On january 11, 2021 CellCentric reported that it has developed the first p300/CBP inhibitor of its kind, to treat targeted types of cancer (Press release, CellCentric, JAN 11, 2021, View Source [SID1234574002]). Today’s cornerstone Cancer Discovery publication summarises CCS1477 and its translational data, mapping the drug’s mechanism of action through to specific biological effects seen in late-stage prostate cancer patients. CCS1477 represents a new way to tackle large and clear clinical unmet needs; for prostate cancer patients whose tumour has progressed despite existing therapeutic options, including enzalutamide or abiraterone; for patients with haematological malignancies, including acute myeloid leukaemia, multiple myeloma and non-Hodgkin’s lymphoma; and for other molecularly targeted tumours.
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CCS1477 is an oral small molecule drug, formulated in a capsule. Its mechanism of action is defined by its binding to the common bromodomain of cancer gene regulators, p300 and CBP. The prostate clinical programme has been led by Professor Johann de Bono, Regius Professor of Cancer Medicine at The Institute of Cancer Research, London, and Clinical Consultant at The Royal Marsden NHS Foundation Trust. Phase I drug safety and dose finding studies are nearly complete, with the drug now entering Phase II expansion and combination studies.

It is known that tumour cells in late stage, drug resistant, prostate cancer are driven by signalling through the androgen receptor (AR). Over time the AR adapts to create versions that still signal cell growth but are no longer responsive to existing treatments which target the AR. CCS1477 binds to twin proteins p300 and CBP and impacts not only the parent AR, but also its adaptations, mutations as well as splice variants (AR-SV). Inhibiting p300/CBP affects other key cancer drivers including c-Myc, which also plays a key role in prostate cancer progression.

In the paper published online today in Cancer Discovery, data is presented that shows the impact of CCS1477 on AR, AR-SV and c-Myc in a range of pre-clinical models. Additionally, biological impact is reported in tumour samples taken from patients dosed with CellCentric’s first-in-class drug. Overall, CCS1477 shows promise for the treatment of patients with advanced prostate cancer. Clinical trials are now continuing to evaluate CCS1477 as a monotherapy, but also in combination with existing drugs, enzalutamide and abiraterone. Recent published data supports the use of p300/CBP inhibitors to re-sensitise tumours to existing second generation anti-hormonal agents.

Professor Johann de Bono commented ‘Having an agent that targets both AR and its adaptions has been the desire of prostate cancer clinicians for many years. These encouraging mechanistic data, with preliminary evidence of effects in patients, places CellCentric’s CCS1477 well for further evaluation with a clear patient need’.

Dr Will West, CEO of CellCentric, added ‘From our foundation in epigenetic research, to publishing translational research for our first of its kind drug, it has been an incredible team effort. It has been great to work so closely and openly with The Institute of Cancer Research and The Royal Marsden, but also to the many other clinical centres now testing our drug across the UK.’

CCS1477 is also being evaluated in patients with blood cancers, including multiple myeloma, AML and lymphomas. Additionally, the compound is being assessed in patients who have tumours with a p300 or CBP genetic mutation, as well as those which are AR+ or over-express Myc. Cancer types here include bladder, breast and small cell lung cancers.

On January 11, 2021 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported the successful completion of the previously announced global offering of 6,900,000 shares (New Shares) (including 6,750,000 shares delivered in the form of 1,125,000 American Depositary Shares, or ADSs) on the Nadaq Capital Market at a price of approximately CHF1.47 per share or $10.00 per ADS, including the full exercise of the underwriter’s option to purchase additional securities. Each ADS represents the right to receive six shares of Addex (Press release, Addex Therapeutics, JAN 11, 2021, View Source [SID1234573912]). The aggregate gross proceeds from the offering are $11.5 million, before deducting the underwriting discounts and commissions and offering expenses payable by Addex.

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Addex intends to use the net proceeds from the global offering, together with cash on hand, mainly to advance development of its portfolio of proprietary drug candidates based on its allosteric modulator development capabilities. These include dipraglurant, an mGlu5 negative allosteric modulator, for use in Parkinson’s disease and dystonia, and its preclinical pipeline.

H.C. Wainwright & Co. acted as sole book-running manager for the offering.

The New Shares are expected to begin trading on the SIX Swiss Exchange on January 12, 2021.

The shares, which are to be settled primarily in the form of ADSs, were offered and sold pursuant to the Company’s previously filed registration statement on Form F-1 (File No. 333-251322), as amended, with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on January 6, 2021. The offering has been made by means of a prospectus. An electronic copy of the final prospectus may be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at [email protected] or on the SEC’s website at SEC.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Addex Therapeutics Ltd in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA"). Neither this document nor any other offering or marketing material relating to these securities, such as the shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the shares may be publicly distributed or otherwise made publicly available in Switzerland.

On January 11, 2021 Ultraviolet radiation can cause a rare type of eye cancer, conjunctival melanoma, according to research funded by Cancer Research UK and others* and published** in Nature Communications today (Monday) (Press release, Cancer Research UK, JAN 11, 2021, View Source [SID1234573894]).

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UV radiation is known to be the key environmental cause of melanoma of the skin, but its role in the development of rarer forms of melanoma in the eye was not known.

This new study has revealed strikingly similar genetic changes in conjunctival melanoma to that of cutaneous (skin) melanoma caused by ultraviolet (UV) radiation.

The team behind today’s findings suggest that treatments used for skin melanoma may also benefit people with this rare form of eye cancer.

The researchers, led by Professor Richard Marais at the Cancer Research UK Manchester Institute, used whole genome sequencing to examine the genetic makeup of melanomas that develop on the conjunctiva, the specialised membrane that covers the front of the eye, to better understand what causes this particular melanoma subtype.

Surprisingly, the researchers found similar genetic changes in tissue samples from people with conjunctival melanoma to the genetic changes that occur in melanoma of the skin attributed to UV radiation.

They showed that people with conjunctival melanoma driven by UV radiation have mutations in the BRAF and RAS genes, which are often seen in skin melanoma. These findings complement a similar study showing that another type of rare type of melanoma of the eye called uveal melanoma***, which develops in the iris, can also be caused by UV radiation.

These two studies suggest that people with particular forms of eye cancer could benefit from treatments that are currently used for skin melanoma, including those which target BRAF mutations, but not yet approved for melanoma of the eye. Those drugs could, if proven to benefit these patients, be given based on the genetics of the tumour, rather than their location in the body.

Professor Richard Marais, based at the Cancer Research UK Manchester Institute and lead author of the study, said: "Our work shows the importance of delving into the underlying biology in rare cancers, which could identify new tailored treatment avenues for people. In this case we have identified mutations in a rare type of eye cancer that could be targeted by drugs used to treat skin cancer."

Now, ongoing work will need to explore if BRAF-targeted therapies, or other immunotherapies used for skin melanoma, could benefit people with conjunctival melanoma.

Professor Marais said: "By showing that UV radiation can cause conjunctival melanoma, we have added to our understanding of the known dangers of the sun for our eyes. It reminds us of the importance of protecting not just your skin, but also your eyes from UV light, be it in everyday life, or where the UV radiation is particularly high and causes the most damage such as on the beach, on a boat, on a mountain."

Karis Betts, Cancer Research UK’s health information manager, said: "This research adds to the picture of what we know about UV radiation leading to genetic changes that cause melanoma. Including this evidence for certain cancers of the eye it gives us even more reason for staying safe in the sun and the need for fully UV protective sunglasses****."

Michelle Mitchell, chief executive at Cancer Research UK, said: "Almost 20 years ago, BRAF was identified as a cancer-causing gene by a group that included Professor Marais and his Cancer Research UK-funded team. This ground-breaking discovery led to the development of drugs that block BRAF, including vemurafenib, and have been used to successfully treat many people with skin melanoma.

"This study is a classic example of how understanding the fundamental biology of a more common cancer can be used to help people with rarer diseases that can be more difficult to study, and often have fewer treatment options."

On January 11, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will participate in the 39th annual J. P. Morgan Healthcare Conference. Johnson Lau, CEO and Board Chairman, and Daniel Lang, Senior Director, Corporate Development, will present a corporate overview at the conference (Press release, Athenex, JAN 11, 2021, View Source [SID1234573867]).

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When: Monday, January 11, 2021, at 8:40 AM ET

Where: Conference Virtual Session

A live audio webcast of the presentation and replay will be available in the "Events & Presentations" section of the Athenex website at View Source

On January 11, 2021 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported it has restructured a clinical development agreement with Cancer Research UK (CRUK), the world’s leading cancer charity, for its unique anti-FcγRIIB antibody, BI-1206 (Press release, BioInvent, JAN 11, 2021, View Source [SID1234573865]). In exchange for a one-time payment, the revised deal simplifies and reduces BioInvent’s obligations to CRUK, which provides BioInvent with more flexibility to carry out development and partnering activities with BI-1206. It follows BioInvent’s exclusive licensing agreement with CASI Pharmaceuticals for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau.

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CRUK conducted and funded a Phase I/IIa clinical trial to evaluate BI-1206 for the treatment of Non-Hodgkin Lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In parallel, BioInvent is conducting a Phase I/II trial of BI-1206 in combination with rituximab for the treatment of NHL. Given the overlap between the BioInvent and CRUK trials, CRUK decided to end the trial being conducted in the UK after the single-agent part of the study. As a result, both parties have also agreed to restructure their agreement concerning BI-1206.

The restructured agreement with CRUK releases BioInvent from obligations to pay development or commercial milestones to CRUK on BI-1206 and reduces the royalties due on net sales to low single digit levels. BioInvent will make a one-time payment of £2.5 million to CRUK.

"Our strengthened financial position gives BioInvent the means and flexibility to further advance our promising, unique anti-FcγRIIB antibody, BI-1206. By simplifying our obligations and licenses, we retain greater control and potential value from the broader development program for BI-1206 across a range of liquid and solid tumors. The data package from our UK trial added value to the clinical development of BI-1206 and I would like to thank the CRUK team for their support during the collaboration," says Martin Welschof, CEO of BioInvent.

BI-1206 is a novel mode-of-action, single inhibitory antibody that blocks the FcγRIIB receptor to unlock anti-cancer immunity in both liquid and solid tumors. BI-1206 is BioInvent’s lead drug candidate and is being investigated in a Phase I/II trial, in combination with anti-PD1 therapy Keytruda (pembrolizumab), in solid tumors, and in a Phase I/IIa trial in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL). Early results from the Phase I open label study in NHL are expected in early 2021.

BioInvent is building a broad pipeline of cancer therapies based on the productivity of its proprietary F.I.R.S.T technology platform and n-CoDeR antibody library. The first-in-class anti-TNFR2 antibody BI-1808 is BioInvent’s third program in clinical development for the treatment of solid tumors and cutaneous T-cell lymphoma and the oncolytic virus BT-001 is the fourth, also for solid tumors.