PharmaShots' Key Highlights of Second Quarter 2024
Shots:
- The second 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 Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B
- This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19
- Our team at PharmaShots has summarized and compiled the insights of Q2'2024
Genmab to Acquire ProfoundBio for Enhancing its Oncology Portfolio
Date: April 03, 2024
Product: Rinatabart Sesutecan (Rina-S)
- Genmab has signed a definitive agreement to acquire ProfoundBio for an aggregate of $1.8B in cash to strengthen its oncology portfolio. The transaction will conclude in H1’24
- Through the acquisition, Genmab gains global rights to ProfoundBio’s ADC portfolio comprising 3 clinical & various preclinical candidates such as rinatabart sesutecan (Rina-S). Additionally, ProfoundBio's ADC technology will be combined with Genmab's Ab platforms for developing products to treat cancer
- Rina-S, FRα targeting Topo1 ADC, is under P-II of P-I/II trial to treat ovarian cancer & other solid tumors. It received the US FDA’s FTD in Jan 2024 to treat FRα-expressing high-grade serous or endometrioid Pt-resistant ovarian cancer
Date: April 04, 2024
Product: ORKA-001 & ORKA-002
- As per the agreement, the pre-merger ARCA stockholders will hold ~2.38% of the merged entity while the pre-merger Oruka stockholders will get ~97.62%. ARCA will pay ~$20M to its pre-merger stockholders before closing plus contribute $5M for the merged entity
- Oruka has secured $275M private investment in its common stock and pre-funded warrants that will support Oruka's operations through 2027 and advance ORKA-001 as well as ORKA-002 through initial clinical proof-of-concept
- Furthermore, the merged entity will develop Oruka’s ORKA-001 (IL-23p19 inhibitor) & ORKA-002 (IL-17A/F inhibitor), the evaluations of which are anticipated in 2025 with ORKA-001’s PK results expected in H2’25
Date: April 05, 2024
Product: N/A
- Johnson & Johnson has signed a definitive agreement to acquire Shockwave Medical, the transaction of which is anticipated to conclude by the mid of 2024
- As per the agreement, Johnson & Johnson will acquire all the Shockwave’s outstanding shares for $335.00 per unit making it a total deal value of ~$13.1B
- Through the acquisition, the company will enhance the MedTech cardiovascular portfolio with its focus on two of the cardiovascular indications incl. coronary artery disease (CAD) and peripheral artery disease (PAD)
Date: April 05, 2024
Product: N/A
- Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications
- As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development & its state-of-the-art along with current Good Manufacturing Practice (cGMP)-approved facilities in Spain & Argentina
- Furthermore, Teva will be responsible for all the regulatory and commercialization activities across the designated areas for easy access to the patients
Date: April 08, 2024
Product: Enhertu
- The approval was supported by 3 P-II studies assessing the safety & efficacy of Enhertu incl. DESTINY-PanTumor02 (5.4mg/kg) for HER2-expressing tumors, DESTINY-Lung01 (5.4mg/kg or 6.4mg/kg) for HER2m or HER2-overexpressing inoperable/metastatic non-squamous NSCLC & DESTINY-CRC02 (5.4mg/kg or 6.4mg/kg) for locally advanced, unresectable or metastatic HER2+ colorectal cancer
- A confirmed ORR of 51.4%, 52.9% & 46.9% while mDoR of 19.4mos., 6.9mos. & 5.5mos. was observed in the DESTINY-PanTumor02, DESTINY-Lung01 & DESTINY-CRC02 studies, respectively
- On the basis of these results, Enhertu has been added to the NCCN guidelines for the treatment of various metastatic tumors
Vertex to Acquire Alpine Immune Sciences for ~$4.9B
Date: April 11, 2024
Product: Povetacicept (ALPN-303)
- Vertex has signed a definitive agreement to acquire Alpine Immune Sciences for $65 per unit making it a total of ~$4.9B in cash. The transaction will conclude in the Q2’24
- The acquisition will add Alpine’s povetacicept (ALPN-303) to the company’s portfolio, which demonstrated effectiveness in the P-II study of IgA nephropathy. The drug’s P-III clinical evaluation in anticipated in H2’24
- Povetacicept is a dual BAFF (B cell activating factor) & APRIL (a proliferation inducing ligand) cytokines antagonist which are responsible for the pathogenesis of various autoimmune diseases by activating, differentiating & sustaining B cells, T cells & innate immune cells
Essential Pharma Acquires Reminyl (galantamine hydrobromide) Oral Capsules from Janssen
Date: April 18, 2024
Product: Reminyl
- Essential Pharma has completed the acquisition of Reminyl oral capsules from Janssen Pharmaceutica to treat mild to moderately severe dementia of the Alzheimer type expanding its CNS medicines portfolio
- Through the acquisition, Essential Pharma has obtained rights to Reminyl across the EEA, Thailand, South Korea and all other current markets for the product except UK, Ireland, Japan & Latin America
- Reminyl is a cholinesterase inhibitor from the company’s CNS drug portfolio developed as a treatment of mild to moderately severe Alzheimer’s dementia
Incyte to Acquire Escient Pharmaceuticals and its MRGPR Antagonist Assets
Date: April 24, 2024
Product: EP262 & EP547
- Incyte to acquire Escient Pharmaceuticals for $750 M plus Escient’s remaining net cash at closing of transaction (based on customary adjustments). Closing of acquisition is anticipated in Q3’24
- Acquisition will enhance Incyte’s R&D activities in Inflammation and Autoimmunity (IAI) by addition of Escient's MRGPR antagonists, EP262 and EP547; possible launch begins in 2029
- Moreover, EP262 in the P-I study showed safety and tolerability at all doses tested with no AEs & SAEs, vital signs, or ECG parameters, whereas TEAEs were mild having incidence lesser than PBO (33.3% vs. 62.5%) and did not rise with change in dose
Labcorp to Acquire Invitae Under US Bankruptcy Code Section 363
Date: April 25, 2024
Product: N/A
- Labcorp won Invitae’s auction bid, in the sale process under US Bankruptcy Code Section 363
- Following the auction, LabCorp will acquire all assets for $239M in cash, plus other non-cash consideration
- The current hearing date of sale approval is May 6, 2024. Deal closing is expected by Q3’24, with court approval, customary regulatory clearances and closing conditions
ONO Pharmaceutical Reports Acquisition of Deciphera Pharmaceuticals for $2.4B
Date: April 30, 2024
Product: Qinlock, Vimseltinib & DCC-3116
- ONO has signed a definitive merger agreement with Deciphera to enhance its oncology portfolio and expand its presence across the US & the EU, strengthening kinase drug discovery research
- Under the agreement, ONO will acquire Deciphera’s outstanding shares for $25.60 per unit in cash followed by merging Deciphera with its subsidiary, totaling $2.4B in equity value. The transaction will conclude in Q3’24
- The acquisition will further add Qinlock (switch-control inhibitor) to treat 4L gastrointestinal stromal tumor (approved in the US & 40 other regions), its drug candidates incl. vimseltinib & DCC-3116 (an ULK inhibitor) along with additional oncology candidates to ONO’s portfolio
Novartis to Acquire Mariana Oncology, Expanding its Radioligand Therapy Pipeline
Date: May 03, 2024
Product: MC-339
- Novartis has agreed to acquire Mariana Oncology to strengthen its radioligand therapy pipeline along with expanding research infrastructure & clinical supply capabilities. The transaction will further support Novartis in oncology & RLT platform innovation
- Under the acquisition, Mariana will receive $1B up front plus an additional $750M on achieving pre-specified milestones
- The acquisition also adds diverse RLT portfolio targeting multiple solid tumors like breast, prostate and lung cancer incl. MC-339 (Ac-based RLT) being developed for small cell lung cancer, to Novartis’ pipeline
Boehringer Ingelheim Collaborates with Walgreens to Improve Clinical Trials Access
Date: May 03, 2024
Product: N/A
- Boehringer Ingelheim has collaborated with Walgreens to enhance clinical trial recruitment, aiming for accessibility and inclusivity. The P-III study opportunities will be offered in Walgreens pharmacies
- The collaboration will utilize Walgreens community pharmacies as study sites for obesity, overweight & type 2 diabetes, thus improving access and addressing equitable health representation in clinical trials. Walgreens will identify and engage patients using advanced, real-world insights
- BI also teams up with EmVenio Research to introduce mobile research units for better reach and clinical trial participation
ARTBIO Partners with Nucleus RadioPharma to Manufacture Pb-212 Radiolabeled Therapeutic Products
Date: May 08, 2024
Product: AB001
- ARTBIO and Nucleus RadioPharma have entered into a strategic manufacturing and supply agreement to manufacture former’s therapeutic product
- Under the agreement, Nucleus will utilize ARTBIO's AlphaDirect 212Pb isolation technology to manufacture 212Pb-radiolabeled therapies for P-I & P-II studies of AB001 in prostate cancer. Nucleus's facility in Rochester, Minn., will supply & manufacture ARTs for Northern & Midwest US patients
- AlphaDirect system produces highly pure 212Pb from common raw materials. Early studies of 212Pb-labeled radiopharmaceuticals demonstrated favorable results, suggesting it could meet significant clinical needs
Johnson & Johnson to Expand its Dermatology Portfolio Through the Acquisition of Proteologix
Date: May 17, 2024
Product: PX128 & PX130
- Johnson & Johnson has agreed to acquire Proteologix to expand its dermatology portfolio for an aggregate of $850M in cash
- The acquisition adds Proteologix’s PX128, which will be entering P-I clinical evaluation to treat severe atopic dermatitis (AD) & moderate to severe asthma as well as PX130, currently under preclinical evaluation for moderate to severe AD, along with additional bispecific antibody programs for a range of diseases to J&J’s portfolio
- PX128 works by inhibiting IL-13-mediated Th2 skin inflammation and TSLP-mediated tissue inflammation while PX130 targets IL-13 similar to PX128 and IL-22, enabling restoration of skin barrier & preventing inflammation from allergens for treating AD & asthma
Fractyl Health Highlights the Preclinical Data of its Pancreatic Gene Therapy at DDW 2024
Date: May 20, 2024
Product: N/A
- Fractyl highlighted preclinical data of Rejuva pancreatic gene therapy candidate under the title, ‘Single-Dose GLP-1-Based Pancreatic Gene Therapy Maintains Weight Loss After Semaglutide Withdrawal and Reduces Hepatic Triglycerides in a Murine Model of Obesity’
- The preclinical data demonstrated a 42% decrease in the liver weight & 67% decrease in the liver triglyceride content vs PBO post 2mos.
- The data also showed a 36% reduction in total cholesterol & a 51% reduction in LDL cholesterol vs PBO post 2mos., suggesting GLP-1 PGTx candidate’s potential of minimizing cardiovascular risk due to increased cholesterol levels. The first GLP-1 PGTx candidate nomination for obesity is expected in H2’24 with further exploration in MASLD/MASH
Swixx Biopharma Acquires Biopas, Expanding its Presence to Latin America
Date: May 22, 2024
Product: N/A
- Swixx BioPharma has agreed to acquire 100% of Pharma Consulting Group’s equity, the holding company of Laboratorios Biopas, to expand its reach into Latin America
- Through the acquisition, the company will have its presence in Latam’s Top 5 markets incl. Argentina, Brazil, Chile, Colombia & Mexico. The transaction is anticipated to conclude in Jun-Jul 2024 post certain regulatory approvals
- Following its Middle East entry in Sep 2023, Swixx BioPharma's acquisition of Biopas enhances its aim of becoming biopharma companies’ preferred partner. The expansion further covers Central & Eastern EU, CIS/Eurasia, MENA & Latin America. Biopas will retain its name and leadership team in Latin America, despite becoming part of Swixx BioPharma
Date: May 23, 2024
Product: Felzartamab & Izastobart
- Biogen acquiring HI-Bio to advance felzartamab & HI-Bio’s pipeline using its global development & commercialization knowledge in rare diseases & scientific immunology expertise. It aims to keep HI-Bio's expertise to establish a San Francisco Bay Area team for immune-mediated diseases
- HI-Bio will receive $1.15B upfront & $650M development milestone for felzartamab (totalling $1.8B); Expected to conclude in Q3’24
- The acquisition adds felzartamab (P-II trials in PMN & AMR, and IgAN; planned P-III studies for same), izastobart (anti-C5aR1 Ab) for complement-mediated diseases, and discovery stage mast cell programs for immune-mediated diseases to Biogen’s portfolio. HI-Bio to present complete P-II AMR & interim IgAN data at ERA 2024
Merck KGaA Reports the Acquisition of Mirus Bio, Strengthening Upstream Portfolio
Date: May 23, 2024
Product: TransIT-VirusGEN
- Merck KGaA has entered into a definitive agreement to acquire Mirus Bio (part of Gamma Biosciences) for an aggregate of $600M to strengthen its upstream portfolio. The transaction is expected to conclude in Q3’24
- The acquisition adds Mirus Bio’s transfection reagents namely, TransIT-VirusGEN, to Merck’s portfolio that are essential for the production of viral vector-based gene therapies
- Furthermore, the acquisition enables Merck advancing its aim to offer wide-ranging solutions for viral vector manufacturing to focus on gene therapies and novel modalities
Johnson & Johnson to Acquire Numab's Yellow Jersey Therapeutics for an Aggregate of ~$1.25B
Date: May 29, 2024
Product: NM26
- Johnson & Johnson has signed a definitive agreement with Numab Therapeutics, acquiring Yellow Jersey Therapeutics (Numab’s subsidiary) to gain worldwide rights of NM26 for an aggregate of ~$1.25B in cash
- NM26, a bispecific Ab, will be progressing to P-II study for treating atopic dermatitis. It targets IL-4Rα, that induces Th2-mediated skin inflammation, as well as IL-31, that affects skin itch & subsequent scratching leading to disease worsening; has the potential in other inflammatory skin diseases involving Th2 inflammation and itch
- Furthermore, the transaction is anticipated to conclude in the H2’24
Merck Expands its Ophthalmologic Portfolio Through the Acquisition of EyeBio
Date: May 30, 2024
Product: Restoret (EYE103)
- Merck has agreed to acquire EyeBio for expanding its ophthalmologic portfolio. The transaction is anticipated to conclude in Q3’24
- Merck will acquire all EyeBio’s outstanding shares for an aggregate of $3B, consisting of $1.3B upfront in cash and up to $1.7B in developmental, regulatory & commercial milestones. Merck expects a $1.3B charge (about $0.50 per unit) in non-GAAP results during the closing quarter
- The acquisition adds EyeBio’s Restoret (EYE103), which will progress into a P-IIb/III study in H2’24 based on the data from P-Ib/IIa (AMARONE) trial for diabetic macular edema (DME) & neovascular age-related macular degeneration (NVAMD), as well as a preclinical pipeline focusing on retinal diseases to Merck’s portfolio. EyeBio will continue Restoret’s development through its expertise as a part of Merck
Stryker Acquires Artelon, Enhancing its Portfolio of Soft Tissue Fixation Solutions
Date: June 04, 2024
Product: N/A
- Stryker has agreed to acquire all the outstanding shares of Artelon. The transaction is contingent upon customary closing conditions; both the companies will operate as separate entities until the deal closure
- The acquisition will add Artelon’s technologies to Stryker’s portfolio, enhancing its products offered to sports medicine as well as foot & ankle consumers. Artelon’s other synthetic technology, developed for improving biological along with mechanical ligament & tendon reconstruction, will further strengthen Stryker’s offerings
- Additionally, through the acquisition, Stryker will be able to compete in the sports medicine as well as foot & ankle markets with the biomaterial technology that promotes the healing of the patient's soft tissues
GSK Acquires Elsie Biotechnologies to Advance Oligonucleotide Platform and Pipeline Therapies
Date: June 07, 2024
Product: N/A
- GSK has completed the acquisition of Elsie Biotechnologies for up to $50M to advance its oligonucleotide platform and pipeline medicines
- Following their partnership in Jul 2023 to investigate the technology, this acquisition enables GSK to advance its platform R&D capabilities by combining Elsie’s oligonucleotide discovery, synthesis & delivery technologies
- The information obtained through the Elsie platform will be utilized with GSK’s expertise in AI and ML to develop predictive models for future oligonucleotide design. Additionally, GSK is developing oligonucleotide therapeutics for addressing chronic hepatitis B and steatotic liver disease and other therapeutic areas
Zomedica Highlights the Data of TRUFORMA Research to Diagnose Thyroid Disease in Cats at ACVIM 2024
Date: June 07, 2024
Product: TRUFORMA Bulk Acoustic Wave (BAW) Platform
- Zomedica highlighted diagnostic abilities of the TRUFORMA Bulk Acoustic Wave (BAW) platform vs chemiluminescent immunoassay (CLIA) platforms in a presentation entitled, 'Evaluation of a Feline-Optimized TSH Assay in Cats with Hyperthyroidism and with Non-Thyroidal Illness'
- The research showed the system’s sensitivity at low ranges & ability to accurately diagnose hyperthyroidism in cats with confounding non-thyroid illness (NTI)
- The platform uses BAW technology for precise & sensitive measurements plus enables diagnosis & treatment of complex thyroid & adrenal conditions, canine non-infectious gastrointestinal disease as well as equine Cushing's disease by generating accurate, fast & reliable data
Date: June 07, 2024
Product: AVEIR DR Leadless Pacemaker System
- Abbott’s AVEIR DR leadless pacemaker system has obtained CE Mark for treating patients with abnormal or slow heart rhythms across the EU. It was FDA-approved in Jun 2023
- The system was assessed under the AVEIR DR i2i global trial that reached its 1EPs of safety & efficacy, depicting a system implant success rate of 98.3% with atrioventricular synchrony among >97% of patients, despite of distinct postures & gaits, after 3mos. of implantation
- The AVEIR DR system consists of AVEIR VR (paces right ventricle) & AVEIR AR (paces right atrium). It uses i2i (implant-to-implant) communication technology to synchronize pacing b/w the two devices using high-frequency pulses transmitted through the body's blood
Moderna Reports the P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19
Date: June 14, 2024
Product: mRNA-1283
- The P-III (NextCOVE) trial investigates the safety & efficacy of mRNA-1283 (50% received 10μg) vs Spikevax (50% received 50μg) among ≥12yrs. old participants (n=11,400) to prevent COVID-19
- The study reached its 1EPs, showing the superiority of the vaccine with greater effectiveness achieved among adults aged ≥18yrs. and a trend in adults aged ≥65yrs. Data will be highlighted at future conferences along with submission for publication
- The data aligned with the immunogenicity outcomes revealed in Mar 2024, depicting the formation of neutralizing antibodies against Omicron BA.4/5 and original SARS-CoV-2 among adults aged ≥65yrs.
Boston Scientific Reports the Acquisition of Silk Road Medical
Date: June 19, 2024
Product: Transcarotid Artery Revascularization (TCAR) Technology
- Boston Scientific has signed a definitive agreement to acquire Silk Road Medical for $27.50 per share, making it an aggregate of ~$1.16B. The transaction will conclude in H2’24, contingent upon customary closing conditions
- The acquisition adds Silk Road Medical’s transcarotid artery revascularization (TCAR) technology, intended to prevent stroke & treat carotid artery disease, to the company’s vascular portfolio
- The TCAR procedure reverses the blood flow by accessing the carotid artery via a small neck incision to prevent plaque from dislodging. A stent is then positioned to stabilize plaque, preventing future strokes
Date: June 28, 2024
Product: N/A
- InfoBionic.Ai and Anumana have signed a joint research agreement for developing & commercializing AI-based remote technology to identify cardiac diseases using Anumana’s ECG-AI technology and InfoBionic.Ai’s MoMe ARC platform
- The collaboration aims at enhancing the ability of InfoBionic.Ai’s MoMe ARC Platform for earlier cardiac disease diagnosis in the remote patient monitoring setting. Both companies will work with the Mayo Clinic for the development
- As per the agreement, Anumana will combine its ECG-AI LEF algorithm with InfoBionic.Ai’s remote cardiac monitoring platform to identify LEF by remote cardiac activity monitoring. Both will confirm the clinical utility of the combined solution for regulatory approval. ECG-AI LEF's review across the EU is ongoing
AbbVie Reports the Acquisition of Celsius Therapeutics
Date: June 28, 2024
Product: CEL383
- AbbVie has purchased all the outstanding shares of Celsius Therapeutics for an aggregate of $250M in cash, contingent upon certain customary adjustments
- The acquisition adds Celsius' CEL383, which has completed the P-I single ascending dose trial assessing its safety, tolerability & PK profile among healthy subjects for treating IBD, to AbbVie’s portfolio
- CEL383, a TREM1 targeting antibody, has demonstrated a decrease in multiple inflammatory mediators relevant to inflammatory conditions by inhibiting TREM1 signaling in non-clinical studies
Pfizer and BioNTech Report the CHMP’s Positive Opinion of Comirnaty JN.1 Vaccine for COVID-19
Date: June 28, 2024
Product: Comirnaty JN.1
- The CHMP has granted positive opinion to Omicron JN.1-adapted COVID-19 vaccine, Comirnaty JN.1, for subjects ≥6mos. of age, following the WHO & EMA recommendations to update vaccines for the 2024-2025 campaign targeting the SARS-CoV-2 variant JN.1
- The opinion was supported by safety & efficacy data from clinical, non-clinical & RWE studies of COVID-19 vaccines, demonstrating enhanced response against various Omicron JN.1 variants such as KP.2, KP.3 & others vs the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
- Both companies are initiating rolling applications with the US FDA, seeking approval for their Omicron KP.2-adapted COVID-19 vaccines for individuals (≥6mos.)
PetPace Brings Out AI-Based Pregnancy Monitoring Module to Improve Pet Health at EVSSAR 2024
Date: June 28, 2024
Product: Pregnancy Monitoring Module
- PetPace introduces an AI-based module ($99 for 4mos. or $150 for 1yr. plus the hardware & standard subscription) focused on maternal pet health that generates insights to minimize complications & improve pet care
- The PetPace Pregnancy Monitoring Module, investigated under a trial in dogs, generates real-time updates & alerts for expecting pets, predicting whelping & identifying warning signs to improve care for pets & newborn pups
- The module forms an AI-based biometric baseline for assessing the pregnancy using essential health data (Learning Stage), monitors the mother’s health with alerts for -ve signs (Gestation Health Monitoring Stage) plus notifies owners 10 days to 12hrs. before labor (Whelping Time Alerts Stage)
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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.
