Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that Dr. Adi Hoess, CEO, will present at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20, 2019 at 3:20 pm GMT / 10:20 am ET in London (Press release, Affimed, NOV 14, 2019, View Source [SID1234551307]).

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A live audio webcast of the presentation will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source, and will be accessible at the same link for 30 days.

On November 14, 2019 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and nine months ended September 30, 2019 (Press release, ProMIS Neurosciences, NOV 14, 2019, View Source [SID1234551302]).

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"Over the course of 2019, the breadth and depth of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities in neurodegenerative diseases," stated Dr. Elliot Goldstein, ProMIS President and CEO. "In the third quarter of this year, we continued to generate further data supporting our antibody candidates for Parkinson’s disease (targeting toxic forms of alpha-synuclein), amyotrophic lateral sclerosis (targeting toxic aggregates of TDP-43) and for Alzheimer’s disease (targeting toxic forms of tau)."

Narrated updates relating to ProMIS’ unique approach and capabilities can be found on the ProMIS website by clicking on the links below:

Click here for strategy overview memorandum from Executive Chairman Eugene Williams: http://bit.ly/ProMIS102319
Click here for Chief Scientific Officer Dr. Neil Cashman’s overview of ProMIS’ unique capability to design and develop antibodies selectively targeting toxic mis-folded proteins that are root causes of neurodegenerative diseases: http://bit.ly/ProMIS2KQ88la
Click here for Chief Development Officer, Dr. Johanne Kaplan’s narrated overview of "Best in Class" therapy for misfolded protein diseases: http://bit.ly/ProMIS110719
Corporate Highlights

On November 13, 2019, subsequent to period-end, the company announced a non-brokered private placement for gross proceeds of up to $6.5 million. A first closing in the amount of $2,055,000 gross proceeds will occur on November 15, 2019.
In July 2019, the Company announced the voting results of the Corporation’s annual meeting of shareholders held on June 27, 2019 in Toronto, Ontario. All of the resolutions announced in the Management Proxy Circular and placed before the Meeting were overwhelmingly approved by the shareholders. All Directors were elected, with each nominee receiving more than 75% of the votes cast.
In July 2019, supporting data for PMN310, the Company’s lead antibody candidate for Alzheimer’s disease (AD) were published in Scientific Reports, a journal of the Nature Research family. In the manuscript, "A Rationally Designed Humanized Antibody Selective for Amyloid Beta Oligomers in Alzheimer’s Disease," the authors demonstrate PMN310’s selectivity for toxic amyloid-beta oligomers (AßOs), a root cause of AD. The results of activity assays show that PMN310 inhibits both the spread and toxicity of AßOs in vitro, and, in mouse studies, that PMN310 prevents AßO-induced loss of memory formation and reduces both synaptic loss and inflammation. PMN310 compared favorably to other Aß-directed antibodies, showing a lack of adverse event-associated binding to Aß plaque.
In July 2019, the Company presented an update on PMN310 for Alzheimer’s disease at the annual Alzheimer’s Association International Conference (AAIC) in Los Angeles. In an oral presentation, Chief Development Officer, Dr. Johanne Kaplan highlighted the therapeutic potential of PMN310 against the toxic oligomer form of AßO, a root cause of AD. Dr. Neil Cashman, ProMIS Chief Scientific Officer delivered data derived from ProMIS’ preclinical program for ALS in a poster presentation demonstrating the role of toxic, misfolded TAR-DNA binding protein 43 (TDP-43) as a root cause of neurogenerative diseases such as ALS and frontotemporal dementia (FTD).
Scientific Advisory Board Appointment

In August 2019, the Company appointed Dr. Andre Strydom to its scientific advisory board (SAB). Dr. Strydom is a world-recognized expert in ageing-related issues in Down syndrome and his research has advanced understanding of AD in Down syndrome patients. His expertise and advocacy will help guide ProMIS development plans relating to treatment of AD in Down syndrome. He is a professor in the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, and Honorary Consultant psychiatrist, South London and the Maudsley NHS Trust.

Financial Results

Results of Operations – Three months ended September 30, 2019 and 2018

Net loss for the three months ended September 30, 2019 was $1,637,714 compared to a net loss of $2,911,981 for the three months ended September 30, 2018, respectively. Included in the net loss amount for the three months ended September 30, 2019 were non-cash expenses of $134,634, representing share-based compensation and amortization of an intangible asset, compared to $385,951 for the three months ended September 30, 2018. The decrease in the net loss in the three months ended September 30, 2019 reflects decreased costs associated with external contract research organizations for internal programs, consultant salaries and associated costs, patent costs and share-based compensation offset by increased general corporate expenditures.

Research and development expenses for the three months ended September 30, 2019 were $1,053,123, as compared to $1,867,648 in the three months ended September 30, 2018. The decrease in the research and development expenses for the three months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributed to decreased costs associated external contract research organizations for internal programs and patent costs offset by increased external consulting costs and share-based compensation.

General and administrative expenses for the three months ended September 30, 2019 were $584,602, as compared to $1,044,596 in the three months ended September 30, 2018. The decrease for the three months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributable to decreased consultant salaries and associated costs, general corporate expenditures and share-based compensation.

Results of Operations – Nine months ended September 30, 2019 and 2018

Net loss for the nine months ended September 30, 2019 was $5,942,821, compared to a net loss of $6,683,714 for the nine months ended September 30, 2018, respectively. Included in the net loss amount for the nine months ended September 30, 2019 were non-cash expenses of $551,968, representing share-based compensation and amortization of an intangible asset, compared to $888,506 for the nine months ended September 30, 2018. The decrease in the net loss in the nine months ended September 30, 2019 reflects decreased costs associated with external contract research organizations for internal programs, patent costs and share-based compensation offset by increased consultant salaries and associated costs and general corporate expenditures.

Research and development expenses for the nine months ended September 30, 2019 were $3,866,394, as compared to $4,096,729 in the nine months ended September 30, 2018. The decrease in the research and development expenses for the nine months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributed to decreased spending on external contract research organizations for internal programs and reduced patent expense offset by increased contracted research salaries and associated costs, external consulting expense and share-based compensation.

General and administrative expenses for the nine months ended September 30, 2019 were $2,076,463, as compared to $2,587,253 in the nine months ended September 30, 2018. The decrease for the nine months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributable to decreased share-based compensation offset by increased consultant salaries and associated costs, general corporate expenditures and foreign exchange.

Outlook

The Company will continue to build on its unique, proprietary discovery and development platform to further characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 and SOD1 in ALS, toxic forms of alpha-synuclein ( in PD and other related disorders, and toxic forms of tau and amyloid beta in AD and other dementias to further support ongoing pharmaceutical partnering discussions.

On November 14, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX) reported financial results for the third quarter ended September 30, 2019 (Press release, Leap Therapeutics, NOV 14, 2019, View Source [SID1234551301]).

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"The body of clinical data we presented in the third quarter for both DKN-01 monotherapy and combination treatment for cancer patients continues to demonstrate impressive activity. Patients with advanced gastroesophageal junction and gastric cancer whose tumors expressed high levels of DKK1 (DKK1-high) achieved higher survival and objective response outcomes to the combination of DKN-01 and KEYTRUDA," commented Christopher K. Mirabelli, Ph.D., President and Chief Executive Officer of Leap. "DKN-01 also showed durable benefit in patients with endometrial cancer with Wnt pathway alterations, including a monotherapy complete response, highlighting the potential utility of DKN-01 for biomarker-targeted patient populations."

Dr. Mirabelli continued: "We also completed enrollment in the dose escalation phase of our clinical trial evaluating TRX518 in combination with BAVENCIO and cyclophosphamide; however, we’ve made the strategic decision to deprioritize further development of TRX518 at this time in order to focus our resources on our more advanced DKN-01 program. The safety profile observed to date was acceptable, and patients who are benefiting from treatment in the TRX518 program will continue to be treated."

DKN-01 Development Program Update

·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented data from the KEYNOTE-731 clinical study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. Study results demonstrated that patients with DKK1-high status had improved outcomes, including longer progression free survival (PFS) independent of PD-L1 Combined Positive Scores (CPS). In ten evaluable gastroesophageal junction and gastric cancer patients who had not received prior PD-1/PD-L1 therapy, DKK1-high patients experienced 22.1 weeks median progression free survival (PFS) and 31.6 weeks median overall survival (OS), with a 50% overall response rate (ORR) and 80% disease control rate (DCR). Fifteen evaluable DKK1-low patients experienced 5.9 weeks PFS and 17.4 weeks OS, with a 20% DCR. PD-L1 CPS did not predict efficacy to the combination of DKN-01 plus KEYTRUDA.

· DKN-01 in GYNECOLOGICAL CANCERS: The Company presented data from the ongoing clinical study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers at the International Gynecologic Cancer Society Annual Global Meeting held in September. In the cohort of sixteen evaluable monotherapy patients with epithelial endometrial cancer (EEC) with identified Wnt signaling mutations, patients had higher response rates and demonstrated longer PFS as compared to patients without Wnt signaling mutations. Specifically, one patient had a complete response and one patient had a partial response, representing a 12.5% single agent ORR, seven patients had a best response of stable disease, and seven patients had progressive disease. In the six evaluable monotherapy EEC patients who did not have any identified Wnt signaling mutations, none had clinical benefit. Patient follow-up is continuing in this study, which has been expanded to include focused cohorts of patients with carcinosarcoma.

·DKN-01 plus OPDIVO in BILIARY TRACT CANCER: The first patients have been dosed in an investigator-initiated clinical study to evaluate DKN-01 in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab) in previously treated patients with advanced biliary tract cancer. The study is being conducted by Massachusetts General Hospital and will enroll up to 36 biliary tract cancer patients who have progressed after one or more lines of systemic therapy for advanced biliary tract cancer. The primary endpoint of the study will be ORR, to be assessed in the overall population as well as in subgroups stratified by

tumor DKK1 and PD-L1 expression. Bristol-Myers Squibb is providing OPDIVO drug supply and partial funding for the study, with Leap providing DKN-01 drug supply as well as additional partial funding.

TRX518 Development Program Update

·FURTHER DEVELOPMENT OF TRX518 HAS BEEN DEPRIORITIZED: Leap has completed enrollment in dose escalation phase of the clinical trial evaluating TRX518 in combination with cyclophosphamide chemotherapy and BAVENCIO (avelumab). However, instead of pursuing additional enrollment through the expansion cohorts in this study as initially planned, the Company has decided to reprioritize resources on the further development of the DKN-01 program. There were no safety or efficacy concerns leading to this decision, and patients who are benefitting from the combination therapy will continue to be treated in the study.

Selected Third Quarter 2019 Financial Results

Net loss was $7.9 million for the third quarter 2019, compared to $6.6 million for the same period in 2018. This increase was primarily due to the recording of a $1.8 million gain in the third quarter 2018 as a result of a change in the fair value of the warrant liability, partially offset by a decrease in research and development expense.

Research and development expenses were $5.8 million for the third quarter 2019, compared to $6.5 million for the same period in 2018. This decrease was primarily due to a decrease of $0.4 million in clinical trial costs as a result of the timing of patient enrollment and a decrease of $0.3 million in manufacturing costs related to clinical trial material manufacturing campaigns.

General and administrative expenses were $2.2 million for the third quarter 2019, compared to $2.1 million for the same period in 2018. The increase was primarily due to a $0.1 million increase in stock based compensation as a result of new stock options granted to employees and directors in 2019.

Cash, cash equivalents and marketable securities totaled $10.1 million at September 30, 2019. Research and development incentive receivables, short term, totaled approximately $752,000 at September 30, 2019.

On November 14, 2019 AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) (Press release, Merck & Co, NOV 14, 2019, View Source [SID1234551299]).

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This is the first acceptance of a regulatory submission for an oral MEK 1/2 monotherapy for patients with NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.

This regulatory submission was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored SPRINT Phase 2 Stratum 1 trial. An objective response rate (ORR) was achieved in 66% of pediatric patients with NF1 and symptomatic, inoperable PNs (n=33/50 patients) when treated with selumetinib as a twice-daily oral monotherapy. ORR was defined as the percentage of patients with a confirmed complete or partial response of ≥ 20% tumor volume reduction.

Selumetinib was granted U.S. FDA Breakthrough Therapy Designation for this population in April of 2019, U.S. FDA Orphan Drug Designation in February of 2018, EU Orphan Drug Designation by the European Medicines Agency in August 2018, and Swissmedic Orphan Drug Status in December 2018. AstraZeneca and Merck have a strategic collaboration agreement to co-develop and co-commercialize selumetinib globally.

About SPRINT
The SPRINT trial is a U.S. NCI CTEP-sponsored Phase 1/2 trial. The Phase 1 trial was designed to identify the optimal Phase 2 dosing regimen, and the results were published in the New England Journal of Medicine.

About Selumetinib
Selumetinib is an investigational MEK 1/2 inhibitor. It is designed to inhibit the MEK enzyme in the RAS/MAPK pathway, a cell-signaling pathway, associated with cancer cell growth and proliferation in a number of different tumor types.

About Neurofibromatosis Type 1 (NF1)
NF1 is an incurable genetic condition that affects one in every 3,000 to 4,000 individuals. It is caused by a spontaneous or inherited mutation in the NF1 gene and is associated with many symptoms, including soft lumps on and under the skin (cutaneous neurofibromas), skin pigmentation (so-called ‘cafe au lait’ spots) and, in 30-50% of patients, tumors develop on the nerve sheaths (plexiform neurofibromas). These plexiform neurofibromas can cause clinical issues such as pain, motor dysfunction, airway dysfunction, bowel/bladder dysfunction and disfigurement as well as having the potential to transform into malignant peripheral nerve sheath tumors (MPNST).

People with NF1 may experience a number of complications such as learning difficulties, visual impairment, twisting and curvature of the spine, high blood pressure, and epilepsy. NF1 also increases a person’s risk of developing other cancers, including malignant brain tumors, MPNST and leukemia. Symptoms begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years.

About the AstraZeneca and Merck Strategic Oncology Collaboration
In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co- commercialize certain oncology products, including investigational selumetinib, a MEK inhibitor. Working together, the companies will develop selumetinib in combination with other potential new medicines and as monotherapy. Independently, the companies will develop selumetinib in combination with their respective PD-L1 and PD-1 medicines.

Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On November 14, 2019 Achilles Therapeutics ("Achilles"), a biopharmaceutical company developing personalised cancer immunotherapies, reported that Dr. Iraj Ali, Chief Executive Officer, will present at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20, 2019 at 8.40 am GMT in London, UK (Press release, Achilles Therapeutics, NOV 14, 2019, View Source [SID1234551298]).

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