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Oncopeptides initiates the first study with melflufen outside multiple myeloma and enrolls the first patient in the phase 1/2 AL amyloidosis study

On August 7, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the first patient has been enrolled in the Immunoglobulin Light Chain (AL) amyloidosis (OP201) study (Press release, Oncopeptides, AUG 7, 2020, View Source [SID1234563150]). This open-label, phase 1/2 study of melflufen and dexamethasone for patients with AL amyloidosis, following at least one prior line of therapy, is the first study to explore the effect of melflufen outside of multiple myeloma.

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"Today we embarked upon the next phase of our journey with melflufen as we initiated patient enrollment in our phase 1/2 AL amyloidosis study," says Klaas Bakker, CMO of Oncopeptides. "This study will build upon the promising pre-clinical data that we presented at ASH (Free ASH Whitepaper) in December of 2019. With a median overall survival of only three and a half years from diagnosis, we hope to see melflufen providing benefit for patients in this clinical setting where new treatment options are desperately needed."

This information was submitted for publication on August 7, 2020 at 08:00 (CET).

About AL amyloidosis
Amyloidosis describes a highly heterogenous collection of diseases that involve some form of protein deposition in one or several organs. Patients with light chain (AL) amyloidosis suffer from a clonal plasma-cell disease, usually a monoclonal gammopathy of unknown significance (MGUS) or more rarely, myeloma. It is a rare disease that occurs in about 30,000 to 45,000 patients in the U.S. and Europe. Current treatment alternatives are limited to a median overall survival of 3.5 years.

About the OP201 AL amyloidosis study
The AL amyloidosis study is an open-label, phase 1/2 dose-escalation and dose-expansion study of melflufen and dexamethasone in patients with Immunoglobulin Light Chain (AL) amyloidosis following at least one prior line of therapy. The study will enroll approximately 40 patients. The primary endpoints in the phase 1 part are safety and tolerability, and in the phase 2 part of the trial Overall Response Rate (ORR). More information about the OP-102 AL amyloidosis study can be found at:
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About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

Pulmatrix Reports Q2 2020 Results and Business Updates

On August 7, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q2 2020 financial results and provides a business update (Press release, Pulmatrix, AUG 7, 2020, View Source [SID1234563149]).

"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said Ted Raad, Chief Executive Officer of Pulmatrix. "The recent publication of data demonstrating the ability of FEND to suppress the exhalation of respiratory droplets, which can transmit airborne infections, leaves us confident that our proprietary NasoCalm technology can be applied to provide an important new OTC hygiene option for addressing the spread of COVID-19. We look forward to an anticipated commercial launch in the fall of this year and believe the royalty stream from the commercialization of FEND, upon the commencement of sales, could be an important source of non-dilutive funding to fuel our internal development pipeline."

Mr. Raad continued, "Together with our partner Cipla, we decided to end our Phase 2 clinical study of Pulmazole for the treatment of asthma patients with ABPA. We are leveraging this pause in our development program to prepare for a new Phase 2b study of longer study duration and inclusion of efficacy endpoints that are intended to better inform and propel the program forward. While we prepare for a potential study start in 3Q 2021, we are working with Cipla to amend the Phase 2 development and commercialization agreement to include the new Phase 2b development plan and budget. In our partnership with Johnson & Johnson, we achieved a significant milestone with the MRHA approval of the PUR1800 Ph1b study, enabling us to start the study in 2H 2020."

Q2 and Recent Highlights:

●Announced partner Sensory Cloud’s progress towards the commercialization of FEND, an over the counter (OTC) nasal hygiene product that is comprised of proprietary Pulmatrix NasoCalm formulations (PUR003 and PUR006) of sodium chloride and calcium chloride salts licensed from Pulmatrix. FEND is designed to provide, among other potential benefits, an ability to suppress the exhalation of droplets of airway lining fluid, which can transmit airborne infection with an anticipated commercial launch in the fall of 2020. Pulmatrix will receive escalating royalties from worldwide revenues upon commencement of sales.

●Announced the publication of NasoCalm development data, along with data generated by Sensory Cloud, in the Quarterly Reviews of Biophysics, demonstrating a reduction in airborne particles in exhaled air over time following FEND administration. These data suggest FEND provides hygienic benefit that may augment current social distancing and hygiene measures for addressing the spread of COVID-19 and other airborne pathogens.

●Due to past enrollment delays, coupled with the impact of the COVID-19 pandemic on enrollment, Pulmatrix and Cipla ended its Phase 2 clinical study of Pulmazole for the treatment of allergic bronchopulmonary Aspergillosis (ABPA). Pulmatrix intends to initiate a new Phase 2b clinical study in 3Q 2021 with up to four months of dosing and the addition of trial efficacy endpoints, replacing the Phase 2 clinical study which focused on safety and tolerability endpoints. Top-line data is anticipated 18 months after site activation start. Due to the changes in the development of Pulmazole, Pulmatrix and Cipla are negotiating amendments to the development and commercialization agreement.

●The Medicines and Healthcare Products Regulatory and Approval Agency (MHRA) approved in July the PUR1800 Ph1b clinical trial, enabling Pulmatrix plans to begin the study in the United Kingdom during 2H 2020.

●Appointed Chris Cabell, M.D. to the Pulmatrix Board of Directors. As current Head of Research & Development and Chief Medical Officer at Arena Pharmaceuticals, with prior experience as Chief Medical and Scientific Officer at Quintiles, Dr. Cabell possesses the critical skills that will be beneficial in the strategy for Pulmatrix pipeline programs. Steven Gills, Ph.D., will step down from the Board of Directors on September 1, 2020.

●Strengthened balance sheet with gross proceeds from a registered direct offering in April and a warrant exercise transaction in July, in order to support ongoing preclinical and anticipated clinical programs for Pulmazole, PUR1800, other pipeline assets and general working capital needs.

Financials

As of June 30, 2020, Pulmatrix had $27.3 million in cash compared to $23.4 million as of December 31, 2019.

Pulmatrix generated $3.5 million of revenue in the second quarter of 2020, compared to $4.8 million in the second quarter of 2019. The revenue for the first quarter of 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI, respectively.

Research and development expenses for the second quarter of 2020 and 2019 were $3.2 million. Included in the second quarter of 2020 costs were pre-clinical toxicology costs for the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study.

General and administrative expenses for the second quarter of 2020 were $1.5 million compared to $3.1 million in the second quarter of 2019. The decrease of $1.6 million was due to decreased spend in employment costs primarily as a result of reduced share-based compensation expense of $1.1 million in 2020, a $0.3 million milestone payment in 2019 and a $0.2 million reduction in legal and patent expense in 2020.

Net loss was $1.2 million for the first quarter of 2020 and $7.8 million for the first quarter of 2019. The net loss for both periods was due to spend on the Pulmazole study and PUR1800 manufacturing costs for the upcoming planned Phase 1b clinical study.

Pulmatrix Reports Q2 2020 Results and Business Updates

On August 7, 2020 Pulmatrix (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q2 2020 financial results and provides a business update (Press release, Pulmatrix, AUG 7, 2020, View Source [SID1234563148]).

"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said , Chief Executive Officer of Pulmatrix. "The recent publication of data demonstrating the ability of FEND to suppress the exhalation of respiratory droplets, which can transmit airborne infections, leaves us confident that our proprietary NasoCalm technology can be applied to provide an important new OTC hygiene option for addressing the spread of COVID-19. We look forward to an anticipated commercial launch in the fall of this year and believe the royalty stream from the commercialization of FEND, upon the commencement of sales, could be an important source of non-dilutive funding to fuel our internal development pipeline."

Q2 and Recent Highlights:

Announced partner Sensory Cloud’s progress towards the commercialization of FEND, an over the counter (OTC) nasal hygiene product that is comprised of proprietary Pulmatrix NasoCalm formulations (PUR003 and PUR006) of sodium chloride and calcium chloride salts licensed from Pulmatrix. FEND is designed to provide, among other potential benefits, an ability to suppress the exhalation of droplets of airway lining fluid, which can transmit airborne infection with an anticipated commercial launch in the fall of 2020. Pulmatrix will receive escalating royalties from worldwide revenues upon commencement of sales.
Announced the publication of NasoCalm development data, along with data generated by Sensory Cloud, in the Quarterly Reviews of Biophysics, demonstrating a reduction in airborne particles in exhaled air over time following FEND administration. These data suggest FEND provides hygienic benefit that may augment current social distancing and hygiene measures for addressing the spread of COVID-19 and other airborne pathogens.
Due to past enrollment delays, coupled with the impact of the COVID-19 pandemic on enrollment, Pulmatrix and Cipla ended its Phase 2 clinical study of Pulmazole for the treatment of allergic bronchopulmonary Aspergillosis (ABPA). Pulmatrix intends to initiate a new Phase 2b clinical study in 3Q 2021 with up to four months of dosing and the addition of trial efficacy endpoints, replacing the Phase 2 clinical study which focused on safety and tolerability endpoints. Top-line data is anticipated 18 months after site activation start. Due to the changes in the development of Pulmazole, Pulmatrix and Cipla are negotiating amendments to the development and commercialization agreement.
The Medicines and Healthcare Products Regulatory and Approval Agency (MHRA) approved in July the PUR1800 Ph1b clinical trial, enabling Pulmatrix plans to begin the study in the United Kingdom during 2H 2020.
Appointed Chris Cabell, M.D. to the Pulmatrix Board of Directors. As current Head of Research & Development and Chief Medical Officer at Arena Pharmaceuticals, with prior experience as Chief Medical and Scientific Officer at Quintiles, Dr. Cabell possesses the critical skills that will be beneficial in the strategy for Pulmatrix pipeline programs. Steven Gills, Ph.D., will step down from the Board of Directors on September 1, 2020.
Strengthened balance sheet with gross proceeds from a registered direct offering in April and a warrant exercise transaction in July, in order to support ongoing preclinical and anticipated clinical programs for Pulmazole, PUR1800, other pipeline assets and general working capital needs.
Financials

As of June 30, 2020, Pulmatrix had $27.3 million in cash compared to $23.4 million as of December 31, 2019.

Athenex Announces $50 Million Revenue Interest Financing with Sagard Healthcare Royalty Partners

On August 6, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into a $50 million Revenue Interest Financing ("RIF") agreement with Sagard Healthcare Royalty Partners, LP ("SHRP"), a division of multi-strategy alternative asset manager Sagard Holdings (the "Agreement") (Press release, Athenex, AUG 6, 2020, View Source [SID1234573874]). The Company expects the proceeds from the financing will be used to fund the commercial launch of oral paclitaxel and encequidar (Oral Paclitaxel), ongoing pipeline development, manufacturing infrastructure, and working capital and general corporate purposes.

The Agreement provides Athenex with $50 million of capital upon approval by the U.S. Food and Drug Administration (FDA) of Oral Paclitaxel for the treatment of metastatic breast cancer. In exchange for funding this capital, SHRP will receive a temporary mid-single digit royalty on net sales of Oral Paclitaxel. The agreement allows the RIF to be repurchased by the Company at an IRR of as low as 13%. The facility has no maturity date and no fixed amortization schedule. Further information with respect to the facility is set forth in a Form 8-K filed by Athenex with the Securities and Exchange Commission on August 6, 2020.

In addition to its Revenue Interest Financing, SHRP and certain of its co-investors have purchased by assignment $50 million of outstanding loans and undrawn commitments from funds managed by Oaktree Capital Management, L.P. ("Oaktree"), becoming lenders under Athenex’s $225 million term loan facility entered into between Oaktree and Athenex in June 2020. There is no incremental capital available to Athenex as a result of this transaction.

"We are delighted to have Sagard Healthcare Royalty Partners as another financial partner, as Athenex continues to make excellent progress towards our goal of bringing important novel cancer therapies like Oral Paclitaxel to patients," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "The recent funding arrangements will provide Athenex further flexibility and cash runway to support our commercial launch activities and ongoing pipeline development. We believe that this Revenue Interest Financing transaction is precedent setting in that it would provide $50 million of additional non-dilutive capital that co-exists with the covenant-light, 6-year $225 million senior term debt provided by Oaktree."

"Revenue Interest Financing is becoming an increasingly attractive option for innovative companies such as Athenex as they look to commercialize novel therapies. We’re excited to be providing this funding and to be partnering with Oaktree Capital Management on the loan facility," said David MacNaughtan, Head of SHRP, which recently completed a second close of its inaugural fund.

Ladenburg Thalmann & Co. Inc. and Royalty/Revenue Interest Capital Advisors LLC served as financial advisors to Athenex and Cooley LLP served as legal counsel to Athenex. Torys LLP served as legal counsel to Sagard Holdings.

Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth

On August 6, 2020 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth), in Houston, Texas (Press release, Immatics Biotechnologies, AUG 6, 2020, View Source [SID1234569554]). The continued collaboration grants Immatics access to UTHealth’s state-of-the-art cGMP manufacturing infrastructure at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, enabling continued production and supply of Immatics’ specialized, cell-based product candidates for testing in multiple clinical trials. Maximum capacity of the facility is anticipated at 48 ACTengine T cell products per month. The new agreement will run until the end of 2024. Under the agreement, UTHealth will provide Immatics with exclusive access to three cGMP suites and support areas for the manufacturing of various Adoptive Cell Therapy (ACT) products. Therapeutic T cell production will be carried out by Immatics’ manufacturing personnel and will be supported by a UTHealth-Immatics joint quality team.

Steffen Walter, Ph.D., Chief Technology Officer at Immatics, commented: "During the last five years, we have established a strong and productive partnership with UTHealth that has enabled the initiation of four ongoing clinical trials. As we remain focused on the development of our clinical pipeline, this extension of our collaboration with UTHealth will fulfill Immatics’ manufacturing needs for our early-stage ACT clinical programs for the next four years. Being able to rely on a partner with profound cell therapy expertise who is familiar with our technologies and can support cGMP cell therapy production is critical to ensuring the advancement of our clinical trials. We look forward to continuing this fruitful collaboration with the experts at UTHealth."

Fabio Triolo, D.d.R., M.Phil., Ph.D., The Clare A. Glassell Distinguished Chair and Director of the Cellular Therapy Core at UTHealth, added: "Signing the extended contract with Immatics fits into our strategy at UTHealth of supporting the development of new treatments for patients in need. We therefore look forward to continuing our collaboration and further leveraging the potential of our manufacturing capabilities."

About Immatics’ ACT Programs
ACTengine is a personalized approach in which the patient’s own T cells are genetically modified to express a novel proprietary TCR cognate to one of Immatics’ proprietary cancer targets which are then reinfused back into the patient. Immatics’ latest proprietary ACTengine manufacturing processes are designed to generate cell product candidates within a short six day manufacturing window and to deliver highly proliferative T cells, with the capability to infiltrate the patient’s tumor and function in a challenging solid tumor microenvironment. The process is designed to rapidly produce younger, better-persisting T cells capable of "serial" killing tumor cells in vitro. Immatics’ is further advancing the ACT concept beyond individualized manufacturing with its product class ACTallo which is being developed to generate "off-the-shelf" cellular therapies.