On May 14, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that positive data from envafolimab in a pivotal trial in China for the treatment of MSI-H/dMMR cancer will be presented by the Company’s corporate partners, 3D Medicines and Alphamab, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Press release, Tracon Pharmaceuticals, MAY 14, 2020, View Source [SID1234558059]).

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ASCO abstract #3021 entitled "Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency" reviewed data available on December 17, 2019 from the ongoing pivotal Phase 2 trial of envafolimab given by subcutaneous injection without an adjuvant in MSI-H/dMMR cancer. The trial enrolled 103 patients with MSI-H colorectal (CRC) or gastric cancer (GC) or with dMMR in other advanced solid tumors, in an open label format with efficacy endpoints, including the primary endpoint of confirmed objective response rate (ORR) determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors.

Key highlights included:

The confirmed ORR in 50 patients with CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) plus those with advanced GC who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments, was 30% (95% CI: 18%, 45%), of whom 80% were responding with median follow-up of 7.5 months at the time of the data cutoff.
The confirmed ORR in the overall population (n=103) was 34% (95% CI: 25%, 44%), of whom 86% were responding with median follow-up of 6.7 months at the time of the data cutoff.
The confirmed ORR in 24 patients with CRC who failed a fluoropyrimidine and oxaliplatin or irinotecan (n=24) was 54% (95% CI: 33%, 74%) of whom 85% were responding at the time of the data cutoff.
Envafolimab was well tolerated with a safety profile similar to that of approved PD-(L)1 checkpoint inhibitors but without infusion related reactions.
"We are impressed by the confirmed ORR of envafolimab from its pivotal trial in Chinese patients with MSI-H/dMMR cancer, which is a genetically defined tumor type," said Charles Theuer, M.D., Ph.D., President and CEO. "We believe these data are important in assessing the potential of this novel subcutaneously administered product candidate in TRACON’s initial indications in the U.S. of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), two soft tissue sarcoma subtypes which have responded to treatment with other checkpoint inhibitors. Moreover, these data indicate that envafolimab’s activity in MSI-H cancer is similar to other checkpoint inhibitors, such as Keytruda or Opdivo but without infusion related reactions. We look forward to initiating our pivotal ENVASARC trial for envafolimab in UPS and MFS in the second half of 2020, for which we recently reached agreement on the key elements with the U.S. FDA."

The complete abstract is available at: View Source

About Envafolimab

Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H/dMMR tumor patients, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. 3D Medicines plans to file a BLA in China for envafolimab in 2020 based on overall response rate and duration of response in MSI-H/dMMR patients. The filing would be based on the the ongoing pivotal phase 2 trial data of envafolimab in MSI-H/dMMR cancer.

On May 14, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that it will present new efficacy and cardiovascular safety data from the Phase 3 HERO study of once-daily, oral relugolix (120 mg) in men with advanced prostate cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, to be held May 29-31, 2020 (Press release, Myovant Sciences, MAY 14, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-present-new-data-relugolix-prostate-cancer [SID1234558058]).

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The new data will be presented by Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO program steering committee member. Dr. Shore’s presentation (#5602), titled "HERO phase III trial: Results comparing relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer" will be included in the oral abstract session, "Genitourinary Cancer—Prostate, Testicular, and Penile," which will be available for on-demand viewing starting at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time on Friday, May 29, 2020.

In April 2020, Myovant submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for relugolix as a potential treatment for men with advanced prostate cancer. The NDA is supported by positive results from the Phase 3 HERO study, a randomized pivotal study comparing relugolix versus leuprolide acetate.

On May 14, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported updated clinical and biomarker results from the monotherapy and combination arms of the Company’s ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) (Press release, Advaxis, MAY 14, 2020, View Source [SID1234558057]). The trial is evaluating ADXS-503, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. ADXS-503 is part of the Company’s ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

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Key data updates:

Sustained clinical benefit in the combination arm, Part B, in the first two evaluable patients who had previously progressed on KEYTRUDA as last therapy whose best response while on KEYTRUDA was stable disease.
One observed partial response and one response of stable disease with 25% reduction in a target lesion, as confirmed in the radiographic scans at 16 weeks of combination therapy
Responses achieved after immediate prior progression on KEYTRUDA with previous best responses of stable disease suggests ADXS-503 may re-sensitize or enhance response to KEYTRUDA
Preliminary biomarker data from seven patients in monotherapy demonstrates:
Activation of cytotoxic and memory CD8+ and CD4+ T cells
CD8+ T cells generated in all seven patients evaluated
Antigen spreading observed in five of seven patients for epitopes not incorporated in ADXS-503
Part A monotherapy has been completed (n=7) with three out of six (50%) evaluable patients showing stable disease.
As a monotherapy, and in combination with KEYTRUDA, ADXS-503 appeared safe and well tolerated with no dose limiting toxicities at the dose-levels evaluated.
"We are thrilled to see sustained clinical benefit with ADXS-503 in combination with KEYTRUDA in these first two evaluable patients who had recently progressed on KEYTRUDA," said Ken Berlin, Chief Executive Officer of Advaxis. "Importantly these responses were achieved in patients with prior best responses that were limited to stable disease during their two years on this checkpoint inhibitor. Taken together, these results leave us increasingly confident that ADXS-503 has the potential to restore or enhance sensitivity to checkpoint inhibitors. In addition, we believe our recent biomarker data, which shows the robust and specific activation of an immune response to ADXS-503 antigens, provides important understanding and validation of the mechanism of action of ADXS-503."

Dr. Andres Gutierrez, Chief Medical Officer at Advaxis, said, "With these promising clinical, safety and immunogenicity data, we have decided to expand Part B of the study, which will continue evaluating patients that have progressed on KEYTRUDA as their last prior therapy. In addition, we will start Part C of the trial to evaluate ADXS-503 with KEYTRUDA combination therapy as a first line treatment for NSCLC patients that cannot tolerate the standard of care regimen with KEYTRUDA in combination with chemotherapy. With the recent dosing of the third patient in Part B, Dose Level 1 which completes this cohort, we anticipate beginning enrollment in the Part B expansion and Part C in early June and look forward to continued progress as we evaluate the ability of ADXS-503 to generate anti-tumor immune responses in advanced NSCLC patients with significant need for new treatment options."

The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed and Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA is currently closed to enrollment. With preliminary encouraging safety and efficacy results, the Company is planning to expand Part B to additional patients at dose level 1 (1 X108 CFU + KEYTRUDA) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA) at a later date. In addition, the Company intends to expand the study to Part C, which will evaluate ADXS-503 in combination with KEYTRUDA (1 X108 CFU + KEYTRUDA) as a first line treatment for patients that are medically unfit to receive the standard of care regimen with KEYTRUDA in combination with chemotherapy.

About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

On May 14, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone) (Press release, Seattle Genetics, MAY 14, 2020, View Source [SID1234558056]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of peripheral T-cell lymphomas (PTCL), including sALCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.

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"The approval of ADCETRIS in combination with CHP for use in the European Union for patients with previously untreated sALCL represents a significant advance for patients who previously were treated with CHOP chemotherapy regimen that was often unsuccessful in leading to long-term remissions," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "The outstanding results from the ECHELON-2 phase 3 trial, which demonstrated superior progression-free survival and overall survival compared to CHOP, led to this important regulatory milestone. We are pleased that our partner Takeda is able to make this clinically meaningful therapeutic option available to patients in Europe."

The results from the ECHELON-2 phase 3 clinical trial were published in The Lancetin December 2018. The marketing authorization for ADCETRIS is valid in all countries of the European Union, Norway, Liechtenstein and Iceland. For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS for injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, (5) for the treatment of adult patients with relapsed or refractory sALCL, and (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See U.S. important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On May 14, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported an oral presentation related to its AUTO3 program, the company’s CAR T cell therapy being investigated in the Alexander study, a Phase 1/2 study in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the Annual Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program beginning May 29 (Press release, Autolus, MAY 14, 2020, View Source [SID1234558054]). The data to be presented will expand on the positive data presented at the EHA (Free EHA Whitepaper)-EBMT 2nd European CAR T Cell Meeting in January 2020.

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Oral Presentation Title: Phase I Alexander study of AUTO3, the first CD19/22 dual targeting CAR T cell therapy, with pembrolizumab in patients with relapsed/refractory (r/r) DLBCL
Oral Abstract Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Abstract: 8001
Date & Time: Hematologic Malignancies forms part of a Highlights Session on Saturday, May 30 at 11:30 Am ET. Video and slide presentations will be available on demand on the ASCO (Free ASCO Whitepaper) conference website beginning Friday, May 29 at 8:00 AM EDT and will remain available for 180 days.
Presenter: Dr. Aravind Ramakrishnan, Medical Director, Bone Marrow Transplant and Cellular Therapy Program, Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center

Investor call on Monday June 1, 2020
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the ASCO (Free ASCO Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 4880556. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 4880556.