On November 12, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that the FDA has approved a request for Investigational New Drug ("IND") status for its drug candidate WP1066 to be used in a Phase 1 clinical trial for the treatment of children with recurrent or refractory malignant brain tumors (Press release, Moleculin, NOV 12, 2019, View Source [SID1234550933]). The request was made by physician researchers at Emory University, including Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial. The trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"This FDA approval gives a green light for Emory University to begin an important clinical trial to explore a new approach to treating pediatric brain cancer," commented Walter Klemp, Moleculin’s Chairman and CEO. "WP1066 is currently in a clinical trial for adult patients with glioblastoma and melanoma metastases to the brain at MD Anderson Cancer Center, and this is a logical extension of that research. WP1066 is an inhibitor of the activated form of a protein called STAT3, a target that has been implicated in a wide range of highly resistant cancers. Preclinical research at Emory University indicated that WP1066 had a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition."

On November 12, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, reported financial results for the third quarter and nine months ended September 30, 2019 (Press release, CASI Pharmaceuticals, NOV 12, 2019, View Source [SID1234550949]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We launched EVOMELA in China during the third quarter and completed our transition to a commercial organization. The sales revenue since the launch and the demand for the drug were greater than our initial expectations and we are now working with our partner and manufacturer to accelerate the production timeline of EVOMELA due to this demand. Our successful launch was driven by our strong commercial team which continues to gain significant insight into the hematology oncology market which we believe will be invaluable as we continue launching additional products in this space. We are excited about our momentum and will continue evaluating additional strategic assets to tactically grow our pipeline."

Third Quarter 2019 Financial Results

·Revenues consisted primarily of product sales of EVOMELA that launched in August 2019. Revenue from EVOMELA was $2.7 million for the third quarter 2019. As commercial sales began in August 2019, revenue for the third quarter 2019 only consisted of approximately 1.5 months of sales.

·Costs of goods sold were $2.6 million for the third quarter 2019. Cost of goods sold have been impacted by a transitional supply agreement that is in the process of being modified with an alternate manufacturer. Cost of goods sold also was impacted by certain non-recurring charges associated with the startup production for the commercial launch. With the alternate supply line and the passing of start-up related charges, we expect the Cost of goods sold to be considerably reduced in the future.

CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850

Phone 240.864.2600 / Fax 301.315.2437

·Research and development expenses for the third quarter 2019 were $1.8 million, compared with $1.8 million for the same period in 2018.

·General and administrative expenses for the third quarter 2019 were $8.0 million, compared with $6.9 million for the same period in 2018. The increase is primarily due to support costs related to the launch of EVOMELA that occurred during August 2019.

·Selling and marketing expenses for the third quarter 2019 were $975,000. The increase is due to selling cost related to commercial sales of EVOMELA that began during August 2019.

·Net loss for the third quarter 2019 was $9.7 million compared to $8.8 million for the same period in 2018.

·As of September 30, 2019, CASI had cash and cash equivalents of $63.2 million compared to $84.2 million as of December 31, 2018. The decrease in cash is primarily due to the Black Belt and Juventas investments made during the second quarter 2019, along with normal operating expenses.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, can be found at www.casipharmaceuticals.com.

About EVOMELA

EVOMELA (melphalan hydrochloride for injection) is an alkaline drug that is approved and in China is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. EVOMELA was previously granted priority review by the China NMPA because multiple myeloma is classified as a rare disease in China, there is no melphalan in any formulation available in China to address this unmet medical need; and EVOMELA has clear therapeutic advantage to currently available therapeutics.

On November 12, 2019 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the third quarter 2019 (Press release, Cue Biopharma, NOV 12, 2019, View Source [SID1234550968]).

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"The third quarter was marked by the dosing of the first patient in our Phase 1 clinical study of CUE-101, which represents a transformative milestone for the company as we continue to grow and develop as a clinical stage company," said Daniel Passeri, chief executive officer. "As part of this continued evolution, the promotion of Dr. Suri to President and CSO helps enhance our productivity and effectiveness by further integrating operational functions and fostering close coordination of preclinical translational studies with clinical development."

Dr. Suri stated, "We have made significant progress on several key programs in addition to CUE-101, including CUE-102, a program selected with our collaboration partner, LG Chem Life Sciences, as well as our early-stage program in auto-immune disease, through our collaboration with Merck. With our first immuno-oncology candidate now in the clinic and additional candidates in lead optimization, Cue Biopharma is well positioned for the potential of significant value inflection over the coming months."

Recent News & Business Updates

Recently initiated dosing a Phase 1 clinical trial to investigate the safety and efficacy of CUE-101 in the treatment of HNSCC. The trial is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and

immunogenicity of CUE-101 as a monotherapy in approximately 50 patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype.

Extended cash runway through an at-the-market equity offering sales agreement for aggregate gross proceeds of up to $30 million with Stifel Nicolaus & Company, Inc. ("Stifel"), who acts as sales agent. As of September 30, 2019, the Company had sold 2,084,615 shares of common stock under the sales agreement for total proceeds of approximately $15.7 million, net of commissions paid, but excluding estimated transaction expenses.

Promoted Anish Suri, Ph.D., to the role of president in addition to his current role as chief scientific officer. As president, Dr. Suri will assume operational and management oversight of corporate functions, as well as research and development activities. Building upon the recent success of entering clinical development with its lead drug candidate CUE-101, the company plans to augment its senior management team with a number of key hires through 2020.

On Friday, November 8, 2019, Cue Biopharma presented a poster on its lead program, CUE-101, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019) titled, "CUE-101, a novel HPV16 E7:pMHC:IL-2:Fc fusion protein, enhances tumor antigen specific T cell activation for the treatment of HPV16-driven malignancies."

Third-Quarter Results & Financial Highlights

The Company reported collaboration revenue of approximately $1.0 million and $0.4 million for the three months ended September 30, 2019 and 2018, respectively.

Research and development expenses were $5.3 million and $10.3 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in research and development expenses of $5.0 million was primarily due to a reduction in headcount, operational efficiencies and a decrease in drug substance manufacturing cost as our full clinical supply for the CUE-101 Phase 1 monotherapy trial was manufactured during 2018.

General and administrative expenses were $2.8 million and $2.9 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in general and administrative expense of $0.1 million was primarily due to a reduction in headcount.

As of September 30, 2019, the Company had approximately $31.3 million in cash and cash equivalents compared with $39.2 million as of December 31, 2018.

The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About CUE-101

CUE-101, our lead program from the CUE-100 series, contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the human papilloma virus 16 E7 protein (HPV16-E7). The drug is a fusion protein designed to target and activate antigen-specific T cells present in the patient’s body to attack HPV16-driven cancers. CUE-101 is currently being tested in a Phase 1 clinical trial for the treatment of HPV16-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). For more information about the trial, please visit clinicaltrial.gov.

About Immuno-STAT

Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, stimulated and expanded outside the body (ex vivo), and reinfused in an activated state.

On November 12, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported third quarter 2019 financial results and business updates, which will be discussed on a conference call scheduled for Wednesday, November 13 at 10:00 a.m. ET (Press release, Abeona Therapeutics, NOV 12, 2019, View Source [SID1234550984]). Interested parties are invited to participate in the call by dialing 844-602-0380 (toll-free domestic) or 862-298-0970 (international) or via webcast at View Source

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"Abeona has made progress on our lead clinical program, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa," said João Siffert, M.D., Chief Executive Officer of Abeona. "We continue to anticipate receiving CMC clearance for this pivotal trial by year-end following the recent submission of additional transport stability data for EB-101, in response to the Clinical Hold Letter received in the quarter, as well as the submission of updated clinical and comparability protocols for the VIITALTM Phase 3 study."

Dr. Siffert continued, "We were also very pleased with the publication of positive long-term data from our Phase 1/2a clinical trial, reinforcing the potential of EB-101 to safely provide durable healing for the most challenging to treat, large and painful RDEB wounds. Three years post treatment, the majority of EB-101-treated wounds remained healed and without pain. We believe that EB-101 is uniquely positioned to address the needs of the majority of RDEB patients who suffer from these types of chronic wounds and we remain dedicated to delivering this therapy to the community."

Third Quarter Financial Results:

Cash, cash equivalents and marketable securities as of September 30, 2019, were $47.9 million compared to $62.5 million as of June 30, 2019. The decrease in cash was driven primarily by the net cash used in operating activities of $18.3 million.

Research and development expenses for the third quarter ended September 30, 2019 were $10.9 million compared to $13.2 million in the same period of 2018. The decrease in R&D expense was primarily attributable to decreased clinical and development work, partially offset by increased salary and related costs from the hiring of additional clinical, regulatory, manufacturing and quality staff.

General and administrative expenses for the third quarter ended September 30, 2019 were $4.7 million compared to $5.0 million in the same period of 2018. The decrease in G&A expenses was primarily due to decreased rental, recruiting, professional fee and salary related costs.

Net loss was $0.35 per share for the third quarter of 2019 compared to $0.34 per share in the same period of 2018.

Third Quarter and Recent Highlights:

●Submitted additional transport stability data for EB-101 in response to September 17 FDA Clinical Hold Letter regarding the planned Phase 3 VIITAL study
Submitted Phase 3 VIITAL clinical trial protocol with updated PRO assessments, and submitted the retrovirus comparability protocol to FDA.
●Presentation of data from the Transpher A Study, the Company’s ongoing Phase 1/2 clinical trial evaluating ABO-102 for the treatment of MPS IIIA, and research updates from its library of novel AIMTM adeno-associated virus capsids at the 27th European Society of Gene and Cell Therapy Congress.
●Publication of positive long-term safety and efficacy data from the Phase 1/2a clinical trial of EB-101 in JCI Insight with collaborators from Stanford University School of Medicine.
●Three years after treatment with EB-101, a majority of RDEB patients had sustained wound healing, with 80% (16/20) of wounds achieving ≥50% healing, and 70% (14/20) achieving ≥75%
●Two years after treatment, only 1 of 6 untreated (17%), prospectively selected control wounds, had ≥50% healing
●50% or greater wound healing was associated with no pain (0/16) and no itch (0/16) at treated sites three years post-treatment, compared with presence of pain in 53% (20/38) and itch in 61% (23/38) of wound sites at baseline
●EB-101 was associated with long-term molecular expression of type VII collagen protein, which plays an important role in anchoring the dermal and epidermal layers of the skin
●No serious treatment-related adverse events were observed during the three-year observation period
●Retained Jefferies LLC as its financial advisor to assist with the review of strategic intiatives focused on advancing the Company’s mission and maximizing stakeholder value.

On November 12, 2019 AVEO Oncology (NASDAQ: AVEO) reported financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, AVEO, NOV 12, 2019, View Source [SID1234551002]).

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"This quarter we have made meaningful progress toward our goal of bringing effective and better tolerated therapies to patients battling kidney and other cancers," said Michael Bailey, president and chief executive officer of AVEO. "We are working to submit our New Drug Application (NDA) in the first quarter of 2020 for tivozanib as a treatment for relapsed/refractory renal cell carcinoma (RCC) and to provide a final overall survival (OS) update for the TIVO-3 study in June 2020. We also continue to make progress in evaluating tivozanib-immunotherapy combinations, with recently reported positive results from the TiNivo study of tivozanib and OPDIVO (nivolumab) in RCC and the initiation of the Phase 1b/2 DEDUCTIVE study with IMFINZI (durvalumab) in hepatocellular carcinoma. Ficlatuzumab also continues to advance in the clinic, with the initiation of CyFi-2, a Phase 2 randomized study in patients with relapsed and refractory acute myeloid leukemia (AML). Critical to this progress, we continue to maintain a strong balance sheet that we believe provides us with a cash runway into the second quarter of 2021."

Tivozanib North America Regulatory and Phase 3 TIVO-3 Study Updates

Announced Plans for TIVO-3 Final OS Analysis and NDA Submission for Tivozanib. Last week, AVEO provided a regulatory update following a meeting with the U.S. Food and Drug Administration (FDA) to discuss results from the August 2019 OS analysis of the TIVO-3 trial and the Company’s proposal to proceed with an NDA for tivozanib in relapsed/refractory RCC.
The Company intends to submit an update to the TIVO-3 statistical analysis plan to the FDA allowing for the final OS analysis to be conducted, followed by an NDA submission in the first quarter of 2020, and expects to report results from the final OS analysis of the TIVO-3 trial in June 2020. The FDA and the Company agreed that if, during the review, the final analysis yields an OS hazard ratio (HR) above 1.00, the Company will withdraw its NDA application. The FDA informed the Company that an Oncologic Drugs Advisory Committee panel would likely be convened to review the final tivozanib data package.

TIVO-3 is the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), to sorafenib in 350 subjects with highly refractory metastatic RCC.

Announced Updated Overall Survival HR of 0.99 in Phase 3 TIVO-3 Trial of Tivozanib in RCC. In September 2019, AVEO announced results from the second prespecified analysis of OS in the TIVO-3 trial. These results included an OS HR, which assesses the relative risk of death for the entirety of the dataset, that was below 1.00 (HR=0.99; 95% CI: 0.76-1.29; p=0.95).
The data cutoff date for the second prespecified analysis was August 15, 2019, two years from the last patient enrolled and approximately ten months from the data cutoff date for the first prespecified analysis. Between the two data cutoff dates, 16 additional OS events were reported on the tivozanib arm and 28 on the sorafenib arm, resulting in a total of 114 OS events on the tivozanib arm and 113 on the sorafenib arm. Median OS, a point in time value of the OS when half of the patients within each arm are still alive, was 16.4 months for tivozanib (95% CI: 13.4-22.2) and 19.7 months for sorafenib (95% CI: 15.0-24.2). As of the second data cutoff date, twenty patients remained progression free on the tivozanib arm and two on the sorafenib arm, with a median duration on study of 32.5 months.

Updated Data from TIVO-3 Trial to be Presented at the 18th International Kidney Cancer Symposium. Updated data from the TIVO-3 trial will be presented during an oral session at the 18th International Kidney Cancer Symposium being held November 15-16, 2019 in Miami. The presentation, titled "Overall Survival from Phase 3 TIVO-3 Study in Advanced Renal Cell Carcinoma", will be presented on Saturday, November 16 at 9:42 a.m. Eastern Time. The presentation will include the recently announced OS data, as well as new data from important subgroups. A copy of the slides will be available in the Publications & Presentations Section of AVEO’s website following the presentation.
Additional Tivozanib Updates

Announced Initiation of Enrollment in Phase 1b/2 DEDUCTIVE Study of Tivozanib in Combination with IMFINZI (durvalumab) in Previously Untreated Metastatic HCC. In September 2019, AVEO announced the initiation of enrollment in the DEDUCTIVE trial, an open-label, multi-center Phase 1b/2 clinical trial evaluating tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with HCC who have not received prior systemic therapy. The trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca. AVEO is serving as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company.
Presented Final PFS Results from Phase 2 Portion of the TiNivo Study of Tivozanib and OPDIVO (nivolumab) in Advanced or Metastatic RCC. In September 2019, AVEO and EUSA Pharma announced the presentation of final progression free survival (PFS) results from the Phase 2 portion of the TiNivo study, a Phase 1b/2 multicenter trial of tivozanib in combination with OPDIVO (nivolumab), Bristol-Myers Squibb’s immune checkpoint, or PD-1, inhibitor, for the treatment of advanced or metastatic RCC. The data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress in Barcelona, Spain.
The combination required few dose reductions and showed additive or synergistic activity for objective response rate and PFS in both treatment naïve and previously treated patients with metastatic RCC. Overall median PFS for the 25 patients treated at the study’s full dose and schedule was 18.9 months (95% CI: 16.4; NR). Median PFS for previously untreated patients (n=12) was 18.5 months, while median PFS for previously treated patients (n=13) had not yet been reached as of the August 27, 2019 data cutoff date. An objective response rate was observed in 56% of patients (complete responses + partial responses), including one treatment naïve patient (1/12) achieving a complete response, and disease control (complete response + partial response + stable disease) was observed in 96% of patients. The most common treatment-related Grade 3/4 adverse event was hypertension, and only 17% of patients required a dose reduction.

A copy of the presentation is available in the Publications & Presentations Section of AVEO’s website.

Announced Kyowa Kirin Buy Back of Tivozanib Non-Oncology Rights from AVEO. In August 2019, AVEO and Kyowa Kirin Co., Ltd. announced that the companies’ license agreement for tivozanib has been amended to allow Kyowa Kirin to buy back the non-oncology rights of tivozanib in AVEO’s territories, which includes the U.S. and EU. Under the terms of the amended license agreement, AVEO received a $25 million upfront payment and a waiver of the $18 million milestone payment due to Kyowa Kirin upon AVEO obtaining U.S. market approval for tivozanib. In addition, AVEO will be eligible to receive up to $391 million in milestone payments upon the successful achievement of certain development and commercial objectives related to tivozanib formulations for the treatment of non-oncology indications. AVEO is also eligible to receive tiered royalty payments on net sales in these indications, which range from a high single-digit to low double-digit percent.
Ficlatuzumab Update

Initiation of the CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML. Last week, AVEO and Biodesix, Inc. announced the initiation of the CyFi-2 study, a randomized Phase 2 clinical study evaluating ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with high-dose cytarabine vs. high-dose cytarabine alone in patients with relapsed and refractory AML.
AVEO will sponsor the CyFi-2 study, which is expected to enroll approximately 60 patients with AML who failed induction chemotherapy or who achieved a complete response but relapsed within one year. The CyFi-2 study is being conducted as part of the companies’ worldwide partnership to develop and commercialize ficlatuzumab. Under the terms of this agreement, AVEO and Biodesix equally share all development costs.

Recent Corporate Update

Appointment of Key Regulatory, Commercial and Medical Affairs Leadership Roles. AVEO announced today the appointment of three individuals to key leadership roles during the fourth quarter:

Darlene Noci, Interim Head of Regulatory Affairs. Ms. Noci brings to AVEO over 20 years of leadership experience in global regulatory affairs and strategic drug development. She received a Bachelor’s degree in Political Science from Adelphi University and a Master’s degree in Government from Harvard University.
Kevin Peacock, Vice President of Marketing. Mr. Peacock brings over 15 years of commercial leadership experience in oncology marketing, strategic planning, and business analytics. He received his Bachelor’s degree in Business Administration from Temple University.
Daniel Powers, D.O., Vice President of Medical Affairs. Dr. Powers brings to AVEO over 20 years of clinical, academic, and biopharmaceutical medical affairs experience. He received his Bachelor’s degree in Chemistry from the University of Massachusetts Boston and a Doctor of Osteopathic Medicine degree from Rowan University. He completed his internship and residency in Internal Medicine at Yale-New Haven Hospital and National Navy Medical Center.
Third Quarter 2019 Financial Results

AVEO ended Q3 2019 with approximately $57.7 million in cash, cash equivalents and marketable securities as compared with $24.4 million at December 31, 2018.
Total revenue for Q3 2019 was approximately $25.7 million compared with $2.5 million for Q3 2018.
Research and development expense for Q3 2019 was $4.0 million compared with $5.2 million for Q3 2018.
General and administrative expense for Q3 2019 was $2.9 million compared with $2.7 million for Q3 2018.
Net income for Q3 2019 was $16.4 million, or net income of $0.10 per basic and diluted share, respectively, compared with a net loss of $22.2 million for Q3 2018, or a loss of $0.18 per basic and diluted share, respectively.
On August 1, 2019, as scheduled and included in the Company’s cash guidance below, the Company resumed principal payments of approximately $0.8 million per month on the $20.0 million Hercules loan that matures on July 1, 2021.
Financial Guidance

AVEO believes that its cash, cash equivalents and marketable securities of approximately $57.7 million at September 30, 2019 would allow the Company to fund its planned operations into the second quarter of 2021. This estimate is a change from the Company’s prior quarter guidance as a result of the Company’s plan to file an NDA for tivozanib, reflecting additional costs related to the NDA filing, as well as limited commercial launch-readiness activities.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC), and acute myeloid leukemia (AML).