On October 16, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company reported that it will presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18 (Press release, Immunomics, OCT 16, 2018, View Source [SID1234530090]). William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM) Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18. William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics, Inc.

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics, Inc.

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On October 16, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 498 million in the third quarter of 2018 compared to USD 317 million in the third quarter of 2017, an increase of 57% (Press release, Genmab, OCT 16, 2018, View Source [SID1234530344]). The 2018 third quarter net sales were USD 318 million in the U.S. and USD 180 million in the rest of the world.

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Johnson & Johnson reported worldwide operational growth (excluding the impact of foreign currency movements) between the two third quarter periods of 60%.The growth was partially offset by a one-time adjustment outside the U.S. related to accruals for retroactive pricing adjustments which negatively impacted this worldwide operational growth by 16 percentage points.

Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

On October 16, 2018 Fresenius reported that it has confirms and narrows its Group guidance1 for FY/18. Group sales are expected to increase at the low end of the original 5% to 8%2 guidance range (in constant currency) (Press release, Fresenius, OCT 16, 2018, View Source [SID1234530132]). Fresenius expects net income3,4 growth at the low end of the original 6% to 9% guidance range (in constant currency). Excluding expenditures for the further development of the biosimilars business, net income3,5 growth is projected at the low end of the original ~10% to 13% guidance range (in constant currency). Narrowing the Group guidance ranges is due to updated expectations at Fresenius Medical Care, Fresenius Kabi and Fresenius Helios.

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Fresenius Medical Care adjusts its outlook for FY/18 as the business development in Q3/18 was below the company’s expectations. Fresenius Medical Care now expects sales growth of 2% to 3%6 in constant currency (previously: 5% to 7%6). Whilst Fresenius Kabi confirms its guidance of 4% to 7% organic sales growth, it now expects to reach the top end of this range. Fresenius Kabi sees a strong development across all product lines and regions with North America standing out. Fresenius Helios confirms and narrows its FY/18 organic sales growth outlook, and now projects growth at the low end of the original 3% to 6% range. The business development in Germany in Q3/18 was below the company’s expectations mainly due to a decline in admissions and additional catalogue effects. In line with market development in Germany, Fresenius Helios sees a trend towards outpatient treatments leading to fewer admissions in its hospitals.

On a comparable basis8, Fresenius Medical Care now expects FY/18 net income7 to increase by 11% to 12%8 in constant currency (previously: 13% to 15%8). On an adjusted basis9, Fresenius Medical Care now expects FY/18 net income7 to increase by 2% to 3%9 in constant currency (previously: 7% to 9%9). Fresenius Kabi increases its FY/18 EBIT outlook and now expects 1% to 3%10 growth in constant currency (previously: -2% to +1%10). The increase is driven by a strong development across all product lines and regions with North America standing out. FY/18 EBIT excluding expenditures for the further development of the biosimilars business is now expected to grow by ~9% to 11%11 in constant currency (previously: ~6% to 9%11). Fresenius Helios adjusts its FY/18 EBIT outlook and now expects 0% to 2% growth (previously: 5% to 8%), driven by lower sales growth in Germany. Moreover, preparatory structural activities for anticipated regulatory requirements (e.g. clustering), as well as a lack of privatization opportunities in the German market continue to weigh on earnings growth.

Fresenius Vamed confirms its outlook for FY/18 and expects organic sales growth in the range of 5% to 10% and FY/18 EBIT growth of 32% to 37%. The integration of the inpatient post-acute care business acquired from Helios Germany is fully on track.

Q3/2018 preliminary financial results

In Q3/18, Fresenius Group sales increased by ~3%12 (~4%12 in constant currency) to ~€8.2 billion (Q3/2017: €8.297 billion). Group net income3 before special items13 increased by ~8% (~8% in constant currency) to ~€445 million (Q3/2017: €413 million). Fresenius Medical Care has increased the provision for the FCPA (Foreign Corrupt Practices Act) related charge by €75 million (not tax deductible). As in 2017, this charge is treated as a special item. Group net income3 before special items13 and before expenses for the further development of the biosimilars business increased by ~13% (~13% in constant currency) to ~€474 million (Q3/2017: €423 million).

Fresenius will publish its detailed Q3/18 and Q1-Q3/18 financial results on October 30, 2018.

On October 16, 2018 JHL Biotech reported that the National Medical Products Administration of the PRC (NMPA) has approved JHL’s Phase I and Phase III Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat several forms of cancer, including advanced non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer (Press release, JHL Biotech, OCT 16, 2018, View Source [SID1234530227]).

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Racho Jordanov, JHL Biotech, Co-Chairman and CEO stated, "We are very excited for our second biosimilar to be approved for clinical trials by the NMPA. This marks the second NMPA approval we have received in just four months and puts us another step closer to our vision of manufacturing biologics of the highest quality from
China for the world."

On October 16, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that it will present results from preclinical studies demonstrating synergistic activity of milciclib with sorafenib (NexavarR) to suppress tumor growth in an orthotopic mouse model of HCC (Press release, Tiziana Life Sciences, OCT 16, 2018, View Source [SID1234530004]). Additional preclinical studies will be presented which also demonstrated synergism between Milciclib and other tyrosine kinase inhibitors (TKIs) such as Regorafenib (StivargaR) and Lenvatinib (LenvimaR). The presentation will take place at the American Association for the Study of Liver Diseases (AASLD) Meetingin San Francisco on 9-11 November 2018.

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The details of the presentation are:

Poster #1543 entitled "Oral Treatment with Milciclib Either Alone or in Combination with Sorafenib Inhibited Tumor Growth in an Orthotopic Model ofHepatocellular Carcinoma"will be presented at the Poster Session III on November 11, 2018.

The data results from pre-clinic studies in mouse models which will inform future research but the information to be presented is an extension of previously announced research and does not, in the view of the Company and its directors, constitute material data requiring dissemination via a regulatory news service. According this information is being released via RNS Reach to inform interested parties of the direction and results of our continuing research activity.

MAJOR HIGHLIGHTS OF THE DATA

· Oral treatment with milciclib (30mg/kg/day) in combination with sorafenib (20mg/kg/day) produced synergistic effect on reduction of HCC-tumor growth in an orthotopic animal model. Since, the doses of milciclib and sorafenib used were sub-optimal, it is possible that the combination treatment at sub-optimal doses may reduce the toxicities of sorafenib or other TKIs.

· While treatment with milciclib as a single agent significantly suppressed growth in cell cultures as well as in animal models, it also exhibited strong synergistic anti-HCC effects with TKIs such as sorafenib, regorafenib and lenvatinib in other pre-clinical studies

· Mechanism of action studies suggest that milciclib exhibits broad-spectrum anti-HCC activity through a different mechanism from TKIs to produce the pronounced synergism.

"We reported earlier that oral treatment with Milciclib was found to be well-tolerated and it achieved both primary and secondary clinical endpoints in two separate phase 2 trials in thymic carcinoma and thymoma. The new pre-clinical research data demonstrating synergism with TKIs is exciting and suggests the potential of Milciclib in combination with one of these approved TKIs to develop a safe and an improved treatment option for HCC patients" said Gabriele Cerrone, Chairman of Tiziana Life Sciences

The complex multi-factorial etiology of HCC warrants an immediate need for drugs with different mechanisms that may produce improved efficacy and safety. The data we have announced from the interim analysis of the ongoing phase 2a clinical study of orally administered milciclib in sorafenib-resistant patients suggests that the treatment is well-tolerated and seems to provide clinical benefits to these patients. We are pleased to see that milciclib produces strong synergistic anti-HCC activity in preclinical studies as these data are important milestones to move forward in our evaluation the potential of Milciclib in combination with one of the approved TKIs to improve safety, efficacy and clinical response rate in HCC patients" said Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.

About Hepatocellular Carcinoma

Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, Pancreatic and colon cancer, thymic carcinoma and thymoma.

A phase 2a multi-centre and multi-country clinical trial (CDKO-125A-010) in sorafenib-refractory or -intolerable patients with unresectable or metastatic HCC is currently being conducted in Greece, Italy and Israel.