On June 13, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported new additions to its leadership team. Matthew Osborne will be joining as Chief Financial Officer, effective June 24, 2019 (Press release, Unum Therapeutics, JUN 13, 2019, View Source [SID1234537075]). Jessica Sachs, M.D., will become Chief Medical Officer, effective July 15, 2019, replacing Michael Vasconcelles, M.D., who is transitioning to a clinical advisory role and departing the company . Mert Aktar has been appointed to the newly created role of Head of Business and Corporate Development. Each new executive has a proven track record of excellence and adds decades of experience to the Unum leadership team.

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"We are excited to welcome Matt, Jessica, and Mert to the leadership team at Unum. They each bring deep experience to their respective functions, and their contributions will be important to our work building our pipeline of engineered T cell therapies across a broad range of cancers," said Chuck Wilson, President and Chief Executive Officer of Unum. "I would also like to thank Mike Vasconcelles for his enormous contributions at Unum over the last several years, and I look forward to continuing to work with him as he transitions into an advisory role."

"I’ve supported many companies throughout my career helping to bring innovative and transformative new therapies to patients, and am excited about Unum’s cutting-edge T cell therapy platforms, ACTR and BOXR, with potential best-in-class product profiles in lymphoma and myeloma, and expanding these platforms in solid tumors," said Mr. Osborne. "I look forward to joining the talented leadership team at Unum and working together to make a difference in the lives of patients with cancer."

Mr. Osborne joins Unum with over 20 years of biotechnology capital markets and corporate industry experience from past roles as an equity research analyst on Wall Street and as a highly-respected corporate communications and investor relations professional in the biotechnology industry. Most recently, he was vice president of corporate affairs, communications and investor relations at Voyager Therapeutics, and he also served as global head of investor relations at Shire plc (now Takeda) during its acquisitions of Baxalta Inc. and Dyax Corp., vice president of corporate communications and investor relations at Synageva BioPharma from its public inception through its acquisition by Alexion Pharmaceuticals, and investor relations at Vertex Pharmaceuticals as part of an Institutional Investor highly-ranked investor relations team. On Wall Street as a biotechnology sell-side analyst, he covered small-to-large cap biotechnology companies at Lazard Capital Markets and Leerink Swann (now SVB Leerink) analyzing the development of several blockbuster drugs across multiple therapeutic areas. Mr. Osborne received a B.S. in Biology from Syracuse University and M.B.A. from the D’Amore-McKim School of Business at Northeastern University.

Dr. Sachs has over 16 years of experience in oncology and pediatrics, including a decade in industry. She has been serving as Vice President of Clinical Sciences at Unum since 2017, where she has been responsible for the clinical development strategy and medical and translational oversight of the Unum portfolio. Prior to joining Unum, Dr. Sachs spent several years at Takeda/Millennium where she led multiple clinical programs in oncology and transplantation, and at Genzyme Corporation, where she was responsible for post-marketing safety surveillance and risk management activities for a variety of oncology products. Dr. Sachs has been a faculty member of the Harvard Medical School since 2007 and is an Assistant in Pediatrics in the Division of Pediatric Hematology/Oncology at the Massachusetts General Hospital. She completed her fellowship in pediatric hematology and oncology at the Dana Farber Cancer Institute and Children’s Hospital Boston. She received her M.D. from Washington University in St. Louis and her B.S. from Duke University.

Mr. Aktar has 19 years of multinational experience in pharmaceuticals and biotechnology, including leadership roles in business development and technical operations. He joins Unum from Shire plc (now Takeda) where he most recently served as global head of hematology and immunology business development. While at Shire, Mr. Aktar led a team responsible for identification, evaluation and execution of global business development opportunities and facilitated the company’s acquisitions of Baxalta Inc. and Dyax Corp. Prior to Shire, Mr. Aktar held positions of increasing responsibility at Biogen, ensuring clinical and commercial supply of biologics across diverse therapeutic areas. Mr. Aktar received a B.S. in Chemical Engineering from Worcester Polytechnic Institute, M.S. in Engineering Management from Tufts University, and M.B.A. from the Massachusetts Institute of Technology Sloan School of Management.

On June 13, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that 17 patients have been enrolled into the first cohort of the first line non-small cell lung cancer (NSCLC) arm (Part A) of the Phase II TACTI-002 clinical trial (Press release, Immutep, JUN 13, 2019, View Source [SID1234537060]). This completes patient recruitment of the initial cohort of the study Part A. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada).

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Patient enrollment for TACTI-002 commenced in early 2019, with the first patient being dosed in March 2019.

Under the Simon’s two-stage design, the initial cohort of first line NSCLC patients may be enlarged by a further 19 patients, if a pre-defined number of responses are observed. Ten study centers are now recruiting patients into the trial across the U.S., Europe and Australia, with three additional sites expected to commence recruitment in the coming months.

Dr Frederic Triebel, Immutep CSO and CMO, commented, "Efti has a unique mode of action. As an antigen presenting cell activator, it is successful in activating dendritic cells that process and present antigens for recognition by the T cell receptor on T lymphocytes. Efti is the only antigen presenting cell activator targeting MHC class II molecules currently in clinical development, setting it apart from other immuno-oncology therapies in the landscape.

It is very encouraging that we are achieving such positive traction with recruitment for our TACTI-002 study of efti, which commenced dosing patients just over three months ago. We expect to report the first data from this trial in mid-2019."

Recruitment is ongoing for the initial cohorts of the 2nd line NSCLC and 2nd line HNSCC of the Phase II TACTI-002 clinical trial. These cohorts may also be enlarged if a pre-defined number of responses are observed.

About TACTI-002 Phase II Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multi centre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.

On June 13, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, President and Chief Operating Officer of Syndax, will present at the JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 10:00 a.m. ET at the St. Regis New York (Press release, Syndax, JUN 13, 2019, View Source [SID1234537061]).

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A live webcast of the Company’s presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On June 13, 2019 Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) reported that the U.S. Food and Drug Administration (FDA) has approved KANJINTI (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (Press release, Amgen, JUN 13, 2019, View Source;p=RssLanding&cat=news&id=2401433 [SID1234537062]).

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"The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "KANJINTI is the third biosimilar from our portfolio to receive FDA approval, highlighting our long-term commitment to providing patients with serious illnesses access to high-quality biological therapies."

KANJINTI was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin based on a comprehensive totality of evidence which included extensive comparative analytical, pharmacokinetic and clinical data. At the time of approval, KANJINTI is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin.

"KANJINTI is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA," said David Nicholson, chief research and development officer at Allergan. "We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen."

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S. and three that are approved in the European Union (EU).

About KANJINTI (trastuzumab-anns) in the U.S.
KANJINTI is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab. KANJINTI has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.

KANJINTI is currently not available commercially. This is not an offer for sale. The following information is derived from the approved label in the U.S.

In the U.S., KANJINTI is approved for:

Adjuvant Breast Cancer
KANJINTI is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
With docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer
KANJINTI is indicated:

In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Gastric Cancer
KANJINTI is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

KANJINTI U.S. Boxed WARNINGS and Important Safety Information

Boxed WARNINGS and Additional Important Safety Information
Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens
Evaluate left ventricular function in all patients prior to and during treatment with KANJINTI. Discontinue KANJINTI treatment in patients receiving adjuvant therapy and withhold KANJINTI in patients with metastatic disease for clinically significant decrease in left ventricular function
Infusion Reactions; Pulmonary Toxicity

Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue KANJINTI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy
Trastuzumab can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
Trastuzumab can also cause asymptomatic decline in LVEF
Discontinue KANJINTI treatment in patients receiving adjuvant breast cancer therapy and withhold KANJINTI in patients with metastatic disease for clinically significant decrease in left ventricular function
Cardiac Monitoring

Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of KANJINTI
Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
Monitor frequently for decreased left ventricular function during and after KANJINTI treatment
Monitor more frequently if KANJINTI is withheld for significant left ventricular cardiac dysfunction
Infusion Reactions

KANJINTI administration can result in serious and fatal infusion reactions
Symptoms usually occur during or within 24 hours of KANJINTI administration
Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension
Monitor patients until symptoms completely resolve
Discontinue KANJINTI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia
Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Verify the pregnancy status of females of reproductive potential prior to the initiation of KANJINTI
Advise pregnant women and females of reproductive potential that exposure to KANJINTI during pregnancy or within 7 months prior to conception can result in fetal harm
Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of KANJINTI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for KANJINTI treatment and any potential adverse effects on the breastfed child from KANJINTI or from the underlying maternal condition
Pulmonary Toxicity

Trastuzumab products can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
Discontinue KANJINTI in patients experiencing pulmonary toxicity
Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Most Common Adverse Reactions

The most common adverse reactions associated with trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.

On June 13, 2019 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will provide a corporate overview at the JMP Securities Life Sciences Conference at 2:00 p.m. EDT in New York City (Press release, CTI BioPharma, JUN 13, 2019, View Source;p=RssLanding&cat=news&id=2401339 [SID1234537063]).

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Presentation details:

Event:

JMP Securities Life Sciences Conference

Date:

Thursday, Jun. 20

Time:

2:00 p.m. EDT