Currency in USD
Last close As at 27/03/2023
USD0.66
▲ −0.03 (−4.35%)
Market capitalisation
USD11m
Research: Healthcare
Context Therapeutics has signed a manufacturing agreement with Lonza to develop CTIM-76 (active ingredient and final product form), its bispecific antibody clinical candidate for claudin 6 (CLDN6)-positive cancers. The collaboration marks a crucial step required to progress CTIM-76 towards the clinic. As a reminder, in December 2022, Context announced the selection of CTIM-76 as its CLDN6 clinical candidate (co-developed with partner Integral Molecular) and is currently undertaking investigative new drug (IND)-enabling studies with the goal of submitting the IND application in Q124.
Context Therapeutics |
Manufacturing agreement with Lonza for CTIM-76 |
Manufacturing update |
Pharma and biotech |
10 January 2023 |
Share price performance Business description
Analysts
Context Therapeutics is a research client of Edison Investment Research Limited |
Context Therapeutics has signed a manufacturing agreement with Lonza to develop CTIM-76 (active ingredient and final product form), its bispecific antibody clinical candidate for claudin 6 (CLDN6)-positive cancers. The collaboration marks a crucial step required to progress CTIM-76 towards the clinic. As a reminder, in December 2022, Context announced the selection of CTIM-76 as its CLDN6 clinical candidate (co-developed with partner Integral Molecular) and is currently undertaking investigative new drug (IND)-enabling studies with the goal of submitting the IND application in Q124.
Year end |
Revenue |
PBT* ($m) |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(3.2) |
(9.28) |
0.0 |
N/A |
N/A |
12/21 |
0.0 |
(10.6) |
(3.74) |
0.0 |
N/A |
N/A |
12/22e |
0.0 |
(18.1) |
(1.13) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(27.4) |
(1.72) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As part of the agreement, Lonza will provide manufacturability assessment, gene and cell line construction and process development for CTIM-76. The drug substance (active ingredient) will be manufactured at Lonza’s Slough, UK, site and the final drug product will be manufactured at the company’s Stein and Visp sites in Switzerland. Due to their inherent complexity, the manufacturing of bispecific antibody drug candidates remains challenging, and we see the selection of Lonza as positive, given its expertise in manufacturing such complex proteins.
As a reminder, CLDN6, a protein coding gene and part of the claudin family of tight junction proteins, is a tumor-specific protein enriched in several malignant tumors – including ovarian, endometrial, sarcoma, gastric and testicular – but is rarely expressed in adult healthy tissue. However, development against this target has been hindered by challenges in accurate selectivity due to CLDN6’s structural complexity and similarity to other claudins such as CLDN9 and CLDN4, both of which are also expressed in healthy tissue.
In December 2022, Context Therapeutics announced the selection of CTIM-76 as its final clinical candidate for its second R&D program, a CLDN6xCD3 bispecific antibody. The company asserts that its CLDN6 candidate has superior selectivity and activity (over 1,000x selectivity for CLDN6 versus CLDN9 and 28x more potency than a competing bispecific T-cell engager, BiTE, in in-vitro studies). Partner Integral Molecular recently published a paper describing its process methodology for selecting CLDN6 antibodies with best-in-class selectivity and specificity versus clinical benchmarks. We see CTIM-76 as holding potential as a new class of therapeutics, contingent on successful clinical progression.
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Research: Metals & Mining
This week, KEFI Gold and Copper (KEFI) released two updates pertaining to its exploration and development in Saudi Arabia. First, it announced an increase in the mineral resource estimate (MRE) and indicated resource at the Hawiah project. The MRE increased by 16%, boasting an additional 4.1Mt and generating a new total of 29.0Mt, with the indicated resource up 14% from 10.9Mt to 12.4Mt, inclusive of oxide material (previously inferred) containing 80,000oz of gold. Second, KEFI announced the award of five additional exploration licences via its Gold and Minerals (GMCO) joint venture in Saudi Arabia, which has since started comprehensive mapping and sampling campaigns over these new licences.
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