On October 18, 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 the C-BOBCAT study led by Prof Louise Emmett has closed for recruitment at St Vincent’s Hospital, Sydney (Press release, Clarity Pharmaceuticals, OCT 18, 2021, View Source [SID1234591502]).

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C-BOBCAT is a pilot trial assessment of the diagnostic value of 64Cu SAR-Bombesin PET/CT imaging for staging of ER/PR + HER2- breast cancer patients with metastatic disease in comparison with conventional imaging (CT, bone scan and 18F FDG PET/CT). SAR-Bombesin has been used to image 7 patients with ER/PR positive metastatic breast cancer under the C-BOBCAT trial and a number of patients via the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) in both breast and prostate cancer patients.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the imaging and safety data acquired during the trial and under the TGA SAS and have made a decision to close the trial early to enable the human clinical data to be used for regulatory submissions, including the upcoming Investigational New Drug (IND) Application filings with the US Food and Drug Administration (FDA) for SAR-Bombesin. As per our recent announcement, Evergreen Theragnostics, Inc. will be one of the US manufacturing groups to supply the Targeted Copper Theranostics for the US-based SAR-Bombesin clinical trial. We anticipate this trial to commence in 2022."

Prof Louise Emmett, Principal Investigator in the C-BOBCAT trial at St Vincent’s Hospital Sydney, commented, "Our collaboration with Clarity on the C-BOBCAT trial has been a very exciting one as the diagnostic program with 64Cu SAR-Bombesin generated evidence of the utility and superiority compared to conventional imaging in some patient subgroups (e.g. 99mTc bone scan, 18F FDG). In addition to these benefits for some breast cancer patients, we also found SAR-Bombesin advantageous for prostate cancer patients who are prostate specific membrane antigen (PSMA) negative, thus validating the product’s pan-cancer application. I look forward to finalising and publishing the results from the C-BOBCAT trial and wish Clarity every success in progressing this asset through clinical development."

Dr Taylor said: "SAR-Bombesin is a promising asset that can be developed for a number of cancer indications. The high uptake and strong product retention visualised by PET imaging of patients at 1, 3 and 24 hours after product administration suggest significant potential for therapy applications with 67Cu SAR-Bombesin. We are excited to further advance its clinical development with a strong focus on regulatory approvals in the US and leverage the results generated in collaboration with some of the leading Australian scientific organisations and hospitals to reach our ultimate goal of improving treatment outcomes for children and adults with cancer."

On October 18, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen) (Press release, Isofol Medical, OCT 18, 2021, View Source [SID1234591501]). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

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Prospectus and new financial information
On October 15, 2021 Isofol announced that Nasdaq Stockholm’s listing committee made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority. The prospectus that has been prepared in connection with the listing was approved and registered today by the Swedish Financial Supervisory Authority and is now available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

The prospectus contains previously unpublished financial information attributable to Isofol’s equity and liabilities and net indebtedness as of July 31, 2021. The financial information, which is also outlined below, is presented due to regulatory requirements, according to which financial information regarding the capital structure must not be older than 90 days at the time of the prospectus’ publication. Note that only interest-bearing liabilities are reported in the tables below. The information has not been reviewed by the Company’s auditor.

Equity and liabilities as of July 31, 2021
KSEK Unaudited
Total current liabilities 1 613
For which guarantees have been issued –
Against other security –
Without secutity 1 613
Total long-term liabilities 687
Guaranteed –
With security –
Without guarantee/security 687
Equity 413 972
Share capital 4 945
Other contributed capital 1 217 607
Retained earnings -809 581
Total 416 272
Net indebtedness as of July 31, 2021
KSEK Unaudited
(A) Cash and cash equivalents 483 906
(B) Other cash and cash equivalents –
(C) Other financial fixed assets –
(D) Liquidity (A) + (B) + (C) 483 906
(E) Current financial liabilities (including debt instruments, but excluding the current portion of long-term financial liabilities) 1 613
(F) Current portion of long-term financial liabilities –
(G) Current financial indebtedness (E + F) 1 613
(H) Net current financial indebtedness (G – D) -482 293
(I) Long-term financial liabilities (excluding current portion and debt instruments) 687
(J) Debt instruments –
(K) Long-term accounts payable and other liabilities –
(L) Long-term financial debt (I + J + K) 687
(M) Total financial indebtedness (H + L) -481 606
Additional information about the listing
The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any action in connection with the listing.

Advisors
Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CEST on October 18, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On October 18, 2021 Orphagen Pharmaceuticals, a privately-held pharmaceutical company, reported that the National Cancer Institute (NCI) has indicated its intention to award the company $2.0 million under the Small Business Innovation Research (SBIR) program to support preclinical development of OR-449, a small molecule drug candidate designed and synthesized by Orphagen, as a first-in-class therapy for adrenocortical carcinoma (ACC), a rare cancer of the adrenal gland with very limited treatment options and a poor prognosis (Press release, Orphagen, OCT 18, 2021, View Source [SID1234591500]).

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OR-449 is a potent and selective inhibitor of steroidogenic factor-1 (SF-1 or NR5A1), an orphan nuclear receptor and transcription factor that is essential for the growth and development of the adrenal gland. Multiple findings indicate that SF-1 has a crucial role in the pathogenesis of ACC.

"Orphagen has a strong platform for nuclear receptor discovery and our technology has allowed us to identify promising antagonists to a previously unexplored nuclear receptor, known as steroidogenic factor-1, or SF-1," said Scott Thacher, CEO of Orphagen and Principal Investigator of this grant. "The discovery and characterization of OR-449, which led to this prestigious award, was the product of an immensely talented team, with expertise in compound screening, medicinal chemistry, the implementation of novel tumor models, and small molecule drug development. The creation of this new drug candidate for ACC patients would not have been possible without the dedicated efforts of Orphagen’s multidisciplinary team."

Notice of first-year funding for this proposal can be found on the NIH web site at: RePORT ⟩ RePORTER (nih.gov).

On October 18, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will host a webcast and conference call on Saturday, November 13, at 5:30 p.m. ET to discuss SITC (Free SITC Whitepaper) clinical data updates for Iovance tumor-infiltrating lymphocyte (TIL) cell therapy in relapsed, refractory lung cancer as well as Iovance TIL in combination with pembrolizumab in patients with advanced cancers (Press release, Iovance Biotherapeutics, OCT 18, 2021, https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-host-conference-call-and-webcast [SID1234591498]).

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Iovance senior leadership will be joined by key opinion leaders and principal investigators in Iovance clinical studies.

The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 3263399. The live webcast can be accessed in the Investors section of the company’s website at www.iovance.com. The archived webcast will be available for one year following the event.

Posters and Presentations at SITC (Free SITC Whitepaper) Annual Meeting (November 12-14, 2021)

Title: Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers
Authors: D O’Malley, et al.
Presentation Type: Oral Presentation
Date and Time: Saturday, November 13, 2021 at 4:20 p.m. ET
Abstract ID: 492

Title: First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Authors: A Schoenfeld, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 458

Title: Successful generation of tumor-infiltrating lymphocyte (TIL) product from renal cell carcinoma (RCC) tumors for adoptive cell therapy
Authors: B Halbert, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 176

Title: Expansion of tumor-infiltrating lymphocytes (TIL) using static bag for the clinical manufacturing rapid expansion protocol (REP) process
Authors: K Onimus, et al.
Presentation Type: Poster (available beginning on Friday, November 12, 2021 at 7 a.m. ET)
Abstract ID: 101

On October 18, 2021 AstraZeneca PLC (AstraZeneca) (NASDAQ: AZN) reported that it has received notification of an unsolicited ‘mini-tender’ offer to holders of American Depositary Shares (ADSs) in AstraZeneca by TRC Capital Investment Corporation of Toronto, Canada (TRC Capital) (Press release, AstraZeneca, OCT 18, 2021, View Source [SID1234591497]). The offer documentation indicates that TRC Capital offers to purchase up to 2,000,000 ADSs, equivalent to approximately 0.06% of the outstanding Ordinary Shares in AstraZeneca, at a price of $57.88 per ADS in cash. TRC Capital’s offer price is 4.5% less than the closing price per share of an ADS on the Nasdaq Stock Market on October 8, 2021, the last trading day before the mini-tender offer commenced.

AstraZeneca does not in any way recommend or endorse the TRC Capital offer and recommends that shareholders reject the offer because the offer price is below the market price for ADSs immediately prior to this announcement.

Shareholders are advised that TRC Capital has reserved the right to delay payment for ADSs tendered, to withdraw its offer at any time and to amend its offer in any respect. TRC Capital may also decline to purchase ADSs tendered if any one of numerous conditions is not satisfied, including receipt by TRC Capital, on terms satisfactory to TRC Capital, of financing necessary to complete the offer or if there is any decrease in the market price of the AstraZeneca ADSs.

AstraZeneca shareholders who have already tendered their ADSs are advised that they may withdraw their shares by providing the written notice of withdrawal as described in the TRC Capital offer documentation prior to 12:01 a.m., New York City time, on November 9, 2021.

TRC Capital over the past several years has made numerous unsolicited ‘mini-tender’ offers for other companies’ shares. Neither AstraZeneca nor any of its directors or officers is affiliated with TRC Capital.

‘Mini-tender’ offers are offers to purchase less than five percent of a company’s outstanding shares, thereby avoiding many of the filing, disclosure and procedural requirements of the United States Securities and Exchange Commission (SEC). ‘Mini-tender’ offers do not therefore provide investors with the same level of protection as provided by larger tender offers under United States securities laws. The SEC has cautioned investors about mini-tender offers noting that "some bidders make mini-tender offers at below-market prices, hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price." The SEC also published investor tips regarding these offers on its website at: View Source

AstraZeneca advises shareholders to obtain current market quotations for their ADSs, to consult with their investment advisors and to exercise caution with respect to this ‘mini-tender’ offer.

AstraZeneca encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosures on the SEC’s website at www.sec.gov/divisions/marketreg/minitenders/sia072401.htm.

AstraZeneca requests that a copy of this announcement be included with all distributions of materials relating to TRC’s mini-tender offer.

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