On November 12, 2018 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported financial results and provided a business update for the third quarter of 2018 (Press release, Neon Therapeutics, NOV 12, 2018, View Source [SID1234531425]).

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"Throughout the third quarter we continued to execute our strategy and are pleased with the progress we have made. Our neoantigen-based platform and product candidates have the potential to have a meaningful impact on patients and we recently presented a series of encouraging data at major scientific meetings that support that goal," said Hugh O’Dowd, president and chief executive officer of Neon. "We are excited to be a leader in the neoantigen field building on the body of science across multiple product candidates that span both T cell and vaccine modalities. Importantly, the strength of our balance sheet supports these promising clinical programs through value-creating inflection points."

Third Quarter and Recent Business Highlights

· In August 2018, Neon announced the appointment of Jolie M. Siegel as general counsel and secretary. Ms. Siegel leads the legal, intellectual property, compliance and corporate governance functions for the company and reports to Hugh O’Dowd, president and chief executive officer of Neon.

· In October 2018, Neon presented updated data from NT-001, its ongoing Phase 1b clinical trial evaluating NEO-PV-01 in the metastatic setting, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany.

· In October 2018, Neon announced a research collaboration with Natera, Inc., utilizing Natera’s Signatera (RUO) circulating tumor DNA assay as a biomarker to assess treatment response to NEO-PV-01 in Neon’s NT-002 clinical trial.

· In November 2018, Neon announced the appointment of Robert Bazemore to its Board of Directors. Mr. Bazemore is currently President and Chief Executive Officer of Epizyme.

· In November 2018, Neon presented supplementary data from NT-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C.

· In November 2018, Neon presented new data relating to its NEO-PTC-01 program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Third Quarter 2018 Financial Results

· Cash Position: As of September 30, 2018, cash, cash equivalents and marketable securities were $121.7 million, as compared to cash, cash equivalents and marketable securities of $79.7 million as of December 31, 2017.

· R&D Expenses: R&D expenses were $14.4 million for the quarter ended September 30, 2018, compared to $11.5 million for the same quarter last year. The increase of $2.9 million was driven by higher personnel costs as well as increased costs related to the advancement of NEO-PV-01.

· G&A Expenses: G&A expenses were $4.6 million for the quarter ended September 30, 2018, compared to $2.6 million for the same quarter last year. The increase of $2.0 million was primarily driven by increased costs of being a public company, including professional fees, personnel costs and other related costs.

· Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $18.4 million for the quarter ended September 30, 2018, or $0.67 per basic and diluted share, as compared to a net loss attributable to common stockholders of $16.5 million for the same quarter last year, or $9.59 per basic and diluted share.

On November 12, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, reported financial results and provided a corporate update for the third quarter ended September 30, 2018 and recent activities (Press release, Unum Therapeutics, NOV 12, 2018, View Source [SID1234531239]).

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"In the third quarter of 2018, we continued to make significant progress advancing our clinical pipeline," said Chuck Wilson, CEO of Unum. "We are excited to announce today that we have selected ACTR707 in combination with rituximab for further development in patients with relapsed or refractory non-Hodgkin lymphoma. Early data from the ATTCK-20-03 trial continue to support our novel ACTR platform and potential best-in-class product profile. In addition, we remain on track with our two additional clinical studies, ATTCK-17-01 in multiple myeloma and ATTCK-34-01 in HER2+ solid tumors, and are looking forward to presenting further updates on all trials at upcoming scientific conferences in December. Finally, we are pleased with our significant progress in developing a second novel technology platform, BOXR, which is designed to improve T cell functionality in solid tumors, and we look forward to developing future products based on this platform."

Recent Highlights

Selected ACTR707 as Lead Candidate for Further Development in r/r NHL: Unum has elected to advance ACTR707 in combination with rituximab as its lead product candidate to treat patients with relapsed or refractory CD20-positive B cell non-Hodgkin lymphoma (r/r NHL). As a result of this decision, Unum intends to conclude enrollment in the ATTCK-20-2 study, in the first half of 2019. The selection of ACTR707 as the lead construct in r/r NHL was based on the emerging clinical data from the Phase I ATTCK-20-03 clinical trial, the continuing progress in the ATTCK-20-03 study, and the Company’s desire to efficiently manage resources. At the first dose level of that trial, three out of six treated patients achieved a complete response, two of which remained ongoing at the time of the September 4 data cut off. Additionally, no dose-limiting toxicities (DLTs), serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. The findings in ATTCK-20-03 build on the encouraging data observed in cohort 1 of the ATTCK-20-2 trial, which evaluated ACTR087 in combination with

rituximab in patients with r/r NHL. Updated data from the ATTCK-20-03 trial will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December.

Continued Progress with ATTCK-17-01 Phase I trial: Unum is continuing to enroll and dose patients in ATTCK-17-01, a Phase I, multi-center, open-label clinical trial designed to test the safety, tolerability, and anti-myeloma activity of ACTR087 used in combination with SEA-BCMA in patients with r/r multiple myeloma through the dose escalation phase of the trial. This is the first clinical trial conducted under the strategic collaboration with Seattle Genetics. Unum plans to report preliminary data from early dose cohorts at the upcoming ASH (Free ASH Whitepaper) meeting in December 2018.

On Track to Initiate ATTCK-34-01 Trial by Year End in Solid Tumors: Unum’s investigational new drug (IND) application for ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers has been accepted, and Unum plans to initiate the multi-center Phase I ATTCK-34-01 trial by the end of 2018, and announce preliminary data in 2019. ATTCK-34-01, Unum’s first ACTR combination study in solid tumors, is a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab and includes a planned expansion at the recommended Phase 2 dose. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further study. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence and trastuzumab pharmacokinetics. Unum expects to present updated preclinical data along with the clinical trial design at the San Antonio Breast Cancer Symposium in December 2018.

Announced New Technology Platform to Expand Clinical Development Efforts in Solid Tumors: At the Society for Immunotherapy (SITC) (Free SITC Whitepaper) meeting in November, Unum presented preclinical data on a new technology platform called "BOXR," or Bolt-On Chimeric Receptor, that improves the functionality of T cells, enabling them to be more effective in solid tumor cancers. BOXR works with ACTR T cells or CAR T cells to significantly improve T cell functionality. Unum will disclose more details on this new platform, as well as its broader efforts in solid tumors, at the upcoming investor event on November 19, 2018, in New York, featuring guest speaker Charles S. Fuchs, MD, MPH, of Yale Cancer Center. The event will be available also via live webcast.

Third Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the third quarter ended September 30, 2018 and 2017, of $2.0 million and $2.3 million, respectively, reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs by Seattle Genetics. Effective January 1, 2018, Unum adopted the new revenue recognition standard, ASC 606, which changed the manner in which the Company recognizes revenue from this collaboration agreement compared to the prior year period.

R&D Expenses: Research and development expenses were $10.3 million for the third quarter ended September 30, 2018, compared to $8.2 million for the same period last year. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs. This was partially offset primarily by a decrease in manufacturing costs incurred for the Phase I clinical trial of ACTR087 in combination with rituximab.

G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2018, were $2.4 million, compared to $1.3 million for the same period last year. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.

Net Loss: Net loss attributable to common stockholders was $10.2 million, or $0.34 per share, for the third quarter ended September 30, 2018, and $7.0 million, or $0.69 per share, for the same period last year.

Cash, Cash Equivalents and Marketable Securities: As of September 30, 2018, Unum had cash, cash equivalents, and marketable securities of $87.1 million. Today, the Company updated its cash runway and now believes that its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements through at least June 2020, without considering $15.0 million in available borrowings under its loan and security agreement, as a result of its decision to conclude enrollment in the ATTCK-20-2 study in the first half of 2019.

On November 12, 2018 BridgeBio Pharma LLC and Cincinnati Children’s Hospital Medical Center reported they are entering into a research collaboration to identify and develop genetic disease therapies (Press release, BridgeBio, NOV 12, 2018, https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-pharma-llc-signs-joint-collaboration-agreement [SID1234576271]). This partnership will combine BridgeBio’s strengths in therapeutic development for diseases of high unmet need with Cincinnati Children’s world-class researchers and clinicians. As a global research center of excellence, Cincinnati Children’s represents an ideal partner for BridgeBio and reinforces BridgeBio’s commitment to collaborating with leading researchers toward the mutual goal of discovering new therapies targeting genetic diseases at the source.

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"BridgeBio is privileged to partner with leading experts at Cincinnati Children’s, an institution whose impact on science and patients we admire. We hope we can help advance the mission by partnering to move therapies forward to patients," said Neil Kumar, co-founder and CEO of BridgeBio.

"We are excited to launch this new alliance with BridgeBio to bring new and innovative therapies to some of the most vulnerable patients impacted by rare and complex genetic diseases," said Margaret Hostetter, MD, Chief Medical Officer of Cincinnati Children’s and Director, Cincinnati Children’s Research Foundation.

"This collaboration exemplifies Cincinnati Children’s commitment to accelerating discoveries towards commercialization through win-win academic-industry partnerships," added Mike Pistone, Director of Acceleration for Cincinnati Children’s Innovation Ventures, the group managing this program.

Under the terms of the agreement, BridgeBio will have the opportunity to sponsor and collaboratively develop selected research programs. The agreement represents a flexible model that facilitates accelerated genetic disease research.

On November 12, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported that Robin L. Washington, Gilead’s Executive Vice President and Chief Financial Officer, and John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of Research & Development, will participate in a fireside chat at the Evercore ISI HealthCONx Conference in Boston on Tuesday, November 27 at 9:30 a.m. Eastern Time (Press release, Gilead Sciences, NOV 12, 2018, View Source;p=irol-newsArticle&ID=2376801 [SID1234531240]).

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The audio portion of the fireside chat will be accessible live through the company’s Investors page at www.gilead.com/investors. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation.

On November 12, 2018 PharmaMar (MSE:PHM) reported a new Antibody Drug Conjugate (ADC) MI180021, the result of linking trastuzumab with the marine molecule PM160057 (Press release, PharmaMar, NOV 12, 2018, View Source [SID1234531335]). This will be presented at the World ADC Congress in San Diego, from 12-15 November 2018.

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PharmaMar’s poster has been selected as one of the top five for an oral presentation at the Congress.

This ADC has shown potent and highly selective activity in tumor cells that overexpress HER2, as found in certain breast, gastric and pancreas cancers, among others.

PM160057 belongs to a new family of molecules of marine origin that kill tumor cells by binding to DNA. This family of new chemical structures with novel mechanisms of action offer the opportunity to develop a new generation of ADCs (also called "magic bullets").

This discovery reinforces the strategy of PharmaMar’s unit dedicated to obtaining compounds for the use of active agents in ADCs. This research has already led to the licensing of the first family of active molecules to Seattle Genetics, world leader in ADCs, for which PharmaMar received an initial payment of $5 million.

According to Carmen Cuevas, Director of R&D at PharmaMar, "MI180021 has a high selectivity against cancer cells that overexpress HER2 receptor, providing a new oportunity to treat patients with these types of cancers, such as breast, gastric and pancreatic."

About ADCs
ADCs are innovative, next-generation immunotherapeutic agents. ADCs consist of an antibody that identifies and targets antigens on the surface of certain tumor cells, a molecule with anti-tumor activity, and a connector that binds them together.

Despite more than 30 years of research to develop ADCs, there are currently only four FDA-approved conjugate antibodies (Kadcyla, Adcetris, Besponsa, and Mylotarg), two of which incorporate microtubule inhibitors (auristatins and maytansins) as active charge; and the other two, using a compound that interacts with DNA (calicheamicin).

Agents that interact with DNA are widely used in cancer treatment.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.