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Onco-this-Week

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Summary: This week’s highlights in Onco-this-Week include FDA approval of Encorafenib + Binimetinib in BRAF+ metastatic melanoma, EU approval of Blinatumomab in Ph- R/R ALL; priority reviews to Glasdegib in 1L AML and to Ibrutinib in Waldenström’s Macroglobulinemia; and revision of FDA labels of Pembrolizumab and Atezolizumab after restrictions on their use in patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

Special Feature in this edition is Onco-this-Week Trivia on FDA-Accelerated Approvals with a special focus on comparison between Keytruda vs Opdivo indications. Read on to know more!

 

This edition of Onco-this-Week is Sponsored by Nano-Tag Biotechnologies

 

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DRUG APPROVALS

FDA approves encorafenib + binimetinib combination for BRAF mutated unresectable or metastatic melanoma based on Ph III COLUMBUS study data

“Despite recent advances, there remains a significant unmet need for treatments that are both effective and well-tolerated for patients with BRAF-mutant melanoma,” said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. “Now, physicians and patients have the option to consider treatment with BRAFTOVI + MEKTOVI, which has been shown to delay disease progression, improve overall survival and is generally well-tolerated.”

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“Nearly half of patients diagnosed with metastatic melanoma test positive for the BRAF mutation,” said Valerie Guild, Co-Founder and President of the AIM at Melanoma Foundation. “Today’s approval is welcome news for the melanoma community as it arms BRAF-mutant late-stage melanoma patients with an important new targeted treatment in their fight against this devastating disease.”

 

European Commission grants full approval for Blinatumomab based on OS data from the Ph III TOWER study in Ph- R/R ALL patients

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“BLINCYTO is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care,” said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. “For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces BLINCYTO as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer.”

 

REGULATORY NEWS

U.S. FDA grants priority review for NDA for Glasdegib in 1L AML patients based on Ph II BRIGHT 1003 study; PDUFA: Dec 2018

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Patients with acute myeloid leukemia who are ineligible for intensive chemotherapy are in critical need of new treatment options to improve their overall survival,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “In an investigational Phase 2 study, glasdegib in combination with low-dose cytarabine showed a significant improvement in overall survival compared to patients who received low-dose cytarabine alone. Glasdegib is the first smoothened inhibitor to potentially offer such a benefit to patients with acute myeloid leukemia, and we are proud that our application was accepted by the FDA for Priority Review.”

 

Puma hopeful to secure Neratinib EU approval as extended adjuvant treatment of HER2+ early stage breast cancer

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Puma Biotechnology, Inc. announced that CHMP of the EMA adopted a positive trend vote recommending the approval of the MAA for neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer. This decision followed a reexamination of the negative opinion announced by the CHMP at its formal meeting with the Company to discuss the MAA on February 23, 2018. The CHMP communicated its intention to hold a final vote at its next meeting.

 

FDA accepts sBLA for Pembrolizumab as adjuvant therapy in advanced melanoma based on RFS data from Ph III KEYNOTE-054 trial, PDUFA: Feb 16, 2019

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“EORTC1325/KEYNOTE-054 was the first trial with KEYTRUDA to demonstrate a recurrence-free survival benefit in the adjuvant setting, and we continue to actively investigate KEYTRUDA in the adjuvant or neoadjuvant setting across our broad clinical development program,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Earlier intervention with adjuvant therapy has proven to be an important factor in reducing the risk of recurrence following surgery for patients with high-risk stage III melanoma. We look forward to working with the FDA on the review of this application, with the goal of bringing KEYTRUDA to patients with advanced melanoma earlier in their treatment.”

 

Ibrutinib sNDA accepted for WM based on Ph III iNNOVATE study results

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“We are excited about the data from the Phase 3 iNNOVATE study, which indicate that IMBRUVICA plus rituximab was able to improve progression-free survival, versus rituximab alone, across all lines of therapy and Waldenström’s macroglobulinemia patient subgroups that were studied,” said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company. “These promising findings build on our commitment to exploring the full potential of IMBRUVICA alone and in combination with other treatments. If approved, this chemotherapy-free combination will provide another treatment opportunity for patients living with this rare disease, which continues to have very limited treatment options.”

 

FDA accepts BMS application for potential treatment of patients with 1L NSCLC who have TMB ≥10 mutations/MB based on results from Part 1 of CheckMate -227; PDUFA: Feb 20, 2019

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Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, “Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients. We look forward to working with the FDA throughout the review process to bring this important treatment option to patients.”

 

FDA restricts the use of Pembrolizumab and Atezolizumab for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy; labels revised

The FDA is restricting the use of Keytruda and Tecentriq for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

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This results from decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

The labels of both drugs have been revised to reflect the restricted indications.

 

RESULTS

Preliminary data from first dosing cohort demonstrating durable effect of PCM-075 + Cytarabine/Decitabine in R/R AML patients

“While we are still quite early in the trial, these data points are encouraging from both a safety and efficacy standpoint,” said Amer Zeidan, MBBS, MHS, Assistant Professor of Medicine, Department of Medicine, and Yale Cancer Center, Yale School of Medicine, Yale University, a leading investigator on the trial.  “There were no dose limiting toxicities seen in the first cohort and treatment was generally well tolerated. We know that treatment with decitabine or low-dose cytarabine in patients with relapsed or refractory AML is rarely effective, and the rare patients who do respond usually require several cycles of therapy to do so. Seeing substantial blast reductions in blood and bone marrow achieved in several patients in the first one to two cycles at this first dose level of PCM-075, combined with significant reductions in PLK1 activity as measured by pTCTP levels, potentially suggests synergistic clinical activity with the combination therapy. We remain excited to see how our patients will do as we go to higher dose levels of PCM-075.”

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“In addition to the preliminary clinical data from our first dose cohort, we are encouraged by the additional pharmacodynamic data for patients in our Phase 1b/2 AML trial,” said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. “This is the first time we have observed a change in PLK1 status in patients during treatment with PCM-075 in combination with either LDAC or decitabine.”

 

Ph III SOLO-1 trial of Olaparib meets primary endpoint of PFS improvement in 1L maintenance BRCA+ ovarian cancer patients

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, “For the first time, we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive LYNPARZA earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”

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Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Building on the strong data we’ve seen with LYNPARZA to date, the data from SOLO-1 reinforce LYNPARZA’s ability to provide meaningful disease control with a well-characterized safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with the regulatory authorities to bring LYNPARZA to women with ovarian cancer in the first-line maintenance setting as quickly as possible.”

 

AXL inhibitor Bemecentinib meets pre-specified efficacy endpoint in stage I of NSCLC Ph II combination trial with Pembrolizumab

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “Immunotherapy has become a major component of the treatment of many cancers – patients who respond to immune checkpoint inhibitors like KEYTRUDA enjoy long-term disease control with excellent quality of life. Unfortunately, only a minority of lung cancer patients receiving KEYTRUDA monotherapy in second-line respond to treatment. The BGBC008 combination trial of bemcentinib with KEYTRUDA evaluates whether the addition of our selective AXL inhibitor will improve the outcome of immunotherapy.

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“Clearing the first efficacy threshold in this ongoing Phase II trial is very encouraging and we intend to begin enrolment for Stage 2 of this study in which 24 further patients will be enrolled under the same protocol. Thus far, we are delighted to see activity in a number of patients receiving this novel treatment regimen. A particularly encouraging finding is that we see responses in patients who are negative for the PD-L1 biomarker, for whom KEYTRUDA monotherapy is not indicated. The second stage of the trial is intended to confirm activity and biomarker correlation in a larger group of patients – comprehensive analysis of the Phase II data will continue and will be presented at a future scientific conference.

“Successfully completing this important milestone further supports our belief in the potential of bemcentinib to become a cornerstone of cancer therapy. We look forward to sharing more details from our Phase II clinical programme during major clinical conferences in the coming months.”

 

Poliovirus therapy for recurrent GBM shows 3-year survival rate of 21%

“Glioblastoma remains a lethal and devastating disease, despite advances in surgical and radiation therapies, as well as new chemotherapy and targeted agents,” said Darell D. Bigner, M.D., Ph.D., emeritus director of The Preston Robert Tisch Brain Tumor Center at Duke and senior author of the study.

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“There is a tremendous need for fundamentally different approaches,” Bigner said. “With the survival rates in this early phase of the poliovirus therapy, we are encouraged and eager to continue with the additional studies that are already underway or planned.”

 

Positive outcomes observed with immune checkpoint inhibitors and radiosurgery for newly diagnosed melanoma brain mets

RESULTS: Thirty-eight patients were included with a median follow-up of 31.6 months. Two-year local control was 92%. Median time to out-of-field CNS and extra-CNS progression were 8.4 and 7.9 months, respectively. Median progression-free survival (PFS) was 3.4 months and median overall survival (OS) was not reached (NR). Twenty-five patients (66%) received anti-CTLA4 and 13 patients (34%) received anti-PD-1+/-anti-CTLA4. Compared with anti-CTLA4, patients that received anti-PD-1+/-anti-CTLA4 had significant improvements in time to out-of-field CNS progression (p = 0.049), extra-CNS progression (p = 0.015), and PFS (p = 0.043), with median time to out-of-field CNS progression of NR vs. 3.1 months, median time to extra-CNS progression of NR vs. 4.4 months, and median PFS of 20.3 vs. 2.4 months. Six patients (16%) developed grade ≥ 2 CNS toxicities (grade 2: 3, grade 3: 3, grade 4/5: 0).

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CONCLUSIONS:

Excellent outcomes were observed in patients that initiated CPIs within 8 weeks of undergoing radiosurgery for newly diagnosed MBM. There appears to be an advantage to anti-PD-1 or combination therapy compared to anti-CTLA4.

Ph III PALOMA-3 trial did not meet secondary endpoint of significant OS improvement in HER2neg HR+ breast cancer patients

“While the difference in overall survival narrowly missed the threshold for statistical significance – a high bar for any trial in this patient population – it is similar, in absolute terms, to the improvement in median progression-free survival previously demonstrated in this trial.1 We are encouraged by these results, which build on the compelling clinical benefit delivered by IBRANCE,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “IBRANCE in combination with endocrine therapy has transformed the treatment landscape for patients with HR+, HER2- metastatic breast cancer.”

 

Ph II CARRIE trial of MM-141 in 1L metastatic Pancreatic Cancer did not meet primary or secondary endpoints; company ceases development

“Pancreatic cancer is the third leading cause of cancer-related death in the Unites States and a very difficult cancer to treat,” said Sergio Santillana, M.D., MSc., Chief Medical Officer of Merrimack. “Although we were unsuccessful in our effort to improve the standard of care for these patients, we want to express our gratitude to our investigators and our team, and, of course, to the patients and their families for their support and participation in the CARRIE study.”

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“While these results are disappointing, looking forward our focus remains on the continued development of our deep, wholly-owned pipeline, including two clinical programs, MM-121 and MM-310, with data readouts expected in 2018,” said Richard Peters, M.D., Ph.D., President and CEO of Merrimack.

 

Sophiris Bio reports top-line interim safety data for its Ph IIb trial of Topsalysin in localized Prostate Cancer

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“We are extremely saddened by the death of a patient after receiving a second administration of topsalysin,” said Randall E. Woods, president and CEO of Sophiris. “Understanding the cause of the patient’s death is our first priority and essential to determining the potential for re-administration of topsalysin in future clinical trials.”

 

Atezolizumab + chemotherapy in Ph III IMpower133 study showed significant OS and PFS improvement in 1L ED SCLC patients

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“These are the first positive Phase III survival results for any immunotherapy-based combination in the initial treatment of extensive-stage small cell lung cancer, a particularly difficult-to-treat type of disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The clinically meaningful results from the IMpower133 study add to the growing body of evidence demonstrating that TECENTRIQ-based combinations may be an effective treatment for different types of advanced lung cancer. We look forward to working with health authorities globally to bring this potential treatment option to people with this type of disease as soon as possible.”

 

Ramucirumab improves survival in poor-prognosis HCC patients with high AFP levels in Ph III REACH and REACH-2 trials

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It also increased progression-free survival (PFS) and objective response rates (ORRs) and was well tolerated, with few additional adverse effects, reported Andrew X. Zhu, MD, PhD, director of Liver Cancer Research at Massachusetts General Hospital, Boston. He presented the new data here at the 2018 World Congress on Gastrointestinal Cancer (WCGC). Highlighting to the audience that the survival benefit was “consistent and robust across all subgroups,” Zhu said, “Ramucirumab represents an important new potential treatment option for patients with advanced HCC and elevated AFP, a population associated with aggressive disease.”

 

Positive topline data in STS patients with NBTXR3 in Ph II/III NCT02379845 trial

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“Data are exceptional and show without any doubt an improvement of radiation therapy impact with a significant number of complete response. NBTXR3 can bring real benefit to patients and it can change the standard of care. This innovation will play a role in many other indications and particularly where radiotherapy is used alone.”  Pr. Sylvie Bonvalot, MD, Head of Sarcoma and Complex Tumor Surgery Unit at Institut Curie, Paris, France and Global Principal Investigator of the PII/III study.

 

SPECIAL STATUSES

Orphan drug designation granted to Altered Energy Metabolism Directed (AEMD) drug CPI-613 for Treatment of Burkitt Lymphoma

Sanjeev Luther, Rafael Pharmaceutical’s President and Chief Executive Officer, said, “CPI 613 is the only investigational drug which has orphan designation to treat this rare disease. Our motto ‘To Save A Life Is to Save a Universe’ illustrates our desire to develop potential treatments for these patients and we are fortunate to launch this study with the renowned Dr. Noy as its Principal Investigator.”

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Ariela Noy, M.D., Medical Oncologist for Lymphoma and AIDS-associated cancers, Memorial Sloan-Kettering Cancer Center, and Chair of the Lymphoma Working Group for the AIDS Malignancy Consortium is the Principal Investigator of this study. Dr. Noy commented, “We look forward to launching this study with CPI-613 for patients with relapsed/refractory Burkitt Lymphoma who do not have any viable treatment options. This could be a potentially life-saving therapy.”

 

Fast Track Designation granted to FRa-targeting DM4 ADC, Mirvetuximab Soravtansine, in Patients with Platinum-Resistant Ovarian Cancer

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“We are pleased the FDA has granted Fast Track designation for mirvetuximab soravtansine,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “Patients with platinum-resistant ovarian cancer have a poor prognosis and we are encouraged by the FDA’s recognition of the significant need for new therapeutic options that may be addressed by mirvetuximab as monotherapy. This important designation is based on the promising safety and activity findings observed to-date and we look forward to working closely with the FDA as we advance the development of mirvetuximab.”

 

TRIAL STATUSES

First patient enrolled in Ph I trial evaluating combination therapy of controlled IL-12 + Nivolumab in recurrent GBM patients

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“We are excited about the first-ever dosing of this combination and its potential to bring a potent and controlled anti-tumor immune response to glioblastoma,” said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at Ziopharm. “By controlling interleukin 12, Ad-RTS-hIL-12 plus veledimex already has shown it can recruit killer T cells into the tumor and increase expression of checkpoints in this microenvironment. The combination with an anti-PD-1 has the potential to further improve anti-cancer effects of IL-12 and provide a much-needed new therapeutic option for patients with brain cancer.”

 

Expansion of DLBCL cohort of Ph II trial of PDC drug, CLR 131

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“Relapse or refractory DLBCL is an aggressive cancer and the initial response rates from the cohort leave us optimistic in CLR 131’s potential to have a positive impact on patients with life-threatening hematologic cancers. We continue to see clinical benefit using CLR 131 across a range of cancer types and we look forward to providing future data updates on this indication and others,” stated James Caruso, president and chief executive officer of Cellectar Biosciences.

 

Basilea starts clinical ph IIa expansion with novel tumor checkpoint controller BAL101553 in ovarian cancer and glioblastoma

 

Dr. Marc Engelhardt, Chief Medical Officer, said: “The start of the phase 2a expansion study marks a significant milestone towards establishing clinical proof-of-concept for our biomarker-driven development strategy with our novel tumor checkpoint controller BAL101553. There are only very limited treatment options available for patients with recurrent glioblastoma and for patients with platinum-resistant or platinum-refractory ovarian cancer. Our decision to explore the potential clinical benefit in these specific patient populations is based on the results from our phase 1 studies and our comprehensive non-clinical profiling.”

 

First patient dosed in Ph II study of the PARP/Tankyrase Inhibitor 2X-121 for breast cancer

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“This Phase 2 study will enable us to rapidly evaluate the efficacy of our PARP inhibitor in metastatic breast cancer patients, using the 2X-121 DRP® using over 400 genes to select likely responders,” said Peter Buhl Jensen CEO of MPI and OV. “We are very encouraged by the DRP data based on the available biopsies from 13 patients from the foregoing phase 1 study. In this small population the DRP could convincingly pick responding patients. Use of PARP inhibitors is a revolution in the right patients and we believe that our DRP can find these patients.” Peter Buhl Jensen further commented.

 

38th patient dosed and 25% enrollment reached in Iomab-B Ph III pivotal SIERRA Trial in AML patients

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Dr. Mark Berger, Actinium’s Chief Medical Officer said, “We are excited to have reached this important milestone for the SIERRA trial.  Patients with active relapsed or refractory AML, particularly older patients, have limited treatment options, poor survival prognoses and few successfully receive a bone marrow transplant.  We believe Iomab-B has the potential to significantly improve outcomes for these patients and we are optimistic that the SIERRA trial will support approval in an indication with significant unmet needs.  We are encouraged that our efforts to expand the choice of regimens in the control arm, the expanded Iomab-B team, and increased communication with trial sites has resulted in the acceleration in enrollment that we expected.  With this important milestone behind us, our team is highly motivated to complete enrollment as efficiently as possible and looks forward to the completion of this consequential trial.”

 

ERYTECH confirms strategic focus of Eryaspase on solid tumors and ceases development in ALL

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ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will focus its development efforts for its product candidate eryaspase on the potential treatment of selected solid tumor indications. The company also announced that it plans to cease its development program for eryaspase in acute lymphoblastic leukemia (ALL), including the withdrawal of its previously submitted MAA for eryaspase for the treatment of relapsed and refractory ALL.

First patient dosed in Ph I/II GBM trial with INO-5401 + PD-1 inhibitor Cemiplimab

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Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “GBM is a devastating cancer, and malignant glioma has already claimed the lives of Senator Ted Kennedy and Beau Biden, the son of the former Vice President Joe Biden. GBM is also the cancer that Senator John McCain and thousands of other patients are battling every year. We are proud to have treated our first patient with a powerful combination of Inovio’s T cell-generating immunotherapy INO-5401 with Regeneron’s PD-1 checkpoint inhibitor this week. This is an important step for Inovio’s plan to use its T cell-generating therapies in combination with PD-1/PD-L1 inhibitors for GBM and for multiple other cancers to improve overall efficacy.  In preclinical studies, combination of Inovio’s T cell-generating immunotherapies along with checkpoint inhibitors have shown to shrink tumors and improve overall survival of tumor-bearing animals. In this GBM trial, our goal is to increase the overall survival of patients facing a disease where neither the standard of care, nor clinical outcomes have not changed in a clinically significant way in more than a decade.”

 

Blueprint Medicines initiates VOYAGER Ph III trial of KIT and PDGFRA kinase inhibitor Avapritinib in advanced GIST patients

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“The initiation of the VOYAGER Phase 3 trial represents an important milestone for Blueprint Medicines, as we advance efforts to achieve registration of avapritinib in a broad GIST population,” said Andy Boral, M.D., Ph.D., Chief Medical Officer of Blueprint Medicines. “With compelling Phase 1 clinical data showing objective responses and prolonged progression free survival in heavily pretreated patients, we believe avapritinib has the potential to offer improved disease control to patients with third-line and later advanced GIST.”

 

Ph II trial of ProscaVax to start in early stage Prostate Cancer patients

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“We are making the final preparations to initiate enrollment, including planned site visits,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Underscored by the compelling data derived from the successfully completed Phase 1a clinical trial and our other research, we are eager to proceed with this study. Our goal is simple: to provide a safe, nontoxic. front-line therapy for prostate cancer patients that are otherwise left with either no therapy or  with much more invasive options that typically have very unpleasant side effects, such as impotence or urinary incontinence.  I’d like to express my gratitude for all the shareholders that have supported us throughout the process to advance our company to this next stage of ProscaVax development.  I believe there is a bright future ahead of us.”

 

First patient enrolled in Ph Ib RCC trial with Pexa-Vec + PD-1 inh Cemiplimab

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“Given the initial activity seen with Pexa-Vec monotherapy and the potential of oncolytic viruses to enhance anti-tumor immunity, combining Pexa-Vec with cemiplimab is quite rational and has the promise to build upon the activity of checkpoint inhibitor therapy alone in RCC.  This trial will not only assess the clinical activity of the two agents but allow us to assess in more depth the changes elicited in anti-tumor immunity following treatment by examining peripheral blood and tumor samples.  This will give us proof of concept data that will help us expand this approach to other tumor types,” stated James Burke, M.D., chief medical officer at SillaJen.

Clinical hold placed on Ph I trial of CD19-targeting ‘sleeping beauty’ CAR-Ts in R/R CD19+ leukemias and lymphomas

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“We know what is needed to address the hold issues and are looking forward to responding to the agency in a timely manner,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “We are undertaking cutting-edge science and are on the verge of a paradigm shift based on our approach to very-rapidly manufacture CD19-specific T cells within two days using our non-viral approach to CAR-T therapy based on the Sleeping Beauty platform.”

 

COLLABORATIONS

MolMed and AbCheck to develop new CARs targeting novel tumor antigens in heme and solid malignancies

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Riccardo Palmisano, MolMed CEO, commented: “This new collaboration plays a key role to complete the picture of the planned and announced enlargement of our CAR pipeline. Leveraging on the unique experience that we developed on CAR T CD44v6, now close to clinical stage in acute myeloid leukemia and multiple myeloma and on the recently signed partnership with Glycostem, with this agreement with AbCheck, a company with extensive expertise in antibodies selection and boasting partnerships with relevant companies and institutions in the CAR field, MolMed is fully prepared to build a robust autologous and allogeneic original CAR T pipeline, able to target both liquid and solid tumors”. Volker Lang, Managing Director of AbCheck, added: “AbCheck is recognized for its proven capability to reliably deliver high-quality human antibodies suitable for clinical development. We are very pleased to employ our unique technology suite to support MolMed’s dedicated team in adding novel therapeutic options to its diverse pipeline. Both CAR-Ts and CAR-NKs represent promising novel immuno-oncology approaches and we are confident that AbCheck’s abilities in antibody discovery and optimization will be an important asset in developing such approaches.”

 

Agios and CStone Pharmaceuticals to develop and commercialize IDH1 inhibitor Ivosidenib in Greater China

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“CStone Pharmaceuticals brings together a highly experienced leadership team and drug development capabilities that will enable us to reach patients with IDH1 mutant cancers in Greater China who could benefit from ivosidenib,” said David Schenkein, M.D., chief executive officer at Agios. “In addition to the clinical development activities that CStone will be leading, we also have the opportunity to leverage CStone’s network to expand our ongoing and future global clinical trials of ivosidenib into Greater China.”

 

Everest Medicine’s subsidiary EverNov to develop and commercialize Novartis’ novel FGFR4 kinase inhibitor, FGF401

“We are pleased to collaborate with Novartis, a global leader in the oncology space, to advance the development of FGF401,” said Sean Cao, Ph.D., interim CEO of EverNov and Managing Director of C-Bridge Capital. “This is the fifth product in our growing portfolio of therapies targeting diseases where there is a high unmet medical need among patients in China and worldwide.”

 

Arcus Biosciences and Infinity Pharmaceuticals to evaluate Triple-Combination (IPI-549 + AB928 + AB122/chemotherapy) trials in TNBC or ovarian cancer patients

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“This partnership with Infinity is important as, for the first time, we will be investigating the potential for the triple combination of a selective PI3K-gamma inhibitor, a dual adenosine receptor antagonist, and either a PD-1 inhibitor or chemotherapy to effectively treat patients with triple negative breast cancer or ovarian cancer,” said Terry Rosen, Ph.D., Chief Executive Officer of Arcus Biosciences. “This collaboration also allows us to expand the number of promising combinations with strong biological rationale that we plan to evaluate in our recently initiated Phase 1/1b trial for AB928. Arcus has carefully considered which immuno-oncology therapies can best target immune suppressive macrophages and has concluded that selective inhibition of PI3K-gamma is a fundamental mechanism for reprogramming macrophages from a pro-tumor to an anti-tumor function.”

 

AbbVie and Calibr announce collaboration for next generation T-cell therapies

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“Calibr has assembled a premier scientific team and developed an innovative cell therapy technology that can take us to the next frontier of cancer treatment,” says Mohit Trikha, Ph.D., vice president and head of Oncology Early Development at AbbVie. “The combination of AbbVie’s oncology discovery and early development expertise and Calibr’s novel switchable CAR-T therapy platform aims to advance the current standard of care, with the potential rapidly advancing new treatment options for patients.”

“We’re delighted to work together with a strong partner like AbbVie to expand the impact of the CAR-T cell field to a broader range of cancers,” says Peter Schultz, Ph.D., chief executive officer of Calibr and Scripps Research.

 

TG Therapeutics and Novimmune SA to develop and commercialize a novel anti-CD47/ anti-CD19 Bispecific Antibody TG-1801

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“We are delighted to see our first bispecific antibody move forward into the clinic with an experienced partner in the field of hematological malignancies, and to provide proof of principle for our completely novel approach,” said Chairman and Chief Executive Eduard Holdener. “We are excited about the potential benefit that this new approach could bring to B-cell lymphoma patients.”

 

DIAGNOSTICS

BRACAnalysis® CDx identifies patients who respond to Lynparza® in SOLO-1 study

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“This is the first study to show that a PARP inhibitor can lead to improved patient outcomes in first line ovarian cancer,” said Mark C. Capone, president and CEO of Myriad Genetics.  “We look forward to partnering with both AstraZeneca and Merck to ensure patients have the broadest possible access to this important therapy option.”

 

About the Author: 

Richa earned her PhD at the National Brain Research Centre, India. For her thesis, she worked on the dreaded Glioblastoma multiforme. That was her first in-depth exposure to academic research in cancer biology. After her PhD, she expanded her research experience by working in the field of immunology at UCLA, USA. After her return to India, Richa switched to a corporate setting but continued her engagement with the cancer field. She is currently loving her work, which affords her the opportunity to continue developing her knowledge in the biomedical field of cancer. Outside of work, she enjoys watching, identifying and photographing birds.

Editor and Blog Design:

Abhi Dey

Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. He is currently an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His current research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR).  When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.

Cover Image: Credits: Annie Cavanagh (2012) CIL:38937, Homo sapiens, colon cancer cell. CIL. Dataset. https://doi.org/doi:10.7295/W9CIL38937. Scanning electron micrograph of human colon cancer cells in culture. Colon cancer is the third most common cancer in Britain. People are more likely to develop this cancer if they eat a diet high in animal fats. Wellcome Images available under the following creative commons usage http://creativecommons.org/licenses/by-nc-nd/2.0/uk/

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The contents of Club SciWri are the copyright of Ph.D. Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers, and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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