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Presentations At The AACR Annual Meeting (April 10-15): AGEN, ALPN, CDAK, GLYC...

virtualmeet 03apr21 lt

The American Association for Cancer Research, or AACR, is a nonprofit organization that was established in 1907 with the goal of preventing and curing cancer through research, education, communication, and collaboration.

The AACR has over 48,000 members from 127 countries and territories, including laboratory, translational, and clinical researchers, other health care practitioners, and cancer advocates.

Many scientific conferences and educational workshops are hosted by the AACR annually. This year, the virtual Annual Meeting will be presented over two one-week periods - April 10-15 and May 17-21, 2021.

The companies listed below are expected to give presentations at the AACR Annual Meeting, which will be held April 10-15.

1. Agenus Inc. (AGEN)

Agenus is an immuno-oncology company developing checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections.

The company will be presenting new data from a phase I/II trial of AGEN1181 as monotherapy and in combination with another drug candidate Balstilimab in subjects with advanced solid tumors at the American Association for Cancer Research (AACR) Annual Meeting.

According to the phase I/II trial results reported in February, AGEN1181 demonstrated activity in difficult-to-treat tumors without the neuroendocrine or significant liver toxicities commonly observed with the currently-approved CTLA-4 antibody Yervoy.

AGEN closed Thursday's trading at $2.87, up 5.51%.

2. Alpine Immune Sciences Inc. (ALPN)

Alpine Immune is a clinical stage biopharmaceutical developing protein-based immunotherapies to treat cancer and autoimmune and inflammatory diseases.

The company's clinical programs include ALPN-101 for lupus, under a phase 2 trial, and ALPN-202 for advanced malignancies, under a phase I trial, dubbed NEON-1.

The progress of the phase I NEON-1 trial is scheduled to be discussed at the American Association for Cancer Research (AACR) Virtual Annual Meeting on Apr.10.

ALPN closed Thursday's trading at $10.78, up 1.70%.

3. Cardiff Oncology Inc. (CRDF)

Cardiff Oncology is a clinical-stage biotechnology company developing new treatment options for cancer patients.

The lead investigational asset is Onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, being developed in combination with standard-of-care chemotherapy and targeted therapeutics.

A phase II study of Onvansertib in combination with Abiraterone and Prednisone in patients with metastatic castration-resistant prostate cancer is ongoing. According to updated results from the phase II trial, presented in February, increasing the number of days of treatment with Onvansertib from 5 to 14 in a 21-day cycle was associated with a greater than two-fold increase (29% to 63%) in disease control rate.

Another indication for which Onvansertib is being explored is KRAS-mutant metastatic colorectal cancer.

A phase I/II trial of Onvansertib in combination with FOLFIRI/Avastin for second line treatment of metastatic colorectal cancer patients with a KRAS mutation is ongoing.
An Expanded Access Program (EAP) to access Onvansertib in combination with standard-of-care FOLFIRI and Avastin for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer who are not able to participate in the ongoing clinical trial is also underway.

Additional observations from the Expanded Access Program for Onvansertib in KRAS-mutated metastatic colorectal cancer are expected to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, taking place virtually from April 10-15, 2021.

CRDF closed Thursday's trading at $9.64, up 4.10%.

4. Codiak BioSciences Inc. (CDAK)

Codiak BioSciences is a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines.
The company's clinical programs include exoSTING for the treatment of solid tumors and exoIL-12 for the treatment of early stage cutaneous T cell lymphoma.

exoSTING is under a phase 1/2 clinical trial for the treatment of advanced/metastatic, recurrent and injectable solid tumors.

exoIL-12 has been studied in healthy volunteers in a phase I study and initial data were reported in February of this year.

The full pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 phase I clinical trial is slated to be presented at the American Association for Cancer Research (AACR) Annual Meeting, to be held April 10-15, 2021.

CDAK closed Thursday's trading at $14.55, down 3.51%.

5. Greenwich LifeSciences Inc. (GLSI)

Greenwich LifeSciences is a clinical-stage biopharmaceutical company developing an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery.

The company's lead product candidate is GP2, a phase III-ready immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery.

In December 2020, the company presented phase IIb clinical trial efficacy data, including clinical outcome and recurrence rate data, which showed that there was a 100% disease survival over 5 years of follow-up if the patients received their primary GP2 treatments following surgery and Herceptin treatment.

The final 5 year analysis of immune response over time for all patients in a phase IIb clinical trial of GP2 for the prevention of recurring breast cancer are expected to be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021.

GLSI closed Thursday's trading at $34.72, up 1.85%.

6. GlycoMimetics Inc. (GLYC)

GlycoMimetics is a hematology-oncology focused biotechnology company.

The company's lead product candidate is Uproleselan, which is under a phase III trial in patients with relapsed/refractory acute myeloid leukemia in the U.S., Australia and in Europe. Enrollment in the trial is expected to be completed in the second half of 2021.

Another phase III clinical trial, which is designed to evaluate Uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, sponsored by the NCI, is also ongoing.

Up next is GMI-1359, which is in a phase Ib proof-of-concept study in advanced breast cancer, with evidence of biologic activity having been observed.

The company will be presenting interim analysis of the phase 1b proof-of-concept study of GMI-1359 at the American Association of Cancer Research (AACR) 2021 Annual Meeting on April 10.

GLYC closed Thursday's (Apr.1, 2021) trading at $3.17, up 5.32%.

7. Iovance Biotherapeutics Inc. (IOVA)

Iovance is a late-stage biotechnology company developing T cell-based immunotherapies for the treatment of patients with solid tumors and blood cancers.

The lead investigational product is Lifileucel, a tumor infiltrating lymphocyte therapy, which is derived from a patient's own immune cells called lymphocytes that have come to the site of tumor to kill the tumor.

Lifileucel is under pivotal phase II trials in metastatic melanoma, dubbed C-144-01, and advanced cervical cancers as well as in a registration-supporting study in non-small cell lung carcinoma.

The C-144-01 study is comprised of 4 cohorts, with each cohort of patients receiving different forms of the tumor-infiltrating lymphocyte (TIL) therapy Lifileucel.

The long-term interim data from Cohort 2 in the C-144-01 clinical study in advanced melanoma is expected to be presented at the upcoming American Association for Cancer Research (AACR) 2021 Annual Meeting on Apr.10.

IOVA closed Thursday's trading at $32.22, up 1.77%.

8. iTeos Therapeutics Inc. (ITOS)

iTeos Therapeutics is a clinical-stage biopharmaceutical company developing a new generation of highly differentiated immuno-oncology therapeutics for patients.

The company has two clinical-stage product candidates, Inupadenant (EOS-850) and EOS-448.

Inupadenant (EOS-850) is currently in a multi-arm phase I/IIa clinical trial in adult patients with advanced solid tumors. EOS-448 is under a phase I/IIa clinical trial in multiple advanced solid tumors.

Initial data from the phase I/IIa clinical trial of EOS-448 in multiple advanced solid tumors is scheduled to be presented at American Association for Cancer Research Annual Meeting on April 12.

ITOS closed Thursday's trading at $35.31, up 3.31%.

9. Molecular Templates Inc. (MTEM)

Molecular Templates is a clinical-stage company developing targeted biologic therapeutics based on its proprietary drug platform technology, known as engineered toxin bodies, or ETBs.

There are four clinical stage candidates in the pipeline - MT-5111 targeting HER2, TAK-169 targeting CD38 in co-development with Takeda, MT-6402 with antigen seeding targeting PD-L1, and MT-3724, for which the company is working to resolve the FDA partial clinical hold.

Last December, the company reported encouraging data from 5 cohorts of its phase I study of MT5111, involving patients with metastatic breast cancer, metastatic biliary tract carcinoma, metastatic pancreatic cancer, metastatic colon adenocarcinoma, and metastatic gastroesophageal junction adenocarcinoma. A sixth cohort, which is a HER2positive breast cancer expansion cohort, is planned to be initiated in 1H21.

The company expects to present the December 2020 interim Phase 1 data of MT5111 at the AACR Annual Meeting, being held April 10-15.

MTEM closed Thursday's trading at $12.44, down 1.43%.

10. Pieris Pharmaceuticals Inc. (PIRS)

Pieris Pharma is a clinical-stage biotechnology company developing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications.

The company has two clinical drug candidates - Cinrebafusp alfa (formerly known as PRS 343) and PRS-060.

Cinrebafusp alfa, as monotherapy and in combination with Atezolizumab, is currently in phase I studies for the treatment of HER2-positive solid tumors.

Last September, the company presented a clinical data update from the phase I monotherapy and Atezolizumab combination studies of PRS-343 for the treatment of HER2-positive solid tumors.

According to the results presented then, clinical benefit was observed in both trials, including one confirmed complete response and three partial responses in the monotherapy trial and four confirmed partial responses in the Atezolizumab combination trial.

Additional clinical benefit and safety data from the highest dose cohort and updated biomarker data across all active dose cohorts from Cinrebafusp alfa phase 1 monotherapy study is expected to be presented at American Association for Cancer Research Annual Meeting 2021.

The company is preparing for the phase II study of Cinrebafusp alfa, which is expected to begin in the summer of 2021.

PRS-060, also known as AZD1402, partnered with AstraZeneca, is under a phase II study in subjects with asthma controlled on medium dose inhaled corticosteroids.

PIRS closed Thursday's trading at $2.59, up 0.78%.

11. TCR2 Therapeutics Inc. (TCRR)

TCR2 Therapeutics is a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer.

The company's clinical programs include TC-210 and TC-110.

TC-210 is under a phase 1/2 clinical trial, focusing on four indications - non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma (MPM) and cholangiocarcinoma.

TC-110 is also under a phase 1/2 clinical trial, and it focuses on three specific areas - adult acute lymphoblastic leukemia (ALL), aggressive non-Hodgkin's lymphoma (NHL), and indolent NHL.

New clinical data from the phase I portion of the phase I/II trial of TC-210 is scheduled to be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting.

TCRR closed Thursday's trading at $22.89, up 3.67%.

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