On June 23, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that held its annual general meeting ("AGM") at which the following principal resolutions were passed (Press release, Isofol Medical, JUN 23, 2021, View Source [SID1234584272]).

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Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability
The AGM resolved to adopt the income statements for the financial year 2020 as well as the balance sheets as of 31 December 2020, as set out in the annual report for the Company and the group. The members of the Board of Directors and the managing director were discharged from liability for the financial year 2020.

Allocation of profit or loss
The AGM resolved, in accordance with the Board of Directors’ proposal, that no dividend shall be paid for 2020 and that the results of the Company shall be carried forward.

Election of board members, auditors, fees to the Board of Directors and auditors
The AGM resolved, in accordance with the nomination committee’s proposal, that the number of members of the Board of Directors shall be eight without deputies and that the number of auditors shall be one registered accounting firm.

In accordance with the nomination committee’s proposal Lennart Jeansson was elected as new member of the Board of Directors and Alain Herrera, Anna Belfrage, Aram Mangasarian, Magnus Björsne, Paula Boultbee, Pär-Ola Mannefred and Robert Marchesani were re-elected as members of the Board of Directors, all for the period until the end of the next AGM. Pär-Ola Mannefred was re-elected as the chairman of the Board of Directors.

The audit firm KPMG AB was re-elected as auditor of the Company, with Jan Malm as auditor-in-charge, for the period until the end of the next AGM.

The AGM further resolved to, in accordance with the nomination committee’s proposal, that fees to the chairman of the board shall be paid with SEK 550,000, to members of the board who are not employed within the Company with SEK 250,000, to the chairman of the audit committee with SEK 75,000, to each of the other members of the audit committee with SEK 40,000, to the chairman of the remuneration committee with SEK 50,000 and to each of the other members of the remuneration committee with SEK 25,000.

The AGM further resolved, in accordance with the nomination committee’s proposal, that board members that board members (in addition to remuneration for expenses relating to travel and accommodation) domiciled in Europe, but outside the Nordic countries, shall receive a remuneration of SEK 7,500 per physical board meeting and board members domiciled in North America shall receive a remuneration of SEK 15,000 per physical board meeting.

The AGM further resolved, in accordance with the nomination committee’s proposal, that the remuneration to the auditor of the Company shall be paid in accordance with approved statement of costs.

Principles for the appointment of the nomination committee
The AGM resolved, in accordance with the nomination committee’s proposal, that the principles for appointment of a nomination committee as adopted at the annual general meeting 2020 and as presented in the convening notice would remain unchanged.

Approval of the Board of Directors’ remuneration report
The AGM resolved, in accordance with the proposal from the board of directors, to approve the remuneration report for the financial year 2020.

Amendment of the articles of association
The Board of Directors’ proposal to amend the articles of association did not achieve the required majority, hence, the proposal was not adopted by the AGM.

Authorisation for the Board of Directors to resolve on issues
The Board of Directors’ proposal regarding issue authorisation to the Board of Directors, did not achieve the required majority, hence, the proposal was not adopted by the AGM.

The information was submitted for publication, through the agency of the contact person set out above, at 18:10 CEST on June 23, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate that is developed to improve the efficiency of 5-FU based (folate-based) chemotherapy primary for advanced colorectal cancer. Arfolitixorin is currently being evaluated in a global phase III-study, AGENT. Arfolitixorin is the active end product of extensively used folate-based drugs and can potentially benefit all patients with advanced colorectal cancer, as arfolitixorin does not require metabolic activation to become effective.

On June 23, 2021 Orum Therapeutics, a biotech company pioneering the development of targeted protein degraders to treat cancer, reported the close of a $84 million Series B financing (Press release, Orum Therapeutics, JUN 23, 2021, View Source [SID1234584289]). This includes a previously announced $30 million financing and $54 million in new funds led by IMM Investment and joined by new investors (KDB Investment and Atinum, among others) and existing investors (Intervest and KB Investment, among others). Orum plans to use the proceeds to advance the Company’s lead therapeutic candidates into clinical trials, explore additional payload chemistries to develop additional payloads that modulate the ubiquitin pathway, and other general corporate purposes.

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Orum’s Antibody neoDegrader Conjugate (AnDC) platform is built on novel targeted protein degrader payloads combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class antibody drug conjugates (ADCs) for the treatment of cancer. The company has developed a new class of ADC payloads, called neoDegraders, to specifically degrade intracellular target proteins within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death.

"AnDCs leverage the strengths of both targeted protein degraders and ADCs while overcoming the limitations of each modality. Advances in ADC therapies have been hampered by a lack of diversity in payloads with a novel mechanism of action to inhibit tumor cell growth, and small molecule degraders do not possess tissue specificity," said Peter U. Park, Ph.D., Chief Scientific Officer of Orum Therapeutics. "The team at Orum has created a unique set of payloads that can target intracellular proteins for degradation. These first-in-class targeted ADC protein degraders have the potential to deliver precise and catalytic tumor-killing action to improve cancer treatment."

The lead therapeutic programs from Orum’s AnDC platform are ORM-5029 for the treatment of solid tumors and ORM-6151 for the treatment of hematological cancers. Each program employs a different antibody drug to specifically deliver Orum’s lead neoDegrader to tumor cells. The company plans to file Investigational New Drug (IND) applications for ORM-5029 and ORM-6151 in 2022 and 2023, respectively.

"We are grateful for the support of our new and returning investors as we continued to pursue our mission of developing new therapeutics to target ‘undruggable’ proteins and help patients with limited treatment options," said Sung Joo Lee, Ph.D., Founder and CEO of Orum Therapeutics. "We believe our AnDC platform overcomes the lack of diversity in ADC payloads and the limitations of current targeted protein degrader technologies. With encouraging preclinical data on our two lead therapeutic candidates, we are excited to use the proceeds to continue to advance our first-in-class tumor-directed targeted protein degraders into the clinic for the treatment of cancer."

On June 23, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported a comprehensive update on its discovery and clinical-stage pipeline at its 2021 virtual R&D Day (Press release, Jounce Therapeutics, JUN 23, 2021, View Source [SID1234584273]). Presentations will highlight Jounce’s productive discovery engine and platform, updates on its discovery pipeline, and progress on the clinical development of JTX-8064. In addition to presentations from Jounce management and scientific team members, key opinion leader and one of Jounce’s scientific founders, Robert Schreiber, Ph.D., Distinguished Professor of Pathology and Immunology at The Washington University School of Medicine, will discuss the scientific rationale for targeting myeloid cells and the therapeutic potential of re-programming macrophages through inhibition of LILRB2.

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"Jounce is at an exciting time in its life cycle and I am incredibly pleased to have the opportunity to share the latest developments on our discovery and clinical stage pipelines, while also sharing a look into our productive and validated Translational Science Platform. More specifically, we will discuss the monotherapy dose escalation status of our INNATE trial of JTX-8064. Thanks to a high level of investigator engagement and dedicated efforts from our team, the timing of expansion cohort initiations is now expected in the third quarter of this year," said Richard Murray, Ph.D., Chief Executive Officer and President of Jounce Therapeutics. "Our pipeline has been built to bring forward new biomarker-enabled immunotherapies to address the evolving unmet needs of cancer patients, whose tumors may be sensitive or resistant to today’s approved immunotherapies."

"One of the key attributes of Jounce’s approach to immuno-oncology is its expertise in developing molecules that target a diverse set of immune cell types within the tumor microenvironment. Through the work of our platform, we have a greater understanding of how immune suppressive macrophages and LILRB2 itself can serve as negative prognostic indicators in several tumor types," said Dmitri Wiederschain, Ph.D., Chief Scientific Officer of Jounce Therapeutics. "We believe that the LILRB family represents attractive immuno-oncology targets with the potential to improve upon and restore responsiveness to PD-(L)1 inhibitors. As such, we are pleased to announce that we are rapidly advancing two additional LILRB family programs through discovery, targeting LILRB1 and LILRB4."

R&D Day Presentation Highlights Include:

Utilization of Jounce’s Translational Science Platform to investigate the tumor microenvironment and identify cell type-specific targets with unique biology
Overview of differentiated biomarker approach from discovery through development
Introduction of new discovery programs focused on additional LILRB family members, including LILRB1 and LILRB4
Update on monotherapy dose escalation and receptor occupancy from the INNATE clinical trial of JTX-8064
Announcement of timing of INNATE clinical trial monotherapy and pimivalimab combination expansion cohort initiation, expected in the third quarter of 2021
Update on continued progress on Jounce’s first biomarker patient selection study, SELECT
Anticipated Milestones:

JTX-8064 (INNATE):
Establish recommended Phase 2 dose
Initiate tumor-specific monotherapy and pimivalimab combination expansion cohorts beginning in the third quarter of 2021
Vopratelimab (SELECT):
Patient enrollment to support clinical data in 2022
Continue to advance multiple new targets through discovery pipeline with goal of an investigational new drug (IND) every 12-18 months
Webcast Details:
A webcast of the R&D Day will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be available for 30 days following the presentation.

On June 23, 2021 Tvardi Therapeutics, Inc. ("Tvardi") a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, reported that it has closed a $74 million Series B financing (Press release, Tvardi Therapeutics, JUN 23, 2021, View Source [SID1234584290]). The financing was led by new investors Slate Path Capital, Palkon Capital, ArrowMark Partners, and 683 Capital, with continued support and participation by existing investors, including Sporos Bioventures. In conjunction with the financing, Jamie McNab, Partner at Slate Path Capital, will join the Tvardi Board of Directors.

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Proceeds from this financing will be used to advance Tvardi’s product candidates through multiple clinical data readouts in mid-stage trials for cancer and fibrosis. The company’s lead product, TTI-101, is currently being studied in a Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. To date, TTI-101 has been well-tolerated and demonstrated multiple durable radiographic objective responses in cancer patients treated with TTI-101 monotherapy.

"We are thrilled to move out of stealth mode and partner with this lineup of long-term institutional investors," said Imran Alibhai, Ph.D., chief executive officer at Tvardi. "With this financing we are positioned to advance the clinical development of our small molecule inhibitors of STAT3 into mid-stage trials as well as grow our team."

Jamie McNab added, "I am excited to join the Board of Directors. Tvardi is the leader in the field of STAT3 biology and has compelling proof of concept clinical data. I look forward to partnering with the management team to advance Tvardi’s mission to develop a new class of breakthrough medicines for cancer, chronic inflammation, and fibrosis."

Keith Flaherty, M.D., a member of Tvardi’s Scientific Advisory Board, Professor of Medicine at Harvard Medical School, and founder of Loxo Oncology and Scorpion Therapeutics said, "STAT3 is a compelling and validated target. Beyond its clinical activity, Tvardi’s lead molecule, TTI-101, has demonstrated direct downregulation of STAT3 in patients. As a physician, I am eager to see the potential of Tvardi’s molecules in diseases of high unmet medical need where STAT3 is a key driver."

On June 23, 2021 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, reported that MB097 is now in pre-clinical development for treatment of patients not responding to anti-PD1 therapy (Press release, Microbiotica, JUN 23, 2021, View Source [SID1234584275]). Clinical trials are due to begin in 2022. MB097 is clinically designed and experimentally validated.

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Studies have shown that the gut microbiome plays a critical and causative role in determining which cancer patients respond to Immune Checkpoint Inhibitor (ICI) therapy. However clinical translation of this ground-breaking discovery has been hampered by large inconsistencies between studies in the intestinal bacteria associated with anti-PD1 efficacy. The Microbiotica platform is unrivalled in the comprehensiveness and precision by which it can profile the microbiome of patients. It has enabled the Company to identify the first microbiome signature predictive of response to ICI therapy across four independent melanoma studies, by analysing MELRESIST, a melanoma study conducted in collaboration with Cambridge University Hospitals. This microbiome signature is a highly predictive clinical biomarker in advanced melanoma and is also predictive in non-small cell lung cancer (NSCLC).

The bacteria most significantly linked to outcome are all elevated in patients that respond to anti-PD1 based therapy, suggesting that gut microbes drive ICI efficacy by enhancing the anti-tumour immune response. MB097 is a Live Bacterial Therapeutic (LBT) comprising nine key species from the signature, and is being developed as a co-therapy with ICI in advanced melanoma and NSCLC. MB097 has shown potent anti-tumour efficacy in a mouse syngeneic tumour model. The bacteria also demonstrate multiple immuno-stimulatory mechanisms in primary human immune cell assays, leading to Cytotoxic T Lymphocyte activation and tumour cell killing in vitro.

Clinical testing of MB097, in combination with anti-PD1, will begin in 2022 with a Phase 1b study conducted in the same melanoma patient population that the microbiome signature was derived from. This is precision medicine enabled by the precise microbiome profiling of Microbiotica’s platform.

ICIs have transformed oncology, having increased the range of cancers that can be treated as well as improving levels of efficacy, including complete remission in some cases. However, response rates tend to be low, typically in the range 10%-40% of patients. Consequently, there is a major unmet need for co-therapies to increase the number of responders and for biomarkers to stratify patients for treatment.

Mike Romanos, Co-founder and CEO, Microbiotica, said:

"Immune Checkpoint Inhibitors have had a major impact on the lives of many cancer patients, however fewer than half respond to this type of immunotherapy. This has driven us to design a microbiome therapeutic to improve patient response rate. Through our MELRESIST study data and our platform, we have been able to identify a consistent bacterial signature predictive of drug response in advanced melanoma and NSCLC.

"The Live Bacterial Therapeutic, MB097, arising from this signature, aims to tap into this predictive signature of ICI therapy response. Preclinical in vivo data and mechanistic in vitro human cell data generated thus far have been hugely encouraging. Coupled with our ongoing collaboration with Cancer Research UK and Cambridge University Hospitals, our IO program is now a significant focus for the Company going forward. The aim is for us to enter the clinic in 2022 with this programme."

Microbiotica’s platform comprises the world’s leading Reference Genome Database and Culture Collection of gut bacteria, and an unrivalled capability to culture and characterise all gut bacteria from patients at scale. This is complemented by a suite of bioinformatic and machine learning tools that enable the identification of previously undetectable gut bacterial signatures linked to patient phenotype.