On December 17, 2015 Bristol-Myers Squibb Company (NYSE:BMY) and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) reported that they have entered into a collaborative agreement as part of Bristol-Myers Squibb’s Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S (Press release, Bristol-Myers Squibb, DEC 17, 2015, View Source [SID:1234508602]). The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.

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As part of the I-O RPM program, Bristol-Myers Squibb and OSUCCC – James will conduct a range of early phase clinical studies, and Bristol-Myers Squibb will fund training positions within the Hematology and Medical Oncology fellowship programs of the Ohio State University College of Medicine, Department of Internal Medicine.

"Immuno-oncology is rapidly evolving with the potential to play a significant role in the treatment of a broad range of cancers and we are committed to finding innovative and efficient ways to further the science, research and development of these compounds for patients," said Laura Bessen, M.D., head of U.S. Medical, Bristol-Myers Squibb. "OSCUCC- James is a leading cancer research institution with a shared goal of improving outcomes for patients and we look forward to our collaboration through the I-O RPM program."

"It is clear based on existing and emerging scientific data that immuno-oncology therapeutics, which harness the patient’s own immune system to attack cancer cells, have tremendous potential to tailor patient treatments based on the individual’s unique tumor characteristics, and this clinical research partnership has the potential to give our patients – both locally and who travel here from across the globe – access to some of the most novel treatments available," said Richard Goldberg, M.D., Physician-in-Chief at The OSUCCC – James.

About I-O RPM

Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. The I-O RPM research program focuses on significant areas of high unmet need marked by poor outcomes among patients with rare population malignancies. A rare population malignancy is a subpopulation within a higher incident disease population. These patients have aggressive disease with an increased potential for early metastasis to multiple sites and/or are initially refractory or subject to early recurrences with conventional cancer therapies. Existing clinical research provide a strong rationale for further research into the potential of immunotherapies for these cancers.

The I-O RPM research program is a multi-institutional initiative with Robert H. Lurie Comprehensive Cancer Center of Northwestern University and the Northwestern Medicine Developmental Therapeutics Institute, Moffitt Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, UCLA and now OSUCCC – James. I-O RPM builds on Bristol-Myers Squibb’s formation in 2012 of the International Immuno-Oncology Network (II-ON), which is a global collaboration between Bristol-Myers Squibb and academia focused on facilitating the translation of scientific research findings into clinical trials and, eventually, clinical practice.

On December 17, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the European Commission has granted orphan drug designation to OXi4503 for the treatment of acute myeloid leukemia (AML) (Press release, OXiGENE, DEC 17, 2015, View Source [SID:1234508604]). The designation provides for ten years of marketing exclusivity in EU member countries following product approval. OXi4503 has previously received orphan drug designation from the U.S. Food and Drug Administration, which provides for seven years of marketing exclusivity after approval.

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"The European Commission’s decision highlights the need for new AML treatment options and improves the commercial potential of OXi4503," stated William D. Schwieterman, M.D. President and Chief Executive Officer of OXiGENE. "We have recently put plans in place to accelerate the development of this promising agent by immediately advancing into the next phase of our ongoing phase 1b/2 clinical trial in the U.S., in which OXi4503 will be used in combination with the approved AML drug cytarabine instead of as a stand-alone investigational agent for the treatment of refractory AML."

Orphan designation in the European Union is granted to product candidates that are intended to treat life-threatening or chronically-debilitating conditions that affect no more than five patients per 10,000 of the EU population. Among other benefits, orphan designation provides for regulatory assistance and scientific advice from the European Medicines Agency during product development.

About OXiGENE

OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company’s investigational drugs include CA4P (fosbretabulin), which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.

On December 16, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"), reported that it will present at Biotech Showcase 2016 (Press release, Provectus Pharmaceuticals, DEC 16, 2015, http://www.pvct.com/pressrelease.html?article=20151216.1 [SID:1234508585]). The Company will summarize its business operations and discuss PV-10, its novel investigational drug for cancer, and PH-10, its topical investigational drug for dermatology.

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The Company’s presentation is currently set for 3:30 pm Pacific Time on January 13, 2016. The presentation is scheduled to take place on Level 4, the Cyril Magnin Foyer.

The presentation will be available on the Company’s website upon conclusion of the live presentation at the conference.

On December 16, 2015 BioInvent International (OMXS: BINV) reported that it is providing an update on its clinical and preclinical drug programs (Press release, BioInvent, DEC 16, 2015, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=6B8448BB1FD836C4 [SID:1234508590]). Several positive interactions with regulatory authorities have taken place and clinical trials with three of the Company’s antibodies are expected to start in 2016. A scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) was held in preparation for the first clinical study of BI-1206. The study plan presented to the regulator, as well as BioInvent’s data, were well received. Cancer Research UK plans to submit the Clinical Trial Application in April 2016.

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With an increased commitment to the BI-505 program, BioInvent will submit a clinical trial application to the US Food and Drug Administration (FDA) in December 2015.

BioInvent and its partner Oncurios is planning to start a clinical trial with TB-403 in medulloblastoma during early 2016.
BioInvent has established itself as a company with strong clinical programs and a strong position in the immuno-oncology area.

BI-1206
BI-1206 is an antibody that blocks the CD32b protein which is overexpressed in lymphoma (cancer in the lymphatic system). By combining today’s standard of care therapy rituximab (Rituxan/MabThera) with BI-1206, it is possible to achieve a better anti-tumour effect. The planned Phase l/ll clinical study will be sponsored, managed and funded by one of the world’s largest scientific non-profit organisations, Cancer Research UK. This is done under an agreement with BioInvent as part of the Clinical Development Partnerships Scheme, a joint initiative between the Centre For Drug Development and Cancer Research Technology.
In a recent scientific advice meeting with the MHRA, the design of the first clinical study with BI-1206 was discussed. The study will enrol patients with non-Hodgkin lymphoma and chronic lymphatic leukaemia.

Cancer Research UK plans to submit a Clinical Trial Application for the Phase I/II study to the MHRA in April 2016. The lead clinical site at the University of Southampton and at least three other clinical trial sites in the UK will be involved in the trial and aim to be ready to open to recruitment as soon as all necessary regulatory and ethical approvals are in place.

In collaboration with leading academic institutions, BioInvent has started preclinical evaluation of BI-1206 against different sub-types of non-Hodgkin lymphoma using human material from biobanks. The results will provide an important basis for designing the continuing clinical programme.

"The meeting with the UK regulatory agency, MHRA, is an important step forward for BI-1206. We have reached an important milestone in this highly innovative program. We are now in a good position to advance this program further towards market registration for carefully selected patient cohorts with the greatest medical need," says Michael Oredsson, CEO of BioInvent.

BI-505
BI-505 is a human antibody against ICAM-1 developed by BioInvent, which will be clinically tested in cooperation with researchers at Penn Medicine as an immuno-oncological therapy to prevent or delay relapse in patients with multiple myeloma (a form of bone marrow cancer) undergoing stem-cell transplantation. Preclinical data indicates improved activity against myeloma when BI-505 is administered in combination with Velcade or Revlimid. BI-505’s favourable safety profile has been demonstrated in a previous phase I trial. This and the unique mechanism of action, "flagging" remaining myeloma cells for elimination by actively recruited macrophages, as well as the potential to inhibit ICAM-1 dependent survival signals between myeloma cells and tumour stroma, indicate a unique possibility of improving the therapeutic effect of stem-cell transplantation.
Bioinvent plans to submit an application to the FDA in the USA, requesting to start the randomised, controlled phase II study on multiple myeloma patients undergoing autologous stem-cell transplantation, by December 2015 with Penn Medicine as the coordinating site.

The study is expected to start in the first quarter of 2016, which is in line with previous communication.

BioInvent has decided to assume overall responsibility for the study as sponsor of the trial. This will improve control of data and enable expansion of the trial to additional sites, if required.

"By taking on overall responsibility and increasing the number of trial centres for the study with BI-505 we can generate data of the quality required by authorities to enter into discussions regarding a registration procedure based on successful phase II data," says Anna Teige Wickenberg, Vice President Clinical Development, BioInvent.

TB-403
BioInvent and its partner Oncurious are planning to start a new clinical study with the antibody TB-403 against certain rare forms of cancer in the brain, nervous system and connective tissue in children and adolescents. TB-403 has already been evaluated in clinical studies in adults for other cancers and has demonstrated a good safety profile. The project’s new direction is based on new knowledge about the antibody’s mechanism of action. BioInvent has the right to 40 percent of all future revenue from the project.

The study, which is expected to start in early 2016, will be implemented in cooperation with a network of specialist clinics in the USA with good access to the relevant patient cohorts.
The preparations for study start are well underway.

The first safety evaluation part of the study includes patients with medulloblastoma (tumour in the cerebellum), neuroblastoma (tumour in the sympathetic nervous system), Ewings sarcoma (tumour in the connective tissue) and alveolar rhabdomyosarcoma (tumour in the connective tissue), whereas children with medulloblastoma will be included in the efficacy evaluation part of the study.

"Children who suffer from these serious cancers are in great need of more effective treatment and we have therefore prioritised designing a study that should give us the answer as to whether TB-403 is effective in children with medulloblastoma," says Michael Oredsson, CEO of BioInvent.

REGULATORY T-CELLS (TREG)
Regulatory T-cells (Tregs) have a strong ability to inhibit various immune responses. A series of clinical studies show that antibodies targeting CTLA-4 and PD-1 can induce a very long-lasting response in some cancer patients. BioInvent’s F.I.R.S.T technology platform is an excellent tool for identification of both target structures and antibodies in the Treg area.
BioInvent has succeeded in identifying high-affinity antibodies with depleting activity against regulatory T-cells
A first pool of mouse-reactive anti-Treg antibodies, which can be screened in well- established preclinical models to identify novel targets particularly suitable for antibody-mediated Treg depletion, or modulation of Treg immune suppressive activity, have been identified. Target: antibody pairs will be used to evaluate new drug targets and antibody mechanism-of-action in preclinical proof-of-concept tests, paving way for human cross-reactive, or functionally equivalent human lead clinical candidate antibodies. BioInvent recently announced that the Company has received a non-exclusive licence for a special type of antibody format, IgG2B. Preclinical trials with IgG2B antibodies have shown that this antibody type has the potential to more independently activate immune cells e.g. macrophages and T cells to promote anticancer immune responses. When targeted to appropriate receptors, the IgG2b isotype is expected to increase chances of developing new effective drugs in the immune-oncology area.
OX-40

BioInvent is working in cooperation with Cancer Research Technology (CRT) and the University of Southampton in the UK to develop new immunotherapeutic cancer drugs based on antibodies that target OX-40 and 4-1BB, two known co-receptors that help activate T-cells and long-lasting antitumor immune responses.
Antibodies with high affinity, agonistic activity on effector T-cells and the ability to eliminate regulatory T-cells in vitro have been generated.

Preclinical in vivo studies to document proof-of-concept for BioInvent’s antibodies in the OX-40 project will be initiated during the first quarter of 2016.

TUMOUR ASSOCIATED MYELOID CELLS (TAM)
Myeloid cells are essential to our innate immune system, but they can also be "hijacked" by tumours to support growth and cancer spread. In the fourth quarter of 2015, BioInvent worked on preparations to develop function-modulating antibodies against tumour associated myeloid cells (TAM), a type of white blood cell that is recruited by cancer cells to sustain growth and spread, and prevent immune attack. Antibody-mediated "reprogramming" of immune-suppressive tumour-associated myeloid cells into anti-tumor effector cells is therefore a very attractive therapeutic concept and represents an area of research in which BioInvent and its partners are at the cutting edge.

"F.I.R.S.T is a unique platform to identify new antibody-based drugs that more specifically destroy, or transform, cancer-driving immune cells such as Treg and TAM. Preclinical data indicates that antibodies against Treg and TAM can significantly improve the effects of the immunotherapies available today and make it possible to treat cancers where current immunotherapies aren’t working due to a strongly suppressed immune response to the cancer," says Björn Frendéus, Chief Scientific Officer, BioInvent.

On December 15, 2015 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11 (Press release, Merck & Co, DEC 15, 2015, View Source [SID:1234508581]).

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GARDASIL 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. GARDASIL 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

"This is an important approval that now aligns the indication for GARDASIL 9 in males and females ages 9 through 26 to that of GARDASIL, and also supports the CDC’s HPV vaccine recommendations for use in males," said Jacques Cholat, M.D., president, Merck Vaccines. "We are pleased that males 16 through 26 years of age will now have access to GARDASIL 9, which includes the most HPV types, to help further reduce the burden of HPV-related diseases."

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) includes the greatest number of HPV types in any available HPV vaccine. GARDASIL 9 adds protection against five additional HPV types — 31, 33, 45, 52 and 58 — in addition to the four original HPV types covered by GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Seven HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90-95 percent of HPV-related anal cancers, approximately 90 percent of cervical cancers, and approximately 80 percent of high-grade cervical lesions (cervical precancers, defined as CIN 2 and CIN 3) worldwide. These seven HPV types also cause 90 percent of HPV-related vulvar cancers and 85 percent of HPV-related vaginal cancers. HPV types 6 and 11 cause approximately 90 percent of genital warts cases in males and females.

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.

CDC’s ACIP Recommendations

Following its February 2015 meeting, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) included GARDASIL 9 in the HPV vaccination recommendations, which added it to the routine recommendations for vaccination of males and females 11 and 12 years of age. The HPV vaccination series can be started at age nine. Only GARDASIL 9 and GARDASIL are indicated and recommended for use in males in the United States. The ACIP also recommends HPV vaccination for females 13 through 26 years of age and for males 13 through 21 years of age who have not been vaccinated previously or who have not completed the 3-dose series.

GARDASIL 9 is covered under the CDC’s Vaccines for Children (VFC) program for both boys and girls. Since 1994, the VFC program has provided vaccines to children through the age of 18 who are Medicaid-eligible, uninsured, underinsured, American Indian or Alaska Native.

"While it is important to remember that the CDC’s ACIP recommends routine HPV vaccination at age 11 or 12, before exposure to the HPV virus, this expanded indication for GARDASIL 9 is exciting because now 16- through 26-year-old young men can get this HPV vaccine," said Anna Giuliano, Ph.D., founding director, Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center & Research Institute, Tampa, and clinical investigator for GARDASIL 9. "It’s important that we collectively work to increase HPV vaccination rates to help prevent HPV-related cancers and diseases."

CDC Reports Low HPV Vaccination Rates, Especially for Males

In 2014, the CDC made increasing HPV vaccination rates a public health priority. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage is especially low in males. In 2014, for boys 13 through 17 years of age, coverage with at least one dose of HPV vaccine was just 41.7 percent, and receipt of the recommended three doses was even lower — just 21.6 percent.

A health care provider recommendation is very important in helping a parent decide to get their son or daughter vaccinated against HPV-related cancers and diseases, and the CDC encourages health care providers to routinely recommend HPV vaccination at 11 or 12 years of age with the same sense of importance used to recommend other adolescent vaccines in order to increase vaccination rates and help protect more individuals against HPV-related cancers and other diseases.

Availability and market transition information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is available, and most managed care plans have already made decisions to cover the cost of GARDASIL 9, including for males 16 through 26 years of age, making the number of plans covering GARDASIL 9 similar to the number covering the cost of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. The approval of GARDASIL 9 for males 16 through 26 years of age is a milestone in the planned transition from GARDASIL to GARDASIL 9, as both products are now approved for the same populations.

The goal in the United States is to fully transition from use of GARDASIL to GARDASIL 9. Merck will ensure availability of and communication around GARDASIL and GARDASIL 9 to allow for a smooth transition.

GARDASIL 9 is available through Merck’s patient assistance program for vaccines. Through this program, Merck provides free vaccines to adults who are uninsured and who are unable to afford vaccines. More information can be found at www.MerckHelps.com.

Clinical Program for Immunogenicity and Safety of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Males 16 through 26 Years of Age

The clinical trial program for GARDASIL 9 was designed to build upon the safety and efficacy established in clinical trials with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. The pivotal efficacy study in females 16 through 26 years of age evaluated the efficacy of GARDASIL 9 to prevent HPV-related cervical, vulvar, and vaginal disease using GARDASIL as a comparator. Effectiveness of GARDASIL 9 against persistent infection and disease related to the nine vaccine HPV types in males 16 through 26 years of age was inferred from a non-inferiority comparison of type-specific antibody geometric mean titers (GMTs) following vaccination with GARDASIL 9 among heterosexual males 16 through 26 years of age with those among females 16 through 26 years of age.

A total of 1,106 heterosexual males and 1,101 females were enrolled in the study. The primary analyses were conducted in the per-protocol population, in which study participants received all three vaccinations within pre-defined day ranges, did not have major deviations from the study protocol, and were seronegative to the relevant HPV type(s) prior to dose one. The analyses found that anti-HPV GMTs at Month 7 among males 16 through 26 years of age were non-inferior to anti-HPV GMTs among females 16 through 26 years of age.

In the clinical studies with GARDASIL 9 in males 16 through 26 years of age, the most common (≥10%) local and systemic adverse reactions reported were injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%).

Important Information about GARDASIL 9

GARDASIL 9 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN.

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

Select Safety Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Dosage and administration for GARDASIL 9

GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh at the following schedule: 0, 2 months, 6 months.

About HPV and related cancers and diseases

In the United States, HPV will infect most sexually active males and females in their lifetime. According to the CDC, there are approximately 14 million new genital HPV infections in the United States each year, half of which occur in people 15 through 24 years of age. For most people, HPV clears on its own, but for others who don’t clear the virus, it could lead to significant cancers and other diseases in males as well as females, and there is no way to predict who will clear the virus.

HPV causes approximately 85-90 percent of anal cancers in both males and females. According to the American Cancer Society, an estimated 2,600 men and 4,600 women in the United States will be diagnosed with anal cancer in 2015, and overall rates have been increasing. There is no routine screening recommended for the general population to reduce the risk of anal cancer.

HPV causes approximately 90 percent of genital warts in both males and females. There are approximately 360,000 cases of genital warts each year in the United States. Treatment of genital warts can be painful, and they may recur after treatment, especially in the first three months. Approximately 3 out of 4 people get them after having genital contact with someone who has genital warts.

In women, HPV also causes virtually all cervical cancer cases. Each day another 35 women are diagnosed with cervical cancer in the United States — about 12,900 women per year. HPV also causes approximately 70-75 percent of vaginal cancer cases and approximately 30 percent of vulvar cancer cases in females. Additionally, there are an estimated 3 million abnormal Pap results, many of which are caused by HPV, that require follow-up each year in the United States.