Latest news with #SouthSanFrancisco
Fast Company
2 days ago
- Business
- Fast Company
23andMe's Anne Wojcicki moves to reopen auction with support from a Fortune 500 company
(Corrects paragraph 3 to say 23andMe filed for bankruptcy in March, not April) The founder of 23andMe, Anne Wojcick i, has asked a U.S. judge to reopen an auction for the genetic testing company, saying she has the support of a Fortune 500 company with a current market capitalization of more than $400 billion. Wojcicki did not name the Fortune 500 company in court filings. South San Francisco, California-based 23andMe filed for bankruptcy in March, seeking to sell its business at auction after a decline in consumer demand and a 2023 data breach that exposed sensitive genetic and personal information of millions of customers. Last month, Regeneron Pharmaceuticals agreed to buy the firm for $256 million, topping a $146 million bid from Wojcicki and TTAM Research Institute, which was founded by Wojcicki and describes itself as a California non-profit public benefit corporation. In a filing dated May 31, Wojcicki claimed that 23andMe's debtors had attempted to tilt the sales process away from TTAM and in favor of Regeneron. TTAM and Wojcicki said in the filing that 23andMe's financial and legal advisers unfairly capped their maximum bid at $250 million due to misplaced concerns about TTAM's 'financial wherewithal'. The plaintiffs said the auction was prematurely concluded before they had the opportunity to submit a bid that would have exceeded $280 million. The company's debtors said the auction results came after an extensive and careful consideration by a four-member special committee of independent directors, according to the filing. According to another filing, 23andMe is seeking court approval to let Wojcicki and Regeneron submit final proposals by June 12. 23andMe is also seeking a $10 million breakup fee for Regeneron if Wojcicki's bid is ultimately accepted. Regeneron said it does not comment on the ongoing proceeding and aims to close the acquisition as intended.
Reuters
3 days ago
- Business
- Reuters
23andMe founder aims to restart auction with major corporate backing
June 1 (Reuters) - The founder of 23andMe ( opens new tab, Anne Wojcicki, has asked a U.S. judge to reopen an auction for the genetic testing company, saying she has the support of a Fortune 500 company with a current market capitalization of more than $400 billion. Wojcicki did not name the Fortune 500 company in court filings. South San Francisco, California-based 23andMe filed for bankruptcy in April, seeking to sell its business at auction after a decline in consumer demand and a 2023 data breach that exposed sensitive genetic and personal information of millions of customers. Last month, Regeneron Pharmaceuticals (REGN.O), opens new tab agreed to buy the firm for $256 million, topping a $146 million bid from Wojcicki and TTAM Research Institute, which was founded by Wojcicki and describes itself as a California non-profit public benefit corporation. In a filing dated May 31, Wojcicki claimed that 23andMe's debtors had attempted to tilt the sales process away from TTAM and in favor of Regeneron. TTAM and Wojcicki said in the filing that 23andMe's financial and legal advisers unfairly capped their maximum bid at $250 million due to misplaced concerns about TTAM's "financial wherewithal". The plaintiffs said the auction was prematurely concluded before they had the opportunity to submit a bid that would have exceeded $280 million. The company's debtors said the auction results came after an extensive and careful consideration by a four-member special committee of independent directors, according to the filing. According to another filing, 23andMe is seeking court approval to let Wojcicki and Regeneron submit final proposals by June 12. 23andMe is also seeking a $10 million breakup fee for Regeneron if Wojcicki's bid is ultimately accepted. Lawyers for 23andMe's debtors, TTAM parties and Regeneron did not immediately respond to emails seeking comment.
Yahoo
3 days ago
- Business
- Yahoo
Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO
Data Highlights Transformative Promise of CAR T in Solid Tumors Phase 1 Trial with ALLO-316 Demonstrated Potential to Provide Meaningful Clinical Benefit in Patients with CD70 TPS ≥ 50% Advanced or Metastatic RCC A Single Dose of ALLO-316 Achieved a 31% Confirmed Response Rate Four of Five Confirmed Responders Remain in Response Including One Ongoing Remission Over 12 Months Robust Expansion, Persistence, and Tumor Infiltration of ALLO-316 Seen with Standard Lymphodepletion, Showcasing Dagger® Technology as a Next-Generation Allogeneic Platform Phase 1 Safety Profile was Manageable; Proactive Diagnostic and Management Strategies Proved Effective in Mitigating IEC-HS While Preserving Efficacy SOUTH SAN FRANCISCO, Calif., June 01, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma (RCC) during an oral presentation at the 2025 ASCO Annual Meeting. The Phase 1 TRAVERSE trial enrolled patients with advanced or metastatic renal cell RCC. Leveraging the proprietary Dagger® technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. The presentation focused on the Phase 1b expansion cohort from the Phase 1 TRAVERSE study in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million AlloCAR T™ cells. 'ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma,' said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. 'Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors.' 'Patients diagnosed with advanced or metastatic renal cell carcinoma often face a median survival in months after exhausting standard therapies,' said Samer A. Srour, MB ChB, MS, Associate Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and lead investigator of the TRAVERSE trial. 'These updated results from a larger cohort of patients with confirmed CD70 positive tumors provide compelling evidence that treatment with ALLO-316 can reduce tumor burden, control disease, and in some cases deliver durable responses. These findings underscore the clinical promise of an allogeneic CAR T to address the significant unmet needs in solid tumors and offer hope to patients who have exhausted other options.' In the Phase 1b expansion cohort, 22 patients whose tumors had progressed on multiple prior therapies were treated with lymphodepletion and 20 were treated with ALLO-316. All patients had tumors resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had ≥2+ prior TKI, and 41% had prior belzutifan. Sixteen of the ALLO-316 treated patients had a high CD70 Tumor Proportion Score (TPS >50%). The Phase 1b expansion cohort evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a standard FC lymphodepletion regimen (fludarabine (30 mg/m2/day) and cyclophosphamide (500 mg/m2/day) for 3 days). The median time from enrollment to the start of therapy was four days. A single dose of ALLO-316 stabilized or reversed disease progression in the majority of patients. In the 16 patients with CD70 TPS ≥50%, the trial demonstrated a Confirmed Overall Response Rate (ORR) of 31% with 44% achieving a minimum of 30% reduction in tumor burden. Of the five confirmed responders, four maintain ongoing responses, with one in sustained remission for over 12 months. The median duration of response (mDOR) has not yet been reached, indicating the potential for long-term disease control. CD70+ patients Phase 1b(N=20) ORR (confirmed CR or PR per RECIST v1.1), n/N (%) 5/20 (25) CD70 TPS ≥50%CD70 TPS <50% 5/16 (31)0/4 (0) RECIST v1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; TPS, tumor proportion score The safety profile of ALLO-316 was manageable and consistent with lymphodepletion and an active CAR T product. The most frequent Grade ≥3 events were hematologic and there were no treatment-related Grade 5 events. The most common all-grade adverse events were cytokine release syndrome (CRS) (68%; with no grade ≥3), neutropenia (68%), decreased white blood cell count (68%), anemia (59%), and thrombocytopenia (55%). Immune effector cell-associated neurotoxicity syndrome (ICANS) was 18% (with no grade ≥3) and no graft-versus-host disease (GvHD) occurred. Improved recognition of IEC-HS symptoms led to diagnosis in 36% of patients with 2 patients (9%) experiencing a short-term Grade 3 (one) or Grade 4 (one patient) event. Newly implemented diagnostic and management algorithms significantly mitigated IEC-HS, with no associated Grade 5 events. TEAEs ≥20% incidence in Phase 1b, n (%) Phase 1b (N=22a) All Grades Grade ≥3 Neutropenia 15 (68) 15 (68) White blood cell count decreased 15 (68) 15 (68) Anemia 13 (59) 9 (41) Thrombocytopenia 12 (55) 6 (27) Nausea 8 (36) 0 ALT increased 7 (32) 2 (9) Peripheral edema 7 (32) 0 Pyrexia 7 (32) 0 Arthralgia 6 (27) 0 AST increased 6 (27) 2 (9) Fatigue 5 (23) 0 Headache 5 (23) 0 AEs of Special Interest Any Grade Grade ≥3 CRS 15 (68) 0 Infection 10 (45) 8 (36) IEC-HS 8 (36) 2 (9)b ICANS 4 (18) 0 Graft-versus-host disease 0 0 IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis. a Includes 2 patients who received LD but did not receive ALLO-316 b One patient experienced G4 IEC-HS based on GI bleeding with subsequent improvement and 1 patient experienced G3 IEC-HS based on hypotension managed without pressors with subsequent improvement. About ALLO-316 (TRAVERSE)ALLO-316 is an AlloCAR T™ investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of 'off-the-shelf' CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit and follow @AllogeneTx on X and LinkedIn. Cautionary Note on Forward-Looking Statements for Allogene This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as 'develop,' 'potential,' 'expect,' 'can,' 'enable,' 'showing,' 'generate,' 'may,' 'could,' 'designed to,' 'promise,' 'hope,' 'ongoing,' 'indicating,' 'mitigate,' 'evaluate,' 'pioneer,' 'goal' or 'will,' including alternative forms thereof, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of ALLO-316 to treat patients with advanced or metastatic RCC or to provide meaningful clinical benefit in patients with advanced RCC; the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors and to generate deep and durable remissions; the potential that ALLO-316 can reduce tumor burden, control disease, and deliver durable responses; the design and potential benefits of our Dagger technology; whether the Dagger® technology will become the next-generation allogeneic platform; ALLO-316 and the Dagger technology's ability to enable robust CAR T cell expansion and persistence and tumor infiltration; the potential of ALLO-316 to address the unmet need in solid tumors or offer hope to patients who have exhausted other options; the transformative potential of our AlloCAR T™ in solid tumors; the potential advantages of the RMAT and Fast Track designation; and our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene's expectations and actual results, including, risks and uncertainties related to: the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; RMAT and Fast Track designations may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval and the designations can be revoked if the criteria for eligibility cease to be met; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene's filings with the Securities and Exchange Commission (SEC), including without limitation under the 'Risk Factors' heading in its Quarterly Report on Form 10-Q for the year ended March 31, 2025. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. AlloCAR T™ and Dagger® are trademarks of Allogene Therapeutics, Inc. Allogene's investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T™ program. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy in to access your portfolio
Yahoo
4 days ago
- Business
- Yahoo
New Data Show Genentech's Itovebi Significantly Extended Survival in a Certain Type of HR-positive Advanced Breast Cancer
– The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone – – The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis – – New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine – SOUTH SAN FRANCISCO, Calif., May 31, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive final results from the overall survival (OS) analysis of the Phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM). "For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed." "The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy," said Professor Nicholas Turner, lead study author and professor of molecular oncology at The Institute of Cancer Research, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. "These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life." The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone. The median OS was 34.0 months (95% CI: 28.4–44.8) for people in the Itovebi arm, compared with 27.0 months (95% CI: 22.8–38.7) in the palbociclib and fulvestrant arm (stratified hazard ratio [HR]=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]). The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months (stratified HR=0.42, 95% CI: 0.32-0.55) in the comparator arm. The Itovebi-based regimen also led to a statistically significant improvement in objective response rate (the percentage of patients whose signs of cancer completely disappear or their tumors shrink significantly after treatment) and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years (stratified HR=0.43; 95% CI: 0.30-0.60). No new safety signals were observed at the time of the final OS analysis, with a low discontinuation due to adverse events supporting good tolerability. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored Phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations. We are exploring additional studies in breast cancer and other tumor types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About the INAVO120 study The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate. Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations: in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with dual HER2 blockade versus dual HER2 blockade and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with CDK4/6i and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in endocrine-sensitive, PIK3CA-mutated HR-positive/HER2-negative breast cancer (INAVO123; NCT06790693). About hormone receptor (HR)-positive breast cancer HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options. The PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors. What is Itovebi? Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy. Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you. It is not known if Itovebi is safe and effective in children. Important Safety Information What are the possible side effects of Itovebi? Itovebi may cause serious side effects, including: High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including: difficulty breathing nausea and vomiting (lasting more than 2 hours) stomach pain excessive thirst dry mouth more frequent urination than usual or a higher amount of urine than normal blurred vision unusually increased appetite weight loss fruity-smelling breath flushed face and dry skin feeling unusually sleepy or tired confusion Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth: pain swelling redness ulcers Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea. Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects. The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include: decreased white blood cell counts, red blood cell counts, and platelet counts decreased blood levels of calcium, potassium, sodium, and magnesium increased creatinine blood levels tiredness increased blood levels of the liver enzyme alanine transaminase (ALT) nausea rash loss of appetite COVID-19 infection headache Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at (877) 436-3683. Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you: have a history of diabetes or high blood sugar have kidney problems are pregnant or plan to become pregnant. Itovebi can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi. You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi. Males with female partners who are able to become pregnant: You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit All trademarks used or mentioned in this release are protected by law. View source version on Contacts Media Contact:Nicole Burkart (650) 467-6800Advocacy Contact:Julie Burns (860) 881-6594Investor Contacts:Loren Kalm (650) 225-3217Bruno Eschli +41 61 687 5284 Sign in to access your portfolio
Yahoo
6 days ago
- Business
- Yahoo
Genentech's Fenebrutinib Maintains Near-Complete Suppression of Disease Activity and Disability Progression for up to Two Years in People With Relapsing Multiple Sclerosis
- Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment - - Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end - SOUTH SAN FRANCISCO, Calif., May 30, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. The latest results for this investigational Bruton's tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Phoenix, Arizona. "These data show that patients treated with fenebrutinib experienced an annualized relapse rate equal to one relapse every 17 years and no observed disability progression up to two years,'' said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "Fenebrutinib is potent, highly selective and the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis, and we look forward to seeing the first of those results later this year." Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks. During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualized relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS). MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected. In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualized rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12 week double-blind period to 0.34 by 96 weeks. The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks. The most common adverse events (AEs) in ≥5% of patients were COVID-19 (10%), urinary tract infection (10%), pharyngitis (6%) and respiratory tract infection (5%). Serious AEs occurred in two patients (2%). During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation. Three Phase III clinical trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies, which will characterize the effects of fenebrutinib on disease progression across the multiple sclerosis spectrum, are expected at the end of 2025. About fenebrutinib Fenebrutinib is an investigational oral, reversible and non-covalent Bruton's tyrosine kinase (BTK) inhibitor that blocks the function of BTK. BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Preclinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases. Fenebrutinib is a dual inhibitor of both B-cell and microglia activation. This dual inhibition may be able to reduce both multiple sclerosis disease activity and disability progression, thereby potentially addressing the key unmet medical need of disability progression in people living with multiple sclerosis. The fenebrutinib Phase III program includes two identical trials in relapsing multiple sclerosis (RMS) (FENhance 1 & 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against Ocrevus. To date, more than 2,700 patients and healthy volunteers have been treated with fenebrutinib in Phase I, II and III clinical programs across multiple diseases, including multiple sclerosis and other autoimmune disorders. About the FENopta study The FENopta study was a global Phase II, randomized, double-blind, placebo-controlled 12-week study to investigate the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 years with relapsing multiple sclerosis (RMS). The primary endpoint was the total number of new T1 gadolinium-enhancing (T1-Gd+) lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks. Secondary endpoints included the number of new or enlarging T2-weighted lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks, and the proportion of patients free from any new T1-Gd+ lesions and new or enlarging T2-weighted lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks. The goal of the FENopta study was to characterize the effect of fenebrutinib on MRI and soluble biomarkers of disease activity and progression, and it included an optional substudy to measure cerebrospinal fluid fenebrutinib levels and biomarkers of neuronal injury. Data from the 12-week study showed that fenebrutinib is central nervous system (CNS) penetrant (crosses the blood-brain barrier) and has the potential to impact mechanisms underlying chronic progressive disease biology in multiple sclerosis patients. Fenebrutinib significantly reduced new T1-Gd+ lesions and new/enlarging T2 lesions compared to placebo. The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib clinical trials and there were no new safety concerns identified. Patients who completed the FENopta study were given the option to take part in an open-label extension (OLE) study, in which all patients receive fenebrutinib up to 192 weeks. About multiple sclerosis Multiple sclerosis (MS) is a chronic disease that affects more than 2.9 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of acquired non-traumatic disability in younger adults. People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their symptoms aren't apparent or don't appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent progression as early as possible. Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus intravenous (IV) infusion, there had been no FDA-approved treatments for PPMS and Ocrevus IV and Ocrevus Zunovo are the only approved treatments for PPMS. About Genentech in neuroscience Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimer's disease, Huntington's disease, Parkinson's disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. About Genentech Access Solutions Access Solutions is part of Genentech's commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit for more information. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit Indications and Important Safety Information What are Ocrevus and Ocrevus Zunovo? Ocrevus and Ocrevus Zunovo are prescription medicines used to treat: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults It is not known if Ocrevus and Ocrevus Zunovo are safe and effective in children. Who should not receive Ocrevus or Ocrevus Zunovo? Do not receive Ocrevus or Ocrevus Zunovo if you: have an active hepatitis B virus (HBV) infection. have had a life-threatening administration reaction to ocrelizumab. have had a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of Ocrevus Zunovo. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or Ocrevus Zunovo or any of their ingredients in the past. What is the most important information I should know about Ocrevus and Ocrevus Zunovo? Ocrevus and Ocrevus Zunovo can cause serious side effects, including: Infusion reactions (Ocrevus): Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Injection reactions (Ocrevus Zunovo): Injection reactions are a common side effect of Ocrevus Zunovo, which can be serious and may require you to be hospitalized. You will be monitored for signs and symptoms of an injection reaction when you receive Ocrevus Zunovo. This will happen during all injections for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection. Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin trouble breathing nausea shortness of breath rash throat irritation or pain headache fatigue hives feeling faint swelling of the throat fast heartbeat tiredness fever dizziness coughing or wheezing redness on your face (flushing) Additionally, for Ocrevus Zunovo: injection site pain swelling redness These infusion and injection reactions can happen during or up to 24 hours after administration. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion or injection. Infection: Infections are a common side effect. Ocrevus and Ocrevus Zunovo increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus and Ocrevus Zunovo, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus or Ocrevus Zunovo. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus or Ocrevus Zunovo until your infection is gone. Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus or Ocrevus Zunovo. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus or Ocrevus Zunovo. Weakened immune system: Ocrevus or Ocrevus Zunovo taken before or after other medicines that weaken the immune system could increase your risk of getting infections. Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with: thinking eyesight strength balance weakness on 1 side of your body using your arms or legs Decreased immunoglobulins: Ocrevus and Ocrevus Zunovo may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels. Before receiving Ocrevus or Ocrevus Zunovo, tell your healthcare provider about all of your medical conditions, including if you: have or think you have an infection. See "What is the most important information I should know about Ocrevus and Ocrevus Zunovo?" have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection. have ever had hepatitis B or are a carrier of the hepatitis B virus. have a history of inflammatory bowel disease or colitis. have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required 'live' or 'live-attenuated' vaccines at least 4 weeks before you start treatment with Ocrevus or Ocrevus Zunovo. You should not receive 'live' or 'live-attenuated' vaccines while you are being treated with Ocrevus or Ocrevus Zunovo and until your healthcare provider tells you that your immune system is no longer weakened. When possible, you should receive any 'non-live' vaccines at least 2 weeks before you start treatment with Ocrevus or Ocrevus Zunovo. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus or Ocrevus Zunovo, talk to your healthcare provider. If you have a baby and you received Ocrevus or Ocrevus Zunovo during your pregnancy, it is important to tell your baby's healthcare provider about receiving Ocrevus or Ocrevus Zunovo so they can decide when your baby should be vaccinated. are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus and Ocrevus Zunovo will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and Ocrevus Zunovo and for 6 months after your last dose of Ocrevus or Ocrevus Zunovo. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving Ocrevus or Ocrevus Zunovo. are breastfeeding or plan to breastfeed. It is not known if Ocrevus and Ocrevus Zunovo pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus or Ocrevus Zunovo. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of Ocrevus and Ocrevus Zunovo? Ocrevus and Ocrevus Zunovo may cause serious side effects, including: Risk of cancers (malignancies) including breast cancer: Follow your healthcare provider's instructions about standard screening guidelines for breast cancer. Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as: Diarrhea (loose stools) or more frequent bowel movements than usual Stools that are black, tarry, sticky or have blood or mucus Severe stomach-area (abdomen) pain or tenderness The most common side effects of Ocrevus Zunovo include: Injection reactions Respiratory tract infections Skin infections These are not all the possible side effects of Ocrevus and Ocrevus Zunovo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555. For more information, go to or call 1-844-627-3887. Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide for Ocrevus. Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide for Ocrevus Zunovo. View source version on Contacts Media Contact:Michelle McCourt(650) 467-6800Advocacy Contact:Lily Rose Atherton(202) 713-0083Investor Contacts:Loren Kalm(650) 225-3217Bruno Eschli+4161 6875284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
