On June 5, 2018 Immune Therapeutics, Inc. (OTCQB:IMUN) ("Immune," "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of two immunomodulating therapies for the treatment of autoimmune diseases, inflammatory diseases, cancer and HIV/AIDS reported a modification of the Company’s 2014 exclusive licensing agreement with Cytocom, Inc., a late stage biotechnology company that specializes in T-Cell activation immunotherapies (Press release, Immune Therapeutics, JUN 5, 2018, https://www.immunetherapeutics.com/2022/08/correction-immune-therapeutics-acquires-10-stake-in-cytocom-obtains-exclusive-rights-to-lodonal-for-pets-in-united-states/ [SID1234618215]).

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In addition to the rights granted in the 2014 agreement to make products containing Lodonal and Met-Enkelphline in Africa, Central America, South American and the Caribbean and to market and distribute the same for human use in certain emerging markets, the newly amended and restated license agreement also grants the Company the exclusive marketing and distribution rights for products containing Lodonal and Met-Enkelphline for treatment of animals in the United States.

According to Global Industry Analysts, Inc., the global market for animal medication is projected to reach US $44.4 billion by 2022, driven by increasing investments in animal drug development in response to unmet animal health needs and developments in veterinary diagnostics and services. The Company is developing its strategy to capture a portion of this market.

The Company’s CEO, Noreen Griffin, stated that: "We are confident in our ability to fast track our development program for companion animals in several qualified OMUMS (The Office of Minor Use and Minor Species) indications. Once approved, the company will receive seven years of exclusive marketing rights, which means we should face no competition from another sponsor marketing the same drug in the same dosage form for the same intended use for that time frame."

The amended and restated license agreement was entered in conjunction with a stock purchase agreement where the Company agreed to acquire 10% of Cytocom’s issued and outstanding common stock in exchange for cancelation of approximately $4,100,000 of debt owed by Cytocom to the Company. Under the original spin-out of Cytocom from the Company, IMUN was required to return all Cytocom shares to Treasury upon the funding of Cytocom, leaving them with no ownership in Cytocom. The Company’s Board, after due discussions and review of Cytocom’s potential, decided to make the investment. The acquisition solidifies the new direction of the strategic alliance between the Company and Cytocom.

Corporate Update

The Company has retained the services of a Ruderfer & Associates, Inc. Verona, NJ 07044 to assist with the search for a new CEO so that Noreen Griffin can be released to serve Cytocom and help grow the value of the Company’s investment in Cytocom.

The Company has filed two new patents in the last 30 days. At this time, the Company has now filed six patents pending applications in the last 18 months. The newest two patents include the use of Lodonal as a combination therapy for inflammation, autoimmune disease and cancer in both humans and animals, as well as use of Met-Enkelphline as a combination immunotherapy in the treatment of cancer.

The Company continues to work with the Pharmacy and Poison Board in Kenya and will update shareholders as soon as the Company receives additional information.

The Company is moving forward in Nigeria with implementing the launch of a marketing program with its partner Fidson Healthcare Plc and is hopeful that the initiative will result in sales in the coming months following the initiative.

On June 5, 2018 Verastem, Inc. (President and CEO: Robert Forrester)(NASDAQ:VSTM) and Yakult Honsha Co., Ltd. (President: Takashige Negishi)(Tokyo:2267), reported their entry into an exclusive licensing agreement for Yakult to develop and commercialize Verastem’s duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for the treatment, prevention or diagnosis of all oncology indications in Japan (Press release, Verastem, JUN 5, 2018, View Source;p=RssLanding&cat=news&id=2353165 [SID1234527168]). Verastem’s New Drug Application (NDA) for duvelisib is currently under review with the U.S. Food and Drug Administration (FDA) and is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). On April 9, 2018, Verastem announced that the FDA had accepted the NDA for filing with Priority Review.

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Under the terms of the agreement, Verastem will receive a one-time upfront payment of $10 million from Yakult. Verastem is eligible to receive up to an additional $90 million if certain future pre-specified development and commercialization milestones are successfully achieved by Yakult, plus double-digit royalties based on future net sales of duvelisib in Japan. In exchange, Yakult will receive exclusive rights to develop and commercialize duvelisib in Japan, at its own cost and expense. Yakult will also fund certain global development costs on a pro-rata basis. Verastem will retain all rights to duvelisib outside of Japan.

"In Japan, current therapies to treat CLL/SLL and FL are extremely limited and duvelisib has robust clinical data supporting its efficacy and safety in both indications, which we can build upon," said Masanori Ito, Head of Pharmaceutical Business Division/Managing Executive Officer, Member of the Board of Yakult. "We are eager to collaborate with Verastem to develop duvelisib in these initial hematologic malignancies, and then plan to later expand development to include the additional indications of PTCL and DLBCL. We believe this collaboration underscores our commitment to innovation, growing our oncology franchise, and commercializing medicines that positively impact the lives of patients in Japan."

"This agreement is an important, validating achievement for both duvelisib and Verastem Oncology and speaks to the significant global potential of this novel therapeutic for a broad range of hematologic malignancies," said Robert Forrester, President and Chief Executive Officer of Verastem. "Yakult is an established oncology leader in Japan that successfully markets several branded anti-cancer therapies, including Elplat and Campto. We look forward to working with the world-class development, regulatory and commercial teams at Yakult as they advance oral duvelisib toward commercialization in Japan."

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On June 5, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that positive data from the SL-701 and SL-801 clinical trials were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL (Press release, Stemline Therapeutics, JUN 5, 2018, View Source [SID1234527186]). The presentations are available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.

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SL-701 – Clinical Highlights

The Phase 2 trial of SL-701 in previously treated GBM patients met its primary endpoint of 12-month overall survival (OS-12)

Long-term survivors: 50% OS-12 with SL-701 + bevacizumab

Major responses, including complete responses (CRs), in second-line GBM

Well-tolerated, with very manageable side effect profile

Long-term survivors were comprised largely of patients with target-specific CD8+ T-cell responses

Median OS of target-specific CD8+ T cell responders not reached

Given the major unmet medical need in GBM and promising safety and efficacy data generated to date with SL-701 + bevacizumab, Stemline is considering next steps including leveraging potential immune-related biomarker in registration-directed trial designs
SL-801 – Clinical Highlights

Manageable safety and tolerability profile, largely grade 1-2 adverse events (AEs), to date
Multiple cases of stable disease (SD) in a heavily pretreated solid tumor patient population
Pharmacokinetic (PK) analyses suggest dose-dependent increases in exposure
Ideal therapeutic dose not yet determined as dose escalation continues
Ivan Bergstein, M.D., Stemline’s CEO, commented, "Our BPDCN disease awareness campaign is kicking into high gear as we approach the end of ASCO (Free ASCO Whitepaper), and we believe that our key messages around BPDCN and CD123 are resonating. Our SL-401 regulatory and pre-launch activities continue to progress, and our timelines remain on track." Dr. Bergstein continued, "Additionally, our SL-701 and SL-801 clinical presentations were very well-received at the conference, and our investigators are excited and engaged. The SL-701 + bevacizumab combination has been well-tolerated and has shown activity, including the emergence of long-term survivors comprised largely of target-specific CD8+ T cell responders. Given the major unmet medical need in GBM and SL-701’s promising safety and efficacy data, we are considering next steps, including applying these immune data in registration-directed trial designs. Additionally, we are encouraged by SL-801’s tolerability profile as we continue to dose escalate in a heavily pretreated solid tumor patient population of unmet medical need. Enrollment is ongoing, and we look forward to further updates later this year."

On June 5, 2018 Verastem, Inc. (President and CEO: Robert Forrester)(NASDAQ:VSTM) and Yakult Honsha Co., Ltd. (President: Takashige Negishi)(Tokyo:2267), reported their entry into an exclusive licensing agreement for Yakult to develop and commercialize Verastem’s duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for the treatment, prevention or diagnosis of all oncology indications in Japan (Press release, Verastem, JUN 5, 2018, View Source;p=RssLanding&cat=news&id=2353165 [SID1234527169]). Verastem’s New Drug Application (NDA) for duvelisib is currently under review with the U.S. Food and Drug Administration (FDA) and is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). On April 9, 2018, Verastem announced that the FDA had accepted the NDA for filing with Priority Review.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Under the terms of the agreement, Verastem will receive a one-time upfront payment of $10 million from Yakult. Verastem is eligible to receive up to an additional $90 million if certain future pre-specified development and commercialization milestones are successfully achieved by Yakult, plus double-digit royalties based on future net sales of duvelisib in Japan. In exchange, Yakult will receive exclusive rights to develop and commercialize duvelisib in Japan, at its own cost and expense. Yakult will also fund certain global development costs on a pro-rata basis. Verastem will retain all rights to duvelisib outside of Japan.

"In Japan, current therapies to treat CLL/SLL and FL are extremely limited and duvelisib has robust clinical data supporting its efficacy and safety in both indications, which we can build upon," said Masanori Ito, Head of Pharmaceutical Business Division/Managing Executive Officer, Member of the Board of Yakult. "We are eager to collaborate with Verastem to develop duvelisib in these initial hematologic malignancies, and then plan to later expand development to include the additional indications of PTCL and DLBCL. We believe this collaboration underscores our commitment to innovation, growing our oncology franchise, and commercializing medicines that positively impact the lives of patients in Japan."

"This agreement is an important, validating achievement for both duvelisib and Verastem Oncology and speaks to the significant global potential of this novel therapeutic for a broad range of hematologic malignancies," said Robert Forrester, President and Chief Executive Officer of Verastem. "Yakult is an established oncology leader in Japan that successfully markets several branded anti-cancer therapies, including Elplat and Campto. We look forward to working with the world-class development, regulatory and commercial teams at Yakult as they advance oral duvelisib toward commercialization in Japan."

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On June 5, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the combination of the PD-L1 antibody atezolizumab (TECENTRIQ), the MEK inhibitor cobimetinib (COTELLIC) and TESARO’s PARP inhibitor ZEJULA (niraparib) in patients with platinum-sensitive ovarian cancer (Press release, TESARO, JUN 5, 2018, View Source [SID1234527187]).

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"This partnership enables us to further expand the clinical assessment of niraparib-based combinations as we work to advance therapies for women living with ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Preclinical data has demonstrated potential synergy between MEK and PARP inhibitors, and there is emerging evidence to support an immunomodulatory role for PARP inhibitors. Data suggest the addition of atezolizumab may potentially further enhance the anti-cancer immune response. We look forward to evaluating the potential for this combination to further prolong responses to chemotherapy."

TESARO and Genentech are also working together to evaluate the combination of ZEJULA and atezolizumab in patients with metastatic bladder cancer as a part of MORPHEUS, Roche’s novel cancer immunotherapy development platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. The planned trial will be conducted by Genentech and is expected to begin by the end of 2018.

TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) are registered trademarks of Genentech, a member of the Roche Group.

About ZEJULA (Niraparib)
ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.