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Movers And Shakers At ESMO 2019: Immunomedics, G1 Therapeutics, Seattle Genetics And More

Shanthi Rexaline

The five-day European Society of Medical Oncology, or ESMO, Congress 2019 is set to conclude Tuesday in Barcelona, Spain.

Touted as a congress where the exchange of translational cancer science of excellence takes place, the gathering brings together pharma and biotech companies focused on oncology research along with other stakeholders.

The following are ESMO presentations that are making an impact in the stock market. 

Immunomedics, Inc. (NASDAQ: IMMU)

Immunomedics presented interim data from Cohort 1 of the Phase 2 TROPHY-U-01 trial — which evaluated sacituzumab in third-line treatment of advanced unresectable/metastatic urothelial cancer — which showed efficacy data inferior to enfortumab vedotin, or EV-103.

EV-103 is being co-developed by Astellas Pharma Inc (OTC: ALPMF) and Seattle Genetics, Inc. (NASDAQ: SGEN).

As opposed to a 29% objective response rate, or ORR, for sacituzumab, enfortumab vedotin showed 44% ORR based on data presented at ASCO 2019.

"While IMMU-132 may exhibit a longer duration of response (DoR) and/or progression free survival (PFS) than EV's 7.6-month DoR and 5.8-month PFS, we must account for the seemingly better patient demographics in TROPHY-U-01," H.C. Wainwright analyst Raghuram Selvaraju said in a Monday note. 

With side effect profiles and mechanisms of resistance generally not overlapping between IMMU-132 and enfortumab vedotin, the analyst said it is likely that when a patient progresses on the first treatment deployed, the other agent might also be used.

"Overall, we remain optimistic about IMMU-132's chances for Breakthrough Therapy Designation and accelerated FDA approval," Selvaraju said.

At last check, shares of Immunomedics were slipping 10.54% to $12.81. 

H..C. Wainwright has a Buy rating on Immunomedics with a $26 price target. 

G1 Therapeutics Inc (NASDAQ: GTHX)

G1 Therapeutics presented Phase 2 data for trilaciclib in patients with metastatic triple-negative breast cancer, or mTNBC, who are receiving chemotherapy.

Trilaciclib, a CDK4/6 inhibitor, is meant to treat damage to bone marrow caused by chemotherapy and improve patient outcomes.

The groups receiving trilaciclib showed an overall survival of 20.1 months for patients with TNBC receiving trilaciclib with gemcitabine/carboplatin versus 12.6 months in patients receiving gemcitabine/carboplatin chemotherapy alone.

When assessed in another indication, extensive-stage small cell lung cancer, trilaciclib did not yield impressive results.

Of the total of 122 patients enrolled in the studies, patients receiving trilaciclib had an ORR of 66.7% compared to 56.8% for patients who received a placebo.

The company also presented data on an oral selective estrogen receptor degrader in postmenopausal women with ER+/HER2- locally advanced or metastatic breast cancer and Phase 1b data for lerociclib as a combo treatment for EGFRMUT non-small cell lung cancer.

H.C. Wainwright estimates revenues of $2.5 billion for trilaciclib and $488 million for lerociclib in 2027.

The firm has a Buy rating on G1 Therapeutics with a $72 price target.

The stock was down 26.17% at $25.08 at the time of publication. 

See also: The Week Ahead In Biotech (Sept. 29-Oct. 5): Conference Presentations, IPOs Hit Top Gear

Seattle Genetics, Inc. (NASDAQ: SGEN)

Seattle Genetics presented initial results from the Phase 1 study of EV-103 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy.

The study, which evaluated 45 patients, showed that 71% of patients with locally advanced or metastatic urothelial cancer had a confirmed response.

"These data are encouraging and support further exploration of a potential platinum-free combination of pembrolizumab and the investigational agent enfortumab vedotin," Roger Dansey, Seattle Genetics' chief medical officer, said in a statement. 

Seattle Genetics shares were rallying 11.79% to $84.96 at the time of publication. 

Merck

Merck made multiple presentations at the ESMO.

The Phase 3 KEYNOTE-522 trial evaluated a regimen of neoadjuvant Keytruda plus chemotherapy followed by adjuvant Keytruda as monotherapy in patients with early stage triple-negative breast cancer, or TNBC.

The treatment arm recorded a statistically significant increase in pathological complete response, or pCR, of 64.8% compared with 51.2% for neoadjuvant chemotherapy.

In the other dual primary endpoint of event-free survival, with a median follow-up of 15.5 months, the treatment arm reduced the risk of the risk of progression in the neoadjuvant phase and recurrence in the adjuvant phase by 37%.

Merck also presented data from trials with Lynparza, which it is co-developing with AstraZeneca plc (NYSE: AZN).

Late-stage results from the Phase 3 PROfound trial in men with previously treated metastatic, castration-resistant prostate cancer with a specific mutation showed a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival.

Merck shares were rallying 2.3% to $84.82 at the time of publication. 

Genocea Biosciences Inc (NASDAQ: GNCA)

Genocea presented immunological results from Part A of the Phase 1/2a study of its GEN-009 neoantigen vaccine candidate, which  showed confirmed immune activity in three different tumor types.

"As we continue to analyze the first-in-human immunological data of GEN-009, we continue to appreciate the differentiated profile of Genocea's ATLAS platform vs. comparables," H.C. Wainwright's Selvaraju said in a note. 

The company has commenced Part B portion of the study, with a preliminary readout expected in mid-2020.
H.C. Wainwright has a Buy rating on Genocea with a $32 price target.

Genocea shares were slipping 6.82% to $2.87 at the time of publication. 

Aileron Therapeutics Inc (NASDAQ: ALRN)

Aileron made a poster presentation of interim data from a Phase 2a trial evaluating ALRN-6924 in combination with Pfizer Inc. (NYSE: PFE)'s Ibrance for the treatment of patients with MDM2-amplified cancers.

In 17 liposarcoma patients, a disease control rate of 88% and a median PFS of 4.4 months was shown, with no partial responses or complete responses.

At last check, Aileron shares were slumping 16.66% to 69 cents. 

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