On May 18, 2016 Oryzon Genomics (ISIN Code: ES0167733015), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in oncology and neurodegenerative diseases, reported that the 2-year R&D collaboration with Roche concerning ORY-1001, licensed to Roche in 2014, has been extended until March 2017 (Press release, , MAY 18, 2016, View Source [SID:1234512557]).

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ORY-1001 (RG6016) is a highly potent and selective inhibitor of LSD1 currently in Phase I/IIA in acute leukemia patients. The license agreement by which the development and commercial rights to ORY- 1001 were granted to Roche, included a 2-year collaborative research program between Oryzon and Roche to further explore the potential of ORY-1001 in oncology and haematology. The program has delivered additional insight into the drug’s mechanism of action, provided support for its use in indications beyond acute leukemia and has expanded the toolbox for future and current clinical trials. Oryzon will continue to support the development of ORY-1001 through an extension of the collaborative research program that will run until March 2017 with the main goal to finalize the transfer of the newly generated technology and knowledge.

Carlos Buesa, Oryzon’s CEO, has declared: "This collaboration between Roche and Oryzon has been highly satisfactory and the success of the collaboration is reflected in four newly filed patent applications. We have been impressed by the experience of our partner and are convinced the results generated will strengthen the further clinical development of ORY-1001. "

On May 18, 2016 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that Alecensa (alectinib), an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression-free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001) (Press release, Genentech, MAY 18, 2016, View Source [SID:1234512543]).

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Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK inhibitor. There were fewer adverse events (AEs) in the Alecensa arm versus the crizotinib arm. Alecensa demonstrated a safety profile consistent with that observed in previous studies with no new or unexpected AEs.

"This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We believe these efficacy and safety results represent a clinically meaningful advancement for people with ALK-positive lung cancer, and we plan to discuss these data with health authorities, including the FDA."

The official data presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting will be on Monday, June 6, from 12:09 – 12:21 P.M. CDT (Abstract #9008).

Alecensa was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. ALEX, a global, randomized Phase III study, is ongoing, comparing Alecensa to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. This study is part of the company’s commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.

About J-ALEX

The J-ALEX study conducted by Chugai is an open-label, randomized Phase III study that compared the efficacy and safety of Alecensa to crizotinib in Japanese people. The J-ALEX study enrolled 207 people with ALK-positive, advanced or recurrent NSCLC who had not been previously treated with an ALK inhibitor. People were randomized to the Alecensa group or the crizotinib group in a one-to-one ratio. Results include:

Alecensa reduced the risk of disease worsening or death (PFS) by 66 percent compared to crizotinib (HR=0.34, 99 percent CI: 0.17-0.70, p<0.0001).
Median PFS was not reached in the Alecensa arm (95 percent CI: 20.3 months-not estimated) versus 10.2 months in the crizotinib arm (95 percent CI: 8.2-12.0).
Grade 3-4 AEs occurred with greater frequency in the crizotinib arm compared to the Alecensa arm (51 percent vs. 27 percent).
The most common AE occurring with > 30 percent frequency with Alecensa was constipation (36 percent). The most common AEs for crizotinib were nausea (74 percent), diarrhea (73 percent), vomiting (59 percent), visual disturbance (55 percent), alteration in taste (dysgeusia; 52 percent), constipation (46 percent), and an elevation in liver enzymes called alanine transaminase (ALT, 32 percent) and aspartate transaminase (AST, 31 percent).

About Lung Cancer

According to the American Cancer Society, it is estimated that more than 224,000 Americans will be diagnosed with lung cancer in 2016, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

About Alecensa

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

This indication is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 2 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:

Feeling tired
Feeling less hungry than usual
Yellowing of the skin or whites of the eyes
Dark urine
Itchy skin
Nausea or vomiting
Pain on the right side of stomach area
Bleeding or bruising more easily than normal
Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:

Trouble breathing
Shortness of breath
Fever
Cough
Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:

Have liver problems
Have lung or breathing problems
Have a slow heartbeat
Are pregnant or plan to become pregnant. Alecensa can harm an unborn baby. Patients taking Alecensa should tell their doctor right away if they become pregnant during treatment with Alecensa or think they may be pregnant
Women who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose of Alecensa
Men who have female partners that are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of Alecensa
Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into breast milk. A patient should not breastfeed during treatment with Alecensa and for one week after the final dose of Alecensa. Patients should talk with their doctor about the best way to feed their baby during this time.
Patients taking Alecensa should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

Tiredness
Constipation
Swelling in hands, feet, ankles, and eyelids
These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or View Source Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have three approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On May 18, 2016 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TECENTRIQ (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant) (Press release, Genentech, MAY 18, 2016, View Source [SID:1234512541]). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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"TECENTRIQ is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We thank the scientists, doctors, patients and their families who made it possible to bring TECENTRIQ to people with advanced urothelial carcinoma."

"Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers," said Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network. "TECENTRIQ is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options."

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. The indication for TECENTRIQ is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Today’s approval of TECENTRIQ is based on the Phase II IMvigor 210 study.

Possible serious side effects with TECENTRIQ include, but are not limited to, lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis), hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas), nervous system problems (neuropathy and meningoencephalitis), eye problems, severe infections and severe infusion reactions. Additional information on these and other side effects can be found below.

TECENTRIQ will be available to people in the United States within one to two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking TECENTRIQ through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Genentech is also evaluating TECENTRIQ in a confirmatory Phase III study (IMvigor 211), which compares TECENTRIQ to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.


About the IMvigor 210 study
IMvigor 210 is an open-label, multicenter, two-cohort Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or mUC, regardless of PD-L1 expression. People in a cohort of the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen (n=310) received a 1200-mg intravenous dose of TECENTRIQ on day one of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR). A summary of the efficacy and safety data from the IMvigor 210 study that supports this accelerated approval is included below. The median follow-up time for this cohort was 14.4 months.


All Patients

PD-L1 Expression Subgroups


n=310



PD-L1 Expression of < 5%

in ICs1

(n=210)



PD-L1 Expression

of ≥ 5% in ICs1

(n=100)

Number of IRF-assessed Confirmed Responders

46

20

26

ORR (%)

(95% CI)

14.8%

(11.1, 19.3)

9.5%

(5.9, 14.3)

26.0%

(17.7, 35.7)

Complete Response (CR) (%)

5.5%

2.4%

12.0%

Partial Response (PR) (%)

9.4%

7.1%

14.0%

Median DOR, months (range)

Not Reached

(2.1+, 13.8+)

12.7 months

(2.1+, 12.7)

Not Reached

(4.2, 13.8+)

1 PD-L1 expression in tumor-infiltrating immune cells (ICs)

+ Denotes a censored value

In a subset of people in the IMvigor 210 study with disease progression following neoadjuvant or adjuvant platinum-containing therapy (n=59), TECENTRIQ shrank tumors (ORR) in 22.0 percent (95 percent CI: 12.3, 34.7) of people.

The most common Grade 3-4 adverse reactions (≥ 2 percent) were: urinary tract infection (9 percent), anemia (8 percent), fatigue (6 percent), dehydration, intestinal obstruction (partial or complete blockage of the bowel), urinary obstruction, hematuria (blood in the urine; 3 percent), dyspnea (difficulty breathing; 4 percent), acute kidney injury, abdominal pain (pain in stomach area; 4 percent), venous thromboembolism (blood clots in the vein), sepsis (blood infection) and pneumonia (lung infection). Three people (0.9 percent) experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death. TECENTRIQ was discontinued for adverse reactions in 3.2 percent (10) of the 310 patients.

About metastatic urothelial carcinoma
According to the American Cancer Society (ACS), it is estimated that more than 76,000 Americans will be diagnosed with bladder cancer in 2016. About 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their lifetime than women.

About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of 350 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.4 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit View Source for more information.

About atezolizumab
Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1. Atezolizumab is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

TECENTRIQ U.S. Indications (pronounced ‘tē-SEN-trik’)

TECENTRIQ is a prescription medicine used to treat:

· A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,

· You have tried chemotherapy that contains platinum, and it did not work or is no longer working.

It is not known if TECENTRIQ is safe and effective in children.

Important Safety Information

Important Information About TECENTRIQ

TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Getting medical treatment right away may help keep these problems from becoming more serious. The healthcare provider may treat the patient with corticosteroid or hormone replacement medicines. The healthcare provider may delay or completely stop treatment with TECENTRIQ if severe side effects occur.



Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.



TECENTRIQ can cause serious side effects, including:

Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis may include: new or worsening cough, shortness of breath, or chest pain
Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, feeling less hungry than usual
Intestinal Problems (colitis) – Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual, blood in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – Signs and symptoms that the hormone glands are not working properly may include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
Nervous System Problems (neuropathy, meningoencephalitis) – Signs of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
Inflammation of the Eyes – Symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
Severe Infections – Symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, facial swelling


The most common side effects of TECENTRIQ include:

· feeling tired

· decreased appetite

nausea
· urinary tract infection

fever
constipation
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.



Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:

· have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system, such as Myasthenia Gravis or Guillain-Barre syndrome; or are being treated for an infection.

· are pregnant or plan to become pregnant.

o TECENTRIQ can harm an unborn baby.

o If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of TECENTRIQ.

· are breastfeeding or plan to breastfeed.

o It is not known if TECENTRIQ passes into the breast milk.

o Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ.

Patients should tell their healthcare provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.



Report side effects to the FDA at (800) FDA-1088, or http:// www.fda.gov/medwatch . Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the TECENTRIQ full Prescribing Information for additional Important Safety Information.

On May 18, 2016 Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, reported that it has signed an agreement with the contract manufacturer EUFETS GmbH, a subsidiary of BioNTech AG, for the production of T-cell receptor-modified T cells (Press release, MediGene, MAY 18, 2016, View Source [SID:1234512540]). EUFETS will set up the cell production together with Medigene for supplying the company’s planned phase I/II TCR studies.

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In its own clinical TCR studies, Medigene plans to equip the patient’s T cells with specially selected T-cell receptors. This transduction called transfer of genetic information is accomplished by viral vectors of the latest generation that are also produced at EUFETS. As part of this new agreement, the transduction and the subsequent cultivation and multiplication of T cells will be carried out according to GMP1in the clean rooms at EUFETS. The modified T cells are infused back into the patient’s body where they should identify and destroy the cancer cells.

Prof. Dolores Schendel, CEO and CSO of Medigene, comments on the agreement: "As with the viral vectors, we want to secure the necessary capacity for our first own TCR studies at an early stage. EUFETS is very experienced in dealing with T cells and is therefore especially suited as a partner. Since the necessary viral vectors are also produced by EUFETS, administration and logistics are additionally simplified."

Dr. Klaus Kühlcke, Managing Director of EUFETS GmbH, adds: "EUFETS will make an important contribution to the implementation of these promising and exciting trials by producing both the vectors and the genetically modified T cells. We are very pleased that this project will further strengthen the good cooperation between EUFETS and Medigene."

About Medigene’s TCR technology: Medigene’s technology for T-cell receptor-modified T cells is one of the company’s highly innovative and complementary immunotherapy platforms for adoptive T-cell therapy. The TCR therapy is designed to treat patients with high tumor loads. The clinical development of Medigene’s TCRs is in preparation.

The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression, by activating and modifying the patient’s T cells outside the body (ex-vivo). A large army of specific T cells to fight the tumor is made available to patients within a short period of time.

In the scope of this platform, Medigene is developing a comprehensive library of recombinant T-cell receptors. Moreover, a good manufacturing practice (GMP[1])-compliant process for their combination with patient-derived T cells is currently being established.

Medigene is preparing the clinical development of its first product candidates. In addition, novel TCRs with specificities for promising tumor-associated antigens will be isolated and characterized. In the years ahead, Medigene plans to initiate up to three clinical TCR trials, the first to be started in 2016/2017 (IIT phase I study with participation of Medigene, subject to grant funding). Medigene-sponsored trials are planned to start in 2017 and in 2018.

Further audio-visual education about Medigene’s TCR technology at: View Source