On January 15, 2019 Biomunex Pharmaceuticals, a biopharmaceutical company focused on providing immuno-therapeutics through the discovery and development of bi- and multi-specific antibodies, reported that it has entered into a licensing agreement with Sanofi (Press release, BIOMUNEX Pharmaceuticals, JAN 15, 2019, View Source [SID1234554044]). Under the terms of the agreement, Sanofi will have access to Biomunex’ proprietary technology to generate and optimize bi- and multi-specific antibody therapeutics. Sanofi will be solely responsible for the research, development, manufacturing and global commercialization activities. This agreement, the first of its kind for Biomunex, is in line with the company’s business model, which is to establish licensing or collaboration agreements and to become a clinical-stage company in the short term.

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Biomunex will receive an initial upfront payment and will be eligible to receive further clinical, regulatory and commercial milestone payments. Further financial details were not disclosed.

"This licensing agreement is a major milestone for Biomunex. It demonstrates the high value of the BiXAb technology and is the starting point for our collaboration strategy with pharmaceutical companies to discover and develop cutting-edge bi- and multi-specific antibodies, giving patients new treatment options," said Pierre-Emmanuel Gerard, MD, founder and CEO of Biomunex. "We believe that the proceeds from this deal, together with the funding round that we expect to finalize in the near future, will help us accelerate the development of Biomunex’ proprietary BiXAb bi- and multi-specific antibody programs in immuno-oncology and other therapeutic areas towards clinical development."

About the BiXAb Platform
Biomunex’ Plug-and-Play BiXAb platform generates next-generation bi- and multi-specific antibodies. This universal modular bi- and multi-specific format enables turnkey formatting of BiXAb from any pair of monospecific monoclonal antibodies as building blocks, with minimal engineering, in a timely and cost-effective manner. BiXAb possesses all the key properties expected of an ideal bi-specific antibody technology (modularity, excellent drug-like properties and manufacturability, multi-specificity potential). This enables Biomunex to develop immuno-oncology drug candidates with high anti-tumor activity demonstrating true synergy on their targets. The BiXAb platform is also suitable to generate innovative bi- and multi-specific antibodies in other therapeutic areas, such as immune-mediated inflammatory and infectious diseases.

On January 15, 2019 INmune Bio, Inc. ("INmune" or the "Company"), an immunotherapy company focused on developing therapies that harness the patient’s innate immune system to fight disease, reported the pricing of its initial public offering ("IPO") at a price to the public of $8.00 per share, for gross proceeds of a minimum of US$8 million and up to US$20 million (Press release, INmune Bio, JAN 15, 2019, View Source [SID1234532777]).

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The Company is offering a minimum of 1,000,000 shares and up to 2,500,000 shares to the public. Upon closing of the IPO, the Company’s common stock will be listed on the Nasdaq Capital Market under the ticker symbol "INMB". The offering will be sold on a best-efforts basis and provided the Company has at least the minimum offering amount in escrow and complies with the other closing conditions is expected to close and trade on the Nasdaq by the end of the month.

Univest Securities, LLC is acting as the lead manager for the IPO and WallachBeth Capital, LLC and WestPark Capital, Inc. are acting as co-managers.

A registration statement relating to this U.S. offering was filed with the Securities and Exchange Commission ("SEC") and was declared effective by the SEC as of December 19, 2018. The offering of these securities is being made only by means of a prospectus, forming a part of the registration statement. Copies of the final prospectus relating to the U.S. offering may be obtained from Univest Securities, LLC, 375 Park Avenue, Unit 1502, New York, NY 10152, by telephone at +1 212 343 8888 or email at [email protected]. In addition, a copy of the prospectus relating to the offering may be obtained via the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 15, 2019 KitovPharma (NASDAQ/TASE:KTOV), an innovative pharmaceutical company, reported new findings from its ongoing collaboration with researchers from the Hebrew University of Jerusalem (Press release, Kitov Pharmaceuticals , JAN 15, 2019, View Source [SID1234532770]). The data reveal NT219’s high affinity and selective binding to its target proteins.

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Hadas Reuveni, Ph.D., Chief Technology Officer at Kitov’s subsidiary, TyrNovo Ltd., in collaboration with Dr. Galia Blum and Dr. Ofra Moshel from the Hebrew University demonstrated that NT219 binds directly to Insulin Receptor Substrates (IRS) 1/2 and to the Signal Transducer and Activator of Transcription 3 (STAT3), both known modulators of tumor survival, metastasis and drug resistance. Data showed that a short exposure of cancerous cells to NT219 was sufficient to trigger irreversible shutdown of these pathways, resulting in a long-term anti-cancer effect.

Based on these latest findings, Kitov and Yissum, the Technology Transfer company of the Hebrew University of Jerusalem, have extended their collaboration agreement in order to deepen the understanding of NT219’s efficacy in overcoming tumors’ resistance to immunotherapy.

As previously reported (Reuveni et al, Cancer Research, 2013) upon binding to IRS1/2 a three-step mechanism is activated. IRS1/2 dissociates from the cell membrane, undergoes serine phosphorylation which prevents rebinding to the receptor, and is finally degraded by the proteasome. This sequence of events leads to the blockage of AKT – a major cancer cell survival pathway.

"We are excited about the new data which demonstrate NT219’s unique mechanism of action. NT219, a new and promising concept in cancer therapy, is designed to prevent, reverse, and delay resistance to anti-cancer drugs. We are developing NT219 as a drug to be used in combination with other therapies that has a potential to overcome cancer drug resistance and to boost the efficacy of numerous oncology drugs on the market today," stated Kitov CEO, Isaac Israel.

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related signal transducers, Insulin Receptor Substrates (IRS) 1/2 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired. NT219 is licensed from Yissum, the technology transfer company of the Hebrew University of Jerusalem.

On January 15, 2019, Stemline Therapeutics, Inc. ("Stemline" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, 8-K, Stemline Therapeutics, JAN 15, 2019, View Source [SID1234532699]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 8,888,889 shares (the "Firm Shares") of the Company’s common stock, $.0001 par value per share ("Common Stock"), at a price to the public of $9.00 per share, less underwriting discounts and commissions. Due to demand, this offering was upsized from the previously announced 6,600,000 shares. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,333,333 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on January 18, 2019, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The net proceeds to the Company are expected to be approximately $80,000,000, assuming no exercise of the option to purchase Additional Shares and after deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

On January 15, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate restructuring to focus resources on its development pipeline, comprising five clinical-stage cancer programs in various solid tumor types and addressing multiple cell types in the tumor microenvironment (Press release, Five Prime Therapeutics, JAN 15, 2019, View Source [SID1234532678]).

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"While we are on track for multiple data read-outs and potential phase advances from our pipeline in 2019, the Executive Team and Board felt it was necessary to sharpen our focus on our current clinical programs and the advancement of our later-stage research initiatives," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "This was a hard decision to make, but we believe that effective use of capital is crucial to supporting our strong pipeline of anti-cancer drug candidates. We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known."

The company is eliminating 41 current positions, representing approximately 20% of its current headcount, and will take a disciplined approach to replacing and adding headcount. The positions eliminated are primarily in areas relating to research, pathology and manufacturing. The company expects that the restructuring and other cost-saving efforts will result in a $10 million reduction in net cash used for operating activities during fiscal year 2019 as compared to 2018, with additional expected savings in 2020 and beyond due to lower ongoing personnel expense. Five Prime estimates that it will incur approximately $2 million of pre-tax charges for severance and other costs related to the restructuring, primarily during the first quarter of 2019.

The company’s financial guidance that it anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities reflects the expected reduction in the company’s operating expenses due to the elimination of positions. The company has no debt and ended 2018 with $270 million in cash, cash equivalents and marketable securities and believes this cash is sufficient to fund programs through multiple data readouts.