On June 20, 2021 MaaT Pharma, a French clinical-stage biotech company specialized in the development of microbiome-based therapies aiming to restore the microbiome/immune system symbiosis in oncology patients, reported that its MEPA (Microbiome Engineering Platform) program was awarded a EURO 1.9 million grant from the Plan France Relance (Press release, MaaT Pharma, JUL 20, 2021, View Source [SID1234584975]). Initiated during the Summer of 2020, Plan France Relance was established to make strategic investments in critical sectors of French industry, including Health.

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"We are very honored and proud to be laureates of the France Relance initiative. The French Government’s commitment to invest in strategic industries is an opportunity for MaaT Pharma, as a key player in the microbiome industry, to further pursue our development plans and to actively contribute to the biomanufacturing of innovative drugs in France. This is a team success, and this financing supports the efforts of women and men at MaaT Pharma who work tirelessly to deliver groundbreaking innovations in microbiome therapeutics," said Hervé Affagard, Founder and CEO at MaaT Pharma. "The France Relance program will support the development of our unique and innovative industrial processes that leverage all the functional diversity of the microbiome to deliver better outcomes in cancer treatment."

MEPA, supporting a new generation of microbiome therapies

MaaT Pharma has developed two approaches for its oncology-focused therapies. The first relies on healthy donor donations ("native" products) and aims to restore the gut microbiota of patients with liquid tumors (notably leukemia). The second is focused on the development of "synthetic" microbiome therapies, which are co-fermented and are designed to colonize the patient’s gut with a functional microbiome to improve response to treatment in patients with solid tumors.

MaaT Pharma’s unique pharmaceutical drug development platform relies on advanced artificial intelligence data analysis tools and on a proprietary technology for the co-fermentation of microbial ecosystems to support the design, development, and large-scale manufacturing of novel Microbiome Ecosystem Therapies (MET).

The grant funding will support a key step in developing this platform, namely the industrialization and standardization of co-fermentation processes according to cGMP manufacturing standards, as well as the manufacturing of clinical batches. Ultimately, MaaT Pharma’s manufacturing platform may be used to deliver a large range of microbiome ecosystem therapies in various indications.

Accelerating the development of products in immuno-oncology

The MEPA program is a new step in Maat Pharma’s development as it supports the expansion of its indications to include solid tumors and the acceleration of its immuno-oncology program.

Recent studies have shown that the gut microbiome composition may improve the therapeutic effect of immune checkpoint inhibitors (ICI). In particular, a patient’s gut microbiome richness1 and diversity2 are predictors of their response to ICI3. Two pilot clinical studies also suggest that gut microbiota transfer from ICI-responding donors to non-responders can restore the response in the latter4.

With its therapies, MaaT Pharma aims to synthetically replicate a responder microbiota, combining high richness and diversity with selected functional networks in each indication of interest to improve the response to immune checkpoint inhibitors.

1 Total number of bacteria present in the gut
2 Total number of different strains present in the gut
3 Gopalakrishnan, V. et al, Science, 2018; Routy et al, Science 2018
4 Davar D. et al, Science 2021 ; Baruch E.N. et al, Science, 2021

On July 20, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that positive new data from its ongoing pancreatic cancer collaboration with the Pancreatic Cancer Institute at Fox Chase Cancer Center (Press release, Lantern Pharma, JUL 20, 2021, View Source;utm_medium=rss&utm_campaign=significant-positive-preclinical-data-lp-184 [SID1234584974]). Preclinical data demonstrated that the drug candidate, LP-184, demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, in in-vivo mouse models in 8 weeks. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same 8 week period.

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Additional positive data on the efficacy and potency of LP-184 was gathered from 6 pancreatic cancer cell lines, and an additional 5 patient-derived xenograft (PDX) ex-vivo tumor models. Significant reduction of cancer cells and cancer cell growth was observed across all pancreatic cancer cell lines and PDX models that were tested in the study with IC50 values being in the nanomolar range (45-270 nM). These data and observations are being prepared for peer-reviewed publications, manuscripts and scientific conferences. Data from this study will be used to power future insights and analysis provided by Lantern’s A.I. platform, RADR , in addition to further enhancing the signature of response for LP-184 in pancreatic cancers. Lantern believes this to be a significant positive advancement for LP-184 in targeted pancreatic cancers and plans to advance the collaboration with Fox Chase Cancer Center into the next phase.

CRISPR knockout data confirmed the importance of PTGR1 in LP-184 cytotoxicity in pancreatic cancer, and validates the RADR-generated hypothesis that PTGR1 plays the leading role in orchestrating responsiveness of tumors to LP-184. The research conducted at Fox Chase Cancer Center leveraged CRISPR editing to silence the gene PTGR1 in pancreatic cancer cells — this resulted in virtually no-response by the pancreatic cancer cells to the drug. Those pancreatic cancer cells with PTGR1 expression (untouched by gene-editing) had heightened response to LP-184 causing cell death and IC50 values in the sub-100nM range. Lantern believes that using a defined genetic signature for patient selection can enhance the likelihood of clinical trial success and focus future clinical trials on those patients that will benefit most from the therapy.

The research has been conducted in collaboration with Dr. Igor Astsaturov, an established, NCI funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center. Results demonstrated that LP-184 significantly and rapidly shrunk pancreatic cancer xenografts in mice, and after treatment with once weekly dosing at 3 mg/kg for 8 weeks, no tumors were present in 1 of 4 treated mice and in 3 of 4 mice the average size of remaining tumors was approximately 7% of the original tumor and 146-fold smaller than the untreated tumors.

Additional research was conducted with Dr. Astsaturov to further confirm the increased sensitivity to LP-184 in tumors that had damage to DNA repair pathways. It was observed that pancreatic tumors that harbored genetic alternations in the following DNA repair pathways — NER (nucleotide excision repair) and HR (homologous recombination) — had 2-fold increased sensitivity to LP-184. This observed data has implications in increasing the potential number of pancreatic cancer patients that can benefit from LP-184, and also in confirming prior Lantern research focused on aiming this drug-candidate at other cancers that have DNA repair pathway mutations. These could be mutations or deficiencies in genes such as: BRCA1, BRCA2, ATM, ATR, ERCC2, ERCC3, ERCC4, ERCC5, ERCC6, FANCD2, RAD51 and PALB2.

"These data mechanistically validate LP-184’s potential as a synthetic lethal agent in many HRD (homologous recombination deficient) and NERD (nucleotide excision repair deficient) cancers." stated Dr. Astsaturov. "As a result, these data may be highly supportive of a future role for LP-184 in a genetically-defined subset of pancreatic cancer."

Pancreatic cancer is an orphan disease and has a five-year survival rate of 7.9%. This means that only approximately 8 in 100 people will have survived for five years and beyond. The 10-year survival rate of the disease is 1%, meaning only approximately 1 in 100 people survive 10 years and beyond. Pancreatic cancer has among the lowest 5-year survival rate of any of the 22 common cancers. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 thousand new cases of pancreatic cancer globally, with over 62,000 occurring in North America annually. Targeting a specific subset of pancreatic cancer patients that are genetically defined has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.

"We are highly encouraged by the results of this preclinical research and look forward to reporting the full results at future scientific conferences and in publications," noted Dr. Kishor Bhatia, Lantern’s Chief Scientific Officer. "The study observed the significant and targeted anti-tumor effects of LP-184, even in pancreatic cancers that were resistant to standard-of-care drugs. Moreover, we also validated through the elegant work done with Dr. Astsaturov’s lab, by use of CRISPR-editing, that PTGR1 does directly link to the anti-tumor activity of LP-184. We expect that we will be able to exploit this biomarker mechanism in various tumors beyond pancreatic in the future."

Lantern believes that LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1 – which occurs in several solid tumors. Analysis with Lantern’s data platform, RADR, indicated that 35-40% of pancreatic cancer transcriptomes in clinical databases have elevated PTGR1 expression. Lantern has also begun discussions on the design of first-in-human clinical studies for LP-184 in collaboration with Dr. Igor Astsaturov and other key opinion leaders in the pancreatic cancer treatment landscape. Lantern plans on initiating IND (Investigational New Drug) application enabling animal studies later this year, and Phase 1 human trials following the filing of a future IND application.

On July 20, 2021 Samsung Biologics (KRX: 207940.KS), one of the world’s leading contract development and manufacturing organization (CDMO), reported that signed a strategic partnership agreement with Kineta, Inc., a clinical-stage biotech company developing novel immunotherapies in oncology (Press release, Kineta, JUL 20, 2021, View Source;utm_medium=rss&utm_campaign=kineta-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-vista-antibody-immunotherapy [SID1234584973]). Samsung Biologics will provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s novel anti-VISTA antibody in development for the treatment of solid tumors.

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VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1, and also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.

The manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco, and its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.

"We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market," said John Rim, CEO of Samsung Biologics. "We will fully utilize our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success."

"Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year", said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. "We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy".

Samsung Biologics offers seamless one-stop CDMO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Bringing quality-driven development services at a greater speed, the company delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.

On July 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its second quarter 2021 financial results on Tuesday, August 3, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, JUL 20, 2021, View Source [SID1234584972]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To access the conference call and webcast, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].

On July 20, 2021 IMV Inc. ("IMV" or the "Corporation") (NASDAQ: IMV; TSX: IMV), a clinical-stage immuno-oncology corporation, reported the closing of its previously-announced underwritten public offering (the "Offering") of 14,285,714 units (the "Units") at a price to the public of US$1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately US$25 million, before deducting underwriting commissions and Offering expenses and excluding any proceeds the Corporation may receive from the exercise of the underlying warrants (Press release, IMV, JUL 20, 2021, View Source [SID1234584971]). Each Unit is comprised of one common share and three-quarters of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant entitles the holder thereof to purchase one common share at a price of US$2.10 per common share, subject to adjustment in certain events, until July 20, 2026. If the warrants are fully exercised it will represent approximately $22.5M of additional gross proceeds.

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The Corporation intends to use the net proceeds of the Offering to continue the clinical development of maveropepimut-S (DPX-Survivac) in diffuse large B cell lymphoma (DLBCL), breast cancer, ovarian cancer, bladder cancer and microsatellite instability high (MSI-H), start the clinical development of a new product, DPX-SurMAGE, in bladder cancer, continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes.

Wells Fargo Securities and Cantor acted as joint book-running managers for the Offering. BTIG acted as lead manager and iA Private Wealth acted as co-manager.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 16, 2020 (the "Registration Statement"), and the Corporation’s Canadian final short form base shelf prospectus dated June 26, 2020, as amended on October 15, 2020 (collectively, the "Base Prospectus"). A preliminary prospectus supplement dated July 14, 2021 relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States, and a final prospectus supplement dated July 15, 2021 relating to the Offering (the "Supplement") was filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States. The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus can be found for free on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained in the United States from Wells Fargo Securities, Attn: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at [email protected] or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected], or in Canada from Wells Fargo Securities Canada, Ltd., 22 Adelaide Street West, Suite 2200, Toronto, ON, M5H 4E3, Attn: Akshay Pattni, email: [email protected] or from Cantor Fitzgerald Canada Corporation, Attn: Equity Capital Markets, 181 University Avenue, Suite 1500, Toronto, ON, M5H 3M7, email: [email protected].

This news 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 province, 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 province, state or jurisdiction.