On October 29, 2021 Prescient Therapeutics Limited (ASX: PTX) reported that it has released the results for September quarter of fiscal year 2022 (Press release, Prescient Therapeutics, OCT 29, 2021, View Source;utm_medium=rss&utm_campaign=prescient-closes-very-productive-september-quarter-with-strong-cash-position [SID1234592169]). The ASX-listed clinical stage oncology company continues to stand strong with excellent financial performance. Several anti-cancer programs of the firm are progressing in the right direction towards multiple value creating milestones.

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With prudent financial management, Prescient ended the quarter with a strong cash position. Below are the key points from its quarterly report:

The firm had a cash balance of AU$14.8 million at quarter end.
Net cash outflows for the quarter were AU$1.2 million, with AU$0.782 million invested in research and development across Australia and the United States.
Several investments were made in the ongoing clinical studies of PTX-100 and PTX-200; pre-clinical development of the OmniCAR platform as well as Cell Therapy Enhancements.
Progress made so far in different therapy programs
Internal OmniCAR Programs: During the reporting period, Prescient received positive in silico results from immunogenicity testing of OmniCAR’s key binding components, SpyTag and SpyCatcher.
Immunogenicity evluates the immune response against a new therapy and the overall safety profile of a new treatment. There can be adverse impacts on CAR-T cell expansion due to increased levels of immunogenicity. In this case, the test outcome was positive as it detected low immunogenicity equivalent to circulating human antibodies.

Prescient Therapeutics (ASX:PXT)

Cell Therapy Enhancement Program: The Cell Therapy Enhancement (CTE) program is maturing well to achieve several striking pre-clinical milestones. The program is being conducted under the guidance of a world-leading research team at the Peter MacCallum Cancer Centre in Melbourne.
The result obtained so far hint at great scope for cancer treatment by enhancing current generation cell therapy approaches. It also holds possibility for next-generation approaches.

PTX-100: Phase 1b results from the PTX-100 basket trial confirmed it to be an excellent safety profile, with no serious adverse events related to the drug. Of particular interest was the efficacy signal observed in two patients with highly aggressive T cell lymphomas. Now, an expansion cohort study will be conducted for PTX-100, focusing on T cell lymphomas, with a potential for subsequent registration study.
Peripheral T cell lymphoma in particular is a cancer of considerable unmet need and represents a potential shorter path to market for PTX100.

PTX-200: The Phase 1b clinical study of PTX-200 and cytarabine in patients with acute myeloid leukemia is screening patients for a higher dose level of 45 mg/m2. No results were posted during the quarter.
Prescient strengthened its Board to advance its OmniCAR GMB program
An acknowledged expert in the treatment of glioblastoma multiforme (GMB), Professor Donald M. O’Rourke has been appointed as a member of the Prescient’s growing international Scientific Advisory Board.

Professor O’Rourke is a tenured Professor at the Department of Neurosurgery in the Perlman School of Medicine at the University of Pennsylvania and the Abramson Cancer Centre where he holds the John Templeton Jr MD Chair in Neurosurgery.

To know more about Prescient Therapeutics Limited, click here.

To stay updated with PTX company activities and announcements, please update your details on their investor centre.

On October 29, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended September 30, 2021 (Press release, ImmunoGen, OCT 29, 2021, View Source [SID1234592168]).

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"We look forward to announcing top-line data from our pivotal SORAYA trial this quarter, including data on the primary endpoint of overall response rate and key secondary endpoint of duration of response. With positive data, we will move quickly to complete the BLA, with the goal of submitting the filing in the first quarter of 2022," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In addition to SORAYA, we continue to advance a broad program to establish mirvetuximab as the standard of care for patients with FRα-positive ovarian cancer. Our confirmatory MIRASOL trial is enrolling at over 160 sites in 18 countries in North America, Europe, Asia, and Australia, and we have initiated the PICCOLO trial, which could support label expansion in recurrent platinum-sensitive ovarian cancer. Beyond mirvetuximab monotherapy, the first patients have been enrolled in the large investigator-sponsored studies evaluating mirvetuximab combined with carboplatin in both the neoadjuvant and recurrent platinum-sensitive settings to support our objective of making mirvetuximab the combination agent of choice in ovarian cancer, and we look forward to sharing our label-enabling combination strategy early next year."

Enyedy continued, "In addition, our IMGN632, IMGC936, and IMGN151 programs are advancing as planned. We anticipate presenting data on IMGN632 in AML at ASH (Free ASH Whitepaper) in December, have escalated dosing in multiple solid tumors with our ADAM-9 targeting ADC, IMGC936, and expect to file the IND for IMGN151, our next-generation FRα-targeting ADC, by year-end. As we close out 2021, we remain focused on execution and look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for commercial launch next year."

RECENT PROGRESS

Further enrolled patients in the confirmatory MIRASOL study for mirvetuximab.
Initiated PICCOLO, a single-arm study of mirvetuximab monotherapy in high folate receptor alpha (FRα) recurrent platinum-sensitive ovarian cancer.
Enrolled the first patients in the investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Advanced accrual in the pivotal 801 Phase 2 study, now known as CADENZA, of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Escalated dosing in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
Appointed Helen M. Thackray, MD, to the Board of Directors.
ANTICIPATED UPCOMING EVENTS

Release top-line data from the pivotal SORAYA study this quarter, with the goal of submitting the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Submit the IND application for IMGN151 by the end of 2021.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022.
Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
FINANCIAL RESULTS

Revenues for the quarter ended September 30, 2021 were $9.2 million, compared with $18.2 million for the quarter ended September 30, 2020. This decrease was driven by a reduction in non-cash royalty revenue due to the completion of the first tranche of payments under the 2015 transaction covering the sale of Kadcyla royalties. Revenues for the quarter ended September 30, 2021 also included recognition of an anticipated $2.5 million partner development milestone fee.

Operating expenses for the third quarter of 2021 were $43.4 million, compared with $34.9 million for the same quarter in 2020. Research and development expenses rose to $33.1 million for the third quarter of 2021, compared with $24.7 million for the third quarter of 2020, driven by increases in clinical trial expenses, personnel and temporary staffing costs, and third-party service fees in support of commercial readiness. General and administrative expenses were essentially flat at $10.3 million and $10.2 million for the third quarters of 2021 and 2020, respectively.

Net loss for the third quarter of 2021 was $37.3 million, or $0.18 per basic and diluted share, compared to a net loss of $22.4 million, or $0.13 per basic and diluted share, for the third quarter of 2020. Weighted average shares outstanding increased to 204.8 million for the 2021 period from 174.5 million in the prior year.

ImmunoGen had $245.8 million in cash and cash equivalents as of September 30, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding as of December 31, 2020. There was no convertible debt outstanding as of September 30, 2021. Cash used in operations was $123.5 million for the first nine months of 2021, compared with cash used in operations of $87.2 million for the same period in 2020. Capital expenditures were $(1.1) million for the first nine months of 2021, compared with net proceeds from the sale of equipment of $0.6 million for the first nine months of 2020.

During the quarter ended September 30, 2021, the Company sold 2.2 million shares of its common stock through its At-the-Market (ATM) facility, generating gross proceeds to the Company of approximately $13 million. In August 2021, the Company entered into a Securities Purchase Agreement pursuant to which the Company agreed to sell to an investor a warrant to purchase up to an aggregate of 5,434,782 shares of the Company’s common stock for a nominal value, generating additional gross proceeds of approximately $30 million.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2021 and now expects:

revenues between $65 million and $75 million;
operating expenses between $190 million and $200 million; and
cash and cash equivalents at December 31, 2021 to be between $190 million and $200 million.
ImmunoGen expects that its current cash will fund operations into the fourth quarter of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 1587202. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

On October 29, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that results from the IMPACT (IMproving Primary screening And Colposcopy Triage) trial demonstrate clear patient benefit in using Roche’s CINtec PLUS Cytology dual-stain biomarker technology as a triage test for women who test positive for high-risk human papillomavirus (HPV). (Press release, Hoffmann-La Roche, OCT 29, 2021, View Source [SID1234592167]) The data from the trial, established from a study cohort of more than 35,000 women aged 25-65 years, was published recently in the International Journal of Cancer.1

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In the IMPACT trial, women who were positive for high-risk HPV received a follow-up triage test to help determine if their cervical cells were transforming to cervical pre-cancer. The biomarker-based CINtec PLUS Cytology test showed a significantly higher sensitivity in detecting cervical pre-cancers, compared to Pap cytology. The Roche test aids clinicians in more confidently determining which women are at increased risk for high-grade cervical pre-cancer and require immediate further diagnostic procedures, and which women may need repeat testing or routine screening.1

Over 604,000 women are diagnosed with cervical cancer worldwide each year and approximately 342,000 die from the disease.2 Persistent infection with high-risk HPV is the principal cause of cervical cancer, implicated in more than 99 percent of cases worldwide.3 Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment.

"As we approach the one-year anniversary of the World Health Organization’s global strategy to accelerate the elimination of cervical cancer, Roche is committed to investing in and leading efforts such as the IMPACT trial to bring forth clinically validated solutions for women," said Thomas Schinecker, CEO Roche Diagnostics. "The elimination of cervical cancer is within reach, and all countries must act now so that women, no matter where in the world they live, no longer die from this preventable disease. Our investment in HPV primary screening and next-generation biomarker technology gives clinicians even more powerful tools in the fight against cervical cancer."

"These latest results from the IMPACT trial confirm data from previous studies that show incorporating the CINtec PLUS Cytology test in cervical cancer screening programs can provide real benefits to both clinicians and their patients," says Dr. Thomas Wright, Professor Emeritus in Pathology and Cell Biology at Columbia University Medical Center, New York. "As a triage test for HPV-positive cervical cancer screening results, the CINtec PLUS Cytology test can be very useful to differentiate women who will benefit most from immediate referral to colposcopy from those women who can be followed up with less invasive methods."

About Cervical Cancer and the IMproving Primary screening And Colposcopy Triage (IMPACT) Trial
Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment. More than 604,000 new cases of cervical cancer are diagnosed each year worldwide. In 2020, cervical cancer was responsible for 7.7 percent of all female cancer deaths.2,4

The landmark IMPACT trial was a prospective observational cervical cancer screening clinical study that enrolled approximately 35,000 women aged 25-65 years who were undergoing routine cervical cancer screening at 32 clinical sites in 16 states across the US. The study provides validation for the clinical utility of cobas HPV testing for primary screening in combination with CINtec PLUS Cytology as a follow-up test for patients with positive screening results.

The study showed that triaging with CINtec PLUS Cytology may lead to significantly improved detection of cervical disease when women are screened for cervical cancer. Cervical screening helps identify women at risk for disease before invasive cancer develops. While most HPV infections resolve on their own, some women who test positive for the virus may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer. Early identification of women who are most at risk is vital.

In the study, HPV-positive women with CINtec PLUS Cytology negative triage test results showed a very low cumulative 1-year risk for disease, which was significantly lower than the risks associated with a negative Pap cytology triage test result in HPV-positive women.

Based on the results of the IMPACT trial, the FDA approved the CINtec PLUS Cytology test to be used as triage for positive HPV test results using cobas HPV on cobas 4800, 6800 and 8800 Systems in primary screening or co-testing programs.

Recommended clinical guidelines have also been evolving in favor of HPV tests for primary screening, supported by an interest to improve outcomes and the availability of technologies to help laboratories achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs.

About CINtec PLUS Cytology
The CINtec PLUS Cytology test detects the simultaneous presence within a single cell of the two biomarkers — p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease. The ability of CINtec PLUS Cytology to distinguish those women who are at a higher risk for cervical disease, in conjunction with the clinician’s assessment of patient screening history and other risk factors, provides labs, physicians and women with the information needed to guide patient management. Women with negative dual-stain results are at significantly lower risk for cervical disease and their bodies can be given more time to clear the HPV infection on their own. This could reduce the number and frequency of follow-up visits, saving some patients worry and time.

The CINtec PLUS Cytology test, which runs on the BenchMark ULTRA IHC/ISH system, is performed using the same sample that is used for HPV or liquid-based Pap cytology tests. This eliminates the need for additional or repeat sample collection or time spent waiting to find out if an infection is clearing.

CINtec PLUS Cytology, now available globally, was FDA approved in March 2020.

On October 29, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first six months (April 1, 2021 – September 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, OCT 29, 2021, View Source [SID1234592166]).

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1. Qualitative information on consolidated financial results for the first six months of FY2021
(1) Business performance
Consolidated financial results (core basis) in the first six months of FY2021 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia and Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") contributed to revenue as well.
-Moreover, other factor for the increase in sales in the first six months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the first quarter of the previous fiscal year because of the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales and distribution for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first six months of FY2021 increased by 5.9% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥651.7 billion.

Core operating profit / Core profit
-Gross profit increased by 6.3% year-on-year to ¥526.9 billion. The cost-to-revenue ratio fell by 0.3 percentage points year-on-year to 19.1%, mainly due to changes in product mix
.-Selling, general and administrative expenses increased by 11.7% year-on-year to ¥270.5 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥10.2 billion year-on-year), investment in systems associated with globalization (increase of approximately ¥5.0 billion year-on-year), the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥3.0 billion year-on-year), and the impact of the foreign exchange rates (increase of ¥8.4 billion year-on-year).

Excluding co-promotion fees of XTANDI in the United States, selling, general and administrative expenses increased by 10.0% year-on-year to ¥199.4 billion.-Research and development (R&D) expenses increased by 6.6% year-on-year to ¥119.1 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota).

-Amortisation of intangible assets increased by 7.2% year-on-year to ¥12.4 billion. 3

As a result of the above, core operating profit decreased by 3.8% year-on-year to ¥125.3 billion, and core profit decreased by 7.0% year-on-year to ¥98.8 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first six months of FY2021 are shown in the table below. The resulting impacts were a ¥24.5 billion increase in revenue and a ¥11.5 billion increase in core operating profit compared with if the exchange rates of the first six months of FY2020 were applied.

On October 28, 2021 AbClon (CEO Jong-seo Lee) and Lee Ensage (CEO Lee Bong-hee) reported business partnership agreement for joint development of CAR-NK cell therapy using gene editing technology (MOU) (Press release, AbClon, OCT 28, 2021, View Source;wr_id=150 [SID1234638632]).

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AppClone developed CAR-T through joint research with Ensage. Beyond platform technology CAR-NK expanding the scope of research and development with technology, In particular, the strategy is to target the cell therapy market from various angles by combining the company’s antibody discovery technology with Nsage’s gene scissors technology.

CAR-NK Cell therapy is a recombinant antigen receptor(CAR, Chimeric Antigen Receptor) Natural killer cells(NK cell) It is a cell therapy product that combines, NK cells and destroys abnormal cells or cancer. Responsible for immunity.

CAR-NK NK cells used to manufacture cell therapy products are isolated from the blood of healthy people. After culturing, these cells are GVHD (graft-versus-host disease), which is a rejection reaction to injection of other cells,Side effects The advantage is that it is low and mass production is possible. CAR-NK cell therapy has not yet been approved at home or abroad, but , is a pipe that global Big Pharma is trying to dominate. As a line, a lot of research and development is underway worldwide.

NSAGE uses a large amount of gene editing Cas12a material and Automated factory-type cell therapy production platform ‘Harmony’ Holds. NSAGE’s gene editing platform is a technology that targets specific targets for incurable diseases, existing stem cells. It is evaluated that it can overcome the limitations of treatment. Major The pipeline is a hemophilia target CAR-NK cell therapy.

AbClone is a new epitope(Epitope, antigenic determinant) Antibody discovery technology targeting ‘NEST (Novel Epitope Screening) Technology)’ has a platform. The NESTplatform provides a large-scale antibody database. It is a technology that can be used in the development of various cell gene therapy products,the company utilizes this to develop antibodies suitable for the purpose. We plan to select CAR-NK and apply it to the development of cell therapy. past 6month IND Blood cancer applied CAR-T Cell therapy ‘AT101’also NEST platform It was discovered through.

Jong-seo Lee, CEO of AppClon, said "the cooperation between the two companies and Through technological convergence, CAR-NK expands the pipeline to cell therapy CAR We will lay the foundation to lead the related industry by upgrading our technology"he emphasized.

Nsage CEO Lee Bong-hee said "AppClone’s Antibody discovery technology and CAR-T technology and our Cas12a gene scissors technology and NK automated production using domain libraries for cell activation, etc., Based on close cooperation between the two companies, highly effective and low-cost allogeneic CAR-NK cells for target cancers such as lung cancer remedy He said that he expects to be able to secure the pipeline early".