On September 17, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, reported results with its SLATE v1 product ("off-the-shelf" shared neoantigen immunotherapy in combination with intravenous nivolumab and subcutaneous ipilimumab) and dosing of the first patient in a Phase 2 clinical trial of the optimized SLATE v2 product (Press release, Gritstone Oncology, SEP 17, 2021, View Source [SID1234592015]). SLATE v2 has been engineered, based on human translational immunology data from v1 patients, to drive a more potent immune response to mutant KRAS neoantigens than were observed with SLATE v1. The data from SLATE v1 will be reviewed during the company’s previously announced investor event taking place today at 1:30pm ET.

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The v1 format of the SLATE immunotherapy was studied in a Phase 1/2 study, in collaboration with Bristol-Myers Squibb, in 26 patients with metastatic solid tumors, largely focused on non-small cell lung cancer (NSCLC), microsatellite-stable colorectal cancer (MSS-CRC) and pancreatic ductal adenocarcinoma (PDAC). There were no safety signals of note with the most common adverse events being low grade, self-limiting fever and injection site reactions. SLATE v1 exhibited evidence of efficacy in patients with NSCLC who had all progressed on prior anti-PD-(L)1 therapy (often in combination with chemotherapy) – with molecular responses (>50% decrease in ctDNA levels in the blood from baseline) observed in 3/5 NSCLC patients who were eligible for analysis.

SLATE v1 demonstrated the greatest activity in 6 NSCLC patients with the KRASmut G12C presented by the HLA protein A*02:01. Among these patients, ctDNA responses were observed in 66% of these patients (2/3 eligible for analysis), correlating with clinical benefit, and a RECIST radiologic response (unconfirmed) was observed in one 2nd line patient who had progressed after 3 months of 1st line chemo-immunotherapy. One patient who had progressed on prior chemo-immunotherapy after 8 months of treatment is nearing completion of 2 years of therapy with persistent ~20% tumor lesion shrinkage. The patient’s ctDNA was undetectable throughout the study.

A next generation, optimized SLATE cassette (v2), which exclusively includes epitopes from mutated KRAS and exhibited immunogenic superiority over v1 in human HLA-transgenic mice, is now in Phase 2 testing in patients with advanced NSCLC and CRC.

"We are excited to dose the first patient with the KRAS-specific version (v2) of our SLATE immunotherapy," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "We are very encouraged by the clinical data generated with v1, and product redesign using translational immunology data has enabled this optimized v2, which we are initially evaluating in more non-small cell lung cancer patients following progression on immunotherapy, as well as patients with microsatellite-stable colorectal cancer. We expect that these treatment settings will enable us to demonstrate the differentiated therapeutic potential of SLATE v2, and we anticipate having initial data by mid-2022. We look forward to presenting the data from SLATE v1 and from our individualized GRANITE program during our investor event in conjunction with ESMO (Free ESMO Whitepaper) 2021 later this week."

The SLATE v2 Phase 2 portion of the study is expected to enroll up to 60 patients with KRAS mutant-driven tumors in total across three cohorts: NSCLC post chemo-immunotherapy, first line MSS-CRC and third-line MSS-CRC. All patients will receive SLATE v2, consisting of a dose of intramuscular adenovirus-based prime with intramuscular self-amplifying mRNA-based boost vaccinations, in combination with PD-1 checkpoint inhibitor Opdivo (nivolumab) and subcutaneous anti-CTLA-4 antibody Yervoy (ipilimumab).
Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.

About SLATE

Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens, or TSNA, that are identified by the company using its proprietary Gritstone EDGETM artificial intelligence platform and tumor HLA peptide sequencing. Gritstone’s SLATE "off-the-shelf" immunotherapy uses a priming adenoviral vector (GRT-C903) and self-amplifying mRNA vector (GRT-R904) to deliver a cassette of shared TSNA, representing mutated gene sequences that are found in multiple patients (such as KRAS mutations). SLATE is being evaluated in combination with immune checkpoint blockade in the Phase 2 portion of its clinical study (NCT03953235).

On September 17, 2021 Midatech Pharma PLC (AIM: MTPH.L; NASDAQ: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported its unaudited interim results for the six months ended 30 June 2021 (Press release, Midatech Pharma, SEP 17, 2021, View Source [SID1234587890]).

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OPERATIONAL HIGHLIGHTS

On 17 June 2021, the Company announced significant progress across a number of R&D programmes including:

Q-Sphera

·Breakthrough data on the successful encapsulation of an exemplar monoclonal antibody (mAb);

·The delivery of proof of concept formulations of MTX214 and MTX216 to the Company’s collaboration partner for the partner’s in vivo studies; and

·The successful development of MTD211, a long-acting formulation of brexpiprazole which, in in vivo studies, demonstrated therapeutic blood levels over a period of three months.

MTX110

·Demonstration, in vitro, of the potency of MTX110 in four patient-derived Glioblastoma cell lines.

FINANCIAL HIGHLIGHTS (including post period end)

·Total revenue in H1 2021 was £0.40m (1H20: £0.17m). Total revenue represents income from R&D collaborations plus grant revenue.

·Research and development costs decreased by 50% to £2.01m (1H20: £3.99m) as a result of the termination of MTD201 and focus on multiple earlier stage programmes.

·Administrative expenses decreased 44% to £1.64m (1H20: £2.93m) due to expenses incurred in connection with the Strategic Review and restructuring in the prior period.

·Net cash used in operating activities (after changes in working capital) in 1H21 was £3.11m, compared with £7.09m in 1H20.

·In July, post period end, the Company raised £10.0m before expenses in an UK Placing of 35.1m ordinary shares at £0.285 per share.

·The cash balance on 30 June 2021 was £4.20m.
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Commenting, Stephen Stamp, CEO and CFO of Midatech said: "We are pleased to report good progress throughout the Company and an expanded and exciting pipeline of programmes and opportunities. The disruption and costs of the restructuring in 2020 are now behind us. The first half of 2021 has been highly productive with three potentially viable Q-Sphera formulations, one internal and two for a collaboration partner. We believe the breakthrough data on the encapsulation of a protein could prove to be a very significant opportunity for Midatech."

The Company will be hosting a webinar at 5.30pm BST / 12.30pm EST on Monday 20 September 2021. The webinar is open to all existing and potential shareholders and those interested in attending may register via the following link where, following registration, they will be provided with access details:

View Source

Participants may submit questions during the webinar or in advance via email to: [email protected]

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"), and is disclosed in accordance with the company’s obligations under Article 17 of MAR.

On September 17, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported the interim analysis results of the Phase 3 ORIENT-16 study evaluating sintilimab in combination with chemotherapy compared to chemotherapy alone for the first-line treatment of advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in an oral presentation at the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Congress 2021 (Abstract # LBA53) (Press release, Innovent Biologics, SEP 17, 2021, View Source [SID1234587908]).

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As of the June 20, 2021 data cutoff date for the interim analysis, 650 patients have been enrolled. Sintilimab in combination with chemotherapy (oxaliplatin and capecitabine) demonstrated superior overall survival (OS) compared to placebo plus chemotherapy, with a 34.0% reduction in the risk of death (HR 0.660; 95%CI, 0.505-0.864; p=0.0023) and a 5.5-month improvement in median OS (18.4 months vs. 12.9 months) in patients with CPS ≥5, and 23.4% reduction in the risk of death and a 2.9-month improvement in mOS (15.2 months vs. 12.3 months) in all randomized patients (the ITT population). The OS benefits were consistent in all prespecified subgroup analyses. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified for the combination of sintilimab and chemotherapy.

The principal investigator of the ORIENT-16 study, Prof. Jianming Xu from the Fifth Medical Center of People’s Liberation Army General Hospital, stated, "ORIENT-16 is the first Phase 3 clinical trial in China to demonstrate an anti-PD-1 antibody in combination with chemotherapy significantly prolonged overall survival in the first-line treatment of advanced gastric cancer. Gastric cancer is one of the most common malignant tumor types globally and nearly half of all cases are diagnosed in China. The prognosis of advanced gastric cancer is very poor. The results of the ORIENT-16 study have the potential to bring a new treatment option to people with gastric cancer."

Dr. Zhou Hui, Senior Vice President of Innovent, stated, "While immunotherapy has greatly changed the treatment paradigm for many malignancies, it has not yet in gastric cancer. The treatment options for advanced gastric cancer are very limited and the ORIENT-16 study aimed to help address this unmet medical need. These results are very encouraging and confirmed the clinical value of sintilimab plus chemotherapy in the first-line treatment of advanced gastric cancer. We are grateful for all the contributions made by every investigator and patient in this study, and we hope that sintilimab can become a new treatment option for people with gastric cancer. Innovent planned to file a supplemental new drug application to the National Medical Products Administration (NMPA) in China based on the results of interim analysis. Up until now, sintilimab has demonstrated improved survival in the first-line treatment of five major types of cancer – nonsquamous non-small cell lung cancer, squamous non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, and gastric cancer."

About the ORIENT-16 Study

ORIENT-16 is a randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (oxaliplatin and capecitabine), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (ClinicalTrials.gov, NCT03745170). The primary endpoint was overall survival, in all randomized and in PD-L1 positive patients.

About Gastric Cancer

Gastric cancer is one of the most common malignant tumor types worldwide. According to GLOBOCAN estimates, there were approximately one million new cases and 769,000 new deaths of gastric cancer in 2020, making it the fifth most common cancer and third leading cause of cancer death globally. About half of all gastric cancer cases occurred in East Asia, mainly in China. The first-line treatment of advanced gastric cancer remains limited. Currently, the five-year survival rate of advanced or metastatic gastric cancer ranges from 5 to 20 percent, and the median overall survival is approximately one year.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has a regulatory submission under review in China for sintilimab for the second-line treatment of squamous non-small cell lung cancer.

Innovent also has three clinical studies of sintilimab that have met their primary endpoints:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma
In combination with oxaliplatin and capecitabine for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma
The second-line treatment of esophageal squamous cell carcinoma
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

On September 17, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that Walter Klemp, President and Chief Executive Officer of Moleculin, will present at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 20, 2021 at 4:35 PM ET (Press release, Moleculin, SEP 17, 2021, View Source [SID1234587891]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

The live webcast of the presentation will be accessible on the the Events page in the Investors section of the Company’s website (www.moleculin.com). The webcast replay will be archived for 90 days following the event.

On September 17, 2021 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported the closing of its initial public offering of 12,420,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 1,620,000 additional shares, at an initial public offering price of $16.00 per share (Press release, Tyra Biosciences, SEP 17, 2021, View Source [SID1234587909]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Tyra, were $198,720,000 million. Tyra’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "TYRA."

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BofA Securities, Jefferies and Cowen acted as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on September 14, 2021. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by telephone at 877-821-7388; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

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