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Aptevo Therapeutics and Alligator Bioscience Present New Preclinical Data for ALG.APV-527 at the Society for Immunotherapy of Cancer 2019 Annual Meeting

On November 8, 2019 Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics and Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy reported that new preclinical data for ALG.APV-527 are being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting at the National Harbor, Maryland, November 6-10, 2019 (Press release, Aptevo Therapeutics, NOV 8, 2019, View Source [SID1234550769]).

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ALG.APV-527 is a novel immunotherapeutic candidate intended for the treatment of a variety of 5T4-positive solid tumors. It is designed to induce signaling through the co-stimulatory receptor 4-1BB (CD137), which is present on activated cytotoxic T cells and natural killer (NK) cells. Once activated, it is designed to promote potent and selective tumor-directed immune activation in the presence of the tumor associated antigen, 5T4, which is present on many different types of solid tumors.

The preclinical data presented at SITC (Free SITC Whitepaper) show that ALG.APV-527 selectively enhances T cell and NK cell responses in the presence of 5T4 in vitro and displays potent and sustained tumor suppression in vivo. The preclinical studies demonstrate that ALG.APV-527:

Enhances CD8+ T cell and NK function and proliferation preferentially over that of CD4+ T cells, upon 5T4-mediated crosslinking
In preliminary in vivo studies in a human 4-1BB knock in model, induces rejection of established murine bladder cancer cells expressing human 5T4 at doses of 20 µg in mice and induces anti-tumor immunological memory responses
Is well tolerated after repeated dosing in a GLP toxicology study above the expected human dose and displays an antibody-like half-life of up to 9.5 days
"We’re pleased that ALG.APV-527 continues to show promising preclinical results," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "The ability of ALG.APV-527 to induce potent anti-tumor T cell and NK cell activity suggests 4-1BB is an attractive target for designing new immuno-oncology therapeutics. Monospecific 4-1BB-directed antibodies have been challenged by dose-limiting liver toxicities. As a novel bispecific antibody ALG.APV-527 may circumvent these challenges and minimize systemic toxicity by stimulating 4-1BB function only when co-engaged with the tumor antigen, 5T4."

"The presented preclinical data strongly support a potent effect of ALG.APV-527 without compromising on safety. The data further strengthens our CTA package and we are eagerly looking forward to discuss this candidate with potential partners to take this exciting asset further into clinical development," commented Christina Furebring, Ph.D., Vice President Preclinical Development at Alligator.

The Alligator/Aptevo poster presentation, entitled "Potent Tumor-Directed T Cell Activation and Tumor Inhibition Induced by a 4-1BB x 5T4 ADAPTIR Bispecific Antibody" is being presented on Saturday, November 9, 2019 from 7:00 am – 8:30 pm ET.

About ALG.APV-527

ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo’s ADAPTIR bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD human scFv library. The ALG.APV-527 bispecific antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other part binding to the 5T4 protein displayed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.

eHealth, Inc. to Present at Upcoming Investor Conferences

On November 8, 2019 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange, reported that its senior management will deliver presentations at the following upcoming investor conferences (Press release, eHealthInsurance, NOV 8, 2019, View Source [SID1234550768]):

28th Annual Credit Suisse Healthcare Conference, on Tuesday, November 12, 2019 at 11:30 a.m. M.T. The conference is being held at The Phoenician Resort in Scottsdale, Arizona.
Stephens Nashville Investment Conference, on Thursday, November 14, 2019 at 1:00 p.m. C.T. The conference is being held at the Omni Nashville, Nashville, TN.
Interested investors can access the live audio webcast of the presentations at www.ehealthinsurance.com under Investor Relations. Please visit the website at least 15 minutes early to register, download, and install any necessary software. A replay of this event will be available on the company’s website shortly after the conclusion of the event and will remain available for 14 days.

eHealth will also hold one-on-one and small group meetings with institutional investors at the 10th Annual Craig-Hallum Alpha Select Conference, on Tuesday, November 12th, 2019. The conference is being held at Sheraton Times Square Hotel, New York, NY.

Checkpoint Therapeutics Announces Presentation of Anti-PD-L1 Cosibelimab Data at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 8, 2019 Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that new pharmacokinetic and target occupancy modeling data for cosibelimab (formerly referred to as CK-301) are being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, taking place in National Harbor, MD (Press release, Checkpoint Therapeutics, NOV 8, 2019, View Source [SID1234550767]).

The poster, entitled, "Semi-mechanistic PK and target-occupancy modeling to support dose justification for anti-PD-L1 clinical candidate CK-301 (TG-1501) in oncology patients," compares pharmacokinetic and tumor target occupancy data at steady state under various dosing regimens of cosibelimab to those of three marketed anti-PD-L1 monoclonal antibodies, atezolizumab, durvalumab and avelumab. The results demonstrate that cosibelimab dosed at 800 mg and 1200 mg once every two weeks or every three weeks is expected to achieve over 99% PD-L1 target occupancy throughout the dosing interval, which is comparable to atezolizumab and durvalumab, and higher than avelumab, at their approved doses. These data support the potential of cosibelimab’s once every two-week and every three-week dosing regimens to achieve and maintain the PD-L1 target occupancy required to restore T-cell function and an anti-tumor response.

These data follow the presentation of positive interim clinical results for cosibelimab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 in September. Checkpoint is currently enrolling cutaneous squamous cell carcinoma patients in an expanded cohort of its ongoing Phase 1 clinical trial to support an initial Biologics License Application submission for cosibelimab. Additional monotherapy and combination Phase 3 clinical trials are planned to expand the potential market opportunity for cosibelimab to multiple non-small cell lung cancer indications.

A copy of the poster presentation is available on the Publications page of the Pipeline section of Checkpoint’s website, www.checkpointtx.com.

Additional information on the meeting can be found on the SITC (Free SITC Whitepaper) website, www.sitcancer.org.

About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% target tumor occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (ADCC) for potential enhanced efficacy in certain tumor types.

Replimune Presents Initial Clinical Data with RP1 that Strongly Supports Expansion of Clinical Programs in Melanoma and Cutaneous Squamous Cell Carcinoma (CSCC)

On November 8, 2019 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it will present data from the Phase 1 part of its Phase 1/2 clinical trial of RP1 as monotherapy and in combination with Opdivo during a poster presentation at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) in National Harbor, Maryland (linked here) (Press release, Replimune, NOV 8, 2019, View Source [SID1234550766]). The Company has also separately released data from initial melanoma patients (linked here) and updated data from CSCC patients (linked here) treated in the Phase 2 part of the clinical trial.

As previously announced, an investor event will begin on November 8, 2019 at 6:30 p.m. ET to review this data. A link to the presentation can be found here and a simultaneous webcast will be available in the Investors and Media section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.

The data demonstrates that RP1 alone and in combination with Opdivo is well tolerated, with clear anti-tumor activity, and confirms the mechanism of action of RP1 alone and in combination with Opdivo. Based on the clinical activity seen, the Company is now planning a new clinical trial in melanoma patients who are refractory to anti-PD1 therapy, along with the previously announced expansion of its CSCC program to include a new clinical trial in solid organ transplant recipients.

"We are very pleased with the data showing that RP1 is well tolerated both alone and in combination with Opdivo, which was the primary objective of the Phase 1 part of the study," said Robert Coffin, Ph.D., President and CEO of Replimune. "In addition to being well tolerated, there was clear evidence of anti-tumor efficacy, particularly in the tumor types where further development of RP1 is focused, as well as strong biomarker data which indicates that broad immune activation was achieved. Based on the strength of this data, we intend to expand our clinical development program for RP1 to include a clinical trial of RP1 in combination with anti-PD1 therapy in melanoma patients who are refractory to treatment with anti-PD1 therapy."

The Phase 1 part of Replimune’s Phase 1/2 clinical trial of RP1 enrolled 36 patients with advanced heavily pre-treated cancers who were refractory to available therapy. Treatment with RP1 alone was given up to five times at various dose levels injected into a single tumor to determine the recommended Phase 2 dose (N=22), following which RP1 was given up to eight times at the recommended dose in combination with Opdivo starting with the second dose of RP1 (N=14). Based on the data, which showed a favorable safety profile for both RP1 alone and in combination with Opdivo, the RP1 dosing regimen moved forward into Phase 2 development was an initial dose of up to 10mL of 1×106 pfu/ml followed by subsequent doses of up to 10mL of 1×107 pfu/ml.

In the dose rising monotherapy part of the Phase 1/2 clinical trial, RP1 was associated with tumor destruction, including delayed systemic post-study tumor reduction without further therapy. In the combination portion of the Phase 1 part of the clinical trial, anti-tumor activity was demonstrated in multiple patients with a variety of tumor types, particularly in CSCC and melanoma, but also in microsatellite instability high (MSI-H) colorectal cancer and esophageal cancer patients. Additionally, the first three of four patients with anti-CTLA-4 and anti-PD-1 refractory cutaneous melanoma treated with RP1 combined with Opdivo are responding to therapy (two patients from the Phase 1 part of the study and one from Phase 2) and clinical activity has been seen in four of the first five patients treated with CSCC. Of particular note, substantial tumor reduction was observed in a number of patients after just the first dose of RP1, but before the introduction of Opdivo two weeks later.

Biomarker data further confirmed the mechanism of action of RP1 alone and in combination with Opdivo, suggesting that RP1 provides broad anti-tumor immune activation. Increases in CD8 T Cells and PD-L1 were seen in serial tumor biopsies across tumor types, and the kinetics of virus detection suggests that robust virus replication in tumors occurs.

Continued recruitment of the Phase 2 part of the clinical trial in cohorts of 30 patients each with melanoma, non-melanoma skin cancers, bladder cancer, and MSI-H tumors is ongoing. Additional data from the Phase 2 part of the clinical trial is expected to be presented in 2020.

About RP1
RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

TG Therapeutics to Host Conference Call on Third Quarter 2019 Financial Results and Business Update

On November 8, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held, Tuesday, November 12, 2019 at 8:30 AM ET to discuss results for the third quarter of 2019 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, NOV 8, 2019, http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-third-quarter-2019 [SID1234550765]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer will host the call.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay on the Company’s website, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.