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On April 24, 2020 QIMR Berghofer Medical Research Institute reported that it has entered a research collaboration and licence agreement with Shanghai-based biopharmaceutical company EpimAb Biotherapeutics to develop bi-specific antibodies against immuno-oncology targets (Press release, QIMR Berghofer Medical Research Institute, APR 24, 2020, View Source [SID1234556536]).
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The novel targets were identified by QIMR Berghofer visiting scientist Professor Bill Dougall and the Coordinator of the Institute’s Immunology Department, Professor Mark Smyth.
Under the agreement, the researchers will test antibodies that act on two immune targets simultaneously using EpimAb’s platform Fabs-In-Tandem Immunoglobulin (FIT-Ig).
Under the terms of the agreement, EpimAb has been granted an exclusive licence to develop the bi-specific antibodies.
QIMR Berghofer’s Acting Director and CEO, Professor David Whiteman AM, welcomed the agreement.
"Professors Bill Dougall and Mark Smyth are world leaders in identifying new immune targets for cancer," he said.
"By partnering with EpimAb – a company that specialises in developing bispecific antibodies – we hope to speed up the development of much-needed new cancer immunotherapies."
Professor Smyth said the bispecifics field had opened up new potential avenues to treat cancer.
"Existing immune checkpoint therapies usually act on a single immune target," Professor Smyth said.
"By developing antibodies that target two immune checkpoints simultaneously, we hope to produce a stronger anti-cancer response.
"EpimAb’s unique platform technology will allow us to further evaluate some of our most recent discoveries."
EpimAb’s CEO and founder, Dr Chengbin Wu, said he looked forward to using the company’s technology to evaluate novel bispecific target pairs developed under the collaboration.
"QIMR Berghofer is one of the pioneering institutes in the discovery of immuno-oncology mechanisms which are playing an important role in today’s treatment of cancer," Dr Wu said.
"We are proud to collaborate with QIMR Berghofer to identify novel target combinations as EpimAb enters the next stage of growth."
The terms of the agreement are commercial-in-confidence.
Special Issue of Acta Medica Academica (AMA) focused on Genomics in Hematology and Oncology Practice A special issue of Acta Medica Academica (AMA) focused on Genomics in Hematology and Oncology Practice was recently edited by Dr. Gordan Srkalovic (Medical Director, Herbert-Herman Cancer Center, Sparrow Health System, Lansing, Michigan, USA). As a guest editor, he brought together a network of leading oncologists in the field to write on Precision Medicine in their areas of expertise. Sparrow Cancer Center is a 1stOncology Healthcare Partner and in this blog article we cover this timely resource that describes the possible boons of Genomics in Cancer Therapy. This full treasure trove of a special issue of Acta Medica Academica is available totally free at the link below so read, enjoy, and push the boundaries of science to find more therapies for cancer throughout the world!
The year of 1999 witnessed a revolution in science, because the United States National Institutes of Health (NIH), along with other institutions of the world, revealed the secret ‘blue-print’ of the genetic code of human species – the human genome. Dr. Francis Collins (Director, NIH) proudly proclaimed in his publication that this would change the that way we think of medicine, and would create new ways to diagnose, prevent, and treat diseases (1). This vision became the template for change. The years kept on flowing, but the progress in Precision Medicine did not occur as predicted, not until more than 15 years later.
Then, in 2016, then-Vice President Joe Biden started a movement out of his own personal tragedy called “The Cancer Moonshot Initiative”. This was meant to accelerate cancer research that was aimed to make various therapies available to more patients, while also improving physicians’ abilities to prevent cancer and detect it at an early age. This fell into the 21st Century Cures Act and was signed into law by President Obama. It opened up the silos between the laboratories, industries, and computer experts, and exploded the field of cancer genomics.
For clarification: Genomics is NOT the same as Genetics! In cancer genomics, the genome of the tumor (not of the person) is carefully studied, and the abnormalities in the cancer genome that cause the development and growth of cancer is analyzed to find improved methods for diagnosing and treating the disease. This tsunami of information has led to fast development of therapies and approvals of targeted therapies that are saving lives with lesser side effects. Lung cancer is a classic example of this. It is hard for us to keep track of all this information. This is where we need a reference, updated, and reliable book – a manual that summarizes the key information for each type of cancer and that can educate the readers on different types of cancer treatments in this new age.
A special issue of Acta Medica Academica (AMA) focused on Genomics in Hematology and Oncology Practice was recently edited by Dr. Gordan Srkalovic (Medical Director, Herbert-Herman Cancer Center, Sparrow Health System, Lansing, Michigan, USA). This blog article seeks to cover this timely resource that describes the possible boons of Genomics in Cancer Therapy. As a guest editor, he brought together a network of leading oncologists in the field to write on Precision Medicine in their areas of expertise. Thus, we have a confluence of knowledge available here, all for free, just for your benefit, dear readers. So read, enjoy, and push the boundaries of science to find more therapies for cancer throughout the world. Here, we have summarized below what you will find inside this treasure trove.
The journal opens with an article by Trivedi et al (2019) that looks at the use of genomics and the changing landscape of clinical practice in the modern medicine (2). The style of medical treatment has changed much over the years and there has been a massive influx of new technologies. The next step is to personalize disease management. However, there are challenges to fully make the jump from genomics to personalized treatments. Here they discuss some of these challenges and evaluate potential solutions.
This is followed by an article by Audeh et al (2019) which explains the 70 gene MammaPrint assay that was developed as the genomic assay for diagnosis of breast cancer. This test was validated with a randomized trial. It is the first US FDA cleared genomic test for breast cancer (3). The authors describe how this assay was created, and what information it can provide to women so that not everyone needs to go through chemotherapy.
Next, Madanat et al (2019) describe the recent advances in the genomics of acute myeloid leukemia (AML) and present the current state of the field (4). Authors summarized an up to date review of all the published data about genes that are commonly mutated, and the genomic pathways involved in AML. The review highlighted the use of genomics to combat AML’s future gene mutations and their interactions. Therefore, this data is important for the future therapeutic directions in the field of AML.
An article by Shi et al (2019) follows this, where the authors aim to summarize recent developments in laboratory work-up on lymphomas and discuss their clinical relevance (5). The paper goes in depth about these developments, but for our purposes, the main importance are ideas regarding research and clinical care of patients. Although there are newer and cheaper ways to test genetic abnormalities some of those are time-consuming and do not provide needed information. Not only that these options are still relatively limited, but also, widespread knowledge about advanced genetic testing is scarce, even among clinicians. Thus, they note the need for lot of basic groundwork before dwelling deeper into the field and trying to utilize it in this context.
We then move on to Castaneda et al (2019) who provide a concise review on the genetics of multiple myeloma (6). The authors describe how the multiple myeloma disease is considered incurable at present and they review the heterogeneity in its clinical presentation that can be traced to cytogenetic abnormalities in the malignant clone. They focus on emerging cytogenetics of multiple myeloma and discuss how the field of genomics in multiple myeloma has grown, as well as the current issues faced by the field. They concluded that personalized medicine is an ongoing challenge for myeloma patients because of the complexity and heterogeneity of the disease. However, they offer hope that as a result of ongoing genomic “revolution”, we could expect development of improved therapies.
Devitt et al (2019) review the current role of genomic testing in the risk, prognosis, and treatment of genitourinary malignancies (7). The authors describe how genitourinary cancers (their focus was prostate, kidney, and urothelial cancers) have not yet experienced the benefits of genomic data as much as other cancers, but the data is helpful in identifying those patients who have a high risk of getting the cancers. They also say that more therapeutic opportunities will be available for these patients in the future.
Next is an article on Lung Cancer Genomics by Parikh (2019) (8). Advanced lung cancers tend to have poor prognoses due to limited treatment options. However, with the use of genomic testing, the landscape of other treatment options is improving all of which can help these patients live longer.
A review article on Genomic-Based Therapy of Gynecologic Malignancies by Markman (2019) looks to inform about the recent advancements made in the use of targeted therapeutics in management (9). Testing of genomic abnormalities has been limited mostly to two genes in these types of cancers. However, with recent advances in precision medicine, the author anticipates that more tests and more options may become available for diagnosis and therapy of gynecological cancers.
Saadeh et al (2019) reviewed the role of precision medicine in oncologic pharmacy practice. This is unique because it talks about pharmacogenomics (PGX) (10). This concept of PGX is part of the precision medicine approach. It studies how genetic variations may influence an individual’s response to drug therapy. It is based on inherited polymorphisms in drug metabolizing enzymes or other targets. Recommendations from PGX can help prevent newer and existing drug toxicities that are common in cancer patients under treatment.
Lastly, Trivedi et. al (2019) describes the experience and outcomes from 54 cases presented to the Molecular Tumor Board (MTB) established at the Herbert-Herman Cancer Center, Sparrow Health Systems (Lansing, Michigan, USA) between 2017 and 2018. During this time, all patients under treatment considerations had different types of cancers. These cases were presented virtually by oncologists and discussed with the scientific and clinical team of Foundation Medicine company. The goal was to identify specific molecular pathways to precisely determine treatment target options or trials for each cancer patient. These patients badly needed other and newer options because their tissue analyses had not shown targetable mutations. Of these patients, 81% had one or more potentially actionable alteration and 22% received genomic-matched therapy as per MTB recommendations. The multidisciplinary approach of MTB combined with new technologies allowed for improved oncology patient care. Therefore, it was concluded that such usage and education about MTB should increase in other community centers as well, so that advances of precision medicine are brought to as many patients as possible. This is a highly novel and innovative approach because it dissolves the boundaries of different disciplines while keeping the patient’s interest at the center.
What comes next in the field? The ultimate goal of precision medicine is to become the method of choice to use for all types of patients, not just cancer patients. By developing a computer skillset that can organize massive amounts of patient data and create algorithms, we can anticipate and prevent disease in patients in any and every field of medicine beyond cancer medicine. This is exactly what the “ALL OF US” movement is doing. So, dear readers, please join in and learn, as the time is ticking away. Get on board. Otherwise, as Dr. Srkalovic says “you will be dinosaurs” and generations may watch you in the Jurassic Park series.
References
1. Collins, Francis S., et al. “A New Initiative on Precision Medicine: NEJM.” New England Journal of Medicine, 17 Mar. 2020.
2. Trivedi H, Kling HM, Treece T, Audeh W, Srkalovic G. Changing Landscape of Clinical-Genomic Oncology Practice. Acta Med Acad. 2019;48(1):6-17.
3. Audeh W, Blumencranz L, Kling HM, Trivedi H, Srkalovic G. Prospective Validation of a Genomic Assay in Breast Cancer: The 70-gene Mamma-Print Assay and the MINDACT Trial. Acta Med Acad. 2019;48(1):18-34.
4. Madanat YF, Kalaycio, ME, Nazha A. Advances in Acute Myeloid Leukemia Genomics, Where Do We Stand in 2018? Acta Med Acad. 2019;48(1):35-44.
5. Shi M, Dao L, Jevremovic D. Laboratory Work-Up of Chronic B-Cell Lymphoid Malignancies– A Value-Based Approach. Acta Med Acad. 2019;48(1):45-56.
6. Castaneda O, Baz R. Multiple Myeloma Genomics – A Concise Review. Acta Med Acad. 2019;48(1):57-67.
7. Devitt ME, Dreicer R. Evolving Role of Genomics in Genitourinary Neoplasms. Acta Med Acad. 2019;48(1):68-77.
8. Parikh AR. Lung Cancer Genomics. Acta Med Acad. 2019;48(1):78-83.
9. Markman M. Genomic-Based Therapy of Gynecologic Malignancies. Acta Med Acad. 2019;48(1):84-9
10. Saadeh C, Bright D, Rustem D. Precision Medicine in Oncology Pharmacy Practice. Acta Med Acad. 2019;48(1):90-104.
11. Trivedi H, Acharya D, Chamarthy U, Hamdan M, Herman J, Srkalovic G, et al. Implementation and Outcomes of a Molecular Tumor Board at Herbert-Herman Cancer Center, Sparrow Hospital. Acta Med Acad. 2019;48(1):105-15.
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On April 23, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release first quarter 2020 financial results on Thursday, May 7, 2020, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update (Press release, Athenex, APR 23, 2020, View Source [SID1234573879]).
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To participate in the call, dial 800-479-1004 (domestic) or 929-477-0324 (international) fifteen minutes before the conference call begins and reference the conference passcode 7976288. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source
On April 23, 2020 ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the pricing of its initial public offering of 7,500,000 shares of its common stock at a price to the public of $16.00 per share (Press release, ORIC Pharmaceuticals, APR 23, 2020, View Source [SID1234556578]). All of the shares of common stock are being offered by ORIC. In addition, ORIC has granted the underwriters a 30-day option to purchase up to 1,125,000 additional shares of common stock at the initial public offering price, less the underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market on April 24, 2020 under the symbol "ORIC." The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by ORIC, are expected to be $120.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on April 28, 2020, subject to the satisfaction of customary closing conditions.
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J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering.
Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on April 23, 2020. The offering is made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].
This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.
On April 23, 2020 Dana-Farber Cancer Institute reported that its first clinical trial in patients with a hard-to-treat form of uterine cancer, a targeted drug that subjects tumor cells to staggering levels of DNA damage caused tumors to shrink in nearly one-third of patients.
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The preliminary results, to be presented online at Thursday’s virtual session of the Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, demonstrated strong activity of WEE1-directed therapy in uterine serous carcinoma (USC), which accounts for about 10% of uterine cancers but up to 40% of deaths from the disease, trial leaders say.
The drug tested in the study – adavosertib – takes advantage of an inherent weakness in the relentless growth of some cancer cells. Their non-stop proliferation creates a condition known as replication stress, where their ability to duplicate their DNA effectively is significantly impaired. The cell cycle – the carefully choreographed process by which cells grow, copy their DNA, and divide into two daughter cells – includes several checkpoints that halt the cycle so DNA can be inspected and repaired, if necessary. In some cancers, a checkpoint fails to function due to a genetic mutation or other problem, allowing the cycle to proceed even as DNA damage accumulates.
USC is one such cancer. More than 90% of cases are marked by a mutation or other abnormality in the TP53 gene, which plays a critical role in the checkpoint between the first phase of cell growth and the DNA-duplication phase. Without a working TP53 gene, cells can barrel into the DNA-duplication phase with extensive DNA damage on board.
The absence of functional TP53 places enormous strain on a checkpoint further on in the cell cycle called G2/M. Providing a final quality check, G2/M, guards the entry to mitosis, the act of dividing into two daughter cells. Hobbling G2/M by blocking one of the proteins involved in it could burden tumor cells with so much DNA damage that they cannot survive.
That is the strategy behind adavosertib, which targets a protein called WEE1 that helps regulate the G2/M checkpoint. The new trial marked the first time the drug, which has been tested in patients with other cancers, including breast and ovarian cancer, was tested in patients with USC.
The trial involved 35 patients, all of whom had previously been treated with platinum-based chemotherapy. They took adavosertib orally on a set schedule. At a median follow-up of 3.8 months, 10 of 34 patients who could be evaluated, had shrinkage of their tumors – a response rate of almost 30%. In some cases, the responses were exceptionally durable, with some patients still responding more than a year after undergoing treatment, study leaders say.
The most common adverse side effects of the treatment were anemia, diarrhea, nausea, and fatigue.
"Adavosertib demonstrated remarkable activity as a single agent in this group of patients," says the study’s lead author, Joyce Liu, MD, MPH, of Dana-Farber. "It’s especially encouraging in a disease such as USC, for which current treatments are of limited effectiveness."