Epsilogen - Series B Investment, Sep 9, 2024
Epsilogen has raised £12.5m ($16.4m) in a Series B expansion round, bringing the total to £43.25m, to advance its IgE antibodies for cancer treatment. The funding, from existing investors including British Patient Capital and the Novartis Venture Fund, will support a Phase Ib trial of MOv18 IgE, targeting platinum-resistant ovarian cancer. MOv18 IgE, a novel therapeutic antibody, showed safety and initial clinical activity in Phase I and has a unique mechanism promoting immune response against tumors.
Full Article: Epsilogen Raises £12.5m in Series B to Advance IgE Antibodies for Cancer Treatment
Phanes Therapeutics - Clinical Trial Updates, Sep 9, 2024
Phanes Therapeutics has dosed the first patient in a clinical study of PT886, a bispecific antibody targeting claudin 18.2 and CD47, in combination with chemotherapy for pancreatic and gastric cancers. PT886, which has received orphan drug and Fast Track designations from the FDA, is being evaluated in the TWINPEAK Phase I/II trial to assess safety and preliminary efficacy in advanced or metastatic cancers. Phanes is also collaborating with Merck to study PT886 in combination with KEYTRUDA® for claudin 18.2-positive pancreatic adenocarcinoma.
Full Article: Phanes Therapeutics Doses First Patient in PT886 Study
CytomX Therapeutics - Clinical Trial Updates, Sep 9, 2024
CytomX Therapeutics has dosed the first patient with CX-801, a dually-masked interferon alpha-2b PROBODY® cytokine, in a Phase 1 study for solid tumors. CX-801 aims to treat both immune-oncology-sensitive and cold tumors. The study will evaluate its safety and clinical activity as monotherapy and in combination with Merck’s KEYTRUDA. The trial targets solid tumors like melanoma and renal cell carcinoma, with plans for potential Phase 1b expansion. CX-801 seeks to reduce systemic toxicity, expanding the therapeutic index of interferon for broader immuno-oncology use.
Full Article: CytomX Doses First Patient with CX-801 in Phase 1 Study
BioInvent - Positive Trial Data, Sep 9, 2024
BioInvent announced positive preliminary results from its Phase 2a study of BI-1808, with three partial responses (PR) and one stable disease (SD) observed in four evaluable patients with Cutaneous T-cell Lymphoma (CTCL), all of whom had progressed after standard therapy. These findings follow earlier data presented at ASCO 2024, where one complete response (CR), one PR, and nine cases of stable disease were reported. BI-1808 continues to show an impressive safety profile.
Full Article: BioInvent Announces Positive Efficacy Data for BI-1808 in CTCL
Relay Therapeutics - Positive Trial Data, Sep 9, 2024
Relay Therapeutics reported promising results from a small clinical trial of its experimental breast cancer drug, RLY-2608, which targets the PI3Ka gene. The drug delayed tumor growth by a median of 9.2 months, outperforming existing therapies like Novartis' Piqray. Additionally, it caused fewer severe side effects, suggesting it could avoid some of the toxicities associated with current PI3Ka inhibitors. Encouraged by the data, Relay plans to advance the drug into pivotal trials next year and is also seeking a partner for its bile duct cancer treatment.
Full Article: Relay Therapeutics Reports Positive Results for Breast Cancer Drug RLY-2608
Boehringer Ingelheim - Positive Trial Data, Sep 10, 2024
Boehringer Ingelheim's Beamion LUNG-1 trial met its primary endpoint, showing that zongertinib, an oral HER2 tyrosine kinase inhibitor, achieved a 66.7% objective response rate and demonstrated a tolerable safety profile in patients with advanced NSCLC and activating HER2 mutations. The drug also showed potential activity against brain metastases. Following an interim analysis, the 120mg dose was selected for further evaluation. Zongertinib is positioned as a promising future treatment for HER2-mutated lung tumors.
Full Article: Boehringer Ingelheim's Zongertinib Shows Positive Results in NSCLC Trial
MAIA Biotechnology - Positive Trial Data, Sep 10, 2024
MAIA Biotechnology announced positive interim results from its Phase 2 THIO-101 study for advanced NSCLC. THIO, a telomere-targeting treatment combined with Regeneron’s Libtayo, showed a median survival follow-up of 10.6 months in third-line treatment, surpassing the standard-of-care survival of 5.8 months. Notably, 16 patients surpassed 12-month survival, with three approaching 17 months. Previous data indicated a 38% overall response rate and 88% disease control rate. The treatment has been well-tolerated, and full efficacy results are expected later this year.
Full Article: MAIA Biotechnology Reports Positive Survival Updates for THIO-101
PhoreMost - Series B Investment, Sep 10, 2024
PhoreMost has secured an additional $12 million in its Series B financing, bringing the total to over $50 million. Led by Parkwalk Advisors and supported by existing investors, the funds will advance PhoreMost's degrader programs in oncology and inflammatory diseases towards preclinical development. The investment also supports its GlueSEEKER™ platform for molecular glue design and expanding pharma collaborations.
Full Article: PhoreMost Secures $50 Million in Series B Financing
Incendia Therapeutics - Clinical Trial Updates, Sep 10, 2024
Incendia Therapeutics has enrolled the first patient in its Phase 1c study of PRTH-101 for advanced or metastatic solid tumors. The study will assess safety, tolerability, and anti-tumor activity, both as a monotherapy and in combination with KEYTRUDA. Data will inform the design of the Phase 2/3 program, with global feasibility planning underway.
Full Article: Incendia Therapeutics Enrolls First Patient in PRTH-101 Trial
OSE Immunotherapeutics - Clinical Trial Updates, Sep 10, 2024
OSE Immunotherapeutics has launched its Phase 3 ‘Artemia’ trial for Tedopi, a neoepitope-based cancer vaccine, in second-line treatment for metastatic non-small cell lung cancer (NSCLC). The trial, approved in 14 countries, will assess Tedopi monotherapy against standard care in HLA-A2 positive patients with secondary resistance to immune checkpoint inhibitors. The primary endpoint is overall survival, with 363 patients participating. Tedopi aims to meet high unmet needs in NSCLC, potentially benefiting up to 46,000 patients annually across major global markets.
Full Article: OSE Immunotherapeutics Launches Phase 3 Tedopi Trial for NSCLC
AstraZeneca and Daiichi Sankyo - Fail Trial Results, Sep 10, 2024
AstraZeneca and Daiichi Sankyo's lung cancer drug, Datopotamab deruxtecan (Dato-DXd), failed to significantly outperform standard chemotherapy in a Phase III trial, leading to a 5% drop in AstraZeneca’s shares. However, the drug showed promising results in a subgroup of non-squamous NSCLC patients, prompting AstraZeneca to shift focus to this group.
Full Article: AstraZeneca's Lung Cancer Drug Falls Short in Phase III Trial
PanTera – Series A Investment, Sep 11, 2024
PanTera, a Belgian radioisotope producer, raised €93 million in a Series A round led by EQT Life Sciences. This record funding will help build a new facility and expand its production of actinium-225 (225-Ac), crucial for targeted cancer therapies. The company aims to address the supply shortage and meet growing demand through innovative production methods and key partnerships with TerraPower Isotopes and Bayer.
Full Article: Next-gen Radiopharmaceutical Manufacturer PanTera Attracts €93M Series A Funding
Radiant Biotherapeutics – Series A Investment, Sep 11, 2024
Radiant Biotherapeutics has raised $35 million in Series A funding, co-led by the Gates Foundation and Amplitude Ventures, to advance its Multabody™ platform. The funds will help develop its lead candidate, 4-1BB, for oncology, inflammation, immunology, and infectious diseases, including HIV. Additional investors include BDC Capital, abrdn, FACIT, and others.
Full Article: Radiant Bio Closes $35 Million Series A Financing to Advance Therapeutic Pipeline
Telix Pharmaceuticals – Positive Trial Data, Sep 11, 2024
Telix Pharmaceuticals' Phase III ZIRCON trial results, published in The Lancet Oncology, demonstrate that TLX250-CDx, a PET imaging agent, is highly accurate in detecting clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses. The study of 300 patients showed 86% sensitivity and 87% specificity, highlighting the non-invasive technique’s potential to revolutionize ccRCC diagnosis and reduce unnecessary surgeries. If approved, TLX250-CDx would be the first targeted PET agent for kidney cancer in the U.S.
Full Article: Telix’s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology
Vironexis Biotherapeutics – FDA Clearance, Sep 12, 2024
Vironexis Biotherapeutics launched from stealth with its TransJoin AAV Gene Therapy Platform and $26M in seed funding. The FDA cleared its lead product, VNX-101, for a Phase 1/2 trial targeting CD19+ acute lymphoblastic leukemia, set to begin in late 2024. The platform aims to improve T-cell therapies for cancer by enhancing safety, efficacy, and manufacturing.
Full Article: Vironexis Biotherapeutics Launches with FDA Clearance for First-Ever AAV-Delivered Cancer Immunotherapy
Monopar Therapeutics – Positive Trial Data, Sep 12, 2024
Monopar Therapeutics announced positive early data from its Phase 1 trial of MNPR-101-Zr, showing effective tumor targeting in patients with uPAR-expressing cancers like triple-negative breast and colorectal. PET scans revealed high uptake of MNPR-101-Zr in metastatic tumors, demonstrating specificity and durability. Monopar plans to begin a Phase 1 therapeutic trial of MNPR-101-Lu later this year and will present further findings at the European Association of Nuclear Medicine 2024 Congress in October.
Full Article: Monopar Announces Positive Early Human Data Validating Tumor Targeting Ability of MNPR-101-Zr
EGLE Therapeutics – Executive Changes, Sep 12, 2024
EGLE Therapeutics appointed Michel Detheux as Chairman and Mojgan Hossein-Nia as Director, representing Takeda Ventures. Detheux, CEO of iTeos Therapeutics, brings expertise in oncology and strategic growth, while Hossein-Nia, a leader at Takeda, has over 30 years of experience in R&D and portfolio management. Their leadership will support EGLE's development of therapies for cancer and autoimmune diseases.
Full Article: EGLE Therapeutics Strengthens Its Board of Directors with Appointment of Michel Detheux as Chairman
Oncternal Therapeutics – Fail Trial Result & Workforce Reduction, Sep 12, 2024
Oncternal Therapeutics is halting all clinical trials and laying off staff as it explores strategic options, including asset sales, mergers, or acquisitions. This decision follows disappointing results for its early-stage trials: ONCT-534, a dual-action androgen receptor inhibitor, showed no significant disease improvement, and ONCT-808, a CAR-T therapy, was associated with a patient death. The company is now focusing on realizing value from its remaining pipeline, which includes zilovertamab and ONCT-216, amid a challenging financing environment. Oncternal’s stock has dropped 60% following the announcement.
Full Article: Oncternal Folds All Clinical Trials After Lackluster Data and Patient Death
Prelude Therapeutics – Positive Trial Data, Sep 13, 2024
Prelude Therapeutics reported positive early Phase 1 data for PRT3789, a SMARCA2 degrader for SMARCA4 mutations, at ESMO Congress 2024. The drug was well-tolerated, with preliminary results showing tumor shrinkage in 7 of 26 advanced NSCLC or esophageal patients, including 3 partial responses. Ongoing studies will continue to assess efficacy and safety.
Full Article: Prelude Therapeutics’ SMARCA2 Degrader PRT3789 Demonstrated Promising Initial Clinical Activity and Safety
Monopar Therapeutics – Positive Trial Data, Sep 13, 2024
Monopar Therapeutics' MNPR-101-Zr Phase 1 trial showed strong tumor targeting in cancers with high uPAR expression. PET imaging revealed high tumor uptake and retention compared to FDG. The company will start a Phase 1 therapeutic trial this fall and present more data at the European Association of Nuclear Medicine 2024 Congress.
Full Article: Monopar Announces Positive Early Human Clinical Data Validating Tumor Targeting Ability of MNPR-101-Zr
Avacta – Clinical Trial Updates, Sep 14, 2024
Avacta Group's Phase 1a trial for AVA6000, a peptide-drug conjugate targeting FAP-positive tumors, showed promising results at ESMO 2024. AVA6000, which pairs doxorubicin with a FAP-cleavable peptide, demonstrated favorable tolerability and early efficacy. The drug achieved durable responses in FAP-high tumors, with notable efficacy in salivary gland cancer and liposarcoma. It showed a better safety profile compared to conventional doxorubicin, with lower rates of severe neutropenia and cardiac toxicity. The trial continues, and future plans include advancing AVA6000 and exploring its combination with other treatments.
Full Article: Avacta Reports Updated Phase 1 Data of AVA6000 Demonstrating Durable Responses in Solid Tumors
Bristol Myers Squibb – Clinical Trial Updates, Sep 14, 2024
Bristol Myers Squibb is advancing Opdualag, its PD-1/LAG-3 combo, into Phase 3 trials for first-line NSCLC. The RELATIVITY1093 trial will test Opdualag plus chemotherapy in stage 4 or recurrent nonsquamous NSCLC with low PD-L1 expression, comparing it to Merck’s Keytruda. A separate Phase 3 trial will focus on high PD-L1 expression.
Full Article: Bristol Myers Moves Opdualag into Phase 3 Trials in Competitive First-Line Lung Cancer Field
IO Biotech – Positive Trial Data, Sep 14, 2024
At ESMO 2024, IO Biotech reported positive Phase 2 results for IO102-IO103 combined with Merck’s KEYTRUDA® in advanced head and neck cancer. Key outcomes include a 44.4% overall response rate, 6.6-month median progression-free survival, and a 66.7% disease control rate. The safety profile was consistent with previous studies, showing no significant added toxicity.
Full Article: IO Biotech Announces Positive Results from Phase 2 Trial of IO102-IO103 in First-Line Treatment of Advanced Head and Neck Cancer
