Blastic Plasmacytoid Dendritic Cell Neoplasm

Pictured: Handshake in front of raining money / Taylor Tieden for BioSpace The slow pace of mergers and acquisitions in 2022 continued into 2023 but has since picked up steam, highlighted by a frenzy of big-dollar M&A announcements and the closing of Pfizer’s $43 billion purchase of Seagen, the largest pharmaceutical or biotech M&A agreement in three years. As M&A activity accelerates in early 2024, BioSpace looks back over the biggest deals in the biopharma sector over the past eight months. This list includes M&A transactions that have closed since July 1. 1. Pfizer Snatches Up Seagen to Expand Oncology Pipeline Closing date: Dec. 14, 2023 Deal value: $43 billion Pfizer acquired Seattle-based Seagen for $43 billion, the largest M&A agreement in the sector in three years and just missing the list of top 10 biopharma deals of all time. With this move, Pfizer took control of Seagen’s antibody-drug conjugate (ADC) technology, fortifying the pharma giant’s standing within the oncology market. Pfizer’s offering came in at $229/share, outbidding others, including Merck and Sanofi. The deal took nine months to consummate after scrutiny by the Federal Trade Commission as well as European regulators. In response to FTC concerns, Pfizer decided to donate the rights of royalties from U.S. sales of its anti-PD-L1 checkpoint inhibitor Bavencio to the American Association for Cancer Research. 2. AbbVie Acquires ADC Developer Immunogen Closing date: Feb. 12, 2024 Deal value: $10.1 million The antibody-drug conjugate (ADC) market is hot, and AbbVie is now in the race after acquiring ImmuoGen for $31.26 per share. The deal offers AbbVie access to ImmunoGen’s ADC Elahere (mirvetuximab soravtansine-gynx), which was granted FDA accelerated approval in 2022, as well as the smaller company’s follow-on pipeline of ADCs, including several in development for treatments such as solid tumors, acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. 3. Biogen Boosts Neuro, Rare Disease Pipelines with Reata Acquisition Closing date: Sept. 26, 2023 Deal value: $7.3 billion Biogen scooped up Reata Pharmaceuticals to bolster its neurological and rare disease businesses. Biogen paid $172.50 per share to score the Texas-based firm. Last year, Reata gained FDA approval for Skyclarys (omaveloxolone), the first authorized treatment for Friedreich’s ataxia in the U.S., and new owner Biogen followed with European Commission approval this month. The purchase also gave Biogen access to Reata’s developmental pipeline, which includes the Hsp90 modulator cemdomespib, being developed for diabetic peripheral neuropathic pain, and the Nrf2 activators RTA 415 and RTA 417, both being assessed for their potential in treating diseases associated with mitochondrial dysfunction, oxidative stress and chronic inflammation. 4. Roche Buys Telavant from Roivant to Acquire IBD Candidate Closing date: Oct. 23, 2023 Deal value: $7.1 billion Roche made an upfront payment of $7.1 billion to secure Telavant Holdings, a company that Roivant previously owned 75% of. The acquisition agreement also includes an additional short-term milestone payment of $150 million. Telavant has the rights in the U.S. and Japan to investigational anti-TL1A antibody RVT-3101, which is being developed for inflammatory bowel conditions, including ulcerative colitis and Crohn’s disease. RVT-3101 is a monoclonal antibody that works by inhibiting the TL1A cytokine, which modulates the site and severity of inflammation and fibrosis by stimulating the TH1 and TH17 pathways. 5. Astellas Nabs Iveric Bio and Its Blindness Therapies Closing date: July 11, 2023 Deal value: $5.9 billion Astellas acquired New Jersey–based Iveric Bio for $5.9 billion in its largest acquisition to date. Under the terms of the agreement, Astellas paid $40 per share. The acquisition grants Astellas access to multiple programs for the treatment of geographic atrophy due to age-related macular degeneration, including Izervay, a complement C5 inhibitor that received FDA approval in August. 6. Danaher Scoops Up Abcam After Shareholder Pushback Closing date: Dec. 6, 2023 Deal value: $5.7 billion Danaher paid $5.7 billion to acquire Abcam, a U.K.-based supplier of antibodies, reagents and other proteomic research tools. The transaction was valued at $24 per share, a price initially deemed too low by Abcam founder-turned-investor Jonathan Milner, who tried to have himself installed as executive chairman last year. 7. BMS Acquires Mirati Therapeutics to Boost Cancer Business Closing date: Jan. 23, 2024 Deal value: $4.8 billion Bristol Myers Squibb took over cancer-focused biotech Mirati Therapeutics in a bid to grow its oncology franchise, at a cost of $58.00 per share. Additionally, Mirati shareholders received nontradeable value rights worth up to $12.00 per share, contingent on the FDA accepting the New Drug Application for Mirati’s candidate MRTX1719 within seven years of the acquisition. That puts the potential total value as high as $5.8 billion. MRTX1719 is a potentially first-in-class PRMT5 inhibitor in early-stage development for several tumor types, including non-small cell lung cancer. The compound is expected to enter Phase II studies in the first half of 2024. 8. Novartis Expands in the Renal Space, Acquiring Chinook Therapeutics Closing date: Aug. 11, 2023 Deal value: $3.2 billion Novartis acquired Seattle-based Chinook Therapeutics, a prominent player in kidney therapeutics, in a deal valued at up to $3.5 billion, or $40 per share. Specifically, Novartis provided an initial cash payment of $3.2 billion and has committed to additional contingent value rights of up to $300 million. Novartis gained access to Chinook's two advanced-stage assets currently under late-stage clinical development for immunoglobulin A nephropathy (IgAN), a rare, progressive autoimmune kidney disease. 9. Roche Acquires Carmot Therapeutics to Enter Weight-Loss Drug Arena Closing date: Jan. 29, 2024 Deal value: $2.7 billion Roche took over Berkeley, California–based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. The Swiss pharma made an upfront payment of $2.7 billion when the deal closed last month, and privately held Carmot’s investors equity holders are eligible for up to $400 million in additional milestone payments. With the purchase, Roche gains access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists aimed at treating obesity. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready for Phase II testing. 10. Lilly Obtains DICE Therapeutics and Its Drug Discovery Platform Closing date: Aug. 9, 2023 Deal value: $2.4 billion To expand its range of treatments for autoimmune diseases, Eli Lilly acquired DICE Therapeutics, a biopharma company based in San Francisco. Lilly reported that the deal is valued at $48 per share. The purchase grants Lilly the opportunity to use DELSCAPE, DICE’s drug discovery and development platform. This platform is designed to optimize the creation of small molecule drugs, allowing for efficient disruption of protein-protein interactions. Deals to Watch On Dec. 22, BMS entered into a definitive $14 billion merger agreement with Karuna Therapeutics, followed four days later by the planned purchase of RayzeBio for $4.1 billion. Neither deal has closed yet. Abbvie announced another monster acquisition late last year: the $8.7 billion deal with Cerevel Therapeutics. This month, Novo Nordisk made a splash with a $16.5 billion offer to take over troubled CDMO Catalent. Also this month, Gilead Sciences announced plans to acquire CymaBay Therapeutics for $4.3 billion. Neil Versel is a senior editor at BioSpace. You can reach him at neil.versel@biospace.com. Follow him on LinkedIn or X. 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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

KAT6 is an emerging target in hormone sensitive breast tumors and other cancers. Overexpression of KAT6A/B correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer – the most common subtype. The molecule has demonstrated strong preclinical activity. Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December. This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties. FLORENCE, Italy and NEW YORK, Jan. 4, 2024 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with clinical stage generative artificial intelligence (AI)-driven biotechnology company Insilico Medicine ("Insilico"), today announced that they have entered into an exclusive licensing agreement granting Stemline the global rights to develop and commercialize a novel, small molecule KAT6A inhibitor designed using Insilico's AI platform, as a potential treatment for hormone sensitive cancers and other oncology indications. Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.[1] Approximately 70% of breast cancers are estrogen receptor positive (ER+), and endocrine therapy remains the backbone of therapy for patients with ER+ breast cancer. However, tumors can develop a resistance to endocrine therapy, which in turn can lead to disease progression. This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance. KAT6A is known to play an important role in several cancers. Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer. In preclinical studies, the molecule has demonstrated potent inhibition against KAT6A in multiple CDX and PDX models with good efficacy and safety. Insilico presented data on the molecule at the San Antonio Breast Cancer Symposium in early December. "We are delighted to enter a collaboration with Insilico that harnesses the power of generative AI as a leader in the field, to explore a promising new treatment approach and potentially unlock transformative new cancer therapies," said Elcin Barker Ergun, CEO of the Menarini Group. "Having brought the first innovation in endocrine therapy after almost 20 years to the U.S. and Europe with elacestrant for ER+, HER2- breast cancer patients, our aim is to further augment patient outcomes, and targeting KAT6A can potentially serve that in breast cancer and beyond." The novel molecule was designed by Insilico's R&D team with the help of its end-to-end Pharma Generative AI platform to inhibit KAT6A and block endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance to endocrine therapies due to mutation or ligand-independent constitutive activation of ER. Currently, endocrine therapy in combination with CDK4/6 inhibitors is the standard treatment for ER+/HER2- breast cancer patients with advanced or metastatic disease. Novel combinations with CDK4/6 inhibitors and/or new oral SERDs are needed to further extend outcomes. "We are excited by the promise of our latest generative AI-designed therapy to provide a new potential treatment option for breast cancer patients," says Alex Zhavoronkov, PhD, founder and co-CEO of Insilico Medicine. "With their innovative vision and deep focus in bringing transformational therapeutics in oncology, Stemline is the ideal partner to lead this molecule into development and through clinical trials." Under the terms of the agreement, Stemline will provide a $12 million upfront payment to Insilico. The combined value of the deal, including all development, regulatory, and commercial milestones, is over $500 million, followed by royalties up to double digits. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit menarini.com. About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline") a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and in the E.U., an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. About Insilico Medicine Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 Feb 4. doi: 10.3322/caac.21660. Epub ahead of print. PMID: 33538338. 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