PharmaShots' Key Highlights of First Quarter 2023

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PharmaShots' Key Highlights of First Quarter 2023


  • The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout
  • Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. The first quarter of the year also showcases multiple approvals of the therapies which include AstraZeneca and Amgen received the US FDA’s approval of Tezspire (tezepelumab) for the treatment of severe asthma
  • Our team at PharmaShots has summarized and complied with the insights of Q1'23

Thermo Fisher Reports Completion of Acquisition of The Binding Site at ~$2.8B

Date - Jan 04, 2023                                                 

Product – N/A

  • The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B at current exchange rates
  • In Oct 2022, the acquisition was initiated and the transaction is expected to be adjusted per share by $0.07 in 2023. Also ~1200 employees of The Binding Site will be part of Thermo Fisher's Diagnostics segment
  • The acquisition will lead to expand Thermo Fisher’s diagnostics pipeline through innovation and monitoring for multiple myeloma by using Freelite’s offerings

WuXi Signed a License Agreement with GSK to Develop Multiple Novel Bi- & Multi-specific T Cell Engagers to Treat Cancer

Date - Jan 05, 2023                                                  

Product – N/A

  • Under the terms of the agreement, WuXi will receive $40M up front & is eligible for up to $1.46B in research, development, regulatory & commercial milestones along with undisclosed tiered royalties
  • GSK received the worldwide rights to research, develop, manufacture & commercialize a preclinical bispecific Ab that targets TAA on tumor cells & CD3 expression on T cells for the treatment of cancer. GSK also has an option for 3 additional discoveries staged bi-/multi-specific TCE Ab
  • The agreement validates WuXi’s CD3 platform & WuXiBody platform which assembles mAb sequence pairs into bispecific constructs whereas GSK aims to enhance its oncology portfolio of tumor cell targeting agents

Chiesi to Acquire Amryt Pharma for ~$1.48B

Date - Jan 09, 2023                                                 

Product – Filsuvez

  • Amryt shareholders will receive $14.50 per ADS up front & CVR of ~$2.50 per ADS (in total about $225M) based on the achievement of milestones related to Amryt's product Filsuvez representing a total transaction value of (~$1.25B in upfront consideration & $0.225B in CVR) at a premium of 107% to Amryt ADS’ closing price on Jan 2023. The transaction is expected to close at the end of H1’23
  • The acquisition will accelerate Chiesi’s rare disease medicine portfolio & expertise that helps to provide therapies to patients with rare diseases. The therapy is already approved in the EU for epidemolysis bullosa
  • The Chiesi’s goal is to improve people’s QoL while Amryt focuses to bring innovative products to new markets

JCR Pharmaceuticals’ JR-141 Receives the US FDA’s Rare Pediatric Disease Designation for the Treatment of Mucopolysaccharidosis Type II

Date - Jan 18, 2023                                                  

Product – JR-141

  • The US FDA has granted RPDD for JR-141, a recombinant fusion protein of an Ab against the human transferrin receptor and idursulfase to treat Mucopolysaccharidosis type II
  • The clinical studies showed the positive effects of JR-141 on CNS symptoms. The company is currently conducting a P-III clinical trial of JR-141 in the US, Brazil, and the EU
  • Under the 2021 collaboration, Takeda was responsible to commercialize JR141 outside of the US incl. Canada, EU, and other regions (Ex-Japan and other Asia-Pacific countries) & also received an exclusive license option to commercialize JR-141 in the US, following the completion of the P-III program

Elicio Therapeutics Entered into a Definitive Merger Agreement with Angion to Advance ELI-002 for Cancer

Date - Jan 18, 2023                                                 

Product – ELI-002

  • Elicio’s stockholders will receive newly issued shares of Angion common stock & $10M in bridge loan. The transaction is expected to close in Q2’23
  • The combined company will operate under the name Elicio Therapeutics & common stock is expected to be listed on the Nasdaq under the ticker symbol “ELTX”. Angion stockholders will own ~ 34.5% & Elicio stockholders will own ~65.5% of the newly combined company
  • The combined companies’ focus is to advance Elicio’s lymph node-targeting amphiphile technology to develop immunotherapies & also focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors is currently being evaluated in the P-I trial (AMPLIFY-201) for PDAC and CRC. The additional P-Ib/II trial is expected to be planned in H2’23

APRINOIA Therapeutics to go Public via Ross Acquisition Corp II SPAC Merger for ~$319.6M

Date - Jan 19, 2023                                                  

Product – APN-1607 and APN-005

  • The combined company will have a pro forma enterprise value of ~$319.6M. APRINOIA will receive $280M in equity value, $7.5M from an affiliate of Ross and $5M from other investors incl. ~$350.6M in ROSS's trust account. The transaction is expected to be completed in H1’23
  • APRINOIA's existing shareholders will hold b/w 42% & 74% of the combined company based on the level of redemptions by ROSS shareholders. APRINOIA & ROSS will become a wholly owned subsidiary of the combined company, APRINOIA Therapeutics & the combined company is expected to be traded on Nasdaq or NYSE
  • APRINOIA focused on developing a pipeline of highly specific CNS diagnostics & therapeutics, incl. APN-1607 & APN-005 for neurodegenerative disease. APN-1607 is in the P-II trial for AD & APN-005 is currently being studied in the P-I study in the US

Ipsen Presents P-III Trial (NAPOLI 3) Results of Onivyde for Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI 2023

Date - Jan 23, 2023                                                 

Product – Onivyde

  • The P-III trial (NAPOLI 3) evaluating Onivyde + 5 fluorouracil/leucovorin & oxaliplatin (NALIRIFOX regimen) vs nab-paclitaxel and gemcitabine in 770 patients with mPDAC across 205 trial site locations in 18 countries
  • The trial met its 1EPs i.e., the Onivyde regimen showed an improvement in OS (11.1 vs 9.2mos.) at the median follow-up of 16.1mos. NALIRIFOX regimen (liposomal irinotecan 50mg/m2 + 5-FU 2400mg/m2 + leucovorin 400mg/m2 + oxaliplatin 60mg/m2) showed an improved OS & PFS
  • The trial also met its 2EPs i.e., patients with NALIRIFOX achieved improved m-PFS (7.4 vs 5.6mos.); ORR (41.8% vs 36.2%) & the safety profile was manageable & consistent with the profiles of the treatment components. The company plans to file an sNDA to the US FDA

Eli Lilly and Boehringer Ingelheim Report the US FDA’s Acceptance of sNDA for Jardiance (empagliflozin) to Treat Chronic Kidney Disease

Date - Jan 23, 2023                                                 

Product – Jardiance

  • The sNDA was based on the P-III trial (EMPA-KIDNEY) results evaluating Jardiance (10mg) vs PBO in 6609 patients across 8 countries with CKD with/out diabetes & with/out albuminuria
  • The results showed a 28% reduction in the risk of kidney disease progression or CV death. The results also showed a reduction in risk of hospitalization for any cause with 14% relative risk reduction (24.8 vs 29.2 events/100 patient-yrs.) in pre-specified 2EPs while the reductions in other 2EPs of hospitalization for HF or CV death or all-cause death were not statistically significant
  • The safety data were consistent with the prior safety profile of Jardiance. The results were presented at ASN Kidney Week 2022 & published in NEJM

Ibex, AstraZeneca, and Daiichi Sankyo Enter into a Collaboration to Develop Galen Breast HER2 for the Detection of Breast Cancer

Date - Jan 25, 2023                                                 

Product – N/A

  • The companies will jointly develop, clinically validate & adopt Galen Breast HER2, to assist pathologists to perform accurate & reproducible assessments of HER2 IHC scoring in breast cancer patients
  • As per the results (presented at SABCS 2022) from the multi-site validation study evaluating Galen Breast HER2 in cohorts of 453 breast tumors, Galen's AI algorithm provided an accurate & automated HER2 score for pathologists
  • Ibex’s Galen Breast HER2 is an IHC-scoring product that detects tumor areas & quantifies HER2 expression into 4 categories (0, 1+, 2+ & 3+). Ibex expects to expand Galen Breast to include automated quantification of additional IHC-stained slides (i.e. ER, PR & Ki-67) to aid pathologists in breast cancer diagnosis

Abbott’s Proclaim XR Spinal Cord Stimulation System Receives the US FDA’s Approval for Painful Diabetic Peripheral Neuropathy

Date - Jan 30, 2023                                                 

Product – Proclaim XR Spinal Cord Stimulation System

  • Abbott has gained US FDA approval for its Proclaim XR spinal cord stimulation system to treat painful diabetic peripheral neuropathy. The system offers alternative options for those patients receiving other medications
  • The system was originally approved in 2019 for treating chronic pain. It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings
  • The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments. In the clinical studies, SCS treatment led to a significant reduction in pain more effectively in lower limbs & improved QoL over conventional medical treatment alone

Sandoz Receives EMA’s CHMP Positive Opinion of Adalimumab Biosimilar

Date - Jan 31, 2023                                                  

Product – Hyrimoz

  • The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization of citrate-free high-concentration formulation of biosimilar Hyrimoz (adalimumab). The authorization incl. multiple indications such as RA & Crohn's disease
  • Hyrimoz was originally approved by the EC in 2018 with a concentration of 50mg/mL. If the adalimumab citrate-free HCF (100 mg/mL) formulation is approved, it offers reduced injection volume and decreases the number required for patients who need 80mg dosing. HCF will have the same auto-injector as Hyrimoz 50mg/mL
  • The P-I PK bridging study met its 1EPs which showed comparable PK and similar safety and immunogenicity b/w the adalimumab 50mg/mL & 100mg/mL (HCF)

uniQure Entered into a License Agreement with Apic Bio for APB-102 to Treat Amyotrophic Lateral Sclerosis in Patients with SOD1 Mutations

Date – Feb 01, 2023                                                 

Product – APB-102

  • Apic Bio to receive $10M up front & is also eligible to receive ~$45M in milestones upon achievement of regulatory approvals in the US & EU and pre-specified annual net sales along with royalty
  • uniQure to get global rights for the development & commercialization of APB-102 & adds to its pipeline of gene therapies for neurological disorders. The IND application for APB-102 has been approved by the US FDA & the therapy also received ODD & FTD. The P-I/II study of APB-102 is expected to be initiated in H2’23
  • In preclinical tests using a SOD1-ALS mouse model, APB-102 significantly increased the survival of the affected mice. At suggested clinical doses, relevant SOD1 reduction in spinal cord motor neurons was also shown in rodents & non-human primates

AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma

Date – Feb 03, 2023                                                 

Product – Tezspire

  • The US FDA has approved Tezspire for self-administration in a pre-filled, single-use pen for patients aged ≥12yrs. with sev. asthma
  • The approval was based on the (PATHFINDER) program incl. results from the P-I trial (PATH-BRIDGE) & P-III trial (PATH-HOME) evaluating Tezspire (210mg). In the (PATH-HOME) trial, 92% of healthcare providers, patients, and caregivers were able to successfully administer Tezspire in the clinic & home along with an improvement in asthma control & safety profile was consistent with prior trials
  • Tezspire is also supplied in a single-dose vial or prefilled syringe. The therapy was approved in the US, EU, Japan & other countries and is under regulatory review in multiple other countries globally

Shanghai Henlius Biotech Reports the First Patient Dosing of HLX15 (biosimilar, daratumumab) in P-I Clinical Trial for Multiple Myeloma

Date – Feb 03, 2023                                                 

Product – HLX15

  • The first patient has been dosed in the P-I trial that consists of 2 parts (parts 1 & 2) evaluating HLX15 (anti-CD38 IgG1κ mAb) vs daratumumab in 234 patients with MM
  • Part 1 is an open-label, two-arm P-Ia study & part 2 is a three-arm P-Ib study evaluating HLX15 (8mg/kg) vs China & US-sourced daratumumab in a ratio (1:1) & (1:1:1) in 24 & 204 patients while part 2 is a three-arm P-Ib study. The early phase of part 1 includes a safety run-in period with 3-6 patients to receive HLX15 (IV), monitored for safety for 1wk.
  • The 1EP is the area under the serum drug concentration-time curve from time 0 to infinity & 2EPs incl. other PK parameters, safety & immunogenicity. In preclinical studies, HLX15 is highly similar to daratumumab

Novartis Published P-III (SUNSHINE) and (SUNRISE) Trials Results of Cosentyx (secukinumab) for Hidradenitis Suppurativa in The Lancet

Date – Feb 06, 2023                                                 

Product – Cosentyx

  • The P-III (SUNSHINE) and (SUNRISE) trials evaluating Cosentyx (300mg, q2w/q4w) vs PBO in more than 1000 patients in 40 countries
  • In both trials, patients treated with Cosentyx (300mg, q2w) achieved HiSCR (45.0% vs 33.7%) & (42.3% vs 31.2%) @16wks., Cosentyx (300mg, q4w) was superior to PBO (46.1% vs 31.2%) & (41.8% vs 33.7%)
  • Treatment response rates continued to improve beyond the 1EPs analysis @16wk., 55% achieved a HiSCR measure @52wk., ≥60% were free of flares, and ≥50% reduction in pain. The safety results were consistent with the well-established profile of Cosentyx with no new signals & long-term efficacy & safety results were also seen who did not respond to biological therapies. The results have been submitted to regulatory authorities in the EU & US with decisions expected in 2023

Merck Reports P-III Trial (NRG-GY018) Results of Keytruda (pembrolizumab) as 1L Treatment for Advanced or Recurrent Endometrial Carcinoma

Date – Feb 06, 2023                                                 

Product – Keytruda

  • The P-III trial (NRG-GY018) evaluating Keytruda + CT vs PBO + CT alone in 819 patients with measurable stage III, IVA, IVB, or recurrent endometrial cancer in pMMR and dMMR cohorts. NCI sponsored the trial
  • The trial met its 1EPs i.e., improvement in PFS at a pre-specified interim analysis. The safety profile was consistent with prior reported studies with no new safety signals & the results will be presented at an upcoming medical meeting & discussed with regulatory authorities
  • The company has a comprehensive clinical development program in EC. Keytruda is being studied as monotx. (KEYNOTE-C93/ENGOT-en15/GOG-3064) & in combination with Lenvima (LEAP-001/ENGOT-en9) for 1L advanced EC along with adjuvant setting (KEYNOTE-B21/ENGOT-en11/GOG-3053)

Sentia Medical Sciences Extends its Research Collaboration with Neurocrine Biosciences to Discover Novel Peptide Therapies for HPA-Driven Diseases

Date – Feb 15, 2023                                                 

Product – N/A

  • Sentia will receive committed research funding to support discovery efforts & is eligible to receive milestones along with royalty based on products that emerge from the collaboration
  • The collaboration will use Sentia’s peptide-based platform & Neurocrine’s drug development expertise in CRF biology to develop and commercialize therapies for a variety of hypothalamic-pituitary-adrenal axis modulated diseases
  • The companies collaborated to discover novel peptide antagonists targeting CRF and advances for the development candidate stage while Neurocrine will be responsible for all further development, manufacturing, regulatory, and commercial activities

Xilis Collaborated with MD Anderson to Advance Novel Technology and Advances Therapeutic Development

Date – Feb 16, 2023                                                 

Product – N/A

  • The preclinical research agreement combines Xilis' MicroOrganoSphere platform with MD Anderson's expertise to advance the development of novel cancer therapies & cancer research
  • Additionally, the collaboration also enables translational research on patient-derived micro tumors & provides new capabilities, improves the efficiency of developing innovative drugs and cell therapies over current xenograft and organoid models, also advances the development of disease models
  • MD Anderson's NK cell therapy program (led by Rezvani) is advancing novel treatments for a variety of cancers using engineered cord blood-derived NK cells

Moderna and Merck Receive the US FDA’s Breakthrough Therapy Designation for mRNA-4157/V940 + Keytruda (pembrolizumab) to Treat High-Risk Melanoma

Date – Feb 23, 2023                                                 

Product – Keytruda

  • The US FDA has granted the BTD for mRNA-4157/V940, a personalized mRNA cancer vaccine in combination with Merck’s Keytruda for the adjuvant treatment of high-risk melanoma following complete resection
  • The designation was based on the P-IIb trial (KEYNOTE-942/mRNA-4157-P201) evaluating mRNA-4157/V940 + Keytruda (200mg, q3w for ~18 cycles) vs Keytruda alone in 157 patients with stage III/IV melanoma which showed a 44% reduction in risk of disease recurrence or death, improvement in the 1EPs of RFS, AEs & safety profile was consistent with prior reported studies, serious TRAEs (14.4% vs 10%)
  • The companies will discuss the findings with regulatory authorities, initiate a P-III study in adjuvant melanoma in 2023 & expand to additional tumor types, incl. NSCLC

VBL Therapeutics Reverse Merged with Notable Labs to Advance Predictive Precision Medicines Platform and Therapeutic Pipeline

Date – Feb 24, 2023                                                 

Product – N/A

  • Notable stockholders will receive newly issued ordinary shares & investors have committed an additional $10.3M in a private placement to Notable, led by Builders VC, B Capital Group, Y Combinator, First Round Capital & Founders Fund. The merger is expected to be close in Q2’23
  • The combined company will advance Notable’s PPMP & therapeutic pipeline incl. volasertib for cancer patients. Notable's PPMP combines biological assays & ML for the purpose of bio-simulating a patient's cancer treatment and predicting their clinical response to actual treatment, P-IIa results of Volasertib are expected in Q3’24 for AML
  • Notable stockholders will own ~76% & VBL shareholders will hold ~24% of the combined company. The combined company is expected to operate under the name Notable Labs, Ltd. with its shares listed on the Nasdaq under the ticker symbol ‘NTBL

Aldeyra Therapeutics Reports the US FDA Acceptance of NDA for Priority Review of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma

Date – Mar 03, 2023                                                 

Product – ADX-2191

  • The US FDA has accepted the NDA for Priority Review of ADX-2191 (methotrexate injection) for PVRL. The US FDA’s decision is expected on June 2023 with the planning to launch ADX-2191 in the US in H2’23
  • The NDA submission was based on the combination of more than three decades of published literature on the safety & efficacy of ADX‑2191 along with the safety data from the P-III trial (GUARD). The P-III trial (GUARD) results showed no safety signals & were found to be well tolerated with no observed treatment-emergent serious AEs
  • ADX-2191 is a sterile, non-compounded IVT formulation of methotrexate for specific rare retinal diseases. The therapy received ODD from the US FDA for PVR, PVRL, and retinitis pigmentosa

Abbott Receives the US FDA Clearance of FreeStyle Libre 2 and FreeStyle Libre 3 Sensors for Diabetes

Date – Mar 07, 2023                                                  

Product – N/A

  • The US FDA has granted clearance to FreeStyle Libre 2 & FreeStyle Libre 3 sensors for integration with an automated insulin delivery system which will be available in the US in 2023
  • The sensors are also cleared for use by children as young as 2yrs. old, for use by women with diabetes who are pregnant & for wear time of up to 15 days. Abbott has ongoing collaborations with insulin pump manufacturers to integrate their systems with both sensors
  • Companies partnering with Abbott incl. Insulet & Tandem to enable future integrations in multiple countries, incl. the US. Abbott received authorization to integrate FreeStyle Libre 3 with the mylife Loop from Ypsomed & CamDiab in Germany & plans launches in the UK, Switzerland & the Netherlands in H1’23

AstraZeneca Reports P-III Trial (ADAURA) Results of Tagrisso (osimertinib) for Adjuvant Treatment of Early-Stage EGFR-Mutated Lung Cancer

Date – Mar 10, 2023                                                 

Product – Tagrisso

  • The P-III trial (ADAURA) evaluating Tagrisso (80mg, qd) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC at 200+ centers across 20+ countries, incl. the US, EU, South America, Asia & the Middle East
  • The results showed a clinical improvement in OS. The safety & tolerability were consistent with its established profile with no new safety concerns & the results data will be presented at an upcoming medical meeting
  • Tagrisso was approved to treat early-stage lung cancer in 90+ countries, incl. in the US, EU, China, and Japan along with additional global regulatory reviews are ongoing. The company has a comprehensive portfolio of approved & potential new therapies for lung cancer

Guardant Health Reports the Submission of Premarket Approval Application to the US FDA for Shield Blood Test to Detect Colorectal Cancer

Date – Mar 13, 2023                                                  

Product – Shield Blood Test

  • The company has submitted the premarket approval application to the US FDA for the Shield blood test. The submission was based on the (ECLIPSE) study evaluating the performance of Shield blood test over screening colonoscopy in ~20,000 avg.-risk adults aged 45 & 84yrs. at 200+ clinical trial sites in rural & urban communities across 34 states
  • Acc. to preliminary results, the Shield test had a sensitivity of 83% & a specificity of 90% for the detection of colorectal cancer. The test also demonstrated 13% sensitivity in detecting advanced adenomas
  • The test identifies specific DNA characteristics that may indicate the presence of cancer & is commercially available only on prescription through healthcare providers for eligible individuals

Pfizer to Acquire Seagen for ~$43B

Date – Mar 14, 2023                                                 

Product – Adcetris, Padcev and Tivdak

  • Pfizer will acquire Seagen for $229/per share in cash representing a total enterprise value of $43B while Seagen expects ~$2.2B of revenue in 2023 from its four in-line therapies & bringing Pfizer $10B+ in risk-adjusted revenues by 2030. The transaction is expected to be completed in late 2023 or early 2024
  • The acquisition will combine Seagen’s ADC technology with Pfizer’s capabilities & expertise to bring new solutions to patients & also advance Seagen’s ADC technology to unlock novel target combinations & next-generation biologics
  • Seagen’s portfolio incl. 4 approved medicines across solid tumors & hematologic malignancies, incl. 3 ADCs: Adcetris, Padcev & Tivdak. It also has a pipeline of drugs under development that incl. treatments for lung cancer & advanced breast cancer

Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara

Date – Mar 17, 2023                                                 

Product – SB17

  • The P-I study evaluating SB17 (45mg) vs Stelara (US & EU sourced) via SC inj. in a ratio (1:1:1) in 201 patients. The primary objective was to demonstrate PK similarity by assessing area under AUCinf and Cmax & secondary objectives was to investigate and compare the safety, tolerability, and immunogenicity b/w three treatment groups
  • The study results showed PK equivalence and comparable safety, tolerability, and immunogenicity profiles b/w SB17 and reference ustekinumab. The results will be presented at AAD 2023
  • Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, hematology, and endocrinology

Selecta and Sobi Report P-III Trial (DISSOLVE I & II) Results of SEL-212 for Chronic Refractory Gout

Date – Mar 21, 2023                                                  

Product – SEL-212

  • The P-III trial (DISSOLVE I & II) evaluates 2 dose levels of SEL-212 vs PBO in adult patients. Both trials met its 1EPs i.e., patients who received monthly doses of SEL-212 achieved a response at high & low doses (0.15 & 0.1mg/kg) in the (DISSOLVE I) trial (56% & 48% vs 4% in PBO); 47% & 41% vs 12% in (DISSOLVE II) trial at 6mos.
  • At both doses, the response rate in patients aged ≥50yrs was 65% & 47% in (DISSOLVE I) and 48% & 45% in (DISSOLVE II) over 14% in PBO with a 69% reduction in mean SU levels at 0.15mg/kg in (DISSOLVE I) trial
  • The therapy showed a favorable safety profile & was well-tolerated across both doses with 3.4% of patients with infusion reactions at high doses. Regulatory submission in the US is expected in H1’24

GSK Reports P-III Trial (RUBY/ENGOT-EN6/GOG3031/NSGO) Results of Jemperli (dostarlimab) for Primary Advanced or Recurrent Endometrial Cancer

Date – Mar 28, 2023                                                 

Product – Jemperli

  • The company highlighted an interim result from part 1 of the P-III trial evaluating Jemperli + CT vs CT + PBO which showed PFS improvement; 72% & 36% reduction in risk of disease progression or death in the dMMR/MSI-H & overall patient population
  • In dMMR/MSI-H & overall population, PFS @24mos. (61.4% vs 18.1%) & (36.1% vs 18.1%); OS (83.3% vs 58.7%) in dMMR/MSI-H. In MMRp/MSS & overall population, PFS @24mos. (28.4% vs 18.8%) & (71.3% vs 56.0%); OS (67.7% vs 55.1%) in MMRp/MSS. The results were presented at ESMO & SGO; published in the NEJM
  • In the overall population, 38.2% vs 15.4% had irAEs & TRAEs leading to treatment discontinuation (17.4% vs 9.3%) in the overall population. The regulatory submissions are expected to be planned in H1’23

BMS’ Sotyktu (deucravacitinib) Receives EC’s Approval for the Treatment of Plaque Psoriasis

Date – Mar 29, 2023                                                 

Product – Sotyktu

  • The approval was based on the P-III trials (POETYK PSO-1 & 2) evaluating Sotyktu (6mg, qd) vs PBO and Otezla in 666 & 1020 patients which showed superior efficacy in improving skin clearance @16 & 24wks. with responses maintained through 52wks.
  • In both trials & time points, patients achieved an sPGA score of 0/1, PASI 75 & PASI 90 response while responses persisted through 52wk., 82% maintained their response at 52wk. in (POETYK PSO-1) trial who achieved PASI 75 at 24wk. while 80% who continued Sotyktu maintained PASI 75 response over 31% withdrew from Sotyktu in the (POETYK PSO-2) trial
  • The (POETYK PSO) LTE trial's additional data also supported approval. The (POETYK) study program demonstrated a consistent safety profile at 3yrs. of continuous treatment

GSK Entered into an Exclusive Licence Agreement and SCYNEXIS to Develop and Commercialise Brexafemme (ibrexafungerp) for Fungal Infection

Date – Mar 31, 2023                                                 

Product – Brexafemme

  • SCYNEXIS to receive $90M up front, $503M in milestones incl. ~$70M in regulatory approval milestones, ~$115M in commercial milestones based on first commercial sale in invasive candidiasis (US/EU); ~$242.5M in sales milestones incl. $77.5M to be paid upon achievement of multiple thresholds up through $200M; $65M upon multiple thresholds b/w $300M & $500M & $50M at each threshold of $750M & $1B along with royalties across all indications
  • SCYNEXIS will also receive ~$75.5M in success-based development milestones & holds rights to all other assets derived from enfumafungin along with leading the execution & costs of the ongoing clinical studies of ibrexafungerp. GSK gets the first rights to negotiate for future compounds developed by Scynexis
  • GSK will get an exclusive license to develop, manufacture & commercialize ibrexafungerp & Brexafemme for all indications in all countries excl. greater China region & certain other countries already out-licensed by SCYNEXIS to third parties

Related Post: PharmaShots' Key Highlights of Fourth Quarter 2022

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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