On March 28, 2017 Selvita S.A. (WSE:SLV), and Berlin-Chemie Menarini, a company of the Menarini Group, reported that both companies have entered into a global license agreement for SEL24, a dual PIM/FLT3 inhibitor currently in Phase I/II trials in acute myeloid leukemia (AML) patients (Press release, Ryvu Therapeutics, MAR 28, 2017, View Source [SID1234562878]).

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SEL24 is a Selvita-developed first-in-class orally available dual PIM/FLT3 kinase inhibitor with a unique activity profile. While it is currently investigated for the treatment of patients with relapsed/refractory (R/R) AML, preclinical data suggest potential activity in other hematological malignancies and solid tumors. The program entered Phase I/II in early 2017.

We are excited to sign a license agreement for SEL24 with the Menarini Group – said Pawel Przewiezlikowski, Chief Executive Officer at Selvita. This collaboration takes us another step closer to delivering a much-needed new treatment for AML patients. Menarini Group dedication to providing transformative therapies for people courageously facing various life-threatening diseases such as cancer, assures us that the potential of SEL24 in treatment of cancer patients will be fully realized.

According to the agreement, Selvita will grant Menarini Group an exclusive license to further research, develop, manufacture and commercialize SEL24 worldwide. Under the terms of the agreement, Selvita will receive an upfront payment, and will be eligible to receive milestone payments and royalty on future sales.

Dr. Reinhard Uppenkamp, Chairman of Berlin Chemie-Menarini, highlighted the scientific capabilities of Selvita: We were impressed of the very high-level scientific know-how of Selvita. I am sure that the collaboration between our two companies on SEL24 will be extremely important for cancer patients.

On March 28, 2017 GeneQuantum Healthcare (Suzhou) Co., Ltd., a high-tech company focused on the research and development of innovative Bio-therapeutics, reported the completion of a RMB40 million (equal to approximately $5.8 million) Series A financing (Press release, GeneQuantum Healthcare, MAR 28, 2017, View Source [SID1234553995]). The lead investor is Oriza Seed Venture Capital ("Oriza Seed"), joined by TF Capital.

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GeneQuantum was founded in August 2013 at Suzhou Industrial Park, and has built-up a world-class bio-conjugation technology platform, focusing on developing series of next generation anti-tumor Antibody-Drug-Conjugates (ADCs) with best-in-class potential. Securing this round of financing will significantly promote the development of current ADC candidates towards IND filling in both US and China, meanwhile further expanding the company’s product pipeline.

"GeneQuantum’s innovative Ligase Dependent Conjugation (LDC) technology, combined with IP protected Automatic On-line Monitoring Conjugation System and Linker Screening & Optimization Facility, provide a holistic solution for the R&D of next generation ADCs," said Dr. Gang Qin, Founder and CEO of GeneQuantum. "In comparison with ADCs produced via conventional technologies, drug candidates generated from the unique LDC platform have shown a drastically enlarged therapeutic window. We believe this will ensure GeneQuantum’s leading role in the field of bio-conjugation therapeutics development. It is our honor to have the acknowledgement and support from Oriza Seed and TF Capital, senior biopharmaceutical investment agencies. This will not only provide us with the financial support needed for IND application, but also bring a wealth of resources. Anchored to our mission ‘Dedication to Innovation, Responsibility for Health’, we will stick to innovation and remain committed to continuously providing global cancer patients with better and safer therapeutics."

"Oriza Seed has been focusing on investing early stage pharmaceutical companies, for us, the most important features are the technology innovation capability of the core team and market potential of the products," said Eric Zhao, Partner of Oriza Seed. "We highly recognize the value of GeneQuantum’s innovative and unique bio-conjugation platform, and would like to facilitate bringing candidate drugs to clinical trials as soon as possible, eventually benefiting patients."

"Since the establishment of TF Capital, we have been dedicated to looking for pharmaceutical companies holding key technologies and a high competition barrier," said Kevin Chiang, CEO of TF Capital. "We are very positive on GeneQuantum’s innovative bio-conjugation technology and the core team’s drug development strategy. The highly effectiveness and persistence of the executive team deeply impressed us. We hope our industry resources will help to accelerate the product development process of GeneQuantum."

On March 28, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that it has achieved pharmacokinetic and pharmacodynamic goals for CB-1158 which, under its agreement with Incyte Corporation, entitles the Company to receive a $12 million payment from Incyte (Press release, Calithera Biosciences, MAR 28, 2017, View Source [SID1234535253]).

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"We are very excited to achieve this early milestone under our collaboration with Incyte as CB-1158 has demonstrated the desired pharmacologic activity in humans, with a corresponding elevation in plasma arginine levels to those achieved with efficacious doses in preclinical models of cancer. Through our collaboration with Incyte, we will continue to evaluate the role of arginase inhibition in the immuno-oncology setting with CB-1158 and we expect to present additional clinical data mid-2017," said Susan Molineaux, President and Chief Executive Officer of Calithera Biosciences.

In January, 2017, Calithera and Incyte established a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in a monotherapy dose escalation clinical trial and also in combination with anti-PD-1 therapy. Additional studies are expected to evaluate CB-1158 in combination with other immuno-oncology agents. About Arginase Arginase is an enzyme produced by immunosuppressive myeloid cells, including myeloid-derived suppressor cells (MDSCs) and neutrophils, which prevents T-cell and natural killer (NK) cell activation in tumors. Arginase exerts its immunosuppressive effect by depleting the amino acid arginine in the tumor microenvironment which subsequently prevents activation and proliferation of the immune system’s cytotoxic T-cells and NK-cells. Inhibition of arginase activity reverses this immunosuppressive block and restores T-cell function. In preclinical models, arginase inhibition has been shown to enhance anti-tumor immunity and inhibit tumor growth.

On March 28, 2017 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for the year ended December 31, 2016 (Filing, Q4/Annual, Galectin Therapeutics, 2016, MAR 28, 2017, View Source [SID1234518377]). These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Galectin Therapeutics management will host a conference call at 9:00 a.m. Eastern time March 28, 2017 to discuss this press release.
To access the conference call dial 844-899-6544 and provide the operator with Pin Number 89964111.
Galectin also invites all interested parties to listen to its conference call via webcast at View Source The webcast will also be available on the investor relations portion of the Company’s website at View Source The webcast will be archived on the Company’s website within two hours of the live call. The webcast will be available on the Company’s website at www.galectintherapeutics.com for 90 days.

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Management Commentary
"Galectin Therapeutics achieved a number of significant milestones in the development of our lead compound, GR-MD-02, during 2016," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "Furthermore, we’ve recently completed equity financings that have generated sufficient funding to cover currently planned expenditures through 2017.
"While non-alcoholic steatohepatitis (NASH) cirrhosis remains GR-MD-02’s primary disease target, a number of additional trials have provided encouraging early results that provide additional insight on the clinical effect of GR-MD-02. In total, what we have seen in our early trials in moderate-to-severe plaque psoriasis and severe atopic dermatitis have consistently shown that GR-MD-02 demonstrates clinically significant, biological activity in humans.
"NASH cirrhosis represents a large unmet medical need with no currently approved therapies, and we are very pleased with our progress in the NASH-CX trial. A drug that can halt progression of, or reverse existing fibrosis, in NASH cirrhosis patients would be a breakthrough therapeutic intervention that may prevent complications, alleviate the need for liver transplant, and even prevent death.
"Our Phase 2b NASH-CX clinical trial enrollment exceeded its target and, to date, 71 patients have completed all 52 weeks of infusions with GR-MD-02, and 155 patients have completed 26 weeks of infusions. More than 3,400 infusions (or 85% of the maximum infusions in the trial) have been administered, with no drug-related serious adverse reactions and a dropout rate that is below the rate included in the trial design. The top-line data readout of the NASH-CX trial remains on track for early December 2017.

"The Providence Cancer Center is continuing two investigator-initiated Phase 1 clinical trials of GR-MD-02 used in combination with approved immunotherapies, Yervoy and Keytruda in patients with advanced melanoma, oral/head and neck cancer (OHN) and non-small cell lung cancer (NSCLC). There have been no safety concerns in either of these studies. Of the five patients with advanced melanoma who underwent combination therapy with GR-MD-02 (2 mg/kg) and Keytruda, one had an impressive partial response, heading towards a complete response, and one had a mixed response.

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"Galectin Therapeutics also announced positive results in studies of GR-MD-02 for patients with serious skin diseases. This an encouraging new indication for GR-MD-02 and one of the previously mentioned demonstrations that the drug is biologically active in humans.

"A Phase 2, exploratory study of GR-MD-02 in patients with severe plaque psoriasis showed all five patients enrolled had significant clinical improvement (mean of 52% improvement) as measured by an objective measurement, the PASI (Psoriasis Area and Severity Index). After receiving 8 mg/kg doses of GR-MD-02 for up to 24 weeks, the fifth patient, who also had the most severe baseline disease, had an 82% PASI improvement approximately one month following the full thirteen infusions (24 weeks).

"In an investigator-initiated protocol, GR-MD-02 was also used to treat three adult patients with severe atopic dermatitis, each of whom had been recalcitrant to multiple therapies over many years. All three patients have had a marked clinical effect with near resolution of pruritus, or itching, and regression of skin lesions. Two patients achieved a 64% and 74% reduction in Eczema Area and Severity Index (EASI), after only 6 weeks and 3 drug infusions. These findings are believed to demonstrate a clinically significant effect of this novel investigational drug in this patient population."

"In summary, we believe that Galectin is in a solid position from clinical, financial and leadership perspectives," Dr. Traber concluded.

Financial Results
For the year ended December 31, 2016, the Company reported a net loss applicable to common stockholders of $22.4 million, or $0.76 per share, compared with a net loss applicable to common stockholders of $21.1 million, or $0.88 per share, for 2015. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program.
Research and development expense for 2016 was $15.3 million, compared with $13.1 million for 2015. The increase primarily relates to costs for the Phase 2 clinical trials begun in 2015, partially offset by lower preclinical costs.
General and administrative expense for 2016 was $6.2 million, compared with $7.0 million for 2015, primarily due to a decrease in stock based compensation.
As of December 31, 2016, the Company had $15.4 million of non-restricted cash and cash equivalents. In January and February 2017, the Company raised a total of $1.5 million in net proceeds from issuance of common stock. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through December 31, 2017.

On March 28, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, reported financial and operational results for the fourth quarter and year ended December 31, 2016 as well as recent corporate progress (Press release, BioTime, MAR 28, 2017, View Source;p=RssLanding&cat=news&id=2257051 [SID1234518294]).

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"Asterias has achieved substantial progress over the last year, highlighted by previously announced positive interim efficacy and safety results from our ongoing SCiStar Phase 1/2a clinical trial, as well as initiation of operations at our new cGMP manufacturing facility for AST-OPC1," said Steve Cartt, President and Chief Executive Officer. "We are particularly encouraged by the results we have seen to date in the SCiStar trial, which we believe provide solid evidence of the potential for AST-OPC1 to help patients with complete paralysis recover arm, hand and finger function. Such recovery is critically important to increasing both independence and quality of life in patients who suffer complete cervical spinal cord injuries. In 2017, we look forward to completing study enrollment, engaging in discussions with the FDA to determine our optimal clinical path forward, and reporting more efficacy and safety data later in the year as it becomes available."

As of February 28, 2017, Asterias’ cash and cash equivalents totaled $19.9 million and combined with its available-for-sale securities totaled $33.5 million.

"Our cash position is significantly improved from the same time last year, which allows us to continue to advance our programs towards important development milestones," said Ryan Chavez, Chief Financial Officer. "We believe we currently have sufficient capital to fund operations through at least the first quarter of 2018."

2016 and Recent Key Achievements

Presented positive early efficacy data from the first cohort of the SCiStar study testing a dose of AST-OPC1 within the predicted efficacious dose range. In this cohort, 10 million AST-OPC1 cells were delivered to patients with neurologically complete (AIS-A 10) cervical injuries. Patients from this cohort showed improvement in upper extremity motor function at 3-months following administration of AST-OPC1. Asterias subsequently reported efficacy results for five patients from this cohort that showed additional motor function improvement at 6-months and 9-months following administration of AST-OPC1. Earlier this month, Asterias reported that the sixth, and final, patient in this cohort showed additional motor function improvement at 6-months following administration of AST-OPC1. The results suggest a meaningful and favorable difference to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 versus the level of expected rates of spontaneous recovery shown from historical control data of a closely matched patient population.
Received FDA clearance to expand the SCiStar study to include two additional cohorts of subjects with less severe AIS-B (motor complete, sensory incomplete) injuries.
Commenced dosing of two additional cohorts in the SCiStar study: AIS-B patients treated with 10 million AST-OPC1 cells; and, following clearance by the study’s Data Monitoring Committee, AIS-A patients treated with the higher dose of 20 million AST-OPC1 cells.
Successfully completed the validation and start-up of its internal current Good Manufacturing Practices (cGMP) manufacturing facility at Asterias headquarters in Fremont, CA in preparation for late-stage clinical trials of AST-OPC1.
Reported positive long-term follow-up results from the Phase 1 clinical trial of AST-OPC1.
Received Orphan Drug Designation from FDA for AST-OPC1 for the treatment of acute spinal cord injury.
Successfully completed an End-of-Phase 2 meeting with the FDA for AST-VAC1 in Acute Myeloid Leukemia (AML).
Completed clinical protocol development and the transfer of the manufacturing processes to produce AST-VAC2 to Cancer Research UK (CRUK) as part of the company’s ongoing partnership with CRUK to conduct a Phase 1/2a study for AST-VAC2 in non-small cell lung cancer.
Financial Results

Total revenues were $1.8 million for the fourth quarter and $7.0 million for the year ended December 31, 2016. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $7.9 million in the fourth quarter and $25.5 million in the year ended December 31, 2016, with the primary driver being expenses associated with our AST-OPC1 program. General and administrative expenses were $2.4 million in the fourth quarter and $15.5 million in the year ended December 31, 2016. Non-cash expenses related to warrants distributed to shareholders other than BioTime earlier in the year, which were included in general and administrative expenses, were $5.3 million.

Net loss was $9.3 million, or $0.20 per share, for the fourth quarter and $35.5 million, or $0.83 per share, for the year ended December 31, 2016. For the year ended December 31, 2016, net cash used in operating activities was $19.0 million and net cash provided from financing activities was $28.5 million.

As of December 31, 2016, Asterias’ cash and cash equivalents totaled $19.8 million and combined with its available-for-sale securities totaled $35.1 million.