On July 22, 2021 Anocca AB, a leader in unlocking the potential of T-cell immunotherapy to deliver transformative therapeutics for cancer, reported the closing of a USD 47 million (SEK 400 million) Series B financing to further advance the company’s industrialised cellular biology platform and progress its pipeline of TCR-T cellular therapies into Phase I/IIa clinical trials (Press release, Anocca, JUL 22, 2021, View Source [SID1234585102]).

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The financing, led by advisor Danske Bank, brings together a distinguished group of investors, with Swedbank Robur Ny Teknik, Ramsbury Invest and significant family offices including those of Harald Mix and Robert Andreen joining existing investors including Mellby Gård, Nidoco and co-founder Mikael Blomqvist via Michano.

Anocca’s CEO and co-founder Reagan Jarvis, said, "This financing round, which takes us to well over $100m raised since our founding in 2014, is further strong endorsement of our pioneering approach to industrialised high-precision analysis of T-cell biology. The team has built and operationalised an industry-leading suite of unique technologies to generate efficient and systematic TCR-T cell therapy pipelines. We will use this substantial financing to accelerate our broad oncology pipeline into the clinic with our in-house manufacturing capabilities. We continue to methodically move towards our vision of delivering blockbuster franchises of next generation T-cell immunotherapies for the treatment of multiple cancer types."

The company’s highly industrialised cellular biology platform replicates human T-cell biology in the laboratory, to generate targeted T-cell therapies with broad applicability in oncology, infectious diseases and autoimmune disorders. The technology platform is comprised of a number of proprietary cell biology and molecular genetics technologies and enables the scalable high-precision analysis needed to develop highly targeted therapeutics that leverage T-cell immunity. The platform is underpinned by proprietary, fully integrated, information management and bioinformatic software tools developed in-house.

Anocca’s platform has delivered a broad pipeline of T-cell receptor (TCR) assets to generate novel TCR-modified T-cell therapies (TCR-T) against multiple antigen classes, including targets that are shared amongst tumours, against specific genetic mutations that drive cancer, and against viruses that cause cancer. TCR-T cellular therapies can unlock an immense target space inaccessible to biologics and CAR-T therapies and is emerging as an important treatment modality for many forms of cancer.

Anocca’s Chairman of the board and early investor, Hans Stråberg said, "To deliver on the potential of new technologies you need to have the infrastructure in place to secure scaling. This is exactly what we have done with Anocca, by taking a systematic approach to building a broad industrialised platform with extensive automation and software tools, in addition to our own cGMP manufacturing facility, allowing us to drive multiple clinical programmes in parallel. This is an outstanding success for European life sciences, with Anocca emerging as a global scientific and technical leader in the field of TCR-T cell immunotherapy."

Lars Hevreng, Financial Advisor at Danske Bank said, "We are delighted to bring together a distinguished syndicate of investors to back Anocca’s further development. The company’s long-term and very strong financial backing will now become even stronger, which will be very important for Reagan and his team to fully pursue their ambitious targets of unlocking the therapeutic potential of Anocca’s TCR-T cell immunotherapy approach."

On July 23, 2021 McKesson Corporation (NYSE: MCK) (the "Company") reported the early tender results as of the Early Tender Time (as defined below) in connection with its previously announced cash tender offer to purchase up to $500,000,000 (subject to increase, the "Tender Cap") aggregate principal amount (the "Offer") of its outstanding 6.00% Notes due 2041 (the "6.00% Notes"), 4.883% Notes due 2044 (the "4.883% Notes"), 7.65% Debentures due 2027 (the "7.65% Debentures"), 4.750% Notes due 2029 (the "4.750% Notes"), 3.950% Notes due 2028 (the "3.950% Notes"), 2.85% Notes due 2023 (the "2.85% Notes") and 3.796% Notes due 2024 (the "3.796% Notes" and together with the 6.00% Notes, the 4.883% Notes, the 7.65% Debentures, the 4.750% Notes, the 3.950% Notes and the 2.85% Notes, the "Notes", and each, a "series" of Notes) (Press release, McKesson, JUL 22, 2021, View Source [SID1234585103]).

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The Company reported that, based on preliminary estimates, it intends to increase the Tender Cap to $922,154,000 aggregate principal amount on the date hereof, subject to determination of the Full Tender Offer Consideration at 10:00 a.m., New York City time, on the date hereof (the "Tender Cap Increase"), in order to accept all of the Notes that were validly tendered and not validly withdrawn at or prior to the Early Tender Time (as defined below).

On July 8, 2021, the Company commenced the Offer in accordance with the terms and conditions set forth in the offer to purchase, dated July 8, 2021 (the "Offer to Purchase"), and the related letter of transmittal (the "Letter of Transmittal" and, together with the Offer to Purchase, the "Offer Documents"), sent to holders of the Notes.

As of 5:00 p.m., New York City time, on July 21, 2021 (the "Early Tender Time"), $922,154,000 aggregate principal amount of the Notes were validly tendered and not validly withdrawn pursuant to the Offer, as set forth in the table below:

Pursuant to the terms of the Offer, the amount of Notes that will be accepted for purchase is subject to the Tender Cap, including the Tender Cap Increase, if applicable. Because the Tender Cap, including the Tender Cap Increase, has been reached in respect of tenders made at or prior to the Early Tender Time, no Notes of any series tendered after the Early Tender Time (regardless of acceptance priority level) will be accepted for purchase. The Company currently expects to accept for purchase 100% of the Notes validly accepted and not validly withdrawn at or prior to the Early Tender Time.

As set forth in the Offer to Purchase, holders who validly tendered and did not validly withdraw their Notes at or prior to the Early Tender Time are eligible to receive the Full Tender Offer Consideration, which will be determined at 10:00 a.m., New York City time, on the date hereof. In addition, holders that validly tender Notes that are accepted for purchase by the Company will receive accrued and unpaid interest from, and including, the last interest payment date for their tendered Notes to, but not including, the settlement date for such Notes, in each case rounded to the nearest cent.

The Withdrawal Deadline for the Offer was 5:00 p.m., New York City time, on July 21, 2021, and has not been extended for any series of Notes. The Offer will expire at 11:59 p.m., New York City time, on August 4, 2021, unless extended or earlier terminated by the Company, with respect to any or all series of Notes.

The Offer is subject to the satisfaction or waiver of certain conditions specified in the Offer to Purchase.

Capitalized terms used in this press release and not defined herein have the meanings given to them in the Offer to Purchase.

Barclays Capital Inc. and Citigroup Global Markets Inc. are acting as lead dealer managers for the Offer and Wells Fargo Securities, LLC is acting as co-dealer manager for the Offer. For additional information regarding the terms of the Offer, please contact: Barclays Capital Inc. toll-free at (212) 528-7581 or collect at (800) 438-3242 or Citigroup Global Markets Inc. toll-free at (800) 558-3745 or collect at (212) 723-6106. Requests for the Offer Documents may be directed to Global Bondholder Services Corporation, which is acting as the Tender Agent and Information Agent for the Offer, at (866)-924-2200 (toll-free) or by email at [email protected].

On July 22, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Bellberry Human Research Ethics Committee (HREC) in Australia has approved the clinical trial application of the phase 1 trial of ATG-101 in patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Antengene, JUL 22, 2021, View Source [SID1234585036]). This approval marks an important milestone for Antengene as ATG-101 is the in-house developed innovative molecule with global rights entering clinical stage. In addition, ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical stage in Australia. This multi-center, open-label, Phase I trial is designed to evaluate the safety and tolerability of ATG-101 as a single agent in patients with advanced solid tumors and NHL.

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According to the World Health Organization’s (WHO) estimates, there were approximately 19.3 million diagnoses of cancer and 10 million cancer-related deaths worldwide in 2020 and most of the top 10 cancer types were solid tumors. As the most common blood cancer, non-Hodgkin lymphoma accounted for 544,000 new cases and 260,000 deaths in 2020 globally with some of the highest incidence rates reported in Australia and New Zealand. Since the majority of cancers become resistant or refractory to conventional therapies (including hormonal treatments, chemotherapy regimens and monoclonal antibodies), there remains enormous unmet needs in the treatment of patients with this disease. While immuno-oncology therapy has improved patient outcomes dramatically over the last 10 years, a growing body of evidence also has shown that bispecific antibodies have the potential to be effective treatments for multiple malignant cancers.

ATG-101, a novel PD-L1/4-1BB bi-specific antibody, can activate anti-tumor immune effectors by blocking the immunosuppressive binding of PD-L1 to PD-1 while at the same time activating 4-1BB immunostimulatory signals, thereby enhancing safety and efficacy. Preclinical studies showed that ATG-101 could activate 4-1BB in a very controlled manner in human peripheral blood mononuclear cells (PBMC). Testing in various animal models, including those resistant to or progressing on anti-PD(L)1 treatment, has confirmed the potent in vivo anti-tumor activity and safety of ATG-101. In addition, in vivo testing has shown that ATG-101 can increase the number of CD8+ T-cells and reduce regulatory T-cells (Treg), a unique mechanism of action that enhances anti-cancer immune profile and can potentially improve treatment outcomes.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, said "Having gained approval for this first-in-human trial of ATG-101 as planned marks a milestone achievement that validates Antengene’s capability in effectively advancing preclinical programs. Exploring a novel mechanism of action, multiple bispecific antibodies have begun entering clinical development in recent years. Compared to monoclonal antibodies, bispecific antibodies have the advantages of being able to target multiple epitopes, with a lower production cost and shorter production cycle than using a combination of conventional monoclonal antibodies, therefore representing a novel therapeutic approach with enormous clinical potential. We have observed that ATG-101 has anti-tumor activities in vivo and in vitro and so we are very enthusiastic to test this approach in the clinic. We will advance the clinical development program and prepare to submit Investigational New Drug (IND) applications for ATG-101 in the U.S. and China this year."

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1 binding and inducing 4-1BB stimulation. In the presence of PD-L1 over-expressed cancer cells, ATG-101 has shown a significant and PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing therapeutic efficacy, and mitigating hepatoxicity simultaneously.

On July 22, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the second quarter of 2021 after the market closes on Wednesday, August 4, 2021 (Press release, Supernus, JUL 22, 2021, View Source;2021.htm [SID1234585087]).

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Jack Khattar, President and CEO, and Jim Kelly, Executive Vice President and CFO, will host a conference call to present the second quarter 2021 financial and business results on Wednesday, August 4, 2021 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under the Investor Relations section. The webcast will be available on the Company’s website for 60 days following the live call.

On July 22, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that three independent industry publications mention PharmaCyte and/or its past clinical trials and their contributions to prior and future work in the treatment of pancreatic cancer (Press release, PharmaCyte Biotech, JUL 22, 2021, View Source [SID1234585104]).

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PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, commenting on the Company’s expected uplist to Nasdaq said, "As we head into the ninth day of a required 10 days of trading following a reverse stock split, we remain above the price requirement necessary to complete our list of criteria for the expected uplist. Our hope is that PharmaCyte will be trading on the highly respected platform and will become a Nasdaq listed company as early as next week."

Waggoner continued, "With a number of recent well-respected scientific review publications supporting the approach that our technology uses as a promising treatment for pancreatic cancer, it is a validation, of sorts, of our approach and technology against the disease by independent scientists."

Three recently published high profile international medical and scientific review articles have highlighted PharmaCyte’s pancreatic cancer treatment. The articles mention (i) the treatment’s use in clinical trials to develop a cellular microencapsulation technology to treat pancreatic cancer; (ii) the use of prodrugs in its treatment; and (iii) the treatment’s role in improving the pancreatic cancer treatment landscape.

First, the respected scientific journal, Drug Discovery Today, published an article by a Spanish academic group, known for their expertise in the field of cellular encapsulation titled, "Cell microencapsulation technologies for sustained drug delivery: Clinical trials and companies." This publication stresses that the Cell-in-a-Box technology has been tested for years at the preclinical level as well as in two previously successful human clinical trials.

The authors summarize the results of the trials, essentially stating that microencapsulated cells that overexpressed cytochrome P450 2B1 (CYP2B1), which metabolizes the chemotherapy prodrug ifosfamide, transformed it into its active metabolites. These microencapsulated cells were implanted in 27 patients with pancreatic cancer. By placing the microencapsulated cells close to the area to be treated, a more focused therapy is obtained and, thus, better results are expected with lower doses of the chemotherapy prodrug ifosfamide.

In the first Phase 1/2 clinical trial using a 1 g/m2/per day dose of ifosfamide, the median survival of patients was doubled and only one of the patients had treatment-related adverse effects. In a second Phase 2 clinical trial, the prodrug ifosfamide per day dose was increased to 2 g/m2/day. The results showed greater severe adverse effects, but the efficacy profile was similar to the results from the Phase 1/2 clinical trial. The publication notes that PharmaCyte is "continuing with these promising clinical trials and are currently conducting the tests required by the regulatory agencies to begin a Phase 2b clinical trial as soon as possible." (Lopez-Mendez et al., 2021, Drug Discovery Today 26, 852-861)

The sentiment expressed by Lopez-Mendez et al. is echoed in another recent review from the World Journal of Gastroenterology, "Room for improvement in the treatment of pancreatic cancer: Novel opportunities from gene targeted therapy," from the Department of Gastroenterology, Addenbrooke’s Hospital, Cambridge, U.K. This particular review specifically states, "The cytochrome P450/ifosfamide system proof of concept from pre-clinical studies has been used to conduct Phase 1 and Phase 2 clinical trials in pancreatic cancer patients with phenomenal success (improvement of 1-year survival by 3-fold and median survival doubled)." (Galanopoulos et al., 2021, World J Gastroenterol 27, 3568-3580)

The third publication supports the activity of PharmaCyte’s pancreatic cancer treatment titled, "Prodrugs and prodrug-activated systems in gene therapy." This publication that appeared in the high impact journal Molecular Therapy states, "At a dose of 1 g/m2, ifosfamide was well tolerated by all patients in the first part of the trial, with regression of tumors in four patients and stable disease in the other participants." (Sheikh et al., 2021, Molecular Therapy 29, 1716-1728)

PharmaCyte’s CEO added, "The positive assessments of our technology and its use in the treatment of pancreatic cancer by the authors of these key publications, underscore how important it is for us to receive the U.S. Food and Drug Administration’s approval to start our clinical trial in locally advanced and inoperable pancreatic cancer."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source