Biotech

Adds Phase 1 Isoform-Selective TGF-beta Inhibitor AVID200 to Expansive Pipeline

Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its transaction to acquire Forbius for their TGF-beta program, including its lead investigational asset AVID200, currently in Phase 1 for oncology and fibrosis.

"We are pleased to complete the transaction with Forbius and add their TGF-beta program to our growing pipeline of innovative assets," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President and President, Research & Early Development, Bristol Myers Squibb. "We look forward to progressing the program through our exceptional research and development capabilities with the goal of helping more patients."

Pursuant to the terms of the transaction, Forbius' non-TGF-beta assets were transferred to a newly formed private company which is being retained by Forbius' existing shareholders.

Davis Polk & Wardwell LLP and Osler, Hoskin & Harcourt LLP served as legal advisors to Bristol Myers Squibb.

About selective inhibition of TGF-beta

TGF-beta isoforms 1 & 3 are believed to be central mediators of tumor microenvironment (TME). Selective inhibition of TGF-beta 1 & 3 is proposed to enhance anti-tumor efficacy by acting synergistically with immunotherapy and has broad potential as an anti-fibrotic therapy across several indications with high unmet need.

About AVID200

AVID200 is a highly potent and isoform-selective TGF-beta inhibitor. AVID200 neutralizes TGF-beta 1 and -beta 3 with picomolar potency. These isoforms are known to be drivers of fibrosis and tumor immune resistance. In contrast, TGF-beta 2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-beta 2 is therefore undesirable. The ability of AVID200 to selectively target TGF-beta 1 and -beta 3 positions it to be an effective and well-tolerated therapeutic in fibrotic diseases and immuno-oncology.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook , and Instagram .

Forward-Looking Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the transaction. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, any delay or inability of Bristol Myers Squibb to realize the expected benefits of the transaction. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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RINVOQ® Approved by European Commission as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis

  • With this approval, RINVOQ ® (upadacitinib 15 mg, once daily) is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in the European Union (EU) 1
  • Approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered meaningful disease control with nearly half of nr-axSpA patients achieving ASAS40 at week 14 (45 percent versus 23 percent; p 2

ABBVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) andor magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). *1

"For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine," said Thomas Hudson , M.D., senior vice president of research and development, chief scientific officer, AbbVie. "AbbVie is proud to offer RINVOQ as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs. RINVOQ is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis."

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Biktarvy® Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection

ALLIANCE Trial Highlights Potential of Biktarvy for Adults with HIV and HBV Coinfection –

– No Cases of Treatment Failure Due to Resistance to Biktarvy was Detected in a Pooled Analysis of Five-Year Data from Two Phase 3 Studies –

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AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib in Crohn's Disease

  • Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment 1-4
  • Safety results were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed 1-8
  • Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain 9,10

ABBVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ ® 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active Crohn's disease. 4,11

"Crohn's disease can be debilitating and have a significant impact on a person's daily life," said Neil Gallagher , M.D., Ph.D., vice president, development, chief medical officer, AbbVie. "Those patients who are still suffering fuel our continued commitment to innovation in care for patients with IBD, and we look forward to potentially introducing a new treatment option for this disruptive condition."

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Aptose to Present at the Canaccord Genuity 42nd Annual Growth Conference

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that Dr. William G. Rice, Chairman, President and CEO of Aptose, and Mr. Fletcher Payne, CFO of Aptose, will attend the Canaccord Genuity 42nd Annual Growth Conference, and Dr. Rice will present at the Conference:

Canaccord Genuity 42 nd Annual Growth Conference

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Bristol Myers Squibb Reports Second Quarter Financial Results for 2022

  • Reports Second Quarter Revenues of $11.9 Billion, an Increase of 2% YoY; or 5% When Adjusted for Foreign Exchange
  • Posts Second Quarter Earnings Per Share of $0.66 and Non-GAAP EPS of $1.93; Includes Net Impact of ($0.14) per share for GAAP and Non-GAAP EPS Due to Acquired IPRD 1 Charges and Licensing Income
  • Delivers Robust Revenue Growth of 11% from In-Line Products and New Product Portfolio; or 16% When Adjusted for Foreign Exchange
  • Expands Oncology Franchise with New Indications for Opdivo and Planned Acquisition of Precision Oncology Company, Turning Point Therapeutics
  • Strengthens Cell Therapy Franchise with Broadest Label for Breyanzi in Relapsed or Refractory Large B-cell Lymphoma after One Prior Therapy
  • Adjusts 2022 GAAP EPS Guidance; Reaffirms Non-GAAP EPS Guidance

Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2022, which reflect continued in-line product growth, strong momentum across the new product portfolio and continued pipeline progress.

"I am very pleased with the continued strong demand for our in-line products and new product portfolio, resulting in solid top and bottom-line growth," said Giovanni Caforio, M.D. , board chair and chief executive officer, Bristol Myers Squibb. "The momentum with our business and strength of our pipeline, gives us significant opportunities to drive continued growth, starting with the anticipated approval for deucravacitinib in moderate to severe plaque psoriasis and the expected transition of milvexian, our next generation anti-thrombotic, to phase 3 development. With our financial strength and dedicated workforce, we are well positioned to help more patients and drive long-term value for our shareholders."

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Aurinia Pharmaceuticals Notification Regarding Inter Partes Patent Review

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ("Aurinia" or the "Company") today received notice regarding the U.S. Patent Office (USPTO) Patent Trial and Appeal Board (PTAB) decision to institute trial on the Inter Partes review ("IPR") filed by Sun Pharmaceuticals, directed at U.S. Patent No. 10,286,036. This patent is related to the LUPKYNIS ® dosing protocol for lupus nephritis.

"While this decision is disappointing, as we have stated from the start of his process, we will vigorously defend this patent," said Peter Greenleaf, President and CEO, Aurinia Pharmaceuticals. "This patent already had significant review at the USPTO before being approved as being a valid patent by that office and we are fully prepared to continue legal proceedings to protect our intellectual property."

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