On June 17, 2022 Lenire Biosciences Inc., a biopharmaceutical company developing novel treatments for Fragile X Syndrome (FXS) and related disorders, reported that it has agreed to a licence from UCL (University College London) for VSN16R, a small molecule positive modulator of large-conductance, calcium-activated potassium ("BK") channels, as a novel therapy for FXS (Press release, UCLB, JUN 17, 2022, View Source [SID1234616071]). The development of this technology was supported by UCL Business (UCLB), the commercialisation company of UCL.

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FXS is a rare, inherited condition that can cause issues including developmental delays, learning and behavioural difficulties, physical abnormalities, anxiety, attention or hyperactivity disorders and autism spectrum disorder. In the UK around 1 in 4,000 men and 1 in 6,000 women are affected by FXS.

VSN16R is an orally bioavailable compound based on anandamide, a natural signalling molecule in the endocannabinoid system in humans. It was developed in the laboratory of Professor David Selwood (Wolfson Institute for Biomedical Research, UCL), as part of a study that has completed phase II human trials for muscle stiffness and involuntary muscle spasms in multiple sclerosis, a common symptom known as spasticity. A large and diverse set of preclinical studies have implicated deficient BK channel activity in the etiology of FXS, and recent studies in a mouse model of the syndrome demonstrated efficacy of VSN16R in rescuing FXS-related phenotypes. Lenire plans to develop VSN16R to treat patients with FXS.

"Extensive research into the role of altered BK channel expression, activity and regulation in FXS models provides a strong rationale for pharmacologically augmenting its activity as a disease-modifying treatment for FXS that may improve many of its core symptoms," shared Dr. Peter Vanderklish, Co-Founder of Lenire.

FXS is the most prevalent inherited form of intellectual disability and a leading cause of autism spectrum disorder. There are currently no disease-modifying therapies for FXS, and some of the most problematic symptoms, such as anxiety, are largely refractory to medications that would be used to treat them in the neurotypical population.

Dr. Craig Erickson, Professor of Psychiatry at Cincinnati Children’s Hospital Medical Center and Director of the Cincinnati Fragile X Research and Treatment Center commented, "We are excited to collaborate with Lenire to test VSN16R in patients with FXS."

Professor David Selwood commented, "The effect of our drug in the disease models is transformative; we are very excited to see this drug go forward to the clinic in people with Fragile X."

Barny Cox, Senior Business Manager at UCLB commented, "With convincing preclinical efficacy in FXS, as well as an excellent clinical safety profile, we are optimistic that VSN16R will prove effective in providing meaningful relief to patients with this debilitating disorder."

On June 17, 2022, NexImmune, Inc., (the "Company" or "NexImmune") reported that it entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. and BTIG, LLC (together, the "Agents"), pursuant to which the Company may offer and sell shares of its common stock, $0.0001 par value per share, having an aggregate offering price of up to $50,000,000 (the "Shares") from time to time through the Agents (the "Offering") (Filing, 8-K, NexImmune, JUN 17, 2022, View Source [SID1234616070]).

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Subject to the terms and conditions of the Sales Agreement, the Agents will use their commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions, by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The Company or the Agents may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions.

The Company has agreed to pay the Agents commissions for their services in acting as agents in the sale of the Shares in the amount of 3.0% of gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide the Agents with customary indemnification and contribution rights.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, which is attached hereto as Exhibit 1.1 and incorporated by reference herein.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, has issued a legal opinion relating to the Offering. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares to be sold under the Sales Agreement, if any, will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-263399), previously filed with the Securities and Exchange Commission (the "SEC") on March 9, 2022, and declared effective by the SEC on March 16, 2022. A prospectus supplement related to the Offering will be filed with the SEC on June 17, 2022. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On June 17, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the company is postponing the start of the live-streamed R&D event on June 20 until 14.00 CEST (Press release, Isofol Medical, JUN 17, 2022, View Source [SID1234616069]). The event, announced on June 14, addresses investors, analysts, and media with a subsequent question and answer session.

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Following the significant interest raised by the event, Isofol hereby wishes to make a clarification regarding its purpose. Reporting of top-line results will not take place during the event. The timeline that was communicated on April 22 in connection with the start of the data analysis of the AGENT study still applies. At that time, the company estimated that it would take two to four months from the start of the analysis until top-line results could be reported. Isofol can now specify that the results will be presented during the latter part of this period.

Agenda for the R&D Event
The AGENT study – its design, patient population, endpoints, and an update including the current status of the study and upcoming top-line results
The medical need for colorectal cancer patients
The current colorectal cancer treatment landscape and the clinical use of current treatments
Clinical, regulatory, and market access demands for introducing new treatments for colorectal cancer
Q&A-session
Questions can be asked prior to the event by sending an email to [email protected] or during the webcast via a chat function. The webcast will also be available on demand on Isofol’s corporate website after the event.

On June 17, 2022 Genmab A/S (Nasdaq: GMAB) reported that it is initiating a share buy-back program to mitigate dilution from warrant exercises and honor our commitments under our Restricted Stock Unit program (Press release, Genmab, JUN 17, 2022, View Source [SID1234616068]). The share buy-back program will be undertaken on the terms set out below and in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation."

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Purpose
The purpose of the share buy-back program is to mitigate dilution caused by warrant exercises and to honor our commitments under the Restricted Stock Unit program.

Time frame
The share buy-back program will start on June 20, 2022 and end on August 31, 2022 (unless Genmab terminates or suspends the program).

Terms
Genmab has appointed Danske Bank as lead manager for the share buy-back program. Danske Bank will make its own trading decisions and act independently of and without influence or involvement from Genmab. Under this share buy-back program Genmab may repurchase up to 370,000 shares.

Shares acquired under the program cannot be purchased at a price exceeding the higher of (i) the price of the latest independent transaction on Nasdaq Copenhagen and (ii) the price of the highest independent bid on Nasdaq Copenhagen at the time of the transaction. The total number of shares that may be purchased on a single trading day may not exceed 25% of the average daily trading volume over the preceding 20 trading days on Nasdaq Copenhagen.

As of June 17, 2022, Genmab holds 233,885 treasury shares equal to 0.36 % of the share capital.

Genmab is entitled to suspend or stop the program at any time subject to announcement to Nasdaq Copenhagen.

Upon initiation of the program, Genmab will issue a weekly announcement in respect of transactions made under the program.

On June 17, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it presented the Phase 1/2 clinical trial design and new preclinical data supporting KVA12.1 as a potential treatment for cancer patients with advanced solid tumors at the Tumor Myeloid-Directed Therapies Summit held on June 14-16 in Boston, MA (Press release, Kineta, JUN 17, 2022, View Source;utm_medium=rss&utm_campaign=kineta-presents-new-preclinical-data-and-phase-1-2-clinical-trial-design-of-kva12-1-at-the-tumor-myeloid-directed-therapies-summit [SID1234616067]).

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Shaarwari Sridhar, Scientist at Kineta, presented a poster outlining the first-in-human clinical trial design and study objectives evaluating KVA12.1 as a monotherapy and in combination with an anti-PD1 immunotherapy. New preclinical and toxicology data supporting advancing KVA12.1 into clinical development were also presented. KVA12.1 is a potential best-in-class VISTA blocking immunotherapy that was discovered through the Company’s proprietary immuno-oncology PiiONEER platform. The Phase 1/2 study will be a multicenter, open label, dose escalation and dose expansion study of intravenous infusion of KVA12.1 as a monotherapy and in combination with a fixed dose of an anti-PD1 antibody in patients with advanced solid tumors. Kineta plans to initiate the Phase 1/2 clinical study in Q4 2022.

"We are very encouraged by the preclinical data and are excited for KVA12.1 to enter the clinic later this year," said Thierry Guillaudeux, PhD, EVP Research and Development at Kineta. "KVA12.1 was developed through Kineta’s PiiONEER platform as an engineered IgG1 monoclonal antibody that binds to a unique epitope at physiologic and acidic Ph levels. It is highly differentiated as it has demonstrated efficacy as a single agent and in combination with PD-1 in multiple tumor models with no CRS-associated cytokine secretion seen in preclinical tox studies."

Phase 1/2 clinical study objectives detailed in the poster presentation include:

Clinical
Safety measurements and DLTs as single agent and in combination with anti-PD1
Overall Response Rate and durability of response using RECISTv1.1
Determined MTD and R2PD
Pharmacologic and Biomarker
PK
Receptor Occupancy
Cytokine and Chemokine profiles in plasma samples
Flow Cytometry for PD marker on Immune cells
Tumor biopsies : multiparameter analysis to evaluate tumor cells as well as Immune infiltrating cells. Characterized expression of immune checkpoint and exhausted markers.
Presentation Details:

Title: KVA12.1 a novel fully human anti-VISTA antibody to treat cancer patients with advanced solid tumors
Date Presented: June 15-16, 2022
Presenter: Shaarwari Sridhar

For further details, please view the poster presentation on Kineta’s website here.