On July 9, 2020 Researchers from IRB Barcelona, the University of Barcelona (UB) and the Sant Joan de Déu Research Institute – Hospital Sant Joan de Déu (SJD) have set up Gate2Brain, a company based on a novel technology developed at IRB Barcelona to transport drugs into the brain (Press release, Gate2Brain, JUL 9, 2020, View Source [SID1234641071]). Gate2Brain is the second joint spin-off between IRB Barcelona and the UB to be funded by the Mind the Gap Programme run by the Botín Foundation.

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Driven by IRB Barcelona associate researcher Meritxell Teixidó, Gate2Brain combines several families of peptides able to cross the blood-brain barrier, a structure that hinders access of most drugs to the brain. "The brain is a precious organ that is strongly protected by a kind of wall. We have managed to develop "keys" that facilitate entry and that we believe could allow different drugs to enter the brain and treat diseases of this organ," explains Teixidó, CEO of the company. The pharmaceutical industry has invested millions of euros in the development of drugs that ultimately did not cross the blood-brain barrier and have consequently been unsuccessful.

Gate2Brain has been set up to exploit the technology developed over the last 15 years in the Peptide and Protein Laboratory headed by Ernest Giralt (Professor at the UB) at IRB Barcelona, in which Teixidó is a Research Associate. The research line that Teixidó has led in recent years has produced three families of shuttle peptides with the ability to cross the blood-brain barrier and deliver therapeutic molecules to the brain that cannot cross it unaided. In addition to IRB Barcelona, ​​the UB has also participated in the development of these families of peptides, and the Sant Joan de Déu Hospital has also been involved in the development of the first product.

The advantages of this technology include the possibility to improve the effectiveness of many treatments, as well as to reduce the amount of drug administered and thus limit side effects.

A multidisciplinary team to drive the company’s growth

Gate2Brain has come about with an initial investment of €500,000 from the Mind the Gap Programme run by the Botín Foundation. In its previous stage, this research line was supported by "la Caixa" Foundation’s CaixaImpulse Programme, to advance with the preclinical study for a specific type of pediatric glioma. A year ago, the technology also received funding from the Agency for the Management of University and Research Grants (AGAUR) in the "Funding for the Knowledge Industry- PRODUCTE" call.

The new company will be based at the Barcelona Science Park, while the experimental work will be conducted at the Sant Joan de Déu Hospital. The company plans to advance the development of a drug to treat a type of childhood brain cancer, as well as evaluate the performance of the drug transport platform in other diseases that require therapeutic agents to cross the blood-brain barrier.

In addition to Teixidó, Gate2Brain has founding partners with a multidisciplinary profile, bringing expertise in basic peptide and protein research, pharmaceutical development, clinical expertise in pediatric oncology, and business insight to drive the company’s growth. According to Teixidó, "the company launch today is the result of the collective success of the research groups and Innovation departments, which I want to thank for their work. We have worked shoulder to shoulder during all this time to finally make the company a reality."

The sixth spin-off created by IRB Barcelona to date

Transfer and innovation are key for IRB Barcelona and, since the launch of the institute, its Innovation Department has promoted the setup of six spin-offs. Its director, Francesc Posas, says, "We are very proud that nearly 15 years of research at IRB Barcelona bear fruit and have brought about a new spin-off as promising as Gate2Brain. In the coming years, we intend to continue to foster spin-offs derived from the fundamental biomedical research done in our centre—companies that will ultimately benefit patients with diseases for which there is currently no cure."

As the unit for technology transfer and innovation at the University of Barcelona, the Bosch i Gimpera Foundation (FBG) is responsible for transferring research results to society through the creation of spin-offs, patent licensing, and through contracts with companies and institutions, thus contributing to the competitiveness of the business fabric and to the improvement of social well-being. In 2019, 826 projects were managed and received €33.85 M funding. Gate2Brain is the 46th spin-off created by the FBG-UB, 28 of which involve participation of the UB.

Backing from Mind the Gap

Since 2010, the Botín Foundation’s Mind the Gap Programme has been promoting entrepreneurship in the Life Sciences in order to help technologies produced by Spanish centres reach the market and generate socio-economic development. To this end, it invests financial (€500,000) and management resources, the latter through an expert advisor who provides guidance and support in the critical aspects of project viability. Since 2016, in addition to the Botín Foundation, Mind the Gap has been operating through a co-financing vehicle involving the participation of a group of private investors.

Gate2Brain joins the eight companies that already form part of the Mind the Gap Programme. To date, these companies have secured €16 M of investment. They have a combined annual turnover of €1.5 M, and in 2019 they provided 53 highly qualified jobs.

Source: Fundación Botín
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On JUly 9, 2020 Blackstone (NYSE: BX) reported the final close of Blackstone Life Sciences V ("BXLS V"), the inaugural Blackstone fund in Life Sciences. BXLS V was oversubscribed and closed at its hard cap of $4.6 billion of total capital commitments — the largest life sciences private fund raised to date (Press release, Blackstone Life Sciences, JUL 9, 2020, View Source [SID1234561811]).

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Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences, said, "Our mission to bring innovative medicines to patients by drawing on our domain expertise and scale capital has resonated with investors. With many more promising products in the life sciences industry’s pipeline than capital available to advance them, we look forward to continuing to bring new treatment options and innovations to the patients who need them."

Blackstone Life Sciences has three main investment strategies: strategic collaborations with established life science companies, late-stage product financings, and growth investments in emerging companies.

Over the past three months, Blackstone Life Sciences invested capital from BXLS V in the following transactions:

In April, Blackstone Life Sciences entered into a $2 billion strategic collaboration with Alnylam, a leading biotechnology company, the largest private financing of a pre-profitability stage biotechnology company. A key element of this investment was the acquisition of a royalty interest in inclisiran, a Novartis-owned LDL lowering medicine that has the potential to transform the lives of patients with heart disease.
In June, Blackstone Life Sciences led a $350 million investment in Reata Pharmaceuticals to help advance the first potential medicine for Alport Syndrome, a kidney disease that afflicts children.
Also in June, Blackstone Life Sciences and Medtronic announced a $337 million strategic collaboration to advance Medtronic‘s next generation of diabetes management products. This was the first investment by Blackstone Life Sciences in the medical devices space.

On July 9, 2020, Vaccinex, Inc. (the "Company"), reported that it entered into a stock purchase agreement (the "Stock Purchase Agreement") with Friedberg Global-Macro Hedge Fund, Ltd. (the "Investor"), pursuant to which the Company agreed to issue and sell to the Investor, and the Investor agreed to purchase from the Company, 1,126,760 shares (the "Shares") of common stock, par value $0.0001 per share, of the Company (the "Common Stock"), at a purchase price of $3.55 per Share (the average closing price of the Common Stock for the five trading days immediately preceding the signing of the Stock Purchase Agreement) (the "Private Placement"), for gross proceeds of $4.0 million (Filing, 8-K, Vaccinex, JUL 9, 2020, View Source [SID1234561808]). The Stock Purchase Agreement contains customary representations and warranties of the parties. The closing of the Private Placement is expected to occur on July 10, 2020 (the "Closing Date").

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The Company intends to use the net proceeds from the Private Placement to fund the ongoing development of pepinemab, the Company’s lead product candidate, and for working capital and general corporate purposes.

Albert D. Friedberg, the Company’s chairman and beneficial owner of a majority of the outstanding Common Stock, controls Friedberg Mercantile Group, the investment manager of the Investor, which exercises voting and dispositive power over shares held directly by the Investor.

The Shares have not been registered under the Securities Act of 1933, as amended (the "1933 Act"), and are being issued and sold in a private placement pursuant to Section 4(a)(2) of the 1933 Act and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission (the "SEC") under the 1933 Act. The Investor represented that it is an "accredited investor" within the meaning of Rule 501 of Regulation D and is acquiring the Shares for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. The Shares were offered without any general solicitation by the Company or its representatives.

On July 10, 2020, the Company entered into a registration rights agreement (the "Registration Rights Agreement") with the Investor that affords the Investor certain registration rights with respect to the Shares. Under the Registration Rights Agreement, the Company has agreed, among other things, to use its reasonable best efforts to file with the SEC a registration statement covering the resale of the Shares by the 60th calendar day following the Closing Date and commercially reasonable efforts to cause such registration statement to become effective on or prior to the 90th calendar day following the Closing Date. The Company has also agreed to use commercially reasonable efforts to keep the registration statement effective until the Shares have been sold thereunder or until the Shares can be sold without restriction. If the Company fails to meet the specified deadlines for the effectiveness of the registration statement, the Company will be required to pay liquidated damages to the Investor, subject to maximum aggregate liquidated damages of 8.0% of the purchase price paid for the Shares. Interest on any unpaid liquidated damages will accrue at a rate of 1.0% per month. In addition, the Company agreed to provide the Investor with certain "piggy-back" registration rights that may require the Company to effect certain registrations to register the Shares for resale in the event that no registration statement registering the Shares is effective and the Company is otherwise filing a registration statement under the 1933 Act. The Registration Rights Agreement also contains certain indemnification and contribution provisions under which the Company and the Investor have agreed to indemnify each other against certain liabilities.

On July 9, 2020 Harbour BioMed (HBM) reported completion of its Series C financing of $102.8 Million to accelerate development of its growing portfolio of next generation biologics targeting cancer, immunologic diseases, and COVID-19 (Press release, Harbour BioMed, JUL 9, 2020, View Source [SID1234561794]). The financing was led by new investors, Hudson Bay Capital; followed by OrbiMed, Country Garden VC, GTJA Investment Group, Octagon Capital, and Sage Partners, with additional investment from existing investor Greater Bay Area Investment Fund. The round follows a $75 million Series B+ financing the Company completed in March 2020.

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"Participation of new and current investors underscores enthusiasm for our clinical portfolio, our antibody discovery and development engine, as well as our strategy to build a leading global biopharmaceutical company," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "We have made great progress with our clinical programs and multiple promising, bi- and monospecific antibodies from our discovery engine that are rapidly moving towards clinical trials. The funding will support final development and initial commercialization of our late stage portfolio and advancement of both our earlier stage discovery and preclinical molecules." The Company has over 30 programs in its pipeline, including an anti-CD73 monoclonal antibody (mAb), a bi-specific anti-BCMAxCD3 mAb and, newly announced, an anti-CCR8 mAb, all in preclinical development and targeted at a variety of cancers.

Ms. Jo-Wen Lin, Asian Healthcare Portfolio Manager at Hudson Bay Capital, said: "We are pleased to support Harbour BioMed and its management team to further develop its pipeline of leading immunology and oncology drugs. We believe the Company’s innovative approach, with next generation technologies that target unmet medical needs, present an exciting growth opportunity."

Ms. Iris Wang, Managing Director of OrbiMed Asia, commented, "Harbour BioMed has built an impressive clinical pipeline and at the same time created a solid foundation for next generation therapeutics through its transgenic mouse platforms. These preclinical programs along with the Company’s clinical assets create new opportunities targeting major indications with substantial global medical needs."

With a patient-centric approach to address unmet medical needs across the world, HBM currently has five products in clinical development. Key programs include:

· HBM9161 (Batoclimab) is a first-in-class fully human anti-FcRn mAb, that significantly reduces pathogenic IgG, with potential to become a portfolio-in-a-product for a variety of autoimmune indications. HBM has received IND approval from China’s National Medical Products Administration (NMPA) and is conducting clinical trials in myasthenia gravis, neuromyelitis optica spectrum disorder, immune thrombocytopenia and Graves’ ophthalmopathy.

· HBM9036 (Tanfanercept) is a novel TNF receptor-1 fragment to treat dry eye disease by inhibiting TNFα. Phase 2 clinical trials with the drug in the U.S. and China have shown promising signals for both clinical efficacy and safety in treating moderate-to-severe dry eye disease. Preparations for the Phase 3 registration trial in China are currently underway.

· HBM4003 is a next-generation anti-CTLA4 mAb in Phase 1 clinical studies in Australia for the treatment of advanced solid tumors. The molecule is the first of several fully human mAbs in development at HBM based on the Company’s heavy chain only (HCAb) technology. HBM4003 has shown extremely promising anti-tumor activity and a favorable safety profile in preclinical studies, suggesting it has potential in both mono- as well as combination therapy with other immuno-oncology drugs. The U.S. FDA recently cleared HBM’s IND to initiate US clinical trials; the NMPA has accepted an IND application for HBM4003 to begin clinical trials in China.

HBM is also building a robust COVID-19 pipeline. Along with Utrecht University and Erasmus Medical Center, HBM recently announced a research collaboration with AbbVie for a monoclonal antibody termed 47D11 for therapeutic/prophylactic use against SARS-CoV2. This fully human antibody, designed to facilitate its development and minimize immune-related side effects, targets a conserved region of the virus’ spike protein, and has been shown in studies published in Nature Communications to block infection by the SARS-CoV-2 (commonly known as COVID-19) and SARS-CoV. This cross-neutralizing feature of the antibody may have potential in mitigating diseases caused by future-emerging related coronaviruses. This and other mAbs in its COVID-19 pipeline are also being currently tested for diagnostic purposes. In addition, the Company also has an ongoing collaboration with Mt. Sinai Health System (New York) for discovering antibodies against SARS-CoV2 using its proprietary H2L2 Harbour Mice platform.

On July 9, 2020 IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, reported First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and binimetinib, a MEK inhibitor, in metastatic uveal melanoma (MUM) (Press release, Ideaya Biosciences, JUL 9, 2020, View Source [SID1234561806]). The clinical combination of IDE196 and binimetinib is being evaluated by IDEAYA with binimetinib being supplied by Pfizer pursuant to a clinical trial collaboration and supply agreement.

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In the MUM setting, IDEAYA’s clinical development strategy focuses on rational combinations, including MEK, and supporting studies through collaborations, such as the Pfizer clinical trial collaboration and supply agreement. IDEAYA’s strategic objective is to enhance the clinical activity of IDE196 through potential synergistic combinations. In the non-MUM GNAQ/11 hotspot mutation basket trial, including skin melanoma, IDEAYA will continue to evaluate IDE196 monotherapy and potential combinations, such as with binimetinib.

At the AACR (Free AACR Whitepaper) Virtual Annual Meeting II held on June 22-24, 2020, IDEAYA presented an abstract on the preclinical evaluation of IDE196 plus MEK combination, entitled "Analysis of drug combinations with the PKC inhibitor IDE196 support dual MEK and PKC inhibition as a rational combination in metastatic uveal melanoma."

"Our preclinical studies with IDE196 and MEK presented at AACR (Free AACR Whitepaper) support our clinical development strategy to focus on combinations as the most promising approach for the MUM indication," said Mick O’Quigley, Vice President, Head of Development Operations. "In addition, we continue to evaluate IDE196 monotherapy and potentially also combinations in the GNAQ/11 hotspot mutation basket trial, in non-MUM indications such as skin melanoma."

IDEAYA anticipates interim data from the MEK combination study in late 2021 to early 2022, at which time the company will evaluate a potential registrational path for MUM and a potential partnership.