Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Shots:

  • Atara to receive $60M upfront and ~$610M as development, regulatory & commercialization milestones + tiered royalties on net sales. The collaboration focuses on off-the-shelf T-cell immunotherapy ATA3271 and ATA2271
  • Atara will lead to IND and process development for ATA3271 and will continue to be responsible for P-I study of ATA2271 while Bayer will be responsible for submitting the IND and subsequent clinical development and commercialization
  • Atara will also provide translational & clinical manufacturing services to be reimbursed by Bayer. In addition, for a limited period, Bayer has a non-exclusive right to negotiate a license for additional Atara CAR T product candidates

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Express Pharma

The post Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors first appeared on PharmaShots.

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Shots:

  • TScan signs exclusive research and option to license agreement with Qiagen to develop T cell-based laboratory tests for detecting prior exposure to the SARS-CoV-2
  • Qiagen gets an option to license the rights and IP for several of TScan discovered immunodominant T cell targets, associated sequences and relevant data for the development and commercialization of IVD tests. In advance of exercising its option, Qiagen has the right to evaluate TScan’s discoveries
  • The targeted immunodominant were identified through the T-Scan TCR/Target discovery platform enabling the mapping of the specific epitopes in SARS-CoV-2

Click here­ to­ read full press release/ article | Ref: Businesswire | Image: TrialSite News

The post Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test first appeared on PharmaShots.

BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

Shots:

  • Dragonfly to receive $475M as up front and is eligible to receive development, regulatory and commercial milestones in addition to 24% royalties on global sales of the therapy. BMS to get exclusive WW license to Dragonfly’s IL-12 investigational immunotherapy program, including its extended half-life cytokine DF6002
  • BMS will be responsible for the development & commercialization of DF6002 and its related products, including strategic decisions, regulatory responsibilities, funding, and manufacturing
  • DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein, currently being evaluated in P-I/II study for patients with advanced solid tumors, which began in Jul’2020. Additionally, BMS plans to advance the research and development of DF6002 in oncology and hematology

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Pharmashots

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




Insights+ Exclusive: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. PharmaShots has compiled a list of 8 new drugs approved by the US FDA in Jun 2020.

1. Viela’s Uplizna (inebilizumab-cdon) Received the US FDA’s Approval to Treat Neuromyelitis Optica Spectrum Disorder (NMOSD)

Published: Jun 11, 2020 | Tags:  Viela, Uplizna, inebilizumab-cdon, Received, the US FDA, Approval, Treat, Neuromyelitis Optica Spectrum Disorder, NMOSD

  • The approval was based on N-MOmentum trial which involved assessing of Uplizna (300mg) vs placebo in 213 patients in the ratio (3:1) at day 1 to day 15 who are anti-AQP4 antibody-positive/negative   
  • The study resulted in anti-AQP4 antibody-positive group remained relapse-free (89% vs 58%) including reductions in NMOSD-related hospitalizations with safety and tolerability profile
  • Uplizna (inebilizumab-cdon) is a humanized CD19-directed mAb and is a novel B cell depleter approved for the treatment of NMOSD in adults who are anti-aquaporin-4 (AQP4) antibody positive

2. ViiV Healthcare’s Tivicay PD (dolutegravir) Received the US FDA’s Approval for Children Living with HIV

Published: Jun 12, 2020 | Tags: ViiV Healthcare, Tivicay PD, dolutegravir, Receives, the US FDA, Approval, Children, Living, HIV

  • The approval is based on ongoing P1093 (NCT03016533) and ODYSSEY (PENTA20, NCT02259127) studies in pediatric patients aged 4 weeks to 18 years, while the second study involves 2L pediatric patients aged four weeks to 18 years
  • The P1093 study was conducted by IMPAACT network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania and ODYSSEY by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa
  • Tivicay and Tivicay PD are a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used in combination with antiretroviral agents to treat HIV-1 infection in adults and in pediatric patients aged at least 4 weeks and weighing at least 3 kg

3. Pharma Mar’s Zepzelca (lurbinectedin) Received the US FDA’s Accelerated Approval for Adult Patients with Metastatic Small Cell Lung Cancer (SCLC)

Published: Jun 15, 2020 | Tags: Pharma Mar, Zepzelca, lurbinectedin, Received, the US FDA, Accelerated Approval, Adult, Patients, Metastatic Small Cell Lung Cancer, SCLC

  • The approval was based on P-II trial assessing Zepzelca in 105 adults Ultragenyx with SCLC at 26 hospitals in the US and EU
  • The study resulted in ORR was 35%, median response duration 5.3 mos., as per investigator assessment using RECIST 1.1 and as per independent review committee, ORR was 30%, median response duration 5.1 months. Project Orbis conducted the review which is an initiative of the FDA Oncology Center of Excellence
  • Zepzelca is an alkylating agent that binds to DNA and interferes with transcription factors and controls cancer cell growth. The product has also received the US FDA’s ODD for SCLC and priority review to this application

4. Ultragenyx’s Dojolvi (UX007/triheptanoin) Received the US FDA’s Approval to Treat Long-Chain Fatty Acid Oxidation Disorders

Published: Jun 15, 2020 | Tags: Ultragenyx, Dojolvi, UX007/triheptanoin, Receives, US FDA, Approval, Treat, Long-Chain, Fatty Acid, Oxidation Disorders

  • The FDA approved Dojolvi as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)
  • The company expects its availability in the next 30 days while for its access the Ultragenyx’s UltraCare program will help patients and caregivers to understand insurance coverage and assist them in finding financial support for Ultragenyx medicines
  • Ultragenyx is a highly purified, pharmaceutical-grade, odd-carbon medium-chain triglyceride consisting of three 7-carbon fatty acids on a glycerol backbone created via a multi-step chemical process

5. Eli Lilly’s Lyumjev (insulin lispro-aabc injection) Received the US FDA’s Approval for Type 1 and Type 2 Diabetes

Published: Jun 15, 2020 | Tags: Eli Lilly, Lyumjev, insulin lispro-aabc injection, Receives, US, FDA, Approval, Type 1, Type 2, Diabetes

  • The approval is based on P-III PRONTO-T1D and PRONTO-T2D studies assessing Lyumjev (insulin lispro-aabc injection, 100 units/mL) and Humalog (insulin lispro injection, 100 units/mL), both in combination with either insulin glargine or insulin degludec in adults with T1D and T2D, respectively
  • Both the studies resulted in meeting its 1EPs of non-inferior A1C reduction @26wks., when both the therapies dosed at mealtime, Lyumjev demonstrated a superior reduction in blood glucose spikes at both 1hr. & 2hrs. after a test meal, safety & tolerability profile is similar for both
  • Lyumjev is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the bloodstream and reduce A1C levels and is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of the excipients in Lyumjev

6. Evoke’s Gimoti (metoclopramide) Received the US FDA’s Approval to Relief Symptoms in Adults with Acute and Recurrent Diabetic Gastroparesis

Published: Jun 19, 2020 | Tags: Evoke, Gimoti, metoclopramide, Receives, the US FDA, Approval, Relief Symptoms, Adults, Acute, Recurrent Diabetic Gastroparesis

  • The US FDA’s approval allows Evoke to access its existing $5M line of credit from Eversana for manufacturing and commercialization of Gimoti
  • The approval will serve as a novel treatment for gastroparesis with expected commercialization in Q4’20
  • Gimoti nasal spray is the novel nasally administered product while Eversana will be responsible for its launch

7. Zogenix’s Fintepla (fenfluramine) Received the US FDA’s Approval for the Treatment of Seizures Associated with Dravet Syndrome

Published: Jun 26, 2020 | Tags: Zogenix, Fintepla, fenfluramine, Received, US, FDA, Approval, Treatment, Seizures, Associated, Dravet Syndrome

  • The US FDA’s approval was based on two P-III studies assessing Fintepla vs PBO in patients aged ≥2yrs. with Dravet syndrome and a safety data from an OLE trial in which many patients received Fintepla for up to 3yrs.
  • In addition to the existing treatment regimens, the therapy demonstrated a reduction in the frequency of monthly convulsive seizure in patients whose seizures were not controlled on one or more antiepileptic drugs
  • The company will launch the therapy through restricted distribution program, called the Fintepla REMS Program, and is expected to be available through Zogenix’s specialty pharmacy partner by July’20

8. Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin) Received the US FDA’s Approval for Early and Metastatic HER2-Positive Breast Cancer

Published: Jun 30, 2020 | Tags: Roche, Phesgo, fixed-dose combination, Perjeta, Herceptin, Received, US, FDA, Approval, Early, Metastatic, Her2-Positive Breast Cancer 

  • The approval was based on P-III FeDeriCa study which involved assessing of Phesgo (SC) + CT vs Perjeta (pertuzumab, IV) & Herceptin (trastuzumab, IV) + CT in 500 patients with HER2+ve early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings evaluated PK, efficacy, and safety
  • The study met its 1EPs showing non-inferior levels of Phesgo (SC) vs Perjeta (IV) in the blood plus no cardiac toxicity was demonstrated also the safety profile was comparable including no new safety signals. Additionally, in the P-II PHranceSCa study, 85% (136/160) patients preferred SC vs IV administration involving less time in the clinic with more comfort
  • Phesgo is an (FD, SC) formulation which involves a combination of pertuzumab + trastuzumab developed using Halozyme Therapeutics’ Enhanze drug delivery technology and administered within 8 mins for initial dosing and 5 mins for maintenance dosing

Related Post : Insights+ Exclusive: The US FDA New Drug Approvals in May 2020