On November 04, 2015 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the third quarter ended September 30, 2015 (Press release, MacroGenics, NOV 4, 2015, View Source [SID:1234507969]).

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"As we strive to create breakthrough biologics and life-changing medicines, the team at MacroGenics was proud to share our progress at our recent R&D Day in New York," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We reported encouraging initial clinical trial results from an ongoing Phase 1 study of enoblituzumab, our Fc-optimized monoclonal antibody that targets B7-H3. We also extended our B7-H3 franchise by advancing MGD009, a DART molecule directed against B7-H3 and CD3, into a Phase 1 study. Furthermore, we recently announced a collaboration with Merck to evaluate margetuximab in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in patients with advanced gastric cancer. This combination of therapeutics could exploit complementary immune-based mechanisms for targeting tumors and provide an important alternative for patients who do not respond to currently available regimens."

Pipeline Update

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2. Recent highlights include:

Phase 1b/2 Gastric Cancer Study in Collaboration with Merck: The Company recently announced a collaboration to evaluate the combination of margetuximab with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1b/2 clinical trial in patients with HER2-positive advanced gastric cancer. Trial startup activities are underway, and the Company expects to begin enrolling patients by the first quarter of 2016.

SOPHIA Study Continues: The Company’s Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is continuing enrollment. This three-year study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy following progression after at least two lines of previous therapy in approximately 530 patients.
B7-H3 Franchise—MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company’s three programs target B7-H3 through complementary mechanisms of action and take advantage of this target’s broad expression across multiple solid tumor types. Recent highlights include:

Enoblituzumab (MGA271): The Company provided an overview of initial data from its ongoing Phase 1 monotherapy clinical study of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. To date, enoblituzumab has been well tolerated in patients and has shown encouraging, initial single-agent activity, including tumor regression in multiple, heavily pre-treated patients. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. The Company continues to enroll patients in additional monotherapy Phase 1 study cohorts as well as in two combination studies with either ipilimumab or pembrolizumab. Data from the ongoing monotherapy study will be presented in a late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7, 2015.

Regains European and Other Regional Rights to Enoblituzumab: In October 2015, Les Laboratoires Servier, or Servier, provided notice that it would not be exercising its option under a 2011 agreement to develop and commercialize enoblituzumab in Europe and other countries. Accordingly, the agreement with Servier regarding enoblituzumab has expired and MacroGenics now controls worldwide development and commercialization rights to enoblituzumab. The agreement between MacroGenics and Servier for development of DART molecules is unaffected by this decision.

MGD009 in Phase 1: MGD009, a Dual-Affinity Re-Targeting, or DART, molecule targeting B7-H3 and CD3, is being tested in a Phase 1 study in patients and is being evaluated across multiple solid tumor types.

B7-H3 Antibody-Drug Conjugate: The Company continues to evaluate antibody drug conjugate (ADC) molecules to induce direct killing of B7-H3 positive tumor cells.

DART Product Candidates—There are currently five DART molecules in clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD011 (CD19 x CD3, also known as JNJ-64052781), MGD010 (CD32B x CD79B) and MGD009 (B7-H3 x CD3). Each of these DART molecules is being evaluated in a Phase 1 clinical study. At its R&D Day, the Company disclosed for the first time two DART molecules that it expects to advance into clinical development in the first half of 2017. These two product candidates include:

MGD013: MacroGenics is developing an Fc-bearing DART molecule, MGD013, to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3. The company presented promising pre-clinical data demonstrating the activity of a DART molecule with these specificities and expects that this bi-specific combination may be useful for treatment of a wide range of solid tumors and hematological malignancies. Beyond MGD013, MacroGenics is generating and evaluating multiple other candidates that target a range of immune regulatory molecules using its DART platform as well as its Trident platform for generating tri-specific molecules.
MGD014: MacroGenics presented pre-clinical data on MGD014, a DART molecule that is being developed to eliminate latent HIV infection. MGD014 will be developed under a contract recently awarded by the National Institute of Allergy and Infectious Diseases for up to $24.5 million. This is the first infectious disease DART program planned for clinical testing.

Corporate Update

Equity Offering: In July, the Company completed an equity offering, raising $141 million in net proceeds, which included exercise of the underwriters’ over-allotment option in full. MacroGenics is using the proceeds of this offering to expand its manufacturing capacity and accelerate development of immune regulatory-based product candidates, including MGD013, advance other research and development programs, in-license or acquire other products or technologies, and for general corporate purposes.

Partners’ DART Molecules Advance: As previously announced, MacroGenics’ collaboration partner, Janssen Biotech, Inc., paid the Company a $10 million milestone during the third quarter of 2015 after dosing a first patient in an open-label Phase 1 study of MGD011. Also, in October 2015, MacroGenics’ collaboration partner, Boehringer Ingelheim, selected a DART molecule for further pre-clinical development. This triggers a $5 million milestone payment to MacroGenics under an October 2010 agreement to discover, develop and commercialize DART therapeutics.

Manufacturing Expansion: During the third quarter, the Company signed a lease for additional space with a focus on expanding its commercial manufacturing capabilities.

Third Quarter 2015 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2015 were $365.8 million, compared to $157.6 million as of December 31, 2014. The Company expects that its cash balance should fund operations into 2018.

Revenue: Total revenues, consisting primarily of revenue from collaborative research, were $14.7 million for the three-month period ended September 30, 2015 compared to $18.4 million for the three-month period ended September 30, 2014. Collaborative research revenue includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the quarter.

R&D Expenses: Research and development expenses were $24.1 million for the three-month period ended September 30, 2015, compared to $18.6 million for the three-month period ended September 30, 2014. This increase was primarily due to preparations for and launch of the margetuximab SOPHIA Phase 3 study, increased activity to prepare for the MGD009 Investigational New Drug (IND) application submission, and costs of other ongoing clinical studies.

G&A Expenses: General and administrative expenses were $6.0 million for the three-month period ended September 30, 2015, compared to $3.7 million for the three-month period ended September 30, 2014. This increase was primarily due to higher labor-related costs, including stock-based compensation expense and information technology-related expenses.

Net Loss: Net loss was $15.4 million for the three-month period ended September 30, 2015, compared to net loss of $3.9 million for the three-month period ended September 30, 2014.

Shares Outstanding: Shares outstanding as of September 30, 2015 were 34,248,240.

On November 4, 2015 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, reported findings that support the potential of ATLAS, the Company’s proprietary rapid antigen identification screening system, to profile responses to immunotherapies for cancer (Press release, Genocea Biosciences, NOV 4, 2015, View Source [SID:1234507945]). This analysis, in which ATLAS identified the specificity and characteristics of T cell responses in cancer patients, will be presented as a late-breaker at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #342, entitled Immunoprofiling of T cell responses in melanoma patients undergoing CPI therapy, will be presented on Saturday, November 7, 2015 between 12:00 – 2:00 p.m. ET.

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In this pilot study, funded by the Ludwig Trust, Genocea partnered with Darren Higgins, Ph.D., professor of microbiology and immunobiology at Harvard Medical School and F. Stephen Hodi, Jr., M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, to conduct a retrospective analysis of 10 checkpoint inhibitor (CPI) treated patients’ T cell responses to 23 known tumor-associated antigens. By analyzing the immune responses of both responders and non-responders to CPI therapy, ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as "decoys," further validating the ability of ATLAS to distinguish clinically relevant targets of T cell responses.

"The breakthroughs we’ve seen in the immuno-oncology field to date have been profound, yet emerging treatment approaches do not yet include an understanding of who may respond to therapy and why," said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. "These findings provide strong proof of concept that ATLAS can take a panoramic view of a large, diverse population of cancer patients and reveal clinically relevant signatures of protective responses. We believe we are uniquely positioned to utilize our technology to enable smarter profiling – indicating what must be present to see a benefit from therapy – as well as smarter identification of T cell antigens to drive cancer vaccine development."

The collaboration with Dana-Farber is ongoing as Genocea continues to analyze more blood samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.

About ATLAS

ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.

On November 04, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2015 (Press release, Momenta Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507948]).

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For the third quarter of 2015, the Company reported total revenues of $13.8 million, including $8.7 million of GlatopaTM (glatiramer acetate injection) profit share. For the nine months ended September 30, 2015, the Company reported total revenues of $67.3 million, including $27.9 million in product revenues from Sandoz’s sales of Glatopa. Momenta reported a net loss of $(30.1) million, or $(0.44) per share for the third quarter compared to a net loss of $(29.1) million, or $(0.56) per share for the same period in 2014. For the nine months ended September 30, 2015, the Company reported a net loss of $(54.1) million, or $(0.88) per share compared to a net loss of $(82.6) million, or $(1.61) per share for the same period in 2014. At September 30, 2015, the Company had cash, cash equivalents, and marketable securities of $374.9 million.

"The launch of Glatopa is going according to plan with Glatopa scripts currently representing approximately 25% to 30% of the once daily glatiramer acetate market," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "As the first marketed generic version of a multiple sclerosis drug, Glatopa is bringing value to both patients and payors."

"We continue to advance our biosimilar and novel drug programs. Our Phase 2 study of necuparanib in pancreatic cancer is advancing and M923, our biosimilar HUMIRA candidate, has entered a pivotal clinical trial," continued Mr. Wheeler. "Our ongoing development activities should also allow us to move M834, our biosimilar ORENCIA candidate, and our two novel recombinant autoimmune candidates into the clinic in 2016."

Third Quarter Highlights and Recent Events

Complex Generics:
GlatopaTM, generic version of daily COPAXONE 20 mg (glatiramer acetate injection)

Sandoz launched Glatopa on June 18, 2015. In the third quarter of 2015, Momenta recorded $8.7 million in product revenues from Sandoz’s Glatopa sales. Glatopa is experiencing positive trade uptake, although the impact on third quarter sales was limited as launch inventory continues to be worked through. In the second quarter of 2015 Momenta’s share of profit on sales of Glatopa was $28.2 million, and after a deduction of $9.0 million in reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses, the Company recorded $19.2 million in product revenue.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz, is under FDA review.

Enoxaparin Sodium Injection

The Company continues to pursue the patent infringement case related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and Actavis. In July 2015, the U.S. Solicitor General, at the request of the Court of Appeals for the Federal Circuit, filed a brief in the case that supported Momenta’s interpretation of the scope of the "safe harbor" provisions under the Hatch Waxman Act. A CAFC decision is expected in 2015.

Biosimilars:

In October 2015, Momenta and Baxalta announced the initiation of a pivotal clinical trial for M923, a biosimilar version of HUMIRA (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.
Momenta continues to develop M834, a biosimilar version of ORENCIA (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential partners to collaborate on the development and commercialization of a portfolio of its biosimilar candidates.

Novel Drug:
Necuparanib (novel oncology candidate)

Momenta’s Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is enrolling. The Company expects to have clinical data available in the first half of 2017.
The Company continues to collect data from the Phase 1 study and plans to publish and/or present updated results following completion of the study.

Autoimmune Drugs
Momenta’s three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.

Third Quarter 2015 Financial Results

Total revenues for the third quarter of 2015 were $13.8 million compared to $9.3 million for the same period in 2014. Total revenues for the third quarter of 2015 includes $8.7 million in product revenue, which represents 50% of contractual profit earned from Sandoz’s sale of Glatopa.

Enoxaparin product revenue decreased from $4.7 million for the third quarter of 2014 to zero for the same period in 2015. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz’ obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. In the third quarter of 2015, Sandoz did not earn a profit on its sales of enoxaparin due to continued competitive pricing.

Collaborative research and development revenue for the third quarter of 2015 was $5.1 million, compared to the $4.6 million recorded in the same quarter last year. The increase is primarily due to an increase in the quarterly amortization of the upfront payment under the Baxalta collaboration.

Research and development expenses for the third quarter of 2015 were $31.7 million, compared to $27.5 million for the same period in 2014. The increase of $4.2 million, or 15%, from the 2014 period primarily resulted from increases of $2.0 million in nonclinical and manufacturing expenditures to advance the novel autoimmune programs, $1.8 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients and $0.3 million in share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the quarter ended September 30, 2015, were $12.5 million, compared with $11.1 million for the same period in 2014. The increase of $1.4 million, or 13%, from the 2014 period primarily resulted from increases of $0.8 million in share-based compensation associated with performance-based stock awards and $0.3 million in professional fees.

At September 30, 2015, Momenta had $374.9 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the company’s two leased facilities.

Financial Guidance
Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $40 – $42 million per quarter for the fourth quarter of 2015.

On November 3, 2015 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the third quarter ending Sept. 30, 2015, and provided a clinical update (Press release, Endocyte, NOV 3, 2015, View Source [SID:1234507923]).

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"Our Phase 1 dose escalation trials of the folate receptor (FR)- and prostate-specific membrane antigen (PSMA)-targeted tubulysin SMDCs, EC1456 and EC1169, continue to progress well. Both SMDCs are being dose escalated on two different schedules," said Ron Ellis, Endocyte’s president and chief executive officer. "Once we have determined the maximum tolerated dose and optimal schedule for each SMDC, we look forward to moving into expansion cohorts where we will evaluate these SMDCs specifically in receptor-positive patients among different tumor types, both as single agents and in combination with standard of care drugs."

Earlier in the third quarter, Endocyte announced the final results from the Phase 2b TARGET trial evaluating its SMDC vintafolide in combination with docetaxel in patients with FR positive recurrent non-small cell lung cancer (NSCLC) at the World Conference on Lung Cancer in Denver, Colorado. Vintafolide plus docetaxel improved overall survival (OS) by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of FR, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). This data is in line with earlier findings from the study of improved progression free survival and higher overall response rates. Final safety results were also consistent with those previously reported.

Third Quarter 2015 Financial Results

Endocyte reported a net loss of $10.0 million, or $0.24 per basic and diluted share, for the third quarter of 2015, compared to a net loss of $5.7 million, or $0.14 per basic share and diluted share, for the same period in 2014. The third quarter of 2014 included the recognition of $3.9 million of revenue related to the former collaboration with Merck.

Research and development expenses were $6.6 million for the third quarter of 2015, compared to $5.7 million for the same period in 2014. The increase in research and development expense was primarily attributable to an increase in expenses for the EC1456 and EC1169 dose escalation trials, the drug manufacturing expense of EC1456, and an increase in compensation expense, including noncash stock compensation, partially offset by the decrease in manufacturing expenses of etarfolatide, our folate-targeted companion molecular imaging agent to vintafolide and EC1456.

General and administrative expenses were $3.8 million for the third quarter of 2015, compared to $4.0 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in legal and patent fees, slightly offset by an increase in compensation expense, including noncash stock compensation.

Cash, cash equivalents and investments were $180.3 million at September 30, 2015, compared to $211.1 million at September 30, 2014, and $206.8 million at December 31, 2014.

Financial Expectations

The Company updated its 2015 financial expectations and now anticipates that its 2015 year-end cash balance will be approximately $170 million.

(Filing, 10-Q, Incyte, NOV 3, 2015, View Source [SID:1234507927])

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