Caribou Biosciences: 2 Clinical Data Updates In 2024 Could Bring Value

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Caribou Biosciences, Inc. is expected to produce results from phase 1 ANTLER study, using CB-010 for the treatment of 2nd-line large B-cell lymphoma patients, at medical meeting Q2 of 2024.Initial ...

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class=\"meta\">\n\n\n2024-04-19 01:59 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4684523-caribou-biosciences-two-clinical-data-updates-in-2024-could-bring-value><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Caribou Biosciences, Inc. is expected to produce results from phase 1 ANTLER study, using CB-010 for the treatment of 2nd-line large B-cell lymphoma patients, at medical meeting Q2 of 2024.Initial ...</p>\n\n<a href=\"https://seekingalpha.com/article/4684523-caribou-biosciences-two-clinical-data-updates-in-2024-could-bring-value\">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":"SG9999003800.SGD","symbol_name":"Nikko AM Global Dividend Equity Acc 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study using CB-010 for patients with lupus nephritis and extrarenal lupus; Trial initiation expected by the end of 2024.Initial dose-escalation data from the phase 1 CaMMouflage study, using CB-011 for the treatment of patients with relapsed or refractory multiple myeloma patients by end of 2024.Solskin Caribou Biosciences, Inc. (NASDAQ:CRBU) is gearing up to present initial dose expansion data from its ongoing phase 1 ANTLER study. This particular early-stage study uses CB-010 for the treatment of patients with 2nd-line relapsed or refractory large B cell lymphoma [r/r LBCL]. Positive data from the dose-escalation portion of the study was already released. What investors can look forward to regarding the advancement of this program would be two catalysts in particular. The first catalyst would be the presentation of phase 1 ANTLER trial data at an upcoming medical conference in Q2 of 2024. This would include initial dose expansion data plus the finding of a recommended phase 2 dose [RP2D] for this trial. Another catalyst would be the announcement of the timing for the initiation of a pivotal phase 3 study using CB-010 for the treatment of this specific patient population. As I will note below, Caribou already had a successful meeting with the FDA in a Type B meeting. During this meeting, there was an alignment on what would qualify as part of a successful registration study for this program. Everything is not riding on only advancing one type of allogenic CAR-T for its pipeline. It has several other CAR-Ts being developed, with another possible good one being CB-011, which is being tested in the ongoing phase 1 CaMMouflage Phase 1 study for the treatment of adults with relapsed or refractory multiple myeloma [r/r MM]. It is also important to highlight this program because it is expected that results from this early-stage study using CB-011 for the treatment of this patient population will be released by the end of 2024. Lastly, the aspect of using its CAR-T is going beyond the scope of only being used for oncology. Matter of fact, CB-010 may also have a use in being able to treat autoimmune diseases. As such, it was given clearance by the FDA to initiate the phase 1 GALLOP study using this allogeneic anti-CD19 CAR-T cell therapy for the treatment of patients with lupus nephritis [LN] and extrarenal lupus. This trial is expected to begin by the end of this year, which would mark another milestone to keep an eye on. The reasoning for initiating the use of CB-010 for the targeting of autoimmune disorders is because of the initial positive data it achieved after testing the use of this CAR-T in the phase 1 ANTLER study treating patients with 2nd-line r/r LBCL. CB-010 For The Treatment Of Patients With Large B-Cell Lymphoma One of the main programs in Caribou's pipeline would be the advancement of CB-010, which is being tested in the ongoing phase 1 ANTLER study for the treatment of patients with 2nd-line relapsed or refractory large B-Cell lymphoma [r/r LBCL]. The thing is that it sought out to target relapsed or refractory non-Hodgkin lymphoma [NHL] patients first, and then also tested a subpopulation as well. In either of these targeting cohort scenarios, a dose of CB-010 was shown to do very well. Consider that these were the ORRs that were observed after patients were given this allogeneic anti-CD-19 CAR-T:  Objective response rate of 94% [15 out of 16 patients] for r/r NHL patient population. Objective response rate of 90% [9 out of 10 patients] for r/r large B-cell patient population.  However, the company believes that it may be prudent to focus on a specific subpopulation. Thus, for the additional patients enrolled in the phase 1 ANTLER study, it was decided to target relapsed/refractory 2nd-line LBCL patients in the ongoing dose expansion portion of this trial. This sets up a major catalyst to look forward to, which is that initial dose expansion data from this early-stage study is expected to be presented at a medical congress in Q2 of 2024. Consider that the global B-Cell lymphoma treatment market is expected to reach $13.14 billion by 2030, this will be a pretty good market opportunity for it to go after. Even if it is only going after the relapsed or refractory patient population only. There are two reasons why this biotech holds great potential in being able to advance its allogeneic CAR-Ts for the treatment of patients with various types of cancers. The first reason is that the dose escalation data shown thus far, which I went over briefly, has the potential to rival that of currently approved autologous CAR-Ts for the same patient population. A second reason would be because, to the company's knowledge, it is the first anti-CD-19 allogeneic CAR-T cell therapy being utilized to target 2nd-line LBCL patients. Another potential milestone to consider would be an update about the advancement of a phase 3 study expected in 2024. That's because Caribou already had a positive Type B meeting with the FDA. It was noted that the proposed design of a phase 3 study would be adequate for a pivotal type. In particular, the FDA noted that the inclusion of a comparator arm of platinum-based immunochemotherapy followed by high-dose chemotherapy [HDCT] and autologous stem cell transplantation [ASCT] would be adequate to move forward with. As I explained at the beginning above, the positive data achieved in the phase 1 ANTLER study gave proof of the drug being active in targeting B-cells effectively. Having said that, the scope of CB-010 goes beyond only being used for the treatment of patients with cancers. Thus, it was able to receive clearance from the FDA for its investigational New Drug [IND] application of CB-010 for the treatment of patients with lupus nephritis [LN] and extrarenal lupus [ERL]. Such a phase 1 study will be known as the GALLOP trial and will begin by the end of this year. The global lupus nephritis market is expected to reach $3.32 billion by 2029. This will be a huge market opportunity for it to go after. If the use of CB-010 is proven to work for this patient population as well, then it could possibly open the door towards the targeting of other B-cell mediated disorders. CB-011 For The Treatment Of Patients With Multiple Myeloma The other candidate in the pipeline, known as CB-011, is being developed for the treatment of patients with relapsed or refractory multiple myeloma [r/r MM]. Multiple Myeloma [MM] is a type of cancer characterized as white blood cells [plasma cells] becoming diseased. These plasma cells are important because they are responsible for generating the antibodies necessary to fight off infections and viruses. Without this happening, the body is unable to effectively fight off against infections, thus leading to a host of symptoms. Such symptoms that these patients with multiple myeloma experience are as follows:  Nausea Infections Weakness Fatigue Bone pain Loss of appetite.  The global multiple myeloma market size is projected to reach $31 billion by 2026. However, in this case here, Caribou is specifically only targeting relapsed or refractory Multiple Myeloma patients. The thing is that patients with this hematological disorder relapse. In a 2016 study that was done, it was noted that about 84% of MM patients had relapsed 1-year after treatment. This CRISPR-edited allogeneic anti-BCMA CAR-T cell therapy is being developed to treat this patient population in the ongoing phase 1 CaMMouflage study. This trial is expected to enroll up to 50 patients who are to receive CB-011 CAR-T following lymphodepletion with cyclophosphamide or fludarabine. Despite this being another shot on goal in the pipeline as a different product, it is highly differentiated compared to CB-010 noted above. How so? That's because CB-011 was developed with a different type of technology known as \"immune cloaking.\" By making specific edits in the genome, it is believed that this would imply an ability for the CAR-T to overcome T-cell and natural killer [NK] cell rejection. In turn, it is possible that such a mediated move could ultimately mean an improved clinical outcome for these patients. This remains to be seen if immune cloaking armoring results in this intended action, but investors won't have to wait long to see such data. It is expected that Caribou will release initial dose-escalation data from the phase 1 CaMMouflage trial by the end of 2024. Financials According to the 10-K SEC Filing, Caribou Biosciences had cash, cash equivalents and marketable securities of $372.4 million as of December 31, 2023. The reason for the cash on hand is that in 2023 it had two financial transactions that were done, which brought in plenty of funds. The first of which was an underwritten public offering done in July 2023. That is when it offered to sell up to $125 million worth of its common stock along with a 30-day option for the underwriters to purchase up to an additional $15 million shares of its common stock at the public offering price. It was able to raise total net proceeds of $134.6 million from this public offering. Not only that, but afterward Pfizer Inc. (PFE) made a $25 million investment in Caribou and placed Sriram Krishnaswami, PhD, vice president and development head, multiple myeloma, Pfizer Global Product Development on Caribou's scientific advisory board. Based on the cash on hand, Caribou Biosciences, Inc. believes its cash runway is into Q1 of 2026. Its cash burn is about $41 million per quarter, which means it has plenty of cash runway for now. Risks To Business There are several risks that investors should be aware of before investing in Caribou Biosciences. The first risk to consider would be regarding the advancement of CB-010 for the treatment of 2nd-line patients with relapsed or refractory large B-cell lymphoma [LBCL], which is being explored in the ongoing phase 1 ANTLER study. It is expected that Caribou will release initial dose expansion data from this early-stage study at an upcoming medical congress. There is no guarantee that this data to be revealed there will turn out to be equivalent to or superior to that of the initial dose-escalation data already released by it. A second risk to consider would be the advancement of CB-010 for the treatment of 2nd-line patients with relapsed or refractory LBCL in a potential phase 3 registration study. As I stated above, there was an alignment with the FDA that a good comparator arm for this late-stage study would be platinum-based immunochemotherapy followed by high-dose chemotherapy [HDCT] and autologous stem cell transplantation [ASCT]. There is no guarantee that CB-010 alone will be enough to beat this comparator arm with statistical significance based on the primary endpoint of this trial. A third risk to consider would be potential competitors for the treatment of patients with large B-cell lymphoma [LBCL]. That's because there is no guarantee that CB-010 will be shown to be more effective than the CD-19 directed CAR-Ts already approved. For instance, Kymriah from Novartis AG (NVS) is one approved CAR-T for adults with r/r Diffuse Large B-cell lymphoma [DLBCL] and other hematological malignancies. Another autologous CD-19 directed CAR-T already approved to treat LBCL patients would be Yescarta from Gilead Sciences, Inc. (GILD). The ultimate goal is for Caribou to use its technology to advance the ability of its allogenic CAR-T platform technology to end up being safer and more effective compared to that of autologous CAR-T. The risk here is that there is no guarantee that CB-010 will be shown to be superior to either of these or any other CAR-T candidates in clinical development. A fourth risk to consider would be the use of CB-010 for the treatment of patients with autoimmune disorders. The company received clearance from the FDA to initiate a phase 1 study targeting patients with lupus nephritis [LN] and extrarenal lupus. The phase 1 study for this program will be known as GALLOP and is expected to be initiated by the end of 2024. Even though CB-010 has shown great promise in being able to treat patients with 2nd-line LBCL, there is no assurance that the same will be shown in patients with autoimmune disorders such as these. Conclusion Caribou Biosciences, Inc. has been able to make significant progress in being able to advance its pipeline with the use of CB-010 for the treatment of patients with 2nd-line LBCL in the ongoing phase 1 ANTLER study. The initial data that was released was only for the dose-escalation portion of this study. The next set of data is going to include the dose expansion portion. If the next set of data turns out better than the prior set released, then I believe it should be viewed positively by the market. This program is highly ideal because an updated timeline for the timing of a phase 3 trial initiation to advance CB-010 is expected in 2024. Especially, since it has already held a positive Type B clinical meeting with the FDA, where it was noted that the proposed trial design with a specific comparator arm would be appropriate to move this program forward. While there are other CAR-T candidates being advanced for the treatment of hematological malignancies, I think a huge positive is the potential for CB-010 to also possibly be capable of treating patients with autoimmune disorders.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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