Clovis Oncology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On February 23, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report fourth quarter and full year 2021 financial results and provide a corporate update before market open on Wednesday, March 2, 2022 (Press release, Jounce Therapeutics, FEB 23, 2022, View Source [SID1234608884]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

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Conference Call and Webcast

To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 8998936. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On February 23, 2022 LIDDS AB reported that LIDDS AB (publ) Year-end report 2021 (Press release, Lidds, FEB 23, 2022, View Source [SID1234608901])

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October – December

Net sales amounted to 2.4 (0.3) MSEK
The operating result for the period was -8.9 (-12.5) MSEK
The net result was -8.9 (-12.5) MSEK corresponding to earnings per share of SEK -0.26 (-0.42)
Cash flow from operating activities amounted to -9.9 (-10.1) MSEK
Cash and cash equivalents amounted to 34.0 (36.1) MSEK
January – December

Net sales amounted to 3.6 (0.3) MSEK
The operating result for the period was -37.3 (-32.3) MSEK
The net result was -37.3 (-32.3) MSEK corresponding to earnings per share of SEK -1.16 (-1.20)
Cash flow from operating activities amounted to -42.6 (-27.4) MSEK
Significant events during 2021

An R&D agreement was signed with Johnson & Johnson Enterprise Innovation Inc (J&J) with an exclusive option for J&J to sign a global license agreement.
LIDDS’ Chinese partner Puheng Pharma announced that an international multi-center study is requested in phase III for a market approval of Liproca Depot in China.
A directed share issue was carried out, bringing proceeds of 45 MSEK before issue costs to the company.
The dose escalating Phase I study for treatment with NanoZolid formulated docetaxel of solid tumors was closed. Data showed that the combination is safe and well tolerated.
Significant events after the reporting period

The R&D project with J&J has moved into the next phase.
A financing agreement of up to 40.8 MSEK signed with Nice&Green
CEO comment

Lately, we have been making great progress in our projects. LIDDS has been able to report topline results from the NanoZolid formulated docetaxel (nanodotax) project. The results show that the systemic exposure of docetaxel after treating solid tumors with nanodotax is low and that activity in both injected lesions and in systemic inflammatory markers was observed. We are pleased to see that the treatment is safe and well tolerated and that the reported adverse events are generally mild and local. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors. We intend to submit data from the study for publication in a scientific journal. Based on the unexpected immunological findings in the phase I study it is important to further investigate the treatment mechanism of NanoZolid formulated docetaxel. We plan to do so in the study approved by the Swedish Medical Product Agency (MPA) in May last year investigating docetaxel in prostate cancer patients preoperatively.

We have also reached a key milestone in January 2022 when the R&D project with Johnson & Johnson Enterprise Innovation Inc. progressed into next phase. The aim is to develop an oncology product based on the NanoZolid technology for an undisclosed indication. We are very proud of this collaboration which is also increasing our know-how and experience on both sides. The project has now entered stage 2 of the feasibility program.

An important regulatory milestone achieved is the scientific advice given by the European Medicines Agency (EMA) on our Liproca Depot phase III study protocol. Overall, EMA agreed with our proposed study design including most importantly the primary endpoint being time to progression and to the suggested number of patients. The scientific advice given by EMA is a key regulatory validation of our clinical plans.

In parallel to moving our clinical projects forward, we have continued to set a new direction for the company strategically. Our projects must meet certain requirements to be included in our project pipeline. Projects must have a clear benefit regarding efficacy and safety while simultaneously being able to meet certain commercial requirements. It may seem obvious, but those criteria have been the guiding stars in the strategic revisit of our portfolio meaning that we have decided to focus on the most promising projects. We have also renamed our projects in development. We are eager to give a detailed presentation of our new strategy, vision, and update on our project portfolio on our upcoming Capital Market Day on the 9th of March 2022. Don’t miss it.

The efforts on making the move to Nasdaq’s main market are continuing. A part of that process, but also as a part of visualizing that LIDDS is taking the next phase in its development, has been to develop a new graphic look and content impacting on both the Year-end report and our website. Our new website will be launched shortly. Please visit www.liddspharma.com for further information.

We are also happy to welcome Matthew Lindon as Chief Scientific Officer from March 1. Matthew has over 20 years’ experience of drug discovery and development from the pharmaceutical sector and will be an important asset when developing LIDDS project portfolio. It is also with great pleasure we can announce that LIDDS has recruited a new Project Manager in Charlotta Grånäs Folkesson. Charlotta has a background as a Project Manager at biotechnology companies such as BioImage A/S and Vipergen ApS and as a scientist at the pharmaceutical company Novo Nordisk A/S in Denmark.

The team that will realize LIDDS vision of becoming a global drug delivery company are starting to come together. LIDDS will, through a small, efficient, and highly specialized organization, continue to focus on developing better and safer treatments with a high value. We started this year with a lot of progress and my colleagues, and I are looking forward to an eventful 2022.

This information is information that the company is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the aforementioned contact persons, on February 23, 2022 at 17.30 CET.

On February 23, 2022 Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), a Taiwan and US-based biopharmaceutical company and TRPharm, a leading Turkish healthcare company, reported that they have entered into an exclusive license agreement for the co-development and commercialisation in Turkey and certain MENA countries of Foresee’s FP-045 program, an oral allosteric Aldehyde Dehydrogenase 2 (ALDH2) activator for the treatment of Fanconi Anemia and other rare and severe diseases (Press release, Foresee Pharmaceuticals, FEB 23, 2022, View Source [SID1234608918]). Under the terms of this partnership, Foresee and TRPharm will collaborate to initially expedite the development of FP-045 in Fanconi Anemia. Turkey and the surrounding region has a high prevalence Fanconi Anemia as well as other rare diseases. Foresee will own all development data which will be used as part of its global development and registration dossier. Upon approval and commercialization in the territory, Foresee will receive significant royalties from the revenue in the territory. TRPharm will have exclusive rights to register and commercialize in the territory and will cover all related costs.

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Dr. Ben Chien, Founder, Chairman and CEO of Foresee commented: "We are very pleased to have established this collaboration with TRPharm, whose established track record of successful development, registrations and launches of rare disease products, including in hematology, makes us confident that they will make a remarkable partner for our FP-045 program. This is our second partnership with TRPharm and we look forward to continuing working together."

İsmet Ince, General Manager of TRPharm, commented "Our purpose in TRPharm is to be the platform where health meets innovative solutions and I can think of no better example for it than this collaboration on FP-045 with Foresee. We are thrilled to have this opportunity to blaze a trail in Fanconi Anemia, which has a particularly high prevalence in our core regions, and provide relief to the patients with significant unmet need. It is an even greater pleasure to be doing this with Foresee, an esteemed international biopharmaceutical company with whom we share common views and a history of productive partnership. This collaboration also marks a step change in our R&D approach and is the culmination of a unique set of capabilities which we have developed over many years. We are confident that they will contribute materially to making this collaboration a rapid success."

On February 23, 2022 The Life Raft Group reported that we continue highlighting recent clinical trials that are still recruiting in the U.S. which investigate potential treatments for GIST patients (Press release, The Life Raft Group, FEB 23, 2022, View Source [SID1234609028]). Our GIST Trials Database lists over 70 trials that are GIST-related and ongoing around the world . Currently there are 12 GIST-related trials recruiting in the United States. In our last article, we listed several for different types of GIST mutations. You can read the previous clinical trials update (December 2021) here:
View Source

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For further information about GIST trials including international trials, visit: The Life Raft Group Clinical Trials Website: View Source If you want to speak with someone about clinical trials, please contact [email protected].

For patients with advanced KIT/PDGFRa mutant GIST:

THE-630 Phase 1/2 – ""A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)" (View Source)

Site is at Dana-Farber Boston, MA Principal Investigator Suzanne George. Started January 3, 2022. The study will be conducted in two parts: a dose escalation phase, followed by an expansion phase. Plans to recruit 160 over a period of 42 months.

In the Phase 1 dose escalation phase oral THE-630 will be administered once daily in a continuous regimen. Primary objectives during the 28-day dose escalation phase are: 1. Number of patients with dose-limiting toxicities. 2. Determination of the recommended Phase 2 dose. 3. Determination of the maximum tolerable dose. 4. Safety analysis – number of participants with treatment emergent adverse events. For the subsequent expansion Phase 2 the primary objective is confirmed Objective Response Rate over a period of up to 24 months after first dose. In the escalation Phase 1 participants with metastatic or unresectable GIST will be admitted.

During the Expansion Phase 2 unresectable or metastatic GIST patients will be divided into 4 cohorts depending on prior TKI therapy. Cohort 4 will include patients who have progressed on or are intolerant to imatinib including patients in the adjuvant setting. The sponsor is Theseus Pharmaceuticals headquartered in Cambridge, MA. Theseus was founded in 2017 and emerged from stealth mode in 2021. On their web page Theseus describes THE-630 as "Our lead program, THE-630, is a pan-variant KIT inhibitor designed for patients with advanced gastrointestinal stromal tumors (GIST) whose cancer has developed resistance to earlier lines of kinase inhibitor therapy." Patients interested in this clinical trial can contact: Theseus Pharmaceuticals, 857-400-9491, [email protected]. NCT05160168

About Phase 1 trials: It is important to recognize that Phase I studies are held to find the highest dose
of the new treatment that can be given safely without causing severe side effects.

• The first few people in the study get a very low dose of the treatment and are watched very closely. If there are only minor side effects, the next feaw participants get a higher dose. This process continues until doctors find a dose that’s most likely to be and effective treatment while having an acceptable level of side effects.

• Safety is the main concern. The research team monitors participants and watches for severe side effects. Due to the small numbers of people in Phase I studies, rare side effects may not be seen until later phases of the trial when more people are receiving the treatment.

• While some people may benefit from being on one, disease response is not the main purpose of a Phase I trial.

Phase I trials carry the most potential risk, but these studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join Phase I trials when all other treatment options have already been tried.