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ESMO Congress Data Readouts: ADAP, AYLA, MGNX, DCPH...

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The European Society for Medical Oncology (ESMO) Congress is a yearly event held in Europe that offers a platform for the presentation of cutting edge clinical data, which support oncologists in providing quality care for cancer patients.

The event, which is usually attended by nearly 30,000 clinicians, researchers, oncology nurses, patient advocates, journalists and representatives of the pharmaceutical industry from all over the world, is scheduled to be held this year between Sep.16 and Sep.21.

The following are some of the companies that will be making presentations at the ESMO Congress.

1. Adaptimmune Therapeutics plc (ADAP)

Adaptimmune will present an update from its phase I SURPASS trial at the ESMO congress on Sep.16.

SURPASS is a phase I trial evaluating the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

As of the August 2nd data cut-off, 25 patients had received ADP-A2M4CD8, and 23 patients had at least one post-baseline scan, according to the company.

Cash position:

As of June 30, 2021, Adaptimmune had cash and cash equivalents of $50.5 million.

ADAP closed Friday's trading at $6.25, up 0.64%.

2. Ayala Pharmaceuticals Inc. (AYLA)

Ayala Pharma will present preliminary data from the 6mg cohort of its ongoing phase II trial of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma harboring Notch-activating mutations, dubbed ACCURACY, at the ESMO, on September 16.

Interim data from the ACCURACY trial, reported last September, showed meaningful clinical activity of AL101 4mg monotherapy with deep responses and 68% disease control rate across 40 evaluable patients, according to the company.

Adenoid Cystic Carcinoma (ACC) is a rare malignancy of the secretory glands including salivary glands, accounting for about 10% of all salivary gland tumors with an annual incidence of 3,400 in the U.S. There is currently no approved standard of care for patients with recurrent/metastatic ACC.

Cash position:

The company's cash and cash equivalents were $44.4 million as of June 30, 2021.

AYLA closed Friday's trading at $14.07, up 3.08%.

3. Zymeworks Inc. (ZYME)

Zymeworks will be presenting new data from a phase II clinical trial evaluating Zanidatamab with chemotherapy in first line HER2-positive Gastroesophageal Adenocarcinoma at the ESMO on Sep.16.

In May of this year, the FDA cleared the company's phase III clinical trial for Zanidatamab in combination with chemotherapy with or without BeiGene's Tislelizumab as a first line treatment for patients with HER2-positive unresectable locally advanced or metastatic Gastroesophageal Adenocarcinoma.

Cash position:

As of June 30, 2021, Zymeworks had $359.8 million in cash.

ZYME closed Friday's trading at $32.40, up 0.87%.

4. Gritstone bio Inc. (GRTS)

Gritstone bio will be providing an update on its phase I/II trial evaluating GRANITE as a late-line therapy for metastatic microsatellite stable colorectal cancer, gastro esophageal cancer and non-small cell lung cancer at the ESMO Annual Meeting on September 17.

GRANITE, an individualized neoantigen-based immunotherapy, is the company's lead oncology product candidate. Enrollment is complete in the phase II expansion cohorts of the phase I/II trial.

Cash position:

Cash, cash equivalents, marketable securities and restricted cash were $176.2 million as of June 30, 2021.

GRTS closed Friday's (Sep.10, 2021) trading at $12.17, up 3.93%.

5. MacroGenics Inc. (MGNX)

MacroGenics will be providing further updates from its phase I dose expansion study of MGC018 in patients with metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC) at the ESMO.

The company presented updated clinical data from the phase I MGC018 study in June of this year, demonstrating anti-tumor activity in patients with melanoma and metastatic castration-resistant prostate cancer.

MacroGenics is also evaluating Margetuximab in combination with Retifanlimab in a phase II/III trial advanced gastric and gastroesophageal junction cancer, dubbed MAHOGANY. Interim safety and efficacy data on all 40 patients enrolled in the first part of Module A of the MAHOGANY study are expected to be reported at the ESMO Congress.

Cash position:

Cash, cash equivalents and marketable securities as of June 30, 2021 were $297.3 million.

MGNX closed Friday's trading at $25.10, up 9.13%.

6. Aileron Therapeutics Inc. (ALRN)

Aileron will present preliminary data from its ongoing phase I study of ALRN-6924 in healthy volunteers at the ESMO.

ALRN-6924 is a novel chemoprotective medicine being developed to treat and protect healthy cells in patients with cancer that harbors p53 mutations to reduce or eliminate chemotherapy-induced side effects.

The company will also be presenting final data from its completed phase Ib study of ALRN-6924 in patients with small cell lung cancer receiving second-line Topotecan treatment.

In October 2020, Aileron presented positive clinical data from the phase Ib trial in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe neutropenia, anemia and thrombocytopenia in patients with p53-mutated SCLC treated with second-line topotecan.

The final data set from this trial, which Aileron will present at ESMO, includes results from 13 additional patients, including two new cohorts of seven patients.

Cash position:

Cash, cash equivalents and investments on June 30, 2021 were $59.5 million.

ALRN closed Friday's trading at $1.27, up 6.72%.

7. Deciphera Pharmaceuticals Inc. (DCPH)

Deciphera Pharma will be presenting updated data from its ongoing phase I/II study of Vimseltinib in patients with Tenosynovial Giant Cell Tumor at the ESMO Congress.

Tenosynovial giant cell tumors (TGCTs) are a group of rare, benign tumors that involve the synovium, bursae and tendon sheath. Synovium is the thin layer of tissue or membrane that covers the inner surface of the joint spaces and the bursae and tendon sheaths. The bursae are small fluid-filled sacs that cushion bones, tendons and muscles around the joints. A tendon sheath is a layer membrane that covers a tendon. Tendons are fibrous tissue that connects muscle to bone. (Source: NORD)

Daiichi Sankyo's Turalio, which was greenlighted by the FDA in August 2019, is the only approved drug for tenosynovial giant cell tumor.

Preliminary results from the phase I/II study of Vimseltinib had shown highly encouraging signs of antitumor activity in TGCT patients, according to the company.

The company will also be presenting updated data from its phase Ib/II study evaluating Rebastinib in combination with paclitaxel in endometrial and platinum-resistant ovarian cancer at the ESMO.

Preliminary results from the phase Ib/II study of Rebastinib in combination with Paclitaxel had demonstrated encouraging anti-tumor activity and favorable tolerability in patients with advanced endometrial cancer, according to Deciphera.

Cash position:

Cash, cash equivalents, and marketable securities totaled $451.0 million at June 30, 2021.

DCPH closed Friday's trading at $32.79, up 3.37%.

8. Syros Pharmaceuticals Inc. (SYRS)

Syros will be presenting additional dose-escalation data, including clinical activity data, from an ongoing phase I trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations, at the ESMO.

SY-5609 has shown robust anti-tumor activity, including complete regressions, in preclinical models of breast, colorectal, lung and ovarian cancers at doses below the maximum tolerated doses, according to the company.

Early dose-escalation data, reported last October, demonstrated proof-of-mechanism at tolerable doses.

Cash position:

Cash, cash equivalents and marketable securities as of June 30, 2021 were $195.3 million.

SYRS closed Friday's trading at $5.07, down 3.98%.

9. NGM Biopharmaceuticals Inc. (NGM)

NGM Biopharma is expected to report interim results from a dose-finding portion of its phase 1a/1b study of NGM120 at the ESMO.

The phase 1a/1b study, initiated in February 2020, is evaluating the safety, tolerability and pharmacokinetics of NGM120 as a monotherapy in patients with select advanced solid tumors (Cohort 1) and in combination with gemcitabine and Abraxane in patients with metastatic pancreatic cancer (Cohort 2).

Cash position:

The company's cash, cash equivalents and short-term marketable securities were $390.6 million as of June 30, 2021.

NGM closed Friday's trading at $23.36, up 9.93%.

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