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4 Biotech Stocks To Watch

Biotech stocks are having a tough time in this risk-off market.

We have a Burial Cross on IBB and IBB continues in a downtrend channel.

Coming up is ASCO, the main oncology event of the year for biotechnology stocks. Detailed and updated clinical trial data will be delivered at the conference from May 31 to June 4, so a number of stocks will be closely watched leading up to and during the conference.

Below are the top 4 biotech stocks to watch in the coming weeks.

Top 4 Biotech Stocks To Watch Next Week

AZN Stock

Lynparza (POLO) for Pancreatic cancer. Phase 3 data released on February 26, 2019 where the PFS primary endpoint met. Data to be presented at ASCO on June 2, 2019.

AstraZeneca will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 31 May to 4 June 2019.

In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers. Highlights include:

  • Late-breaking results from the Lynparza POLO trial, the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, a devastating diagnosis with critical unmet medical need. This is the first Phase III trial to validate a targeted treatment in a biomarker-selected population of pancreatic cancer.
  • Results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment. This data underscores Lynparza’s clinical benefit irrespective of line of treatment for women with BRCAm advanced ovarian cancer and the importance of knowing BRCA status at diagnosis.
  • Three-year overall survival (OS) data from the Phase III PACIFIC trial providing new evidence of the long-term survival benefit for Imfinzi in unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease had not progressed following chemoradiation therapy. Imfinzi is the only immunotherapy to demonstrate significant OS benefits in this curative-intent setting, and this data reaffirms the PACIFIC regimen as the standard of care for these patients.

Dave Fredrickson, Executive Vice President, Oncology, said: “AstraZeneca continues to break traditional treatment boundaries through new targeted approaches and the prioritisation of earlier intervention. This year at ASCO, our data for Lynparza in BRCA-mutated metastatic pancreatic cancer and for Imfinzi in unresectable Stage III non-small cell lung cancer illustrate our ambition to change medical practice for better patient outcomes.”

CLDX Stock

CDX-3379 for recurrent/metastatic head and neck squamous cell cancer.

Phase 2 data due at ASCO June 1, 2019.

“Celldex presented positive data across multiple programs at AACR in April, including from our promising CDX-1140 program,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “We have successfully cleared a critical hurdle for CD40 agonists, reaching dose levels with good systemic exposure that are biologically active and well tolerated. Importantly, these dose levels exceed the maximum tolerated dose levels reported with other CD40 agonists, which we believe may support enhanced tissue and tumor penetration. We are also pleased with the results to date in our unique combination of CDX-1140 with CDX-301, where CDX-301 amplifies the numbers of dendritic cells in patients prior to their activation with CDX-1140. To this end, we continue to believe that CDX-1140 can play a very important role in cancer immunotherapy, especially in combination with drugs that target other key immune pathways and are actively planning additional combination cohorts to begin later this year.”

“We also recently completed the first stage of the Phase 2 study of CDX-3379 and are pleased that this portion of the study met the clinical criteria that are required to progress the study to the next stage. We look forward to presenting more detailed data from this study at ASCOin early June. We are currently conducting a thorough analysis of the overall CDX-3379 program in collaboration with our clinical advisors to determine the optimal path for this candidate. In conclusion, we continue to make considerable progress across our entire pipeline and look forward to updating shareholders over the course of the year,” said Marucci.

Recent Highlights:

  • CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

    • Enrollment is nearing completion in the monotherapy arm and progressing on track in the CDX-301 combination arm of the Phase 1 dose-escalation study of CDX-1140 with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. Seven monotherapy dosing cohorts ranging from 0.01 to 1.5 mg/kg have been completed and the dose limiting toxicity (DLT) window successfully cleared; patients are currently being enrolled in the final monotherapy cohort at 3.0 mg/kg. Two combination cohorts in solid tumors (0.09 and 0.18 mg/kg) with CDX-301 have been completed and the DLT window successfully cleared. Patients enrolled in the third cohort at 0.36 mg/kg have been dosed and are currently completing the DLT observation period. Assuming successful clearance, the 0.72 mg/kg combination cohort with CDX-301 should open shortly.

    • Additional patient enrollment (backfill) has been initiated to characterize the effects of CDX-1140 in the tumor microenvironment and expansion cohorts are being actively planned. Future combination opportunities include PD-1 or PD-L1 inhibitors, chemotherapy, radiation therapy and Celldex’s potent CD27 agonist monoclonal antibody varlilumab.

    • Data from the ongoing study were presented at the American Association for Cancer Research (AACR) Annual Meeting 2019 in April and support that CDX-1140 is a potent activator of CD40 and can be safely administered at doses that Celldex believes will support good tissue and tumor penetration. 

  • CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including head and neck squamous cell cancer (HNSCC) and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.

    • As previously reported, enrollment is complete in the first stage of the Phase 2 study (n=13) of CDX-3379 in advanced HNSCC in combination with Erbitux® in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy. According to the study’s Simon two-stage design, if at least one patient achieves an objective response in the first stage, enrollment may progress to the second stage. While a confirmed complete response has been documented, Celldex is currently conducting a comprehensive review to inform decisions on potential future development. Celldex plans to present updated data from the study in a poster session at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting on Saturday, June 1, 2019.

  • Celldex continues to advance a robust preclinical portfolio with data from multiple programs presented at AACR.

    • Data from the Company’s CDX-527 bispecific candidate and its TAM program were presented at the AACR Annual Meeting 2019 in April. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. TAM receptors (Tyro3, Axl, MerTK) are receptor tyrosine kinases (RTKs) expressed in innate immune cells. These receptors have been gaining importance in the immunotherapy field due to their role as checkpoint molecules on macrophages, dendritic cells, and other immune cells, where they can negatively regulate anti-tumor immunity.

MGNX Stock

Margetuximab SOPHIA study for Metastatic breast cancer. Phase 3 data released February 6, 2019 met primary endpoint. Detailed data due at ASCO June 4, 2019.

“In February, we reported topline results from SOPHIA showing that in the Phase 3 trial, progression-free survival was prolonged following treatment with margetuximab and chemotherapy compared to trastuzumab with chemotherapy. We look forward to presenting detailed results at ASCO. In addition, we anticipate submitting a BLA for this program to the FDA in the second half of 2019. If approved by regulators, margetuximab could offer the potential of a new treatment option for patients living with HER2-positive metastatic breast cancer in a third line and beyond setting where there are currently no FDA-approved therapies. In seeking to address unmet needs of patients with HER2-postive cancers beyond breast cancer, we plan to initiate in the second half of 2019 a registration-directed trial to evaluate margetuximab for treating gastric cancer patients in the frontline setting,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.

“Mechanistically, we believe the results achieved in the SOPHIA study have validated our Fc-optimization technology, also used in enoblituzumab, our investigational monoclonal antibody targeting B7-H3,” continued Dr. Koenig. “To date, we have made tremendous progress with our immuno-oncology pipeline of nine clinical product candidates with multiple molecules demonstrating clinical proof of concept to support ongoing and/or planned registration studies.”

Key Pipeline Updates

Margetuximab. Recent updates related to the Company’s investigational Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2) include:

  • Oral Presentation of SOPHIA Data at ASCO; Plans to Submit BLA in 2H2019: In February 2019, MacroGenics announced that SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer, met the trial’s first sequential primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. An abstract containing data from SOPHIA was selected for presentation in an oral session to be held on Tuesday, June 4, 2019 at the American Society of Clinical Oncology(ASCO) Annual Meeting. MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for margetuximab, based on the PFS results, in the second half of 2019.
  • Additional Validating Mechanistic Data in Posters at AACR and ASCO: Data presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2019 showed improved Fc-dependent activity of margetuximab compared to trastuzumab in vitro. These preclinical data validate the molecule’s underlying mechanism of action and the Company’s Fc-optimization platform. In addition, an abstract containing data describing HER2-specific immunity observed in patients with HER2-positive cancers treated with margetuximab in the Phase 1 trial was selected for presentation in a poster session at ASCO on Sunday, June 2, 2019.
  • Plans to Initiate Front-line Gastric Cancer Trial in 2H2019: At the ASCO Gastrointestinal Cancers Symposium in January 2019, data were presented demonstrating encouraging anti-tumor activity and acceptable safety and tolerability of margetuximab in combination with an anti-PD-1 mAb in a Phase 2 clinical trial in patients with HER2-positive gastric or gastroesophageal junction cancer. MacroGenics and its partner in Greater China, Zai Lab, expect to initiate a Phase 2/3 registration-directed clinical trial of margetuximab in combination with checkpoint inhibitor molecules, including MGA012 (anti-PD-1 mAb) and MGD013 (bispecific PD-1 x LAG-3 DART® molecule) in the second half of 2019.

NKTR Stock

NKTR-214 and nivolumab sarcomas. Phase 2 data to be presented at ASCO June 3, 2019.

Nektar Therapeutics announced five abstracts accepted for presentation at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held from May 31 to June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois. The abstracts published in advance of the ASCO Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time today on the ASCO meeting website at http://www.abstract.asco.org.

“We are pleased to announce the presentation of five abstracts for our lead I-O investigational candidate, bempegaldesleukin, which includes important translational clinical data for the combination of bempeg with nivolumab as well as early data from an investigator-sponsored pilot study conducted in patients with heavily pre-treated, rapidly progressing and refractory sarcomas,” said Stephen Doberstein, Ph.D., Chief Research & Development Officer at Nektar. “We are also highlighting several registrational trials underway for bempeg plus nivo in patients with melanoma and RCC. We believe bempeg has a unique and non-overlapping mechanism which synergizes with various immunotherapies, including checkpoint inhibitors, to improve the body’s cancer-fighting immune response and potentially improve treatment outcomes for patients with a variety of cancers.”  

Details of abstract presentations are as follows:

Developmental Immunotherapy and Tumor Immunobiology
Abstract #2584/Poster Board #228* 
Title: “Overcoming genetically-based resistance mechanisms to PD-1 blockade”, Torrejon, D., et al. 
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A
*2019 ASCO Annual Meeting Merit Award recipient

Abstract #2623/Poster Board #267
Title: “Baseline tumor-immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab”, Hurwitz, M., et al. 
Date:Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A

Emerging Combinations in Sarcoma Immunotherapy
Abstract #11010
Title: “Pilot study of bempegaldesleukin (NKTR-214) and nivolumab in patients with sarcomas”
Presenter: Sandra D’Angelo, M.D., Memorial Sloan Kettering Cancer Center
Date: Monday, June 3, 2019, 11:30 a.m. – 1:00 p.m. Central Time
Location: McCormick Place, S100a

Details of Trials in Progress poster presentations are as follows:

Melanoma/Skin Cancers
Abstract TPS9601/Poster Board #168b (Trials in progress (TiP) abstract)
Title: “CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL)”, Khushalani, N., et al. 
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

Genitourinary (Nonprostate) Cancer
Abstract TPS4595/Poster Board #416b (Trials in progress (TiP) abstract)
Title: “A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s choice) in patients with previously untreated advanced renal cell carcinoma”, Tannir, N., et al. 
Date:Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

Bempegaldesleukin is an investigational, first-in-class, CD122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. Bempegaldesleukin stimulates these cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3 Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

Nektar Therapeutics is a research-based, development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.