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Editor’s Note: This week in Onco-this-Week check out EU’s approval of Cabozantinib in 1L RCC which followed its FDA approval in December. We have also featured the longer follow-up data of Alectinib in Ph III ALEX trial that shows continued reduction in disease progression. Also in this edition, watch out for the clinical updates to be presented at ASCO by Genentech and others. This week’s infographic is themed from the news of the first patient dosed for eFT508 in eFFECTORs Ph2 trial in colorectal cancer. In our educational video section, we bring the 2nd part of the series on orphan drugs and their costs borne by patients/insurance. All this and a lot more oncology news to catch-up on in the current edition, so enjoy reading and stay healthy!- Abhi Dey   

Make Time+Break Time= Cancer Protection

From Visually.

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

 

Note from our Sponsor: “Did you Know Most of our single-domain antibody-based affinity tools resist high salt, up to 60 °C or 4 M urea without loosing their binding capability? Consult us or refer to the product data sheet for specific details.”

“NanoTag Biotechnologies is a German company founded in July 2015 by scientists with a strong background in biochemistry as well as quantitative super-resolution imaging. Situated in Göttingen, we are in constant exchange with scientists developing and applying tools for innovative cutting-edge research. The inspiring atmosphere created by leading scientists and an excellent network of entrepreneurship is an ideal breeding ground for our vision to produce thoroughly validated high-quality tools for life-sciences, biotechnology and bio-medical research. Currently, our portfolio mainly focuses on single-domain antibody-based affinity reagents (“Tags”) for biochemical and fluorescence-based applications. In the near future, we are going to expand our portfolio to enzymes, affinity resins and secondary reagents for various immunoassays (IP, IF, IHC, IHC-P, WB…). Feel free to contact us anytime to discuss custom projects.”

 

Cover image: [Courtesy: Felipe Opazo (CEO) Nano-Tag Biotechnologies]3T3 cells decorated with the rabbit anti-beta-Actin (SYSY cat. no. 251 003) were stained with FluoTag-X2 anti-Rabbit Atto 565 with additional DAPI stain. (For more info click here)

 

Educational Video: Last week (link), we argued that the benefits of the Orphan Drug Act are more elusive than commonly assumed. But what are its costs? That’s the topic of this week’s Healthcare Triage. “An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development.” Source: Wikipedia

 

DRUG APPROVALS

Anlotinib gets approval in 3L NSCLC in China

Anlotinib was granted marketing authorization by Chinese FDA (CFDA). With the brand name as “FOCUS V”, Anlotinib has potential to become a standard therapy for 3L treatment of heavily pre-treated advanced lung cancer patients in the light of its clinically-proven efficacy supported with a manageable safety profile. Anlotinib is also being tested for its efficacy in other more than ten other cancers.

Cabozantinib gets EU approval in 1L intermediate- or poor-risk RCC patients on the basis of Ph II CABOSUN trial results

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen.  “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx® across different indications.”

Giuseppe Procopio, M.D., Head of the Genitourinary Unit at Fondazione Istituto Nazionale Tumori Milan, stated: “The value of treatment with Cabometyx® has been corroborated by the data generated in clinical trials, and since 2016 physicians have also witnessed the potential of it when treating patients following VEGF-targeted therapy. For both of these reasons, physicians will be pleased to soon have access to this new first-line treatment option for intermediate- or poor- risk advanced RCC patients.”

REGULATORY NEWS

Oncolytics Biotech receives Special Protocol Assessment agreement from FDA for Ph III trial of Pelareorep in metastatic Breast Cancer

“This agreement with the FDA, outlining the specific clinical pathway forward in metastatic breast cancer, is an important milestone in advancing pelareorep along a path to potential regulatory approval,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “It’s a confirmation from the FDA that our design and protocols will support an application for approval and advances pelareorep to be a phase 3 asset. We now look forward to implementation of the Agency’s guidance and to the advancement of pelareorep through this final phase of clinical development.”

MediciNova Announces Opening of INDA for PDE4/10 inhibitor MN-166 (ibudilast) in GBM

“We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-166 in GBM, a devastating type of cancer with a high recurrence rate and very poor prognosis.  As we previously reported, combination treatment of MN-166 (ibudilast) and TMZ improved survival compared to TMZ-only treatment in a GBM animal model study,” commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.  

FDA accepts re-submission of BLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar; BSUFA date: Nov 3, 2018

“We appreciate FDA’s prompt action on our file and look forward to working with them on the review,” said Denny Lanfear, President and CEO of Coherus BioSciences.  “We believe that CHS-1701 is well-positioned to deliver greater access to oncology patients and savings to the healthcare system. We are continuing to make good progress in building inventory of CHS-1701 and in preparing for commercial launch in the U.S.”

IND application to be filed for Tri-specific Killer Engager (“TriKE”) asset OXS-3550 in mid-2018

“The expected filing of the IND for our first TriKE product candidate in mid-2018 is representative of the overall progress we are making as a company,” said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. “We look forward to updating our shareholders on our progress throughout 2018 as we continue to execute on our objectives.”

BioLineRx granted European Patent for CXCR4 inh BL-8040 + Cytarabine in AML till March 2034

“The long-term patent exclusivity we have received from the European Patent Office for BL-8040 in combination with cytarabine provides us with significant additional patent protection in AML, one of BL-8040’s key indications,” said Philip A. Serlin, Chief Executive Officer of BioLineRx. “In this regard, we are moving forward in full force with two ongoing trials in the AML space – a Phase 2b in consolidation AML and a Phase 1b/2 in maintenance AML, in addition to the continued follow-up on encouraging overall survival results shown in our recently completed relapsed/refractory AML study.”

SPECIAL STATUSES

Radioiodinated PDC asset CLR131 gets orphan drug designation in Rhabdomyosarcoma

“Rhabdomyosarcoma is the most common type of tissue sarcoma in children.  While initial response to treatment is generally favorable, there is an important need for new treatments, especially in children who experience relapse.” said John Friend, M.D., chief medical officer of Cellectar.  “Cellectar is committed to working closely with the FDA to fully evaluate the potential for targeted delivery of CLR 131 to address this currently unmet medical need.”

TRIAL RESULTS

Encouraging response rates observed in R/R HL patients treated with PD-1 inhibitor, Sintilimab

“Sintilimab, jointly developed by Innovent Biologics and Eli Lilly and Company, is a novel anti-PD-1 antibody with global IP rights.  I am very grateful for my colleagues at Innovent Biologics, various government agencies and our partner Lilly for their effort and dedication.”  said Dr. Michael Yu, the founder and CEO of Innovent Biologics. “Sintilimab will bring new hope for patients with relapsed and refractory classical Hodgkin Lymphoma in China.  Our mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Now we have just completed the very first critical step toward that mission.”

“We are very pleased with the Lilly/Innovent research and development collaboration.  Together, we are making progress toward our shared goal of bringing innovative medicines to China. We firmly believe that our in-depth collaboration with Innovent may bring medical advances that eventually benefit many cancer patients throughout China,” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology.

Ph III ALEX trial’s 3-yr follow up data demonstrated sustained benefit in the reduction of the risk of disease progression or death (57%) for people treated with Alectinib

“Follow-up results from the ALEX study demonstrate the significant sustained benefit of Alecensa, showing that people with metastatic ALK-positive non-small cell lung cancer lived for almost three years without their disease progressing,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “These results further support the use of Alecensa as a standard of care for people who are newly diagnosed with this form of lung cancer.”

Addition of Nelarabine provided further benefit for patients with moderate or high risk of T-ALL recurrence in Ph III trial

“T-cell ALL is a disease that requires the use of a very intense and complex chemotherapy regimen. Historically, about 80% of people live at least four years after being treated for their disease, but we felt we could and must do better,” said lead study author Kimberly Dunsmore, MD, professor, Virginia Tech Carilion School of Medicine in Roanoke. “Our trial shows that we could further increase survival rates by about 10%, which is very encouraging.”

Rucaparib provides clinical benefit to patients with advanced pancreatic cancer and a BRCA1/2 mutation

Rucaparib provided clinical benefit to patients with advanced pancreatic cancer and a BRCA1/2 mutation with a objective response rate of 15.8%; , and demonstrated an acceptable safety profile. The disease control rate (CR, partial response, or stable disease for ≥ 12 weeks) was 31.6% (6 of 19) in all patients and 44.4% (4 of 9) in those who had received one prior chemotherapy regimen.

TRIAL STATUSES

eFFECTOR initiates doing in Ph II trial of EFT508 + Avelumab in MSS CRC

“We are rapidly expanding our Phase 2 program for eFT508 in a range of cancers and in combination with checkpoint inhibitors such as anti-PD-1 and anti-PD-L1,” said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. “Establishing the tolerability of eFT508 in combination with a checkpoint inhibitor at a dose that thoroughly inhibits its target is an important milestone in the development of our eFT508 combination program. Our hope is that by targeting dysregulated protein translation, which is a hallmark of a number of cancers, we will help provide new avenues for overcoming tumor resistance to existing checkpoint inhibitor therapies, such as in the treatment of MSS CRC.”

First patient dosed in Ph Ia/Ib trial of PD-1 inhibitor CS1003 in Australia

“We are excited to announce initiation of clinical development for PD-1 inhibitor CS1003, our second pipeline candidate to enter Phase I studies in Australia after the CTLA-4 mAb CS1002 within one month,” said Dr. Frank Jiang, Chief Executive Officer at CStone. “CS1003 is cross-reactive with human and mouse PD-1 which enables quick pre-clinical proof of concept experiments in combination with novel targets, leading to global first-in-combination potential. Because of this unique feature, CS1003 is critical to CStone’s combination strategy in cancer immunotherapy.”

As noted by Dr. Jason Yang, Chief Medical Officer of CStone, “In preclinical studies, CS1003 demonstrated high affinity and selectivity for PD-1, as well as synergistic anti-tumor effects with multiple small-molecule drugs in animal models. The launch of this clinical program will allow us to gather important safety and efficacy data on CS1003. This will lay the foundation for future development of this molecule, in particular as the basis of combination therapies.”

“We are excited to be enrolling our first patient treated with CS1003 and are hopeful that this novel immunotherapy drug will add to the available therapeutic options for advanced-stage tumors, either by itself or in combination with other drugs,” said Dr. Charlotte Lemech, MBBS, BSc, FRACP, MD, lead investigator for this trial at Scientia Clinical Research Ltd.

Nucleic acid synthesis inhibitor RX-3117 and nab-paclitaxel Ph IIa trial in 1L Metastatic Pancreatic Cancer Patients Advances to Second Stage

“This SMC recommendation allows us to enter the second stage of the trial and continue to treat patients with the maximum tolerated doses of both RX-3117 and Abraxane, which we believe may lead to better clinical outcomes,” said Ely Benaim, M.D., chief medical officer of Rexahn. “Current standard of care for metastatic pancreatic cancer utilizes gemcitabine and Abraxane in combination; however, not all patients can tolerate this regimen because of unacceptable toxicities. Poor tolerability often results in dose reductions of both agents and a shortening of treatment durations. RX-3117 selectively targets cancer cells providing a potential advantage over gemcitabine.”

Ph Ib/II trial of ROR1 inhibitor Cirmtuzumab + Ibrutinib combination starts in B-cell malignancies (MCL, CLL, SLL)

“There remains significant unmet medical need for patients with B-cell malignancies because current drug treatments can induce partial responses, but these are temporary. It is our hope that adding cirmtuzumab to standard of care ibrutinib will induce complete responses that may be durable,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “Our collaboration with Dr. Thomas Kipps of UC San Diego has shown that cirmtuzumab and ibrutinib synergistically block multiple signaling pathways that are important in the pathogenesis and progression of B-cell lymphomas and leukemias and provide a strong rationale for combination therapy.”

ACQUISITIONS, COLLBORATIONS AND MERGERS

Lilly Announces Agreement To Acquire ARMO BioSciences

“At Lilly Oncology, we are dedicated to developing cancer medicines that will make a meaningful difference for patients,” said Sue Mahony, Ph.D., Lilly senior vice president and president of Lilly Oncology. “The acquisition of ARMO BioSciences adds a promising next generation clinical immunotherapy asset to Lilly’s portfolio of innovative oncology medicines.”

“As we develop our immuno-oncology portfolio, Lilly will pursue medicines that use the body’s immune system in new ways to treat cancer,” added Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology, “We believe that pegilodecakin has a unique immunologic mechanism of action that could eventually allow physicians to offer new hope for many cancer patients.”

“ARMO is proud of the work we have done to advance the study of immunotherapies and of the development of pegilodecakin to-date,” said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. “Given the resources that Lilly, a leader in oncology R&D, can bring to bear to maximize the value of pegilodecakin and the rest of the ARMO pipeline, we believe it is in the best interest of ARMO, our stockholders and the patients we serve, to execute this transaction.”

Lilly acquires AurKa Pharma to expand oncology pipeline with early-phase asset being studied in multiple tumor types

“The acquisition of AurKa Pharma supports Lilly’s external innovation strategy, in which we seek to partner with leading life science venture capital firms in order to identify, support and access promising innovation in areas of unmet medical need,” said Darren Carroll, senior vice president of corporate business development at Lilly. “We are excited with the value TVM created for this compound through its early-Phase studies, and we look forward to more opportunities in the future.”

“Lilly Oncology is focused on the development of innovative cancer therapies that can make a meaningful difference for patients,” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. “The acquisition of AurKa Pharma expands our pipeline with a promising oncology compound targeting a distinct cell cycle pathway. The work done by AurKa will allow Lilly to leverage emerging data about cancers in which this molecule might be effective, and determine if it can be beneficial to people living with various forms of cancer.”

“Through the unique healthcare venture capital model pioneered by TVM Capital Life Science, companies such as AurKa have been established to more quickly and efficiently bring promising compounds to clinical proof-of-concept,” said Luc Marengere, Ph.D., Managing Partner at TVM Capital Life Science. “We are pleased that the scientific advances made by AurKa could contribute to the development of AK-01 and hopefully help deliver a potential new medicine for cancer patients.”

TapImmune and Marker Therapeutics merge to create new I/O company

Peter Hoang, President and CEO of TapImmune, stated, “I believe that the new therapies we are acquiring with Marker in this transaction represent the next major leap forward in cell therapy for cancer. The merger adds to our product pipeline a synergistic portfolio of highly-differentiated T cell therapies that has demonstrated potentially groundbreaking results in early clinical trials in lymphoma, acute myeloid leukemia (AML), and multiple myeloma.”

“With this merger, I believe we have the opportunity to significantly disrupt the CAR-T and TCR field,” added Mr. Hoang.

“Executing this strategic merger with Marker Therapeutics will be fundamentally transformational for TapImmune, enriching our strong immuno-oncology pipeline with a revolutionary multi-antigen targeted cell therapy platform. We believe this technology will be a game-changer for the cell therapy industry, potentially overcoming the well-known limitations of today’s CAR-T and TCR approaches,” concluded Mr. Hoang. “Combined with the four ongoing Phase 2 clinical trials in the TapImmune platform, I believe we are creating a best-in-class cancer immunotherapy platform. With Marker’s peptide-based cell therapy platform, we believe that there is an excellent fit with TapImmune’s extensive experience and expertise in the research, development, manufacturing and manipulation of peptide-based immunotherapies. Furthermore, the integration of the two companies provides us with a compelling opportunity to create a unique and highly differentiated company in the immuno-oncology field.”

John Wilson, CEO of Marker, said, “I feel very fortunate to have been entrusted with one of the premier programs of Baylor College of Medicine’s Center for Cell and Gene Therapy, and to integrate it with TapImmune to provide this exceptional technology with a strong commercial pathway. We have great respect for the work that the TapImmune team has done within the immuno-oncology field and believe integrating our respective peptide-based technologies will drive significant advances in the field. By combining TapImmune’s experience and expertise in multi-epitope peptide-based approaches to T cell activation with Marker’s multi-targeted T cell therapy, while simultaneously leveraging the know-how and facilities of Baylor College of Medicine’s Center for Cell and Gene Therapy, we intend to chart a groundbreaking course toward more effective, less complex, non-toxic and cost-effective cancer treatments. Our respective development teams are eager to join forces and drive a unique product pipeline to patients in need. We believe the merger will accelerate clinical development, particularly for the cell therapy platform, which has generated encouraging patient responses in our clinical trials to date. I look forward to taking a position on the post-merger Board of Directors where I can leverage my T cell manufacturing expertise and help the Company implement a highly practical and economical manufacturing platform. By avoiding the need for genetic engineering, the manufacturing process can be greatly simplified, providing us with a great opportunity to successfully address the cost issues that currently plague the field.”

Daiichi Sankyo to acquire licenses to Zymeworks’ Azymetric™ and EFECT™ technology platforms to develop two additional bispecific antibody therapeutics

“With a successful track record and our first bispecific antibody incorporating the Azymetric and EFECT technology having achieved a key research milestone in 2017, we look forward to adding two more bispecific compounds to our pipeline,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “We are exceptionally impressed with the robust impact that Zymeworks’ technology brings to antibody development.”

“Expanding our relationship with a leading global pharmaceutical partner like Daiichi Sankyo is extremely satisfying as it underscores the power, versatility, and attractiveness of our technology platforms,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Having already used our platforms to discover one bispecific antibody, Daiichi Sankyo now has increased access to our technology to create additional therapeutic candidates. We are pleased to be working with a healthcare pioneer with a proven track record of over 100 years of innovation leading to major breakthroughs in patient care.”

Fate Therapeutics and MSKCC Expand Scope of License Agreement to include Gene-edited T-cell Immunotherapies including dual targeted CAR-T product FT819

“Engineering stem cells and using master iPSC lines for the renewable production of off-the-shelf CAR T cells has the potential to advance the cancer immunotherapy landscape,” said Dr. Sadelain. “We are pleased with the breakthrough discoveries accomplished under our ongoing collaboration with Fate Therapeutics, and look forward to continuing our advancement together of off-the-shelf CAR T-cell products toward clinical development.”

“The use of a gene-edited master iPSC line for the manufacture of off-the-shelf T-cell immunotherapies ensures complete removal of endogenous TCR expression, which is critical to avoid the life-threatening complication of graft-versus-host disease that is seen in allogeneic T-cell therapy,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “The incorporation of these latest MSK technologies into our development of FT819 and our iPSC product platform advances our leadership position in developing off-the-shelf T-cell immunotherapies with improved safety, enhanced potency and expanded therapeutic reach.”

Infographically speaking….

 

Colorectal cancer: What You Need to Know

From Visually.

 

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.

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The contents of Club SciWri are the copyright of PhD 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.

 

 

 

Disclaimer: The authors and editors for Onco-this-week declare no financial benefits or remuneration from the sponsors. The sponsorships support the non-profit organization, PhD Career Support Group. The research conducted by authors and editors is a voluntary effort to popularize science for the public on behalf of PhD CSG.

This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

 

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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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