On November 4, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the third quarter of 2021 and provided a business update (Press release, Regeneron, NOV 4, 2021, View Source [SID1234594449]).

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"Regeneron had another strong quarter of core business growth, with EYLEA and Dupixent reaching more patients than ever and progress made across our diverse pipeline," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We secured a new U.S. government supply agreement and are delivering an additional 1.4 million doses of REGEN-COV. Our Biologics License Application for REGEN-COV as treatment and prophylaxis was accepted by the FDA for priority review, with a mid-April 2022 action date. During the third quarter, we announced positive data from Phase 3 trials of Dupixent in chronic spontaneous urticaria and pediatric atopic dermatitis. We also recently announced positive data from Phase 3 trials of Dupixent in eosinophilic esophagitis and prurigo nodularis, and that the FDA approval in pediatric asthma was extended to children as young as six. Finally, our abstracts that will be released today for the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting highlight programs across the hematology portfolio, including our BCMA and C5 antibodies."

"Regeneron performed extremely well in the third quarter with strong top- and bottom-line growth driven by an increasingly diversified core business," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We are approaching the end of 2021 with positive momentum as we continue to invest in our broad pipeline to drive sustained long-term growth."

Business Highlights

Key Pipeline Progress
Regeneron has over 30 product candidates in clinical development, including six marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

In August 2021, the Company announced that an ongoing Phase 2 trial evaluating an 8 mg dose of aflibercept in patients with neovascular age-related macular degeneration (wet AMD) met its primary safety and efficacy endpoints. The high-dose aflibercept formulation is currently also being evaluated in two large Phase 3 trials in wet AMD and diabetic macular edema (DME), which are expected to report results in the second half of 2022.
Dupixent (dupilumab)

In October 2021, the U.S. Food and Drug Administration (FDA) approved Dupixent for children aged 6 to 11 years with moderate-to-severe asthma.
In July 2021, the Company and Sanofi announced that a Phase 3 trial in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks.
In October 2021, the Company and Sanofi announced that a second Phase 3 trial in adults and adolescents with eosinophilic esophagitis (EoE) met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. A rolling supplemental Biologics License Application (sBLA) has been initiated for adults and adolescents with EoE.
In October 2021, the Company and Sanofi announced that a Phase 3 trial in adults with uncontrolled prurigo nodularis met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. Results from an additional Phase 3 trial in prurigo nodularis are expected to be reported in the first half of 2022.
In August 2021, the Company and Sanofi announced that a Phase 3 trial in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis met its primary and all secondary endpoints, and the companies expect to complete regulatory submissions in the United States and European Union (EU) in the coming months.
REGEN-COV (casirivimab and imdevimab)(2), a dual antibody cocktail to SARS-CoV-2 virus

In September 2021, the Company announced an agreement to supply the U.S. government with an additional 1.4 million doses of REGEN-COV (of which over 300,000 doses were delivered during the third quarter of 2021). Pursuant to the agreement, the U.S. government is obligated to purchase REGEN-COV doses delivered by January 31, 2022, resulting in aggregate payments to the Company of up to $2.940 billion. Roche will supply a portion of the doses to Regeneron to fulfill Regeneron’s agreement with the U.S. government.
The FDA accepted for priority review the BLA for COVID-19 treatment in non-hospitalized patients and as prophylaxis in certain individuals, with a target action date of April 13, 2022. A Marketing Authorization Application (MAA) for COVID-19 treatment in infected non-hospitalized patients or as prophylaxis was also submitted in the EU.
In September 2021, the Company announced that a Phase 3 trial in patients hospitalized with COVID-19 met its primary endpoint, showing REGEN-COV significantly reduced viral load. The FDA is currently reviewing the Company’s request to expand the Emergency Use Authorization (EUA) to include treatment in hospital settings, and the Company plans to submit a BLA and MAA for this patient population in the coming months.
The New England Journal of Medicine published positive detailed results from the Phase 3 trial that assessed the ability of REGEN-COV to treat COVID-19 in infected high-risk non-hospitalized patients.
Oncology Programs

The FDA accepted for priority review, with a target action date of January 30, 2022, the sBLA for Libtayo (cemiplimab) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The MAA in the EU is expected to be submitted by the end of the year.
Positive data from the Phase 3 trial of Libtayo, in combination with chemotherapy, in patients with advanced non-small cell lung cancer, were presented at the European Society for Medical Oncology Virtual Congress 2021. These results will form the basis of regulatory submissions, which are planned in the United States and EU in the coming months.
A Phase 1 study of REGN5093-M114, a bispecific antibody-drug conjugate targeting two distinct MET epitopes, was initiated in MET-altered advanced non-small cell lung cancer.
Pozelimab, an antibody to C5

A Phase 3 study of pozelimab in combination with cemdisiran, a siRNA therapeutic, in myasthenia gravis was initiated.
REGN5713-5714-5715, a multi-antibody therapy to Bet v 1

The initial Phase 3 study in birch allergic patients with allergic rhinoconjunctivitis met its primary endpoint with a reduction in the combined allergic rhinitis symptom and medication score. The Company is currently evaluating further development plans, including an additional Phase 3 study during an upcoming birch pollen season.
Third Quarter 2021 Financial Results

Revenues

Total revenues increased by 51% to $3.453 billion in the third quarter of 2021, compared to $2.294 billion in the third quarter of 2020. Total revenues excluding (i) REGEN-COV (casirivimab and imdevimab) net product sales in the United States and (ii) the Company’s share of gross profits in connection with sales of casirivimab and imdevimab pursuant to the Roche collaboration agreement, increased by 18% to $2.649 billion in the third quarter of 2021, compared to the third quarter of 2020(1).

Net product sales recorded by the Company consist of the following:

During the third quarter of 2021, the Company commenced deliveries of REGEN-COV under its September 2021 supply agreement with the U.S. government (as described above).

Total revenues also include collaboration revenues(3) of $1.074 billion in the third quarter of 2021, compared to $653 million in the third quarter of 2020. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $387 million in the third quarter of 2021, compared to $213 million in the third quarter of 2020. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits. In addition, in both the third quarter of 2021 and 2020, the Company earned $50 million sales-based milestones from Sanofi based upon sales of antibodies outside the United States on a rolling twelve-month basis. In the third quarter of 2021, the Company also recorded Roche collaboration revenue of $127 million in connection with the true-up payment owed from Roche in connection with global gross profits from sales of the casirivimab and imdevimab antibody cocktail.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue decreased in the third quarter of 2021, compared to the third quarter of 2020, primarily due to lower amounts recognized in connection with the Company’s agreements with the Biomedical Advanced Research Development Authority (BARDA) related to funding of certain development activities for COVID-19 antibodies, and, to a lesser extent, Inmazeb.

The increase in SG&A expenses in the third quarter of 2021 was primarily due to higher headcount-related costs and an increase in commercialization-related expenses for EYLEA, including direct-to-consumer advertising.
The increase in COGS in the third quarter of 2021 was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in the United States.
The increase in COCM in the third quarter of 2021 was primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent.
Other operating expense (income), net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with the Company’s collaborative arrangements. The decrease in other operating income in the third quarter of 2021 was primarily due to the recognition of a cumulative catch-up adjustment of $67 million arising from an update to the estimate of the total R&D costs expected to be incurred under the Sanofi Immuno-oncology collaboration agreement.
Other Financial Information

In the third quarter of 2021, the Company’s GAAP effective tax rate was 10.2%, compared to 15.6% in the third quarter of 2020. The decrease in the third quarter 2021 GAAP effective tax rate, compared to the third quarter of 2020, was due in part to the positive impact of stock-based compensation in the third quarter of 2021. In the third quarter of 2021, the non-GAAP effective tax rate was 10.8%, compared to 16.3% in the third quarter of 2020.

GAAP net income per diluted share was $14.33 in the third quarter of 2021, compared to GAAP net income per diluted share of $7.39 in the third quarter of 2020. Non-GAAP net income per diluted share was $15.37 in the third quarter of 2021, compared to non-GAAP net income per diluted share of $8.36 in the third quarter of 2020. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Net cash provided by operating activities in the first nine months of 2021 was $4.709 billion, compared to $1.387 billion in the first nine months of 2020, resulting in $4.312 billion in free cash flow(1) for the first nine months of 2021, compared to $934 million for the first nine months of 2020. The increase in free cash flow was primarily due to the Company’s collection of amounts due from the U.S. government in connection with REGEN-COV sales in 2021.

2021 Financial Guidance(4)

The Company’s full year 2021 financial guidance consists of the following components:

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its third quarter 2021 financial and operating results on Thursday, November 4, 2021, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast on the "Investors and Media" page of Regeneron’s website at www.regeneron.com. To participate via telephone, please register in advance at View Source Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On November 4, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that it will report third quarter 2021 financial results and provide a corporate update after the market close on Wednesday, November 10, 2021 (Press release, aTyr Pharma, NOV 4, 2021, https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-webcast-conference-call-reporting-third-quarter-2021 [SID1234594465]). Management will host a conference call and webcast to review the results and provide an operational update.

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On November 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the third quarter 2021, recent business highlights and key catalysts over the next several months (Press release, Atara Biotherapeutics, NOV 4, 2021, View Source [SID1234594484]).

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"Atara continues to make meaningful progress across our strategic priorities and with positive data from our pivotal Phase 3 ALLELE study and imminent EU regulatory submission, we are now at an inflection point as we work to deliver tab-cel, a potentially transformative first-in-kind therapy, to patients in need," said Pascal Touchon, President and Chief Executive Officer of Atara. "We are equally encouraged by new data confirming our conviction for ATA188 as the first investigational therapy to reverse disability in progressive multiple sclerosis, and upcoming milestones related to our potentially best-in-class CAR T portfolio that does not require TCR or HLA gene editing."

Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

First presentation of new positive data from the pivotal Phase 3 ALLELE study, reinforcing the transformative potential of tab-cel, has been accepted as an oral session at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
Top-line data with additional patients and extended follow up confirm a strong objective response rate (ORR) and a safety profile in line with prior results, demonstrate durability of response, and will support the imminent EU Marketing Authorization Application (MAA) submission
An ORR, as measured by independent oncologic response adjudication (IORA) assessment, of 50% (19/38, 95% CI: 33.4, 66.6) was observed, with an ORR of 50% (12/24, 95% CI: 29.1, 70.9) in PTLD following SOT and 50% (7/14, CI: 23.0, 77.0) in PTLD following HCT, with a best overall response of Complete Response (CR; n=5, SOT; n=5, HCT) or Partial Response (PR; n=7, SOT; n=2, HCT)
Overall, the median time to response (TTR) was 1.1 months (0.7-4.7). Of 19 responders, 11 had a duration of response (DOR) lasting more than six months and median DOR has not been reached yet
The one-year survival rate was 61.1% overall (57.4% for SOT, and 66.8% for HCT). Those who responded had a longer survival compared to the non-responders, with a median overall survival (OS) not evaluable (NE) (95% CI: 16.4, NE) and 1-year survival rate of 89.2% (95% CI: 63.1, 97.2)
Safety findings were consistent with previously published data, with no new signals. There were no reports of tumor flare reaction, and no confirmed evidence of graft versus host disease (GvHD), organ rejection, infusion reactions, or cytokine release syndrome (CRS) related to tab-cel
At ASH (Free ASH Whitepaper), Atara will present additional data on tab-cel through several abstracts, including a second oral presentation on long term OS from Phase 2 and multi-center Expanded Access Protocol (EAP) studies in relapsed/refractory EBV+ PTLD showing median OS of 54.6 months in all patients and OS at two years reaching over 86% in responders whether patients experienced CR or PR
Following successful interactions with the European Medicines Agency (EMA), and their recent granting of accelerated assessment to tab-cel, Atara will imminently submit a MAA for tab-cel, with an EU approval decision anticipated in H2 2022
The previously announced exclusive agreement with Pierre Fabre for the commercialization of tab-cel in Europe, the Middle East, Africa, and other select emerging markets for EBV-positive cancers has started strongly. Atara will retain full rights to tab-cel in other major markets, including North America, Asia Pacific, and Latin America
Atara has continued to make good progress through Type B meetings with the U.S. Food and Drug Administration (FDA)
After gaining clarity, alignment on key comparability methodology has been reached
Based on the requests from FDA following recent interactions, Atara will provide the Agency with additional analyses of CMC data already generated
FDA has not requested additional studies or manufacturing lots
Atara subsequently plans to have further interactions with the FDA in Q1 2022 and complete the Biologics License Application (BLA) submission for tab-cel in Q2 2022
Tab-cel for Potential Additional Indications

Atara is committed to pursuing the development of tab-cel in additional EBV-positive patient populations, with a primary focus on immunodeficiency-associated lymphoproliferative diseases (IA-LPDs)
Enrollment is continuing at sites in the Phase 2 multi-cohort study, which is evaluating six patient populations, including four within IA-LPDs and two in other EBV-driven diseases, in the U.S. and EU. Phase 2 study data is expected in 2023
ATA188 for Progressive Multiple Sclerosis

Positive momentum around the ATA188 program continues to build, with increasing awareness of and excitement for the transformative potential of ATA188 in multiple sclerosis (MS) among the medical community and industry
At the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in October, Atara presented translational data based on magnetization transfer ratio (MTR), an imaging biomarker of myelin density, and updated Phase 1 open-label extension (OLE) clinical data in patients with progressive MS treated with ATA188 for up to 39 months
Findings continue to demonstrate that patients may achieve sustained disability improvement (SDI) at a higher rate and longer duration than would be expected based on the natural history of progressive MS; the majority of SDI is driven by improvement in the expanded disability status scale (EDSS)
In seven of eight patients, SDI was maintained at all subsequent timepoints up to 33 months, with multiple patients regaining enough function that they no longer needed a walking aid and were able to walk a few hundred meters unassisted. Most patients in the OLE were progression free, which could be another significant measure of clinical benefit in people with progressive MS
Magnetic Resonance Imaging (MRI) results showed increases in MTR suggestive of remyelination. In patients treated with ATA188 who achieved sustained EDSS improvement versus those who did not, MTR for non-enhancing T2 chronic brain lesions increased at six months and this increase achieved statistical significance at 12 months; A similar trend of MTR increase was also seen in normal-appearing brain tissue
These MTR data, where the time course for increase in MTR parallels the EDSS improvements observed, provides evidence that remyelination may be the driver for clinical improvement, and supports a potential biological basis for clinical EDSS improvements observed with ATA188
Updated results from the ongoing OLE demonstrate continued safety and tolerability of ATA188 with up to three annual treatments. As of August 2021, no fatal adverse events, grade >3 events, dose-limiting toxicities, CRS, or GvHD were observed
Atara is continuing to make good progress with enrollment of the Phase 2 randomized, double-blind, placebo-controlled dose-expansion EMBOLD study evaluating the efficacy and safety of ATA188 in patients with progressive MS, across clinical sites in North America and Australia
An interim analysis to assess efficacy and safety is planned for H1 2022. The Company plans to communicate its decision on next steps for the program, including rationale, while still maintaining the integrity of the study
Atara expects to complete enrollment for EMBOLD in H1 2022
Atara will present encore data at the 29th Annual Meeting of the European Charcot Foundation in November 2021. The Company will present an overview of the methodology planned to determine the potential pharmacodynamic effect of ATA188, by quantifying a decrease of EBV infected cells following treatment with ATA188
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

The global strategic collaboration for ATA2271 and ATA3271 with Bayer continues to progress, with work advancing across both mesothelin-partnered CAR-T immunotherapy programs
The first presentation of preclinical, clinical, and translational data from the lowest dose cohorts of the open-label, single-arm Phase 1 clinical study of ATA2271, an autologous CAR-T therapy targeting mesothelin, designed to improve efficacy, persistence, and durability of response for patients with advanced mesothelioma, will take place during a Mini Oral session at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress on December 9, 2021 (presentation #46MO)
Atara is continuing to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD-1 dominant negative receptor (DNR) and 1XX CAR co-stimulatory signaling domain technologies and expects an IND filing in H2 2022
Preclinical data for ATA3271 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 10-14, 2021 (poster #136)
ATA3219 (B-cell Malignancies)

Atara is making good progress and expects to submit an IND for ATA3219, an off-the-shelf, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies, in Q1 2022
Leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform, ATA3219 is a potential best-in-class therapy that does not require T-cell receptor (TCR) or human leukocyte antigen (HLA) gene editing
Allogeneic T Cell Platform Development

To date, the safety and tolerability of Atara’s allogeneic EBV T-cell therapies and platform has been validated by clinical studies and experience in approximately 400 patients in various disease areas
We have established a new Atara Research Center (ARC) to house the Company’s Translational and Pre-Clinical Sciences, Process Sciences, and Analytical Development teams. New capabilities will support our product pipeline and further drive innovation by leveraging our unique and differentiated allogeneic cell therapy platform
Third Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments as of September 30, 2021 totaled $357.2 million, as compared to $373.4 million as of June 30, 2021
The September 30, 2021 cash balance includes $46.4 million from the sale of 3,123,570 shares of common stock through the Company’s at-the-market (ATM) facility
Atara believes that its cash as of September 30, 2021, together with the $45.0 million upfront payment received as a result of our entry into the Pierre Fabre Commercialization Agreement, is sufficient to fund planned operations into the second quarter of 2023
License and collaboration revenue was $5.4 million for the third quarter 2021 and consisted of revenue from activities performed under the Bayer Collaboration Agreements. Atara did not recognize any license and collaboration revenue for the same period in 2020
Net cash used in operating activities was $59.0 million for the third quarter 2021, as compared to $53.0 million for the same period in 2020
Atara reported net losses of $84.7 million, or $0.90 per share, for the third quarter 2021, as compared to $74.3 million, or $0.92 per share, for the same period in 2020
Total operating expenses include non-cash expenses of $16.0 million for the third quarter 2021, as compared to $15.4 million for the same period in 2020
Research and development expenses were $70.3 million for the third quarter 2021, as compared to $59.9 million for the same period in 2020
The increase in the third quarter 2021 was primarily due increased research and clinical trial costs related to the Company’s ATA188 and CAR T programs, and higher employee-related costs from increased headcount
Research and development expenses include $7.8 million of non-cash stock-based compensation expenses for the third quarter 2021, as compared to $8.2 million for the same period in 2020
General and administrative expenses were $19.8 million for the third quarter 2021, as compared to $14.8 million for the same period in 2020
The increase was primarily driven by higher compensation-related costs from increased headcount and activities to support our anticipated tab-cel launch
General and administrative expenses include $5.9 million of non-cash stock-based compensation expenses for the second quarter 2021, as compared to $5.1 million for the same period in 2020
Conference Call and Webcast Details

Atara will host a live conference call and webcast today, Thursday, November 4, 2021, at 8:30 a.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 888-437-3179 for domestic callers and 862-298-0702 for international callers, using the conference ID 13723551. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.

On November 4, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that two abstracts have been accepted for poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Harpoon Therapeutics, NOV 4, 2021, View Source [SID1234594501]). The meeting will be held virtually and in person in Atlanta, Ga. from December 11-14, 2021.

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Abstract details:

Title: An Interim Report on a Phase 1/2 Study of HPN217, a Half-Life Extended Tri-Specific T Cell Activating Construct (TriTAC) Targeting B Cell Maturation Antigen for the Treatment of Relapsed/Refractory Multiple Myeloma
Publication Number: 1654
Submission ID: 148176
Authors: Sumit Madan, M.D., et al.
Session Name: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Poster Presentation Date and Time: Saturday, December 11, 2021 5:30 p.m. – 7:30 p.m. ET
Location: Georgia World Congress Center, Hall B5
Title: The Effects of BCMA Expression, Soluble BCMA, and Combination Therapeutics on the Anti-Tumor Activity of HPN217, a BCMA-Targeting Tri-Specific T Cell Engager Against Multiple Myeloma
Publication Number: 1185
Submission ID: 151880
Authors: Patrick Ng, Ph.D., et al.
Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster I
Poster Presentation Date and Time: Saturday, December 11, 2021 5:30 p.m. – 7:30 p.m. ET
Location: Georgia World Congress Center, Hall B5
The posters will be available for viewing on December 11, 2021 at 9 a.m. ET and will be available on Harpoon’s website following the presentation.

For more details about the ASH (Free ASH Whitepaper) Annual Meeting please visit: View Source

On November 4, 2021 Primmune Therapeutics reported that it has received $8.4 million in a second tranche of the Company’s Series A financing. The total proceeds for the equity raised in the Series A was $31.4 million (Press release, Primmune Therapeutics, NOV 4, 2021, View Source [SID1234594518]). These funds will be used to support the further clinical development of PRTX007 as a TherAjuvant for acute viral diseases, pre-cancerous lesions, and advanced cancer. PRTX007 is a novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonist that has both therapeutic and adjuvant properties.

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"Given the initial results from our Phase 1 study in healthy volunteers, we achieved our target clinical milestone that triggered a second tranche of $8.4 million from our existing investors. These funds will be used to set the stage for Primmune’s expansion into multiple definitive efficacy studies," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "In 2022, we intend to study PRTX007 in ambulatory respiratory syncytial virus (RSV), outpatient SARS-CoV-2, human papilloma virus (HPV) driven high-grade squamous intraepithelial lesions (HSIL) of the cervix, and in the neo-adjuvant setting in combination with checkpoint inhibitors in advanced cancer."

About TherAjuvants

Primmune Therapeutics coined the term TherAjuvants to reference its lead candidate PRTX007, a toll-like receptor 7 (TLR7) agonist with a combination of therapeutic and adjuvant mechanisms of action. PRTX007 is designed to provide immediate benefit to patients through controlled stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 uniquely engages TLR7 and targeted immune cells without exacerbating inflammation, a critical feature in treating respiratory viral infections. TherAjuvants differ from therapeutic vaccines in that the source of the antigens presented to the patient’s immune system come from the treated pathology. Additionally, TherAjuvants differ from most small molecule approaches in that they target the patient’s immune system and not tumor cells or virally encoded targets.