PharmaShots' Key Highlights of First Quarter 2024
Shots:
- The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B
- This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS' P-III results for Krazati
- Our team at PharmaShots has summarized and compiled the insights of Q1'2024
Roche to Acquire LumiraDx's Point of Care Technology for $295M
Date - January 02, 2024
Product – N/A
- Roche is set to acquire specific segments of LumiraDx Group, focusing on its Point of Care technology. The transaction is anticipated to conclude by mid-2024, with the integrated entities becoming part of Roche Diagnostics
- Roche will pay $295M, with an additional payment of ~$55M for reimbursing funds related to LumiraDx's Point of Care technology platform. This acquisition is part of a pre-packaged UK administration sale, endorsed by LumiraDx Group's senior secured lender
- The platform has a potential for additional high medical value tests and offers a broad range of immunoassay and clinical chemistry tests
Tome Biosciences to Acquire Replace Therapeutics for ~$185M
Date - January 03, 2024
Product – N/A
- Tome expects to acquire Replace for its novel PGI method that allows insertion & deletion of small DNA sequences. Earlier Replace was a part of Rewrite Therapeutics, acquired by Intellia Therapeutics
- Under the terms of the agreement, Tome will acquire Replace through a merger transaction of $65M in up front & near-term milestone payments totaling the deal value to $185M through a mix of stock & cash
- Complementing Tome's DNA PGI technology, integrase-mediated PGI (I-PGI), Replace's PGI technology combines the site-specificity of CRISPR/Cas9 with the writing enzyme DNA ligase to precisely manipulate small DNA sequences as the ligase-mediated PGI (L-PGI) technology is well-suited for 10s to 100s of base pair DNA edits
GSK to Acquire Aiolos Bio for ~$1.4B
Date - January 09, 2024
Product – N/A
- GSK has entered into an agreement to acquire Aiolos Bio to expand its respiratory pipeline by receiving access to Aiolos’ lead molecules incl. AIO-001
- AIO-001 is a long-acting anti-thymic stromal lymphopoietin (TSLP) mAb that is expected to be evaluated in a P-II clinical trial for the treatment of patients with asthma. Moreover, Aiolos received the exclusive license for AIO-001 outside of Greater China by Jiangsu Hengrui Pharmaceuticals
- As per the agreement, Aiolos will receive an up front payment of $1B along with $400M in success-based regulatory milestone payments. Additionaly, GSK will owe Jiangsu Hengrui Pharmaceuticals certain success-based milestone payments plus tiered royalties
Johnson & Johnson Acquires Ambrx Biopharma for ~$2.0B
Date - January 09, 2024
Product – N/A
- Johnson & Johnson has signed a definitive agreement to acquire Ambrx Biopharma to strengthen its oncology portfolio through Ambrx preclinical & clinical ADC programs for the treatment of multiple cancer indications inc. ARX517 (mCRPC), ARX788 (HER2+ breast cancer) & ARX305 (renal cell carcinoma)
- Under the terms of the agreement, Johnson & Johnson will acquire all the outstanding shares of Ambrx’s common stock for $28.00/share in cash through a merger of Ambrx with a subsidiary of the Company
- Moreover, ~$1.9B estimated net value of the transaction is based on Ambrx’s estimated fully diluted shares outstanding, less estimated net cash at the time of closing. The transaction is expected to close by H1’24
Merck & Co. Acquires Harpoon Therapeutics for ~$680M
Date - January 09, 2024
Product – N/A
- Merck signed a definitive merger agreement to acquire Harpoon to enhance its oncology pipeline with Harpoon’s portfolio of novel T-cell engagers developed through the company’s TriTAC & ProTriTAC platform
- The acquisition includes Harpoon’s lead asset HPN328, a T-cell engager targeting DLL3, currently being evaluated in a P-I/II clinical trial for safety, tolerability & PK as monotx. in patient with advanced cancers associated with expression of DLL3 incl. SCLC. Harpoon’s pipeline also includes HPN217 & HPN601
- Under the terms of the agreement, Merck will acquire all outstanding shares of Harpoon for a price per share of $23.00 in cash for a total equity value of $680M. The transaction is expected to close by H1’24
Basilea Pharmaceutica Acquires Spexis’ Preclinical Antibiotics Program for $2.34M
Date - January 15, 2024
Product – N/A
- Basilea Pharmaceutica and Spexis have signed an asset purchase agreement for preclinical antibiotics program focusing on gram-negative bacteria, incl. novel multidrug-resistant strains
- As per the agreement, Basilea acquires all program compounds, know-how, and intellectual property from Spexis for a total payment of $2.34M (CHF 2M) which includes an up front payment, a transfer-related payment, and a potential final milestone payment linked to near-term external funding for the program's development
- Additionally, Basilea also takes over Spexis' rights and obligations, incl. potential low single-digit percentage royalties on sales through licensing agreements
Sanofi Reports Dupixent’s (dupilumab) US Label Update for its Use in Atopic Dermatitis
Date - January 17, 2024
Product – Dupixent
- Dupixent’s US label has been updated for its use in 12yrs. and older atopic dermatitis patients with uncontrolled moderate-to-severe hand and/or foot involvement
- The update was supported by the results from P-III (LIBERTY-AD-HAFT) study assessing Dupixent (n=67; adults: 300mg, adolescents: 200mg/300mg based on body weight, Q2W) vs PBO (n=66) in total 133 atopic dermatitis patients with moderate-to-severe hand and/or foot involvement who had insufficient response or intolerance to topical corticosteroids
- The results at 16wks. demonstrated that 52% experienced reduced itch vs 14% and 40% of them attained clear/almost clear skin vs 17% with PBO on hands and feet
Date - January 23, 2024
Product – N/A
- Sanofi signed a definitive agreement to acquire Inhibrx following the spin-off of non-INBRX-101 assets into Inhibrx Biosciences. The transaction is expected to close by Q2’24
- As per the agreement, Sanofi will acquire all outstanding shares of Inhibrx for $30.0 per share in cash adding to an equity value of ~$1.7B, will pay Inhibrx’s outstanding third-party debt & will retain 8% equity in New Inhibrx through $200M investment
- Inhibrx’s shareholders will receive one non-transferable CVR per Inhibrx share entitling its holders to receive a deferred cash payment of $5/share CVR for a total CVR value of $800M (upon achieving regulatory milestones). The shareholders will also receive 0.25 share in New Inhibrx per Inhibrix share
Date - January 31, 2024
Product – N/A
- Agilent signed a collaboration agreement with Incyte to leverage Agilent’s expertise in the development of companion diagnostics (CDx) for the development and commercialization of hematology and oncology portfolio
- The collaboration integrates both companies to collaborate on CDx development programs. Through the agreement, Agilent expects to expand its companion diagnostic portfolio with novel biomarkers
- Moreover, the collaboration gives Incyte the leverage to use Agilent’s expertise in IVD assay development, global regulatory approvals & commercialization to support clinical trials, potential registration & commercialization of CDx in the US & EU
The US FDA Approves NuvoAir’s Air Next Spirometer for In-Home Use
Date - January 31, 2024
Product – N/A
- The US FDA has granted 510(k) clearance to NuvoAir’s Air Next Spirometer for in-home use as a full spirometer, enabling the expansion of the clinical operations to support patients with heart or lung conditions
- Air Next can provide valuable clinical results to ensure continuous patient monitoring by performing full spirometry at home. These results help the clinical team to identify changes for immediate care before lung function deteriorates to the point of requiring hospitalization
- Additionally, the 510(k) clearance enables the use of the Air Next Spirometer for ATS 2019-compliant spirometry in clinical studies throughout the US and the EU
Date – February 2, 2024
Product - Genius Digital Diagnostics System
- The US FDA has cleared Hologic's Genius Digital Diagnostics System that links AI with volumetric imaging technology to diagnose pre-cancerous lesions and cervical cancer cells. It is available in the EU, Australia & New Zealand while its US commercial availability is anticipated in early 2024
- The system includes Genius Digital Imager for acquiring images, Genius Cervical AI algorithm to analyze images, Genius Image Management Server for storing images and Genius Review Station for reviewing local or remote cases
- Moreover, unlike conventional pap tests, this system screens the patient's samples digitally using an AI algorithm to identify the cells to be reviewed by cytologists and pathologists
Sirius Therapeutics Commences P-I Study of SRSD107 for Treating Thromboembolic Disorders
Date – February 2, 2024
Product - SRSD107
- Sirius Therapeutics has dosed the first participant with SRSD107 in the P-I, FIH, study on Jan 30, 2024
- The P-I trial investigates the safety, tolerability and PK/PD of SRSD107 at single ascending doses and multiple ascending doses among healthy individuals in Australia
- SRSD107 is a double-stranded siRNA targeting coagulation factor XI mRNA to inhibit FXI protein expression blocking the intrinsic coagulation pathway thus promoting anticoagulant and anti-thrombotic effects
Date – February 2, 2024
Product - QL1706
- The company reported results from the P-II study evaluating the efficacy of QL1706 + CT with/without bevacizumab for the treatment of patients (n=91) with EGFR wild-type and mutant advanced NSCLC
- The results showed that QL1706 + CT with/without bevacizumab demonstrated effective treatment for advanced NSCLC. In EGFR wild-type NSCLC patients, the ORR was 45%, mPFS was 6.8mos., median iDOR was 11.5mos., and mDOR was not attained
- Moreover, QL1706 + CT & bevacizumab demonstrated an ORR of 54.8% and mPFS of 8.5mos. in EGFR-mutant NSCLC patients who progressed after EGFR-TKI therapy suggesting its potential over PD-1 inhibitor combined with CT and bevacizumab
Inmagene Biopharmaceuticals Exercises Option to License HUTCHMED’s IMG-007 and IMG-004
Date – February 2, 2024
Product - IMG-007 and IMG-004
- HUTCHMED’s IMG-007 and IMG-004 are licensed by Inmagene as “options to license” under the terms of the agreement signed in Jan 2021. Inmagene will further develop, manufacture and commercialize the drugs
- As per the terms, HUTCHMED, for each of its drugs, will obtain ~$92.5M milestones for their development and ~$135M on achieving commercial milestones plus royalties associated with commercialization
- Additionally, Inmagene has commenced two P-IIa studies evaluating IMG-007 for treating adults with moderate-to-severe atopic dermatitis and alopecia areata. It also concluded P-I single ascending dose (SAD) trial for immunological diseases
Date – February 2, 2024
Product - N/A
- Under the collaboration, Kiora is entitled to receive $16M upfront payment, ~$285M milestones based on clinical, regulatory & commercial development, up to low 20% tiered royalties on net sales as well as reimbursement for KIO-301 R&D expenses while TOI obtains exclusive global (excl. Asia) development and commercialization rights of KIO-301 to treat degenerative retinal diseases
- Kiora will be responsible for the P-II trial and TOI will be responsible for the P-III study, regional marketing approvals plus all the commercial activities incl. sales, marketing and market access
- Furthermore, the agreement will cover ophthalmic indications incl. retinitis pigmentosa across the globe excl. China, Japan, and some Asian regions
Novartis Reports Acquisition of MorphoSys for ~$2.9B
Date – February 06, 2024
Product - N/A
- Novartis has signed an agreement to acquire MorphoSys as a strategic step to enhance its oncology and hematology pipeline by owning programs incl. pelabresib, being evaluated in the P-II study as a 2L treatment for essential thrombocythemia & tulmimetostat, targeting EZH1 and EZH2 proteins, being investigated for solid tumors or lymphomas
- Novartis will take over all MorphoSys’ no-par value bearer shares for ~$73 each, making it a total of ~$2.9B in cash
- The transaction, to be concluded in H1'24, has certain closing conditions with Novartis seeking a minimum 65% acceptance of MorphoSys’ outstanding shares and regulatory approvals. MorphoSys will function as an independent company until the closure
Date – February 06, 2024
Product - Nexviazyme
- The P-II (Mini-COMET) trial evaluates the safety & efficacy of Nexviazyme (20/40mg/kg, Q2W) in patients (n=22; under 18yrs. old) with IOPD previously treated with alglucosidase alfa treated for ≥6mos. showing a clinical decline (Cohorts 1 & 2) or suboptimal response (Cohort 3)
- Sanofi also presented safety results from the P-III (Baby-COMET) trial evaluating the safety & efficacy of Nexviazyme in IOPD treatment-naïve patients & the 8yrs. follow up data from the P-II/III (NEO-EXT) study evaluating safety, tolerability, PK, PD & exploratory efficacy of Nexviazyme in LOPD patients
- The results depicted the clinical safety, benefit & durability of Nexviazyme across a wide-range of Pompe disease patient groups. Results expected to be presented at the WORLDSymposium 2024
Merck Animal Health Reports Acquisition of Elanco Animal Health’s Aqua Business for ~$1.3B
Date – February 06, 2024
Product - N/A
- Merck Animal Health has entered into a definitive agreement to acquire Elanco’s aqua business for strengthening its aqua portfolio by owning Clynav, a DNA-based vaccine for protecting Atlantic salmon against pancreas disease and Imvixa, for anti-parasitic sea lice treatment
- The acquisition, to be concluded by mid-2024, comes with a portfolio of products for warm water production, complementing its warm water vaccine portfolio and DNA-based vaccine technology to develop novel vaccines for the aqua industry
- Furthermore, the deal includes a portfolio of medicines, vaccines, nutritional and supplements for aquatic species, two related aqua manufacturing facilities in Canada & Vietnam along with a research facility in Chile
Gilead Sciences to Acquire CymaBay Therapeutics for ~$4.3B
Date – February 13, 2024
Product - N/A
- The acquisition was made as a step to expand its existing liver portfolio by the addition of CymaBay’s Seladelpar, a treatment for PBC including pruritus
- Gilead will commence a tender offer to acquire all outstanding shares of CymaBay’s common stock for $32.5/share in cash at a 27% 1-day premium adding to an equity value of $4.3B following the completion of which, Gilead will acquire all the remaining shares not tendered in the offer through a second step merger at the same price
- Seladelpar (oral selective PPARδ agonist) was evaluated in a P-III (RESPONSE) trial based on the results of which the US FDA accepted CymaBay’s NDA, granted priority review & assigned a PDUFA date of Aug 14, 2024
Date – February 29, 2024
Product - SNB-101
- SN Bioscience’s SNB-101 has received ODD on Feb 27 from the US FDA for the treatment of pancreatic cancer on the basis of preclinical results. It has previously received the US FDA’s ODD for treating SCLC in Jul 2023
- The preclinical results demonstrated the drug’s efficacy as compared to Abraxane & Onivyde (existing 1L treatments) in animal models for pancreatic cancer
- Additionally, in Nov 2023, the company received approval for SNB-101’s P-II trial in Korea. The approval for P-I study has been received in the US (NCT04640480) & Korea while the INDs for P-II studies are expected in H2’24 across the US and the EU
Date - March 05, 2023
Product – N/A
- Bayer & BridgeBio have collaborated under which Bayer gains exclusive license for the commercialization of acoramidis to treat ATTR-CM in the EU
- Under the collaboration, BridgeBio is entitled to receive ~$310M payment incl. upfront & near-term milestones, additional undisclosed sales-based milestones as well as low-thirties percent tiered royalties
- Moreover, the MAA for the drug was filed to the EMA in Jan 2024 with the approval anticipated in 2025 and the NDA for the same has been accepted by the US FDA, based on the P-III (ATTRibute-CM) study, with the decision expected on Nov 29, 2024
Telix Reports the Acquisition of ARTMS and its Advanced Isotope Production Platform
Date - March 05, 2023
Product – N/A
- Telix has signed an agreement to acquire ARTMS along with its manufacturing plant & stockpile of ultra-pure rare metals for the production of consumable target
- Telix will make an upfront payment of $15.0M in cash & $42.5M as equity (5,674,636 of its common stocks), $24.5M as development & commercial milestones plus net sales-based low-single to low-double-digit percentages cash earn-outs for ARTMS or Telix products developed using ARTMS products
- Furthermore, the deal also includes ARTMS’ cyclotron-based isotope production system, QUANTM Irradiation System (QIS), used to produce medical isotopes such as zirconium-89 (89Zr), gallium-68 (68Ga), technetium‐99m (99mTc) & copper-64 (64Cu)
Date - March 05, 2023
Product – Simoa phospho-Tau 217
- The US FDA has granted breakthrough device designation to the company’s Simoa phospho-Tau 217 (p-Tau 217) blood test for the diagnosis of Alzheimer’s Disease (AD)
- The Simoa p-Tau 217 test is a semi-quantitative in vitro diagnostic immunoassay that utilizes Quanterix HD-X immunoassay system to measure the concentration of p-Tau 217 in plasma
- The test is indicated for patients with cognitive impairment & who are under evaluation for AD risk. The final diagnosis is done after interpreting the test results with other diagnostic tools
Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)
Date - March 06, 2023
Product – Denosumab
- Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs
- The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk associated with Jubbonti in advanced CKD, incl. dialysis-dependent patients
- Wyost is indicated for preventing SREs in MM patients & solid tumor bone metastases, giant cell bone tumor & refractory hypercalcemia while Jubbonti is approved for osteoporosis in postmenopausal women & to increase bone mass associated with certain conditions
Date - March 07, 2023
Product – FreeStyle Libre System
- The studies used Optum's de-identified Market Clarity Data focusing on US adults with T2D & HbA1c ≥8%. The 1st study "FreeStyle Libre improves HbA1c in people receiving GLP-1 therapy for type 2 diabetes" assessed patients (n=1,781, 55±10yrs.) on GLP-1 therapy receiving 1st FreeStyle Libre b/w 2018 & 2022
- The 2nd study, "Initiating GLP-1 therapy in combination with FreeStyle Libre provides greater benefit compared to GLP-1 therapy alone," had patients receiving 1st GLP-1 b/w 2018 & 2022 who were given 1st FreeStyle Libre sensor within ±30 days of 1st GLP-1 therapy
- The 1st study showed a -1.5% improvement in HbA1C 6mos. post the addition of FreeStyle & 2nd study showed a -2.4% vs -1.7% reduction in HbA1C with GLP-1 + FreeStyle vs GLP-1
Date - March 11, 2023
Product – Amlitelimab
- The 2 parts P-IIb (STREAM-AD) study assesses amlitelimab (250mg with 500mg loading dose, 250mg, 125mg, 62.5mg, Q4W) for treating moderate-to-severe atopic dermatitis patients (n=390) with inadequate control using topical therapies or where such therapies were inadvisable
- The data showed that the responders to amlitelimab in 2nd part of the study who attained EASI-75 or IGA 0/1 during 24wk. period (part 1) were re-randomized for 28wks. to evaluate the maintenance of clinical response (part 2). Patients continuing amlitelimab & those with withdrawn treatment maintained high responder rates in all dosing arms
- The pooled dose-arms analysis revealed IGA 0/1 response maintained in 71.9% vs 57% & EASI-75 response was maintained in 69% vs 61.6% with continued vs withdrawn treatment
Date - March 20, 2023
Product – N/A
- AstraZeneca has signed a definitive agreement to acquire Fusion to expedite the development of radioconjugates for cancer treatment
- AstraZeneca will acquire all of Fusion’s outstanding shares for $21.00/unit in cash making it a total of ~$2B & a non-transferable CVR of $3.00/unit in cash on reaching a specific regulatory milestone, making a total deal value of ~$2.4B. It will further acquire its cash, cash equivalents & short-term investments for $234M as of Dec 31, 2023
- The acquisition adds Fusion’s RC pipeline incl. FPI-2265, under P-II trial for mCRPC, to AstraZeneca’s portfolio as well as new expertise in R&D plus manufacturing & supply chain capabilities in Ac-based RCs along with strengthening its presence across Canada
AbbVie Reports the Acquisition of Landos Biopharma for ~$212.5M
Date - March 26, 2023
Product – NX-13
- AbbVie signed a definitive agreement to acquire Landos Biopharma as a step to strengthen its Inflammatory and Autoimmune Disease portfolio through the acquisition of Landos’ lead asset, NX-13
- Under the terms of the agreement, AbbVie will acquire Landos for $20.42 per share in cashupon closing adding to an aggregate of $137.5M along with a non-tradable CVR per share with a value of up to $11.14 per share summing to an aggregate of $75M upon achieving clinical development milestone. The transaction is expected to close by Q2’24
- NX-13 (250/750mg) is an oral NLRX1 agonist currently being evaluated for safety, efficacy & PK vs PBO in the P-II (NEXUS) clinical trial in patients (n=80) with moderate to severe UC
Novo Nordisk Reports the Acquisition of Cardior Pharmaceuticals for ~$1.11B
Date - March 26, 2023
Product – CDR132L
- Novo Nordisk signed an agreement to acquire Cardior to enhance and strengthen its Cardiovascular Disease pipeline through Cardior's lead assets including CDR132L for heart failure & preclinical assets CDR348T & CDR641L for hypertrophic cardiomyopathy
- As per the terms of the agreement, Cardior will receive an aggregate of ~$1.11B as up front, development & commercial milestones
- CDR132L is currently being evaluated in the P-II (HFrEF) clinical trial in patients suffering from myocardial infarction, the first patient for which was dosed in Jul 2022. Moreover, Novo expects to initiate a 2nd P-II clinical trial for the evaluation of CDR132L in chronic heart failure patients with cardiac hypertrophy
AstraZeneca Reports Acquisition of Amolyt Pharma for ~$1.05B
Date - March 27, 2023
Product – N/A
- AstraZeneca has signed a definitive agreement to acquire Amolyt Pharma to enhance its rare disease pipeline, Alexion, beyond complement inhibition
- As per the agreement, AstraZeneca will acquire all outstanding shares of Amolyt for a total of ~$1.05B (on cash & debt-free basis) which includes $800M upfront at closing plus an additional contingent of $250M on achieving specified regulatory milestone. The transaction is expected to close at the end of Q3’24
- The acquisition will further strengthen the company’s bone metabolism pipeline by adding Amolyt’s eneboparatide (AZP-3601), a PTH receptor 1 (PTHR1) agonist, currently under P-III clinical evaluation for the treatment of chronic hypoparathyroidism
Related Post: PharmaShots' Key Highlights of Fourth Quarter 2023
Tags
Roche
LumiraDx
Tome
Replace
GSK
Aiolos Bio
Johnson & Johnson
Ambrx Biopharma
Merck
Harpoon
Basilea
Spexis
Sanofi
Inhibrx
Agilent
Incyte
Hologic
Sirius Therapeutics
Qilu Pharmaceutical
HUTCHMED
Inmagene
Kiora
Théa Open
Novartis
MorphoSys
Merck Animal Health
Elanco
CymaBay
Gilead
SN Bioscience
Bayer
BridgeBio
Telix
Sandoz
Abbott
AstraZeneca
Fusion
Abbive
Landos Biopharma
Novo Nordisk
Cardior
Amolyt Pharma
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
