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 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 Hong Kong Science and Technology Parks Corporation (HKSTP) reported that it is partnering global research-driven biopharmaceutical leader, Boehringer Ingelheim Venture Fund Limited (BIVF) in a strategic co-incubation collaboration to promote and nurture startups on research and development for infectious diseases and immunology (Press release, Boehringer Ingelheim, JUN 17, 2022, View Source [SID1234616072]).

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HKSTP is dedicated to collaborating with sector leaders in building the strongest I&T eco-system to help startups via business development, mentorship and investment initiatives. In the last five years, the number of biotech companies at HKSTP have tripled from 50 to over 150, which has also synched with the Government’s strategic focus on biomedical technology with allocation of HK$10 billion to develop life and health technology as a key future growth sector for Hong Kong.

This partnership between HKSTP and BIVF marks a key milestone to drive the Hong Kong’s biomedical technology development. Both local and global qualified startups in infectious diseases and immunology can apply to the incubation programme to access the full capabilities of the HKSTP ecosystem and BIVF’s extensive biotech funding network. Incubatees can access one-on-one coaching and assessment to track key research milestones, while receiving expert guidance from HKSTP on commercialisation, manufacturing, scaling-up and marketing strategy to ensure successful innovation, plus vital funding opportunities and investment insight from BI.

Mr. Albert Wong, CEO of HKSTP, said: "Hong Kong is now Asia’s largest and the world’s second largest fundraising hub for biotech. As HKSTP marks our 20th year of propelling success and innovation, our mission is to drive the growth of biotech to another level with world class leaders like BIVF. We will maximise the GBA growth opportunities for high-potential tech talents and early-stage startups to ensure the region emerges as a global I&T powerhouse."

Dr. Grace Lau, Head of Institute for Translational Research of HKSTP, said: "Our partnership with BIVF, provides early-stage startups and promising university spinoffs with vital support at the most critical stage of their long and challenging biotech innovation journey. Incubatees will have access to our Incu-Bio Programme, with total incubatees doubling up in the last five years. The startups can also access funding support of up to HK$6 million, with financial subsidies and upfront grants to cover regulatory activities such as clinical trials."

"The world has faced growing public health challenges in recent years. As Boehringer Ingelheim’s strategic investment arm, BIVF focuses on the development of new science in areas with huge unmet medical needs such infectious diseases and immunology," said Dr. Frank Kalkbrenner, Global Head of the BIVF. "The co-incubation program jointly initiated by HKSTP and BIVF will enable us to identify more breakthrough technologies in the early stage of development. With the funding and infrastructure support offered by HKSTP and BI‘s expertise and experiences in the successful development of breakthrough mediactions for patients, we foster the startup companies and bridge the gap between science and industry for the local ecosystem. We look forward to developing together with HKSTP next-generation therapies in the fields of infectious diseases and immunology with long term partnerships."

"The innovation competency of biopharmaceuticals in Asia is rising quickly. To grab the opportunities in this market, Boehringer Ingelheim has set up the External Innovation Hub in China which brings our Research Beyond Borders, Business Development & Licensing and Venture Fund groups under one umbrella. Now we’re thrilled to see that the biopharmaceutical industry is picking up rapidly in the Guangdong–Hong Kong–Macau Greater Bay Area, it’s a great opportunity for us to partner with HKSTP to develop the local ecosystem, and further enhance China’s dual-circulation scheme. We hope to offer our continuous support to more home-grown innovations to be recognized on the global market and eventually benefit the patients worldwide." said Mr. Felix Gutsche, President & CEO, Boehringer Ingelheim China.

Programme incubatees will also benefit from HKSTP’s rapidly-growing biotech R&D capabilities including the HKSTP Institute for Translational Research (ITR), enabling biomedical startups to turn their innovative biomedical technologies to life-changing impact for patients and society. Also available to startups is HKSTP’s Incu-Bio program providing dedicated biotech mentorship, business matching, entrepreneur-in-residence, and access to R&D facilities and the Science Parks’ diverse talent pool.

On June 17, 2022 Xspray Pharma (Nasdaq Stockholm: Xspray) reported that the US Food and Drug Administration (FDA) has granted Dasynoc Orphan Drug Designation (ODD) in the US for the treatment of chronic myeloid leukemia (CML) (Press release, Xspray, JUN 17, 2022, View Source [SID1234649576]).

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The FDA decision to grant the designation is based on the plausible hypothesis that Dasynoc may be clinically superior to the same drug(s) already approved for the same indication because Xspray Pharmas product candidate may provide a major contribution to patient care due to the gastric pH-resistant qualities of its formulation and in the context of significant concomitant use of acid reducing agents in the CML population.

"We are very pleased that our product candidate Dasynoc has been granted this orphan drug designation. This is our second product candidate to be granted this designation and it confirms both our technology and the unmet medical need that Xspray Pharma can address. This strengthens us in our goal to work with improved oncology pharmaceuticals and to provide patients a better quality of life", said Per Andersson, CEO of Xspray Pharma.

Dasynoc is Xspray Pharmas first product candidate and is currently under FDA review for approval. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

Chronic myeloid leukemia – CML
CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the "Philadelphia chromosome," which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients. About 15% of all leukemia is CML. In 2020 it was projected that 8,450 people in the US would be diagnosed with CML and in 2017, there were an estimated 58,000 people living with the disease in the US.

On June 17, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported multiple presentations of data evaluating its first VDC, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (CM)) (Press release, Aura Biosciences, JUN 17, 2022, View Source [SID1234616073]). The presentations include updated safety results from the Phase 2 trial using suprachoroidal (SC) administration, final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration as well as top-line data from the Retrospective Match Case Control study comparing the long-term visual acuity outcomes following treatment with belzupacap sarotalocan versus treatment with plaque brachytherapy, the current standard of care. The results will be presented at the International Society of Ocular Oncology (ISOO) 2022 Bi-Annual Meeting, the largest global ocular oncology meeting, being held June 17-21, 2022, in Leiden, the Netherlands.

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"The final safety and efficacy data from the Phase 1b/2 trial using IVT administration, along with the data from the ongoing Phase 2 trial using SC administration, continues to support the value of a vision preserving therapy for the first line treatment of patients with early-stage CM," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "We remain on track with our Phase 2 SC study and we plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Aura is also excited to share the topline results of the retrospective matched case control study as well."

Details for ISOO 2022 presentations:

Title: A Phase 1b/2 trial of AU-011, a first-in-class targeted therapy for the treatment of choroidal melanoma via intravitreal administration
Presenter: Carol L. Shields, MD, Wills Eye Hospital and Cadmus C. Rich MD, Aura Biosciences
Session: S17 Other Intraocular Tumors
Date/Time: Monday, June 20, 2022 from 09:32 a.m. – 09:40 a.m. CEST

Title: A Phase 2 trial of a first-in-class targeted therapy for choroidal melanoma via suprachoroidal (SC) administration
Presenter: Ivana K. Kim, MD, Massachusetts Eye and Ear
Session: S13 Uveal Melanoma: Clinic and Case
Date/Time: Sunday, June 19, 2022 from 11:24 a.m. – 11:32 a.m. CEST

Industry Symposium: New Developments in AU-011, an Investigational Virus-Like Drug Conjugate (VDC) for the treatment of Ocular Cancer and Metastatic Disease
Presenter: Cadmus Rich, MD, Chief Medical Officer and Head of R&D Aura Biosciences
Date/Time: Sunday, June 19, 2022 from 12:30 p.m. – 01:15 p.m. CEST