On June 16, 2022 Vaxart, Inc. (Nasdaq: VXRT) reported that it will host a question-and-answer webcast with investors and analysts on Wednesday, June 22, 2022, at 1:00 p.m. Eastern Time (Press release, Aviragen Therapeutics, JUN 16, 2022, View Source [SID1234616038]). During the webcast, Andrei Floroiu, President and Chief Executive Officer, Dr. Sean Tucker, SVP and Chief Scientific Officer, and Dr. James Cummings, Chief Medical Officer, will provide an overview of the Company’s oral vaccine programs.

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The Company will take written questions from investors and analysts. Please visit the webcast link to RSVP and submit written questions. Questions may also be submitted in advance to [email protected].

A replay of the webcast will be available on the Investors page of the Company’s website at www.vaxart.com approximately two hours following the conclusion of the event.

As previously announced, Vaxart’s 2022 annual meeting of stockholders has been adjourned to Wednesday, July 6, 2022, at 12:30 p.m. Eastern Time. Vaxart encourages all stockholders of record on April 11, 2022, to vote their shares or change their votes in favor of all the proposals being submitted at the annual meeting by 11:59 p.m. Eastern Time on July 5, 2022.

On June 16, 2022 Exelixis, Inc. (Nasdaq: EXEL) and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) reported that the companies have entered into an option and license agreement focused on the identification and development of novel antibodies for use in IO therapeutics (Press release, Exelixis, JUN 16, 2022, View Source [SID1234616017]). The collaboration is intended to expand Exelixis’ portfolio of antibody-based therapies and will combine BioInvent’s cancer immunology and antibody biology expertise with Exelixis’ expertise and resources in antibody engineering and antibody-drug conjugate (ADC) technologies, and proven history of developing and commercializing oncology therapeutics. Target and antibody discovery will be performed using BioInvent’s proprietary n-CoDeR antibody library and patient-centric F.I.R.S.T screening platform, which together allow for parallel target and antibody discovery.

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Under the terms of the agreement, Exelixis will pay BioInvent an upfront fee of $25 million in exchange for rights to select three targets identified using BioInvent’s proprietary F.I.R.S.T platform and n-CoDeR library. BioInvent will be responsible for initial target and antibody discovery activities, and characterization of antibody mechanism of action. Exelixis will have the right to exercise an option to in-license any of the target programs upon identification of a development candidate directed to that target. Upon option exercise, Exelixis will pay BioInvent an option exercise fee and will assume responsibility for all future development and commercialization activities for the development candidate, including potential ADC and bispecific antibody engineering activities. In addition, BioInvent will be eligible for success-based development and commercialization milestones, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

"Expanding our biotherapeutics pipeline is a key strategic priority, and this agreement provides Exelixis with access to BioInvent’s antibody and cancer immunology expertise centered around the innovative F.I.R.S.T discovery platform, which rapidly screens samples from patients with cancer to identify antibodies and targets with promising therapeutic potential," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. "We believe this patient-centric and biology-driven approach has great potential to identify novel targets and enable the development of differentiated antibody-based IO therapies."

"BioInvent is committed to translating our expertise in cancer immunology and antibody mechanism of action into innovative IO therapies that can improve outcomes for patients," said Martin Welschof, CEO, BioInvent. "Exelixis has a demonstrated track record of success in both commercializing important new oncology medicines and establishing highly productive collaborations that integrate diverse and complementary skill sets and technologies – such as toxin and cytokine conjugation of monoclonal antibodies for ADC and bispecific monoclonal antibody technologies – to enable the identification and development of innovative therapies with significant clinical and commercial potential. We believe that our cancer immunology expertise and discovery platform will support Exelixis’ mission to expand its biologic pipeline, and we very much look forward to working together."

June 16, 2022 Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, reported two financing transactions (Press release, Akero Therapeutics, JUN 16, 2022, View Source [SID1234616039]). The first is a $25 million equity investment by Pfizer Inc. (NYSE: PFE) at $9.90 per share. The second is a term loan facility providing Akero with access to up to $100 million from Hercules Capital, Inc. (NYSE: HTGC), of which $10 million will be drawn at transaction close. Together with existing cash, proceeds will support Akero’s continued development of efruxifermin (EFX), a long-acting analog of fibroblast growth factor 21 (FGF21), including two ongoing Phase 2b clinical trials in patients with pre-cirrhotic and cirrhotic nonalcoholic steatohepatitis (NASH); manufacture of a drug product-device combination for use in Phase 3 clinical trials; and starting a Phase 3 clinical trial program. If the term loan is fully drawn, proceeds from these two transactions together with budget optimization efforts are expected to fund Akero’s current operating plan until the third quarter of 2024. This extends Akero’s previously announced cash guidance by a full year (from the third quarter of 2023 to the third quarter of 2024), two years beyond the anticipated readout of the HARMONY study in the third quarter of this year.

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"Pfizer has deep expertise and history in addressing health challenges that affect millions of patients around the world, including cardiometabolic diseases. We are honored and excited to have their confidence, collaboration and support," said Andrew Cheng, M.D. Ph.D., president and chief executive officer of Akero. "In addition, Hercules Capital has a rich history of investing in innovative biotechnology companies. We are very grateful for their significant partnership and support. With our existing cash on hand, we expect these two financings will extend our cash runway a full two years beyond our upcoming HARMONY readout, providing us the flexibility to optimize our capital structure to support the continued development of EFX."

Pfizer is investing in Akero through the Pfizer Breakthrough Growth Initiative (PBGI), which seeks to support biotechnology companies that share its commitment to delivering transformative therapies for patients in therapeutic areas consistent with Pfizer’s core areas of focus. Under the terms of the agreement, Akero has agreed to sell 2,525,252 shares to Pfizer at a price of $9.90 per share, for gross proceeds of $25 million. The shares of common stock were offered and sold to Pfizer in a registered direct offering conducted without an underwriter or placement agent. The offering is expected to close on or about June 17, 2022. Following the transaction, Pfizer will own approximately 6.7% of Akero’s outstanding common stock. As part of the transaction, Akero will establish a Scientific Advisory Board, with Pfizer appointing one member. Akero will maintain ownership and control of EFX, the rest of its pipeline, and Akero’s operations.

"EFX has quickly emerged as a promising potential NASH therapy, with a strong record of clinical trial data," said Jeff Pfefferkorn, Ph.D., Vice President of Discovery & Development, Internal Medicine Research Unit, Pfizer, who is expected to join Akero’s newly formed Scientific Advisory Board. "NASH is a priority therapeutic area for Pfizer due to the substantial global unmet medical need it represents, and we are excited to support Akero as it advances EFX towards a potential Phase 3 study."

The $100 million term loan facility is being provided by Hercules Capital, a leader in customized specialty financing for life science companies. Under the terms of the loan agreement, $10 million will be drawn at closing. An additional $10 million is immediately available to Akero at its sole discretion. Akero may draw an additional $35 million in two separate tranches upon achievement of near-term clinical and financial milestones. An additional $45 million may be drawn in a third tranche, subject to the approval of Hercules Capital. The loan bears an initial interest rate of 7.65% and adjusts with future changes in the prime rate. Akero will pay interest only for the first 24 months, extendable to 36 months on achievement of certain milestones. The loan matures 54 months from closing in December 2026. "We believe there is tremendous patient and clinical value in financing the development of potentially innovative treatments for NASH," said Cristy Barnes, Managing Director at Hercules Capital. "We’re excited to support Akero – both now and in the future – in its continued clinical development of EFX for the treatment of advanced NASH."

On June 16, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported the completion of enrollment in the first cohort of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM) (Press release, Cytori Therapeutics, JUN 16, 2022, View Source [SID1234616040]).

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"We are pleased with initial response to the ReSPECT-LM trial by patients and physicians and the very early promising drug performance," said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. "Patients seemed to tolerate 186RNL infusions and the drug circulated completely and rapidly throughout the cebrebrospinal fluid space. We intend to provide enrollment and complete clinical updates in the third quarter of 2022."

The investigational drug, 186RNL, is a proprietary nanoscale compound with a unique chelated radioisotope that is administered locally as a single dose via a conventional Ommaya reservoir. Rhenium-186 is a dual energy emitter (beta and gamma) with a short average path length for high precision, low dose rate that is safer for normal tissues, and high radiation density that overwhelms innate DNA repair mechanisms. The dual energy emission allows real time evaluation and monitoring of the 186RNL administration.

The ReSPECT-LM trial (NCT05034497) is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design. It will evaluate the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation and/or chemotherapy treatment. The primary endpoints of the study are the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.

The ReSPECT-LM Phase 1/2a clinical trial follows preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in two animal models of LM.

In November 2021, the Company announced that the FDA granted Fast Track designation to 186RNL for the treatment of LM. Fast Track designation confers several benefits to the drug development program including 1) more frequent meetings with and written communication from FDA, 2) eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and 3) Rolling Review, which allows a drug company to submit completed sections of its New Drug Application (NDA) for review by FDA, rather than wait until every section of the NDA is completed before the entire application can be reviewed.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer and is usually terminal with one-year and two-year survival of just 7% and 3% respectively. LM can originate from solid tumors, primary brain tumors, or hematological malignancies.

On June 16, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that the first bispecific antibody-receptor recombinant protein targeting human CD47 x HER2 (IMM2902), authorized by the United States Patent Office (APPLICATION No.: US 16/535,075) (Press release, ImmuneOnco Biopharma, JUN 16, 2022, View Source [SID1234655660]). As the most important pharmaceutical markets in the world, the United States took the lead in approving the patent authorization of IMM2902, which will greatly improve the market competitiveness of the product. The patent authorization and approval of the IMM2902 project in China, Japan, the European Union and other countries/regions is also in progress.

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IMM2902 is a CD47 x HER2 bispecific antibody in the world’s most cutting-edge research field for solid tumors. The project was previously approved by the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) to conduct clinical trials on June 29 and August 21, 2021, respectively. The new drug candidate targeting CD47 has entered the clinical research stage. On February 15, 2022, IMM2902 completed the first subject enrollment and dosing, and the clinical trial is progressing smoothly. The IMM2902 project was authorized by the US Patent Office is another major milestone for the company!

Dr. Tian, Wenzhi, the founder, chairman and CEO of ImmuneOnco, said: "I am very pleased to see that our IMM2902 project invention patent has been authorized by the US Patent Office. The IMM2902 is designed based on our mAb-Trap technology platform. It is a bi-specific molecule targeting CD47 and HER2. The molecule is developed through the high affinity activity of HER2 to enable the drug to preferentially bind to tumor cells, so that at the same time it has the characteristics of not binding to human erythrocytes and avoiding the "antigen sink effect", thus greatly enhancing the specific synergistic effect of the dual targets against tumors. IMM2902 will have great value of clinical and commercial potentials."