#tafasitamab

[oncozine]

Developing Transformative Therapies for Patients with Diffuse Large B-cell Lymphoma

#cancer #cd19 #hematology #incyte. #lymphoma #morphosys #tafasitamab

[vietnamstar]

Specialised Therapeutics Enters into a New Supply and Distribution Agreement with Incyte to Launch Two New Cancer Therapies, Tafasitamab and Pemigatinib, in Australia, New Zealand and Singapore

Specialised Therapeutics Enters into a New Supply and Distribution Agreement with Incyte to Launch Two New Cancer Therapies, Tafasitamab and Pemigatinib, in Australia, New Zealand and Singapore

SINGAPORE, Oct. 22, 2021 /PRNewswire/ — Independent pharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) will partner with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), to launch and distribute two new medicines for its haematology and oncology portfolios, tafasitamab (sold as Monjuvi® in the United States and Minjuvi® in Europe) and…

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#PR Newswire

[pharmaphorumuk]

FDA sets May date for verdict on ADC’s lymphoma drug Lonca

ADC Therapeutics could claim its first product approval in the US next May, after the FDA started a priority review of lead drug Lonca for diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma.

Lonca – short for loncastuximab tesirine (formerly ADCT-402) – is an antibody-drug conjugate that combines an antibody against CD19 linked to a cell-killing drug. If approved, it would be a rival to CD19-targeting cell therapies from Novartis (Kymriah) and Gilead Sciences (Yescarta) in the third-line treatment of DLBCL.

The FDA has started a six-month review of Lonca for the treatment of relapsed or refractory DLBCL, with an action date of 21 May next year, and ADC says it hopes to have the drug on the market before the end of 2021.

Chief executive Chris Martin said the Swiss biotech has been working on building its salesforce in anticipation of the positive verdict from the FDA, and reckons it can now cover 90% of haematology and oncology specialists who treat DLBCL in the US.

The FDA is reviewing the ADC based mainly on the results of the LOTIS 2 trial, which Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior systemic therapy. Around 40% to 50% of DLBCL patients are refractory to or relapse after front-line therapy.

The single-arm, 145-patient trial showed an overall response rate of 48.3% and a complete response rate of 24.1%, with Lonca as of a 6 April data cut-off point.

“Based on feedback from physicians on Lonca’s efficacy, tolerability protocol and ease of administration, we believe Lonca has the opportunity to become the standard of care in third-line, based on our competitive profile versus other available options,” Martin told analysts on a conference call earlier this month.

ADC Therapeutics is also testing Lonca in earlier lines of therapy. It is running a phase 3 trial (LOTIS 5) of the medicine in combination with rituximab in second-line DLBCL patients, and a phase 1/2 study (LOTIS 3) of Lonca paired with AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib) with relapsed or refractory DLBCL or mantle cell lymphoma (MCL).

The Swiss company is also planning to begin a dose finding study of Lonca in combination with R-CHOP chemotherapy in previously untreated DLBCL patients in the first half of 2021, according to Jay Feingold, its chief medical officer.

In the third-line setting, the two approved CAR-T therapies – Yescarta and Kymriah – are making headway but like all autologous cell therapies require a complex treatment pathway that involves harvesting of immune, growth and modification of the cells outside the body, and the reintroduction of the modified cells to fight that cancer.

While the efficacy can be dramatic and CAR-T’s are potentially curative, the procedure itself can have significant side effects, and is labour-intensive and expensive to carry out.

Other competition is also emerging in relapsed/refractory DLBCL, and that is good news for patients desperately in need of new treatment options.

Among these is MorphoSys and Incyte’s CD19-targeting monoclonal antibody Monjuvi (tafasitamab), which was approved in combination with Bristol-Myers Squibb/Celgene’s Revlimid (lenalidomide) as a second-line treatment for DLBCL in August.

Roche’s ADC Polivy (polatuzumab) – which targets CD79b – was meanwhile approved for third-line DLBCL treatment last year in the US and earlier this year in Europe.

The post FDA sets May date for verdict on ADC’s lymphoma drug Lonca appeared first on .

from https://pharmaphorum.com/news/fda-sets-may-date-for-verdict-on-adcs-lymphoma-drug-lonca/

[adwaitcoherent]

ANTIBODIES MARKET ANALYSIS by Coherent Market Insights

Antibodies Market To Surpass US$ 384.0 Billion By 2027 - Coherent Market Insights

PDF COPY:

https://www.coherentmarketinsights.com/insight/request-pdf/2629

Antibody, also called as immunoglobulin, is a protein produced by plasma cells in response to specific antigens. These antibodies can be used as therapeutic as well as diagnostic purposes for several indications, including cancers, autoimmune disorders, inflammatory & infectious diseases and others.

The global antibodies market is estimated to account for US$ 147,385.1 Mn in terms of value and is expected to reach US$ 384,011.6 Mn by the end of 2027.

Global Antibodies Market: Drivers

Therapeutic monoclonal antibodies find wide application in oncology, neurobiology, autoimmunology, and cardiology. Increasing prevalence of chronic disease is expected to propel growth of the global antibodies market. For instance, according to the World Health Organization, around 18.1 million new cases and 9.6 million deaths were registered due to cancer worldwide in 2018.

Moreover, availability of inexpensive biosimilar antibody therapeutics is also expected to aid in growth of the market. For instance, in December 2019, the World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab –– a monoclonal antibody for the treatment of early stage breast cancer. On an average trastuzumab costs US$ 20,000. However, the biosimilar version of trastuzumab is generally 65% cheaper than the originator.

North America region held dominant position in the global antibodies market in 2018, accounting for 44.5% share in terms of value, followed by Europe.

Global Antibodies Market: Restraints

High cost of therapeutic antibodies is expected to hamper growth of the global antibodies market. For instance, in the U.S., the monthly treatment cost for rheumatoid arthritis with Humira is over US$ 5,500.

Use of antibodies may lead to some side effects such as serum sickness, acute anaphylaxis, and specific target-related adverse effects, which is also expected to hinder the market growth.

Global Antibodies Market: Opportunities

The patent of several blockbuster antibody products is set to expire in the near future. Therefore, key players in the market can focus on launching biosimilar antibodies to enhance their market share.

Moreover, evolution of clear regulatory approval process for biosimilars in emerging markets represents additional opportunity for antibody-based products. For instance, in 2012, Central Drugs Standard Control Organization, Gov. of India released regulatory requirements for marketing approval of similar biologics in India, which was revised in 2016 for more clarity. According to the revision, the reference biologic may be approved or marketed either in India or any other International Council for Harmonization countries.

Drug type segment in the global antibodies market was valued at US$ 131,472.4 in 2018 and is expected to reach US$ 384,011.6 by 2027 at a CAGR of 12.5% during the forecast period.

Market Trends/Key Takeaways

The adoption of antibody-based drugs for the treatment of cancer has significantly increased. Monoclonal antibody therapeutics offer high specificity, activity, favorable pharmacokinetics, and standardized manufacturing processes. Moreover, antibodies can increase immune response against cancer cells through complement-dependent cytotoxicity or antibody dependent cellular cytotoxicity.

The use of antibodies as a diagnostic reagents for the identification of disease markers or proteins based on immunoassays has decreased. This is attributed to increasing accuracy of molecular diagnostic tools.

Regulations:

North America

U.S.

Therapeutic antibodies are the biological products which are regulated by both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER)

Therapeutic antibody products (including monoclonal antibody, antibody drug conjugates, Fc fragment proteins) are subject to submission of biologics license application (BLA)

Manufacturers of therapeutic antibody products thus needed to submit BLA to CBER or CDER under 21 CFR 601.2, which contains safety, purity and potency data from clinical and non-clinical laboratory studies and other manufacturing information

Whereas, diagnostic antibodies are classified under in vitro diagnostic device (IVD) as Analyte Specific Reagents (ASR) and thus subject to regulations under 21CFR864.4020

Diagnostic antibodies which are used in immunological testing of infectious diseases are classified as Class II IVDs whereas antibodies used for diagnosis of highly contagious diseases such as HIV, TB are classified as Class III IVDs, both of which require to obtain premarket approval under section  510 (k) of  S. federal food drug and cosmetics (FD&C) act

In U.S., biosimilar biologics product approval is submitted to FDA under section 351(k) of the Public Health Service Act

Global Antibodies Market: Competitive Landscape

Major players operating in the global antibodies market include, Novartis AG, F. Hoffmann-La Roche Ltd., Johnson & Johnson Services, Inc., Takeda Pharmaceutical Company Limited, Amgen Inc., Biogen Inc., Bristol-Myers Squibb Company, AbbVie Inc., Sanofi, Eli Lilly and Co., Iovance Biotherapeutics, Inc., Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd.

Global Antibodies Market: Key Developments

Key players in the market are focused on adopting partnership and collaboration strategies to expand their product portfolio. For instance, in January 2020, MorphoSys AG collaborated with Incyte Corporation for development and commercialization of MorphoSys’ tafasitamab, a humanized Fc-engineered monoclonal antibody against CD19.

Similarly, in January 2020, Ligand Pharmaceuticals Inc. entered into a license agreement with Pandion Therapeutics, under which the later will use Ligand’s OmniAb antibody discovery platform in exchange of an up-front platform access fee, development and regulatory milestone payments, and potential royalties on sales of marketed products.

Buy Now:

https://www.coherentmarketinsights.com/insight/buy-now/2629

“*” marked represents similar segmentation in other categories in the respective section.

About Us: Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. Our client base includes players from across all business verticals in over 150 countries worldwide. We do offer wide range of services such as Industry analysis, Consulting services, Market Intelligence, Customized research services and much more. We have expertise in many fields such as healthcare, chemicals and materials, Automation, semiconductors, electronics, energy, food and beverage, packaging and many more. Visit our website to know more.

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#Market Analysis #Market Research #Coherent Market Insights

[viralpearl-blog]

Morphosys CFO says tafasitamab drug sales potential above $1 billion: magazine FRANKFURT (Reuters) - German biotech company Morphosys’ tafasitamab, the group’s most advanced drug which is currently being tested, has sales potential of significantly more than $1 billion a year, its finance chief said in remarks to a magazine.

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FDA hands MorphoSys and Incyte a quick OKAY on their prospective hit CAR-T alternative

August 3, 2020 07: 22 AM EDT Upgraded 10: 25 AM

FDA hands MorphoSys and Incyte a fast OKAY on their possible hit CAR-T alternative

Jason Mast

Associate Editor

Nearly 3 years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for usage in refractory diffuse large B-cell lymphoma( DBLCL).

The first approved sign is in second-line DBLCL, for clients ineligible for autologous stem cell transplant.

SVB Leerink’s Geoffrey Porges called the approval a” best case scenario,” noting it had actually been unclear whether the drug would be approved for second-line or third-line therapy.

” We believe the CAR-T like efficacy demonstrated by tafa, along with its favorable safety profile should allow broad adoption in the 2L setting,” Porges composed in a note to investors,” and expect the product to be chosen over Roche’s CD79 ADC Polivy.”

Simon Moroney

Previous MorphoSys CEO Simon Moroney placed Monjuvi as an option for patients who can’t manage the intense physical tension of high-dose chemotherapy or stem cell transplant, or of CAR-T. In addition to the pricey and prolonged procedure of drawing out, dealing with and re-implanting T cells, CAR-T therapies also require patients to undergo” conditioning “regimens of intensive chemotherapy to clean out the bone marrow and basically provide a pocket for the new cells to take hold.

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By contrast, Monjuvi is an anti-CD19 antibody that is given intravenously and needs no conditioning.

” Our patients tend to be older– median age in the trial is 72, ” Moroneytold MedCity News last June, describing participants in their critical Stage II study.” They have comorbidities and are not eligible for CAR-T. ”

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The FDA decision is an accelerated approval based upon arise from that Stage II research study. Topline results released in 2015 revealed a55% general reaction rate and a%complete reaction rate. The latest data, released in May, showed a59?tion rate, a 39%complete reaction rate, and a typical period of reaction that had actually increased to346 months — nearly 3 years. The complete response rates remained in line with the early CAR-T trials, and the FDA granted the drug top priority review.

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Jean-Paul Kress

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Both MorphoSys and Incyte have staked a lot on Monjuvi. MorphoSys raised $208 millionin an IPO in2018, funneling much of that cash into constructing out a United States business operation in anticipation of their lead drug’s approval. They tapped the United States business lead for Merck KGaA’s Bavencio, David Trexler, to lead that effort. And after Moroney’s retirement, Jean-Paul Kress actioned in to lead a brand-new phase for the company.

Incyte, on the other hand, invested$900 millionearlierthis year to join with Incyte on the industrial launch, hoping the CAR-T alternative could pour some oil into asputteringR&D engine. Mizuho’s Goldstein said the drug would help diversify Incyte’s revenue base, however its overall effect may be muted.

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” Monjuvi might not have adequate effect in the near term to modify the essential photo for the company,” she said of Incyte.

Goldstein likewise called the drug “recognition” for Xencor’s platform. The California biotech initially developed the antibody. The approval set off a$25 million turning point for them.

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August 3,202010: 24 AM EDT

CymaBay flashes favorable results from the trial they have to relaunch

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Jason Mast

Partner Editor

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2 weeks after the FDA raisedits clinical hold on their lead drug, CymaBay said it showed favorable outcomes in an aborted Phase III trial.

August 3,202006:50 AM EDT Updated07:34 AM

So Covid -19 leader BioNTech has a cancer vaccine in advancement? Yes, and Regeneron just leapt in for the PhII combination research study

Prior to the coronavirus international emergency took the R&D show in biopharma, the leaders in the race to develop brand-new mRNA therapies had a big interest in determining if their tech might be utilized to create a reliable cancer

vaccine after all the first-gen tries had actually failed to impress.

So possibly it’s not unexpected that an

early cut of

the information at frontrunner BioNTech went mainly unnoticed.

Unless you were at Regeneron.

Premium subscription needed

Unlock this short article in addition to other advantages by subscribing to among our paid strategies.

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August 3,202008:11 AM EDT Upgraded09: 34AM

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Covid-19 roundup: Eli Lilly retrofits RVs for first-of-its-kind antibody trial with NIH; Amgen, AbbVie, Takeda team on a drug

Jason Mast

Associate Editor

Eli Lilly and the NIH will start a first-of-its-kind trial that scientists and developers have actually spoken about for months as a method of offering momentary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400- person trial with the National Institute for Allergy and Transmittable Illness to evaluate whether its speculative Covid-19 reducing the effects of antibody can avoid people in nursing houses and helped living centers from establishing the disease. The concept, known as passive resistance, is that rather than waiting on a vaccine to cause people to develop antibodies, doctors can provide lab-grown antibodies. Ideally, those antibodies will either attack the brand-new SARS-CoV-2 infection, if the client has just recently been exposed, or persist in the blood for a number of weeks and prevent infection or illness for that period.

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August 3,2020:32 AM EDT

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Immunic’s lead MS drug strikes primary and essential secondary endpoints in PhII, but concerns stay

Max Gelman

Partner Editor

Simply a week after its lead program began registering patients in a study to deal with Covid-19, Immunic Therapies is making more waves.

This time, the biotech is offering a peek at topline data from a Phase II trial studying the efficacy of vidofludimus calcium, or IMU-838, in relapsing-remitting several sclerosis clients. Taken orally, the prospect satisfied its main endpoint in minimizing the cumulative variety of combined special active MRI lesions after24 weeks for a45 mg dosage compared to a placebo, in addition to a crucial secondary endpoint in such decreases for the30 mg dosage.

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August 3,202008:35AM EDT

7 plucky diagnostics companies win a $249 M round of contracts after making it through NIH’s Covid-19 ‘Shark Tank ‘competitors

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Nicole DeFeudis

Partner Editor

As United States Covid-19 deaths creep past150,00 0

and authorities

worry the importance of contact tracing, the NIH’s Rapid Velocity of Diagnostics (RADx) program has actually tattooed contracts amounting to$ 2487 million to expand testing capabilities.

Frank Zhang( AP Images)

August 3,202007:

22 AM EDT

Tony Coles, Cerevel Therapeutics CEO

Two years earlier, after Pfizer abruptly shut down its entire neuroscience department, Bain Capital bet$ 350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapies.

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Now Coles is steering Cerevel public, in what he says is the largest ever deal of its kind.

Keep reading Endpoints with a totally free subscription

Unlock this story instantly and sign up with86,300 biopharma pros checking out Endpoints daily– and it’s free.

Levi Garraway, Roche CMO

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Roche snags an FDA approval for an innovative melanoma drug mixed drink– however it’s up versus some intense competitors

Nicole DeFeudis

Roche’s PD-L1 inhibitor Tecentriq snagged an FDA approval to deal with certain innovative cancer malignancy clients in a three-drug mixed drink, supplying another option for clients with a generally poor diagnosis.

In a Stage III IMspire150 research study, Tecentriq integrated with Cotellic (cobimetinib) and Zelboraf (vemurafenib )significantly beat a placebo mix in extending progression-free survival in BRAF V600mutation-positive advanced cancer malignancy patients.

from Job Search Tips https://jobsearchtips.net/fda-hands-morphosys-and-incyte-a-quick-okay-on-their-prospective-hit-car-t-alternative/

[companynewshq]

[apano-investments]

MorphoSys: FDA prüft Krebsmittel Tafasitamab/Lenalidomid vorrangig

http://dlvr.it/RR410c

[dinafbrownil]

Incyte pays MorphoSys $750M upfront in lymphoma drug partnership

The deal, worth up to $2B in milestones and other other payments, involves the monoclonal antibody tafasitamab, for which MorphoSys recently submitted an FDA approval application.

from Updates By Dina https://medcitynews.com/2020/01/incyte-pays-morphosys-750m-upfront-in-lymphoma-drug-partnership/

[patentanwalt-reinert]

(dpa-AFX) Das Biotechunternehmen Morphosys rechnet beim Hoffnungsträger Tafasitamab mit der US-Zulassung bis Mitte 2020. Zu diesem Zeitpunkt wolle man auch in Europa einen entsprechenden Antrag stellen, sagte Finanzvorstand Jens Holstein "Euro am Sonntag". "Dann dürfte es allerdings ein Jahr bis zur...

#FacebookPages

[generoussheepblaze]

German biotech company Morphosys' tafasitamab, the group's most advanced drug which is currently being tested, has sales potential of significantly more than $1 billion a year, its finance chief said in remarks to a magazine.

from Reuters: Health News https://reut.rs/35No7rV http://bit.ly/2zwRqiM

#IFTTT #Blogger

[vernelllintner]

Morphosys CFO says tafasitamab drug sales potential above $1 billion: magazine

German biotech company Morphosys’ tafasitamab, the group’s most advanced drug which is currently being tested, has sales potential of significantly more than $1 billion a year, its finance chief said in remarks to a magazine.

https://reut.rs/2rACr8t

from WordPress https://vernelllintner.wordpress.com/2019/11/30/morphosys-cfo-says-tafasitamab-drug-sales-potential-above-1-billion-magazine/

#Natural Remedies #Reuters: Health News

[pharmaphorumuk]

Incyte/Morphosys take on CAR-Ts as lymphoma antibody Monjuvi approved in US

Incyte and Morphosys’ Monjuvi antibody therapy has been approved for certain patients with lymphoma, as the companies hope to provide a more convenient alternative to expensive and cumbersome CAR-T therapy.

At the beginning of the year Incyte paid $750m to Morphosys for the CD-19 targeting antibody, which has been approved in combination with BMS’ Revlimid (lenalidomide) for adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified.

The indication also covers DLBCL arising from low grade lymphoma and patients not eligible for autologous stem cell transplant.

Monjuvi (tafasitamab) targets the CD-19, a protein on the surface of B-cells that is also targeted by Amgen’s bispecific antibody Blincyto (blinatumomab) for acute lymphoblastic leukaemia (ALL), as well as two CAR-T therapies – Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) – that are already approved for DLBCL and other B-cell cancers.

Under the agreement with Morphosys the companies will co-market the drugs in the US, while Incyte has exclusive rights outside the US.

The deal with Morphosys could see Incyte pay up to $1.1 billion should certain targets be achieved.

Xencor, which developed the drug before licensing it to Morphosys in 2010, will receive a $25 million milestone payment and a royalty on worldwide net sales.

There was no word from the companies on pricing, but an antibody drug is likely to be less expensive than the rival CAR-T therapies also approved in DLBCL, at least in the short term.

Novartis and Gilead have priced their CAR-Ts at $373,000 for adult DLBCL, covering the cost of a single shot of the cell therapy.

Monjuvi will be taken in a longer cycle and antibody therapies already on the market cost several thousand dollars per month.

Still it’s unlikely that the price will exceed the headline cost of the CAR-Ts and they will also be more convenient.

CAR-Ts are made by harvesting a patient’s own cells and modifying them to fight cancer, a lengthy process that might not appeal to all patients.

There are also dangerous side-effects with CAR-Ts, where doctors often have to manage “cytokine storms” where the immune system goes into overdrive and begins to attack a patient’s own body.

The FDA approval of Monjuvi was based on data from the MorphoSys-sponsored phase 2 L-MIND study, an open label, multicentre, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.

Results from the study showed an overall response rate of 55%, including a complete response rate of 37% and a partial response rate of 18%.

Warnings and precautions for Monjuvi included infusion-related reactions, serious or severe myelosuppression (including neutropenia (50%), thrombocytopenia (18%), and anemia (7%)), infections (73%) and embryo-foetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients.

This accelerated approval may depend on further confirmatory data from larger trials.

The post Incyte/Morphosys take on CAR-Ts as lymphoma antibody Monjuvi approved in US appeared first on .

from https://pharmaphorum.com/news/incyte-morphosys-take-on-car-ts-as-lymphoma-antibody-monjuvi-approved-in-us/

[daniablub]

Morphosys to Boost Size of Tafasitamab Drug Trial on Encouraging Interim Data

German biotech company Morphosys said more patients would be recruited for a study testing its most advanced drug against a common type of blood cancer, following an encouraging interim data readout. Reuters Health Information from Medscape Medical News Headlines https://ift.tt/37vVl0S via IFTTT

#IFTTT #Medscape Medical News Headlines

[viralpearl-blog]

Morphosys to boost size of tafasitamab drug trial on encouraging interim data FRANKFURT (Reuters) - German biotech company Morphosys said more patients would be recruited for a study testing its most advanced drug against a common type of blood cancer, following an encouraging interim data readout.