RECIST

HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer

Retrieved on: 
Tuesday, August 29, 2023
Adenocarcinoma, Independent Review Committee, AE, RECIST, Breakthrough therapy, PFS, Incidence, HKEX, Patient, GEJ, National Medical Products Administration, MET, Stomach, Safety, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.
  • The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer or GEJ adenocarcinoma patients with MET amplification.
  • Primary endpoint is objective response rate (“ORR”) evaluated by the Independent Review Committee (“IRC”) (RECIST 1.1).
  • Secondary endpoints include progression free survival (PFS) and incidence of various adverse events (AE), among others.

QSAM Biosciences Provides Update to Shareholders on Phase 1 Progress and Preliminary Clinical Data

Retrieved on: 
Wednesday, August 16, 2023
CT, Radiation, Bone, Neoplasm, PSMA, PSMA5, Bone metastasis, Survival, RECIST, Cancer, OTCQB, Spine, Breast, Prostate, Radiopharmaceutical, Lung, Incidence, Patient, Physician, Prostate cancer, Diagnosis, QSAM, Lung cancer, FDA, Letter, Ecosystem, Environment, Social media, Safety, Breast cancer, Medical imaging, Pharmaceutical industry, Female, SUV, Q4

In patients one and three, we saw no progression of tumor size at the four month follow-up.

Key Points: 
  • In patients one and three, we saw no progression of tumor size at the four month follow-up.
  • We must remind our shareholders, however, that these results are very early and are not necessarily indicative of future results in our trials.
  • Further, this summary is not a formal read-out of data, but rather, a preliminary analysis of our Cohort 1 findings.
  • Ultimately, however, our primary mission is to help the hundreds of thousands of adults and children each year suffering from bone cancer.

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

Retrieved on: 
Tuesday, August 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.

Black Diamond Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

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Friday, August 11, 2023
Diamond, FGFR, MAP, Myenteric plexus, DNA, AACR, Central nervous system, PRS, GBM, Diarrhea, RECIST, Clinical trial, Cancer, MAPK, Black Diamond, BRAF, Mutation, TKI, G&A, Toxicity, Appetite, Lung cancer, Paronychia, CNS, Rash, Glioblastoma, II, M26 Modular Accessory Shotgun System, Development, State Administrative Expenses, RAS, Patient, Investment, EGFR, Stomatitis, Administration, Drug discovery, Nausea, Neoplasm, Poster, R, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, ORR, Food, Safety, Fatigue, RAF, Medical imaging, Pharmaceutical industry, Security (finance), Life insurance, NSCLC

and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
  • Black Diamond initiated a Phase 1 clinical trial for BDTX-4933 in select indications for patients harboring all-class BRAF or RAS mutations in the second quarter of 2023.
  • Net cash used in operations was $14.4 million for the second quarter of 2023 compared to $18.1 million for the second quarter of 2022.
  • Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents and investments.

SQZ Biotechnologies Reports Second Quarter 2023 Financial Results and Recent Portfolio Updates

Retrieved on: 
Thursday, August 10, 2023
Oncology, Health, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, Senior management, CR, OTC, Interim, RECIST, Research, Incident management team, Partnership, SQZ, Pharmaceutical industry, Cryptocurrency, Rare-earth element

SQZ Biotechnologies Company (OTC: SQZB), focused on unlocking the full potential of cell therapies, today reported second quarter 2023 financial results and recent portfolio updates.

Key Points: 
  • SQZ Biotechnologies Company (OTC: SQZB), focused on unlocking the full potential of cell therapies, today reported second quarter 2023 financial results and recent portfolio updates.
  • “We made steady progress in the enrollment of our two clinical trials and anticipate monotherapy data readouts for each program later this year,” said Howard Bernstein, M.D., Ph.D., Interim Chief Executive Officer and Member of the Board of Directors.
  • “We recently announced our intent to explore the Company’s potential financing options and strategic alternatives.
  • The Management Team and the Board are committed to exploring all potential paths that could advance our programs and our technology.”
    A confirmed complete response (CR), by RECIST 1.1 criteria, was observed in the first patient in the lowest-dose cohort of the SQZ-AAC-HPV-101 Phase 1 clinical trial for HPV16+ solid tumors
    Programs for Partnership and Collaboration:
    The Company is actively seeking potential partnerships, collaborations or strategic alternatives to advance its oncology programs and platforms
    Revenue for the quarter ended June 30, 2023, was $0.2 compared to $3.0 million for the same period in 2022
    Research and development expenses for the quarter ended June 30, 2023, were $12.7 million compared to $18.8 million for the same period in 2022
    General and administrative expenses for the quarter ended June 30, 2023, were $4.6 million compared to $7.0 million for the same period in 2022
    Net loss for the quarter ended June 30, 2023, was $16.8 million, compared to $22.2 million for the same period in 2022

Shattuck Labs Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, August 10, 2023
Mirvetuximab soravtansine, CD47, Completeness, TP53, Macrophage, Neoplasm, American Society of Clinical Oncology, Clinical trial, RECIST, Cancer, Pharmacokinetics, ASCO, AML, Azacitidine, Patient, CD40, Autoimmune disease, Society, Safety, Pharmaceutical industry, PROC

AUSTIN, TX and DURHAM, NC, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended June 30, 2023, and provided recent business highlights.

Key Points: 
  • Initial data from the ongoing Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected in the fourth quarter of 2023.
  • Complete dose-escalation data, as monotherapy and in combination with azacitidine, for Phase 1A clinical trial of SL-172154 in primarily relapsed/refractory AML and HR-MDS expected in the fourth quarter of 2023.
  • We expect to complete enrollment for the two expansion cohorts in the fourth quarter of 2023.
  • Subsequently, in the second quarter of 2023, we performed an additional toxicology study in non-human primates that was designed to expand upon the initial non-human primate study.

Molecular Templates, Inc. Reports Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, August 10, 2023
Intellectual property, PR, Therapy, PD, Symantec Endpoint Protection, Bank statement, Neoplasm, Immunomodulatory imide drug, Food, Aes, Food and Drug Administration, RECIST, MHC, Cancer, Bristol Myers Squibb, NSCLC, Immunoglobulin A, Bone disease, Sale, Monocyte, CD8, HIV disease progression rates, MDSC, PD-L1, Patient, CMV, TME, Biology, BMS, Private placement, FDA, ETB, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Partial-response maximum-likelihood, WalletHub, BCMA, Safety, Conference, Pharmaceutical industry, Nursing, Medical imaging, Security (finance), Vaccine, Medical device, Palladium

Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.

Key Points: 
  • Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.
  • Revenues for the second quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol Myers Squibb and grant revenue from CPRIT.
  • Total research and development expenses for the second quarter of 2023 were $13.4 million, compared with $21.4 million for the same period in 2022.
  • Total general and administrative expenses for the second quarter of 2023 were $5.2 million, compared with $6.6 million for the same period in 2022.

Monopar Therapeutics Reports Second Quarter 2023 Financial Results and Recent Developments

Retrieved on: 
Thursday, August 10, 2023
National University of Singapore, National university, VOICE, LVEF, Receptor (biochemistry), RECIST, Cancer, Clinical trial, PET, G&A, Cardiotoxicity, Patient, Investment, ASTS, Doxorubicin, FIH, NUS, Pharmaceutical industry, Medical imaging, Extrusion, Cryptocurrency, Validation (drug manufacture)

WILMETTE, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-­stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced second quarter 2023 financial results and summarized recent developments.

Key Points: 
  • WILMETTE, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-­stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced second quarter 2023 financial results and summarized recent developments.
  • Results for the Second Quarter Ended June 30, 2023 Compared to the Second Quarter Ended June 30, 2022
    Cash, cash equivalents and short­-term investments as of June 30, 2023 were $10.2 million.
  • Net loss for the second quarter of 2023 was $2.2 million or $0.16 per share compared to net loss of $2.8 million or $0.22 per share for the second quarter of 2022.
  • G&A expenses for the three months ended June 30, 2023 were $733,000, compared to $685,000 for the three months ended June 30, 2022.

Repare Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Clinical Ovarian Cancer & Other Gynecologic Malignancies, IST, Neoplasm, RECIST, Rash, MRR, Patient, ATR, PPP2R1A, Diarrhea, Clinical trial, Princess Margaret Cancer Centre, ADP, FOLFIRI, Platinum, Toxicity, Carboplatin, Vomiting, Ono, CCNE1, IND, Safety, Net, DNA, AACR, CBR, American Association for Cancer Research, DNA repair, Anemia, FBXW7, Research, Therapy, PARP, ORR, Partnership, Nature Medicine, Progression-free survival, Paclitaxel, Fast Track, Bristol Myers Squibb, Endometrial cancer, BID, PKMYT1, Nausea, BMS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FTD, Food, Aplastic anemia, Pharmaceutical industry, Medical imaging, Vaccine, Reinsurance, G&A, Reparenting

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023.
  • In April 2023, we received a payment of $4 million from Roche for additional revisions to the clinical development plan under the Roche Agreement.
  • The article, entitled “Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results” can be accessed here .
  • Second Quarter 2023 Financial Results:
    Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of June 30, 2023 were $280.7 million, which Repare believes will be sufficient to fund its planned operations into 2026.

Harpoon Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, August 9, 2023
Amgen, Business development, Epithelial cell adhesion molecule, CRS, BeiGene, ESMO, RECIST, Business, G&A, Oncology, Completeness, European Society for Medical Oncology, Harpoon, SCLC, DLL3, Cove, AbbVie, Patient, IMS, Toxic epidermal necrolysis, Research, R, Therapy, BCMA, Pharmaceutical industry, Mineral wool, Nursing, Rare-earth element, Cryptocurrency

SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) --  Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • Revenue for the second quarter ended June 30, 2023 was $20.2 million, compared to $8.3 million for the second quarter ended June 30, 2022.
  • Research and development (R&D) expense for the second quarter ended June 30, 2023 was $12.2 million, compared to $20.7 million for the second quarter ended June 30, 2022.
  • General and administrative (G&A) expense for the second quarter ended June 30, 2023 was $3.8 million, compared to $5.1 million for the second quarter ended June 30, 2022.
  • Net income attributable to common stockholders for the second quarter ended June 30, 2023 was $1.1 million compared to a net loss attributable to common stockholders of $17.4 million for the second quarter ended June 30, 2022.