On July 21, 2019 PACT Pharma, a leader in the fields of cancer immunology and cell therapy in collaboration with a team at UCLA, reported new data demonstrating for the first time the ability to identify mutation targets unique to each person’s cancer and verify the cancer specificity of multiple cloned T cell receptors (Press release, PACT Pharma, JUL 21, 2019, View Source [SID1234537638]). Each patient’s cancer has a private signature of mutations, creating an opportunity to develop fully personalized immune therapies that have the potential to eradicate tumor cells. Defining these cancer mutation targets for each person, known as neoantigens, enables the company to use its proprietary gene engineering technologies to manufacture an immune cell therapy product for each person with cancer. The presentation was at the AACR (Free AACR Whitepaper)’s Special Conference on Immune Cell Therapies for Cancer. The company has begun enrolling patients with advanced solid tumors in its Phase 1 dose escalation study of NeoTCR-P1, an autologous gene-edited TCR T cell product that targets personalized neoantigens (View Source).

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"These exciting results open a bold new frontier for directing a person’s own immune system to treat patients with solid cancers, an area that hasn’t yet seen the successes of immune cell therapies that we have seen for blood cancers," said PACT’s Chief Executive Officer Alex Franzusoff, Ph.D. "While it is early, the results demonstrate the possibility for PACT’s approach to ignite a patient’s immune response directly against their unique tumor mutation signature, within a clinically relevant timeframe, with potential applicability to most cancers and all ethnicities across the globe."

Today’s data is relevant because they show that mutations that build up in tumors, creating the unique tumor mutation "signature" that drives each patient’s cancer, have already triggered each person’s immune system to target those unique mutations, but at a very low level. Now those low-level targeted immune responses can be analyzed with greater accuracy, used to manufacture a truly personalized treatment that is tailored for each patient with cancer, and evaluated in clinical trials.

The company’s approach is designed to select and confirm tumor-exclusive mutations to empower a patient’s immune system to target their specific cancer. PACT utilizes bioinformatics to identify the mutation blueprint of each person’s tumor, and then uses its barcoded snare technologies to capture pre-existing T cells from the blood that already recognize and target the unique mutations. From that group, a proprietary selection platform is used to identify the ideal T cell receptors for specific mutations. Once the target is authenticated, the company uses non-viral gene editing to engineer the ideal mutation-targeted T cell receptors into T cells from the same patient. When reinfused back to the patient, these T cells have the potential to eliminate tumor cells that express these unique mutations.

"The results presented today show that PACT’s approach of neoantigen-specific T cell capture and non-viral precision genome engineering is indeed groundbreaking and promising for a new chapter in personalized immune cell therapies for patients with solid cancers," said Antoni Ribas, a professor of medicine at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, who is a co-author of the study and also a co-founder of PACT. "The demonstration that T cell receptor-engineered T cells using the PACT approach can specifically kill that same person’s cancer cells is based on the analysis of immune cells captured from the blood of a patient with a long-lasting response to anti-PD-1 therapy."

The evolution of personalized immune-oncology treatments
Recently, a new generation of personalized cellular therapies for cancer has emerged. Rapid sequencing technologies, bioinformatics, and genetic/cellular engineering — in addition to a deeper understanding of clinical immunology and a renaissance in immunotherapy — have made these advancements possible. Designer immune-oncology treatments have been developed, including CAR-T cell therapies, cancer vaccines and tumor-infiltrating lymphocyte therapies.

While transformative, these therapeutic approaches face limitations. CAR-T cells only recognize shared cancer targets expressed on the cell surface, which, while effective for blood cancers, have not been applied successfully to patients with solid cancers, and cancer vaccines are often too slow to address a rapidly growing tumor burden. Further, tumor-infiltrating lymphocytes can be impractical—and at times even impossible—to generate for every patient due to the difficulty of isolating limited numbers of specific tumor-targeting immune cells and then needing to greatly expand their numbers for patient dosing. In the case of expanded immune cells in particular, they often become exhausted before reinfusion, which may limit their value for eliminating the cancer throughout the body.

In order to truly tailor cancer treatments to individuals, the therapy must target each patient’s unique cancer signature–including different tissue compatibility receptors of the immune system, or HLA, in each person. These HLA receptors are key to immune recognition, which is what limits organ sharing between people. PACT’s approach captures this nuance. Custom tailored, yet for a global population, PACT’s approach is designed to select and authenticate tumor-exclusive mutations to empower the patient’s immune system to target their specific cancer for a lasting effect. PACT plans to further investigate the safety and effectiveness of this technology in a series of clinical trials, starting with a first-in-human Phase 1 clinical trial at clinical sites in California.

On July 21, 2019 Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, reported that the company was notified by the U.S. Food & Drug Administration (FDA) on the clearance of the Investigational New Drug (IND) application which allows the company to initiate its Phase Ib clinical trial of HQP1351, a novel drug candidate developed by Ascentage Pharma, for the treatment of patients with tyrosine kinase inhibitors (TKI)-resistant chronic myeloid leukemia (CML) in the United States (Press release, Ascentage Pharma, JUL 21, 2019, View Source;resistant-chronic-myeloid-leukemia-patients-in-the-us-300888373.html [SID1234537658]).

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HQP1351 is the sixth molecule to receive clearance of IND from the FDA for Ascentage Pharma. The Company submitted data generated from over 100 subjects in the Phase I clinical trial in China to the FDA to support the IND application.

This clinical study is a bridging Phase Ib clinical trial with three dose cohorts (30mg, 40mg and 50mg), which is more efficient than the traditional 3+3 dose-escalation study and is expected to accelerate the progress of this clinical trial. It is designed to evaluate the safety, tolerability, and pharmacokinetic (PK) of HQP1351 in CML patients who are resistant or intolerant to at least second-line TKIs and to confirm the recommended Phase II dose (RP2D). This clinical study will be led by Hagop Kantarjian, M.D., Chair of Department of Leukemia at MD Anderson Cancer Center, and other prominent US research centers and hospitals will also participate.

HQP1351 is designed to address the acquired drug resistance from the treatment using Imatinib. Such resistance is developed in 20-30% of patients treated with the drug develop acquired drug resistance, thus representing a major challenge to the treatment of CML. HQP1351 is an oral, third-generation BCR-ABL TKI targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. The agent is currently in pivotal Phase II clinical trial and is the first third-generation BCR-ABL inhibitor targeting drug-resistant CML in China. A New Drug Application (NDA) submission is planned upon the successful completion of the pivotal Phase II clinical studies in China.

As previously announced, the updated data from HQP1351 Phase I study in China was accepted as an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting last December. The preliminary data showed that HQP1351 was effective in the treatment of first and second generation TKI-resistant CML, especially the highly resistant CML with T315I mutation, with improved safety profile compared to other agents in the same class. This result demonstrates HQP1351’s best-in-class potential for treating TKI-resistant CML.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented: "Ascentage Pharma used the clinical data from its HQP1351 Phase1 clinical trial in China to support the US IND application. This FDA agreed Phase Ib clinical trial design could significantly accelerate HQP1351’s global clinical development program. Drug-resistant CML represents significant unmet clinical need and we hope that HQP1351 will soon benefit patients worldwide."

About HQP1351
HQP1351 is a novel kinase inhibitor developed by Ascentage Pharma. It is an oral third-generation BCR-ABL inhibitor targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. A Phase I clinical trial for patients with TKI-resistant CML has been completed and a pivotal Phase II clinical trial was initiated in China. It also entered a Phase I trial in patients with GIST in China.

On July 20, 2019 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine, evaluating the Company’s MultiTAA T cell therapy in patients with pancreatic adenocarcinoma (Clinical trial, Marker Therapeutics, JUL 20, 2019, View Source [SID1234537636]). The data were reviewed today in an oral presentation during a plenary session, as well as a poster presentation, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy conference held in San Francisco, California from July 19-22, 2019.

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"Pancreatic cancer continues to be one of the most challenging solid tumor malignancies to treat and survival rates have not seen a meaningful improvement in more than 40 years," said Brandon G. Smaglo, M.D., FACP, lead investigator and Assistant Professor of Oncology at Baylor College of Medicine. "We are encouraged by these interim data which suggest that MultiTAA therapy may contribute to more durable responses without added toxicity when used in combination with standard-of-care chemotherapy, or as a second-line therapy for patients who are chemo-refractory. Additionally, despite the particularly dense desmoplastic stroma surrounding pancreatic tumors—which has been long considered a major obstacle for T cell effectiveness—our study of patients with borderline surgically resectable disease suggests that MultiTAA cells are capable of meaningfully infiltrating the tumor."

Trial Overview

Title: Targeting pancreatic cancer using non-engineered, multi-antigen specific T cells (TACTOPS)

The trial plans to enroll a total of 45 patients with advanced or borderline resectable pancreatic adenocarcinoma in a three-arm trial. Arm A is for patients with unresectable/metastatic disease who are responding to standard first-line chemotherapy. Arm B is for patients with progressive disease or therapy intolerance. Arm C is an exploratory arm for patients with surgically resectable disease. To date, a total of 19 patients have been administered infusions of MultiTAA T cell therapy (ten patients in Arm A, six patients in Arm B and three patients in Arm C).

Interim Results

Arm A: This arm was designed to evaluate the safety and potential efficacy of using MultiTAA cells as part of first-line treatment for patients with pancreatic cancer. These patients in the chemo-responsive arm have completed or will complete at least three months of standard-of-care chemotherapy (gemcitabine/nab-paclitaxel or FOLFIRINOX) – the period during which a response to chemotherapy would typically occur – before receiving up to six administrations of MultiTAA T cells in conjunction with chemotherapy.

Out of the 9 evaluable patients (one patient was too early to be evaluated):
3 patients experienced objective responses after administration of MultiTAA cells
1 patient experienced a complete response
2 patients experienced partial responses
4 patients experienced stable disease; 2 patients within stable disease boundaries (+20%/-30%) saw reversal of tumor growth – tumors previously growing after chemotherapy alone showed shrinkage after administration of MultiTAA cells
1 patient experienced a mixed response (some lesions increased in size and others decreased for a net zero change in size of tumor lesions)
1 patient experienced disease progression
Overall tumor volume shrinkage was observed in six out of the eight patients with a measurable tumor after administration of MultiTAA cells. One evaluable patient did not have tumor measurements for analysis.
Of the 9 evaluable patients, over half have survived to or beyond the historical median overall survival associated with their respective chemotherapy regimens, and 7 of the 9 patients remain alive.
In patients responding to therapy, significant expansion of the infused MultiTAA cells was observed, along with broad-based epitope spreading, with significant expansion of endogenous T cells specific for other tumor specific antigens.
Arm B: This arm was designed to evaluate the use of MultiTAA cells as a second-line therapy for patients who have failed first-line chemotherapy. The patients in this chemo-refractory arm are either ineligible for chemotherapy or have progressed on chemotherapy and have received or are receiving up to six doses of MultiTAA T cells as a monotherapy.

Of the 6 patients treated and evaluable:
3 patients experienced stable disease or clinical disease stabilization
2 patients who previously had progressive disease experienced clinical disease stabilization for up to two months
1 has maintained stable disease for 7 months (ongoing)
3 experienced clinical decline
Among the patients who saw clinical disease stabilization, significant expansion of the infused MultiTAA cells was observed, along with broad-based epitope spreading, with significant expansion of endogenous T cells specific for other tumor specific antigens.
Arm C: This arm was designed to assess T cell infiltration and expansion. These patients with borderline surgically resectable disease received or will receive a dose of T cells following chemotherapy, radiotherapy or combination prior to surgical resection and up to five additional doses of T cells after surgery.

In these patients, MultiTAA T cells were measurable in meaningful numbers as detected by correlative analysis of resected tumor, and significant expansion of the infused MultiTAA cells was observed, along with broad-based epitope spreading, with significant expansion of endogenous T cells specific for other tumor specific antigens.
Overall, investigators observed a clinical benefit correlated with the detection of tumor-reactive T cells in patient peripheral blood (Arms A, B and C) and within tumor biopsy samples (Arm C) post-infusion. T cells exhibited activity against both targeted antigens as well as non-targeted TAAs including WT-1, AFP, MART-1 and numerous antigens of the MAGE family, indicating induction of antigen/epitope spreading.

No infusion-related systemic- or neurotoxicity was observed, and patients continue to be evaluated and enrolled in the trial.

Peter L. Hoang, President & CEO of Marker Therapeutics commented: "We are encouraged by the early clinical results we have seen in this clinical trial for patients who otherwise have few therapeutic options and a dire prognostic outcome, and we are optimistic about the prospect of potentially validating the use of MultiTAA therapy in the context of first-line and second-line care for patients with pancreatic adenocarcinoma. Moreover, we are very pleased with the data we see of MultiTAA T cell infiltration and subsequent epitope spreading observed in this trial, suggesting that MultiTAA therapy may initiate and contribute to a potent and durable treatment effect. We plan to continue following these patients and enroll new patients to further evaluate durability."

Conference Call and Webcast
For those unable to attend the presentations at AACR (Free AACR Whitepaper), Marker will host a conference call and webcast on Monday, July 22nd at 5:30am PDT/8:30am EDT featuring Dr. Brandon Smaglo, as well as Marker senior management. A live webcast of the investor presentation will be available in the investors section of the Company’s website at View Source and will be available for replay following the event.

About MultiTAA
Marker’s Multi-Antigen Targeted (MultiTAA) platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s blood capable of recognizing a broad range of tumor antigens. In early clinical trials, the multi-antigen approach has been well tolerated and shown to enhance tumor destroying capability and is one of the first therapies to consistently demonstrate epitope spreading – inducing the patient’s own T cells to expand, potentially contributing to a lasting anti-tumor effect. Unlike other cell therapies which require pre-conditioning regimens and hospitalization, MultiTAA is designed to be administered in an outpatient setting.

On July 19, 2019 Genmab A/S (CSE:GEN, Nasdaq:GMAB) reported that its licensing partner, Janssen Biotech, Inc., has submitted an application for the extension of the DARZALEX marketing authorization to the European Medicines Agency (EMA) (Press release, Genmab, JUL 19, 2019, View Source [SID1234537615]). This application seeks approval for the use of the subcutaneous (SubQ) formulation of daratumumab in multiple myeloma indications where the intravenous formulation of daratumumab is currently approved. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"Janssen has now submitted applications for approval of the subcutaneous formulation of daratumumab in both the U.S. and in Europe and we are looking forward to the possibility of multiple myeloma patients in both regions having access to this more convenient formulation of DARZALEX, which allows for both faster dosing and fewer infusion-related reactions according to recently presented data from the COLUMBA study," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on data from two ongoing studies: the Phase III non-inferiority COLUMBA study, which is comparing the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and preliminary non-public data from the Phase II PLEIADES study, which is evaluating daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA data were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress.

About the COLUMBA (MMY3012) study
The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that includes 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SubQ daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) study
The Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 240 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg subcutaneous daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg subcutaneous daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On July 19, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson is reported with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.1,2 (Press release, Johnson & Johnson, JUL 19, 2019, View Source [SID1234537634])

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The WHO’s Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.1

"The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families," said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which are supported by the highest quality scientific evidence."

The foundation of Janssen’s scientific understanding in prostate cancer is based on the knowledge acquired through the development of innovative treatment options for mCRPC. Abiraterone acetate is an oral androgen biosynthesis inhibitor that is approved for the treatment of both mCRPC and metastatic hormone-sensitive prostate cancer, in Europe.3,4

"The addition of abiraterone acetate to the Essential Medicines List is a significant milestone for Janssen Oncology, reflecting the tireless efforts in recent years to bring optimal treatment options to patients with mCRPC," said Biljana Naumovic, Vice President Commercial Strategy Lead Oncology for Europe, Middle East & Africa, Cilag GmbH International. "This direction from the WHO further emphasises that our work is not yet over. It is critical that patients with prostate cancer have access to treatments that their clinicians feel can benefit them and that we continue to support the prostate cancer community in our common goal of making cancer a manageable and potentially one day, a curable condition."