Blast! Gilead Sciences or The $20 billion acquisition of Next Generation Antibody Drug Concedes (ADC) developer Immunomedics!

!--, Sept. 13, 2020 // -- Gilead Sciences is close to a deal to buy Immunomedics for $20 billion, the Wall Street Journal reported on Saturday.
deal will further expand Gilead's cancer treatment portfolio.
discussions between Gilead and Immunomedics initially revolved around a partnership before moving on to full-scale takeover talks, the Wall Street Journal reported, citing people familiar with the matter.
said Gilead and Immunomedics had not yet responded to Reuters' request for comment.
, Immunomedics' share price has almost doubled so far this year, with a market capitalisation of nearly $10bn.
Gilead, for its part, has struck several deals so far this year to expand its oncology pipeline: (1) a $300 million equity investment in Tizona Therapeutics in July; $7.5 billion to buy a 49.9% stake in Pionyr Immunotherapeutics and have exclusive options to acquire the remaining 50.1% of the shares; Biosciences has struck a $2 billion, decade-long partnership to develop a range of immuno-oncology assets for popular targets such as PD-1, CD73 and TIGIT;
Immunomedics is a pioneer in next-generation antibody drug concedes (ADCs) that help cancer patients change their lives.
at the heart of its proprietary ADC platform is the use of a new type of link that does not require enzymes to release payloads and delivers active drugs within tumor cells and in tumor microenvirons, resulting in a near-side effect (bystander effect).
April, the company's first commercial ADC product, Trodelvy (sacituzumab govitecan-hziy), received accelerated FDA approval for adult patients with metastasis triple-negative breast cancer (mTNBC) who had previously received at least two treatments for metastasis diseases.
it's worth noting that Trodelvy is the first FDA-approved ADC drug specifically for relapsed or refractic mTNBC, and the first FDA-approved ADC drug to target Trap-2.
the approval is based on data on the total mitigation rate (ORR=33.3%) and mitigation duration (medium DOR=7.7 months) of the one-arm multi-center Phase II study.
Trodelvy's active pharmaceutical ingredient is sacituzumab govitecan, a new, pioneering antibody drug concedes (ADC) drug that is made up of a humanized IgG1 antibody targeted at TROP-2 antigens and a metabolic active product of the chemotherapy drug Ilitican, a topological isomerase I inhibitor.
Trop-2 is a cellular surface glycoprotein expressed in many solid tumors, especially in more than 90 percent of TNBC.
Trodelvy and Trout-2 target and deliver the cancer drug SN-38 to kill cancer cells.
Currently, Immunomedics has an extensive development program for Trodelvy, including ongoing studies to treat Trodelvy as a single-drug treatment or in a coalition with other drugs, to treat TNBC, metastatic urethra cancer, hormone-positive/human skin growth factor 2-negative (HR-/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), etc.
, Immunomedics announced that the Validation III ASCENT Study (NCT02574455) had reached the primary and critical secondary end points.
the study was designed under the FDA Special Program Assessment (SPA) to validate the promising efficacy and safety shown by Trodelvy in supporting its approved Phase II study.
ASCENT is an international, open-label Phase III study that included more than 500 mTNBC patients who had negative brain metastasis and had previously received at least two therapies to treat metastasis.
study, patients were randomly divided into two groups, one receiving Trodelvy and the other receiving chemotherapy chosen by a doctor.
end point is progress-free lifetime (PFS), and secondary endpoints include total lifetime (OS), ORR, DOR, time of mitigation, safety, and tolerance.
data show that the study reached its main endpoint: the Trodelvy group showed a statistically significant improvement in PFS compared to the chemotherapy group (medium PFS: 5.6 months (95% CI: 4.3-6.3) vs. 1.7 months . 95% CI: 1.5-2.6) and a significant reduction in the risk of disease progressity by 59% (HR=0.41, 95% CI: 0.32-0.52, p 0.0001).
this study also reached a critical secondary endpoint (OS and ORR).
the study, Trodelvy's safety was consistent with FDA-approved drug labeling information.
most common level 3 or 4 adverse events are neutral granulocyte reduction and diarrhea, with no new safety signals observed.
results of the study will be presented at an upcoming medical conference.
based on the data, Immunomedics plans to submit a Supplementary Biologics Licensing Application (sBLA) later this year, moving Trodelvy from accelerated approval to full approval.
data from the Validative Phase III ASCENT study confirm the results of previous Phase II clinics and suggest that Trodelvy has the potential to change mTNBC standard care.
based on these data, Trodelvy will set a new benchmark for scientific and clinical innovation in mTNBC patients, while providing a new alternative to commonly used drugs in clinical practice.
important, the study also validated Trodelvy's manageable safety, making it a good combination of drugs with other therapies, including immunotherapy.
!--/ewebeditor:page--!--ewebeditor:page title"--breast cancer is the most common type of cancer among women, with more than 2 million cases diagnosed worldwide each year.
breast cancer (TNBC) accounts for about 15 percent of all breast cancers, and is more common among women under the age of 50 than other types of breast cancer.
TNBC refers to breast cancer, which is negatively expressed, with rapid progress and poor prognostication, with a five-year survival rate of less than 15%.
TNBC is ineffective for hormone therapy and HER2 targeted therapies such as Roche Herceptin, and clinical options are limited, relying heavily on chemotherapy.
Trodelvy was approved through an expedited approval process and has previously been granted breakthrough drug eligibility (BTD) and priority review by the FDA.
Trodelvy has the potential to become a standard care drug for mTNBC treatments.
comes after analysts pointed out that Trodelvy represents a significant improvement over Standard Care, which is expected to peak at more than $1 billion after it available.
and the success of this Proven III clinical event will undoubtedly further enhance Trodelvy's commercial potential.
TNBC Therapeutics, in March 2019, Roche PD-L1 oncology immunotherapy Tecentriq (Tai Sanqi, generic name: atezolizumab, Atili pearl monoanti) was approved by the FDA for accelerated, combined chemotherapy (Abraxane, injection with yew alcohol (albumin binding)) first-line treatment of PD-L1-positive late-stage or metastasis TNBC patients.
this approval, making Tecentriq and Abraxane the first cancer immunotherapy treatment for TNBC.
the approval is based on data from the Phase III IMpassion130 study: Tecentriq and Abraxane significantly reduced the risk of disease progression or death by 40% in PD-L1-positive patients compared to placebo and Abraxane (Mid PFS: 7.4 months vs 4.8 months, HR=0.60,95%CI:0.48-0.77, p.0001).
However, in August of this year, tecentriq-yew alcohol first-line therapeutic metastasis TNBC Phase III IMpassion131 study failed: in the PD-L1-positive patient population, tecentriq-yew alcohol was not statistically significant in terms of progress-free survival (PFS) at the main endpoint compared to placebo-sequoia alcohol.
the total lifetime (OS) of the secondary endpoint is negative and the data is premature at the time of analysis.
recently, the FDA issued a warning message to healthcare professionals and oncologists about the clinical failure of Tecentriq and Yew alcohol III IMpassion131.
fda notes that in clinical practice, health care providers should not replace Abraxane (albumin-binding yew alcohol) with yew alcohol.
() Original source: Gilead nears deal to buy Immunomedics for more than $20 billion, WSJ reports !--/ewebeditor:page--