TOLREMO Raises CHF 2.4 Million in Seed Financing

On September 18, 2018 TOLREMO therapeutics AG ("TOLREMO"), a privately held research-stage biotechnology company, reported the completion of a fundraiser with private investors of 2.4 million Swiss Francs (Press release, TOLREMO, SEP 18, 2017, View Source [SID1234525826]). The proceeds will be used to advance the company’s discovery and development of breakthrough medicines to target drug resistance in cancer therapy.

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Dr. Stefanie Flückiger-Mangual, Chief Executive Officer and co-founder of TOLREMO, commented: "Cancer patients often respond favorably to modern therapies, but in many cases long-term survival is limited by the development of drug resistance. During several years of research at ETH Zurich, we discovered that, surprisingly, the development of drug resistance already starts early on following initiation of cancer therapy. We have developed a deep understanding of the molecular mechanisms involved in this and our goal is to intervene with these mechanisms in order to eradicate the seed of drug resistance and extend patient survival."

TOLREMO’s science-based drug discovery and development pipeline is fueled by a unique drug screening platform for which a patent has been filed. In addition to discovering and developing novel anti-drug resistance molecules, the platform is also used to identify novel ways of combining approved drugs to prevent drug resistance in cancer therapy.

Dr. Isaac Kobrin, Chairman of the Board and a co-founder of TOLREMO, commented: "We believe that TOLREMO is poised to reach several key milestones in the development of novel cancer therapies within the next 12 to 18 months. The currently raised funds of 2.4 million Swiss Francs are expected to cover that period and prepare the grounds for the future growth of the company."

TECENTRIQ GO29695 (NCT02431208) and BO29562 (NCT02631577) partial clinical hold reactive statement

On September 15, 2017 Roche reported that based on emerging safety data from clinical trials evaluating pembrolizumab in combination with either lenalidomide or pomalidomide in multiple myeloma, the FDA has requested that a Phase Ib and a Phase Ib/II TECENTRIQ study be placed on partial clinical hold (Press release, Hoffmann-La Roche, SEP 15, 2017, View Source [SID1234520536]). At Roche/Genentech we remain committed to patient safety and will continue to work closely with the FDA. It is our understanding that the FDA is evaluating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in combination with an immunomodulatory medicine to determine if it is a class-wide (anti-PD1/PDL1) concern in multiple myeloma/blood cancers or a specific concern with certain combinations with immunomodulatory medicines.

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The two studies include cohorts evaluating TECENTRIQ in combination with an immunomodulatory medicine (IMiDs) in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma. While the partial clinical hold is in place, patients who are currently enrolled in these trials and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled. Although the trials are early and ongoing, we have not seen evidence of similar findings of increased death or serious events with the use of TECENTRIQ in combination with immunomodulatory medicines.

10-Q/A [Amend] – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q/A [Amend], Heat Biologics, SEP 15, 2017, View Source [SID1234520540])

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Halozyme Licenses New Enhanze Target For $30 Million Upfront Payment, Future Milestones And Royalties

On September 14, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported it licensed its ENHANZE drug-delivery technology to Roche for exclusive development of an undisclosed therapeutic target (Press release, Halozyme, SEPT 14, 2017, View Source [SID1234527667]).

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Under terms of the agreement, Halozyme will receive an initial $30 million with the potential to earn additional payments of up to $160 million subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive tiered, mid-single digit royalties on sales of commercialized products.

"We are pleased to broaden our longstanding collaboration with Roche to include selection of a new target," said Dr. Helen Torley, president and CEO. "With each new licensing agreement, we see the potential for our global partners to advance their innovative therapies, reducing the treatment burden for patients, caregivers and payers through shorter administration times or a less frequent dosing regimen."

The Halozyme/Roche relationship dates back to the original global collaboration and licensing agreement for the ENHANZE technology signed in 2006. From this agreement, Roche developed two subcutaneous formulations of cancer drugs for markets worldwide. More recently, the relationship expanded to include the study of Halozyme’s investigational oncology drug, PEGPH20, with atezolizumab as part of a clinical collaboration announced in 2016.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous delivery.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

10-Q – Quarterly report [Sections 13 or 15(d)]

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, SEP 14, 2017, View Source [SID1234522112]).

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