Biotech General Discussion

We used our BPIQ platform to identify smid-cap biopharma cancer companies with a major readout upcoming in September. We found 11 of them! See the table and text below for more details, likely to be the big or suspected stock movers, classified by implied volatility data.

SMMT

- Ivonescimab / NSCLC (PDL1-positive) / Ph3 ✔️

- Ivonescimab is a bispecific antibody that binds PD-1 & VEGF. PD-1 & VEGF blockades have the potential to drive synergistic anti-tumor activity. The Ph3 HARMONi-2 trial in NSCLC demonstrates clinically meaningful PFS benefit and is the first drug to achieve benefit over Pembrolizumab monotherapy.

NUVB

- Taletrectinib / NSCLC (ROS1-positive) / Ph2 ✔️

- Oral, potent, selective, next-generation ROS1 inhibitor differentiated by response rate, duration of response, and tolerability. Currently completing two pivotal studies in Non-small cell lung cancer. The latest TRUST-II study data will be presented at #WCLC2024 in September.

MGNX

- Vobramitamab duocarmazine (vobra duo) / mCRPC / Ph2 ✔️

- vobra duo 📸 - An antibody-drug conjugate (ADC) that targets B7-H3 & studied in patients with metastatic Castration-resistant Prostate Cancer (mCRPC). Completed enrollment of the TAMARACK study in Q4 '23 & has reached its landmark primary endpoint of 6-month rPFS rate. Study participants are monitored for adverse events, disease progression, and survival.

-Updated TAMARACK safety and efficacy data at #ESMO2024 & mature efficacy findings in H2 '24.

- Prior results 📸

BCYC

- BT8009 (zelenectide pevedotin) / Metastatic bladder (urothelial) cancer / Ph2/3

- zelenectide pevedotin, First-in-class BTC® molecule, potential to treat Nectin-4 expressing tumors. Abstract with updated monotherapy data in mUC accepted for poster presentation at ESMO Congress 2024 being held on September 13-17,2024.

PSTV

- 186RNL™ (BMEDA-Chelated Rhenium NanoLiposome) / Glioblastoma / Ph2

- Rhenium-186 is a nuclear reactor-produced 1.8 mm average radiation path length of beta energy. Suitable for treating small and medium size tumors that include glioblastoma (GBM). Previous studies successfully reduced tumors without significant toxicity. ReSPECT-GBM Phase 2 trial update is upcoming at CNS Conference & interim data in Q4 '24.

- Prior results 📸

AFMD

- AFM24 & atezolizumab / NSCLC (EGFRmut) / Ph2 ✔️

- AFM24 is an EGFR-binding ICE® molecule that kills EGFR-expressing tumors. The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity. ORR and PFS data from EGFRmut cohort is upcoming.

EVAX

- EVX-01 + pembrolizumab/ Metastatic Melanoma / Ph2

- EVX-01 is a peptide-based neoantigen cancer therapy intended for the treatment of melanoma. It has shown promising clinical results, with 67% ORR from Phase 1 and the Ph2 trial is ongoing. One-year clinical data readout at #ESMO2024 in September.

- Prior results 📸

AFMD

- AFM13 (Acimtamig) + AB-101/ Hodgkin Lymphoma (cHL) / Ph2 ✔️

- Acimtamig is a first-in-class innate cell engager molecule. Monotherapy & Combination study with Allogenic NK cells has delivered robust POC. Data readout from the 12 patients in cohorts 1 and 2 is upcoming this month.

GRTS

- GRANITE /MSS-CRC / Ph2/3 ✔️

- GRANITE is a personalized vaccine program that generates Neoantigen-Specific T Cells, kills tumor cells, and appeared to prolong OS. Preliminary results from the ongoing randomized Phase 2 study suggest meaningful clinical benefit in front-line metastatic microsatellite-stable colorectal cancer (MSS-CRC) and report mature progression-free survival (PFS) data in 3Q 2024.

BDTX

- BDTX-1535/ NSCLC (2L/3L EGFRm) / Ph2 ✔️

- Oral, brain-penetrant masterkey inhibitor of oncogenic EGFR mutations. Initial Phase 2 data in 2L/3L NSCLC patients on track for Q3 2024.

SLS

- SLS009 (GFH009) +/- venetoclax & azacitidine / Acute Myeloid Leukemia (AML) / Ph2a ✔️

- SLS009 is a highly selective CDK9 inhibitor. It is used synergistically with venetoclax to block the antiapoptotic effects of both MCL1 and BCL2. Additional updates upcoming.

 Footnote: ✔️ Confirmed by implied volatility data.

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#SMMT #NUVB #MGNX #BCYC #PSTV #AFMD #GRTS #BDTX #SLS

This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.

Article history:

First published 09/05/24 SK & EJV