A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (Anti-FRα Antibody-drug Conjugate) in Adult Patients With Recurrent Gynaecological Cancers

IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with recurrent endometrial cancer; recurrent, high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers; or recurrent cervical cancers. All participants will be, in the opinion of the investigator, appropriate for nonplatinum single-agent therapy for their next line of therapy.

Start Date11 Jan 2023

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Opugotamig olatansine

100 Translational Medicine associated with Opugotamig olatansine

100 Patents (Medical) associated with Opugotamig olatansine

News (Medical) associated with Opugotamig olatansine

12 Feb 2024

·www.prnewswire.com

AbbVie Completes Acquisition of ImmunoGen

Adds flagship antibody-drug conjugate (ADC) ELAHERE® (mirvetuximab soravtansine-gynx) for folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) to AbbVie's portfolio ImmunoGen's pipeline complements AbbVie's existing oncology pipeline with potential to be transformative across multiple solid tumors and hematologic malignancies ImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand into earlier lines of therapy and additional patient populations AbbVie reaffirms previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25 which now includes a $0.42 per share dilutive impact related to the ImmunoGen acquisition and the pending Cerevel Therapeutics acquisition AbbVie updates previously issued 2024 first-quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30 which now includes a $0.04 per share dilutive impact related to the ImmunoGen acquisition NORTH CHICAGO, Ill., Feb. 12, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that it has completed its acquisition of ImmunoGen (NASDAQ: IMGN). With the completion of the acquisition, ImmunoGen is now part of AbbVie. "Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," said Robert A. Michael, president and chief operating officer, AbbVie. "The addition of ImmunoGen's treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie." ELAHERE® (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA granted accelerated approval for ELAHERE in folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) patients based on response data. Results from a confirmatory trial currently under review by the FDA show that ELAHERE is the first targeted agent to offer a survival benefit in PROC, with label expansion opportunities across larger segments of the ovarian cancer market. ImmunoGen's follow-on pipeline of ADCs further builds on AbbVie's existing solid tumor pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies. Through focused R&D efforts, AbbVie has developed novel ADC technology and has unique strengths in antibody engineering, drug linker chemistry and toxin research. AbbVie and ImmunoGen's combined capabilities represent an opportunity to deliver potentially transformative ADC therapies to patients. ImmunoGen's investigational Phase 1 asset, IMGN-151, is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, currently in Phase 2, is an investigational anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN. For additional background on the acquisition, please read the announcement press release here and view AbbVie's investor presentation here. Financial Terms AbbVie has acquired all outstanding ImmunoGen common stock for $31.26 per share. It is expected that ImmunoGen's common stock will cease to trade on the NASDAQ stock exchange prior to market open on February 12, 2024. AbbVie expects its acquisition of ImmunoGen to be accretive to AbbVie's diluted EPS beginning in 2027 and significantly accretive over the long-term. Full-Year 2024 Outlook AbbVie is reaffirming its previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25. This guidance now includes a $0.42 per share dilutive impact related to the completed ImmunoGen acquisition, as well as the pending Cerevel Therapeutics acquisition, which is anticipated to close in mid-2024. AbbVie's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2024, as both cannot be reliably forecasted. AbbVie is updating its previously issued 2024 first-quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30. This guidance now includes a $0.04 per share dilutive impact related to the ImmunoGen acquisition. AbbVie's 2024 first-quarter adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred in the quarter, as both cannot be reliably forecasted. About ELAHERE (mirvetuximab soravtansine-gynx) ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The prescribing information includes a boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities. Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin. Please see full Prescribing Information, including Boxed Warning for ELAHERE. About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the ability to realize the anticipated benefits of the ImmunoGen acquisition on the anticipated timeframe or at all, risks that the cost to consummate the ImmunoGen acquisition or to obtain the anticipated benefits of the acquisition could be greater than expected, the risk that the ImmunoGen business will not be integrated successfully, disruption from the ImmunoGen acquisition making it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities, negative effects of the consummation of the acquisition on business or employee relationships or the market price of AbbVie's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition or ImmunoGen's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie

ImmunotherapyDrug ApprovalPhase 2Phase 1Breakthrough Therapy

30 Nov 2023

·medcitynews.com

AbbVie Tries Its Hand at ADCs Again With $10.1B Immunogen Acquisition

The Big Pharma world saw yet another multibillion-dollar deal in the hot field of antibody drug conjugates (ADCs) on Thursday. AbbVie announced plans to acquire ImmunoGen — and the Massachusetts-based biotech’s recently approved ADC treatment for ovarian cancer — for $10.1 billion in cash. A year ago, ImmunoGen’s ovarian cancer drug, named Elahere, became the first ADC approved by the FDA to treat ovarian cancer. By acquiring this asset, North Chicago-based AbbVie is seeking to strengthen its presence in the solid tumor space — a move the company is making as its two most profitable drugs, Humira and Imbruvica, begin to face daunting competition. Humira’s exclusivity expired this year, and Imbruvica sales are down due to the introduction of BeiGene’s oral treatment Brukinsa. The deal follows several other large acquisitions that have occurred in the ADC space this year. Pfizer announced its $43 billion acquisition of Seagen, which is considered an ADC pioneer, in March. In October, Merck announced a joint development and commercialization deal for three Daiichi Sankyo ADC treatments — if milestones are met, Merck could end up paying Daiichi Sankyo up to $22 billion. Some other examples of large drugmakers that have recently picked up ADC assets include Bristol Myers Squibb, AstraZeneca, GSK and BioNTech. ADCs are a popular target for pharma acquisitions because they boast promising potential to make cancer treatment more effective. These drugs deliver toxic payloads directly to cancer cells, aiming to minimize damage to healthy cells and improve precision when attacking tumors. Elahere is meant to treat ovarian cancer patients who have demonstrated a resistance to platinum-based chemotherapies. The drug targets folate receptor alpha, a protein that is often overexpressed on the surface of ovarian cancer cells. The ADC is approved for use in ovarian cancer patients who have a high expression of this protein and have also already received one to three prior treatment regimens. The drug generated $212 million in sales during the first three quarters of 2023. By buying an ADC that is already on the market, AbbVie could be trying to avoid the fate it suffered after its first big ADC deal. In 2016, AbbVie paid $5.8 billion to acquire cancer drugmaker Stemcentrx and its lead ADC candidate, Rova-T. The deal was meant to beef up AbbVie’s cancer portfolio with a lucrative drug, but Rova-T ended up failing multiple small cell lung cancer trials. In 2019, AbbVie admitted that the drug wasn’t going anywhere and eliminated the entire development program. One industry expert — Dave Latshaw, former AI drug development lead at Johnson & Johnson and current CEO of BioPhy — thinks AbbVie’s new deal signals that it is ready to move on from the Stemcentrx flop. “The acquisition of ImmunoGen shows Abbvie’s commitment to ADCs and highlights their willingness to push past previous strategic blunders in the same modality. While the move looks to be primarily about Elahere, which has shown great clinical results in ovarian cancer, the price highlights that they are confident in the rest of ImmunoGen’s pipeline as well and generally bullish on the ADC space,” he wrote in an email. With the acquisition, AbbVie gains access to the ImmunoGen’s pipeline of ADCs along with Elahere. Two of the most notable assets in the pipeline include IMGN-151, another ADC to treat ovarian cancer, and pivekimab sunirine, which targets a rare blood cancer. Damien Conover, director of healthcare equity research for Morningstar, wrote in an emailed statement that he thinks AbbVie “is largely paying a fair price” for ImmunoGen. He projects that Elahere’s peak annual sales will be close to $2 billion. Conover anticipates widespread adoption of Elahere among ovarian cancer patients whose initial treatment proved ineffective. This expectation is grounded in the findings of a recent phase 3 study, which revealed that the drug reduced tumor size and extended the lifespan of ovarian cancer patients when compared to traditional chemotherapy options. “Additional studies in platinum-sensitive ovarian cancer patients should come out over the next few years and could potentially almost double the market size, adding upside potential to our projection if the data is positive,” Conover wrote. He also believes the deal will help drive adjusted-earnings growth over the next five years, which is crucial considering how Humira biosimilars will likely create a drag on earnings for several years. Another industry leader — Trilliant Health CEO Hal Andrews — also thinks that the deal seems like a solid one. “Pharmaceutical companies have access to data earlier than everyone else, and their M&A activity is a reliable indicator of emerging disease trends. Given national trends of increasing cancer mortality in the 30-39, this transaction makes a ton of sense,” he wrote via email. The deal is expected to close in mid-2024, subject to regulatory approval.

AcquisitionDrug ApprovalImmunotherapyPhase 3ADC

30 Nov 2023

·www.fiercepharma.com

AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field

AbbVie is rejoining the likes of AstraZeneca, BioNTech, Gilead Sciences, GSK, Merck & Co. and Pfizer on a roster of pharma companies that have spent mightily to acquire ADC programs. The sizzling antibody-drug conjugate (ADC) field is at the center of another major life sciences deal. This time, AbbVie is shelling out $10.1 billion in cash to acquire ImmunoGen, maker of the ovarian cancer treatment Elahere, which won accelerated approval from the FDA about a year ago. The acquisition accelerates AbbVie’s entry into the solid tumor space and strengthens the company’s oncology pipeline, CEO Rick Gonzalez said on a call Thursday. Establishing a strong presence in solid tumors has been a “strategic priority for AbbVie,” and ImmunoGen represents an “extremely compelling opportunity,” he said. With the buyout, AbbVie is rejoining the likes of AstraZeneca, BioNTech, Gilead Sciences, GSK, Merck & Co. and Pfizer on a list of pharma companies that have spent mightily to acquire ADC programs. By deal value, the proposed buyout ranks third among biopharma M&A transactions announced this year, trailing Pfizer’s $43 billion offer for another ADC giant, Seagen, and Merck’s $10.8 billion takeover of immunology company Prometheus. AbbVie was actually one of the earliest Big Pharma companies to identify ADCs as a promising field. Back in 2011, when AbbVie was still part of Abbott, the company paid $8 million upfront to Seagen (then called Seattle Genetics) to utilize the latter’s ADC technology on a single cancer target. Now, ImmunoGen could give AbbVie a chance to clear its ADC reputation after another of its deals in the space turned into a flop. AbbVie's first large ADC play came in 2016 when the company put down $5.8 billion to acquire Stemcentrx. But the crown jewel of the deal, DLL3-targeted ADC Rova-T, failed multiple small cell lung cancer trials until AbbVie eventually admitted defeat and scrapped the entire program in 2019. Rova-T was one of the most notable failures of the ADC field, and the setback disrupted AbbVie’s plan to move into solid tumors. This time, AbbVie is getting an ADC that’s already on the market. An FRα-directed ADC, Elahere was approved by the FDA in November 2022 as a treatment for advanced ovarian cancer that’s resistant to platinum chemotherapy. Earlier this year, the drug’s MIRASOL confirmatory trial was hailed at a landmark success. In the study, Elahere became the first medicine to show an overall survival benefit in platinum-resistant ovarian cancer. The drug is expected to generate around $500 million in sales in 2024, and Wall Street analysts on average projected about $2 billion in peak sales at the end of the decade, according to Barclays. To reach that threshold, Elahere will need to move into earlier lines of treatment later this decade. Trials are ongoing to test Elahere—either by itself or with bevacizumab—in FRα-high, platinum-sensitive ovarian cancer. And AbbVie plans to explore adding Elahere to either bevacizumab or PARP inhibitors in the first-line maintenance setting, with phase 3 studies expected to begin in 2024 and 2025, respectively. AbbVie made the ImmunoGen announcement just as the company’s own c-Met ADC candidate telisotuzumab-vedotin (Teliso-V) showed a 35% response rate in EGFR wild type, advanced nonsquamous non-small cell lung cancer. With the mid-stage results, AbbVie is preparing to seek accelerated approval with the FDA. Tapping more than four decades of ADC experience from ImmunoGen will likely make AbbVie a formidable player in the ADC space, William Blair analysts said in a Thursday note. AbbVie’s infrastructure, combined with ImmunoGen’s know-how, could help further entrench Elahere in ovarian cancer and expedite development of the biotech’s pipeline, the analysts said. ImmunoGen’s clinical assets include IMGN-151, an anti-FRα follow-on to Elahere with the potential to move beyond ovarian cancer. The biotech also has an anti-CD123 ADC in phase 2 testing for a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm. Within oncology, blood cancer is AbbVie’s home turf. Together with Johnson & Johnson, AbbVie sells the BTK inhibitor Imbruvica, which has lately come under pressure from competitor drugs from AstraZeneca and BeiGene. Besides Teliso-V, AbbVie’s internal ADC pipeline remains in early-stage development. It includes a c-Met follow-up coded ABBV-400, two anti-SEZ6 candidates, ABBV-011 and ABBV-706, as well as drugs targeting B7-H3, CD19 and LRRC15. During AbbVie’s third-quarter earnings call, CEO Rich Gonzalez said the company opted to prioritize internal ADC work instead of pursuing a transaction with Daiichi Sankyo, which counts AZ and Merck as partners. That comment came in response to a question about Daiichi and Merck's megablockbuster ADC deal from the prior week. “The reality is we believe we have what we need with [ABBV-400],” Gonzalez said. “We believe that platform—and we own that platform, we've developed it internally—would give us everything that we need in that area,” Gonzalez added. AbbVie expects the ImmunoGen deal to close in the middle of 2024. Meanwhile, the U.S. Federal Trade Commission has recently adopted a more aggressive stance on biopharma M&A deals. The antitrust agency is currently taking a closer look at Pfizer’s Seagen buy. The ImmunoGen deal “would have no overlap from an FTC standpoint, based on our portfolio and our market presence,” Gonzalez said Thursday.

Drug ApprovalPhase 2AcquisitionPhase 3ADC

100 Deals associated with Opugotamig olatansine

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Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube Carcinoma	Phase 1	United States	AbbVie, Inc.	11 Jan 2023
high grade serous adenocarcinoma of ovary	Phase 1	United States	AbbVie, Inc.	11 Jan 2023
Primary peritoneal carcinoma	Phase 1	United States	AbbVie, Inc.	11 Jan 2023
Recurrent Cervical Cancer	Phase 1	United States	AbbVie, Inc.	11 Jan 2023
Recurrent Endometrial Cancer	Phase 1	United States	AbbVie, Inc.	11 Jan 2023
Ovarian Cancer	Phase 1	United States	AbbVie, Inc.	-
Non-Small Cell Lung Cancer	Preclinical	United States	ImmunoGen, Inc.	26 Feb 2024
Triple Negative Breast Cancer	Preclinical	United States	ImmunoGen, Inc.	26 Feb 2024

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