Английская Википедия:Genmab
Шаблон:Short description Шаблон:Infobox company
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.[1] The company is based in Copenhagen, Denmark – internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, The Netherlands, Genmab U.S., Inc. in Princeton, USA, and Genmab K.K. in Tokyo, Japan. Genmab is a dual-listed company with shares traded on both the Copenhagen Stock Exchange in Denmark[2] and the NASDAQ Global Select Market in the US.[3]
The company has 8 approved antibodies (monoclonal and bispecific) used in 8 marketed products, covering cancer indications and autoimmune diseases.[4]
Proprietary, marketed with partners:
- Epkinly/Tepkinly (epcoritamab) for the treatment of Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (AbbVie)
- Tivdak (tisotumab vedotin) for the treatment of previously treated recurrent or metastatic cervical cancer (Seagen)
Marketed by partners:
- Darzalex (IV) (daratumumab) / Darzalex Faspro (SC) (daratumumab and hyaluronidase) for the treatment of all stages of multiple myeloma as combination therapy or monotherapy, and for the treatment of newly diagnosed amyloid light-chain (AL) amyloidosis (Janssen)
- Kesimpta (ofatumumab) for the treatment of relapsing remitting multiple sclerosis (Novartis)
- Rybrevant (amivantamab) for the treatment of non-small-cell lung cancer (EGFR exon 20 insertion mutations) (Janssen)
- Talvey (talquetamab) for the treatment of relapsed/refractory MM (Janssen)
- Tecvayli (teclistamab) for the treatment of relapsed/refractory MM (Janssen)
- Tepezza (teprotumumab) for the treatment of thyroid eye disease (Horizon)
Furthermore both Genmab and its partners have a whole range of antibody programs, building on Genmab technologies, in clinical and pre-clinical development in both cancer and autoimmune diseases.
Genmab have several late stage clinical programs for tisotumab vedotin (cervical cancer, ovarian cancer and solid tumors) and epcoritamab (B-cell non-Hodgkin lymphoma and Relapsed/refractory Follicular lymphoma).
The partners have, among others, clinical programs for daratumumab (non-MM blood cancers), amivantamab (gastric cancer and esophageal cancer), Mim8 (Factor VIII mimetic bi-specific antibody) (Haemophilia A), inclacumab (VOC in Sickle cell disease) and teprotumumab (diffuse cutaneous systemic sclerosis).Шаблон:Citation needed
Technology
Genmab's technology is licensed from Medarex to create fully human high affinity antibodies using transgenic mice. These antibodies are less likely to elicit an allergic reaction and other side effects compared with other types of man-made antibodies containing other animal proteins because the IgG antibodies produced have human proteins. This technology is called the HuMab-Mouse technology. One benefit of using this type of technology is that there is no need for humanization or complicated genetic engineering to make this antibody fit for humans which cuts down on expenses and time spent developing it. It can be generated within months and can be selected to bind to specific antigens such as tumor cells and other infectious agents.
Genmab also has developed its own technology called UniBody, which is used to make smaller antibodies in contrast to the traditional full sized monoclonal antibody. Its smaller size allows for better distribution over larger target areas like tumors. The UniBody can only bind to one site and doesn’t elicit a harmful immune response by binding to two sites and over-activating cell growth. It does not kill target cells but rather silences or inhibits them. Thus it can be used to treat certain cancers, inflammations, allergies and asthmas, where killing the cell isn’t the objective.[5]
The technology modifies the human IgG4 antibody. Normally the IgG4 is considered inert and doesn’t elicit an immune response. However, they are also unstable and fall apart easily, which makes them unsuitable for therapeutic use. Genmab changes the shape of the IgG4 antibody by eliminating the hinge, the part of the antibody that creates the “Y” shape. This halves the antibody, creating a smaller version now known as their UniBody. This smaller version can only bind to one site and does not stimulate cancer cells to grow.[6]
History
Genmab was founded as a European spin-off of American Biotech company Medarex in February 1999. Danish investment firm BankInvest, under Florian Schönharting, provided the seed investment for the company to start up in Copenhagen. Like Medarex, Genmab began work producing monoclonal antibodies for life-threatening or debilitating diseases. Rising quickly in the Biotech world, Genmab attracted many investors, especially venture capital firms. The company went public in October 2000, earning DKK 1.56 billion, and had a second public offering in January 2006, yielding DKK 800 million.
The company's initial R&D location was a nine-story building in Utrecht Science Park, in the Netherlands; this was replaced with an "R&D Center" also in Utrecht, in June 2018.[7] By mid-2019, this new facility was at capacity, and plans were set afoot to build an adjacent, connected facility.[7]
By 2001, Medarex and Genmab had come back together in a drug development partnership, which highlighted the manufacturing deficit and clinical development expertise of Genmab relative to Medarex.[8]
In 2005, the Biotechnology Industry Organization (BIO) and the Long Island Life Sciences Initiative honored Genmab with a James D. Watson Helix Award.[9]
2008 saw the company purchasing a 22,000-litre, 36-acre antibody manufacturing plant in Brooklyn Park, Minnesota from PDL BioPharma, with plans to retain all 170 employees thereat.[7][10] However, the company ran into financial trouble originating from several quarters, and a decision to sell the facility was reached in late 2009, after Genmab had started producing development scale batches from the facility.[7] In 2008, the world was experiencing a financial crisis as a whole, and GlaxoSmithKline decided to exit oncology, which impacted co-development of ofatumumab, an oncology-directed product.[7] In tandem with the sale of the plant, the company reorganized and planned to dismiss about 300 employees.[7] Selling the facility, though, proved very difficult, due in large part to the global financial crisis; by 2012, Genmab had decided to simply write-off the entire facility from the company's balance sheets.[7] A sale of the facility to Baxter came in February 2013.[7]
Following the failed strategy of in-housing manufacturing, Genmab chose to thereafter completely outsource both manufacturing and the conduct of clinical trials.[7]
The Company's first product, Arzerra (ofatumumab) reached the US market in 2009 for refractory chronic lymphocytic leukemia.[11]Шаблон:Failed verification
Executive history
Lisa N. Drakeman, Ph.D. had been a vice president at Medarex and wife of Donald Drakeman, Medarex's CEO and President at the time. Drakeman was one of Genmab's co-founders and was appointed chief executive officer (CEO) of the company upon incorporation in 1999, also joining the board of directors.[7] Шаблон:As of, Drakeman remained in the CEO role,[12] but by 2010 she had announced her retirement.[7]
In 2010, Jan Van de Winkel, a co-founder of the firm, was appointed as President and CEO of Genmab.[7] Since the company started in 1999, he had been Genmab's chief scientific officer (CSO); he had concurrently served as head of research, then president of R&D.[7] Шаблон:As of, Van de Winkel remained CEO of the firm.[7] Van de Winkel is a scientist, having produced more than 300 publications during his career.[7]
Partnerships
Amgen: In May 1999, Genmab entered a sub-license agreement with Amgen where it would gain rights to the IL15 antibodies. In October 2001, this was replaced by a direct license agreement where Amgen retained exclusive commercialization options for the products through phase II. Amgen has also expanded its agreement to a new antibody program targeting additional disease targets. Amgen has discontinued development of the IL15 antibody, AMG 714, in psoriasis and rheumatoid arthritis based on disappointing results from recent clinical studies. Amgen is exploring options to maximize the value of this asset, but as this time, no further internal development of a lead indication is planned.
GlaxoSmithKline: In December 2006, Genmab entered a deal with GlaxoSmithKline to co-develop and commercialize ofatumumab,[13] a drug that could be used for treatment in CD20 positive B-cell chronic lymphocytic leukemia, follicular non-Hodgkin’s lymphoma, rheumatoid arthritis and other indications. The agreement gave Genmab a license fee of DKK 582 million (Шаблон:US$) and GSK bought 4,471,202 shares of Genmab for DKK 2,033 million (Шаблон:US$). The potential value of this agreement could be DKK 12.0 billion (Шаблон:US$) if all milestones are reached and commercial success is reached in the fields of cancer, autoimmune, and inflammatory disease.[13] The intention of GlaxoSmithKline to exit oncology, disagreement around milestones reached, and financial difficulties of Genmab, led to re-negotiation of the partnership in mid-2010, resulting in an immediate Шаблон:US$ payment by GlaxoSmithKline and future financial and licensing concessions on the part of Genmab.[7]
In addition, Genmab has collaborations with Roche (RG1507, a monoclonal antibody directed against IGF-1R, collaboration was terminated in 2009)[14]
Products and pipeline
Status, as of 14 February 2024[4]
Genmab's Proprietary Products
Approved Medicines/Products
| Approved Product | Target | Developed by | Disease indications | Approval Year |
|---|---|---|---|---|
| EPKINLY/TEPKINLY (epcoritamab) | CD3, CD20 | 50:50 Genmab/AbbVie | Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) | 2023[15] |
| Tivdak (tisotumab vedotin) | TF | 50:50 Genmab/Seagen | Recurrent or metastatic Cervical cancer | 2021 |
Pipeline, Including Further Development for Approved Medicines
| Product | Target | Developed by | Disease indications | Most Advanced Development Phase |
|---|---|---|---|---|
| Epcoritamab | CD3, CD20 | 50:50 Genmab/AbbVie | Relapsed/refractory DLBCL | III |
| " | " | " | Relapsed/refractory Follicular lymphoma (FL) | III |
| " | " | " | First line DLBCL | III |
| " | " | " | B-cell non-Hodgkin lymphoma (B-NHL) | II |
| " | " | " | Relapsed/refractory chronic lymphocytic leukemia (CLL) & Richter's syndrome | I/II |
| " | " | " | Indolent NHL, pediatric patients | I |
| Tisotumab vedotin | TF | 50:50 Genmab/Seagen | Cervical cancer | III |
| " | " | " | Solid tumors | II |
| Acasunlimab (GEN1046/BNT311) |
PD-L1, 4-1BB | 50:50 Genmab/BioNTech | Non-small-cell lung cancer (NSCLC) | II |
| " | " | " | Advanced endometrial cancer | II |
| " | " | " | Solid tumors | I/II |
| Tecaginlimab (GEN1042/BNT312) |
CD40, 4-1BB | " | Solid tumors | II |
| HexaBody-CD38 (GEN3014) |
CD38 | Genmab (under an exclusive worldwide license/option agreement with Janssen) | Hematologic malignancies | II |
| DuoBody-CD3xB7H4 (GEN1047) |
CD3, B7H4 | Genmab | Solid tumors | II |
| HexaBody-CD27 (GEN1053/BNT313) |
CD27 | 50:50 Genmab/BioNTech | Solid tumors | I |
| GEN1056 (BNT322) |
Undisclosed | " | Solid tumors | I |
| DuoBody-CD3xCD20 GEN3017 |
CD3, CD20 | Genmab | Relapsed/refractory Hodgkin lymphoma (HL) & NHL | I |
Programs Incorporating Genmab’s Innovation and Technology
Approved Medicines/Products
| Approved Product | Target | Discovered and/or Developed & Marketed By | Disease indications | Approval Year | Royalties |
|---|---|---|---|---|---|
| DARZALEX (iv) (daratumumab) and DARZALEX FASPRO (subcu.) (daratumumab and hyaluronidase) | CD38 | Janssen | Multiple myeloma (MM) | 2015 (iv), 2020 (sc) | 0-$3bn tiered: 14.92% (avg.), >$3bn fixed: 20% |
| DARZALEX FASPRO | CD38 | Janssen | AL Amyloidosis | 2021 | As for MM |
| Kesimpta (ofatumumab) | CD20 | Novartis | Relapsing remitting multiple sclerosis (RRMS) | 2020 | 10% |
| TEPEZZA (teprotumumab) | IGF-1R | Amgen (under sublicense from Roche) |
Thyroid eye disease (TED) | 2020 | 6% (Jan Van de Winkel[16]) |
| RYBREVANT (amivantamab) | EGFR, cMet | Janssen | NSCLC | 2021 | 8-10% |
| TECVAYLI (teclistamab) | BCMA, CD3 | Janssen | Relapsed/refractory MM (RRMM) | 2022 | ~5-6% |
| TALVEY (talquetamab) | GPRC5D, CD3 | Janssen | RRMM | 2023 | ~5-6% |
Pipeline, Partner-owned products incorporating Genmab’s innovation, ≥Phase 2 Development
| Product | Target | Discovered and/or Developed & Marketed By | Disease indications | Most Advanced Development Phase | Royalties |
|---|---|---|---|---|---|
| Amivantamab | EGFR, cMet | Janssen | Advanced or Metastatic Gastric or Esophageal cancer | II | 8-10% |
| Amivantamab | " | " | Hepatocellular carcinoma | II | " |
| Amivantamab | " | " | Advanced or metastatic colorectal cancer | I/II | " |
| Inclacumab | selectin P | Pfizer | VOC in Sickle cell disease | III Est. prim. completion 2023-12 |
5-6% (Jan Van de Winkel: "mid single-digit"[16]) |
| Mim8 (Factor VIII mimetic bispecific antibody) |
FIXa, FX | Novo Nordisk | Haemophilia A | III Est. prim. completion 2024-05 |
5-6% (Jan Van de Winkel: "mid single-digit"[16]) |
| Camidanlumab tesirine (ADCT-301) |
CD25 | ADC Therapeutics | Relapsed/refractory HL | II 2022-11: FDA has advised ADCT that an ongoing ph3 study - preferably with full enrollment - is needed to support a BLA submission. ADCT therefore plans to conduct a ph3 study for which full enrollment is estimated to take 2 years.[17] |
5-9% tiered (GMAB: "mid-to-high single-digit tiered") |
| Ordesekimab | IL-15 | Sanofi | Gluten-free diet non-responsive Celiac disease | II | - |
| Lu AF82422 | Alpha-Synuclein | Lundbeck | Multiple system atrophy (MSA) | II | - |
References
Шаблон:OMX Copenhagen 20 companies Шаблон:Authority control
- ↑ Шаблон:Cite report
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ 4,0 4,1 Ошибка цитирования Неверный тег
<ref>; для сносокAR2023не указан текст - ↑ Шаблон:Cite webШаблон:Self-published source
- ↑ Шаблон:Cite webШаблон:Self-published source
- ↑ 7,00 7,01 7,02 7,03 7,04 7,05 7,06 7,07 7,08 7,09 7,10 7,11 7,12 7,13 7,14 7,15 Шаблон:Cite magazine
- ↑ Шаблон:Cite news
- ↑ Шаблон:Cite press release
- ↑ Шаблон:Cite news
- ↑ Шаблон:Cite webШаблон:Self-published source
- ↑ Шаблон:Cite news
- ↑ 13,0 13,1 Шаблон:Cite news
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ 16,0 16,1 16,2 Шаблон:Cite web
- ↑ Шаблон:Cite web
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