On April 18, 2016 Halozyme Therapeutics (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported preclinical data for the discovery and early development of two potential drug candidates, an immune checkpoint inhibitor targeting adenosine and a novel antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) (Press release, Halozyme, APR 18, 2016, View Source [SID:1234510997]).

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These new preclinical programs complement Halozyme’s lead oncology asset, PEGPH20, an investigational new drug (IND) under clinical evaluation for the treatment of pancreatic, lung and gastric cancers.

The potential drug candidates are PEGylated adenosine deaminase 2, or PEG-ADA2, an immune checkpoint inhibitor that targets immuno-suppressive adenosine, which may accumulate to high levels in the tumor microenvironment. PEG-ADA2 is currently in early preclinical development with the next milestone expected to be final drug candidate selection by the end of 2016.

HTI-1511 is a novel anti-EGFR ADC to treat solid tumors, including those with drug-resistant mutations. It is also in pre-clinical development, with a drug candidate selected, good laboratory practices (GLP) toxicity studies planned for 2017 and chemistry, manufacturing and controls (CMC) development activities to support a future IND filing underway.

"We expand our oncology pipeline today with two assets that complement our growing body of research into the structural, biochemical and immunological properties of the tumor microenvironment," said Dr. Helen Torley, president and chief executive officer. "Our new PEG-ADA2 and HTI-1511 anti-EGFR ADC show early promise as our scientists continue to characterize them for potential clinical study in the future.

"In addition, our ongoing research of lead asset, PEGPH20, continues to build scientific evidence of potential benefits in remodeling the tumor microenvironment, including the potential to increase access of immune therapies and chemotherapies. This week we will share new research in animal models showing increased tumor regression when immune checkpoint inhibitors are used in combination with PEGPH20 in tumor models with high levels of hyaluronan."

The new studies are being introduced during poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual conference, taking place April 17-20 in New Orleans.

PEG-ADA2

Halozyme’s PEG-ADA2 was engineered to decrease the concentration of adenosine in the tumor microenvironment, and PEGylated to prolong its circulation in the body. Accumulation of adenosine is believed to contribute to a suppressed immune response to certain solid tumors.

In preclinical studies, Halozyme’s PEG-ADA2 demonstrated tumor growth inhibition in certain colon, lung and pancreatic cancer models. Treatment with PEG-ADA2 resulted in an increase in infiltration of T cells and lowering of tumor adenosine levels. Halozyme scientists have also identified a potential biomarker for tumors that may respond to PEG-ADA2 therapy.

The company plans to continue its ongoing study and characterization of PEG-ADA2 with the goal of determining its suitability as a targeted therapy for clinical study.

HTI-1511 Anti-EGFR ADC

Halozyme’s HTI-1511 was engineered to bind to EGFR at the low pH of the tumor microenvironment while decreasing or attenuating the binding at the neutral pH of skin. The result in preclinical studies to date is a targeted therapy with an acceptable safety profile.

HTI-1511 has been developed as a next generation ADC with a potent cytotoxin, monomethyl auristatin E to treat EGFR-positive tumors, including those with KRAS and BRAF mutations. In preclinical studies, HTI-1511 has demonstrated tumor growth inhibition or regression in colon, lung and cholangiocarcinoma models, including patient derived xenograft (PDx) models with known KRAS and BRAF mutations.

The company has initiated a range of studies to prepare for an IND filing for HTI-1511 with the target of initiating early clinical study in 2018.

Halozyme Webcast and Conference Call

Dr. Torley and Halozyme Chief Scientific Officer, Dr. Michael LaBarre will host a meeting for investment professionals today, Monday, April 18 at 4 p.m. ET (3 p.m. CT, 1 p.m. PT). The event will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the event.

To access the webcast and additional documents related to the event, please visit www.halozyme.com approximately fifteen minutes prior to the start time to register, download and install any necessary audio software. The live event may be accessed by calling (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 987221. A telephone replay will be available after the event by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay passcode 13259083.

Halozyme’s AACR (Free AACR Whitepaper) Poster Presentations include:

PEGylated recombinant hyaluronidase PH20 enhances pemetrexed antitumor efficacy in a human non-small cell lung cancer model, Sun., April 17, 1-5 p.m. CT
Preclinical evaluation of a next-generation EGFR targeting antibody-drug conjugate that promotes regression in KRAS and BRAF tumors, Mon., April 18, 8 a.m. – noon CT
Enzymatic depletion of adenosine by PEGylated, engineered adenosine deaminase 2 (PEG-ADA2): a novel immunotherapeutic approach to treat solid tumors, Mon., April 18, 8 a.m. – noon CT
PEGPH20 increases the anticancer activity of standard chemotherapy combinations, vincristine (VIN) and D actinomycin (DACT), in a Wilms xenograft model, Mon., April 18, 1-5 p.m. CT
PEGylated recombinant hyaluronidase PH20 (PEGPH20) enhances checkpoint inhibitor efficacy in syngeneic mouse models of cancer, Weds., April 20, 8 a.m. – noon CT
About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer.

Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

On April 18, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported that it has achieved a first preclinical milestone for CGEN-15022 pursuant to its cancer immunotherapy collaboration with Bayer (Filing, 6-K, Compugen, APR 18, 2016, View Source [SID:1234510994]). The collaboration provides for the research, development, and commercialization of antibody-based cancer therapeutics against two novel Compugen-discovered immune checkpoint regulators, CGEN-15001T and CGEN-15022.

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In December 2015, the Company announced the achievement of the third preclinical milestone for CGEN-15001T, the more advanced of the two programs, which at that time was transferred to Bayer’s full control for further preclinical and clinical development activities, and worldwide commercialization, under milestone and royalty bearing licenses from Compugen.

Pursuant to an amendment to the agreement, CGEN-15022’s anti-cancer immune response continues to be evaluated under the joint preclinical research program.

For additional information, please refer to Compugen’s recent Form 6-K filing.

About the Compugen/Bayer Agreement
In August 2013, Compugen and Bayer entered into a collaboration and license agreement for the development and commercialization of antibody-based cancer immune therapeutics against two novel Compugen-discovered immune checkpoint regulator candidates. Compugen received an upfront payment of $10 million and is eligible to receive over $500 million in potential milestone payments for both checkpoint programs, plus the remaining portion of an additional $30 million of potential milestone payments associated with joint preclinical research for the two programs.

On April 18, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) (Press release, Merck & Co, APR 18, 2016, View Source [SID:1234510976]). This is the fourth Breakthrough Therapy Designation granted for KEYTRUDA.

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"Merck has launched an ambitious clinical development program examining the efficacy of KEYTRUDA in a broad range of solid and blood cancers, and our studies of relapsed or refractory classical Hodgkin lymphoma are quite promising," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "The FDA’s Breakthrough Designation for this blood cancer provides an important mechanism to assist us in bringing this immunotherapy to patients who could benefit from its use."

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. KEYTRUDA was previously granted breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer (NSCLC), and advanced colorectal cancer.

The Breakthrough Therapy Designation in cHL is based on data from the ongoing Phase 1b KEYNOTE-013 and Phase 2 KEYNOTE-087 studies evaluating single agent KEYTRUDA in patients with cHL. Findings from the KEYNOTE-013 study were presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and data from KEYNOTE-087 will be presented at an upcoming medical meeting.

The KEYTRUDA clinical development program includes patients with more than 30 tumor types in more than 250 clinical trials, including more than 100 trials that combine KEYTRUDA with other cancer treatments. Registration-enabling trials of KEYTRUDA are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, ovarian cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, and other tumors, with further trials in planning for other cancers.

About KEYTRUDA (pembrolizumab) Injection 100 mg

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications.

About Hodgkin Lymphoma

Lymphoma is a type of blood cancer that affects the lymphatic system, which removes excess fluids from the body and produces immune cells. Lymphoma cells are abnormal lymphocytes which multiply and collect in the lymph nodes and other tissues. Normal lymphocytes are a type of white blood cell that fight infection. Hodgkin lymphoma (also called Hodgkin disease) is a specific type of lymphoma and includes two subtypes: classical Hodgkin lymphoma (cHL) and nodular lymphocyte predominant Hodgkin lymphoma. In 2016, it is estimated that more than 8,500 people will be diagnosed with Hodgkin lymphoma in the U.S. alone and cHL accounts for 95 percent of all Hodgkin lymphoma cases.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-mediated pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2.0%) of 1567 patients with melanoma, including Grade 1 (0.8%), 2 (0.8%), and 3 (0.4%) pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis and more frequently in patients with a history of asthma/chronic obstructive pulmonary disease (5.4%) or prior thoracic radiation (6.0%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-mediated colitis occurred in 31 (2%) of 1567 patients with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%) colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-mediated hepatitis occurred in patients receiving KEYTRUDA. Hepatitis occurred in 16 (1%) of 1567 patients with melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 13 (0.8%) of 1567 patients with melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%) hypophysitis. Hypophysitis occurred in 1 (0.2%) of 550 patients with NSCLC, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

Hyperthyroidism occurred in 51 (3.3%) of 1567 patients with melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 127 (8.1%) of 1567 patients with melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%) hypothyroidism. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA (pembrolizumab) for Grade 3 or 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 3 (0.1%) of 2117 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti hyperglycemics in patients with severe hyperglycemia.

Immune-mediated nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in 7 (0.4%) of 1567 patients with melanoma including, Grade 2 (0.2%), 3 (0.2%), and 4 (0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant, immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 1567 patients with melanoma: arthritis (1.6%), exfoliative dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of 550 patients with NSCLC: rash, vasculitis, hemolytic anemia, serum sickness, and myasthenia gravis.

Severe and life-threatening infusion-related reactions have been reported in 3 (0.1%) of 2117 patients. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA (pembrolizumab).

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

In Trial 6, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea (2.5%). The most common adverse reactions with KEYTRUDA vs ipilimumab were fatigue (28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.

In Trial 2, KEYTRUDA was discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (≥1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea (1%), and maculo-papular rash (1%). The most common adverse reactions with KEYTRUDA vs chemotherapy were fatigue (43% with KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%), constipation (22% vs 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs 20%), and decreased appetite (20% with KEYTRUDA). Corresponding incidence rates are listed for chemotherapy only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 14% of 550 patients with NSCLC. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported at least 2% of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), cough (29%), decreased appetite (25%), and dyspnea (23%).

No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On April 18, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its extensive ADC technology portfolio, reported the start of clinical testing of the Company’s IMGN779 product candidate for the treatment of AML, a CD33-positive cancer (Press release, ImmunoGen, APR 18, 2016, View Source [SID:1234510974]).

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IMGN779 contains a CD33-targeting antibody – enabling it to bind to AML cells – with a powerful cancer-killing agent attached to kill them. IMGN779 is the first ADC to utilize one of ImmunoGen’s new family of indolino-benzodiazepine cancer-killing agents, which the Company calls IGNs. DNA-alkylating IGNs have been designed to be ultra-potent, yet provide the tolerability necessary for ongoing retreatment.

"There is substantial need for new therapies for AML and considerable appeal to an ADC approach," said Ravi Chari, Ph.D., VP of Chemistry and Biochemistry. "A key challenge has been achieving the potency needed for clinical benefit with the tolerability required for continued patient retreatment. We developed our DNA-alkylating IGNs to meet these dual needs and believe this innovative new class can further extend the types of cancers that can be effectively treated with ADC therapeutics."

The IMGN779 Phase 1 trial in CD33-positive AML will assess two alternative dosing schedules – weekly and biweekly administration – concurrently in its dose-finding stage. The selected dose and schedule will then be used in the two planned expansion cohorts: one assessing IMGN779 in patients with AML in first relapse and one assessing it in patients with relapsed/refractory AML.

"IMGN779 has the potential to make an important difference for patients with AML," said Anna Berkenblit, MD, VP and Chief Medical Officer. "This Phase 1 trial has been designed to efficiently inform the development pathway for IMGN779 by assessing alternative dosing schedules concurrently and then evaluating the selected schedule in specific under-served patient populations."

About Acute Myeloid Leukemia (AML)

AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leaves the patient vulnerable to infections, bleeding problems and anemia.

It is estimated that, in the US alone, 20,000 patients will be diagnosed with AML this year and 10,000 patients will die from the disease.1 CD33 is expressed in virtually all cases of AML.

About IMGN779

IMGN779 comprises a CD33-targeting antibody with a potent DNA-alkylating agent, the IGN DGN462, attached. The antibody serves to target the ADC to the CD33-positive AML cells which DGN462 can then kill. IMGN779 is wholly owned by ImmunoGen.

About IGNs

IGNs are a new class of cancer-killing agent developed by ImmunoGen for use in ADCs. Ultra-potent, these DNA-alkylating indolino-benzodiazepines are expected to extend the types of cancers able to be effectively treated with ADC therapies beyond those addressable with ImmunoGen’s well-established tubulin-acting agents. Such cancers can include ones insensitive to tubulin-acting agents and/or with reduced antigen expression.