This week’s Hematology update highlights regulatory progress, advancing clinical development, new trial milestones, and ongoing efforts to expand treatment options across hematologic diseases.
In Today’s Newsletter
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🩸 VAS-101 Phase I sickle cell readout [1] [US • 24 Jun 2026]
https://www.prnewswire.com/news-releases/vascarta-announces-phase-i-results-of-vas-101-administered-sublingually-in-sickle-cell-disease-patients-302809748.html
Context: VAS-101 (Vascarta; Vasceptor, curcumin gel) was tested sublingually in five sickle cell disease patients over 29 days.
Key point: Vascarta reported safety and tolerability, plus directional improvements in ePROs and RBC sickling biomarkers.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 TSC-101 ALLOHA Phase 1 Cohort C data [2] [US • 22 Jun 2026]
https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-announces-positive-initial-data-cohort-c
Context: TSC-101 (TScan Therapeutics; TCR-T therapy) is being evaluated after allogeneic HCT in heme malignancies.
Key point: TScan reported complete donor chimerism in 11 of 14 dosed patients about three weeks after first infusion.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 ARC-02 first patient dosed in NHL Phase 1 [3] [Switzerland/US • 23 Jun 2026]
https://www.businesswire.com/news/home/20260623627184/en/Araris-Biotech-AG-and-Taiho-Oncology-Announce-Dosing-of-First-Patient-in-Phase-1-Trial-of-ARC-02-a-Novel-ADC-for-the-Treatment-of-Non-Hodgkin-Lymphoma
Context: ARC-02 (Araris Biotech/Taiho Oncology; CD79b-targeted ADC) uses MMAE, AraLinQ ADC technology, and Arastatin linker-payload.
Key point: Araris and Taiho dosed the first patient in a Phase 1 trial for non-Hodgkin lymphoma.
Implication: Signals pipeline investment and modality expansion.
💉 BESREMi Pen FDA approval and US launch [4] [US • 26 Jun 2026]
https://us.pharmaessentia.com/pharmaessentia-announces-fda-approval-and-u-s-launch-of-besremi-pen-ropeginterferon-alfa-2b-njft-for-polycythemia-vera/
Context: BESREMi (PharmaEssentia; ropeginterferon alfa-2b-njft) is FDA-approved for adults with polycythemia vera.
Key point: PharmaEssentia announced FDA approval and US launch of the BESREMi Pen, a pre-filled self-administration device.
Implication: May expand screening, initiation, and follow-up at scale.
🧫 TECVAYLI plus daratumumab CHMP recommendation [5] [EU • 26 Jun 2026]
https://www.jnj.com/media-center/press-releases/chmp-recommendation-advances-johnson-johnsons-tecvayli-teclistamab-plus-daratumumab-as-a-potential-standard-of-care-for-relapsed-refractory-multiple-myeloma
Context: TECVAYLI (Johnson & Johnson; teclistamab) plus daratumumab was studied in Phase 3 MajesTEC-3.
Key point: CHMP recommended the combination for adult relapsed/refractory multiple myeloma after at least one prior therapy.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Jaypirca CHMP recommendation in CLL [6] [EU • 26 Jun 2026]
https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-recommended-chmp-approval-0
Context: Jaypirca (Lilly; pirtobrutinib) is a non-covalent BTK inhibitor evaluated in Phase 3 BRUIN CLL-313 and BRUIN CLL-314.
Key point: CHMP recommended Jaypirca for adults with CLL across all lines of therapy, regardless of prior BTK inhibitor treatment.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Curis TAKEAIM-CLL site activation update [7] [26 Jun 2026]
https://www.prnewswire.com/news-releases/curis-announces-eleven-active-clinical-sites-in-takeaim-cll-study-reaffirms-patient-dosing-guidance-and-reports-stockholder-approval-of-reverse-stock-split-302811922.html
Context: TAKEAIM-CLL (Curis) is an ongoing CLL study; detailed clinical data were not specified in the supplied text.
Key point: Curis announced eleven active clinical sites, reaffirmed patient dosing guidance, and reported stockholder approval of a reverse stock split.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Hematology news this week centered on regulatory expansion, trial execution, and earlier-line treatment strategies.
- CHMP opinions for TECVAYLI plus daratumumab and Jaypirca could broaden EU options in RRMM and CLL if approved by the European Commission.
- TScan, Araris/Taiho, and Curis updates show movement across cell therapy, ADCs, and targeted oncology trials.
- PharmaEssentia’s BESREMi Pen reflects lifecycle management aimed at simplifying long-term polycythemia vera treatment.
- Vascarta’s VAS-101 results remain early and small, but add a directional signal in sickle cell disease pain and RBC biology.
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FAQ
What did Vascarta report for VAS-101 in sickle cell disease?
Vascarta reported safety and tolerability in five patients receiving low-dose sublingual VAS-101. The company also reported directional ePRO and RBC biomarker changes. [1]
Why does TScan’s TSC-101 Cohort C update matter?
TScan reported complete donor chimerism in 11 of 14 dosed patients about three weeks after first infusion. The company said Phase 3 ALLOHA-2 remains on track. [2]
What is ARC-02 from Araris Biotech and Taiho Oncology?
ARC-02 is a CD79b-targeted ADC for non-Hodgkin lymphoma. It uses MMAE and Araris’ AraLinQ and Arastatin technologies. [3]
What changed for BESREMi in polycythemia vera?
PharmaEssentia announced FDA approval and US launch of the BESREMi Pen. The device is designed to simplify self-administration for adults with PV. [4]
What did CHMP recommend for TECVAYLI plus daratumumab?
CHMP recommended TECVAYLI plus daratumumab for adult relapsed/refractory multiple myeloma after at least one prior therapy. The recommendation is based on Phase 3 MajesTEC-3. [5]
What did CHMP recommend for Jaypirca in CLL?
CHMP recommended Jaypirca for adults with CLL across all lines of therapy, regardless of prior BTK inhibitor treatment. Lilly said European Commission action is expected in 1–2 months. [6]
Entities / Keywords
VAS-101, Vasceptor, Vascarta, sickle cell disease, SCD, curcumin gel, RBC sickling kinetics, ePROs
TSC-101, TScan Therapeutics, ALLOHA, ALLOHA-2, TCR-T, allogeneic HCT, donor chimerism
ARC-02, Araris Biotech, Taiho Oncology, CD79b, ADC, AraLinQ, Arastatin, MMAE, non-Hodgkin lymphoma, NHL
BESREMi, BESREMi Pen, ropeginterferon alfa-2b-njft, PharmaEssentia, polycythemia vera, PV
TECVAYLI, teclistamab, daratumumab, Johnson & Johnson, CHMP, EMA, MajesTEC-3, RRMM
Jaypirca, pirtobrutinib, Lilly, non-covalent BTK inhibitor, CLL, BRUIN CLL-313, BRUIN CLL-314
Curis, TAKEAIM-CLL, clinical site activation, dosing guidance, reverse stock split
References
- https://www.prnewswire.com/news-releases/vascarta-announces-phase-i-results-of-vas-101-administered-sublingually-in-sickle-cell-disease-patients-302809748.html
- https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-announces-positive-initial-data-cohort-c
- https://www.businesswire.com/news/home/20260623627184/en/Araris-Biotech-AG-and-Taiho-Oncology-Announce-Dosing-of-First-Patient-in-Phase-1-Trial-of-ARC-02-a-Novel-ADC-for-the-Treatment-of-Non-Hodgkin-Lymphoma
- https://us.pharmaessentia.com/pharmaessentia-announces-fda-approval-and-u-s-launch-of-besremi-pen-ropeginterferon-alfa-2b-njft-for-polycythemia-vera/
- https://www.jnj.com/media-center/press-releases/chmp-recommendation-advances-johnson-johnsons-tecvayli-teclistamab-plus-daratumumab-as-a-potential-standard-of-care-for-relapsed-refractory-multiple-myeloma
- https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-recommended-chmp-approval-0
- https://www.prnewswire.com/news-releases/curis-announces-eleven-active-clinical-sites-in-takeaim-cll-study-reaffirms-patient-dosing-guidance-and-reports-stockholder-approval-of-reverse-stock-split-302811922.html