On September 24, 2018 Affibody AB ("Affibody"), a clinical stage biopharmaceutical company developing a portfolio of innovative drug projects, reported that a major Nordic study ("Affibody-3") will begin using Affibody’s PET imaging agent ABY-025 (Press release, Affibody, SEP 24, 2018, View Source [SID1234575703]). ABY-025 is a novel Affibody molecule imaging tracer that with high precision can identify HER2 status in breast cancer patients . The researchers will be investigating a new ABY-025 based method developed at Uppsala University and the PET center at Uppsala University Hospital that has the potential to improve personalized breast cancer treatment.

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"Since 2015, we have performed two smaller studies at Uppsala University Hospital with more than 20 patients showing very promising results. If we can demonstrate that the method works in larger scale, we believe it can quickly become a new "gold" standard worldwide. This would mean that difficult and stressful biopsies can be avoided for many breast cancer patients," says Dr. Henrik Lindman, Physician at the Oncology Clinic, Uppsala University Hospital, who is running the study together with Dr. Jens Sörensen, Physician at the PET center in the hospital.

In patients with so-called HER2-positive breast cancer, a large amount of the HER2 protein is present on the surface of the cancer cells. The more concentrated the protein, the more aggressive the disease. The new PET method involves a small protein-tracer, ABY-025, labeled with radioactive gallium. This procedure is done at the PET center at Uppsala University Hospital. ABY-025 is administered to the patient, finding and attaching to the HER2 protein. The PET camera then records the tracer signals and calculates the patient’s exact HER2 status, enabling the physician to prescribe medication more accurately.

"Several drugs effective against HER2 positive breast cancer have been available many years now. However, when selecting treatment, it is extremely important to know if the woman has HER2-positive metastases and how much HER2 protein is present on the cell surface. Our new method has two major advantages – you do not have to take tissue samples to get answers, an unpleasant experience for the patient, and we can also simultaneously map all tumors in the body," says Dr. Lindman.

"We are very proud of the way by which the ABY-025 development is conducted. The unique partnership that Affibody has with the principle investigators of Affibody-3 reflects our corporate ambition to build an extensive network of renowned researchers and clinicians in order to be able to fully capture the value of our proprietary platforms. We look forward to continue to build more such relationships", said David Bejker, CEO of Affibody.

About Affibody-3

Affibody-3 is a pan-Nordic clinical study led from Uppsala University Hospital. In total, 120 women with breast cancer from 7-8 hospitals in Sweden, Denmark and Finland will be included in the study. Eligible patients should have HER2 positive or borderline HER2 positive, breast cancer with proliferation in the body or only in the breast. The purpose is to find out if the patients have HER2-positive tumors with the aid of a radioactively labeled tracer, ABY-025, and PET camera, something which is of great importance for the correct choice of treatment.

About ABY-025

The PET imaging agent ABY-025 is based on an Affibody molecule that binds strongly to HER2. The high affinity and rapid clearance of ABY-025 from blood and normal organs allows HER2 assessment within hours.

On September 24, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in upcoming investor conferences, including the 2018 Cantor Global Healthcare Conference, the LEERINK Partners Roundtable Series: Rare Disease & Oncology, and the ROTH Battle of the NASH Thrones Investor Conference (Press release, CymaBay Therapeutics, SEP 24, 2018, View Source [SID1234529535]).

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2018 Cantor Global Healthcare Conference
Date: Monday, October 1
Time: 8:55am Eastern Time
Location: Intercontinental Barclay New York Hotel
Webcast: View Source

LEERINK Partners Roundtable Series: Rare Disease & Oncology
Date: Tuesday, October 2
Time: 8:30am Eastern Time
Location: Lotte New York Palace Hotel
Webcast: View Source

ROTH Battle of the NASH Thrones Investor Conference
Date: Wednesday, October 17
Time: Panel discussions and 1-on-1 meetings
Location: Park Hyatt New York Hotel

On September 24, 2018 Sangamo Therapeutics, Inc. (Nasdaq: SGMO) reported that management will participate in the following healthcare investor and industry conferences in September and October (Press release, Sangamo Therapeutics, SEP 24, 2018, View Source [SID1234529552]).

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2018 Jefferies Gene Therapy Summit, New York, NY, September 27, 2018
Sangamo’s presentation is scheduled for 2:05 p.m. ET on Thursday.

Cantor Fitzgerald 2018 Global Healthcare Conference, New York, NY, October 1-3, 2018
Sangamo’s presentation is scheduled for 12:15 p.m. ET on Tuesday, October 2nd.

ARM Cell & Gene Meeting on the Mesa, La Jolla, CA, October 3-5, 2018
Sangamo’s presentation is scheduled for 3:15 p.m. PT on Wednesday, October 3rd. Earlier that day, Sandy Macrae, CEO of Sangamo, is also scheduled to participate in a panel discussion titled, "Spotlight: Commercializing Gene Therapies for Hemophilia" at 10:45 a.m. PT.

2018 Chardan Genetic Medicines Conference, New York, NY, October 9, 2018
Sangamo’s presentation is scheduled for 3:15 p.m. ET on Tuesday.

The presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will be archived on the Sangamo website for two weeks after the events.

On September 24, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from the Phase III IMpower132 study of Tecentriq (atezolizumab) plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the initial (first-line) treatment of people with non-squamous, non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, SEP 24, 2018, View Source [SID1234529662]). This interim analysis showed that Tecentriq and chemotherapy reduced the risk of disease worsening or death (progression-free survival, PFS) by 40% compared with chemotherapy alone (PFS=7.6 versus 5.2 months; hazard ratio [HR]=0.60, 95% CI: 0.49-0.72; p<0.0001).1 While a numerical improvement of 4.5 months for the co-primary endpoint of overall survival (OS) was observed, at this interim analysis statistical significance has not yet been met (median OS=18.1 versus 13.6 months; HR=0.81, 95% CI: 0.64-1.03; p=0.0797). The study will continue as planned, with final OS results expected next year. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

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"This is our third Phase III trial in non-squamous non-small cell lung cancer demonstrating that a Tecentriq -based regimen can help reduce the risk of disease progression for people living with this disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will discuss these results with health authorities globally."

Data will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC) on Monday 24 September at 14:35-14:45 EDT (Abstract OA05.07 Oral) and featured in the official WCLC press conference at 09:45-10:30 EDT.

About the IMpower132 study
IMpower132 is a Phase III, open-label, randomised study evaluating the efficacy and safety of Tecentriq plus chemotherapy (cisplatin or carboplatin and pemetrexed) versus chemotherapy alone in chemotherapy-naïve patients with NSCLC. The study enrolled 578 people who were randomised equally (1:1) to receive:

Tecentriq in combination with cisplatin or carboplatin and pemetrexed (Arm A),
or Cisplatin or carboplatin and pemetrexed (Arm B, control arm)
During the treatment-induction phase, people received Tecentriq, pemetrexed and investigator’s choice of either cisplatin or carboplatin on Day 1 of every three weeks for a dosing period of four or six cycles. People who experienced clinical benefit during the induction phase began maintenance therapy until disease progression.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1
OS
IMpower132 met its PFS co-primary endpoint as per the study protocol. A summary of the results are included below:

Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events (AEs) were reported in 53.6 percent of people receiving Tecentriq plus chemotherapy compared to 39.1 percent of people receiving chemotherapy alone.

About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.3

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

On September 24, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has entered into purchase agreements with several institutional investors for the purchase in a registered direct offering of 286,633 shares of its common stock at a public offering price of $17.02 per share, for expected gross proceeds of approximately $4.9 million before placement agent fees and other offering expenses payable by Altimmune (Press release, Altimmune, SEP 24, 2018, View Source [SID1234529902]). The offering is expected to close on or about September 26, 2018, subject to customary closing conditions.

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Altimmune intends to use the net proceeds from this offering for the continued advancement of development activities for our clinical-stage product pipeline, general corporate purposes, and strategic growth opportunities.

Roth Capital Partners acted as sole placement agent for the offering.

The securities described above are being offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.