Artiva: Natural Killer Cell Biotech With 1st Half Of 2025 Lupus Treatment Data

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Artiva Biotherapeutics, Inc. debuts on NASDAQ with a $167 million IPO, expected to close on July 22, 2024.AlloNK therapy aims to enhance efficacy of B-cell depleting monoclonal antibodies for ...

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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nArtiva: Natural Killer Cell Biotech With 1st Half Of 2025 Lupus Treatment Data\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-07-23 03:55 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4705575-artiva-natural-killer-cell-biotech-with-1st-half-of-2025-lupus-treatment-data><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Artiva Biotherapeutics, Inc. debuts on NASDAQ with a $167 million IPO, expected to close on July 22, 2024.AlloNK therapy aims to enhance efficacy of B-cell depleting monoclonal antibodies for ...</p>\n\n<a href=\"https://seekingalpha.com/article/4705575-artiva-natural-killer-cell-biotech-with-1st-half-of-2025-lupus-treatment-data\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://seekingalpha.com/article/4705575-artiva-natural-killer-cell-biotech-with-1st-half-of-2025-lupus-treatment-data","article_id":"2453571780","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2453571780","pubTimestamp":1721678103,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Well, as I stated above, current agents used to target B-cell mediated autoimmune disorders like rituximab and obinutuzumab work well. They were able to help reduce the relapse rate when being","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","ARTV":"Artiva Biotherapeutics, Inc.","BIIB":"渤健公司","BK4532":"文艺复兴科技持仓","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4588":"碎股","IE00B19Z9Z06.USD":"Legg Mason ClearBridge - US Aggressive Growth A Acc USD","RHHBY":"罗氏控股","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4533":"AQR资本管理(全球第二大对冲基金)","AFMD":"Affimed NV","03165":"华夏欧优股对冲","LU0234570918.USD":"高盛全球核心股票组合Acc Close","BK4585":"ETF&股票定投概念","IE00B894F039.SGD":"Legg Mason ClearBridge - US Aggressive Growth A Acc SGD-H","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4139":"生物科技","IE00B19Z9P08.USD":"LEGG MASON CLEARBRIDGE US AGGRESSIVE GROWTH \"A\" (USD) INC"},"translate_title":"Artiva：自然杀伤细胞生物技术，拥有2025年上半年狼疮治疗数据","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AFMD":1,"RHHBY":1,"BIIB":1,"ARTV":1,"03165":0.6},"content_text":"Artiva Biotherapeutics, Inc. debuts on NASDAQ with a $167 million IPO, expected to close on July 22, 2024.AlloNK therapy aims to enhance efficacy of B-cell depleting monoclonal antibodies for autoimmune disorders and cancers.Initial data from either investigator trial or phase 1/1b study using AlloNK + rituximab combination for treatment of patients with SLE/LN/autoimmune disorders, expected in the 1st half of 2025.The global market for systemic lupus erythematosus and lupus nephritis is estimated to reach $4.2 billion by 2031.   Patamaporn Umnahanant/E+ via Getty Images Artiva Biotherapeutics, Inc. (NASDAQ:ARTV) just recently had its debut on the NASDAQ, where it announced the pricing of an upsized $167 million initial public offering. Such a transaction is expected to close today on July 22, 2024. This biotech is ideal because it is hoping to change the landscape completely when it comes to currently available B-cell depleting therapies. Monoclonal antibodies such as rituximab and obinutuzumab have done well against several types of cancers and autoimmune disorders. They work by depleting B-cells in hopes of reducing disease and/or progression. However, this company is hoping that its allogenic natural killer [NK] cell therapy AlloNK [Formerly AB-101] can be added in combination with rituximab and obinutuzumab to enhance efficacy observed when targeting patients with autoimmune disorders like systemic lupus erythematosus [SLE] or Lupus Nephritis [LN]. There is a catalyst opportunity for investors to look forward to here because data is expected in the first part of next year as it relates to this program. That is, it intends to release initial data from this or a basket of intent-to-treat [ITT] autoimmune disorder patients, from a phase 1/2 study in the 1st half of 2025. This is a bit of a risk for sure, but there is one thing to keep in mind, which is that prior preliminary data had been released using AlloNK for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma [NHL]. Patients were given both monotherapy and combination therapy of AlloNK and the dual therapy is what ended up paying off. The point here is that the initial data points to two paths, which is AlloNK being added to current B-cell monoclonal antibodies to further enhance the treatment paradigm for these patients with B-cell mediated autoimmune disorders. With the IPO set to bring in a huge cash infusion, plus data expected in the early part of next year, I believe that investors could benefit with any potential gains made. AlloNK To Enhance Upon Use Of B-cell Depleting Monoclonal Antibodies With the IPO underway and the expected closing to happen today, I believe that the company is well-equipped to change the autoimmune disorder treatment landscape. How will it do this? Well, as I stated above, current agents used to target B-cell mediated autoimmune disorders like rituximab and obinutuzumab work well. They were able to help reduce the relapse rate when being compared to standard corticosteroid regimens. There is a way to possibly still help the patients that relapse on rituximab or other similar agents. This could be possible in the fact that AlloNK might be able to deepen responses observed for these patients. It is designed to attach to B-cell targeting monoclonal antibody via CD16. The process is as follows:  B-cell targeting monoclonal antibody [rituximab, obinutuzumab, or other B-cell depleting agent] attaches to disease or pathogenic B-cell via the B-cell antigen AlloNK attaches to the B-cell targeting monoclonal antibody via CD16 [The point here is for NK cell AlloNK to enhance upon the possible response compared to B-cell targeting monoclonal antibody alone].  The result of this process should end up being an antibody dependent cellular cytotoxicity [ADCC] response to kill the tumor in question. The company has a considerable focus to go after the systemic lupus erythematosus and/or Lupus Nephritis markets. Systemic lupus erythematosus [SLE] is a type of autoimmune disorder where the immune system attacks the patient's own healthy tissues. This is a problematic disorder, and the problem here remains in terms of relapses still occurring despite treatment with CD-19/CD-20 monoclonal antibodies. Some symptoms for these patients with SLE are:  Joint pain  Arthritis  Random fever  Hair loss  Swollen lymph nodes.  It is important to note, though, that when SLE or Lupus occurs in the kidneys, this is known as Lupus Nephritis [LN]. The issue is that with lupus affecting the kidneys of a patient, it could lead to kidney failure. The global market for systemic lupus erythematosus and lupus nephritis is estimated to reach $4.2 billion by 2031. This is a huge market opportunity, especially when you consider the number of refractory patients that could be targeted with both of these patient populations. For instance, just looking at the LN patients alone, 30% of them do not respond to currently available treatment options. It is possible that adding AlloNK to anti-CD-19 or anti-CD-20 monoclonal antibodies might further enhance upon the response that is obtained, compared to either of these agents alone. To see if the combination of AlloNK + rituximab or obinutuzumab is capable of being able to help patients with autoimmune disorders, Artiva launched a phase 1/1b study and then an investigator-initiated basket study targeting ITT autoimmune disorder patients. The goal is to emphasize the Lupus/SLE indications first, but to go after several other autoimmune disorders with the investigator-initiated trial. The global market for autoimmune disorder therapies is expected to grow to $90.7 billion by 2024. The potential expansion opportunity for AlloNK, if successful, could be in targeting other disorders like: Rheumatoid Arthritis [RA], Systemic Sclerosis [SSc], myasthenia gravis [MG], Myositis and many others. However, the opportunity could be significantly higher. That's because in its IPO filing, it notes that global autoimmune disorder sales in 2023 reached $160 billion. It is expected that a total of 51 patients will be recruited into this phase 1/1b study. Like with most other cell therapy companies, patients must first receive lymphodepleting chemotherapy agents such as fludarabine and cyclophosphamide before being given AlloNK + rituximab or AlloNK + obinutuzumab. Rituximab is marketed as Rituxan by Roche (OTCQX:RHHBY) and Biogen (BIIB) as an anti-C20 monoclonal antibody for several types of cancers. The other similar monoclonal antibody, obinutuzumab, is marketed as Gazyva by Roche as well, which has been approved to treat various types of cancers. There is a catalyst opportunity expected with this program, in that initial data from either the investigator-initiated trial or the phase 1/1b study targeting autoimmune disorder patients, is expected in the 1st half of 2025. Prior Data Establishes Initial Proof Of Activity Of AlloNK In B-Cell Malignancies It remains to be seen if the AlloNK combinations, being explored in the ongoing early-stage studies, end up being successful. However, there were some preliminary results released from the phase 1/2 trial using AlloNK that established clinical activity in patients with relapsed/refractory non-Hodgkin lymphoma [NHL] of B-cell origin. This particular trial recruited two different cohorts as follows:  Monotherapy cohort — Where patients only received treatment with AlloNK alone — 15 patients  Combination cohort — where patients received combination of AlloNK + B-cell CD-20 monoclonal antibody targeting agent rituximab — 9 patients.  Regarding the monotherapy arm, the data wasn't that bad. AlloNK given alone in 13 evaluable patients was able to elicit an objective response rate [ORR] of 38.5%. However, in this study, the treatment from Artiva achieved the intended function of proving that its allogenic off-the-shelf NK cell therapy was able to enhance ORR when added to B-cell monoclonal antibody targeting agents. That is in the 7 evaluable patients from the combination cohort above, the ORR percentage was 57.1%. This data is especially to be considered good in terms of the patient population of NHL patients that was sought after. These were very sick patients who were heavily pre-treated having received an average range of 4 prior therapies [ranging from 2 prior therapies to 11 prior therapies] before being given either monotherapy or combination therapy with AlloNK. About two-thirds of them had aggressive B-NHL. The whole premise for this biotech is to improve upon cell therapy for B-cell mediated disorder patients. Current CAR-Ts may have limitations in terms of scalability, patient access and safety. How will Artiva's AlloNK solve all of these? The way it will solve this problem regarding each of these are as follows:  Scalability — in terms of this, AlloNK is developed based on allogeneic donor process which doesn't require genetic modification and is cryopreserved — The advantage of this is the ability to have treatment instantly available  Patient compliance — regarding this, the problem is solved in terms of AlloNK being able to be administered to patients in an outpatient setting with no monitoring being necessary [a cell therapy that can better effectively deplete B-cells, but at the same time not require hospitalization or other monitoring afterward] Safety/Cost — Problem of being able to mass produce product at scale at a lower cost, along with the ability to provide patients with an effective therapy that lacks heavy side effects [phase 1/2 study in aggressive B-NHL patients showed that despite each patient going through 16 doses of AlloNK no ICANS/neurotoxicity or graft-versus-host disease observed].  The goal of improved safety makes a lot of sense, especially since the design of the non-genetically modified NK cells was that of enhancing the ability to effectively kill cancer cells, while leaving healthy tissue alone. The final point to make is that this study is continuing to dose patients at the 4 billion combination dose level. This means that ultimately, response rates may or may not improve. The bottom-line is for this biotech to improve upon the treatment paradigm of these patient with B-cell mediated disorders. Why is there a need for this? Besides a lot of these patients becoming refractory to current treatments, long-term use of several of them leads to secondary complication issues. Treatments that are taken over an extended period of time that may cause secondary issues are: Steroids, TNFa agents, interleukin inhibitors mycophenolate mofetil [MMF] and others. They can cause problems ranging from infections/cancer, cardiovascular disease, diabetes, and many others. Financials The company is expected to complete its IPO today. It intends to offer 13,920,000 shares of its common stock with a price of $12 per share to the public. The gross proceeds from this upsized offering are expected to be $167 million, as I have noted directly above. However, there was a 30-day option given to the underwriters in that they could offer and sell 2,088,000 additional shares of common stock at this very same public offering price. Should the underwriters exercise these additional shares, then the total gross proceeds to be raised before expenses from this offering, would be $178,649,280. Its cash burn is $64 million per year, and this is broken down with $50.2 million in operating expenses for the year ending December 2023 and then $13.9 million of general and administrative expenses during the same period. As of December 31st, 2023, it had cash and cash equivalents of $53.5 million. With this cash on hand, the guidance was that it would only have enough funds to operate its business, or cash runway, for at least 12 months. However, this IPO that it's about to complete is expected to bring in a considerable amount of money and thus, in my eyes, there is no risk of a near-term cash raising activity. The cash brought in should be enough to help fund its business for about 2 years or more. Thus it should be in good shape here for an extended period of time. Risks To Business There are several risks that investors should be aware of before investing in Artiva Biotherapeutics. The first risk to consider would be in terms of the development of AlloNK + rituximab/obinutuzumab for the treatment of patients with SLE. There are two studies to worry about here which is the basket investigator-trial and then the phase 1/1b study targeting patients with LN. There is no assurance that positive data will be achieved in one or both of these studies, nor that the response rates are to continue to improve over an extended period of time. Even if the AlloNK combination proves to be effective in treating patients with SLE/LN, there is no guarantee that it will eventually be ideal in treating other types of autoimmune disorders. A second risk to consider would be in terms of the advancement of AlloNk + rituximab for the treatment of patients with B-NHL or other B-cell malignancies. While the initial ORR of the combination in B-NHL patients was 57.1% from 7 evaluable patients, there is no guarantee that other patients recruited into this trial will achieve a similar or superior ORR. Nor, that the 4 billion dose combination level is going to result in better response rates. The third and final risk to consider would be with respect to the collaboration between Artiva and Affimed (AFMD). That's because AlloNK was combined to be explored with Affimed's acimtamig [AFM13] for the treatment of patients with relapsed/refractory Hodgkin Lymphoma [HL] and CD30+ positive peripheral T-cell lymphoma [PTCL]. This combination to treat both of these patient populations is being tested in the ongoing phase 2 LuminICE-203 study. Enrollment for this mid-stage trial was initiated in October of 2023 and preliminary data had already been released for it. I believe this data hallmarks a good outcome for both Artiva and Affimed. That's because there was an ORR of 85.7% achieved in the first 7 treatment refractory HL patients. The risk is that there is no assurance that further patients are going to respond similarly. Nor, that the other patient population being targeted CD30+ positive PTCL patients will achieve a similar type of response. Conclusion Artiva Biotherapeutics has been able to make great progress with respect to the development of its allogenic NK cells to treat patients with B-cell malignancies and B-cell mediated autoimmune disorders. As I have shown above, it has been able to do well when it combined its AlloNK cell therapy in combination with rituximab when treating patients with relapsed/refractory NHL of B-cell origin. This was only observed in 7 evaluable patients, but the belief is that the combination of AlloNK may work in treating patients with autoimmune disorders as well. That's because the mechanism of action of depleting B-cells in B-cell malignancies could also end up paying off when targeting B-cell mediated autoimmune disorders. This remains to be seen, but investors only have to wait until the first part of 2025 to see if this combination is also able to help patients with autoimmune diseases like SLE and/or LN. It appears as though the logic of using allogeneic NK cells to attach to B-cell targeting agents via CD-19 seems too illicit a strong ADCC effect. This remains to be seen in several other patients to be enrolled, but it appears as though the mechanism of action of AlloNK is paying off.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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