On August 17, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company focused on novel immunotherapy platforms for the treatment of solid tumors, reported that the company is proceeding with the expansion of its LUMINOS-103 trial, with a new sub-study evaluating PVSRIPO in adult patients with head and neck squamous cell carcinoma (HNSCC)(Press release, Istari Oncology, AUG 17, 2021, View Source [SID1234590820]). LUMINOS-103 is a Phase 1/2, open-label, multi-center, single-arm basket trial evaluating the administration of PVSRIPO with or without PD-1/L1 inhibitors across multiple tumor types. The company began the LUMINOS-103 basket trial earlier this year, opening recruitment to patients with bladder cancer in two separate cohorts.

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Istari Oncology’s PVSRIPO is a novel intratumoral viral immunotherapy that activates a patient’s innate and adaptive immune system to facilitate a systemic anti-tumor immune response. PVSRIPO enters solid tumor cells and antigen presenting cells (APCs) in the tumor microenvironment via CD155 (the poliovirus receptor). CD155 is expressed on nearly all solid tumors, giving PVSRIPO the potential to treat a variety of cancers.

"We enter this next phase of PVSRIPO development in patients with solid tumors with great enthusiasm as we progress toward further evaluating the impact of PVSRIPO on patients with head and neck squamous cell carcinoma," said Matt Stober, president and chief executive officer at Istari Oncology. "With patient recruitment underway for our LUMINOS-103 bladder cancer cohorts, and the expectation that future cohorts focusing on other solid tumors will be added in the near future, we are proud to broaden the PVSRIPO clinical development program."

HNSCC is a heterogeneous group of malignant tumors typically caused by alcohol and tobacco consumption, although an increasing number of HNSCC cases arise due to persistent infection with high-risk human papilloma virus (HPV). The treatment of HNSCC remains challenging, and a substantial proportion of patients with this condition die from their disease, especially those with recurrent and metastatic disease.

"This year more than 66,000 people in the U.S. – approximately 49,000 men and 18,000 women – will develop head and neck cancer," said Amanda Hollinger, MPA, executive director, Head & Neck Cancer Alliance. "As we continue to focus on advancing prevention, detection, treatment, and rehabilitation of people with head and neck cancer, we will be closely watching the progress of Istari’s head and neck sub-study with great anticipation and optimism."

For more information about Istari Oncology and its ongoing clinical trials and research on PVSRIPO, visit www.istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of polio vaccine-specific T cells. PVSRIPO has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

On August 17, 2021 Candel Therapeutics, Inc. ("Candel"), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported the closing of the issuance of an additional 887,994 shares of its common stock at a public offering price of $8.00 per share (Press release, Candel Therapeutics, AUG 17, 2021, View Source [SID1234587572]). The shares were issued pursuant to a partial exercise of the underwriters’ option to purchase additional shares of common stock in connection with Candel’s previously announced initial public offering of 9,000,000 shares of its common stock. The gross proceeds from the exercise of the option to purchase additional shares were approximately $7.1 million, bringing the aggregate gross proceeds to Candel from its initial public offering to approximately $79.1 million, before deducting underwriting discounts and commissions and other offering expenses.

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Jefferies, Credit Suisse, BMO Capital Markets and UBS Investment Bank acted as joint book-running managers for the offering.

The registration statement relating to these securities has been filed with the Securities and Exchange Commission ("SEC") and became effective on July 26, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; BMO Capital Markets Corp., 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627 or by email to [email protected]; or UBS Securities LLC, Attn: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at 888-827-7275 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 17, 2021 CureVac reported that it has revealed in its latest financial report that its lung cancer program with German biotechnology company Boehringer Ingelheim has been terminated (Press release, CureVac, AUG 17, 2021, View Source [SID1234586796]).

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The move ends a €500m exclusive treatment exploration and development partnership which both parties signed seven years ago (2014). The collaboration focused on the viability of using CureVac’s CV9202 therapeutic mRNA vaccine with afatinib in patients who have been diagnosed with advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). It was also being tested in combination with chemo-radiation therapy in patients who have unresectable stage III NSCLC.

However, in a brief statement hidden among its financials, CureVac said that it had terminated the agreement in June, with the process expected to be finalized by November 2021.

The company said that despite the decision to discontinue their partnership on the project, the two firms will still continue to find ways to collaborate on other ways to use CureVac’s RNA technology for other potential treatment purposes. While it did not explicitly state a reason, CureVac added that they were working with a "legacy program" that used an older protamine formulation, which was being developed seven years ago. It also stated that it is continuing its Phase I of II clinical trial for the potential of BI1361849 for NSCLC.

CureVac did not provide any further details about the termination or any other plans moving forward. However, what is noticeable is that it comes just two months after it reported weak efficacy results of only 47% for an mRNA vaccine against COVID-19. Other rival medications had an efficacy of more than 90%. Industry observers had been setting their sights on the vaccine as it was thought to last longer and cost less.

"While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging," said CureVac’s Chief Executive Officer, Dr. Franz-Werner Haas, in a statement. "In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge."

The CureVac-Boehringer trial involved 40,000 participants, with 75% based in Latin America and 25% in Europe. The 47% who showed efficacy represented around 46 cases from the vaccinated group and 88 cases in the placebo group. As part of that deal, CureVac received €35 million and was set to achieve milestone payments of as much as €430 million plus royalties from future sales.

Boehringer has yet to issue an official statement about this revelation.

On August 17, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported that the U.S. Food and Drug Administration (FDA) approved a second indication for GSK’s JEMPERLI (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options (Press release, AnaptysBio, AUG 17, 2021, View Source [SID1234586736]).

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JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date. JEMPERLI is the first AnaptysBio-generated antibody to obtain FDA approval, and this is the second indication for JEMPERLI to be approved by the FDA in 2021. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"We are pleased that JEMPERLI has been FDA-approved for a second indication and will be available to a broader cohort of solid tumor patients," said Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio’s capital-efficient business model is focused upon advancing our wholly-owned first-in-class antibodies to multiple clinical catalysts over the upcoming 18 months and is supported by milestone and royalty revenues under our GSK collaboration."

AnaptysBio has earned a $20 million milestone payment as a result of this second FDA approval for JEMPERLI in dMMR recurrent or advanced solid tumors. Earlier in 2021, AnaptysBio received a milestone payment of $10 million from GSK for acceptance of the BLA filing with the FDA for this second indication. AnaptysBio also received $20 million and $10 million milestone payments in April 2021 for FDA and European Medicines Agency (EMA) approvals of JEMPERLI for adult patients with a certain type of endometrial cancer, after having received a total of $15 million from GSK during 2020 for the FDA’s and EMA’s acceptances of these BLA and Marketing Authorisation Application (MAA) filings for JEMPERLI. We anticipate an additional $15 million and $165 million in milestone payments upon achievement of certain JEMPERLI regulatory and commercial milestones, respectively. Royalties due to AnaptysBio for JEMPERLI range from 8% to 25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. GSK has recently disclosed peak year annual sales estimates of £1-2 billion for JEMPERLI.1

JEMPERLI is also being developed by GSK for the treatment of other tumor types and treatment settings, including currently ongoing phase III trials in recurrent or primary advanced endometrial cancer in combination with chemotherapy standard of care (RUBY) and the phase III FIRST study of platinum-based therapy with JEMPERLI and niraparib versus standard of care platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer. In addition, JEMPERLI is being evaluated as monotherapy and in combination therapy across multiple tumor types and other cancers, including platinum-resistant ovarian cancer, non-small cell lung cancer, multiple myeloma and melanoma.

In the US, prevalence of dMMR across solid tumors has been estimated at 14%. Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy. Tumors with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but may also be found in other solid tumors.

GSK continues to develop additional antibodies partnered with AnaptysBio, including cobolimab, an AnaptysBio-generated anti-TIM-3 antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist antibody. Under the terms of the collaboration, AnaptysBio is due to receive development and regulatory milestone payments for each of the first two indications for each of these antibodies. AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this collaboration. In addition, AnaptysBio will receive royalties ranging from 4% to 8% on global net sales of cobolimab and GSK4074386 and 1% of GSK’s global net sales of ZejulaTM.

On August 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will hold a conference call and live webcast on Wednesday, August 25, 2021 at 4:30 p.m. Eastern Time (ET) to review its second quarter 2021 financial results and provide a business update (Press release, Ascendis Pharma, AUG 17, 2021, View Source [SID1234586726]).

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Conference Call Details

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.