On November 10, 2021 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the third quarter ended September 30, 2021 (Press release, Century Therapeutics, NOV 10, 2021, View Source [SID1234595221]).

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"We continue to deepen investments in cellular reprogramming, genetic engineering, and manufacturing, in order to advance our iPSC platforms, with an ultimate goal of developing therapies that can meaningfully advance cancer care," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We are making tangible progress in advancing our lead candidate, CNTY-101, into the clinic, with our IND filing on track for mid-2022. Additionally, through our recently announced collaboration with Outpace Bio, we are further investing in new technologies as we execute on our vision of building a next-generation cell therapy platform. We expect to provide scientific updates on our programs later this year and at our upcoming virtual research and development update."

Business Highlights

Entered into a research collaboration agreement with Outpace Bio to explore Outpace’s protein solutions for cell therapy to potentially enhance the functionality of Century’s iPSC platform. The collaboration’s initial program will focus on hematological malignancies with an option to expand to additional candidates.
Included in the small-cap Russell 2000 Index as a part of the 3Q21 Russell Indexes IPO additions.
Upcoming Milestones

Pre-clinical data from the Company’s CNTY-101 program and CAR-iT platform to be presented in two posters at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on December 11-14, 2021 in Atlanta, Georgia, and virtually.
Virtual research and development update to be held on Thursday, December 16, 2021 from 8:00-9:30 AM EST. Century’s management team will discuss an update on the Company’s iPSC technology platform and pipeline. Eduardo Sotomayor, M.D., Director of the Cancer Institute at Tampa General Hospital, will discuss the current treatment paradigm for B-cell malignancies. For additional information on how to access the event, please visit the Events & Presentations section of Century’s website.
Current Good Manufacturing Practice (cGMP) manufacturing facility expected to be operational in early 2022.
CNTY-101 IND filing remains on track for mid-2022.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $400.3 million as of September 30, 2021, as compared to $440.0 million as of June 30, 2021.
Research and Development (R&D) expenses: R&D expenses were $19.5 million for the three months ended September 30, 2021, compared to $10.8 million for the same period in 2020. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s research and development capabilities, costs for preclinical studies, costs for laboratory supplies, and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $6.3 million for the three months ended September 30, 2021, compared to $2.3 million for the same period in 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company.
Net loss: Net loss was $26.0 million for the three months ended September 30, 2021, compared to $13.1 million for the same period in 2020.

On November 10, 2021 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will participate in an analyst-led fireside chat at the Jefferies London Healthcare Conference at 11:20 AM GMT (6:20AM ET) on Tuesday, November 16, 2021 (Press release, Pacira Pharmaceuticals, NOV 10, 2021, View Source [SID1234595272]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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On November 10, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that its Chief Executive Officer, Michael Engsig and Chief Innovation and Strategy Officer, Agnete Fredriksen, will present at Jefferies London Healthcare Conference on November 16, 2021 at 9.40 am CET and be available for 1:1 investor meetings (Press release, Vaccibody, NOV 10, 2021, View Source [SID1234595668]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The presentation may be viewed here: View Source

On November 10, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that it has completed recruitment for the initial dosimetry phase of its US-based SECuRE clinical trial (NCT04868604)1 investigating SAR-bisPSMA Targeted Copper Theranostics (TCT) in patients with metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, NOV 10, 2021, View Source [SID1234595055]).

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The SECuRE trial is a Phase I/IIa theranostic trial for identification and treatment of prostate specific membrane antigen (PSMA)-expressing mCRPC using TCT. 64Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The initial dosimetry phase utilised 64Cu SAR-bisPSMA to determine biodistribution and dosimetry of the products in humans. The SECuRE trial is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this trial is to determine the safety and efficacy of 67Cu SAR-bisPSMA as a therapy.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased to have quickly and successfully completed the recruitment for the initial dosimetry phase of the SECuRE trial in mCRPC using our optimised next-generation PSMA agent, SAR-bisPSMA, and look forward to progressing through the safety review shortly. We are excited to move quickly to the therapy phase with 67Cu SAR-bisPSMA at all seven clinical sites selected for this trial in the US.

"The PET imaging data acquired in the SECuRE trial to date looks very promising and the images confirm our excellent preclinical results of high tumour targeting and retention whilst seeing washout in other tissues. We are excited with the comparison to the standard of care bone scan (the recommended modality for bone imaging in clinical trials according to the Prostate Cancer Clinical Trials Working Group 3), indicating that 64Cu SAR-bisPSMA is able to visualise bone involvement. This further supports the emerging evidence of increased sensitivity and specificity of PSMA PET tracers for detecting micrometastatic disease compared to conventional imaging. With the recently updated US National Comprehensive Cancer Network Guidelines now allowing FDA-approved PSMA PET agents to be used as an alternative to conventional imaging, we are really looking forward to progressing this product quickly through clinical trials with the added value of manufacturing, logistics and patient benefits that 64Cu provides.

"Our TCT platform uniquely uses the same chemical entity for both diagnosis and therapy, leading to high accuracy and high precision, and highlights the benefits of generating 64Cu imaging data from 1h to 72h after administration to help determine the suitability of treatment with 67Cu. We strongly believe SAR-bisPSMA will be an important pillar in the next generation of radiopharmaceuticals, with blockbuster potential both diagnostically and therapeutically. The central manufacture, logistical and treatment advantages of TCT associated with using the isotope pairing of 64Cu and 67Cu in large patient populations such as prostate cancer will provide significant benefits to both patients and clinicians in comparison to current products in the market."

Dr Luke Nordquist, CEO, Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, who treated patients in the initial dosimetry phase of the trial, commented, "I am very impressed with the data from the initial dosimetry phase and we look forward to progressing the SECuRE trial into the therapy phase and further validating the benefits of the 64Cu SAR-bisPSMA and 67Cu SAR-bisPSMA products for both clinicians and patients. Current standard of care SPECT imaging agents don’t have the resolution of the new PET agents, however the new PET agents rely on radionuclides with very short half-lives such as 18F and 68Ga, which limits their availability and utilisation. Having access to centrally manufactured PET imaging products with a more suitable half-life, such as 64Cu, will significantly improve patient care and address the current backlog of patients waiting for critical imaging scans. Importantly, the potential for improved prostate cancer diagnosis and treatment will have significant benefits for prostate cancer patients."

Dr Taylor said: "The future of radiopharmaceuticals is here, where patient care is not dictated by the limited half-life of the isotope, and instead focuses on what is important for the patient, clinician and treating staff – safety, efficacy, access and flexibility. The further expansion of radiopharmaceuticals into more indications, with greater utilisation from a broad spectrum of clinicians, will be dependent upon centralised, large volume and simple supply logistics of isotopes and ready-to-use radiopharmaceuticals whilst focusing on long-term environmental impacts of the supply chain. Clarity’s ability to centrally manufacture and broadly distribute large volumes of copper-based products, without long lived radioactive waste products or dependance on nuclear reactors, will be a significant factor in addressing large markets in a sustainable manner. To that end, we are very excited to be quickly advancing our TCT platform and numerous TCT products through clinical trials to generate compelling clinical data and move closer to achieving our ultimate goal of developing better treatments for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. In 2021, the National Cancer Institute estimated 248,530 new cases of prostate cancer in the US and around 34,130 deaths from the disease3. Annually, there are around ~34,000 men in the US who are diagnosed with mCRCP4, ~90% of whom have tumours which express PSMA5.

References
gov Identifier: NCT04868604 View Source
Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries View Source
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
A. Silver, I. Pellicer, W. R. Fair, W. D. Heston and C. Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3, 81-85, January 1997

On November 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Alpine Immune Sciences, NOV 10, 2021, View Source [SID1234595087]).

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"We continue to make considerable progress across our portfolio and anticipate opportunities to share clinical updates for both ALPN-202 and ALPN-303 in the first half of 2022," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Importantly, the recently completed private placement will enable us to accelerate and expand development plans for both of these molecules, as well as our discovery pipeline, as we work to advance innovative therapies to treat cancer, autoimmune and inflammatory diseases."

Third Quarter 2021 and Recent Corporate and Clinical Updates

ALPN-303: Dual APRIL/BAFF inhibitor (autoimmune/inflammation)
Data demonstrating the superior efficacy of ALPN-303 in preclinical models was shared in an oral presentation in the Plenary III session of the American College of Rheumatology (ACR) Convergence 2021 Annual Meeting.
A first-in-human, phase 1 study of ALPN-303 is expected to begin enrolling in the fourth quarter of 2021 with topline results expected in the first half of 2022. The randomized, placebo-controlled study in healthy adult participants will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously and subcutaneously administered ALPN-303.
ALPN-202: Conditional CD28 co-stimulator and dual checkpoint inhibitor (oncology)
A trial-in-progress presentation on NEON-2, a phase 1 study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, will be shared at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on Friday, November 12, 2021. The poster (#497) will be available both on site and as an ePoster.
NEON-1, a phase 1 study of ALPN-202 monotherapy in patients with advanced malignancies, continues to proceed, with completion of dose escalation anticipated in the fourth quarter of 2021. Further updates are anticipated for the first half of 2022.
Corporate: $91M securities offering completed September 2021
Completed a private placement of common stock and prefunded warrants, for gross proceeds of approximately $91.0 million, which was led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.
Third Quarter 2021 Financial Results

As of September 30, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $219.9 million. We recorded net losses of $13.5 million and $6.1 million for the quarters ended September 30, 2021 and 2020, respectively.

Collaboration revenue for the quarter ended September 30, 2021 was $8.5 million compared to $1.9 million for the quarter ended September 30, 2020. The increase was primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the quarter ended September 30, 2021 were $18.3 million compared to $6.2 million for the quarter ended September 30, 2020. The increase was primarily attributable to clinical trial activities for the acazicolcept and ALPN-202 studies, direct research activities, contract manufacturing and process development of our product candidates, and personnel-related expenses.

General and administrative expenses for the quarter ended September 30, 2021 were $3.5 million compared to $2.7 million for the quarter ended September 30, 2020. The increase was primarily attributable to personnel-related expenses to support the growth and expansion of our business.

Alpine expects that its current cash resources are sufficient to fund Alpine’s planned operations through 2023.