US FDA Project ASHA - International Collaboration in Research, May 12, 2024
Indian-American physician Geetika Srivastava, trained at AIIMS, leads the FDA's 'Project Asha' to boost cancer clinical trials in India. As a haematologist-medical oncologist and FDA medical officer, Srivastava reviews cancer drug applications while treating patients. The initiative aims to address India's low participation in global oncology trials, with only 1.5% conducted in the country. Originating from commitments made during Prime Minister Narendra Modi's 2023 US visit, 'Project Asha' seeks to enhance India's role in multinational trials. Srivastava is engaging with stakeholders, including physicians, patients, regulators, and sponsors, to advance the project.
Full Article: Holding onto Hope: Meet an Indian-American Oncologist Leading US FDA's 'Project Asha' to Increase Cancer Trials in India
Asieris Pharmaceuticals - New Drug Application Approval, May 12, 2024
Photocure ASA announces that its partner Asieris Pharmaceuticals' new drug application for Cevira® has been accepted by the National Medical Products Administration in China. Cevira, a photodynamic therapy system, offers a non-surgical treatment option for high-grade squamous intraepithelial lesions, potentially revolutionizing the approach to managing pre-cervical cancer. This milestone underscores the collaborative efforts between Photocure and Asieris in advancing innovative healthcare solutions.
Full Article: Photocure Partner Asieris Announces New Drug Application Acceptance for Regulatory Review of Cevira in China
MiNK Therapeutics - Private Placement, May 13, 2024
MiNK Therapeutics, a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune-mediated diseases, announced a $5.8 million private placement financing to accelerate clinical trials of its leading therapy, MiNK-215, targeting solid tumors. This funding will support the clinical entry of MiNK-215, aimed at overcoming limitations of traditional immune checkpoint inhibitors, by early 2025. MiNK also appointed Yekaterina ("Katie") Chudnovsky as Board Observer, recognizing her extensive experience in patient advocacy and medical research.
Full Article: MiNK Therapeutics Announces $5.8 Million Private Placement and Appointment of Board Observer
Sanofi, AstraZeneca, & Pfizer - Company Investments, AstraZeneca, May 13, 2024
Ahead of the Choose France economic summit, pharmaceutical giants, including Sanofi, Pfizer, and AstraZeneca, announced a combined investment of approximately $2.16 billion in France. Sanofi will invest over $1.08 billion to enhance biomanufacturing and essential medicine production, focusing on expanding its Vitry-sur-Seine site and creating 500 jobs. Pfizer and AstraZeneca will invest $539 million and $388 million, respectively, to bolster R&D and manufacturing. Additionally, Sanofi entered a $1 billion collaboration with Fulcrum Therapeutics to develop losmapimod for muscular dystrophy, with Sanofi securing exclusive marketing rights outside the U.S.
Full Article: Sanofi, Pfizer, AstraZeneca Pledge Nearly $2.16B in Total Investments in France
AstraZeneca - Ongoing Competition, May 13, 2024
Bristol Myers Squibb's phase 3 trial of Opdivo combined with Yervoy and chemoradiotherapy failed to outperform AstraZeneca's Imfinzi in treating unresectable stage 3 non-small cell lung cancer (NSCLC). Despite hopes that this regimen could improve outcomes by leveraging increased PD-L1 expression from chemoradiotherapy, the study did not extend progression-free survival compared to Imfinzi. This leaves Imfinzi, approved in 2018, as the standard treatment for this indication. The study's adverse events were consistent with known profiles of the drugs involved.
Full Article: Bristol Myers Chalks Failure as AstraZeneca's Imfinzi Stays King in Stage 3 Lung Cancer
Atossa Therapeutics - Financial Status, May 13, 2024
Atossa Therapeutics advanced the development of its lead asset (Z)-endoxifen for breast cancer during Q1 2024, maintaining a strong cash position of $84 million with no debt. The company initiated a new combination study, presented promising monotherapy data, and fully enrolled its second Phase 2 study. With R&D investment rising to $3.7 million, total operating expenses remained steady at $7 million. CEO Dr. Steven Quay emphasized the focus on progressing (Z)-endoxifen and preparing for crucial data readouts in the latter half of the year.
Full Article: Atossa Therapeutics Maintains Strong Cash Position While Advancing Breast Cancer Therapy in Q1
Lycia Therapeutics - Series C Investment, May 13, 2024
Lycia Therapeutics has concluded a successful $106.6 million Series C financing round, led by Venrock Healthcare Capital Partners, with participation from new and existing investors. The company's innovative approach, utilizing lysosomal targeting chimeras (LYTACs), aims to target the extracellular proteome, including challenging proteins associated with autoimmune and inflammatory diseases. With the funds, Lycia plans to advance its lead programs into clinical trials and expand its team to support its transition into clinical-stage development.
Ajax Therapeutics - Series C Investment, May 14, 2024
Ajax Therapeutics closed a $95 million Series C financing, led by Goldman Sachs Alternatives, to advance its Type II JAK2 inhibitor, AJ1-11095, for myelofibrosis treatment. Developed with Schrödinger, AJ1-11095 aims to provide superior efficacy and disease modification compared to existing JAK2 inhibitors. The funds will also support further development of Ajax’s pipeline for myeloproliferative neoplasms.
Full Article: Ajax Therapeutics Raises $95 Million
Kura Oncology - Clinical Trial Updates, May 14, 2024
Kura Oncology has finished enrolling 85 patients in the Phase 2 segment of KOMET-001, a trial evaluating ziftomenib for relapsed or refractory NPM1-mutant acute myeloid leukemia (AML). Topline data is expected in early 2025. Ziftomenib shows promise as a potential breakthrough treatment, supported by its favorable safety profile and encouraging clinical activity.
Full Article: Kura Oncology Completes Enrollment in Registration-Directed Trial of Ziftomenib in NPM1-Mutant AML
Kineta - Clinical Trial Updates, May 15, 2024
Kineta, Inc., a biotech company focusing on cancer immunotherapy, announced financial results for Q1 2024 and a corporate update. Following a significant restructuring in February 2024 to cut costs and conserve cash, including staff reductions and pausing enrollment in the VISTA-101 Phase 1/2 trial for KVA12123 due to funding challenges, the company is exploring strategic options to boost shareholder value. Despite these hurdles, Kineta remains optimistic about the clinical progress of KVA12123, with promising early results and plans for further updates in Q2 2024.
Full Article: Kineta Reports Q1, Provides Update on Phase 1/2 VISTA-101 Trial
Atossa Therapeutics - Clinical Trial Updates, May 15, 2024
Atossa Therapeutics Inc has completed dosing the last patient in its Karisma-Endoxifen clinical trial, targeting breast cancer risk reduction. The phase two trial included 240 participants with measurable mammographic breast density (MBD), randomly assigned to receive either a placebo or doses of (Z)-endoxifen for six months. CEO Steven Quay looks forward to sharing data with regulators to potentially advance to a Phase 3 study. Atossa's oral (Z)-endoxifen formulation, bypassing liver metabolism, shows promise in effectively inhibiting estrogen receptors.
Full Article: Atossa Therapeutics Gives Final Dose in Breast Cancer Prevention Study
Bolt Biotherapeutics - Company Downsizing, May 15, 2024
Bolt Biotherapeutics is halting development of its lead cancer drug, trastuzumab imbotolimod, and will lay off 50% of its workforce. This decision follows the company's conclusion that the drug would not meet its advancement criteria. Bolt will now focus on two earlier-stage candidates, BDC-3042 and BDC-4182, supported by collaborations with Genmab and Toray. Additionally, leadership changes include Willie Quinn replacing Randal Schatzman as CEO. These strategic shifts aim to extend Bolt's cash runway into late 2026, though the company's stock has dropped significantly following the announcements.
Full Article: Bolt Biotherapeutics Layoffs, CEO Change, Restructuring Pipeline
Intensity Therapeutics - Executive Changes, May 15, 2024
Intensity Therapeutics appointed Thomas Dubin to its Board of Directors, increasing the board size to five, with four being independent. Dubin, joining on May 14, 2024, and serving on the Audit Committee, brings extensive experience in pharmaceutical business development and regulatory affairs. His previous roles include chief legal officer at Alexion Pharmaceuticals and VP at ChiRex, Inc. The company believes his expertise will be valuable as they advance their cancer treatment, INT230-6, into Phase 3 clinical development.
Full Article: Intensity Therapeutics Inc. Announces the Appointment of Thomas Dubin to Its Board of Directors
Verismo Therapeutics - FDA Approval, May 15, 2024
The FDA has cleared Verismo Therapeutics' IND application to advance its CAR-T therapy, SynKIR-310, into a Phase I trial. The CELESTIAL-301 trial, starting in late 2024, will enroll patients with relapsed or refractory B-cell non-Hodgkin lymphomas, including those with prior CAR-T therapy. Verismo’s KIR-CAR platform aims to enhance long-term T cell function, addressing the need for more effective post-relapse therapies. SynKIR-310 targets CD19 to activate T cells for targeted tumor cell destruction.
Full Article: FDA Clears IND for Verismo Therapeutics CAR-T Therapy
Arvinas and Pfizer - Clinical Trial Updates, May 16, 2024
Arvinas and Pfizer's updated Phase 1b trial data show that vepdegestrant combined with palbociclib continues to be effective and safe for advanced ER+/HER2- breast cancer patients. At the 200 mg dose, the median progression-free survival was 13.9 months, with a 63% clinical benefit rate and a 41.9% overall response rate. These results, consistent with earlier findings, highlight the potential of vepdegestrant as a new standard-of-care therapy.
Amgen - FDA Approval, May 16, 2024
Amgen announced FDA approval of IMDELLTRA™ (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after platinum-based chemotherapy. This accelerated approval is based on positive response rates and duration of response observed in clinical trials. IMDELLTRA, the first DLL3-targeting Bispecific T-cell Engager therapy, activates T cells to attack tumor cells, showing a median overall survival of 14.3 months and a 40% response rate in trials. The approval marks a significant advancement in ES-SCLC treatment.
Enhertu - Positive Trial Data, May 16, 2024
Trastuzumab deruxtecan demonstrated tolerable anti-tumor activity in HER2-overexpressing or HER2-mutant unresectable or metastatic non–small cell lung cancer (NSCLC), according to the phase 2 DESTINY-Lung01 trial published in The Lancet Oncology. In the study, cohorts 1 and 1A showed confirmed objective response rates (ORR) of 26.5% and 34.1%, respectively, with partial responses in 27% and 29% of patients. The disease control rate (DCR) was 69.4% for cohort 1 and 78.0% for cohort 1A, with median durations of response (DOR) of 5.8 and 6.2 months, respectively. The median progression-free survival (PFS) was 5.7 months for cohort 1 and 6.7 months for cohort 1A, highlighting the potential of T-DXd as a treatment option in this patient population.
Full Article: T-DXd Produces Tolerable Anti-Tumor Activity in HER2-Overexpressing NSCLC
Dr. Richard Scolyer's Innovative Cancer Treatment, May 16, 2024
Dr. Richard Scolyer, a pioneering pathologist who survived glioblastoma, a deadly brain tumor, made headlines for his unconventional treatment. Alongside Dr. Georgina Long, they administered a combination of immunotherapy drugs before surgery, a groundbreaking approach inspired by melanoma research principles. Despite risks, including the drugs potentially not reaching his brain, Scolyer's treatment yielded miraculous results, with his tumor shrinking enough for successful surgery. While this neoadjuvant therapy is novel for glioblastoma, it aligns with ongoing immunotherapy research in other cancers. Scolyer's case underscores the potential of innovative approaches in cancer treatment, though further research is needed for broader application.
Full Article: What to Know About Immunotherapy: Innovative Treatment Doc Used on His Own Cancer
Carisma Therapeutics - Clinical Trial Updates, May 16, 2024
Carisma Therapeutics initiates Phase 1 trial for CT-0525, targeting solid tumors with HER2 overexpression. It's the first human testing of CAR-Monocytes in this setting, showing promise for new cancer treatments. Initial data expected by late 2024. Collaboration with leading cancer centers underscores its potential impact. Details available at clinicaltrials.gov (NCT06254807). Trial's design to be presented at ASCO 2024 Annual Meeting.
Full Article: Carisma Therapeutics Announces First Patient Dosed in Phase 1 Trial
Erasca's Restructuring - Restructuring, May 17, 2024
Erasca is restructuring its clinical pipeline, discontinuing three programs, and licensing two cancer therapies. The company paid $12.5 million upfront to Joyo Pharmatech for global rights (excluding China regions) to ERAS-0015, a pan-RAS molecular glue therapy, with potential milestone payments up to $176.5 million. A Phase I trial for ERAS-0015 will begin in 2026. Additionally, Erasca licensed ERAS-4001, a pan-KRAS inhibitor, from Medshine Discovery for $10 million upfront and up to $160 million in milestones. The Phase I trial for ERAS-4001 will also start in 2026.
Full Article: Erasca Trims Workforce and Pipeline to Focus on KRAS and Molecular Glues
Targeted Oncology - Positive Trial Data, May 17, 2024
TNO155, in combination with spartalizumab or ribociclib, shows potential in treating solid tumors with HER2 overexpression. In a phase 1b study, TNO155 with spartalizumab demonstrated a disease control rate (DCR) of 26.3%, while with ribociclib, it showed a DCR of 13.0%. Notably, TNO155 at recommended doses yielded promising results. Side effects were manageable, with no new safety concerns identified. These findings offer hope for advancing cancer treatment options.
Full Article: TNO155 and Targeted Therapies Lead to Positive Responses in Solid Tumors
