Monoclonal antibodies

Leap Therapeutics Presents TRX518 Data at ESMO Immuno-Oncology Congress 2018 and Updated Data from DKN-01 Study in Biliary Tract Cancer

Retrieved on: 
Friday, December 14, 2018
Cancer, Medicine, Antineoplastic drugs, Breakthrough therapy, Monoclonal antibodies, Bristol-Myers Squibb, Nivolumab, Pembrolizumab, Cholangiocarcinoma

Nearly all of these patients had received prior gemcitabine therapy, and nine (47%) remained on study for more than four cycles.

Key Points: 
  • Nearly all of these patients had received prior gemcitabine therapy, and nine (47%) remained on study for more than four cycles.
  • The combination arms evaluating TRX518 in combination with Keytruda or Opdivo enrolled fourteen patients in the dose escalation cohorts as of December 5, 2018.
  • Enrollment is now complete in the dose escalation cohort for TRX518 and Keytruda and continues in the high dose escalation cohort of TRX518 and Opdivo.
  • The open-label, Phase I/II study enrolled fifty-one patients with advanced biliary tract cancer (BTC).

Oxford BioTherapeutics Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Five Bispecific Antibody Programs for up to $450 Million

Retrieved on: 
Tuesday, December 11, 2018
Biotechnology, Immunology, Nature, Monoclonal antibodies, Biopharmaceutical, Pharmaceutical industry, Pharmacy, Cancer immunotherapy, Bispecific monoclonal antibody

"Our immuno-oncology (IO) collaboration with WuXi Biologics, around the WuXiBody bispecific platform and clinical mid-stage PD-L1 antibody, is a significant step for OBT to deepen and broaden our exciting first-in-class IO pipeline," said Dr. Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics.

Key Points: 
  • "Our immuno-oncology (IO) collaboration with WuXi Biologics, around the WuXiBody bispecific platform and clinical mid-stage PD-L1 antibody, is a significant step for OBT to deepen and broaden our exciting first-in-class IO pipeline," said Dr. Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics.
  • "We are excited to expand our strategic partnership with OBT to include the proprietary WuXiBody platform.
  • WuXi Biologics will continue to invest to develop next-generation globally leading technologies to transform biologics discovery, development and manufacturing."
  • WuXiBody, a proprietary bispecific antibody platform of WuXi Biologics, is potentially the Best-in-Class bispecific platform in the field.

Oxford BioTherapeutics Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Five Bispecific Antibody Programs for up to $450 Million

Retrieved on: 
Tuesday, December 11, 2018
Biotechnology, Immunology, Nature, Monoclonal antibodies, Biopharmaceutical, Pharmaceutical industry, Pharmacy, Cancer immunotherapy, Bispecific monoclonal antibody

"Our immuno-oncology (IO) collaboration with WuXi Biologics, around the WuXiBody bispecific platform and clinical mid-stage PD-L1 antibody, is a significant step for OBT to deepen and broaden our exciting first-in-class IO pipeline," said Dr. Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics.

Key Points: 
  • "Our immuno-oncology (IO) collaboration with WuXi Biologics, around the WuXiBody bispecific platform and clinical mid-stage PD-L1 antibody, is a significant step for OBT to deepen and broaden our exciting first-in-class IO pipeline," said Dr. Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics.
  • "We are excited to expand our strategic partnership with OBT to include the proprietary WuXiBody platform.
  • WuXi Biologics will continue to invest to develop next-generation globally leading technologies to transform biologics discovery, development and manufacturing."
  • WuXiBody, a proprietary bispecific antibody platform of WuXi Biologics, is potentially the Best-in-Class bispecific platform in the field.

Spherix Global Insights Reports Sun Dermatology's Ilumya Faces Challenges in A Crowded Psoriasis Market

Retrieved on: 
Wednesday, December 5, 2018
Monoclonal antibodies, Tildrakizumab, Food and Drug Administration, Health

In addition, nearly half of sampled dermatologists indicate that Tremfya's status as the first IL-23 to market is a significant advantage over subsequent approvals, including Ilumya.

Key Points: 
  • In addition, nearly half of sampled dermatologists indicate that Tremfya's status as the first IL-23 to market is a significant advantage over subsequent approvals, including Ilumya.
  • Being the second to market agent is challenging enough, but not supporting Ilumya with the right promotion could be crippling.
  • Ilumya was approved by the FDA at the end March of this year, yet was not made available to patients until recently.
  • Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets.

Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-OX40 Monoclonal Antibody IBI101

Retrieved on: 
Wednesday, December 5, 2018
Medicine, Biotechnology, Health, Immunology, Immune system, CD134, Monoclonal antibodies, Biopharmaceutical, Immune checkpoint, Biological therapy for inflammatory bowel disease

IBI101 is the third molecule from Innovent approved for clinical trials by FDA.

Key Points: 
  • IBI101 is the third molecule from Innovent approved for clinical trials by FDA.
  • Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval from FDA for an anti-OX40 monoclonal antibody.
  • The FDA IND approval of anti-OX40 monoclonal antibody once again demonstrates Innovent's research and development capability.
  • IBI101 is a recombinant fully human anti-OX40 (tumor necrosis factor receptor superfamily member 4) monoclonal antibody.

New DARZALEX® (daratumumab) Phase 3 Study Shows Efficacy and Safety Data of Anti-CD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma

Retrieved on: 
Tuesday, December 4, 2018
Medicine, Orphan drugs, Cancer, Health, Monoclonal antibodies, Cancer treatments, Antineoplastic drugs, RTT, Daratumumab, Lenalidomide, Multiple myeloma, Chemotherapy

The randomized, open-label, multicenter Phase 3 study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73).

Key Points: 
  • The randomized, open-label, multicenter Phase 3 study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73).
  • Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX.
  • Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA).
  • "Janssen Announces DARZALEX (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible."

Actinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting

Retrieved on: 
Tuesday, December 4, 2018
7+3, RTT, Antibody-drug conjugates, Acute myeloid leukemia, Monoclonal antibodies, Midostaurin

AML patients with active, relapsed or refractory AML have dismal prognoses and are typically not offered curative transplant as an option.

Key Points: 
  • AML patients with active, relapsed or refractory AML have dismal prognoses and are typically not offered curative transplant as an option.
  • However, with Iomab-B targeted conditioning, a complete remission prior to starting the Iomab-B conditioning is not necessary for a successful transplant.
  • Dr. Mark Berger, Actinium's Chief Medical Officer said, "We believe that Iomab-B represents a potentially disruptive modality for targeted conditioning.
  • Iomab-B, Actinium's lead targeted conditioning product candidate, is currently enrolling patients in the pivotal Phase 3 SIERRA trial in patients age 55 or older, with active, relapsed or refractory AML.

News Tips From NYU School Of Medicine And Perlmutter Cancer Center Researchers At The 60th American Society Of Hematology Meeting, Dec. 1-4, In San Diego, Calif.

Retrieved on: 
Monday, December 3, 2018
Cancer, Medicine, Bristol-Myers Squibb, RTT, Antineoplastic drugs, Monoclonal antibodies, Breakthrough therapy, Nivolumab, Ipilimumab, Checkpoint inhibitor, Lymphoma, Non-Hodgkin lymphoma

Subsequent therapy with so-called checkpoint-blockade inhibitors, such as ipilimumab (Yervoy) and nivolumab (Opdivo), were also not successful in controlling cancer spread.

Key Points: 
  • Subsequent therapy with so-called checkpoint-blockade inhibitors, such as ipilimumab (Yervoy) and nivolumab (Opdivo), were also not successful in controlling cancer spread.
  • However, in 59 patients with non-Hodgkin lymphoma, 30 responded to additional chemotherapy or other drug treatment after having received checkpoint inhibitors.
  • In 112 patients with Hodgkin lymphoma who received checkpoint blockade therapy, 81 needed some form of follow-up drug treatment.
  • The poster will be presented in Hall GH at the San Diego Convention Center at 9:15 pm EST.

Interim Data from the Ongoing HORIZON Trial with Melflufen Presented in an Oral Presentation at the 60th American Society of Hematology Meeting

Retrieved on: 
Monday, December 3, 2018
Medicine, Orphan drugs, Chemistry, Health, Monoclonal antibodies, Cancer treatments, Breakthrough therapy, Daratumumab, Bortezomib, Multiple myeloma, Melflufen

Melflufen (Ygalo), a peptide conjugated alkylator belonging to a novel class of peptidase-enhanced compounds, targets multiple myeloma (MM) cells with a unique mechanism of action.

Key Points: 
  • Melflufen (Ygalo), a peptide conjugated alkylator belonging to a novel class of peptidase-enhanced compounds, targets multiple myeloma (MM) cells with a unique mechanism of action.
  • ANCHOR is a phase I/II study where melflufen is administered in combination with either bortezomib or daratumumab in RRMM patients.
  • The first interim data from the study was presented in a poster presentation on December 1, 2018 at ASH.
  • Melflufen will potentially provide physicians with a new treatment option for patients suffering from this serious disease.

Interim Data from the Ongoing HORIZON Trial with Melflufen Presented in an Oral Presentation at the 60th American Society of Hematology Meeting

Retrieved on: 
Monday, December 3, 2018
Medicine, Orphan drugs, Chemistry, Health, Monoclonal antibodies, Cancer treatments, Breakthrough therapy, Daratumumab, Bortezomib, Multiple myeloma, Melflufen

Melflufen (Ygalo), a peptide conjugated alkylator belonging to a novel class of peptidase-enhanced compounds, targets multiple myeloma (MM) cells with a unique mechanism of action.

Key Points: 
  • Melflufen (Ygalo), a peptide conjugated alkylator belonging to a novel class of peptidase-enhanced compounds, targets multiple myeloma (MM) cells with a unique mechanism of action.
  • ANCHOR is a phase I/II study where melflufen is administered in combination with either bortezomib or daratumumab in RRMM patients.
  • The first interim data from the study was presented in a poster presentation on December 1, 2018 at ASH.
  • Melflufen will potentially provide physicians with a new treatment option for patients suffering from this serious disease.