MorphoSys - Drug safety concerns, Apr 28, 2024
MorphoSys faces a safety concern with its experimental myelofibrosis treatment, pelabresib, a key aspect of its proposed acquisition by Novartis. Physicians in a Phase 3 study reported instances of patients progressing rapidly from myelofibrosis to acute myeloid leukemia after pelabresib treatment. The FDA issued a warning letter to study physicians due to an imbalance in severe cancer progressions, heightening monitoring efforts.
Full Article: MorphoSys Faces Safety Concerns with Pelabresib in Myelofibrosis
Silence Therapeutics - Executive Changes, Apr 29, 2024
Silence Therapeutics plc announced the retirement of Alistair Gray from its Board of Directors, effective May 1, 2024. Gray, who served since 2015, contributed significantly to the company's evolution into a global player in RNA interference medicines. Chairman Iain Ross expressed gratitude for Gray's contributions, acknowledging the company's progress under his tenure. Gray thanked his colleagues and highlighted the advancements made during his time, citing the leadership of Ross and CEO Craig Tooman.
Full Article: Silence Therapeutics Announces Retirement of Alistair Gray from Board of Directors
ONO Pharmaceutical - Acquisition, Apr 29, 2024
Deciphera Pharmaceuticals is being acquired by ONO Pharmaceutical for $2.4 billion, aiming to enhance ONO's oncology portfolio and expand its global presence. The deal values Deciphera at $25.60 per share in cash. J.P. Morgan Securities LLC is advising Deciphera, and BofA Securities is advising ONO.
Full Article: Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical for $2.4 Billion
Clarity Pharmaceuticals - Positive trial data, Apr 30, 2024
A patient in the SECuRE trial for metastatic castrate-resistant prostate cancer achieved complete response after two cycles of 67Cu-SAR-bisPSMA treatment. The therapy, administered under an Expanded Access Program, demonstrated significant PSA reduction and favorable safety profile. The trial, enrolling heavily pre-treated patients, aims to explore multiple doses for potential therapeutic benefits. Principal investigator Luke Nordquist expressed optimism about the therapy's potential.
Full Article: Multi-Dose Treatment with 67Cu-SAR-bisPSMA in mCRPC Shows Promise
Jacobio Pharma - Positive trial data, Apr 30, 2024
Jacobio Pharma reported positive Phase II data for glecirasib, a KRAS G12C inhibitor, at the ASCO Plenary Series. Results showed a 47.9% objective response rate in second-line non-small cell lung cancer patients, with manageable safety. Prof. Yuankai Shi highlighted glecirasib's efficacy and safety compared to chemotherapy, offering potential as a treatment option for patients with KRAS G12C mutation.
Full Article: Jacobio Pharma Announces Positive Phase II Data for Glecirasib
Pacific Biosciences - Company Downsizing, Apr 30, 2024
Pacific Biosciences has laid off 195 employees and will close its San Diego location to streamline operations. CEO Christian Henry cited disappointing financial results for the first quarter, leading to cost-cutting measures. The firm plans to reduce operating costs by $50-75 million annually while continuing to develop sequencing instruments. In Nasdaq trading, PacBio shares rose 6 percent to $1.70.
Full Article: Pacific Biosciences Lays Off 195 Employees, Will Close San Diego Location
Infinitopes - Seed Funding, Apr 30, 2024
Infinitopes has successfully closed a £12.8 million seed funding round led by Octopus Ventures, with participation from various organizations, including Cancer Research Horizons and the Cancer Research Institute. The funding will support the development of cancer vaccines, particularly its lead asset, ITOP1, set to begin a phase I/IIa study in Q3 2024. Infinitopes aims to advance precision antigen discovery and vaccine vector technologies to treat a range of cancers, building on its collaboration with Cancer Research UK and leveraging innovative CRUK-funded science from Oxford University.
Full Article: Integrated Cancer Biotech Infinitopes Secures £12.8M Seed Financing
Defence Therapeutics Inc. - Positive trial data, May 1, 2024
Defence Therapeutics' pre-clinical trial of its ARM-002TM pancreatic cancer vaccine, combined with an anti-PD-1 immune-checkpoint inhibitor, showed promising results in animals. All treated animals survived for over 40 days with impaired tumor growth. This success prompts Defence to focus its Phase I trial on pancreatic cancer, addressing the limited treatment options for this challenging disease.
Full Article: Pancreatic Cancer: Successful Trial Against Melanoma
Merck - New research center, May 1, 2024
Merck is investing €300 million in a new research center in Darmstadt, Germany, focusing on antibody manufacturing and mRNA applications. The center, expected to house 550 employees by 2027, aims to advance life science technologies and support research on medical challenges like cancer and infectious diseases.
Full Article: Merck Invests €300 Million in New German Research Centre
Enlaza Therapeutics - Series A investment, May 1, 2024
Enlaza Therapeutics secured $100 million in a Series A funding round led by JP Morgan Asset Management’s private capital division, with participation from existing and new investors. The funding will drive the development of Enlaza’s covalent protein technologies and advance its pipeline programs toward clinical trials. Stephen Squinto from JP Morgan's life sciences group has joined Enlaza's board of directors. Enlaza's War-Lock platform aims to create highly specific therapeutic warheads that attach covalently to drug targets, potentially enhancing efficacy while reducing side effects.
Full Article: Enlaza Therapeutics Raises $100M in Series A Funding
KAZIA - Positive trial data, May 1, 2024
Kazia Therapeutics' EVT801 Phase 1 trial achieved its primary and secondary objectives, determining the maximal tolerated dose at 500mg BID and recommending 400mg BID as the phase 2 dose. EVT801 showed tolerability across all doses and promising clinical activity, particularly in advanced ovarian cancer patients. Further details will be shared at an upcoming scientific conference in late 2024.
Full Article: Kazia Reports Successful Stage 1 Completion of EVT801 Phase 1 Clinical Trial
Smart Immune - Positive trial data, May 2, 2024
Smart Immune treated the first patient at the final dose level in its Phase I/II ReSET-02 trial, evaluating SMART101, a T cell therapy for adult acute leukemia post-transplant. The trial progresses well with promising safety profiles, and SMART101 has received Orphan Drug and Fast Track Designations from regulatory authorities.
Full Article: Smart Immune Treats Adult Acute Leukemia Patient at Final Dose Level in Phase I/II ReSET-02 Trial
Memgen - Positive trial data, May 2, 2024
Moffitt Cancer Center is leading a phase 1 trial's next phase, combining MEM-288 with Opdivo to treat NSCLC that progressed after standard therapy. Earlier findings showed MEM-288's potential in solid cancers without toxicities. The study aims to evaluate response rates, safety, and immune responses in eligible NSCLC patients.
Full Article: Oncolytic Virus to Be Studied in Advanced Lung Cancer
BridgeBio - Venture Capital Investment, May 2, 2024
BridgeBio Pharma has secured $200 million to fuel its cancer-focused offshoot, BridgeBio Oncology Therapeutics (BBOT), in advancing a pipeline led by a KRAS inhibitor through early-phase tests. BBOT, formerly TheRas, originated from a collaboration with Leidos Biomedical Research in 2017, licensing a KRAS G12C inhibitor and two other assets. With one asset in clinical trials and two nearing human testing, BBOT aims for significant clinical milestones in the next 18-24 months, starting with a phase 1 trial of its KRAS G12C inhibitor BBO-8520 in non-small cell lung cancer, alone or with Keytruda.
Full Article: BridgeBio Taps VCs for $200M, Fueling Oncology Offshoot's Push to Surpass KRAS Class
Novartis - Acquisition, May 2, 2024
Novartis has acquired Mariana Oncology for $1 billion, bolstering its radioligand therapy portfolio with potential milestone payments of up to $750 million. Mariana, known for its preclinical cancer pipeline led by MC-339, aims to target small cell lung cancer cells with a radioactive actinium payload while minimizing harm to healthy tissue. This acquisition enhances Novartis's radiopharmaceutical capabilities and aligns with its strategy to expand cancer treatment options.
Full Article: Novartis Buys Mariana Oncology in $1B Acquisition, Bolsters Radiopharma Assets
PDS Biotechnology - Executive Changes, May 2, 2024
PDS Biotech appointed Stephan Toutain as its new Chief Operating Officer, effective May 1, 2024. With over 30 years of experience in oncology and orphan drugs markets, Toutain has held key roles at companies like Anavex Life Sciences and Alnylam Pharmaceuticals. As part of his employment, he was granted a stock option to purchase 200,000 shares of PDS Biotech's common stock.
Full Article: PDS Biotechnology Appoints Stephan Toutain as COO
Targeted Oncology - Positive trial data, May 3, 2024
EG-70, a nonviral gene therapy, achieved a 73% complete response rate in patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), according to findings presented at the American Urological Association 2024 Annual Meeting. The phase 1/2 LEGEND study showed promising efficacy with manageable adverse events. EG-70 activates localized immune responses within the bladder to eliminate tumors effectively, with the phase 2 trial ongoing to assess its complete response rate at 12 months.
Full Article: EG-70 Elicits Promising Complete Responses in NMIBC
Amgen - Sales Growth, May 3, 2024
Amgen's oncology unit reported over $2 billion in global sales in Q1 2024, contributing to a 22% increase in overall revenue, surpassing Wall Street estimates. Key products like Blincyto, Vectibix, and Lumakras showed significant revenue growth. Amgen plans FDA submissions for Lumakras combination therapy and expects decisions on tarlatamab and Blincyto in June. The company is advancing studies of other therapies and revised its 2024 revenue guidance upwards.
Full Article: Amgen's Lumakras Reports Double-Digit Sales Growth in Q1
ImmuneSensor - Executive Changes, May 3, 2024
Thomas W. Dubensky Jr., Ph.D., is the new president and CEO of ImmuneSensor Therapeutics, a Dallas-based biopharma specializing in cGAS-STING pathway therapies for inflammation, autoimmunity, and oncology. Dr. Dubensky brings extensive experience in drug development, particularly in cancer immunotherapy and infectious diseases. His appointment aims to advance the company's proprietary pipeline, including ongoing clinical trials.
Full Article: ImmuneSensor Therapeutics Announces New President & CEO
Context Therapeutics - FDA clearance, May 4, 2024
Philadelphia-based Context Therapeutics has gained FDA clearance for its Investigational New Drug application for CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody. This enables the company to initiate a phase 1 clinical trial targeting CLDN6-positive gynecologic and testicular cancers, with the first patient expected to be dosed in mid-2024. CTIM-76, a selective CLDN6 x CD3 bispecific antibody, holds promise for treating various solid tumors, including ovarian, endometrial, testicular, and lung cancers.
Full Article: FDA Clears Context Therapeutics' CTIM-76 for Phase 1 Clinical Trial
