On December 3, 2020 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community on Tuesday, Dec. 8, at 4:00 p.m. ET following the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Amgen, DEC 3, 2020, View Source [SID1234572148]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of the clinical development team, will participate to discuss our oncology and hematology programs with a focus on Amgen’s innovative BiTE platform including the first clinical data for AMG 701 and analyses from a BLINCYTO (blinatumomab) Phase 3 pediatric study.

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Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On December 3, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported a clinical update from the company’s ongoing dose-escalation Phase 1 study of STRO-002, a folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC), for patients with ovarian cancer (Press release, Sutro Biopharma, DEC 3, 2020, View Source [SID1234572147]).

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STRO-002-GM1 is a single-arm monotherapy dose-escalation study for patients with ovarian cancer not selected based on their FolRα-expression levels. The dose-escalation portion of the study was fully enrolled with 39 patients in August 2020. Patients were heavily pre-treated and had a median of 6 prior lines of therapy, including standard of care platinum-based regimens, bevacizumab, PARP inhibitors, and checkpoint inhibitors.

The dose-escalation study included 34 patients treated with clinically active dose levels, 2.9 mg/kg or higher, of which 31 patients had post-baseline scans and were evaluable for RECIST responses. At the data cutoff of October 30, 2020, median time on treatment was 19 weeks and 10 patients remained on treatment. Results out of 31 evaluable patients included:

10 patients met RECIST criteria for response. Of which, 1 patient achieved a complete response (CR) and 9 patients achieved a partial response (PR). Of the PRs, 3 were confirmed PRs (cPRs) and 6 unconfirmed PRs (uPRs)
23 patients (74%) achieved disease control at 12 weeks
18 patients (58%) achieved disease control at 16 weeks
4 patients (13%) were on treatment for 52 weeks. 3 patients remained on treatment beyond 64 weeks
STRO-002 continues to be well-tolerated and 86% of all treatment-emergent adverse events (AEs) were Grade 1 or 2. Of note, prophylactic corticosteroid eye drops have not been required and no ocular toxicity signals have been observed. The most common Grade 3 and 4 AEs were reversible neutropenia. Grade 3 arthralgia (15.4%) and neuropathy (7.7%) were observed and managed with standard medical treatment, including dose reductions or delays without evidence of compromised efficacy.

"We are encouraged to see meaningful clinical benefit from STRO-002 for patients with advanced platinum-resistant and refractory ovarian cancer. The women on the study are heavily pretreated and have limited treatment options as many have received experimental agents and participated in other clinical trials," said Dr. Lainie P. Martin, Leader of Gynecology/Oncology Program at Hospital of the University of Pennsylvania and an investigator on the STRO-002 study. "The deepening of responses in patients as well as disease control over time demonstrates STRO-002 to be an important potential treatment option for patients with ovarian cancer."

"We are seeing improved outcomes in disease control and RECIST responses as the data matures and will continue to follow the patients who remain on study for further deepening of responses or clinical benefit," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "The broad therapeutic index of STRO-002 should allow for long-term dosing and dose intensity. Although a maximum tolerated dose was not reached, we have identified dose levels of 4.3 and 5.2 mg/kg that we plan to randomize in the dose-expansion. We plan to dose the first patient January 2021 and will be treating less heavily pre-treated ovarian cancer patients. An expansion cohort for FolRα-selected endometrial cancer is planned for next year."

"We are rapidly moving forward with further development of STRO-002, the FolRα-targeted ADC program. Based on emerging IHC data from our dose-escalation, we have seen responses and stable disease at various FolRα-expression levels. For dose-expansion, we will be collecting required tissue samples at enrollment and using an established assay to determine if a FolRα-selection enrichment strategy is needed," said Bill Newell, Chief Executive Officer of Sutro Biopharma. "Additional data from the dose-expansion will inform regulatory discussions, accelerate registration strategy, and identify the broadest population that may benefit from STRO-002."

STRO-002 Virtual Event Information

The data will be presented and discussed by investigators from two STRO-002 clinical trial sites:

Lainie P. Martin, M.D. – Leader, Gynecology/Oncology Program and Associate Professor of Medicine at Hospital of the University of Pennsylvania; Dr. Martin is also a member of Sutro’s Clinical Advisory Board
R. Wendel Naumann, M.D. – Professor & Director of Gynecologic Oncology Research and Associate Medical Director of Clinical Trials at Levine Cancer Institute – Atrium Health in Charlotte, North Carolina; Dr. Naumann is also a member of Sutro’s Clinical Advisory Board
To access the live virtual event on Thursday, Dec. 3, at 2pm PT (5pm ET), please click here. An archived webcast of the event will be available on the Investor section of the company’s website at ir.sutrobio.com for approximately 30 days.

About the Phase 1 Trial of STRO-002 in Ovarian Cancer

STRO-002-GM1, the Phase 1 open-label, multicenter, dose escalation trial with dose expansion of STRO–002, has completed enrollment. Follow-up is ongoing and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian and primary peritoneal cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF cell-free protein synthesis and XpressCF+ site-specific conjugation technologies.

On December 3, 2020 Silverback Therapeutics, Inc. ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported the pricing of its initial public offering of 11,500,000 shares of its common stock at a price to the public of $21.00 per share (Press release, Silverback Therapeutics, DEC 3, 2020, View Source [SID1234572146]). The gross proceeds to Silverback from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $241.5 million. All of the shares are being offered by Silverback. In addition, Silverback has granted the underwriters a 30-day option to purchase up to an additional 1,725,000 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

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The shares are expected to begin trading on the Nasdaq Global Market on December 4, 2020, under the ticker symbol "SBTX." The offering is expected to close on December 8, 2020, subject to customary closing conditions.

Goldman Sachs & Co. LLC, SVB Leerink and Stifel are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as the lead manager for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission (SEC) and became effective on December 3, 2020. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering may be obtained, when available, from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 3, 2020 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, will present the Phase 1b/2 trial results of TG4001, a HPV16 targeted therapeutic vaccine, in combination with avelumab (BAVENCIO), a human anti-PD-L1 antibody, in HPV16-positive recurrent and/or metastatic malignancies at ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2020, December 9-12, 2020 (Press release, Transgene, DEC 3, 2020, View Source [SID1234572145]).

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These data will be presented by the principal investigator, Professor Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Institut Curie (Paris) in an oral presentation on December 12, 2020 at 12:40 pm CET.

Professor Christophe Le Tourneau added: "Current treatments for HPV-16 positive cancer patients do not address the viral origin of the disease. These data are a very encouraging first step to hopefully provide patients with better treatment options, particularly for patients with advanced disease who have a devastating disease with poor prognosis."

Number and title of the abstract and mini-oral presentation: (abstract #276, presentation #63 MO) TG4001 therapeutic vaccination combined with PD-L1 blocker avelumab remodels the tumor microenvironment (TME) and drives antitumor responses in Human PapillomaVirus (HPV)+ malignancies

Authors: Christophe Le Tourneau, Philippe Cassier, Frédéric Rolland, Sébastien Salas, Jean-Marc Limacher, Olivier Capitain, Olivier Lantz, Ana Lalanne, Christina Ekwegbara, Annette Tavernaro, Hakim Makhloufi, Kaïdre Bendjama, Jean-Pierre Delord.

Session date and time: Mini Oral Session 2, December 12, 2020, 12:35-1:55 pm CET (Channel 1). The session consists of short oral presentations by authors, followed by expert discussion and perspectives.

Key results of the trial (n=34 evaluable patients):

­ The combination of TG4001 and avelumab demonstrated a clinically relevant anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers.
­ The presence of liver metastases has a notable impact on outcome in terms of ORR and PFS. In patients without liver metastases, an ORR of 34.8% and a median PFS of 5.6 months were achieved.
­ The disease control rate (DCR) at 12 weeks was 56.6% in patients without liver metastasis, against 9.1% in patients with liver metastasis.
­ The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system.
­ These results warrant further confirmation in a larger controlled randomized study.

About the trial
The purpose of this exploratory, multi-center, open-label Phase 1b/2 trial is to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor (avelumab) in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancers who have disease progression after at least one line of systemic treatment (NCT03260023).

Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and a world expert in drug development and head and neck cancers, is the Principal Investigator of the study. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE). Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

Thirty-four patients received TG4001 at the dose of 5×107 pfu, SC, weekly for 6 weeks, every 2 weeks up to six months, and every 12 weeks thereafter, in combination with avelumab at 10 mg/kg, IV every two weeks, until disease progression. The primary endpoint of the Phase 2 part is the overall response rate (ORR, using RECIST 1.1). Secondary endpoints include progression-free survival, overall survival, disease control rate and other immunological parameters.

***

About TG4001
TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens, that can be found in HPV16-related tumors, and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 300 individuals, demonstrating good safety, significant HPV clearance rate and promising efficacy results [1, 2]. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in HPV-mediated solid tumors.

About HPV-Positive Cancers
HPV-positive cancers comprise a variety of malignancies, including head and neck cancers and anogenital cancers [3]. Squamous cell carcinoma of the head and neck (SCCHN) is a heterogeneous group of cancers that can affect sites including the oral cavity, pharynx, and larynx [4]. The incidence of HPV16-related SCCHN has significantly increased in recent years [4]. HPV16 infection is associated with more than 85% of oropharynx squamous cell carcinomas [4], i.e. approximately 10,000 patients at metastatic stage and receiving a second line of treatment [5]. Other HPV16-positive cancers include cervical [6], vaginal [7], vulvar [8], anal [9] and penile [10] cancers, i.e. approximately 15,000 cancers at metastatic stage and eligible for a second line of treatment [11].

Current treatments include chemoradiotherapy, immune checkpoint inhibitors, or surgical resection with radiotherapy. However, better options are needed for advanced and metastatic HPV+ cancers. It is thought that this immunotherapy combined with other immunotherapeutic agents such as immune checkpoint inhibitors could provide a promising potential treatment option that would address this strong medical need [12,13]. With immune checkpoint inhibitors, median overall survival remains inferior to 11 months [14-20] and median progression-free survival is between 2 and 4 months [14-20]. In this heterogenous group of malignancies, overall response rates are around 10–15% [14-20].

Avelumab Approved Indications
Avelumab (BAVENCIO) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

On December 3, 2020 Physicians’ Education Resource, LLC (PER), reported critical insights on practice-changing treatment strategies in hematology care as part of its Friday Satellite Symposia (FSS) at this year’s 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Dec. 4 (Press release, Physicians’ Education Resource, DEC 3, 2020, View Source [SID1234572144]).

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This program series will feature up to 15 continuing medical education (CME)-certified symposia sessions that delve into the evolving future of medicine and patient care-associated various specialties in hematology. The interactive virtual webcasts will explore evidence-based strategies, optimized testing approaches and the latest breakthrough treatment paradigms to improve patient care.

"For years, hematologists have joined PER for high-quality CME during the ASH (Free ASH Whitepaper) Friday Satellite Symposia, said Phil Talamo, president of PER. "This year, PER’s Friday Satellite Symposia will feature a discussion of new data and insights that will provide practical strategies that apply to the care of patients, presented by some of the world’s renowned expert faculty in hematology. We hope you’ll join us for this fully interactive, virtual educational event to get answers to your most challenging questions."

The PER FSS sessions include the following:

"Understanding Cold Agglutinin Disease: How Do Emerging Treatment Options Have the Potential to Transform Patient Outcomes?"
"Taking Action with Minimal Residual Disease: Technique, Role, and Utilization of MRD to Improve Outcomes in Patients with Hematologic Malignancies"
"Individualizing Treatment Plans and Optimizing Outcomes for Patients with MF and PV: Stories Behind The Science"
"The Evolving Role of PI3K Inhibitors for the Management of Hematologic Malignancies: Integration of Recent Data Sets Into Clinical Practice"
"D" is for Diagnosis: Detecting and Treating Rare Disorders in Hematologic Practice"
"Medical Crossfire: Exploring the Modern Management of Acute Lymphoblastic Leukemia from AYA to Adult"
"T-Cell Lymphoma Tumor Board: Application of Novel Agents for the Treatment of PTCL and CTCL"
"New Targets, New Data, New Guidelines: Assessing Treatment Options to Personalize Care in B-Cell Lymphomas"
"Medical Crossfire: Bridging Unmet Needs With Emerging Data in Relapsed/Refractory DLBCL to Improve Patient Outcomes"
"Sickle Cell Disease: Targeting Complications to Improve Long-Term Implications"
"Advances in CAR T-Cell Therapy: What Does the Future Look Like?"
"How to Do It Interactive Workshop: Taking Action With Clinical Advances in Chronic Lymphocytic Leukemia"
"Leveraging Clinical Data and Trials to Inform Treatment for Patients With GvHD: An Expert Case-Based Discussion"
"Improving Outcomes in MDS and MPN: Tailoring Treatment Based on Patient- and Disease-Specific Factors"
"State of the Art Care in Relapsed/Refractory Multiple Myeloma: Novel Targets, Combinations, and Treatment Approaches"
Throughout these programs, the top minds in hematology and hematology/oncology will provide valuable expertise and perspective on a variety of hematology-focused topics. In addition, learners will have the ability to submit questions and participate in expert discussions via PER’s custom, interactive platform, along with VIP-level access to network with key opinion leaders for a more private discussion.