Genentech

Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress

Retrieved on: 
Tuesday, November 14, 2023
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MANNHEIM, Germany, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the third quarter of 2023.

Key Points: 
  • MANNHEIM, Germany, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the third quarter of 2023.
  • Total revenue for the quarter ended September 30, 2023, was €2.0 million compared with €14.9 million for the quarter ended September 30, 2022.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on November 14, 2023, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2023 financial results and corporate developments.

Kronos Bio Reports Recent Business Progress and Third-Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Safety, SAN, D, Carcinoma, Sarcoma, Investment, PD, Cohort study, Patient, Research, Chordoma, Lung cancer, Conference, KRON, Ovarian cancer, Cancer, Mechanism of action, AACR, Genentech, Life insurance, Rare-earth element, Pharmaceutical industry

SAN MATEO, Calif., and CAMBRIDGE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and third-quarter 2023 financial results.

Key Points: 
  • $198.4 million in cash, cash equivalents and investments as of September 30, 2023
    SAN MATEO, Calif., and CAMBRIDGE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and third-quarter 2023 financial results.
  • “This quarter, we made great strides in advancing our clinical programs as well as our discovery projects and Genentech collaboration,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio.
  • Kronos Bio expects that these efforts, which include a 19% reduction in force, will extend its cash runway into 2026.
  • Net Loss: Net loss for the third quarter of 2023 was $31.4 million, or $0.54 per share, including non-cash stock-based compensation expense of $6.3 million.

Sosei Heptares Operational Highlights and Consolidated Results for the Third Quarter and First Nine Months of 2023

Retrieved on: 
Friday, November 10, 2023
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Tokyo, Japan and Cambridge, UK, 10 November 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the third quarter and nine months ended 30 September 2023.

Key Points: 
  • Tokyo, Japan and Cambridge, UK, 10 November 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the third quarter and nine months ended 30 September 2023.
  • Lean, go-to-market commercial model, well positioned to scale rapidly to generate significant value from Japan and APAC (ex-China) geographic expansion.
  • Note regarding the Idorsia transaction: the quarter ended 30 September 2023 (Q3 2023) is the first period in which the Group has consolidated the financial results of Idorsia’s former Japanese and South Korean businesses.
  • Revenue totalled JPY 5,474 million (US$39.6 million*), a decrease of JPY 3,167 million (US$27.9 million) vs. the prior corresponding period.

Aiolos Bio Strengthens and Expands Leadership Team with Key Appointments

Retrieved on: 
Tuesday, December 12, 2023
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, COPD, Atlas Venture, Entrepreneurship, DBV Technologies, Rockefeller University, Investment, PD, Respiratory system, Patient, Strategic planning, Element, Doctor of Philosophy, M&A, Galvani Bioelectronics, GSK, MedImmune, Caregiver, Atopic dermatitis, R, Publishing, Atlas, McKinsey & Company, Asthma, Pharmaceutical industry, Neuroscience, Aeolus, Genentech

“We are delighted to welcome René and Tapan as key members of our leadership team at this exciting time for the Company as we prepare to initiate a Phase 2 clinical trial for our lead drug candidate, AIO-001, in moderate-to-severe asthma patients,” said Khurem Farooq, Co-Founder and Chief Executive Officer of Aiolos Bio.

Key Points: 
  • “We are delighted to welcome René and Tapan as key members of our leadership team at this exciting time for the Company as we prepare to initiate a Phase 2 clinical trial for our lead drug candidate, AIO-001, in moderate-to-severe asthma patients,” said Khurem Farooq, Co-Founder and Chief Executive Officer of Aiolos Bio.
  • “I’m thrilled to be joining the talented team at Aiolos Bio,” said Dr. Van der Merwe.
  • We look forward to presenting and publishing data in 2024.” Dr. Van der Merwe will join Aiolos Bio effective January 2,2024.
  • He joins Aiolos Bio from Bain Capital Life Sciences where he led and managed investments across therapeutic areas.

New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Doxorubicin, Safety, Lenalidomide, Progression-free survival, Bone marrow, ASH, CRS, Disease, DLBCL, Prednisone, B-cell lymphoma, Rituximab, Patient, Roche, PFS, ROG, Follicular lymphoma, Phases of clinical research, Polatuzumab vedotin, Exposition, Vincristine, GemOx, Cyclophosphamide, Society, OS, Cytokine release syndrome, HIV disease progression rates, Lymphoma, Fine chemical, Pharmaceutical industry, Medical device, Mosunetuzumab, Genentech, Phase, Nature Medicine

Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Key Points: 
  • Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
  • After a median follow-up of 32 months, 55% of patients with a complete response (CR) were in remission at 24 months.
  • Data showed that 83.3% of patients achieved a complete metabolic response (95% CI: 62.6-95.3), and responses were ongoing at data cut-off.
  • The data support further investigation of this SC formulation of Lunsumio and highlight its potential as a tailored monotherapy or combination outpatient therapy for FL, including in community practices.

New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emicizumab-kxwh) for Babies With Severe hemophilia A

Retrieved on: 
Saturday, December 9, 2023
Research, Infectious Diseases, Baby, Maternity, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Safety, Haemophilia, Pediatrics, Pathology, ASH, University, Risk, World Federation of Hemophilia, HAVEN, Roche, World government, Death, ROG, Pharmacokinetics, Caregiver, Trauma, Phase, Intraparenchymal hemorrhage, Biomarker, Parent, Society, Vein, Life, Intracranial hemorrhage, Pharmaceutical industry, Birth control, Emicizumab, Genentech

Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.

Key Points: 
  • Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.
  • However, for many babies with hemophilia A, prophylaxis is not started until after the first year of life because of the high treatment burden.
  • Hemlibra, which is already approved and being used to treat babies with hemophilia A, provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • It is approved for the routine prophylaxis of people with hemophilia A in more than 115 countries worldwide.

Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Retrieved on: 
Friday, December 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ROG, Risk, Fulvestrant, Roche, PFS, Progression-free survival, Death, Phase, Fine chemical, Birth control, Genentech

The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p

Key Points: 
  • The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p
  • The discontinuation rate in the inavolisib treatment group was 6.8% compared to 0.6% for palbociclib and fulvestrant alone.
  • Inavolisib, an investigational oral therapy, is currently being investigated in three Phase III clinical studies in people with PIK3CA-mutated locally advanced or metastatic breast cancer (INAVO120, INAVO121, INAVO122).
  • PIK3CA mutations are found in approximately 40% of HR-positive breast cancers and can lead to mutated PI3Kα protein, which contributes to uncontrolled tumor growth, disease progression and resistance to endocrine-based treatment.

Genentech’s Kadcyla Is the First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment

Retrieved on: 
Friday, December 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ROG, Risk, Disease, Trastuzumab emtansine, Rated R, Recurrence, OS, Roche, EBC, Death, Pharmaceutical industry, Trastuzumab, Genentech

Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.

Key Points: 
  • Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.
  • “With these new data, Kadcyla is the first targeted therapy to demonstrate a significant survival benefit in people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment."
  • Approximately one in five people with breast cancer will be HER2-positive, a particularly aggressive form of the disease.
  • Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane.

Mission Bio Announces Over 20 Presentations Demonstrating the Utility of Tapestri Across AML, Multiple Myeloma, and Lymphoma at the 2023 ASH Annual Meeting

Retrieved on: 
Thursday, December 7, 2023
Science, Other Science, Research, Oncology, General Health, Health, Genetics, Clinical Trials, Harvard University, Multiple myeloma, Bone marrow, Identification, Landscape, DNA, MIT, ASH, Clonal hematopoiesis, University of Navarra, MFC, Patient, PCR, Mission, Cell, Medicine, Differentiation, MD Anderson Cancer Center, B cell, MRD, Merck, Blood, CNV, Flow cytometry, Exposition, MD, Survival, AML, Doctor of Philosophy, Society, Translational medicine, Genetic heterogeneity, Hospital, Genentech, Pharmaceutical industry, Vaccine, Hematology, Franses Tapestry Archive

The widespread adoption of Tapestri for hematological research and therapeutic development signifies the importance of single-cell multi-omic data and indicates a potential new gold standard in precision medicine.

Key Points: 
  • The widespread adoption of Tapestri for hematological research and therapeutic development signifies the importance of single-cell multi-omic data and indicates a potential new gold standard in precision medicine.
  • Detected MRD-positive patients, which were deemed negative by MFC and PCR,
    Differentiated between clonal hematopoiesis (CH) clones and leukemic clones.
  • Data from other blood cancer studies will be presented by leading researchers in over 24 presentations leveraging Mission Bio’s Tapestri Platform, showcasing its broad application in hematology.
  • For a complete list of ASH presentations using Tapestri, please visit our website .

Alzheon Promotes Glenn E. Pauly to Chief Commercial Officer and Strengthens Commercial Organization with New Executive Appointments to Lead Planned U.S. Commercial Launch of Oral ALZ-801/Valiltramiprosate in 2025

Retrieved on: 
Tuesday, December 5, 2023
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“Alzheon’s novel therapeutic approach has an opportunity to transform the standard of care and improve access to treatment for all Alzheimer’s patients.

Key Points: 
  • “Alzheon’s novel therapeutic approach has an opportunity to transform the standard of care and improve access to treatment for all Alzheimer’s patients.
  • He has more than 20 years of commercial launch, sales, market access, and leadership experience in the biopharmaceutical industry.
  • Previously, Mr. Greene held commercial and executive roles at Janssen, Otsuka, and Biogen, with over a dozen launches in CNS disorders and Alzheimer’s.
  • Having these strong leaders further enhances our ability to establish critical partnerships and patient advocacy programs to support a successful commercial launch in 2025.”