On June 14, 2021 Isofol Medical AB (publ) (Nasdaq First North Premier Growth Market: ISOFOL) ("Isofol" or the "Company") reported that fully guaranteed new share issue with preferential rights for the Company’s existing shareholders (the "Rights Issue"), which ended on June 10, 2021, was oversubscribed (Press release, Isofol Medical, JUN 14, 2021, View Source [SID1234583958]). Due to the strong demand from strategic investors, a directed issue with deviation from the shareholders’ preferential rights of approximately SEK 100 million (the "Over-Allotment Option") was exercised. Through the Rights Issue and the Over-Allotment Option, Isofol will receive proceeds amounting to approximately SEK 500 million before transaction costs.

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Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the United Kingdom, US, Canada, Japan, Australia, Hong Kong, New Zealand or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

The result of the Rights Issue of maximum 62,524,474 shares shows that 61,550,652 new shares, corresponding to approximately 98.4 percent of the Rights Issue, have been subscribed for with subscription rights. Additionally, 27,532,079 shares were subscribed for without subscription rights of which 973,822 shares, corresponding to 1.6 percent of the Rights Issue, have been allotted to investors that have subscribed for shares without subscription rights. The Rights Issue is thus oversubscribed. Allotment of shares subscribed for without subscription rights has been made in accordance with the resolved allotment principles. Notice of allotment of shares subscribed for without subscription rights will only be sent to those who have been allotted shares. Payment shall be made in accordance with the instructions on the contract note. Nominee-registered shareholders will receive notice of allotment and payment in accordance with the procedures of each nominee.

Due to the oversubscription of the Rights Issue, the Board of Directors of Isofol has exercised the Over-Allotment Option to meet additional demand from strategic investors through a directed issue of 15,625,000 new shares. The Over-Allotment Option was directed to a few reputable investors, broadening Isofol’s shareholder base.

Isofol’s CEO, Ulf Jungnelius, comments: "We are very happy and satisfied with the strong support that both existing and new shareholders have shown us in the rights issue that made it possible to exercise the over-allotment option. The rights issue in combination with the over-allotment Option provides Isofol with the financial resources required to complete the global Phase III AGENT study and secure funding beyond the submission of the application with the FDA."

Following the Rights Issue and Over-Allotment Option, Isofol’s share capital will increase by approximately SEK 2,392,767.2 to approximately SEK 4,945,252.1 and the number of shares in Isofol will increase by 78,149,474 shares to 161,515,440 shares.

The shares subscribed for with subscription rights are expected to be registered with the Swedish Companies Registration Office (the "SCRO") on or about June 15, 2021 and are expected to begin trading on Nasdaq First North Premier Growth Market on June 18, 2021.

The shares subscribed for without subscription rights and through exercise of the Over-Allotment Option are expected to be registered with the SCRO on or about June 24, 2021 and are expected to begin trading on Nasdaq First North Premier Growth Market on June 30, 2021.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Schjødt law firm acts as legal adviser to the Joint Bookrunners. Ashurst LLP acts as legal adviser to the Joint Bookrunners as to US securities law.

For further information, please contact

This is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 10:00 CEST on June 14, 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 June 14, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported that Dr. Brian Schwartz will present a summary of recent eganelisib clinical data followed by a Q&A session at the Keystone Symposia Precision Oncology: Translating Discovery to the Clinic Meeting taking place on June 21, 2021 (Press release, Infinity Pharmaceuticals, JUN 14, 2021, View Source [SID1234583957]).

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Presentation Details:

Title:

Eganelisib (IPI-549) Activity as a Macrophage Reprogramming Therapeutic Candidate in 1L Metastatic TNBC, 2L Metastatic Urothelial Cancer and Other Solid Tumors

Date:

Monday, June 21

Time:

9:00 am – 11:00 am MT

The webcast of the presentation can be accessed in the Investors/Media section of Infinity’s website at www.infi.com and will be available on Infinity’s website for 30 days following the event.

On June 14, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUN 14, 2021, View Source [SID1234583956]).

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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 share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from June 7, 2021 to June 11, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 273,606 shares as treasury shares, corresponding to 0.42% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On June 14, 2021 iTeos Therapeutics (NASD: ITOS) and GlaxoSmithKline plc (LSE/NYSE: GSK) reported an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer (Press release, iTeos Therapeutics, JUN 14, 2021, View Source [SID1234583955]). TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as a promising target for the next generation of immuno-oncology therapies based on compelling preclinical data and a phase II randomised clinical trial. With this collaboration GSK is uniquely positioned with access to antibodies that synergistically target all three known CD226 checkpoints – TIGIT, CD96 and PVRIG.

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Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Immuno-oncology has transformed cancer care but unfortunately less than 30 percent of patients respond to treatment with the current leading immune checkpoint inhibitors. Based on the underlying science, we believe that combinations of a PD-1, TIGIT, CD96 and PVRIG inhibitor could become transformative medicines for many patients with cancer. We are excited to collaborate with the team at iTeos and together we can play a leading role in the next generation of immuno-oncology therapies."

Since GSK validated the role of CD226 axis targets as important in oncology, it has been strategically building a carefully constructed set of assets to target this network of checkpoint inhibitors. The addition of EOS-448 results in GSK being the only company with antibodies targeting all three known checkpoints – TIGIT (via EOS-448), CD96 (via GSK’608), and PVRIG (via GSK’562). Together with GSK’s recently approved anti-PD-1, Jemperli (dostarlimab), this comprehensive portfolio of potential next generation immuno-oncology agents will be explored through various novel combinations, including doublets and triplets, to evaluate their potential to transform treatment options for patients with multiple different cancers.

Michel Detheux, President and CEO, iTeos, said: "Through this transformative collaboration, iTeos now has access to GSK’s best-in-class resources which will provide us with a significant advantage in a highly competitive, global market. We have chosen GSK because of their commercial capabilities, experience in immuno-oncology and their commitment to invest in the rapid advancement of our TIGIT programme and create a clear path forward for EOS-448. Inspired by the multifaceted mechanism of action of EOS-448 and promising early results in clinical trials, this collaboration allows us to accelerate and expand the clinical development of EOS-448. We are more confident than ever in our ability to succeed. This collaboration validates our science and provides a catalyst for the future of iTeos. The collaboration with GSK will allow our team to continue to develop next generation immunotherapies starting with inupadenant, our highly differentiated clinical-stage A2A adenosine receptor antagonist, and to drive scientific innovation with our expertise in tumour immunology to build our pipeline."

EOS-448 is currently in an open-label phase I study in patients with advanced solid tumours. GSK and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022. GSK’608 (anti-CD96 being developed in collaboration with 23andMe) is in phase I as monotherapy and in combination with dostarlimab. GSK expects to submit an Investigational New Drug application for GSK’562 (anti-PVRIG in-licensed as SRF-813 from Surface Oncology) by mid-2022.

Under the terms of the collaboration agreement, iTeos will receive an upfront payment of $625 million. iTeos will be eligible to receive up to an additional $1.45 billion in milestone payments, should the EOS-448 programme achieve certain development and commercial milestones.

Within the collaboration, GSK and iTeos will share responsibility and costs for the global development of EOS-448 and will jointly commercialise and equally split profits in the US. Outside of the US, GSK will receive an exclusive license for commercialisation and iTeos will receive tiered royalty payments.

The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

Conference Call Details
iTeos will host a conference call to discuss the agreement today, Monday, June 14 at 8:30 a.m. ET. Details are as follows:

Participant Dial-In: (833) 607-1661
International Dial-In: (914) 987-7874
Conference ID: 4598012
Webcast: View Source

The live audio webcast will also be accessible from the Events page of the Company’s IR website at View Source A replay will be available on the Company’s website approximately two hours after completion of the event and for 30 days following the call.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On June 14, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors (Press release, Exelixis, JUN 14, 2021, View Source [SID1234583954]). The objective of the study is to evaluate the safety, tolerability and efficacy of XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor (TKI), in combination with: nivolumab (OPDIVO); nivolumab and ipilimumab (YERVOY); and nivolumab and bempegaldesleukin. Exelixis is sponsoring STELLAR-002 and Bristol Myers Squibb will provide nivolumab, ipilimumab and bempegaldesleukin for use in the trial. Nektar Therapeutics (Nasdaq: NKTR) will supply bempegaldesleukin to Bristol Myers Squibb through their existing global development and commercialization collaboration, which is evaluating nivolumab in combination with bempegaldesleukin, an investigational CD122-preferential IL-2–pathway agonist.

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"We are excited to expand our development of XL092 with another comprehensive phase 1b trial evaluating its potential in combination with immuno-oncology therapies," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Building on our long-standing and successful collaboration with Bristol Myers Squibb to evaluate our flagship product in combination with their checkpoint inhibitors, we now look forward to this new collaboration focused on XL092 as we explore how our next-generation tyrosine kinase inhibitor may help patients with advanced genitourinary cancers, who often face a poor prognosis or limited treatment options following disease progression."

STELLAR-002 will begin with a dose-escalation phase to determine the recommend dose for each of the XL092 combination therapies: XL092 in combination with nivolumab, XL092 in combination with nivolumab and ipilimumab and XL092 in combination with nivolumab and bempegaldesleukin. Depending on the dose-escalation results, the trial may enroll patients with the following genitourinary cancers:

previously untreated advanced or metastatic clear cell renal cell carcinoma (RCC)
second-line advanced or metastatic clear cell RCC following treatment with an immune checkpoint inhibitor combination therapy
metastatic castration-resistant prostate cancer following treatment with one novel hormonal therapy
second-line urothelial carcinoma following platinum-based combination therapy
urothelial carcinoma that has progressed following immune checkpoint inhibitors and no more than two prior systemic therapies
previously untreated advanced or metastatic non-clear cell RCC
During the cohort-expansion stage, patients in each cohort will be randomized to multiple treatment arms. To better understand the individual contribution of the therapies, treatment arms may include XL092 monotherapy, XL092 and nivolumab, and combinations of XL092 and nivolumab and ipilimumab or nivolumab and bempegaldesleukin.

About XL092

XL092 is a next-generation oral TKI that targets VEGF receptors, MET, AXL, MER and other kinases implicated in cancer’s growth and spread. In designing XL092, Exelixis sought to build upon the experience and target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug discovery activities.

About Genitourinary Cancers

Genitourinary cancers are those that affect the urinary tract, prostate, testicles or penis — parts of the body involved in reproduction and urine production and excretion — and include renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC) and urothelial carcinomas.1

The American Cancer Society’s (ACS) 2021 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 Papillary RCC accounts for about 15% of all renal cell cancers.4,5 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%.2 Approximately 32,000 patients in the U.S. and over 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021, with nearly 15,000 patients in need of a first-line treatment in the U.S.6
According to the ACS, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.2 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC.7Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years.8,9,10
Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.11 Bladder cancer occurs mainly in older people, with 90% of patients aged 55 or older.12 With an estimated 84,000 new cases expected to be diagnosed in 2021, bladder cancer accounts for about 5% of all new cases of cancer in the U.S. each year.2,13 It is the fourth most common cancer in men.2