On August 28, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported its participation in the following upcoming investor conferences in September (Press release, Affimed, AUG 28, 2019, View Source [SID1234539066]):

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Wells Fargo Securities 2019 Healthcare Conference. Affimed’s Chief Executive Officer, Dr. Adi Hoess, will present on Wednesday, September 4, 2019 at 9:05 a.m. Eastern Time.
Citi’s 14th Annual Biotech Conference. Affimed will host meetings with investors at the conference on Thursday, September 5, 2019.
A live webcast of the presentation at the Wells Fargo Securities 2019 Healthcare Conference can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source and will be available for 30 days following the event.

On August 28, 2019 Starpharma reported its annual report and financial results for the year ended 30 June 2019 (Press release, Starpharma, AUG 28, 2019, View Source [SID1234539065]).

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Financial Results

Cash position at 30 June of $41.3M
Net cash burn[1] of $10.1M (FY18: $9.9M)
Total revenue and other income of $2.7M (FY18: $5.0M)
Reported loss of $14.3M (FY18: $10.3M)
Receipt of $4.0M R&D tax incentive
Key activities

VivaGel

VivaGel BV launched in Europe by Mundipharma, under the brand name Betadine BVTM;
VivaGel BV launched in Australia by Aspen Pharmacare, under the brand name Fleurstat BVgel;
VivaGel BV was licensed to ITF Pharma, Inc. for the US for milestones of up to US$101 million in addition to escalating royalties;
First Asian regulatory approvals received for BetadineTM BV Gel;
VivaGel condom launched in Japan under Okamoto’s Zero Zero Three (‘003’) brand;
US FDA completed its review of the VivaGel BV NDA and advised it requires confirmatory clinical data prior to approval; and
Positive independent market research was conducted in the US for SPL7013 ophthalmic drops for viral conjunctivitis and a patent was granted for the product.
DEP drug delivery

Starpharma signed a Development and Option Agreement with AstraZeneca to progress the development of a DEP version of one of their major marketed oncology medicines;
First patent granted for Starpharma’s DEP dendrimers with AstraZeneca’s Bcl2/xL inhibitors, including AZD0466;
Clinical trials for DEP docetaxel (phase 2) and DEP cabazitaxel (phase 1 / 2) progressed well with new sites opened and cohorts expanded;
Approval to commence DEP irinotecan phase 1 / 2 trial;
DEP irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar) and cetuximab (Erbitux), in the irinotecan-refractory HT-29 human colon cancer model;
DEP irinotecan showed impressive efficacy and safety benefits over standard irinotecan in combination with 5-FU in a human pancreatic cancer model;
DEP docetaxel and DEP cabazitaxel outperformed both gemcitabine and Abraxane in a human pancreatic cancer model; and
A range of DEP radiopharmaceutical and other DEP candidates are undergoing testing in a variety of models.
Starpharma CEO, Dr Jackie Fairley, commented: "Starpharma has achieved significant milestones across the business this year, including international product launches, new commercial deals, and trial progress for our three high-potential, clinical-stage DEP products. The company is in a strong financial position with more than $40 million in cash at bank. With our anticipated revenues from products on market and future launches, we are well placed for future growth".

Commenting further on the 2019 financial year’s achievements and outlook, Dr Fairley added: "During the year, VivaGel BV was launched in both Europe and Australia and we recently received the first Asian regulatory approvals for this breakthrough product. VivaGel BV has now been licensed for more than 160 countries and we look forward to further approvals and launches in the coming months across Mundipharma’s regions. We also negotiated an attractive licensing deal for VivaGel BV in the US with specialty pharmaceutical company, ITF Pharma, Inc., however the US regulator has requested confirmatory data and Starpharma is currently working to pursue approval as quickly as possible to bring this innovative product to the US market".

"In our DEP portfolio, we were delighted to add another commercial deal with AstraZeneca for a DEP version of one of their major marketed oncology products, and are excited for the first DEP IND to be filed by AstraZeneca for AZD0466. We also progressed with our own internal clinical DEP programs – reporting positive interim results for both DEP docetaxel and DEP cabazitaxel – and recently advanced our third internal DEP product, DEP irinotecan, into the clinic. We also added a suite of excellent preclinical data from our DEP platform, further demonstrating the versatility of our drug delivery technology, and we continued to build our pipeline of DEP candidates".

"In the year ahead, we look forward to our partner’s further launches of VivaGel BV and building sales momentum, while progressing our three clinical stage internal DEP products alongside AstraZeneca’s first DEP product, AZD0466. We also continue to explore the potential expansion opportunities for our clinical programs into new indications and combination therapies to build further value in our DEP products and to create the greatest potential for patient outcomes", concluded Dr Fairley.

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 4.5MB)

[1] Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents from 30 June 2018 to 30 June 2019.

On August 28, 2019 Varian (NYSE: VAR) has reported it completed the installation of the cyclotron for its ProBeam Compact single-room proton therapy system at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine — part of the University of Miami Health System (Press release, Varian Medical Systems, AUG 28, 2019, View Source [SID1234539064]). The cyclotron is a particle accelerator and a significant piece of the equipment in the ProBeam proton therapy system. The Center is scheduled to begin patient treatment in the summer of 2020.

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Proton therapy is an advanced form of cancer care. It uses protons, accelerated to about two-thirds the speed of light, or more than 100,000 miles per second, to destroy cancer cells, while minimizing exposure to nearby healthy tissues. The Varian ProBeam Compact system is the only single room system capable of fully rotational intensity modulated proton therapy (IMPT). Treatments can be delivered with an unmatched combination of speed, flexibility and cost efficiency.

The full-featured ProBeam Compact system includes the cyclotron, Varian’s unique pencil-beam scanning technology for intensity modulated proton therapy (IMPT), a fully rotational gantry, robotic patient positioning tools, and a comprehensive suite of motion management tools. It includes integrated cone beam CT imaging for positioning the patient based on high quality anatomical images with excellent soft tissue resolution.

"We selected Varian as our partner because we wanted a company that understood our mission to reduce the human burden from cancer through research, education, prevention, and the delivery of quality patient care," said Dr. Stephen D. Nimer, director of Sylvester. "We are excited to bring innovative cancer treatments to patients in our state and region. They will benefit from having access to therapies that provide superior dose distribution, spare healthy surrounding tissue and most importantly, give our patients a better quality of life during and after treatment. With Varian’s help, we are treating cancer more effectively and efficiently."

"We look forward to continuing this partnership and making this advanced cancer fighting technology available to more patients in Florida," said Kolleen Kennedy, president, Proton Solutions and chief growth officer, Varian. "This advanced treatment technology has the potential to offer new hope to many cancer patients across the state and the country."

For more information on ProBeam and its Compact single-room configuration, visit: www.varian.com/probeamcompact

On August 28, 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 members of the management team will participate in four upcoming investor conferences (Press release, Syndax, AUG 28, 2019, View Source [SID1234539063]). The details for the four conferences are:

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Citi’s 14th Annual Biotech Conference at the Four Seasons Hotel Boston on Wednesday, September 4, 2019.

Baird’s 2019 Global Healthcare Conference at the InterContinental New York Barclay on Thursday, September 5, 2019. Fireside chat at 9:05 a.m. ET.

Morgan Stanley 17th Annual Global Healthcare Conference at the Grand Hyatt Hotel New York on Monday, September ‘s9, 2019. Fireside chat at 4:50 p.m. ET.

H.C. Wainwright 21st Annual Global Investment Conference at the Lotte New York Palace Hotel on Tuesday, September 10, 2019. Corporate presentation at 1:45 p.m. ET.

Live webcasts of the Baird Global Healthcare Conference, Morgan Stanley’s 17th Annual Global Healthcare Conference, and H.C. Wainwright’s 21st Annual Global Investment Conference presentations 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 August 28, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2019 (Press release, MEI Pharma, AUG 28, 2019, View Source [SID1234539062]).

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"It was a very productive year, with each of the four clinical-stage programs within our oncology portfolio advancing in development, led by ME-401 and the initiation of our global Phase 2 study which may support an accelerated approval of a marketing application with FDA, the BeiGene clinical collaboration to combine ME-401 with zanubrutinib, BeiGene’s BTK inhibitor, and a regional licensing deal with Kyowa Kirin for the development and commercialization of ME-401 in Japan," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We were also pleased to report the progress made from all our programs as featured at key medical meetings including ICML 2019, ASCO (Free ASCO Whitepaper) 2019 and ASH (Free ASH Whitepaper) 2018."

Dr. Gold continued: "Looking to the year ahead, we are in a great position to continue strengthening our foundation and creating value through data generation across our development pipeline, evaluating drug combination opportunities, unlocking innovations like the intermittent schedule for ME-401, and exploring additional collaboration and licensing opportunities to most effectively leverage the potential of our drug candidates."

Fiscal Year 2019 and Recent Highlights

ME-401 for B-Cell Malignancies

In October 2018, MEI (the Company) entered into a clinical collaboration to evaluate in patients with B-cell malignancies the safety and efficacy of ME-401 in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase ("BTK") inhibitor
In October 2018, MEI entered into a license, development and commercialization agreement granting Kyowa Kirin Company exclusive rights to develop and commercialize ME-401 in Japan. MEI received a $10.0 million upfront payment and is eligible to receive up to $87.5 million in additional development and commercialization milestones, and royalties on sales.
In December 2018, the Company initiated the ongoing Phase 2 clinical trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma which may support an accelerated approval of a marketing application with FDA.
In December 2018, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the Company presented interim results from the ongoing Phase 1b study demonstrating that ME-401 continues to be associated with overall high objective response rates as a single agent and in combination with rituximab. Lower rates of Grade 3 adverse events of special interest were observed in patients on the intermittent dosing schedule.
In June 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the International Conference on Malignant Lymphoma (ICML), the Company presented updated data from the ongoing ME-401 Phase 1b study demonstrating an 80% overall response rate in patients with relapsed or refractory follicular lymphoma and an 83% overall response rate in patients with relapsed or refractory follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma. The intermittent dosing schedule demonstrated comparable overall response rates with a lower rate of delayed Grade 3 adverse events of special interest (≤10%) compared to the continuous dosing schedule.
Voruciclib for B-Cell Malignancies and Acute Myeloid Leukemia ("AML")

In December 2018 at ASH (Free ASH Whitepaper), the Company presented preclinical data demonstrating that voruciclib synergistically induced apoptosis at clinically relevant concentrations when combined with venetoclax (marketed as Venclexta) in human derived AML cells lines and patient samples.
ME-344 for Solid Tumors

In June 2019 at ASCO (Free ASCO Whitepaper), the Company presented the data from an investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with early HER2-negative breast cancer. The data demonstrated proof of biologic anti-tumor activity as measured by a statistically significant reduction in Ki67, a measure of cell proliferation that is highly correlated with tumor response, in patients treated with ME-344 compared to an increase in the group receiving saline.
Pracinostat for Myelodysplastic Syndrome ("MDS")

In December 2018 at ASH (Free ASH Whitepaper), the Company and Helsinn Healthcare presented interim results from the ongoing Phase 2 study evaluating pracinostat in combination with azacitidine for the treatment of patients with IPSS-R high/very high-risk of MDS. The data demonstrate a 9% discontinuation rate due to adverse events, a substantially lower rate than observed in an earlier Phase 2 study, as well as an encouraging 36% complete response rate among patients receiving at least 6 cycles of treatment.
In February 2019, the Company and Helsinn Healthcare published data in the medical journal, Blood Advances, from a Phase 2 study evaluating the safety and efficacy of pracinostat in combination with azacitidine for the treatment of patients suffering from AML who cannot undergo treatment with intensive chemotherapy. The full article can be found here.
Corporate Highlights

In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso continues as the Company’s general counsel and head of corporate development.
In July 2019, Tamar Howson, M.S., MBA a highly experienced business development executive with over 30 years of service in the pharmaceutical and biotechnology industry joined the Board of Directors.
Fiscal Year 2019 Financial Results

As of June 30, 2019, MEI had $79.8 million in cash, cash equivalents, short-term investments, and common stock proceeds receivable, with no outstanding debt.
For the year ended June 30, 2019, cash used in operations was $39.4 million, compared to $21.0 million for 2018
Research and development expenses were $32.3 million for the year ended June 30, 2019, compared to $17.0 million for 2018. The increase was primarily related to increased activities in all clinical programs including development costs associated with ME-401 and voruciclib.
General and administrative expenses were $14.6 million for the year ended June 30, 2019, compared to $9.8 million for 2018. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses incurred during the year ended June 30, 2019.
MEI recognized revenues of $4.9 million for the year ended June 30, 2019, compared to $1.6 million for the year ended June 30, 2018. Revenues resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin license agreements. Revenue increased due to higher levels of research and development activities during the year ended June 30, 2019.
Net loss was $16.8 million, or $0.24 per share, for the fiscal year ended June 30, 2019, compared to net loss of $40.1 million, or $0.97 per share for 2018. The Company had 73,544,576 shares of common stock outstanding as of June 30, 2019, compared with 70,406,283 shares as of June 30, 2018.
The adjusted net loss for the fiscal year ended June 30, 2019, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure), was $44.5 million.
Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, August 28, 2019, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 48926540. The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.