On August 22, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy (Press release, Clarity Pharmaceuticals, AUG 22, 2024, View Source [SID1234646029]).

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The FDA’s Fast Track Designation is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For 64Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a potentially faster review process once Clarity submits its product approval application. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Receiving Fast Track Designation for 64Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product. The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic."

Clarity’s ongoing clinical program with 64Cu-SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence (BCR) of their disease. The completed Phase I PROPELLER study demonstrated favourable safety and efficacy results in patients with prostate cancer prior to radical prostatectomy. Driven by the compelling findings from the PROPELLER study, Clarity commenced a registrational Phase III trial in this patient population, CLARIFY, where recruitment is ongoing. In parallel, the Phase I/II trial, COBRA, 64Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer lesions in patients with BCR. Based on the results from the COBRA study, Clarity commenced planning of a second registrational Phase III imaging trial. The Fast Track Designation is supported by the initial clinical evidence suggesting that 64Cu-SAR-bisPSMA may offer improved lesion detection compared to existing prostate cancer diagnostics.

"We believe that 64Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis. Due to its dual targeting structure, bisPSMA, and the longer half-life of copper-64, enabling next-day imaging, this unique product has shown higher tumour uptake and retention and exhibited a capability of detecting much smaller lesions. The longer half-life of the isotope also translates into a longer shelf-life than currently used diagnostic radiopharmaceuticals, allowing for centralised manufacture and wider distribution, while also supporting flexible patient scheduling. These features are not available with gallium-68 and fluorine-18 based diagnostics. Clarity is committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management.

"This designation highlights the potential of 64Cu-SAR-bisPSMA to provide a novel diagnostic option for patients with prostate cancer and address the limitations of the current-generation diagnostic radiopharmaceuticals," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) Technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR Technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the U.S. FDA. A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

On August 22, 2024 Bridge Biotherapeutics ("Bridge", KQ288330), a clinical-stage biotech company, reported that it has entered into a joint research agreement with HitGen Inc. ("HitGen", SSE: 688222.SH), a Chinese drug discovery platform company (Press release, Bridge Biotherapeutics, AUG 22, 2024, View Source [SID1234646063]). This collaboration builds on successful initial hit finding and identification work from HitGen’s DNA-encoded library (DEL), aiming to further develop the novel hits as promising drug candidates for cancer.

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Bridge plans to strengthen its existing oncology portfolio, which is centered on EGFR inhibitors for lung cancer treatment, through new anticancer drug candidates targeting undisclosed targets. Over the past year, the company has established its own analytical methods through preliminary research to discover new targeted anticancer drugs that are expected to show high anticancer effects across various cancer types. With the launch of this joint research with HitGen, it is anticipated that the derivation of effective substances, optimization, and securing of lead compounds will progress rapidly within the next year.

HitGen is a world leader in the development of DEL technology and applications to early-stage small molecule drug discovery. Its platform includes over 1.2 trillion small molecules generated by the DEL technology, and the efficiency of the screening process has made it possible for HitGen to enable drug discovery projects for many organizations around the world. The company has made tremendous improvements over the last few years, making it an integrated drug discovery company focusing on DEL, synthetic therapeutic oligonucleotide (STO), targeted protein degradation (TPD), fragment-based drug discovery and structure-based drug design (FBDD/SBDD).

James Lee, CEO of Bridge Biotherapeutics stated, "By collaborating with HitGen, we will accelerate the discovery of new targeted anticancer drugs." He added, "We will challenge ourselves to develop drugs that can provide anticancer treatment effects even for genetically mutated cancers, which have been difficult to develop until now."

Dr. Jin Li, Chairman of the Board and CEO of HitGen Inc., expressed, " We are pleased to collaborate with Bridge Biotherapeutics team in generating novel drug candidates based on the screening platform we possess," and stated, "We will contribute to the acceleration of new anticancer drug discovery based on the expertise of both companies."

Bridge Biotherapeutics has initiated the fourth cohort in the Phase 1 clinical trial for its leading candidate drug BBT-207 for the treatment of non-small cell lung cancer. Through this collaboration with HitGen, the company is embarking on the discovery of new anticancer drugs as part of its efforts to strengthen its cancer portfolio.

On August 22, 2024 Medivir reported financial summary for the quarter ended June 30, 2024 (Press release, Medivir, AUG 22, 2024, View Source;interim-report-january–june-2024-302228384.html [SID1234646064]).

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Net turnover amounted to SEK 1.1 (2.0) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.7 (-26.3) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.47).
Cash flow from operating activities amounted to SEK -26.3 (-17.9) million.
Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million.
Significant events during the quarter

In April it was announced that Medivir’s partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701.
In April it was announced that Medivir completed a so-called Type C meeting with the FDA and that the company’s preparations for the planned phase 2b study in the fostrox program are progressing according to plan, with a few adjustments in study design that have limited impact on timeline and study size.
In April, MIV-711 was granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes Disease (LCPD), an unusual hip disease that affects children between the ages 2 and 12.
The AGM in May re-elected board members Uli Hacksell, Lennart Hansson, Bengt Westermark and Yilmaz Mahshid, and elected Angelica Loskog and Anna Törner as new board members. Uli Hacksell was re-elected as Chairman of the Board.
In June it was announced that Medivir has selected a global CRO partner for the planned phase 2b study evaluating fostrox+ Lenvima compared to Lenvima alone in second-line liver cancer/hepatocellular cancer (HCC).
On June 26 new positive data showing further improved effect with longer time to progression in Medivir’s ongoing phase 1b/2a trial of fostrox + Lenvima in advanced HCC, were presented at the ESMO (Free ESMO Whitepaper) GI Cancer Congress in Munich.
January – June
Financial summary for the period

Net turnover amounted to SEK 1.6 (2.4) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -63.3 (-45.2) million. Basic and diluted earnings per share amounted to SEK -0.55 (-0.81).
Cash flow from operating activities amounted to SEK -61.3 (-34.1) million.
Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million.
Events after the end of the period

In July it was announced that Medivir will present updated clinical data from the phase 1b/2a study with fostrox in advanced HCC, at the ESMO (Free ESMO Whitepaper) Cancer Congress in Barcelona in September
Conference call for investors, analysts and the media

The Interim Report January – June 2024 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Thursday, August 22, 2024, at 14.00 (CET).

To access the webcast and find information about the teleconference, please klick HERE!

The conference call will also be streamed via a link on the website: www.medivir.com/investors/calendar.

The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message

Medivir is working decisively to ensure that the combination of fostrox and Lenvima becomes the first approved treatment alternative after first line standard-of-care in advanced liver cancer. At the ESMO (Free ESMO Whitepaper)-GI congress in Munich in June, we presented new data from the ongoing phase 1b/2a study. These data indicate that fostrox + Lenvima provides a substantially better effect than previously shown in second-line liver cancer treatment, which generated significant positive attention, both from analysts and clinical experts.

Our ongoing phase 1b/2a study with fostrox + Lenvima continues to show increasingly promising data and we see the opportunity to become the first approved medical treatment in a market worth ~$2.5 billion annually.

The data presented at the ESMO (Free ESMO Whitepaper)-GI congress in Munich at the end of June showed good tolerability during longer treatment and that the clinical effect has continued to improve. The Objective Response Rate (ORR) was 24%, higher than the 5–10% ORR seen in other published studies in second-line HCC. The estimated median time to progression at the time of ESMO (Free ESMO Whitepaper)-GI was 10.8 months, which is substantially better than what’s been shown in other studies in second-line HCC. It is tremendously encouraging that the patient in the study who has benefited the longest is still responding to treatment after 2 years.

We now look forward to presenting detailed and mature data highlighting the combination’s clinical value in second-line liver cancer at the ESMO (Free ESMO Whitepaper) Congress in Barcelona in mid-September.

The strong and continuously improving data strengthen our belief in the combination’s potential as the first approved treatment option in second-line liver cancer. Preparations for our planned phase 2b study continue based on the feedback we received at our Type C meeting with the FDA.

For the phase 2b study, we have recently chosen a CRO partner with a global presence and a strong track record in oncology studies and in particular HCC studies. We are now initiating the next study phase to identify investigators and hospitals for the study and to complete the study protocol. This will lead us to opening an IND in the US, which is expected to take place in H2 2024.

Regarding the projects out-licensed to collaborators, our partner Vetbiolix, a veterinary biotechnology company based in France, was in April able to report positive results from a clinical Proof-of-Concept study in periodontitis (tooth loss) in dogs with its candidate drug VBX-1000 (MIV-701), which was out-licensed to Vetbiolix in 2019. Vetbiolix is now preparing to evaluate VBX-1000 in a phase 2/3 study in dogs. Tooth loss is an immense problem for dogs and today there is no approved treatment. Vetbiolix estimates that the global market for oral care in pets amounts to approximately SEK 3 billion.

Our project for partnership MIV-711 received Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease from the FDA. It creates new opportunities for collaborations and future income.

At the annual general meeting, our board of directors was strengthened with two new members, Angelica Loskog and Anna Törner. Their competence and experience will contribute strongly to Medivir’s success, where the clinical development of fostrox is our focus.

We are convinced of the potential of fostrox to become a valuable treatment option that makes a real difference to patients with liver cancer. There is a clear need and an obvious place for fostrox in the treatment landscape. Our goal is to become the first approved treatment alternative in second-line for patients with primary liver cancer. I look forward to keeping you informed of Medivir’s continued development.

On August 22, 2024 I Peace, a pioneering CDMO in induced pluripotent stem (iPS) cells, and iCamuno Biotherapeutics, a biotech company developing iPS cell-based therapies, reported a significant milestone with the dosing of the first patient in a clinical trial using iPS cell-derived natural killer (iNK) cells for ovarian cancer immunotherapy (Press release, iCamuno Biotherapeutics, AUG 22, 2024, View Source [SID1234646065]). iCamuno will lead the trial, which will test the safety and efficacy of NK cells made from I Peace’s cGMP-compliant iPS cells using iCamuno’s NK cell differentiation technology.

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Natural killer (NK) cells are a critical component of the anti-cancer immune system, with natural abilities to recognize and destroy tumor cells. This trial leverages iCamuno’s abilities to create cGMP-grade iPS cell-derived NK cells with improved consistency and effector function. The initial phase will focus on ovarian cancer, with potential expansion to a broader range of diseases.

"We are thrilled to reach this moment," said Koji Tanabe, CEO and founder at I Peace. "Dosing the first patient in this trial using our iPS cell line is a significant milestone in our goal to develop innovative immunotherapies for cancer."

"This is an important milestone for iCamuno," said Ethan Liu, Chairman and co-founder of iCamuno. "Given their safety and efficacy in preclinical testing, we are hopeful that our iNK cells will be a valuable weapon in the battle against ovarian cancer."

On August 22, 2024 ImmuneOnco Biopharmaceuticals reported on a voluntary basis to inform shareholders and potential investors of the Company about the latest business development of the Group (Press release, ImmuneOnco Biopharma, AUG 22, 2024, View Source [SID1234655702]).

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Reference is made to the announcement of the Company dated August 1, 2024, in relation to the entry into a license and collaboration agreement (the "License and Collaboration Agreement") dated August 1, 2024, between the Company and SynBioTx Inc.("SynBioTx").

The board (the "Board") of directors ("Directors", and each a "Director") of the Company is pleased to announce that the Company has received an upfront payment of US$10 million from SynBioTx in line with the License and Collaboration Agreement. Pursuant to the License and Collaboration Agreement, the Company expects to receive potential nearterm payments of up to US$40 million in the future, the earliest of which is expected to be received in September of 2024. Furthermore, the Company and SynBioTx have established a joint Clinical Development & Operations Committee and will actively advance the development of the IMM2510 and IMM27M.

ABOUT IMM2510
IMM2510, independently developed by the Group, is a bispecific molecule with a mAbTrap structure targeting vascular endothelial growth factor (VEGF) and programmed cell death ligand 1 (PD-L1). IMM2510 can inhibit angiogenesis, leading to tumor shrinkage, and sensitize tumor cells to immune responses, while activating T cells, NK cells, and macrophages via the blockade of PD-L1/programmed cell death protein 1 (PD-1) interaction and the induction of Fc-mediated antibody-dependent cellular cytotoxicity (ADCC)/antibody-dependent cellular phagocytosis (ADCP) activity.

ABOUT IMM27M
IMM27M is a new generation cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)antibody with enhanced ADCC activity. It can induce potent immune responses targeting CTLA-4 overexpressed immune-suppressive Treg cells and promote Treg depletion from the tumor microenvironment (TME), thus enhancing T-cell antitumor response.