On April 13, 2021 Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company focused on developing a novel MabPair platform for antibody-based combination therapies for the treatment of cancer, inflammation and autoimmune disease, reported a clinical update on its first MabPair product PSB205 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Sound Biologics, APR 13, 2021, View Source [SID1234577995]). Dr Li Zhang of Sun Yat-Sen University Cancer Centre (SYSUCC), Guangzhou, China presented a poster on Phase 1 Clinical Trial results of PSB205, a combination of anti-PD1 and anti-CTLA-4 antibodies that are manufactured together as a single product, in patients with advanced malignant tumors. The study is sponsored by Qilu Pharma in China.

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Details of the presentation:

Presentation Title: Development and Preliminary Clinical Activity of QL1706 (PSB205), a Combination of anti-PD1 and anti-CTLA-4 Antibodies Manufactured Together as a Single Product

Session Title/Category: Phase I Clinical Trials

Session Type: E-Poster Session, 8:30 AM – 11:59 PM, Saturday, April 10

Poster Number: CT119

Forty-seven patients, 95% of whom had refractory Naso-Pharyngeal (NPC) or lung (NSCLC) cancers, were enrolled at a single clinic with over 5 ascending dose levels in a standard 3+3 design. A dose of 5 mg/kg was selected for continued clinical development. The most common side effects were Grade 1 pruritus and rash. Dose-limiting immune-related reactions occurred only at doses higher than 5 mg/kg. The Overall Rate of Response (ORR) was 29% among 35 patients evaluable for tumor response; among 20 patients without prior exposure to checkpoint-targeted immunotherapy, 40 % achieved Partial Response (PR), whereas 2 of 10 patients (20%) previously treated and progressed on earlier immunotherapy realized PR. For 5 patients on study, pre-study checkpoint inhibitor exposure status was unknown due to earlier participation in a still-blinded randomized immunotherapy trial.

"The Phase 1 data presented at AACR (Free AACR Whitepaper) provides encouraging proof-of-concept and early clinical validation of the MabPair platform," commented Sound Biologics’ Chief Executive Officer Wei Yan, PhD. "The early data offer multiple opportunities for further development of this dual immune checkpoint blockade product."

About PSB205

PSB205 is a first-in-class bifunctional product that contains a mixture of unique anti-PD-1 and anti-CTLA-4 monoclonal antibodies produced by a single cell line via the company’s proprietary MabPairTM technology. MabPair products offer many advantages over bispecific antibodies. The relative ratio of the two antibodies in the MabPair can be well controlled, and each antibody is individually engineered for optimal target coverage, effector function, pharmacokinetics and exposure. The anti-CTLA-4 component of the MabPair is designed with a shorter half-life than currently available anti-CTLA-4 antibodies in an effort to reduce known side effects associated with CTLA-4 blockade. Preclinical studies with PSB205 demonstrated superior efficacy in tumor models compared to either checkpoint inhibitor alone. PSB205 represents a potentially best-in-class immuno-oncology product that promises to exhibit robust combination activity while being significantly more tolerable to patients than currently approved anti-PD-1/anti-CTLA-4 combinations. Parallel Phase 1 studies in a broad range of refractory solid tumors are currently ongoing in China and the United States (www.clinicaltrials.gov; NCT03986606), and the AACR (Free AACR Whitepaper) poster represents the first release of clinical data from one of these studies.

On April 13, 2021 Arcellx, a privately held clinical-stage biopharmaceutical company, reported that it raised $115 million in a Series C financing to advance its pipeline of adaptive and controllable cell therapies (Press release, Arcellx, APR 13, 2021, View Source [SID1234577962]). The proceeds will support the company’s development of CART-ddBCMA, a BCMA-specific CAR-modified T-cell therapy currently in Phase 1 and anticipated to begin a pivotal trial in 2022. In addition, the funding will support initiation of clinical trials evaluating ACLX-001 and ACLX-002, cell therapies derived from Arcellx’s uniquely controllable ARC-SparX platform, in multiple myeloma (MM) and acute myelogenous leukemia (AML), respectively.

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This financing follows FDA clearance of Arcellx’s IND for ACLX-001, the first ARC-SparX program to enter clinical trials, and Arcellx’s initial release of clinical results at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. In the ASH (Free ASH Whitepaper) release, the CART-ddBCMA data showed all six multiple myeloma patients responded per IMWG criteria, with four of those patients achieving stringent complete response. The therapy was also well-tolerated, and CAR-T related toxicities resolved rapidly.

Participants in the Series C financing include both existing and new investors to Arcellx. The financing was co-led by Samsara BioCapital and CAM Capital, joined by new investors Adage, Asymmetry, CaaS Capital, Cambrian Bio, Sixty Degree, Soleus Capital, Surveyor Capital (a Citadel company), Suvretta, and Terra Magnum Capital Partners, and existing investors NEA, Novo Holdings, SR One, Takeda Ventures, LG Tech, and Clough Capital.

"With support from this high caliber syndicate, Arcellx is poised to elevate the field of cell therapy by advancing our treatments for a range of cancers," said Rami Elghandour, Chairman and Chief Executive Officer of Arcellx. "Our platform of both single infusion and controllable CAR-Ts based on our novel synthetic binding domain is built to address the limitations of cell therapy with the opportunity to improve efficacy, reduce toxicity, and shorten the time to intervention while expanding into new indications. This financing positions us to advance to a registrational study in multiple myeloma and to initiate a Phase 1 study in AML in 2022 as well as progress our solid tumor targets toward the clinic. It’s also a reflection of our incredibly talented and diverse team that is powering Arcellx forward. We appreciate the support of our new and existing investors as we advance our novel therapies to the benefit of cancer patients most in need."

"Based on the early clinical data, we believe that CART-ddBCMA represents a potential best-in class therapy for multiple myeloma and with the support of this financing will be positioned to move into pivotal trials next year. We’re also excited about the opportunity for CART-ddBCMA to move into earlier lines of treatment for multiple myeloma based on the safety profile in this early data set. In addition, the ARC-SparX platform will be the first adaptive and controllable CAR-T system to enter the clinic and provides a unique approach to building next generation cell therapies. We look forward to partnering with the Arcellx team to help bring these important therapies to patients," said Mike Dybbs, Ph.D., Partner, Samsara BioCapital.

On April 13, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that it anticipates reported and organic revenue growth of 98% and 90%, respectively, for the first quarter ended April 4, 2021 (Press release, PerkinElmer, APR 13, 2021, View Source [SID1234577980]).

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PerkinElmer’s strong revenue performance was driven by broad-based momentum across the portfolio. In total, non-COVID-19, or core, demand increased approximately 10% organically year-over-year, and COVID-19 related solutions contributed approximately $535 million of revenue in the first quarter.

PerkinElmer will release its first quarter 2021 financial results after market close on Tuesday, May 4, 2021. The Company will host a conference call the same day at 5:00 p.m. ET to discuss these results. Prahlad Singh, president and chief executive officer, and Jamey Mock, senior vice president and chief financial officer, will host the conference call.

To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 7294952. A live audio webcast of the call will also be available on the Investors section of the Company’s Web site at www.perkinelmer.com.

A replay of the webcast will be available beginning at 7:00 p.m. ET, Tuesday, May 4, 2021 through the Investors section of the Company’s website at www.perkinelmer.com.

In addition, PerkinElmer announced today that Steve Willoughby will be named vice president of investor relations effective May 5, 2021. Mr. Willoughby will assume this role from Bryan Kipp, who has transitioned into the role of vice president and general manager of Life Sciences integration.

Steve Willoughby joins PerkinElmer from Cleveland Research Company (CRC), an independent equity and market research firm with an exceptional reputation for ground-level intelligence. Most recently, Mr. Willoughby served as partner and senior analyst at CRC, providing detailed research, analysis and financial models on the Life Sciences and Managed Care industries to institutional investors across the United States and Europe. In 2018, Thomson Reuters StarMine named Mr. Willoughby the number-one analyst in the Life Science tools sector.

On April 13, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, April 29, at 4:30 p.m. ET to discuss first quarter 2021 financial results and provide a general business update (Press release, BioMarin, APR 13, 2021, prnewswire.com/news-releases/biomarin-to-host-first-quarter-2021-financial-results-conference-call-and-webcast-on-thursday-april-29-at-430pm-et-301266955.html [SID1234577996]).

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Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

On April 10, 2021 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the first presentation of preclinical data demonstrating potent single-agent anti-tumor activity in preclinical cancer models with systemically administered TAC-001, the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform (Press release, Tallac Therapeutics, APR 10, 2021, View Source [SID1234579743]). The data will be presented today as part of the Immunomodulatory Agents and Interventions Session at Week I of the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting (#AACR21) taking place April 10-15, 2021.

Toll-like receptor (TLR) agonists are a novel class of immunotherapy that generate both an innate and
adaptive immune response which may produce more robust and durable anti-cancer immunity to help
overcome resistance to standard-of-care oncology treatments. TLR9 is a key intracellular TLR present in
broad immune cell populations such as B lymphocytes and myeloid cells. Recent studies have shown that
the likelihood of patients responding to immune checkpoint inhibitor therapy may depend on B cells in
the tumor.i B cells play pivotal roles in the immune defense system, which bridge the innate and the
adaptive immunities against cancers.ii In preclinical studies, the activation of TLR9 in human and mouse
models drives B cell proliferation and differentiation.iii

"The results presented today at AACR (Free AACR Whitepaper) elucidate the unique properties of TAC-001 responsible for
integrating B cells and TLR9 activation which trigger innate and adaptive immune responses to create
potent, systemically delivered anti-tumor immunity across solid tumor types," said Dr. Hong I. Wan,
president, CEO and co-founder of Tallac Therapeutics. "The emerging data on TAC-001 continues to
strengthen our understanding of the roles that B cells and TLR9 activation play in eliciting anti-tumor
immunity in checkpoint inhibitor resistant and refractory settings and will help guide our clinical
development strategy."

In the e-poster, titled "TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells,
promotes anti-tumor immunity and favorable safety profile following systemic administration in
preclinical models," investigators present data providing evidence that in vitro targeted delivery of TAC001 leads to superior TLR9 activation in B cells, increased expression of co-stimulatory molecules and
cross-presentation leading to T cell proliferation. In vivo, TAC-001 demonstrated robust, curative and
durable single agent anti-tumor activity in checkpoint inhibitor resistant and refractory tumor models.
Additionally, the systemic administration of TAC-001 was shown to trigger both innate and adaptive
immunity by increasing B cell infiltration, T effector cell functions and modulation in suppressive myeloid
cells within the tumor microenvironment. These results support the development of TAC-001 for a broad
range of solid tumor malignancies.

AACR Poster Presentation Details:

Title: TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells, promotes antitumor immunity and favorable safety profile following systemic administration in preclinical models
Session Type: E-Poster Session
Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Track: Immunology, Clinical Research Excluding Trials
Permanent Abstract Number: 1721
About TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent Toll-like
Receptor 9 agonist (T-CpG) conjugated to an anti-CD22 antibody, a receptor restricted to B cells.
TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization
of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies
demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to potent antitumor activity. TAC-001 is being developed to systemically deliver targeted immune activation in solid
tumor cancers.