imugene’s CD19 oncolytic virotherapy in patients with advanced or metastatic solid tumours.

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The OASIS trial is a Phase 1 dose escalation study that explores two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion. onCARlytics, a CD19-expressing oncolytic virus, is being investigated both as a monotherapy and in combination with the CD19-targeting bispecific antibody blinatumomab, an established cancer immunotherapy.

Imugene Managing Director & CEO Leslie Chong said: "We are pleased to have dosed the first patient in the intratumoural arm of our OASIS trial. With CD19 being a well-established target in blood cancers, we are optimistic about the effectiveness it could show in solid tumours. onCARlytics has the potential to induce expression of CD19 on the surface of solid tumours and allowing existing CD19 therapies to recognise and attack the cancer. We’re pleased to continue advancing this prospective new treatment option for those in need."

OASIS is currently being conducted at seven sites in the U.S. including City of Hope, University of Cincinnati, and MD Anderson Cancer Center, with the potential to open a total of 10 sites to recruit up to approximately 40 patients with advanced solid cancers that have spread. The primary objective of the trial is to evaluate the safety and efficacy of onCARlytics, either by IT injection or IV infusion, either alone, or in combination with blinatumomab. In February, the first patient with bile tract cancer was dosed in the IV monotherapy arm of the trial at City of Hope in California. Subject to the rate of patient enrolment, preliminary IT and/or IV combination status is expected in the fourth quarter of 2024.

The trial is titled: "A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors." See View Source