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ClubSciWri begins a new collaboration with Richa Tewari for Medness. Richa will be presenting the latest news in Oncology as weekly blog- Onco This Week. In the first edition itself she has enumerated 25+ news items on major results, trial statuses, collaborations, financial reports and regulatory topics from across the world. We believe this news digest will provide the students, investigators and market analysts with a comprehensive list of trends in oncology. 

RESULTS

TAT 2018: Epigenetics therapy shows promise in Lymphoma patients

Novel molecules targeting epigenetics have shown noteworthy early activity in patients with lymphoma, according to the data shown at the TAT (Targeted Anticancer Therapies) International Congress 2018 in Paris, France. ESMO’s (European Society for Medical Oncology) phase-I oncology conference featured early clinical studies with BET inhibitors and EZH2 inhibitors.

CDK4/6 inhibitor Trilaciclib shows myelopreservation and favorable trends for ORR, DOR and PFS in SCLC patients in Ph 2a trial

“The data from this trial showed clear evidence that trilaciclib preserved bone marrow and immune system function from the damaging effects of chemotherapy,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “Moreover, the myelopreservation effects demonstrated by trilaciclib improved patient outcomes. Chemotherapy continues to be a cornerstone of cancer treatment, and trilaciclib has the potential to benefit many of these patients.”

Ras protein mimetic Rigosertib shows efficacy in Ph 1/2 trial in MDS patients

Rigosertib, a small molecule, inhibits cellular signaling by serving as a Ras protein mimetic. Ras (a family of proteins involved in transmitting signals within cells) when switched “on”, triggers other proteins that eventually turn on genes that control cell growth, differentiation and survival.

About the image: Blood smear from an adult female with a myelodysplastic syndrome related to radiotherapy and chemotherapy for Hodgkin disease. A hypogranular neutrophil with a pseudo-Pelger-Huet nucleus is shown. The red blood cells show marked poikilocytosis, in part related to post-splenectomy status. (Wright-Giemsa stain) (Source: Wikipedia)

Servier and Pfizer to present results of UCART19 first-in-human trials at the 44th EBMT meeting

FAILED TRIAL: Ph 3 GLOBE study in recurrent Glioblastoma patients did not meet primary end-point of OS improvement

Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics, said “We are disappointed that our encouraging Phase 2 data were not replicated in the GLOBE Phase 3 study, and once we receive the full and final data we will be analyzing them carefully to better understand the outcome of the study. We are grateful to the trial investigators, site personnel, patients and caregivers who participated in GLOBE. We believe that VB-111 may still hold promise for other indications we currently or may study in the future.”

LABEL UPDATES

Nivolumab the first and only FDA-Approved PD-1 inhibitor to offer Q4W dosing

“At Bristol-Myers Squibb, we are united in our mission to fight cancer from all angles and recognize every patient has unique needs. From the introduction of our first Immuno-Oncology agent through today’s approval of flexible dosing options at two- or four-week intervals, we are relentless in pursuing innovative options for the cancer community,” said Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb. “With this approval, we now offer the most robust range of dosing options for an Immuno-Oncology medicine, providing enhanced flexibility to help address each patient’s specific needs.”

 

TRIAL STATUSES

First patient receives cycle 1 of PCM-075 + LDAC in AML trial

Benitec Biopharma Ltd launches its Ph 2 SCCHN trial of BB-401 in Australia

Chief Executive Officer Greg West said, “I am delighted that we have received approval to commence the study in Australia. This represents an important milestone for us in the progression of BB-401 as a treatment option for patients with advanced head and neck cancer who have failed all other treatment modalities. We are on track to start screening patients shortly.”


GlycoMimetics announces design of Ph 3 trial for E-selectin antagonist GMI-1271 in R/R AML

“GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, as well as lower than expected induction-related mortality rates. Treatment in this patient population was well tolerated, with minimal adverse effects.”- GlycoMimetics, Inc.


Daiichi Sankyo, Inc. starts Ph 2 Study of HER2-targeting ADC DS-8201 in HER2-expressing advanced CRC patients

“Given the existing unmet medical need for advanced colorectal cancer, we are exploring the smart delivery of chemotherapy with DS-8201 as a potential new type of targeted treatment for patients with HER2-expressing disease who have progressed on or become resistant to standard therapies,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Similar to our breast and gastric cancer programs, we are pursuing a development path focused first on patients with HER2-overexpressing tumors followed by potential expansion to include patients with advanced colorectal cancer with lower levels of HER2 expression.”


Ph 1 trial of CD48-targeting ADC SGN-CD48A initiated in R/R Multiple Myeloma

“Multiple myeloma is the second most common blood cancer in the US and remains an incurable disease despite recent medical advances. Patients are in need of new targeted treatment options that increase durable remissions,” said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. “SGN-CD48A uses our latest ADC technology, and the initiation of this phase 1 trial in relapsed or refractory multiple myeloma highlights our continued leadership in ADCs as we address this challenging disease.”


First melanoma patient dosed in Ph 1 cohort expansions with Pegzilarginase

“Given our encouraging dose escalation data with pegzilarginase, the start of these Phase 1 cohort expansions is an important next step in targeting the advanced solid tumors that we believe are vulnerable to arginine depletion,” said Anthony Quinn, MB ChB, Ph.D., interim chief executive officer of Aeglea. “This is an exciting time at Aeglea as we assess the clinical activity of sustained arginine depletion in melanoma. We expect to report topline data in the fourth quarter of this year.”

 

ACQUISITIONS


Seattle Genetics completes acquisition of Cascadian Therapeutics, Inc.

“This acquisition expands Seattle Genetics’ late-stage pipeline, providing another opportunity to bring a targeted therapy to cancer patients with a significant unmet medical need, and advances our goal of becoming a global, multi-product oncology company,” said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “Tucatinib, which is in an ongoing pivotal trial called HER2CLIMB, has the potential to provide a differentiated approach to treating HER2-positive metastatic breast cancer based on its activity and tolerability profile. In addition, it may have a role in earlier lines of metastatic breast cancer therapy and in other solid tumors. We look forward to joining efforts with the Cascadian team towards our common goal of improving outcomes for people with cancer.”

COLLABORATIONS

Bavarian Nordic to test CV301+Nivo in MSS CRC patients

“To date, there are no checkpoint inhibitors approved for the treatment of microsatellite stable colorectal cancer. This trial marks an important step in exploring indications where checkpoint inhibitors have not been successful as a monotherapy,” said Paul Chaplin, President and CEO of Bavarian Nordic remarked. “We believe that CV301 – with its ability to elicit T-cells against specific tumor antigens – has the potential to address cancers in which monotherapy checkpoint inhibition may not be possible, and we are happy to further explore how we can best serve patients in need of new therapies.”

About the image: Micrograph of a colorectal adenocarcinoma metastasis to a lymph node. The cancerous cells are at the top center-left of the image, in glands(circular/ovoid structures) and eosinophilic (bright pink). H&E stain. (Source: Wikimedia Commons)

Aptose Biosciences, Inc. in license agreement for dual BET/kinase targeting program with Ohm Oncology

“Aptose has proven to be an excellent integrated drug discovery partner for LAXAI and this agreement is the outgrowth of our collaboration started in 2015,” said Vamsidhar Maddipatla, President of LAXAI Life Sciences.  “We greatly appreciate the faith Aptose put in LAXAI in signing this discovery stage program.”  Ajit Gill, President and CEO of OHM Oncology, added,  “We look forward to working in partnership with Aptose and leveraging their experience in developing this molecule to treat certain types of cancers.”

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Merck and Eisai enter strategic collaboration for Lenvatinib

“Aiming to maximize the potential of LENVIMA and expedite the creation of innovative treatments in this age of “Cancer Evolution,” we have entered into this collaboration with Merck who developed the anti-PD-1 antibody KEYTRUDA,” commented Haruo Naito, Representative Corporate Officer and CEO of Eisai Co., Ltd. “By providing new treatment options including for refractory cancers with no hopes for a cure to date, we are striving to further contribute to increasing the benefits provided to patients and their families.” “Together with Eisai, we aim to maximize the value of LENVIMA for its current indications while jointly pursuing additional approvals in combination with KEYTRUDA across a wide range of cancers,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. “There is strong scientific evidence supporting synergistic effects of KEYTRUDA when used in combination with LENVIMA, and the companies have already received Breakthrough Therapy Designation from the U.S. FDA for the KEYTRUDA/LENVIMA combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world.”

 

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REGULATORY FOCUS

FDA panel backs Blinatumomab for MRD+ ALL, PDUFA: 29Mar18

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EMA granted orphan medicinal product designation to Toca 511 & Toca FC for glioma patients

“The European Medicines Agency’s (EMA) granting of orphan medicinal product designation to Toca 511 & Toca FC emphasizes the urgent need for new therapies that may benefit patients living with glioma,” said John Wood, vice president, regulatory affairs and quality, at Tocagen. “We are committed to working closely with the EMA under this orphan designation and our previously announced PRIME (PRIority MEdicines) designation to bring our product candidate to European patients and physicians as quickly as possible.”

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ICER panel split on value of CAR-Ts

“The Institute for Clinical and Economic Review’s California Technology Assessment Forum voted that the value of Kymriah tisagenlecleucel was intermediate, while the panel was mixed on whether the value of Yescarta axicabtagene ciloleucel was intermediate or low.”- Source- Biocentury

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FINANCIAL RESULTS

Curis reports Q4 and year-end 2017 financial results

“2017 exemplified Curis’s business strategy, marking the Company’s first time with three anti-cancer drug candidates in clinical development” said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. “We are excited about CUDC-907 treatment providing durable responses in nearly 1 in 4 DLBCL patients whose cancers have MYC alterations. We are working closely with regulatory authorities to define a pivotal path to register CUDC-907 in this patient population, which has no viable treatment options.”

“Our progress with testing CA-170, the first and only oral small molecule checkpoint inhibitor, has now extended beyond the Phase 1 trial, with our partner Aurigene having initiated a Phase 2 trial in India.  This will greatly accelerate access to select populations of patients that have not experienced prior immunotherapy.”

“As noted, with initiation of patient enrollment in CA-4948’s Phase 1 lymphoma study, for the first time, Curis has 3 different cancer drugs in clinical testing at the same time.  We are excited about the prospects for these drugs and their value to Curis’s success in 2018.”

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Tocagen Inc. reports Q4 and year-end 2017 financial results

“We had an excellent finish to the year with the acceleration of Toca 511 & Toca FC development into a pivotal Phase 3 trial and the presentation of updated data demonstrating continued favorable safety and long-term durable responses in patients with recurrent high-grade glioma,” said Marty Duvall, chief executive officer of Tocagen. “With the closing of our upsized public offering in 2017 and enrollment in our Phase 3 trial remaining on track to complete in 2018, we believe we are well positioned to advance our lead program and platform technology in the year ahead.”

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Mirati Therapeutics reports Q4 and year-end 2017 financial results

“We made significant progress in our key programs in 2017,” said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. “Promising data from the sitravatinib and KRAS programs encouraged us to pursue a more aggressive approach to accelerate development, supported by the successful financing we completed in November. In early 2018, we initiated a strategic regional partnership with BeiGene Ltd. that we anticipate will rapidly expand the development of sitravatinib in multiple tumor types. We expect to report multiple key catalysts in 2018, including a mid-year clinical update for our sitravatinib program. Our KRAS inhibitor program, an important yet elusive target, is growing and we remain on track for an IND filing in the fourth quarter of 2018.”

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Spectrum Pharmaceuticals, Inc. reports Q4 and year-end 2017 financial results

“2017 was a landmark year for Spectrum driven by advancements in our pipeline,” said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. “Poziotinib has the potential to be a life-altering therapy for cancer patients with exon-20 insertion mutations. ROLONTIS gives Spectrum a near-term opportunity to compete in a blockbuster market. We expect several pipeline milestones in 2018 and we look forward to keeping you updated.”

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GlycoMimetics reports Q4 and year-end 2017 financial results

“Highlighting the fourth quarter of 2017, GlycoMimetics presented a robust data set for its Phase 1/2 study of GMI-1271 for the treatment of AML patients. This data provided the basis for discussions with the U.S. FDA focused on a Phase 3 trial design – the result of which we announced yesterday. The ongoing discussions were made possible via our Breakthrough Therapy designation for GMI-1271 for the treatment of relapsed/refractory AML patients, and we now plan to initiate our own Phase 3 trial in this patient population later this year,” noted Rachel King, Chief Executive Officer.

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BioLineRx reports Q4 and year-end 2017 financial results

Philip A. Serlin, Chief Executive Officer of BioLineRx, stated, “We are very proud of the continued advancement and on-target execution of our oncology programs in 2017. During the year, we initiated several clinical studies for our lead asset, BL-8040, including our first pivotal Phase 3 study in autologous stem-cell mobilization, as well as a number of studies under our immunotherapy collaborations with Genentech and MD Anderson Cancer Center. Furthermore, we announced encouraging clinical results demonstrating the therapeutic potential of BL-8040 – the recently reported partial results from the monotherapy stage of our Phase 2a COMBAT study in pancreatic cancer showed robust mobilization and increased infiltration of anti-tumor-specific T cells into the tumor microenvironment, supporting previously reported BL-8040 data; and BL-8040 in combination with Ara-C demonstrated significant improvement in overall survival in our phase 2a study in relapsed/refractory AML.”

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“We are also excited by the potential of our second oncology asset, AGI-134, acquired in early 2017, with new pre-clinical data demonstrating induced regression of primary tumors following intratumoral injection. We expect to initiate a Phase 1/2a study for this product in multiple solid tumors by mid-2018. We will continue the steady execution on all our programs during 2018, and we look forward to reporting on key milestones over the next six to 12 months, including data read-outs from several Phase 2 studies and lead-in results from our Phase 3 trial in autologous stem cell mobilization,” concluded Mr. Serlin.


Array BioPharma Inc. reports financial results for Q2 of fiscal 2018

“We believe the strength of the COLUMBUS data, with a remarkable median overall survival of 33.6 months and median progression-free survival of 14.9 months, highlights the potential of the encorafenib and binimetinib combination for patients with BRAF-mutant melanoma,” said Ron Squarer, Chief Executive Officer. “These data, together with our impressive, recently presented results in BRAF-mutant colorectal cancer, and our strong cash balance, position us well to advance our innovative therapies for patients with cancer.”

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Syndax Pharmaceuticals reports Q4 and year-end 2017 financial results

“In 2017, we continued to advance our pipeline of potentially transformative best-in-class candidates for the treatment of various cancers. We made significant progress on the clinical development of both our lead product candidate, entinostat, and SNDX-6352, our monoclonal antibody that blocks the colony stimulating factor 1 receptor. We also expanded our pipeline with the addition of a portfolio of preclinical, orally-available small molecule Menin-MLL inhibitors,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “We look forward to several key data readouts in the next six months, including progression free survival data from the Phase 3 E2112 trial of entinostat in combination with exemestane for advanced HR+, HER2- breast cancer. We also anticipate results next quarter from the PD-(L)1 refractory melanoma and NSCLC cohorts of ENCORE 601, as well as initial data and a decision on whether to advance to the second stage of the ENCORE 601 cohort of patients with microsatellite stable colorectal cancer.”

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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.

Blog Design: Abhinav Dey

Image Source: Pixabay, Wikipedia and Twitter

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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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