00:00 (upbeat music)
00:02 Today we're gonna be joined by a very exciting company
00:05 in the biotech space, Kandel Therapeutics.
00:07 We're lucky enough to talk to Francesca Barone,
00:10 the Chief Scientific Officer.
00:11 Francesca, how are you doing today?
00:13 - I'm very good, thank you for having us,
00:15 talking about Kandel.
00:17 - Of course, thank you for joining us.
00:19 Before we get into it, do you mind just giving us
00:20 a brief overview of Kandel Therapeutics?
00:23 - Sure, so Kandel is a clinical stage
00:26 biopharmaceutical company,
00:28 and we are focused on the developing
00:32 of multimodal biological immunotherapies
00:36 to help patients fight cancer.
00:39 We have two clinical candidates.
00:41 One is CAN 3110, and the other one is CAN 2409.
00:45 They are both viruses that are delivered intratumorally.
00:50 They've got different mechanism of actions,
00:52 and they are already developed
00:54 in different phases of clinical trials.
00:57 CAN 3110 is currently in a phase 1b clinical trials,
01:02 while CAN 2409 is in phase two in lung cancer
01:07 and pancreatic cancer,
01:08 and is actually in phase three in prostate cancer.
01:11 We also have a new discovery platform
01:14 that is based on HSV,
01:16 and has been recently unveiled,
01:19 and is called the Enlightened Discovery Platform.
01:21 - Can you tell us a little bit more about CAN 3110?
01:26 What is it, and how does it work?
01:27 - So CA 3110, CAN 3110, we call it in-house,
01:32 is a clinical candidate.
01:35 It's the second clinical candidate for Kandel Therapeutics.
01:38 It's a real oncolytic virus.
01:41 That means that this is a virus
01:43 that is delivered at the site of the tumor,
01:45 and it kills tumor cells.
01:48 And by doing that, it releases tumor antigens
01:51 that normally are hidden inside the tumor cells themselves.
01:55 It causes inflammation in the tumor,
01:57 and it also attracts immune cells.
02:00 And so you have a reaction against the tumor,
02:02 both at the site of injection, but also systemically,
02:05 because the tumor cell are capable
02:07 to get out in the circulation and go around in the body.
02:12 And so mount a very systemic anti-tumoral response.
02:16 CAN 3110 is different from the other oncolytic viruses.
02:21 All the other oncolytic viruses in development
02:25 tend to be replication defective.
02:27 That means that there've been a removal of a gene
02:31 that causes tumor replication,
02:33 that causes viral replication.
02:35 But in CAN 3110, we've been able to selectively place
02:40 this gene under a control of a promoter
02:43 that enables CAN 3110 only to replicate
02:47 and therefore kill tumor cells.
02:50 - Got it.
02:50 Well, CAN 3110 is currently being evaluated in glioma.
02:54 Can you tell us more about glioma,
02:55 the current treatment landscape,
02:57 and how you're utilizing CAN 3110
02:59 to address the unmet need?
03:01 - So glioma is one of the most daring indications
03:07 in terms of cancer.
03:08 So this has got normally patient with high-grade glioma,
03:12 and in particular, recurrent high-grade glioma,
03:15 that is the indication where CAN 3110
03:18 is currently in development,
03:20 have a very short expectation of life.
03:24 So normally, the median overall survival for this patient
03:28 is less than six to nine months.
03:31 These are patients that have been already treated
03:33 for glioma in the first instance,
03:36 and they've recurred.
03:37 That means that they failed the first standard of care,
03:41 that is surgery, radiotherapy, chemotherapy.
03:44 And so there are very little therapeutic options
03:47 for these patients.
03:48 There are some experimental treatments,
03:51 but none of them has really shown improvement
03:54 in the overall survival.
03:56 And we have just recently reported instead some data
04:00 that really make us believe that CAN 3110
04:03 is an option for this treatment
04:05 for this patient population.
04:07 - And then Francesca,
04:08 can we dive a little more into recent data
04:10 from the CAN 3110 phase one trial published in Nature
04:14 in the significance?
04:15 - Yeah, these are the data that I was alluding to before.
04:18 In this publication in Nature in October,
04:22 we have reported the FAST,
04:25 the data on the FAST cohort of patient treated.
04:28 So we have 50 patients that have been treated
04:30 with a single dose of CAN 3110,
04:33 and we've achieved the median overall survival
04:35 of 12 months in this patient population
04:38 that is almost doubling the expected median
04:41 overall survival for patients with recurrent high-grade glioma.
04:44 What is very exciting is that when we started to look
04:47 at factors associated with survival,
04:50 we detected that patient that had pre-existent immunity
04:53 against HSV1, that is the type of virus
04:57 that CAN 3110 has been modified from,
05:00 have actually even increased the survival advantage.
05:05 And this means that the pre-existent immunity
05:08 against the virus supports the anti-tumor response.
05:13 And so in this patient,
05:15 we've achieved a median overall survival
05:16 of almost 14 months.
05:19 The patient that had this pre-existent immunity
05:21 were the one that mounted even a stronger
05:24 immune response after treatment.
05:27 And so they were the one that were able
05:29 to expand their T-cell repertoire and T-cell activity,
05:34 cytotoxic activity against the tumor cells.
05:37 - And Francesco, you recently received
05:39 FDA FASTRAC designation for recurrent high-grade glioma.
05:43 What does this designation mean for Kandel,
05:45 and what can we expect results from your phase 1B trial?
05:50 - So this has been a very important recognition
05:52 for us and for the program.
05:54 FASTRAC designation is a recognition from the FDA
05:58 that the program has value and the program is recognized
06:03 to be evaluated in a slightly different way.
06:06 So we have some advantages in terms of being,
06:10 undergoing a faster review for the data.
06:13 And so the FDA is a statement of a really close collaboration
06:17 between the company and the FDA to speed up
06:20 the process of development for encouraging
06:24 investigational agents like CAN3110.
06:28 For us, it's extremely important,
06:30 this support in the next phase of development.
06:32 At the moment, we are testing CAN3110
06:35 in multiple injections cohort.
06:38 The data that I mentioned to you before
06:41 about the pre-existing immunity to HSV1
06:44 is not just in patient that had these antibodies
06:47 to start with, but also in patient that were able
06:50 to acquire antiviral antibodies after the first injection.
06:54 And this makes us really believe that
06:56 if we give multiple injection of CAN3110,
07:00 we can potentiate the response against the virus
07:03 and therefore against the tumor itself.
07:06 So we are very excited about the possibility
07:08 of exploring this in the current open cohort.
07:12 And we have planned to disclose data
07:15 on this multiple injection cohort
07:17 in the second half of 2024.
07:20 - Beautiful.
07:20 Well, outside of what you just outlined,
07:23 what is next for CAN3110?
07:26 - Oh, we are very excited about actually
07:27 the next phases of development of this agent.
07:30 What I told you before is that we've modified this virus
07:34 to be responding to a specific protein
07:38 that is inside the tumor cells.
07:40 And this is not just present
07:42 in recurrent high-grade glioma cells, it's called nesting.
07:46 And it's a protein that is expressed
07:48 in other type of tumors, very aggressive tumors,
07:51 like melanoma, for example,
07:53 or triple negative breast cancer or sarcoma.
07:56 So we now want to test the CAN3110 in this other indication.
08:00 We're gonna do some preclinical work, some safety work,
08:04 and then we're gonna be very excited to test this
08:06 in this new indications.
08:10 - Well, Francesca, thank you so much.
08:12 It's been a pleasure to learn more
08:13 about Candle Therapeutics and CAN3110.
08:17 Again, Candle Therapeutics is trading
08:19 on the NASDAQ ticker CADL.
08:22 Thank you again, Francesca.
08:23 - Thank you so much for having me.
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