On July 10, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, reported that ITM has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, which is manufactured at the RadioMedix Spica Center in Houston, Texas, U.S. and distributed under the brand name GeGant (Press release, ITM Isotopen Technologien Munchen, JUL 10, 2020, View Source [SID1234561814]).

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The RadioMedix Spica Center is a 21 CFR 211 compliant, and GMP radiopharmaceutical manufacturing facility dedicated to late-stage investigational and commercial stage radiopharmaceutical manufacturing and distribution. Thousands of 68Ge/68Ga Generators can be produced, annually at this center. This high production capacity enables us to meet the rapidly increasing demand for Gallium-68 in the United States.

The medical, short-lived radioisotope Gallium-68 is used for Positron Emission Tomography (PET) imaging when labeled to a tumor-specific targeting molecule for diagnosis and staging of various cancers, like neuroendocrine tumors or prostate cancer, and for evaluation of response to therapy. PET-imaging is an excellent approach for healthcare professionals looking for precise localization in diagnostic imaging. GeGant allows fast and convenient onsite production of high-quality Gallium-68 for radiolabeling. As well as showing a low breakthrough of Germanium-68, GeGant is available in the sizes of 1 GBq (30 mCi), 2 GBq (50 mCi), and 4 GBq (100 mCi), being among the largest 68Ge/68Ga Generators on the market.

"We are living in an exciting time in the field of nuclear medicine and the menu of targeted PET imaging agents will only grow. 68Ga is among the most important players in this field" said Dr. Ebrahim Delpassand, CEO of RadioMedix. "We are excited to be able to accomplish this milestone in collaboration with our long-term partner ITM, Germany. RadioMedix will be the manufacturer of ITM 68Ge/68Ga Generators, for the first time in the United States. Our high manufacturing capacity will address the significant shortage of this essential device in the market and increases patients’ access to a variety of 68Ga labeled radiopharmaceuticals in the field of oncology." continued Dr. Delpassand.

Steffen Schuster, CEO of ITM said: "We are very pleased to see this DMF submission in the U.S. has taken our close and long-term partnership with RadioMedix to a new level and will enable us to take full advantage of RadioMedix’s great production opportunities." Steffen Schuster added: "With RadioMedix as our strategic partner, we are looking forward to GeGant significantly increasing the availability of Gallium-68 in the U.S. We are confident that we can make a substantial contribution to meeting the growing demand of Targeted Radionuclide Therapies and Diagnostics within the U.S. market."

About GeGant
GeGant is a next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator allowing fast and convenient onsite-production of the short-lived, medical radioisotope Gallium-68 (68Ga), used in Targeted Radionuclide Therapy for diagnosis and staging of cancers like neuroendocrine tumors or prostate cancer. 68Ga is a radiopharmaceutical precursor, and it is not intended for direct use in patients. Conjugated to a tumor-specific targeting molecule (e.g. peptide or antibody), Gallium-68 is applied for diagnostic imaging via positron emission tomography (PET). It is to be used only for the radiolabeling of targeting molecules that have been specifically developed and authorized for radiolabeling with 68Ga. 68Ga-PET-imaging is an excellent approach for healthcare professionals looking for precise localization in diagnostic imaging. As well as for diagnosis and staging of tumors, Gallium-68 based imaging is used for therapy planning and dosimetry in preparation for Targeted Radionuclide Therapy with its therapeutic companion radioisotope Lutetium-177.

GeGant is a fully shielded source of high-quality Gallium-68 available in different sizes from 1 to 4 GBq, making it the largest 68Ge/68Ga Generator on the market. Gallium-68 is continuously produced by decay of its parent radioisotope Germanium-68 and eluted with low acidic hydrochloric acid. It is suitable for radiolabeling of tumor-specific targeting molecules without prior prepurification.

On July 10, 2020, Caladrius Biosciences, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited investors (the "Purchasers") (Filing, 8-K, Caladrius Biosciences, JUL 10, 2020, View Source [SID1234561812]). Pursuant to the terms of the Purchase Agreement, the Company agreed to sell to the Purchasers an aggregate of (i) 969,694 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock") and (ii) warrants to purchase up to an aggregate of 484,847 shares of Common Stock (the "Warrants"), at a purchase price equal to $2.0625 per share and accompanying Warrant. The Warrants are exercisable immediately upon issuance and will expire five and one-half years from the issuance date.

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The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), termination provisions, and other obligations and rights of the parties. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

In connection with the offering, the Company entered into a Registration Rights Agreement (the "Registration Rights Agreement") with the Purchasers, pursuant to which the Company is obligated, among other things, to (i) file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") following the closing of the offering for purposes of registering the Shares and the shares of Common Stock issuable upon the exercise of the Warrants (the "Warrant Shares") for resale by the Purchasers, (ii) use its commercially reasonable efforts to have the registration statement declared effective promptly after filing, and in any event no later than 90 days after the closing of the offering (or 120 days after the closing of the offering if the registration statement is reviewed by the SEC), and (iii) maintain the registration until all registrable securities (a) have been sold pursuant to the registration statement or Rule 144 or (b) may be sold pursuant to Rule 144 under the Securities Act, without restriction as to volume. The Registration Rights Agreement contains customary terms and conditions for a transaction of this type, including certain customary cash penalties on the Company for its failure to satisfy specified filing and effectiveness time periods.

The offering is exempt from registration pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) the Securities Act and Regulation D under the Securities Act. The Shares, the Warrants and the Warrant Shares being sold and issued in connection with the Purchase Agreement are not registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from the registration requirements. Each purchaser will be an "accredited investor" as such term is defined in Rule 501(a) under the Securities Act. The Warrants are not and will not be listed for trading on any national securities exchange.

The net proceeds to the Company from the private placement are expected to be approximately $1.98 million, after deducting estimated offering expenses payable by the Company. The private placement is expected to close on or about July 13, 2020, subject to satisfaction of customary closing conditions.

On July 10, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the European Patent Office has issued an Intention to Grant notice for the first European patent covering Anixa’s novel CAR-T cancer treatment technology, which has been licensed from The Wistar Institute and is being developed at the Moffitt Cancer Center (Press release, Anixa Biosciences, JUL 10, 2020, View Source [SID1234561810]).

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The patent is titled "METHODS AND COMPOSITIONS FOR TREATING CANCER," and the inventors are Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt. Dr. Conejo-Garcia is the Chair of the Department of Immunology at Moffitt Cancer Center and Dr. Alfredo Perales-Puchalt, formerly of The Wistar Institute, is currently Vice President of R&D at Geneos Therapeutics. The patent is assigned to The Wistar Institute and Anixa Biosciences’ majority-owned subsidiary, Certainty Therapeutics, Inc., is the exclusive, world-wide licensee.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are pleased to receive this notification from the European Patent Office (EPO), and the protection this groundbreaking technology will have throughout the European Union, in addition to the existing patents in the United States. Our CAR-T cancer technology takes advantage of specific hormone–hormone receptor biology to address malignancies and may hold promise to be the first successful CAR-T therapy against solid tumors. While our initial focus is the treatment of ovarian cancer, the technology covered by the patent is broad and may also be effective in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action."

"Protecting intellectual property is critical for the advancement of new therapies, such as our CAR-T technology, which has been exclusively licensed to Anixa’s subsidiary, Certainty Therapeutics. As a minority shareholder of Certainty, we are looking forward to continued advancement of the therapy into the clinic where we hope this will help many cancer patients," said Heather Steinman, PhD, MBA, Vice President of Business Development at The Wistar Institute.

On July 10, 2020 AskAt Inc. reported that it received that allowance of a substance patent for its EP4 receptor antagonist (AAT-008), Application No. PI0414130-0 was published in Brazilian Industrial Property Journal (Official Gazette) No: 2582 of June 30, 2020 (Press release, AskAt, JUL 10, 2020, View Source [SID1234561807]).

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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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