Nuvalent - Clinical Trial Updates, Jul 22, 2024
Nuvalent has begun the HEROEX-1 Phase 1a/1b trial of NVL-330, a HER2-selective inhibitor, in pre-treated HER2-altered NSCLC patients. The trial will assess NVL-330's safety, tolerability, anti-tumor activity, recommended Phase 2 dose, and pharmacokinetics. Preclinical studies indicate NVL-330's potential against HER2 exon 20 mutations, selectivity for HER2 over wild-type EGFR, and brain penetrance. This is Nuvalent's third clinical program in three years.
Full Article: Nuvalent announces first patient dosed in HEROEX-1 Phase 1a/1b
Allarity Therapeutics - Company Updates, Jul 22, 2024
Allarity Therapeutics announced financial improvements with a $20M cash balance extending into 2026 and pausing their ATM offering. The company is now focused on stenoparib, showing promising results in Phase 2 trials for recurrent ovarian cancer. Allarity received a Wells Notice from the SEC regarding past NDA disclosures for Dovitinib. They also proposed a reverse stock split to maintain NASDAQ listing compliance.
Full Article: Allarity Therapeutics outlines company's 2024 progress and objectives
Oxford BioTherapeutics - Milestones & Achievements, Jul 22, 2024
Oxford BioTherapeutics was named 'Tech SME of the Year' at the 2024 Thames Valley Tech & Innovation Awards for its innovation in cancer therapies, particularly in the ADC and T-Cell Engager space. The award highlights OBT's technological advancements, including the OGAP®-Verify platform. This follows their 2023 recognition as 'Tech Company of the Year' and for 'Special Recognition' at the Thames Valley SME Growth 100 Awards.
Full Article: Oxford BioTherapeutics named Best Tech SME of the Year at Thames Valley Tech & Innovation Awards 2024
BeiGene - Company Updates, Jul 23, 2024
BeiGene has opened an $800 million, 400,000-square-foot biologics manufacturing and R&D facility in Hopewell, New Jersey. This site, constructed over three years, is expected to create hundreds of high-tech jobs by the end of 2025. BeiGene focuses on oncology drugs, utilizing innovative approaches like targeted protein degraders and antibody-drug conjugates, alongside traditional methods like monoclonal antibodies and small molecules.
Full Article: BeiGene debuts $800M biologics plant, set to create hundreds of new jobs
Third Arc Bio - Series A Investment, Jul 23, 2024
Third Arc Bio, founded by J&J veterans with $165 million in funding, aims to develop multifunctional antibodies for solid tumors and autoimmune diseases. Led by former J&J executives, the company plans to advance multiple clinical trials starting early next year.
Full Article: J&J vets burst into biotech with $165M Third Arc series A
Anixa Biosciences - Company Updates, Jul 23, 2024
Anixa Biosciences, Inc., in collaboration with the Cleveland Clinic, has been developing a vaccine to prevent triple-negative breast cancer (TNBC), the most lethal form of the disease. Currently, they are conducting a Phase 1 trial with 16 women who have received three vaccinations. This research represents a significant step toward the hope of one day eradicating breast cancer.
Full Article: Breast cancer vaccine undergoing new clinical trials
Fuzionaire Theranostics - Executive Changes, Jul 23, 2024
Fuzionaire Theranostics added Li Boynton to its Board of Directors and Klaus Kopka, PhD, to its Advisory Board. Boynton brings healthcare finance expertise, while Kopka is a renowned radiopharmaceuticals expert. This strengthens Fuzionaire's clinical development, particularly for its GRPR-targeting radiopharmaceuticals now advancing to patient tests in Germany. Collaborations with McGill and McMaster Universities, backed by a CIHR grant, will further develop the HetSiFA® platform for theranostics.
Full Article: Fuzionaire Theranostics adds new board members
INIMMUNE - Clinical Trial Updates, Jul 24, 2024
Inimmune has begun its Phase 1 trial of INI-4001 for advanced solid tumors, assessing safety and tolerability. The trial includes single dose escalation monotherapy and combination therapy with checkpoint inhibitors. Pre-clinical studies showed promise for INI-4001 as both a monotherapy and in combination. The trial will conclude by the end of 2025.
Full Article: Inimmune announces first cancer patient dosed in Phase 1 clinical study using the immunotherapeutic INI-4001
ImmuneOnco Biopharmaceuticals - Clinical Trial Updates, Jul 24, 2024
ImmuneOnco Biopharmaceuticals has initiated a Phase Ib clinical trial, dosing the first patient with IMM2510 and IMM27M for advanced solid tumors. IMM2510 targets VEGF and PD-L1, while IMM27M is a CTLA-4 antibody enhancing T-cell antitumor activity. The company notes that the development and market success of these drugs are not guaranteed.
Full Article: ImmuneOnco begins clinical trial for cancer drugs
Dren Bio & Novartis - Collaboration, Jul 24, 2024
Dren Bio has entered a strategic collaboration with Novartis to develop bispecific antibodies for cancer using Dren Bio's Targeted Myeloid Engager and Phagocytosis Platform. Novartis will invest $150 million upfront, including a $25 million equity investment, with Dren Bio eligible for up to $2.85 billion in milestone payments and tiered royalties. Novartis will handle development, manufacturing, and commercialization post-clinical candidate selection. This partnership aims to leverage Novartis' oncology expertise and Dren Bio's innovative platform to create new cancer therapies.
Full Article: Dren Bio announces strategic collaboration with Novartis to develop novel targeted myeloid engagers for cancer
AstraZeneca - Company Updates, Jul 25, 2024
AstraZeneca's Enhertu, partnered with Daiichi Sankyo, saw only a 1.6% sales increase in Q2 2024 despite its tumor-agnostic approval in the U.S. Sales slowed due to inventory issues in China, but AstraZeneca expects growth in China, Europe, and the U.S. later this year. Enhertu aims to solidify its position in HER2-low breast cancer treatment, with further advances anticipated from upcoming trials.
Full Article: Enhertu stalls AstraZeneca, Daiichi Sankyo charts harder yards
Roche - Company Updates, Jul 25, 2024
Roche's Phesgo sales rose 60% in H1 2024 to CHF 799 million, aiding a 5% growth in its HER2 franchise to CHF 4.5 billion. Alecensa and Tecentriq also saw gains, with modest growth expected for Tecentriq. Roche is advancing inavolisib for breast cancer, projecting CHF 2 billion in peak sales. Despite some trial discontinuations, overall revenues increased 5% at CER, leading to raised full-year guidance for 2024.
Full Article: Roche reports 5% CER growth in pharmaceutical sales, driven by strong performance
Ariceum Therapeutics - Clinical Trial Updates, Jul 25, 2024
Ariceum Therapeutics has initiated a Phase 1 trial for 123I-ATT001, a radiopharmaceutical PARP inhibitor, in recurrent glioblastoma patients at University College London Hospitals. This trial, led by Dr. Paul Mulholland, aims to assess safety and early efficacy. Approved by the UK’s MHRA, ATT001 targets cancer cells with Iodine-123, causing lethal damage while sparing healthy tissue. Ariceum plans further trials in other cancers expressing PARP.
Full Article: Ariceum Therapeutics commences Phase 1 clinical trial in patients with recurrent glioblastoma
Cue Biopharma - Company Downsizing, Jul 26, 2024
Cue Biopharma is prioritizing preclinical autoimmune programs over clinical-stage oncology drugs, leading to a 25% workforce reduction. Despite promising cancer trial results, the company focuses on autoimmune therapies to create near-term value, seeking partnerships to continue oncology developments and extend its cash runway into mid-2025.
Full Article: Cue Biopharma lays off 25%, prioritizing preclinical autoimmune assets over clinical cancer drugs
Merus - Clinical Trial Updates, Jul 26, 2024
Merus has begun a Phase 3 trial for petosemtamab, targeting EGFR and LGR5, in previously treated recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) patients. Approved by the FDA, the trial will compare petosemtamab's efficacy and safety to standard chemotherapy or cetuximab, with plans to enroll about 500 patients. Petosemtamab aims to inhibit EGFR signaling and enhance cell-mediated cytotoxicity.
Full Article: Merus begins Phase 3 trial for petosemtamab in recurrent/metastatic head and neck cancer
Bristol Myers Squibb - Company Updates, Jul 26, 2024
Bristol Myers Squibb reported strong Q2 2024 sales growth for its CAR T-cell therapy Breyanzi, thanks to expanded manufacturing capacity. Breyanzi sales rose 53% to $153 million. The company, streamlining operations for long-term growth, saw total revenue increase 9% to $12.20 billion. Key oncology drugs like Opdivo and Yervoy also posted gains. Despite a 28% drop in Abecma sales, BMS remains optimistic about future growth. The company revised its 2024 revenue guidance to the upper end of the low single-digit range and increased its EPS forecast.
Full Article: Bristol Myers Squibb reports 53% increase in Q2 Breyanzi sales
