RECIST

Monopar Announces Encouraging Clinical Data from Ongoing Camsirubicin Phase 1b Trial

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Wednesday, November 16, 2022
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WILMETTE, Ill., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR),a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients.

Key Points: 
  • WILMETTE, Ill., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR),a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients.
  • The current Phase 1b study is designed to evaluate whether camsirubicin can be dosed even higher than previously achieved and continue for longer than doxorubicin.
  • The Phase 1b trial is an open label dose escalation design to determine the maximum tolerated dose of camsirubicin in advanced soft tissue sarcoma (ASTS) patients.
  • The Phase 1b clinical trial has enrolled 11 patients (8 female and 3 male) to-date ranging in age from 26 to 81 years (median = 49 years).

ImmunoMet Therapeutics Announces First Patient Dosed in a Phase 1b Trial of IM156 in Pancreatic Cancer

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Thursday, November 17, 2022
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ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-cancer and anti-fibrotic therapies, today announces that the first patient has been dosed in the single-arm Phase 1b trial of IM156 in combination with gemcitabine and nab-paclitaxel as frontline therapy in patients with advanced pancreatic cancer.

Key Points: 
  • ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-cancer and anti-fibrotic therapies, today announces that the first patient has been dosed in the single-arm Phase 1b trial of IM156 in combination with gemcitabine and nab-paclitaxel as frontline therapy in patients with advanced pancreatic cancer.
  • This clinical trial evaluates the potential of IM156 in combination with gemcitabine and nab-paclitaxel to address resistance and improve patient outcomes.
  • The trial includes a dose escalation phase followed by an expansion phase, treating a total of approximately 25 patients with advanced pancreatic cancer.
  • We are hopeful that this potentially best-in-class OxPhos inhibitor can improve outcomes for these patients, said Dean Welsch, CEO of ImmunoMet Therapeutics.

Scholar Rock Reports Third Quarter 2022 Financial Results and Highlights Business Progress

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Monday, November 14, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Medicare Part D, Clinical trial, Cancer, Security (finance), Growth, Society for Immunotherapy of Cancer, Spectrochimica Acta Part B, Immunotherapy, Silicon Valley Bank, R, Medical Affairs Bureau, FAQ, Social media, SMA, Research, DRAGON, Society, CMO, RECIST, Intellectual property, Executive, COVID-19, Rock, Silicon, SAPPHIRE, Ageing, Merck, File, Annual general meeting, Spinal muscular atrophy, Drug Quality and Security Act, Human, Gongshi, Acceleron Pharma, Neurology, WMS, Fibrosis, Risk, Neuromuscular Disorders, Degenerative disease, Net, Head, SITC, Patient, Pharmaceutical industry, Palladium, Part

I am excited to strengthen our experienced executive team with the addition of Scholar Rocks new CMO, Dr. Jing Marantz.

Key Points: 
  • I am excited to strengthen our experienced executive team with the addition of Scholar Rocks new CMO, Dr. Jing Marantz.
  • Revenue was $0 for the quarter ended September 30, 2022, compared to $5.5 million for the quarter ended September 30, 2021.
  • General and administrative expense was $10.5 million for the quarter ended September 30, 2022, compared to $11.3 million for the quarter ended September 30, 2021.
  • Scholar Rock is a registered trademark of Scholar Rock, Inc.

OncoSec presents encouraging early data with TAVO™-EP combined with nivolumab (Opdivo®) in neoadjuvant melanoma

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Tuesday, November 15, 2022
SAN, SEC, Hyponatremia, Society, Immunotherapy, Recurrence, PR, ORR, MD, RECIST, Neoadjuvant therapy, IVA, Patient, IL-12, Forward-looking statement, PMR, Risk, Nivolumab, Safety, Senior, Translation, TILS, Interim, Company, Chain reaction, Melanoma, IST, PD, Annual report, Death, Private Securities Litigation Reform Act, CD8, EP, CR, NASDAQ, H. Lee Moffitt Cancer Center & Research Institute, Electroporation, Toxicity, SITC, Immune system, SD, Tumor microenvironment, PD-L1, U.S. Securities and Exchange Commission, TIS, Compugen (Israeli company), Drug, Securities & Exchange Commission of Pakistan, Poster, Pharmaceutical industry

This IST is evaluating TAVO, OncoSec's proprietary interleukin 12 (IL-12) encoding plasmid delivered by intratumoral electroporation (TAVO-EP), in combination with intravenous nivolumab.

Key Points: 
  • This IST is evaluating TAVO, OncoSec's proprietary interleukin 12 (IL-12) encoding plasmid delivered by intratumoral electroporation (TAVO-EP), in combination with intravenous nivolumab.
  • The poster entitled, "Neoadjuvant Immunotherapy with intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with intravenous nivolumab in patients with operable locoregionally advanced melanoma", is available on OncoSec's website.
  • Following the neoadjuvant treatment period, surgery was performed and adjuvant nivolumab was continued for up to 1 year.
  • "We are encouraged with these early data in neoadjuvant melanoma because the expected pathological CR rate with single agent nivolumab in this treatment setting is around 30%.

Antengene Highlights Encouraging ATG-008 Efficacy Results From TORCH-2 Study in Combination with PD-1 Antibody in Relapsed/Metastatic Cervical Cancer

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Tuesday, November 15, 2022
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In the TORCH study, 2 of the 3 patients with PRs were previously treated with a PD-1/PD-L1 antibody.

Key Points: 
  • In the TORCH study, 2 of the 3 patients with PRs were previously treated with a PD-1/PD-L1 antibody.
  • The updated and detailed study results of the TORCH and TORCH-2 will be presented at international scientific conferences in 2023.
  • As of the Oct 21, 2022 efficacy evaluation, 21 cervical cancer patients had been dosed with the ATG-008/toripalimab combination including 9 patients (42.9%) who were PD-L1 positive.
  • Initial results of the TORCH-2 study were presented at the 2022 American Society of Clinical Oncology (ASCO 2022) Annual Meeting.

Sapience Therapeutics Announces Poster Presentation on ST101 Efficacy from Phase 2 Study in Recurrent Glioblastoma (GBM) at Society for Neuro-Oncology (SNO) Annual Meeting

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Monday, November 14, 2022
Glioma, Fast Track, AML, RECIST, Therapy, PK, European Commission, Forward-looking statement, Factor X, Safety, FDA, C/EBP, Glioblastoma, Cancer, Trial of the century, PD, Patient, Annual general meeting, GBM, SNO, HIV disease progression rates, Royal commission, Pakistan Society of Neuro-Oncology, Pharmaceutical industry, Fine chemical, Wisdom

ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients in an ongoing Phase 2 study.

Key Points: 
  • ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients in an ongoing Phase 2 study.
  • These data will be presented in the ST101 poster at the SNO meeting.
  • ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors.
  • The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion.

EQS-News: CureVac Presents Preliminary Data from Phase 1 Study Expansion of Oncology Candidate CV8102

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Friday, November 11, 2022
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TBINGEN, Germany/ Boston, USA November 11, 2022 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced data from the Phase 1 expansion study of CV8102, the companys non-coding RNA candidate in oncology.

Key Points: 
  • TBINGEN, Germany/ Boston, USA November 11, 2022 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced data from the Phase 1 expansion study of CV8102, the companys non-coding RNA candidate in oncology.
  • Preliminary results from the completed Phase 1 expansion study in patients with PD-1 refractory melanoma confirm a robust safety profile of CV8102 as a single agent and in combination with anti-PD-1 antibodies.
  • The data we collected in the heavily pretreated patients of our Phase 1 expansion study further confirm the safety and immuno-modulatory activity of CV8102, said Ulrike Gnad-Vogt, interim Chief Development Officer at CureVac.
  • The Phase 1, open-label, dose escalation and expansion study of CV8102 aims to assess safety, tolerability and efficacy of CV8102 as a single agent and in combination with licensed PD1-antibodies.

OncoSec Announces Positive Clinical Data of the KEYNOTE-695 Trial Assessing TAVO-EP in Combination with Pembrolizumab (Keytruda®) in Patients with Advanced Melanoma Refractory to anti-PD-1 Treatment

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Friday, November 11, 2022
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Three patients achieved a complete response (CR) and 16 patients had a partial response (PR).

Key Points: 
  • Three patients achieved a complete response (CR) and 16 patients had a partial response (PR).
  • The trial enrolled and collected safety data on 105 patients who had received at least 12 weeks of anti-PD-1 treatment and had confirmed disease progression.
  • Therefore, the KEYNOTE-695 data highlight the value of intratumoral IL-12 as treatment for patients with checkpoint inhibitor refractory melanoma.
  • Importantly, TAVO-EP in combination with pembrolizumab in this highly refractory patient population with no standard-of-care treatment options showed durable responses and good tolerability.

Intensity Therapeutics' INT230-6 Demonstrates Increased Survival as Either Monotherapy or in Combination with Pembrolizumab in Patients with Relapsed, Refractory, Metastatic Solid Tumor Cancers

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Friday, November 11, 2022
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WESTPORT, Conn., Nov. 11, 2022 /PRNewswire/ -- Intensity Therapeutics, Inc.  ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral therapies designed to kill tumors and increase immune system recognition of cancers, announced that data from its ongoing phase 1/2 clinical trial demonstrating the efficacy and tolerability of INT230-6, either as monotherapy or in combination with pembrolizumab in patients with relapsed, refractory and metastatic solid tumors, will be presented today at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting being held in Boston and virtually November 8-12, 2022.

Key Points: 
  • "The active drug agents of INT230-6 remain in the tumor following injection and cause some cancer cell death and tumor shrinkage, as suggested by this study.
  • This effect appears to have some positive impact on the tumor immune microenvironment with increasing levels of CD4+ and CD8+ T-cells.
  • While the analysis is exploratory, survival seems to be extended with increased dosing, relative to incoming tumor burden.
  • That said, using the tumor diffusive product, INT230-6, appears to be a new approach in metastatic and refractory disease alone and in combination with pembrolizumab."

Rain Therapeutics Reports Third Quarter 2022 Financial Results and Highlights Recent Progress

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Thursday, November 10, 2022
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We plan to initiate the MANTRA-4 trial next quarter and remain very excited about this second tumor agnostic basket strategy.

Key Points: 
  • We plan to initiate the MANTRA-4 trial next quarter and remain very excited about this second tumor agnostic basket strategy.
  • As of September 30, 2022, Rain had $90.7 million in cash, cash equivalents and short-term investments as compared to $140.2 million at December 31, 2021.
  • As of September 30, 2022, Rain had approximately 26.6 million shares of common stock outstanding.
  • The management of Rain Therapeutics will host a conference call and webcast for the investment community today, November 10, 2022 at 2:00 pm PT (5:00 pm ET).