On September 18, 2018 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that the first patient has started treatment in the company’s Phase II BRIDGE trial designed to study the Pharmacokinetics (PK), safety and efficacy of Ygalo in combination with dexamethasone in multiple myeloma patients with renal impairment (Press release, Oncopeptides, SEP 18, 2018, View Source [SID1234529532]).

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Multiple myeloma commonly results in deteriorating renal function. This makes BRIDGE an important study to show treating physicians how Ygalo can be used in Relapsed Refractory Multiple Myeloma (RRMM) patients with renal impairment.

CEO comment

"In addition to our pivotal study OCEAN, this is the third ongoing clinical trial to gather information about Ygalo in different groups of myeloma patients. It is important to map out Ygalo’s efficacy and side effect profile in myeloma patients at various stages of the disease to guide treating physicians about Ygalo’s clinical benefit profile. The BRIDGE study is an important positioning study since it seems Ygalo’s treatment profile does not vary with kidney function in the same way as for other multiple myeloma treatments that has limitations in use or effect in these patients" said Jakob Lindberg, CEO of Oncopeptides.

Ygalo in clinical development

Ygalo has been investigated in the treatment of late-stage relapsed refractory multiple myeloma (RRMM) patients. This was done in the clinical study O-12-M1 where strong final results were reported in December 2017. Currently, four clinical studies, including BRIDGE, are ongoing with Ygalo.

In the BRIDGE study the pharmacokinetics (PK), safety and also efficacy will be evaluated in RRMM patients, also suffering from renal impairment, a common complication in MM patients, Ygalo is administered together with dexamethasone.

ANCHOR is a Phase I/II study, where Ygalo is administered in combination with either bortezomib+dexamethasone or daratumumab+dexamethasone in RMM or RRMM patients. The results from this study aim to create understanding and knowledge among treating physicians for how Ygalo can be used in combination with these drugs. In addition, the results could open up for the use of Ygalo in earlier lines of treatment.

HORIZON is a Phase II study that studies the effect of Ygalo in late-stage RRMM patients with few or no remaining established treatment options. Interim data from this study was reported in June 2018 at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting (EHA) (Free EHA Whitepaper).

OCEAN is Oncopeptides´ pivotal Phase III study where Ygalo is compared directly head-to-head with current standard of care, pomalidomide, in late-stage RRMM patients.

FACTS – BRIDGE

Performed in Europe
Phase II study that will include 25 patients
A PK study in which Ygalo is administered together with dexamethasone (steroid)
The study will show how Ygalo should be used in patients with renal impairment
Results are expected late 2019
BRIDGE will increase Ygalos market opportunity by opening up for use in patients with renal impairment, which is a common complication in patients with multiple myeloma
For further information, please contact or visit www.oncopeptides.se:

Jakob Lindberg, CEO of Oncopeptides
Phone: +46 (0)8 615 20 40
E-mail: [email protected]

Rein Piir, Head of Investor Relations at Oncopeptides
Cell phone. +46 708 537 292
E-mail: [email protected]

The information was submitted through the agency of the contact person above for publication at 11.30 CET on September 18, 2018.

About Ygalo

Ygalo, an alkylating peptide, belongs to a novel class of peptidase-enhanced compounds (PEnCs) and targets the multiple myeloma (MM) tumor transformation process with a unique mechanism of action. Aminopeptidases are heavily over-expressed in MM and are key to the transformational process of the tumor cells. Ygalo selectively targets MM through aminopeptidase-driven accumulation; in vitro experiments show a 50-fold enrichment of alkylating metabolites in MM cells. The enrichment results in selective cytotoxicity (increased on-target potency and decreased off-target toxicity), and that resistance pathways of existing myeloma treatments (including alkylators) is overcome. Ygalo also demonstrates strong anti-angiogenic properties.

About Multiple Myeloma

Multiple myeloma is a hematological cancer of the B-cells (antibody producing cells) with no cure. Currently, the median overall survival is roughly 5 years and improving (Source: National Cancer Institute).

Today, approximately 170,000 patients live with multiple myeloma in the EU and the US while 57,000 patients get diagnosed and 26,000 patients die from the disease annually (Source: American Cancer Society, Global Data 2015 and National Cancer Institute). The underlying increase in number of multiple myeloma patients is slightly more than 1% per year where an aging population is the main reason for growth. However, the growth in late-stage multiple myeloma patients, which is studied in the OCEAN trial with Ygalo, is more than 10% per year due to improvements in earlier lines of therapy, i.e. more patients survive the first years with multiple myeloma and become late-stage multi-refractory patients with a significant medical need for more treatment options.

Treating Multiple Myeloma

Multiple myeloma is mainly treated through five different treatment modalities – alkylators, CD-38 binding antibodies, IMiDs, proteasome inhibitors and steroids. Due to the high mutation frequency of myeloma cells, patients have several different active cancers (cancer cell clones) at the same time with different protein expression patterns. Because of this heterogeneity of the disease in each patient, broad spectrum agents such as alkylators, IMiDs, proteasome inhibitors and steroids are the back-bone in multiple myeloma treatment. In the case of the new targeted agents, they will predominantly be used in combination with broad spectrum agents to ensure that all the patient’s cancer cells get appropriately treated. Immuno-oncological compounds have so far had limited success in the treatment of multiple myeloma.

On September 18, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the first patient has been dosed in a Phase 2 study evaluating the combination therapy of its cancer immunotherapy, CV301, and Roches’s checkpoint inhibitor, atezolizumab (TECENTRIQ), for the treatment of patients with locally advanced or metastatic urothelial bladder cancer (Press release, Bavarian Nordic, SEP 18, 2018, View Source [SID1234529475]).

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Bavarian Nordic’s CV301 targets tumor-associated antigens, CEA and MUC1, which are overexpressed on multiple solid tumors, including bladder cancer. Preclinical data has shown that vaccination resulted in the induction of tumor specific T-cells that infiltrated the tumor resulting in the upregulation of PD-L1 on tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

CV301 is administered in an innovative manner designed to generate a potent and durable T-cell response. Patients receive an enhanced priming regimen of the highly attenuated, non-replicating vaccinia virus MVA-BN-CV301 in 4 different injection sites on days 1 and 22, followed by boosters of the recombinant fowlpox virus FPV-CV301 at tapering intervals throughout the two years they are receiving atezolizumab.

The Phase 2, single-arm, multi-institutional clinical trial is designed to study the combination of CV301 with atezolizumab as a first-line treatment for patients with urothelial bladder cancer who are not eligible for cisplatin-containing chemotherapy (Cohort 1) and as a second-line treatment for patients who have previously been treated with cisplatin-based chemotherapies. The study is expected to enroll 68 patients, using a two-stage design within each cohort.

Stage 1 is planned to enroll approximately 40% of the subjects, with a threshold of around 25% of the subjects needing to achieve an objective response before enrolling the rest of the patients in Stage 2. Key secondary measures will also be evaluated, including: progression free survival (PFS), overall survival (OS) and duration of response.

"Today represents another large step forward in the development of our CV301 program and understanding its potential in bladder cancer," said Paul Chaplin, President and CEO of Bavarian Nordic. "We are hopeful that the preclinical data demonstrating a synergistic effect of CV301 with checkpoint inhibition will translate into a new, much-needed treatment option for patients living with this disease."

For more information on the trial, please visit: View Source

About CV301
CV301 is an active immunotherapy candidate that targets two tumor-associated antigens, CEA and MUC1, long known to be overexpressed in most solid tumors. The poxvirus-based prime/boost vaccine incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules. Preclinical data shows that antigen specific vaccination results in T cell infiltration into areas of antigen expression and upregulation of PD-L1 on antigen expressing tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

On September 18, 2018 Biogen Inc. (Nasdaq:BIIB) reported it will report third quarter 2018 financial results Tuesday, October 23, 2018, before the financial markets open (Press release, Biogen, SEP 18, 2018, View Source [SID1234529476]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

On September 18, 2018 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, reported that the completion of a $2.7M financing effort, which includes an over-subscribed $2M round in venture-backed capital and over $670K in non-dilutive capital (Press release, PhoenixMD, SEP 18, 2018, View Source [SID1234536960]). The venture round is led by Pallasite Ventures and includes new angel investors and existing angel investors from prior funding rounds. PhoenixMD intends to use the proceeds to advance its lead asset PMD-026 through IND-enabling studies and to develop a sophisticated companion diagnostic test to determine which patients have high levels of activated RSK2, the protein that PMD-026 disrupts.

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"This financing is a critical step forward in bringing the first disease-modifying therapeutic treatment to women suffering from TNBC. The PhoenixMD team is committed to innovating in the breast cancer field and we are excited to deploy Pallasite’s investment to such an experienced team to solve an unmet medical need," said Chris Bissonnette, Ph.D., Managing Partner of Pallasite Ventures. In connection with the financing, Dr. Bissonnette has joined PhoenixMD’s Board of Directors.

"We are thrilled to close our first venture-backed round with such high-quality investors, which is a major achievement for the company," said Sandra E. Dunn, Ph.D., CEO of PhoenixMD. "The proceeds from this financing, and the non-dilutive capital from recent research grants will advance PMD-026 through critical IND-enabling studies and will begin planning around our upcoming Phase 1 study, which we are very excited to initiate."

About Triple Negative Breast Cancer (TNBC) and RSK Kinases

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. It is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are still no targeted therapies available for TNBC.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2. Inhibiting RSK2 eliminates TNBC cells completely, including cancer stem cells, which give rise to cancer recurrence. PhoenixMD, with its novel, targeted approach, is focused on creating patented cancer RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Currently, there are no approved targeted therapies for TNBC, although several drugs are subject to research studies and clinical trials. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

On September 18, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018 at 9:30 am at the Sofitel Hotel in New York City (Press release, MediciNova, SEP 18, 2018, View Source;p=irol-newsArticle&ID=2367994 [SID1234529477]). Management will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Ladenburg Thalmann.

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