On August 13, 2019 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported financial results for the second quarter ended June 30, 2019, and provided an overview of Atreca’s recent developments (Press release, Atreca, AUG 13, 2019, View Source [SID1234538759]).

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"The second quarter of 2019 was a highly productive period for Atreca, highlighted by the completion of our successful initial public offering, which further strengthens our ability to execute on the promise of our differentiated technology platform drawn from a deep understanding of the human immune response," said John Orwin, Chief Executive Officer. "We believe our lead product candidate, ATRC-101, represents an exciting and novel approach to cancer therapy with the potential to drive better outcomes for patients across a variety of solid tumors. We look forward to submitting the Investigational New Drug (IND) application for ATRC-101 later this year and initiating a Phase 1b clinical trial in patients with solid tumors in early 2020."

Recent Developments and Highlights

·In June 2019, Atreca successfully completed its initial public offering, raising $130.8 million in net proceeds.

·In July 2019, Atreca further strengthened its management team with the appointments of Lisa L. Decker, Ph.D., as Chief Business Officer and Courtney J. Phillips as General Counsel.

Upcoming Milestones

·Atreca anticipates filing an IND application with the U.S. Food and Drug Administration for ATRC-101 in late 2019 and initiating a Phase 1b clinical trial in patients with solid tumors in early 2020.

Second Quarter 2019 Financial Results

·As of June 30, 2019, cash and cash equivalents and short-term investments totaled $219.7 million. This includes net proceeds of approximately $130.8 million from Atreca’s June 2019 initial public offering of common stock, after deducting the underwriting discounts and commissions and expenses of the offering.

·Research and development expenses for the three months ended June 30, 2019 were $15.9 million, including non-cash share-based compensation expense of $752,000.

·General and administrative expenses for the three months ended June 30, 2019 were $3.5 million, including non-cash share-based compensation expense of $607,000.

·Atreca reported a net loss of $17.9 million, or basic and diluted net loss per share attributable to common stockholders of $3.67, for the three months ended June 30, 2019.

On August 13, 2019 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines, reported second quarter 2019 financial results and provided an overview of operational progress (Press release, Rubius Therapeutics, AUG 13, 2019, View Source [SID1234538800]).

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"During the second quarter, we continued to advance our promising pipeline of Red Cell Therapeutics for the potential treatment of rare diseases, cancer and autoimmune diseases," said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics. "In addition, we have been working closely with our contract manufacturer to improve its ability to consistently produce product in 200-liter bioreactors. We expect to begin enrolling patients in the near term and remain on track to deliver initial clinical data by year-end. Finally, we continue to make great progress on the buildout of our new manufacturing facility in Smithfield, RI to provide GMP manufacturing for clinical supply."

Second Quarter Highlights and Upcoming Milestones

·Rubius is working closely with its contract manufacturer to improve its ability to consistently produce product in 200-liter bioreactors in order for Rubius to begin enrolling patients in its Phase 1b clinical trial for patients with phenylketonuria (PKU) in the near term.

·Rubius plans to report initial clinical data from the first patients enrolled in the trial by year-end, including:

·Preliminary safety;

·Longevity of RTX-134 cells in circulation; and

· Proof-of-mechanism as measured by production of trans-cinnamic acid, the metabolite of phenylalanine when degraded by phenylalanine ammonia lyase, or PAL.

·The Company continued to strengthen its leadership by appointing Kris Elverum as senior vice president of business development and strategy to oversee corporate strategy and create and execute potential new business development opportunities.

·On June 5, 2019, Rubius announced the issuance of three patents from the U.S. Patent and Trademark Office related to its rare disease and oncology programs and platform.

·Two of the issued patents cover composition of matter and methods of use for the Company’s lead investigational cellular therapy, RTX-134, for the treatment of patients with PKU.

·The third patent, the Company’s first issued composition of matter patent in immuno-oncology, relates to human cells having a checkpoint inhibitor linked to the cell surface.

·Today, in total, Rubius Therapeutics has 30 patent families and more than 130 pending patent applications worldwide.

Second Quarter Financial Results

Net loss for the second quarter of 2019 was $39.4 million or $0.50 per common share, compared to $21.2 million or $2.43 per common share in the second quarter of 2018.

In the second quarter of 2019, Rubius invested $27.5 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $11.4 million in the second quarter of 2018. This year-over-year increase was driven primarily by $7.6 million in incremental R&D program spending in preparation for the Company’s Phase 1b clinical trial for RTX-134 and towards preclinical activities for Rubius’ lead oncology programs, including RTX-240. In addition, $7.4 million in incremental R&D spending was driven by increased R&D headcount, including technical operations, a move into larger facilities and purchasing lab supplies to support Rubius’ goal of delivering four to five INDs across 2019 and 2020. R&D stock-based compensation also increased by $1.9 million.

G&A expenses were $13.8 million during the second quarter of 2019, as compared to $9.0 million for the second quarter of 2018. The higher costs were primarily driven by a $1.5 million increase in personnel and facility costs due to increased headcount in the general and administrative function, as well as increases in professional fees and infrastructure costs to support the Company’s growth. G&A stock-based compensation also increased by $2.8 million.

Six Month Financial Results

Net loss for the first six months of 2019 was $72.0 million or $0.92 per common share, compared to $35.7 million or $4.17 per common share in the first six months of 2018.

In the six months ended June 30, 2019, Rubius invested $48.4 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $20.9 million in the first six months of 2018. This year-over-year increase was largely due to an additional $14.9 million in R&D personnel, including technical operations, facilities and lab supplies to support the Company’s pipeline expansion in 2019 and 2020 and $11.2 million in R&D program spending, including preparing for the RTX-134 Phase 1b clinical trial and preclinical activities for Rubius’ lead oncology programs, including RTX-240. R&D stock-based compensation also increased by $3.6 million.

G&A expenses were $27.3 million during the first six months of 2019, as compared to $14.1 million for the same period in 2018. The higher costs were primarily driven by a $7.9 million increase in stock-based compensation and a $3.7 million increase in personnel costs and facility costs due to increased headcount in our general and administrative function, as well as increases in professional fees and infrastructure costs to support the Company’s growth.

Cash Position

As of June 30, 2019, cash, cash equivalents and investments were $362.3 million as compared to $404.1 million as of December 31, 2018, providing Rubius with a cash runway into 2021. During the year, the Company used $52.7 million of cash to fund operations and $17.4 million to fund capital expenditures, including work related to the buildout of Rubius’ manufacturing facility. In addition, during the quarter, the Company drew down a second tranche of $25.0 million from its $75.0 million loan agreement with Solar Capital, which leaves a third tranche of $25.0 million that can be drawn through June 2020, subject to the satisfaction of certain financial covenants.

On August 13, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported an update on the first 20 patients enrolled in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 in combination with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM (Press release, DelMar Pharmaceuticals, AUG 13, 2019, View Source [SID1234538649]).

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As of August 1, 2019, 17 of the first 20 enrolled patients have received at least their first assessment (two patients have not been enrolled long enough to receive their first assessment and one patient died before their first assessment). "Best Overall Response" for these patients per investigator assessment were:

Nine have been assessed as having achieved a complete response (CR) (9/17, or 53%)
Seven have been assessed with stable disease (SD), (7/17, or 41%)
One has been assessed as disease progression (PD) (1/17, or 6%)
Importantly, 16 of the 20 patients enrolled (80%) were still alive as of the August 1, 2019 data cut-off date. The Company recently announced the enrollment of the 20th patient into this trial.

Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at the Harvard Medical School, and Dr. John de Groot, Professor and Chairman ad interim in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center (MDACC), are considered key opinion leaders in the brain cancer field and currently serve as DelMar Scientific Advisory Board members. Dr. Reardon commented, "Both John and I agree that we desperately need something better to offer our patients and we feel that VAL-083 has some promise and potential."

Dr. Reardon added, "For a tumor such as GBM, which is intrinsically infiltrative and destructive in the brain, stabilization of disease is an important achievement."

Professor Zhong-ping Chen, Founder Chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center (SYSUCC), who is the study’s principal investigator, stated, "We are pleased to be leading this Phase 2 trial for first-line GBM treatment with DelMar, and are encouraged by the enhanced levels of tumor shrinkage and the complete responses we are observing after treatment with VAL-083 in combination with radiation. These preliminary data appear to support the premise that VAL-083 has the potential to provide a valuable treatment option for these patients. We look forward to completing full enrollment in the study as soon as possible."

This Phase 2 trial which is being conducted at SYSUCC in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation. Of the 20 patients enrolled, 17 (85%) have received their two-month (post-third cycle) MRI and investigator assessment, 13 (65%) have received their five-month MRI and investigator assessment, and seven (35%) have received their eight-month MRI and investigator assessment. Two patients (10%) have not been on the study long enough to reach their first assessment, and one patient (5%) died before their first assessment. Assessments are based on the trial investigator’s clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria.

Saiid Zarrabian, DelMar’s president and chief executive officer, noted, "We continue to be encouraged by these early results and look forward to the completion of enrollment for our two, late-stage, Phase 2 studies. These results support our optimism that VAL-083 may provide a better treatment option than currently available treatments."

This Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

The Company also recently announced the initiation of an adjuvant arm to the MDACC study to provide early disease data on VAL-083. This arm will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. This arm is in addition to a trial arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled, and both arms are being conducted at MDACC.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class" bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers, including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

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On August 13, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported the dosing of the first patient in China for the Phase I registrational study of BLU-667, which was discovered by the company’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, AUG 13, 2019, View Source [SID1234538606]). This clinical trial is a part of the ongoing, global Phase I ARROW trial that is designed to evaluate the overall response rate (ORR), duration of response, pharmacokinetics, pharmacodynamics and safety of BLU-667 in patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors.

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Among all malignant tumors, lung cancer has the highest incidence and mortality rates in the world. Due to heightened risk factors such as pollution and the prevalence of smoking in China, there are approximately 730,000 new cases of lung cancer and 610,000 lung cancer-related deaths reported in China each year[1]. NSCLC accounts for 80-85% of all lung cancers and RET fusions occur in approximately 1-2% of all NSCLC cases. Both platinum-based chemotherapy, the standard first-line treatment for RET-fusion NSCLC, and the second-line treatment of cytotoxic drugs or immune checkpoint inhibitor-based monotherapies offer limited efficacy. As a result, patients experience significant physical and psychological burdens and a lower quality of life.

Thyroid cancer is the most common type of endocrine cancer, and has shown rising incidence rates in recent years. There are approximately 90,000 new cases of thyroid cancer and 6,800 thyroid cancer-related deaths in China each year[1]. MTC accounts for 2-5% of all thyroid cancers, and RET mutations occur in nearly all hereditary MTC patients and approximately 50% of all sporadic MTC patients[2]. Currently there is no effective standard of care treatment approved for MTC patients in China.

BLU-667 is an orally available, highly selective and potent RET inhibitor. In June 2018, CStone obtained exclusive rights from Blueprint Medicines to develop and commercialize three therapeutic candidates, including BLU-667, in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights to the three therapeutic candidates in the rest of the world.

In June 2019, Blueprint Medicines reported updated results from the ARROW clinical trial. BLU-667 showed durable anti-tumor activity regardless of RET-altered tumor type and was well-tolerated. As of the data cutoff date of April 28, 2019:

In 35 evaluable patients previously treated with platinum-based chemotherapy[3]. BLU-667 demonstrated an ORR of 60% (one complete response and 20 partial responses (PR); all responses were confirmed) and a disease control rate (DCR) of 100%.
In 16 evaluable RET-mutant MTC patients previously treated with cabozantinib or vandetanib, BLU-667 demonstrated an ORR of 63% (nine confirmed PRs, one PR pending confirmation) and a DCR of 94%[4] .
These patients with RET-fusion NSCLC and RET-mutant MTC received a starting dose of 400 mg once daily, which is the recommended Phase 2 dose. Across all patients, BLU-667 was well-tolerated and most adverse events reported by investigators were Grade 1 or 2.
Dr. Frank Jiang, Chairman and CEO of CStone, commented: "In China, lung cancer has the highest incidence rate and mortality rate among all malignancies. BLU-667 is an agent with great potential, and it could address the existing treatment gap for RET-fusion NSCLC and other RET-altered tumors in this country. I am pleased that through our dedicated efforts, we have successfully carried out the dosing of the first patient in China as a part of the ongoing, global registrational study."

"Precision medicines such as BLU-667 may be highly effective in treating genomically defined cancers and bring significant clinical benefit to patients. The global ARROW study has thus far produced promising clinical data. I am confident that with CStone’s effective execution, we can efficiently accelerate this clinical trial in China so that Chinese patients with RET-altered tumors can access this therapy as soon as possible," noted Dr. Jason Yang, CStone’s Chief Medical Officer.

[1]. Chen W, et al. Cancer statistics in China, 2015. CA Cancer J Clin 2016; 66(2): 115-32.

[2]. Priya SR, et al. Targeted Therapy for Medullary Thyroid Cancer: A Review. Front. Oncol. 7:238.

[3]. Justin F. Gainor, et al. Clinical activity and tolerability of BLU-667, a highly potent and selective RET inhibitor, in patients (pts) with advanced RET-fusion+ non-small cell lung cancer (NSCLC). 2019 ASCO (Free ASCO Whitepaper) Abstract 9008.

[4]. Matthew H. Taylor, et al. Activity and tolerability of BLU-667, a highly potent and selective RET inhibitor, in patients with advanced RET-altered thyroid cancers. 2019 ASCO (Free ASCO Whitepaper) Abstract 6018.

About BLU-667

BLU-667 is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. Blueprint Medicines is developing BLU-667 for the treatment of patients with RET-altered NSCLC, MTC and other solid tumors. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-fusion positive NSCLC that has progressed following platinum-based chemotherapy, and RET-mutation positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

BLU-667 was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. In preclinical studies, BLU-667 consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, BLU-667 demonstrated markedly improved selectivity for RET compared to pharmacologically relevant kinases, including approximately 90-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, BLU-667 has the potential to overcome and prevent the emergence of clinical resistance. Blueprint Medicines believes this approach will enable durable clinical responses across a diverse range of RET alterations, with a favorable safety profile.

On August 13, 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 six months ended June 30, 2019 (Press release, ProMIS Neurosciences, AUG 13, 2019, View Source [SID1234538627]).

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"Over the course of the first half 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 Eugene Williams, ProMIS’ Executive Chairman. "In the second quarter of this year, we were able to identify novel antibodies for Alzheimer’s disease (AD) with selectivity for the neurotoxic form of tau. This is in addition to the prior identification of antibody candidates selectively targeting toxic forms of alpha-synuclein (α-syn) for Parkinson’s disease (PD) and toxic, aggregated forms of TDP43 for amyotrophic lateral sclerosis (ALS)."

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 Chief Medical Officer Dr. James Kupiec’s update on demonstrating early proof-of-concept with biomarkers and focused patient populations
Click here for Chief Scientific Officer Dr. Neil Cashman’s overview of ProMIS’ unique capability to design and develop antibodies selectively targeting toxic misfolded proteins that are a root cause of neurodegenerative diseases
Click here for Chief Development Officer, Dr. Johanne Kaplan’s podium presentation at the Alzheimer’s Association International Conference (AAIC) 2019 showing selective targeting of toxic oligomers by PMN310, a monoclonal antibody rationally designed for greater therapeutic potency in AD
Corporate Highlights

In June 2019, the Company completed a private placement of 4,680,000 common share units at a price of $0.25 per unit resulting in gross proceeds of approximately $1,170,000 ($1,093,492 net of share issuance costs). Each unit consisted of one common share and one common share warrant. The common shares are subject to a four-month hold period from the date of issuance. Each warrant is exercisable into one common share at a price of $0.35 per share at any time for five years.
In May 2019, ProMIS announced the identification of novel antibodies for AD with selectivity for the neurotoxic form of tau. ProMIS leveraged its proprietary drug discovery and development platform to identify several novel antibodies that selectively bind toxic oligomers of tau. The platform produced antibodies that meet a key success factor for a viable Alzheimer’s disease therapy: the ability to selectively target the neurotoxic form of a protein, while sparing the normal forms of the protein, a challenge that has contributed to recent late-stage clinical trial failures. The platform not only generates high-quality antibody candidates, it delivers powerful, validated candidates in months versus years. Used in combination with new biomarkers for Alzheimer’s disease, researchers could dramatically improve the success and speed of future therapy development efforts.
In June 2019, ProMIS presented key data on monoclonal antibody PMN310 for AD at the Keystone Symposium on Neurodegenerative Diseases: New Insights and Therapeutic Opportunities. For nearly fifty years, the conference has attracted the world’s most accomplished researchers in neurodegenerative diseases to discuss future directions in therapy and care. ProMIS Chief Development Officer Dr. Johanne Kaplan presented data showing that PMN310 possesses superior selectivity for amyloid beta toxic oligomers and improved therapeutic potential compared with other amyloid beta-directed antibodies.
Scientific Advisory Board Appointment
In June 2019, the Company appointed C. Warren Olanow, MD, FRCPC, FAAN, FRCP(Hon) to its scientific advisory board (SAB). Dr. Olanow has dedicated his career to the study of neurodegeneration, particularly Parkinson’s disease, through his work in academia, scientific research, clinical trials and professional societies. He is the previous Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of Neurology at the Mount Sinai School of Medicine in New York City and is presently Professor Emeritus in the Department of Neurology and in the Department of Neuroscience. He also serves as Chief Executive Officer of CLINTREX, a pharmaceutical advisory firm that has designed numerous clinical trials in neurodegenerative disease for the pharmaceutical industry.

Financial Results

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

Net loss for the three months ended June 30, 2019 was $1,858,530, compared to a net loss of $2,214,861 for the three months ended June 30, 2018, respectively. Included in the net loss amount for the three months ended June 30, 2019 were non-cash expenses of $153,461, representing share-based compensation and amortization of an intangible asset, compared to $173,544 for the three months ended June 30, 2018. The decrease in the net loss in the three months ended June 30, 2019 reflects a decrease in 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 three months ended June 30, 2019 were $1,042,618, as compared to $1,531,075 in the three months ended June 30, 2018. The decrease in research and development expense for the three months ended June 30, 2019 is primarily attributed to decreased costs associated external contract research organizations for internal programs and patent costs offset by higher contracted research salaries and associated costs, and higher share-based compensation.

General and administrative expenses for the three months ended June 30, 2019 were $815,937, as compared to $683,786 in the three months ended June 30, 2018. The increase in general and administrative expense for the three months ended June 30, 2019 is primarily attributable to increased consultant salaries and associated costs and general corporate expenditures offset by decreased share-based compensation.

Results of Operations – Six months ended June 30, 2019 and 2018

Net loss for the six months ended June 30, 2019 was $4,305,107, compared to a net loss of $3,771,733 for the six months ended June 30, 2018, respectively. Included in the net loss amount for the six months ended June 30, 2019 were non-cash expenses of $417,334, representing share-based compensation and amortization of an intangible asset, compared to $502,555 for the six months ended June 30, 2018. The increase in the net loss in the six months ended June 30, 2019 reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs and general corporate expenditures.

Research and development expenses for the six months ended June 30, 2019 were $2,813,271, as compared to $2,229,082 in the six months ended June 30, 2018. The increase in research and development expense for the six months ended June 30, 2019 is primarily attributed to increased spending on external contract research organizations for internal programs, higher contracted research salaries and associated costs, and higher share-based compensation offset by reduced patent costs.

General and administrative expenses for the six months ended June 30, 2019 were $1,491,861, as compared to $1,542,656 in the six months ended June 30, 2018. The decrease in general and administrative expense for the six months ended June 30, 2019 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 TDP43 and SOD1 in ALS, toxic forms of α-syn in PD and other α-syn-related disorders, and toxic forms of tau and amyloid beta in AD and other dementias to further support ongoing pharmaceutical partnering discussions.