On December 15, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported an overview of its cis-targeting platform and growing pipeline of highly differentiated precision immunotherapies (Press release, Asher Biotherapeutics, DEC 15, 2021, View Source [SID1234597237]). The update follows presentations by Asher Bio on its cis-targeting technology at PEGS Europe: Protein & Antibody Engineering Summit, held November 2-4, 2021 in Barcelona, and the Antibody Engineering & Therapeutics (AET) Conference, held December 12-16, 2021 in San Diego .

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"We were delighted to present additional details on our cis-targeting technology at recent scientific conferences," said Andy Yeung, Ph.D., Chief Technology Officer and Founder of Asher Bio. "Our platform enables us to build a broad pipeline of potentially best-in-class precision immunotherapies, each of which engages both an immunomodulatory receptor and a specific target on the same cell. By focusing our potent immunomodulators selectively on only the desired immune cell type, we believe we can deliver improved clinical outcomes, offering patients more efficacious medicines that carry a reduced risk of off-target toxicities. Importantly, our approach can be applied systematically to target multiple classes of immunomodulators to a diverse set of immune cell types, creating numerous opportunities to generate new immunotherapies for a range of cancers, autoimmune and infectious diseases."

As outlined in Asher Bio’s presentations at PEGS Europe and AET, the company’s proprietary cis-targeting platform yields immunotherapies that selectively activate specific immune cell subsets, in order to avoid the pleiotropic effects that characterize the systemic delivery of existing cytokines and immunotherapies. Asher Bio is applying its modular toolkit, which includes a library of targeting arms and engineered cytokines that can be readily recombined to generate new molecules, to rapidly build and de-risk a portfolio of drug candidates for treatments in multiple disease areas.

"Since our founding, we progressed our three most advanced programs – all of which leverage our discoveries in IL-2 and other cis-targeted cytokines for the treatment of oncology – through preclinical proof-of-concept, demonstrating the reproducibility of our approach and providing the foundation for us to build a portfolio of potentially best-in-class immunotherapies," said Ivana Djuretic, Ph.D., Chief Scientific Officer and Founder of Asher Bio. "We look forward to building on this momentum as we advance our existing programs toward the clinic and apply our proprietary cis-targeting technology to discover, develop and, ultimately, deliver novel molecules with the potential to restore hope, health and happiness to many more patients."

The presentations at PEGS Europe and AET provide additional detail on Asher Bio’s cis-targeting technology and support the company’s emerging pipeline of cis-targeted immunotherapies:

Asher Bio’s lead program, AB248, is a fusion protein that selectively activates the interleukein-2 (IL-2) receptor pathway on CD8+ T cells. In preclinical studies, AB248 has demonstrated highly compelling anti-tumor activity across multiple mouse tumor models, showing superior efficacy and tolerability compared to wild-type IL-2 and other not-α IL-2 therapies currently in clinical development. Asher Bio expects to file an investigational new drug application with the U.S. Food and Drug Administration in the third quarter of 2022.
Beyond AB248, Asher Bio is advancing two additional programs for the treatment of cancer, both of which have achieved preclinical proof of concept:
A cis-targeted cytokine that selectively activates STAT3 signaling in CD8+ T cells, promoting cytotoxicity, memory cell differentiation and survival, all of which are signals potentially complementary to the proliferation signal provided by IL-2 and STAT5 activation.
A CAR-T cis-targeted IL-2 that selectively expands CAR-Ts post-adoptive transfer, supporting better engraftment, peak expansion and persistence, all of which have been correlated with improved clinical efficacy and outcomes.
The scientific overview presented at PEGS Europe and AET is now available in the "Presentations and Posters" section of Asher Bio’s website: View Source

On December 15, 2021 Mythic Therapeutics reported its launch to develop smarter and safer antibody-drug conjugates (ADCs) with an oversubscribed Series B financing round of $103 million (Press release, Mythic Therapeutics, DEC 15, 2021, View Source [SID1234597235]). Viking Global Investors led the round, along with new investors including Venrock Healthcare Capital Partners, Foresite Capital, Perceptive Advisors, and Highside Capital. Existing Mythic investors participating in the round include Venrock, First Round Capital, OMX Ventures, Lifeforce Capital, and Refactor Capital. The proceeds from Mythic’s Series B will finance the lead program through first-in-human clinical studies in lung cancer and fund pipeline development.

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"We are thrilled to partner with this distinguished group of investors," said Alex Nichols, PhD, co-founder, President, and CEO of Mythic Therapeutics. "This financing validates the FateControl approach and supports our efforts to achieve expanded use of Mythic’s ADCs within and across indications, translating to improved outcomes for patients with unmet medical needs."

Although the development history of ADCs spans more than four decades, the clinical benefit of ADCs has so far remained limited to a subset of diseases and targets with optimal biological characteristics, such as high levels of target expression. Mythic has developed a breakthrough approach to expand the role of ADCs in precision medicine by dramatically improving ADC therapeutic index against a broad set of molecular targets and patient profiles.

"To date, approaches to improve the performance of ADCs have focused primarily on innovation in one of three dimensions: linker and payload chemistries, conjugation technology, and new target biology," said Brian Fiske, PhD, co-founder and Chief Scientific Officer of Mythic Therapeutics. "Mythic seeks to improve the clinical performance of ADCs by introducing a new dimension of ADC technology focused on manipulating the fate of ADCs within the cell."

ADCs are designed to specifically deliver a therapeutic payload to a target tissue or disease site. However, studies have demonstrated that the vast majority of payload is ultimately released non-specifically throughout the body, causing systemic toxicity and reducing efficacy. Mythic’s FateControl technology increases the amount of ADC that is internalized by the target tissue while reducing payload release in non-targeted tissues, thereby improving therapeutic index independent of the linker and payload. Mythic’s lead program in lung cancer has the potential to drive a multi-fold expansion of the number of lung cancer patients eligible for treatment using ADCs; the company plans on developing a pipeline of products incorporating its platform technology.

"Venrock was attracted by Mythic’s innovative strategy to overcome one of the most historically challenging obstacles to realizing the full potential of ADCs for patients," said Bryan Roberts of Venrock, a member of Mythic’s Board of Directors. "The progress this team has made in a short time reinforces our deep conviction in Mythic’s ability to develop a pipeline of safer and more effective ADCs, beginning with their lead program. We are delighted to be part of the Mythic story."

Leadership

Alex Nichols, PhD, Co-Founder, President, CEO, and Director
Brian Fiske, PhD, Co-Founder, Chief Scientific Officer, and Director
Sandra Poole, MASc, PEng, Chief Operating Officer
In addition to Alex and Brian, the Mythic Therapeutics Board of Directors is comprised of:

Bryan Roberts, PhD, Partner, Venrock
Josh Kopelman, Partner, First Round Capital
Peter Hecht, PhD, Co-Founder and CEO, Cyclerion; Co-Founder and former CEO, Ironwood Pharmaceuticals
Scientific Advisory Board

Douglas E. Williams, PhD, President and CEO, Codiak Biosciences
John Lambert, PhD, former EVP and CSO, ImmunoGen
Michael Vasconcelles, MD, Chief Medical Officer, Flatiron Health
Richard Gregory, PhD, former CSO, ImmunoGen and former head of R&D, Sanofi
Scott J. Dylla, PhD, Co-Founder and Former CSO, Stemcentrx

On December 15, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that Aram Mangasarian, CEO of NOXXON, and Bryan Jennings, CFO of NOXXON, will participate and be available for meetings at several banking and investor conferences in early 2022 (Press release, NOXXON, DEC 15, 2021, View Source [SID1234597233]).

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LifeSci Partners Corporate Access Event, January 5-7, 2022, digital event
Corporate Access Event organized by LifeSci Partners will feature more than 200 innovative publicly traded and privately held biotechnology, medical technology, pharmaceutical, life sciences, and digital health companies from across the globe. The event will include one-on-one meetings with company senior management teams and panel discussions featuring KOLs, CEOs, specialized investors, and healthcare experts highlighting the most relevant topics impacting the life sciences industry today. The NOXXON team will be available for meetings. Registration for the event is required.

H.C. Wainwright BIOCONNECT Virtual Conference, January 10-13, 2022, digital event
BIOCONNECT hosted by H.C. Wainwright aims to connect life sciences companies with a diverse roster of investors. NOXXON’s corporate video presentation will be available on demand from January 10 at 7:00 a.m. ET. The team welcomes meetings with the investment community during the conference. Registration for the event is required.

BIOMED EVENT 2022, January 26, 2022, Paris, France
The 7th edition of the BIOMED EVENT organized by INVEST SECURITIES, will host numerous European listed biotech/medtech companies and institutional investors. NOXXON’s CEO will be available for one-on-one and group meetings throughout the day. Registration for the event is required.

LSX World Congress, February 8-9, 2022, London, UK or February 14-25, 2022, digital event
The 8th LSX World Congress will gather the founders and CEOs of innovative start-ups through to big pharma and aims to provide platform for companies to share their cutting-edge research and technology. The Congress offers one-on-one partnering, connecting the biotech, healthtech and medtech industry c-suite with the sector’s most active investors, pharma and health technology BD&L teams, R&D leaders, KOLs and top tier service companies who are driving the sector forward. NOXXON’s in-person or virtual participation will be driven by the conditions imposed by the pandemic. More information about the event can be found here.

On December 15, 2021 Avenue Therapeutics, Inc. (or the "Company") (NASDAQ: ATXI), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported the closing of its public offering of 1,910,100 shares of common stock at a public offering price of $1.07 (Press release, Avenue Therapeutics, DEC 15, 2021, View Source [SID1234597229]). The gross proceeds of the offering were approximately $2.0 million before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted Aegis Capital Corp. a 45-day option to purchase up to an additional 286,430 shares of common stock to cover over-allotments, if any, at the public offering price, less the underwriting discount.

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The common stock is trading on The Nasdaq Capital Market under the symbol "ATXI".

Aegis Capital Corp. acted as the sole book-running manager for the offering.

A registration statement on Form S-3 relating to common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on December 10, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

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 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 December 15, 2021 PharmaCyte Biotech, Inc. NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the financial results for its second quarter ended October 31, 2021, and provided an overview of recent operational highlights (PharmaCyte’s Fiscal Year begins May 1 and ends April 30) (Press release, PharmaCyte Biotech, DEC 15, 2021, View Source [SID1234597228]).

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Cash Position: PharmaCyte had approximately $87 million in cash on hand as of October 31, 2021.

Recent Q2 Highlights—Corporate:

Common stock was listed on Nasdaq Capital Markets as the Company began trading as a Nasdaq-listed company
Closed on a $15-million public offering
Closed on a $70-million registered direct offering
Company had warrant conversions of approximately $10.7 million
PharmaCyte expanded its Product Pipeline beyond its Cancer Program to include a Diabetes Program and a Malignant Ascites Program.
Recent Highlights—Pipeline Products:

The Company’s capital raises allowed PharmaCyte to spend what was needed in Research and Development (R&D) expenses to perform the work required to have the FDA imposed clinical hold lifted. PharmaCyte will issue a 2021 year-end update to detail which tests/studies have been completed, which have commenced, and which remain for PharmaCyte to present to the FDA with updated data in its effort to lift the FDA’s clinical hold.
In August 2021, PharmaCyte announced its clinical trial product, CypCaps remains stable and active at 18 months after completing the 18-month timepoint of ongoing product stability testing required by the U.S. Food and Drug Administration (FDA).
In September 2021, the Company announced the first test results of the biocompatibility studies of its CypCaps clinical trial product candidate. These positive results were from an "In Vitro Complement Activation Study of Empty Cellulose Sulphate Capsules," the same capsules PharmaCyte plans to use in its treatment to treat locally advanced, inoperable pancreatic cancer (LAPC). The first results showed that the capsule material does not activate a major line of the human body’s innate defense – the complement system.
In September 2021, PharmaCyte announced the results of a second FDA-required test of biocompatibility of its CypCaps product for the treatment of LAPC. The results showed that the empty capsule material is "non-hemolytic." The data showed that the capsule material does not cause blood cells to lyse either after direct or indirect contact with blood. Moreover, it confirms prior data that was observed previously in animal models and previous clinical trials.
In September 2021, PharmaCyte announced the results from a third test of biocompatibility of its CypCaps product candidate for pancreatic cancer. The results showed that the empty capsule material is not "mutagenic." A mutagen is a physical or chemical agent that permanently changes genetic material, usually DNA, in an organism and thus increases the frequency of mutations above the natural background level.
Since the close of PharmaCyte’s quarter ended October 31, 2021, the PharmaCyte announced that: (i) the empty capsule material that makes up its CypCaps pancreatic cancer product does not cause skin irritation, (ii) the commencement of a pivotal study to determine if PharmaCyte’s treatment for pancreatic cancer, which PharmaCyte plans to use for the treatment of LAPC—CypCaps combined with the cancer killing chemotherapy prodrug ifosfamide—can also delay the rate of production and accumulation of malignant ascites. This is fluid that accumulates in the abdominal cavity from various cancers, and (iii) the results of an additional, more detailed, analysis of the integration site of the cytochrome P450 2B1 gene from the Company’s genetically modified cell clone that it uses in PharmaCyte’s CypCaps product for the treatment of LAPC.
Recent Highlights—Financial:

During the three months ended October 31, 2021, PharmaCyte’s cash balance and total assets increased by approximately $86 million.

On October 31, 2021, PharmaCyte’s total stockholder equity increased by approximately $86 million from July 31, 2021.

Other PharmaCyte expenses decreased by approximately $25,000 and $23,000 for the three and six months ended October 31, 2021.

Operating expenses increased for the three months ended October 31, 2021, by approximately $55,000 and $197,000 for the six months ended October 31, 2021, due to costs associated with an uplist to Nasdaq Capital Markets, the closing of two public offerings, and putting those funds to use in the start of new tests and studies related to lifting the FDA clinical hold on PharmaCyte’s proposed treatment for LAPC.

PharmaCyte’s R&D expenses increased from the start of its fiscal year to about $360,000 to date. The two capital raises PharmaCyte conducted in August 2021 allowed for these necessary expenses to be possible.

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