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MedNess: bite-size biopharma and medtech news

15th September, 2020

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Gilead Sciences to Acquire Immunomedics
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide.”
Collated by :Richa Tewari, PhD
Onco I-Analyse
The FDA issues warning against the utilization of Tecentriq-paclitaxel combination for the treatment of breast cancer
On 8th September, the US FDA issued a safety alert to healthcare providers, clinical trial PIs and patients that the ph 3 IMpasssion131 study, evaluating the efficacy and safety of Tecentriq + paclitaxel combination vs. paclitaxel monotherapy in 1L, PD-L1+, mTNBC patients did not show benefits in disease progression or overall survival.
The warning comes a month after Roche announced that IMpassion131 failed to meet primary and important secondary endpoints of significantly reducing the risk of cancer progression and death. Infact, interim OS data showed a negative trend favouring paclitaxel monotherapy over the Tecentriq + paclitaxel combination in PD-L1+ and ITT patient populations.
However, in March 2019, Tecentriq + Abraxane (nanoparticle albumin bound paclitaxel) was granted conditional approval by the FDA based on the ph 3
IMpassion130 study. This combination demonstrated significantly meaningful PFS and OS benefits in PD-L1+ (≥1% TIC) locally advanced or metastatic TNBC. The albumin bound paclitaxel is linked to preferential uptake into cancer cells, thereby leading to higher anti-tumour activity.
As per the FDA, continued approval for Tecentriq + Abraxane “may be contingent on proven benefit of the treatment in additional trials”. Given the precedence that checkpoint inhibitors have failed confirmatory trials before, but the conditional approval was not revoked, it remains to be seen if the FDA will rescind Tecentriq’s approval in combination with Abraxane in 1L, PD-L1+ TNBC. Roche is actively discussing this situation with the FDA. The FDA warned HCPs to not substitute Abraxane with paclitaxel in clinical practice.
The FDA will continue to review the findings from IMpasssion131 until the final analysis and will communicate any potential changes in Tecentriq’s prescribing information. Additionally, the agency will review the breast cancer trials evaluating Tecentriq + paclitaxel combination and will recommend changes, if needed. However, patients receiving the combination therapy for additional oncology indications are advised to continue the therapy as per their HCPs.
Collated by :Shilpa Rawal, PhD
Drug Approvals
NMPA approves ZEJULA® (Niraparib) for 1L Maintenance Treatment of Ovarian Cancer in China
“We believe ZEJULA is a potential best-in-class PARP inhibitor. It is the first and only PARP inhibitor approved anywhere globally, including in China as monotherapy for all-comer patients in the first-line and recurrent maintenance treatment settings,” said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. “The NMPA’s rapid approval of our sNDA for ZEJULA underscores the unmet medical needs it serves and further enables Zai Lab to make a meaningful impact on the way ovarian cancer is treated in China.”
Regulatory News
FDA Breakthrough Therapy Designation for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
“The Breakthrough Therapy designation granted by FDA recognizes the significant clinical benefits Toripalimab has shown for the treatment of nasopharyngeal carcinoma,” commented Dr. Ning Li, Chief Executive Officer of Junshi Biosciences. “Junshi prioritizes cancer types with high prevalence in China such as nasopharyngeal carcinoma, lung and liver cancer, but we found that great unmet medical needs also exist in other countries where patients are endangered by this deadly disease. The BTD will allow us to work with the FDA closely to bring the therapy to patients worldwide expeditiously.”
Trial Results
FAILED TRIAL: Ph 3 TOURMALINE-MM2 trial of NINLARO™ (ixazomib) + lenalidomide & dexamethasone in 1L transplant-ineligible multiple myeloma patients didn’t meet primary endpoint of PFS significance
“There is a specific need in newly diagnosed multiple myeloma, given there are currently no approved all-oral, proteasome inhibitor-based treatment options,” said Thierry Facon, MD, Lille University Hospital, principal investigator and lead author of TOURMALINE-MM2. “Findings from the TOURMALINE-MM2 trial are important overall for this patient population as well as across multiple subgroups including patients with high-risk cytogenetics. We hope these data will help inform future research and further progress for the multiple myeloma community.”
Ph 2 CheckMate 650 trial results efficacy of ipilimumab + nivolumab combination in mCRPC patients
“Historically, prostate cancer has been very resistant to checkpoint inhibitors because it is immunologically cold with few tumor-infiltrating T cells,” said principal investigator Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology. “These results suggest that a combination approach to increase T cell infiltration and then block inhibitory pathways may be a useful strategy for treating these patients. Going forward, we plan to optimize the schedule and dosing to improve the safety profile.”
Data on CLR 131 Ph 2 CLOVER-1 Study in Triple Class Refractory Multiple Myeloma Patients Reported
“We remain encouraged by the consistency of CLR 131’s efficacy and tolerability data in these extremely challenging to treat triple class refractory multiple myeloma patients,” said Dr. John Friend, CMO of Cellectar Biosciences. “A 40% ORR is a clinically meaningful outcome. For reference purposes, two recently approved drugs received a 25% and 31% ORR in triple class refractory patients. We look forward to the further development of CLR 131, a first in class phospholipid radio conjugate that may provide a significant benefit to patients and treatment alternative for clinicians."
Click here for more Trial Results
Trial/Program Status
Two new study arms of the I-SPY 2 TRIAL launched to evaluate combination of oral paclitaxel + encequidar with dostarlimab
“We’re very excited to enter this treatment combination into the trial,” noted Laura Esserman, MD, the lead investigator for the I-SPY 2 study. “We believe Athenex’s oral paclitaxel combined with encequidar will be much easier for patients, may be more tolerable, and in combination, improve the chance of complete response, which is our goal.  We are looking to test combinations that have greater efficacy and less toxicity.  Importantly, I-SPY 2 allows us to determine which combinations work best for patients based on tumor biology. The change to an oral taxane backbone is a very important step to reducing toxicity for all patients.”
Ph 3 Portion of Ph 2/3 trial of Leukine® + Ipilumimab and Nivolumab in 1L Melanoma patients initiated
“GM-CSF has unique immunomodulatory properties that have the potential to substantially benefit patients with cancer. I am particularly pleased, given the many years we have spent in understanding the role of GM-CSF in the laboratory and the clinical setting,” said Dr. Hodi. He added “This study in the front line setting is intended to confirm and broaden the findings in the randomized Phase 2 trial EA1608, which demonstrated improved efficacy and toxicity when sargramostim was added to ipilimumab.”
Click here for more Trial Progress
Collated by : Richa Tewari, PhD
Medness @ HealthIT
AI in assessing pregnancy-risk factors
According to a study published in American Journal of Pathology, an AI program educated to read placental slides can be utilized to assess risks for the new mothers in future pregnancies.
As the current standard of care goes, physicians may examine the placenta of the mother of a newborn to look for a particular set of blood vessel lesion (decidual vasculopathy), which are considered as an indicator of preeclamsia during future pregnancies. It is characterized by high blood pressure and damage to another organ system, such as, liver and kidneys and can be fatal to both the mother and baby. Pathologists are trained to recognize the signs using microscopy related anatomic pathology diagnosis tools. Following a similar concept, a machine learning program
(Multiresolution Hierarchical Convolutional Neural Networks) has been developed by a team at Carnegie Mellon University that can scan large number of frames to identify signs of pathology while distinguishing the healthy vs. diseased vessels. So far, the tool has achieved individual blood vessel classification rates at a 94 percent sensitivity and 96 percent specificity. Not only does the system offers a reliable assistance to the physicians and pathologists, it also bears a promise to reduce healthcare cost while improving life expectancy and outcome efficacy. The full study can be read here.
Case management made easy with AI
A newly developed automated data extraction system developed by Change Healthcare will be able to process structured as well as unstructured data from patient history or EHR (electronic health record). InterQual AutoReview™ solution, the first version of the system is already trained to read clinical notes and diagnostic information from structured data, such as, lab results, medications, and vital signs. These data pulled directly from the EHR has shown a 75% reduction in the administrative burden of conducting reviews. The new addition by Change Healthcare AI introduces a Natural Language Processing model trained by in house clinicians which can identify diagnostic information as well. This includes unstructured form of data, such as, symptomatic radiology reports showing pneumonia, bowel obstruction, pancreatitis, and other conditions. The significance of the system relates directly to the time saved for case managers conducting medical necessity reviews, with deciphering made easy and less time-consuming with the InterQual system. Read the news with video here.
Medness Reviews
Aibra’s 20 second COVID-19 screening device shows promising results in pilot test
A 20 second COVID-19 saliva test developed by the British company iAbra has slated to launch following a pilot test in London’s Heathrow airport. After a three-week field test in the airport, the company’s CEO John Holland Kaye has urged the British government to fast track the technology.
The Virolens device, is based on microscopic holographic imaging uses a digital camera attached to a microscope and artificial intelligence-powered software trained to identify the virus from other cells.
According to iAbra’s manufacturing partner TT Electronics, the machine provides a rapid, low-cost, repeatable method of screening, allowing hundreds of cartridge-based tests to be performed each day. From validation studies by the University of Bristol, the system’s false-negative rate is pegged at 0.2%, alongside a false-positive rate of 3.3%.
The technology holds promise for large-scale rapid testing, which is currently the need of the hour and is about to undergo clinical trials for medical use.
GlaxoSmithKline earns FDA approval for triple-drug combo Trelegy in asthma treatment
The FDA gave a thumbs-up to GlaxoSmithKline's Trelegy as a maintenance therapy for asthma, making it the first once-daily, triple-drug inhaler approved in that indication.
The agency based its review on findings from the phase 3 Captain head-to-head study, which showed Trelegy topped GSK's Breo Ellipta at improving lung function after 24 weeks in patients with uncontrollable asthma.
Trelegy secured the FDA nod despite missing the study's secondary endpoint, where it failed perform better than Breo when it came to reducing incidence of episodes where symptoms suddenly worsen. The FDA approval did not include label language for acute bronchospasm relief.
This approval will give GSK a lead in its fight against rival British drugmaker AstraZeneca's Breztri Aerosphere, which is also pursuing a nod in asthma after its initial FDA approval earlier this year. 
Conference Coverage
ESMO 2020 COVERAGE
  1. Full scientific program of the ESMO Congress 2020
  2. Genmab to present results from the phase 2 innovaTV 204 study evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer
  3. Regeneron Pharmaceuticals and Sanofi to present new, positive data for the PD-1 inhibitor Libtayo® (cemiplimab)
  4. Zai Lab to present clinical data from Ph 3 NORA trial of niraparib
  5. Merck announces that pivotal Studies for KEYTRUDA in Esophageal Cancer (KEYNOTE-590) and LYNPARZA® in Prostate Cancer (PROfound) are Selected for Presidential Symposium Sessions in addition to data from vibostolimab (MK-7684), MK-4830; and MK-6482
  6. Eisai to present abstracts highlighting updates regarding LENVIMA®, Halaven® and its liposomal formulation
  7. Clovis Oncology to present six e-posters highlighting clinical data from the lucitanib and Rubraca® (rucaparib) clinical development programs
  8. Immunomedics announces oral presentations of the ASCENT study in mTNBC and the TROPHY U-01 study in metastatic urothelial cancer, as well as an investigator-sponsored study of Trodelvy in brain tumors
  9. Bayer to present long-term efficacy and safety results of Vitrakvi® (larotrectinib), tolerability and treatment response data from the Ph 3 ARAMIS trial of NUBEQA® (darolutamide) in nmCRPC patients and investigational use of Stivarga® (regorafenib) and Xofigo® (radium Ra 223 dichloride) in combination with immunotherapies
  10. Alkermes to present new clinical data from Ph 1/2 ARTISTRY-1 trial of ALSK 4230 as monotherapy and in combination with pembrolizumab in patients with refractory solid tumors
  11. BMS to present data from pivotal Ph 3 CheckMate-577, CheckMate-649, CheckMate-9ER, CheckMate-214 and CheckMate-9LA trials
  12. Pfizer to present data from Ph 3 CROWN trial in addition to updates from BAVENCIO® (avelumab), BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib), IBRANCE® (palbociclib) and other programs
  13. Lilly to present data from 20 studies across oncology product portfolio including Ph 3 monarchE study of Verzenio® (abemaciclib) in high risk HR+, HER2- early breast cancer patients
  14. AstraZeneca to present 114 abstracts including OS data from Ph 3 PROfound, ADAURA, PACIFIC and CASPIAN trials
  15. Checkpoint Therapeutics to present updated interim safety and efficacy data from the ongoing registration-enabling clinical trial of cosibelimab in mCSCC patients
  16. Immutep Limited to present new data Ph 2 TACTI-002 and the investigator-initiated Ph 1 clinical trial, INSIGHT which includes INSIGHT-004
  17. Oryzon Genomics to present additional data from CLEPSIDRA Ph 2 trial in rSCLC patients treated with the epigenetic drug iadademstat in combination with platinum-etoposide
  18. Autolus Therapeutics to present updates from Ph 1/2 AUTO3 program in R/R DLBCL patients
  19. Genocea Biosciences to present incremental follow-up data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2 trial
  20. Mersana Therapeutics to present updated interim data from the ovarian cancer cohort of the ongoing Ph 1 expansion study evaluating XMT-1536
Medness Business
Onco-News

Seattle Genetics and Merck to globally develop and commercialize ladiratuzumab vedotin; Merck also exclusively licenses to commercialize TUKYSA® (tucatinib) outside of the U.S., Canada and Europe
“These two strategic collaborations will enable us to further diversify Merck’s broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. “We look forward to working with the team at Seattle Genetics to advance the clinical program for ladiratuzumab vedotin, which has shown compelling signals of efficacy in early studies, and to bring TUKYSA to even more patients with cancer around the world.”

AVEO Oncology Regains Full Global Rights to Ficlatuzumab
“We are very pleased to regain full rights to another late-stage asset. This comes at a strategic point in our Company’s history, as we continue to build a commercial biopharmaceutical company with a broad oncology portfolio that has the potential to enable a long-term, sustainable growth model,” said Michael Bailey, president and chief executive officer of AVEO. “The early data we have seen in the randomized, open-label HNSCC study with ficlatuzumab combined with cetuximab (ERBITUX®) has led us to the decision to secure additional clinical manufacturing capacity, which we expect to fund within our previously announced cash runway guidance, in order to prepare for a potential HNSCC pivotal study. We look forward to presenting final results from the Phase 2 study in the middle of 2021, and to providing an update on our potential pivotal program within that timeframe.”
BioPharma and MedTech
Orasis Pharmaceuticals secured $30 million Series C funding for Presbyopia treatment
Orasis (Herzliya, Israel) is an ophthalmic pharmaceutical company developing eyedrop as a remedy for presbyopia. This Israeli biotech raised $30 million series C funding to advance their research to treat presbyopia noninvasively. The financing round was led by new investor Bluestem Capital and returning investor Visionary Ventures, Sequoia Capital, SBI (Japan) Innovation Fund, Maverick Ventures Israel, LifeSci Venture Partners, and additional investors.
Presbyopia, an age-related ocular condition that creates difficulties to focus on near objects. This condition is most prevalent in mid-forties people and it affects nearly 2 billion people worldwide. Aging leads to reduced elasticity of the lens of the eye which in turn affects the ability to focus at close range. Most people use reading glasses to overcome presbyopia.
Orasis has developed the drug CSF-1, a corrective eyedrop that has shown exceptional safety and tolerability profile in phase 2b clinical study. $30 million funding will advance the phase 3 clinical trial and commercialization of the product. Orasis is also competing with the rival product presbysol from Abbvie, which is also expected to enter phase 3 trial this year. Elad Kedar, CEO of Orasis is hopeful that with this huge funding from the investors, soon they can start the phase 3 clinical trial.
Recursion bagged $239 million series D funding and partnering with Bayers for therapeutic advancement of fibrotic disease with AI-based drug discovery  
US-based Recursion Pharmaceuticals, Inc (Salt Lake City, US) is a digital biology company that formed an alliance with German company Bayers, raising $239 million. The long-term aim of this collaboration is to capitalize on the therapeutic small molecules library from Bayers and the artificial intelligence-based drug discovery platform of Recursion.
This strategic agreement focused on fibrotic diseases of the lung, kidney, heart, and more will pay Recursion $30 million upfront for the partnership, along with $100 million each for up to 10 programs the companies could pursue. The funding also includes $50 million from Leaps by Bayer, the impact investment arm of Bayer, as well as funding from Casdin Capital, Baillie Gifford, and other investors.
While an AI-based drug discovery company relies on already existing datasets, Recursion is hybrid biotech that utilizes both in house scientists and software engineers to create massive datasets and bringing the drugs through clinical development. Recursion already has multiple drugs in the
pipeline including the rare disease Neurofibromatosis Type 2 and three other candidates in phase 2.
Overall, this partnership signifies one of the largest deals which can change the era of drug discovery permanently relying on AI-based next-generation therapies. Juergen Eckhardt, Head of Leaps by Bayer commented “Recursion is a leading digitally-powered drug discovery company to lift biotech research to new horizons with the use of artificial intelligence and pioneers transformational machine-learning powered drug discovery with the potential to develop curative treatments in the future.”
Click here for mergers , aquisitions and more business news
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Shilpa Rawal, PhD
Onco I-Analyse
Debarati Banik
HealthIT
Rinki Saha
BioPharma News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. 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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