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Marker Therapeutics Announces Completion of New Manufacturing Facility to Support Clinical Development of MultiTAA-Specific T Cell Therapy Product Candidates

Wednesday, January 13, 2021 - 12:00pm

The Company has initiated the technology transfer process and expects the cGMP manufacturing facility to be fully operational in the first half of 2021.

Key Points: 
  • The Company has initiated the technology transfer process and expects the cGMP manufacturing facility to be fully operational in the first half of 2021.
  • "With the recent initiation of our Phase 2 study in post-transplant AML, this new facility will assist with the timely manufacture of MT-401.
  • The manufacturing of Marker's MultiTAA-specific T cell therapy for AML begins with collecting T cells from healthy donors.
  • As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Medivir presents MIV-818 data at ASCO Gastrointestinal Cancers Symposium

Tuesday, January 12, 2021 - 7:46am

The presentation will be given on January 15, 2021, at 2 pm CET during the Hepatobiliary Cancer session (presentation number 309).

Key Points: 
  • The presentation will be given on January 15, 2021, at 2 pm CET during the Hepatobiliary Cancer session (presentation number 309).
  • The inter-patient dose escalation phase Ib part is currently ongoing at a dose of 40 mg for 5 days in 21-day cycles.
  • Details of all presentations for the 2021 ASCO GI Symposium are available at the conference website: LINK
    MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects.
  • Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership.

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Thursday, January 7, 2021 - 11:10am

The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China.

Key Points: 
  • The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.
  • Rivipansel, a pan-selectin antagonist, is being explored for use in treatment of acute VOC in sickle cell disease.

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Thursday, January 7, 2021 - 12:10pm

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.

Key Points: 
  • Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.

Preliminary Results from NexImmune’s Phase 1/2 Trial of NEXI-001 in AML Presented at 62nd ASH Annual Meeting and Exposition

Monday, December 7, 2020 - 10:31pm

Biomarker data characterizing initial immunologic responses for the first three patients analyzed were also shared.

Key Points: 
  • Biomarker data characterizing initial immunologic responses for the first three patients analyzed were also shared.
  • Relapse after allo-HSCT is the leading cause of death in patients with AML and represents a significant challenge for treating physicians.
  • The initial Safety Evaluation Phase determines the safety and tolerability of a single infusion of NEXI-001 at escalating dose levels.
  • The modular design of the AIM platform enables rapid expansion across multiple therapeutic areas, with both cell therapy and injectable products.

Treadwell Announces Two Presentations at the 2020 ASH Annual Meeting Featuring Clinical Trial Updates on Lead Product Candidate, CFI-400945

Monday, December 7, 2020 - 9:01pm

The first presentation described the efficacy results from an investigator-initiated Phase 1 dose escalation study in AML/MDS.

Key Points: 
  • The first presentation described the efficacy results from an investigator-initiated Phase 1 dose escalation study in AML/MDS.
  • We are very encouraged by the promising preliminary Phase 1 study results which included single agent, durable remissions.
  • This compelling early data supports the continued investigation of CFI-400945 for the potential treatment of patients with acute myeloid leukemia (AML), said Principal Investigator, Karen W.L.
  • Yee, Leukemia Program, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.

ORYZON Presents New Robust Phase II Iadademstat Efficacy Data in AML at ASH-2020

Monday, December 7, 2020 - 1:00pm

The data were presented at the virtual 62nd Congress of the American Society of Hematology, ASH-2020, in an e-poster entitled, Robust Efficacy Signals in elderly AML Patients treated with Iadademstat in Combination with Azacitidine (ALICE Phase IIa Trial).

Key Points: 
  • The data were presented at the virtual 62nd Congress of the American Society of Hematology, ASH-2020, in an e-poster entitled, Robust Efficacy Signals in elderly AML Patients treated with Iadademstat in Combination with Azacitidine (ALICE Phase IIa Trial).
  • Another patient who was treated for only 20 weeks achieved CR and was transfusion independent for a total of 77 weeks.
  • A third patient, who had achieved CR and was also transfusion independent, died due to Covid-19 infection at week 48.
  • Dr. Carlos Buesa, Oryzons CEO, said: "These latest results from the Phase II ALICE trial are very impressive.

BerGenBio Presents Updated Clinical Data From Two Phase II Studies Of Bemcentinib in AML and MDS Patients At Ash 2020

Sunday, December 6, 2020 - 7:23pm

The data indicates that treatment with the bemcentinib-LDAC combination shows promising efficacy in relapsed patients who are unfit for intensive chemotherapy.

Key Points: 
  • The data indicates that treatment with the bemcentinib-LDAC combination shows promising efficacy in relapsed patients who are unfit for intensive chemotherapy.
  • Richard Godfrey, Chief Executive Officer of BerGenBio, said: "We are pleased to continue sharing updates from our phase II clinical studies assessing bemcentinib with the scientific and medical community.
  • MDS is associated with increased risk of developing AML and immune dysfunctions are seen in patients both with lower and higher-risk MDS.
  • Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme.

BerGenBio Presents Updated Clinical Data From Two Phase II Studies Of Bemcentinib in AML and MDS Patients At Ash 2020

Sunday, December 6, 2020 - 7:22pm

The data indicates that treatment with the bemcentinib-LDAC combination shows promising efficacy in relapsed patients who are unfit for intensive chemotherapy.

Key Points: 
  • The data indicates that treatment with the bemcentinib-LDAC combination shows promising efficacy in relapsed patients who are unfit for intensive chemotherapy.
  • Richard Godfrey, Chief Executive Officer of BerGenBio, said: "We are pleased to continue sharing updates from our phase II clinical studies assessing bemcentinib with the scientific and medical community.
  • MDS is associated with increased risk of developing AML and immune dysfunctions are seen in patients both with lower and higher-risk MDS.
  • Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme.

MacroGenics Presents Flotetuzumab Data in Patients with Refractory Acute Myeloid Leukemia at the 2020 ASH Annual Meeting

Sunday, December 6, 2020 - 6:00pm

Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT.

Key Points: 
  • Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT.
  • More detailed flotetuzumab clinical data in the TP53MUT AML population is available via a separate poster presentation at ASH (see TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in Acute Myeloid Leukemia, Session 617).
  • The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), which occurred in all patients.
  • In addition to the above data provided in an oral presentation, five additional presentations related to flotetuzumab and AML have or will be presented at ASH.