Maverick Therapeutics Announces First Peer-Reviewed Publication Describing the Design and Development of the COBRA™ Platform

On August 6, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported the publication of a peer-reviewed article in mAbs, a leading journal focused on the science of antibody research and development. The article, titled "COBRA: a highly potent conditionally active T cell engager engineered for the treatment of solid tumors," establishes Maverick’s core platform in the context of the current T cell engager landscape as applied to solid tumors, and highlights Maverick’s technological advances in developing the next generation of conditionally active T cell engaging therapies for solid tumors. The article was published online in mAbs, Volume 12 Issue 1 and can be accessed at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The publication marks an exciting achievement for our company as the first peer-reviewed article that substantiates the innovative science behind our COBRA platform and what sets it apart from other bispecific T cell engaging therapies," said Jim Scibetta, Chief Executive Officer, Maverick Therapeutics. "This new mechanism of action elegantly safeguards healthy tissue and creates a wide therapeutic window to more thoroughly eradicate tumors. It also establishes for Maverick a robust platform for fulfilling unmet needs in the treatment of solid tumors and advances our company’s vision to develop the next generation of safe and efficacious treatments to address a broad number of solid tumor cancers."

The COBRA therapeutic platform takes advantage of the tumor’s highly proteolytic microenvironment for T cell activation, allowing it to safely target solid tumors with highly specific and potent activity. The publication describes the current limitations of inherently active first-generation T cell engagers as applied to solid tumors and Maverick’s unique approach in bispecific antibody design to develop a solution.

"We are encouraged by the interest and quick-turn of this publication, which lays out the on-target off-tumor toxicity problem with current T cell engagers for the treatment of solid tumors and describes the rationale for creating protease-activated prodrugs as a solution," said Robert DuBridge, Ph.D., EVP, Research and Chief Technology Officer, Maverick Therapeutics. "I, along with the team at Maverick, look forward to further validating our novel COBRA platform as we prepare for upcoming clinical activity in 2021."

Maverick’s first-in-class COBRA programs, MVC-101 and MVC-280, have generated promising preclinical data designed to validate the COBRA mechanism of action and be predictive of translation to patients. Preclinical models for MVC-101 and MVC-280 indicate that these conditionally active molecules have a therapeutic index that is up to 100 times greater than that of an inherently active first-generation T cell engager. Maverick expects to initiate a Phase 1 trial of MVC-101 in Q1 2021 and MVC-280 in H2 2021.

About the COBRA Platform
Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought trifecta in cancer care; high specificity, high potency and reduced toxicity.

About MVC-101
Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target the Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non small cell lung cancers. Maverick expects to initiate a Phase 1 trial in Q1 2021.

About MVC-280
Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1 trial in H2 2021.

Syros Reports Second Quarter 2020 Financial Results and Highlights Key Accomplishments and Upcoming Milestones

On August 6, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2020 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 6, 2020, View Source [SID1234563176]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Despite the unforeseen challenges of recent months, our team at Syros has shown remarkable resiliency, continuing to execute with excellence as we advance our product candidates toward key data readouts and progress earlier-stage research," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We completed enrollment in our Phase 2 trial of SY-1425, opened a new combination cohort in treatment-resistant breast cancer patients in our Phase 1 trial of SY-5609, and presented new preclinical data on SY-5609 in colorectal cancer that further highlights CDK7 inhibition as a potentially transformative targeted approach for difficult-to-treat cancers.

Looking ahead, the second half of 2020 promises to be an exciting time for Syros, with planned data readouts for SY-1425 in two RARA-positive AML patient populations and the first clinical data from the Phase 1 trial of SY-5609 in select solid tumor patients. These data will provide valuable insights that will help inform next steps and, hopefully, bring us closer to our vision of building an enduring company with medicines that provide a profound benefit for patients."

Upcoming Milestones

SY-1425

Report potential proof-of-concept data in the fourth quarter of 2020 from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in the fourth quarter of 2020 from the ongoing, fully-enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-5609

Report initial safety, tolerability, pharmacokinetic and pharmacodynamic data in the fourth quarter of 2020 from the ongoing Phase 1 dose-escalation trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology that harbor Rb pathway alterations.
Report additional dose-escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline

Nominate next development candidate by the end of 2021.
Recent Pipeline Highlights

In June 2020, Syros initiated enrollment in a new Phase 1 trial cohort evaluating the safety of escalating doses of SY-5609 in combination with fulvestrant in HR-positive metastatic breast cancer patients who have progressed after treatment with a CDK4/6 inhibitor.
In May 2020, Syros presented new preclinical data for SY-5609 at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO20). Data showed that SY-5609 inhibits tumor growth, including inducing sustained regressions, at well-tolerated doses in colorectal cancer models, supporting the inclusion of colorectal cancer patients in Syros’ ongoing Phase 1 trial. Also at ASCO (Free ASCO Whitepaper)20, Syros detailed the design of its ongoing Phase 1 trial of SY-5609.
Second Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2020 were $108.7 million, compared with $91.4 million of cash, cash equivalents and marketable securities on December 31, 2019. This increase reflects the $20 million upfront payment received in connection with Syros’ entry into a collaboration with Global Blood Therapeutics, Inc. (GBT) in December 2019, the $20 million that Syros drew down from its senior secured loan facility with Oxford Finance, LLC in February 2020, and $12.3 million from the sale of common stock under Syros’ at-the-market sales facility in the first quarter.

For the second quarter of 2020, Syros reported a net loss of $17.2 million, or $0.38 per share, compared to a net loss of $19.5 million, or $0.47 per share, for the same period in 2019.

Revenues were $3.2 million for the second quarter of 2020, compare to $0.5 million for the same period in 2019. In the second quarter of 2020, $2.5 million in revenue was recognized under Syros’ collaboration with GBT and $0.7 million was recognized under its collaboration with Incyte Corporation (Incyte). All revenues recognized in the second quarter of 2019 were under Syros’ collaboration with Incyte.
Research and development (R&D) expenses were $14.8 million for the second quarter of 2020, as compared to $15.5 million for the same period in 2019. This decrease was primarily attributable to the deprioritization of SY-1365.
General and administrative (G&A) expenses were $5.1 million for the second quarter of 2020, as compared to $5.2 million for the same period in 2019.
Financial Guidance

Based on its current plans, Syros believes that its existing cash and cash equivalents will be sufficient to fund its planned operating expenses and capital expenditures requirements into 2022, beyond key milestones expected for both SY-1425 and SY-5609.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2020 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 9542188. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.

TAE Life Sciences to Present at Solebury Trout Summer 2020 Private Company Showcase

On August 6, 2020 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy solutions (BNCT), reported that Bruce Bauer, Chief Executive Officer, will present a corporate overview at the Summer 2020 Private Company Showcase, hosted by Solebury Trout, on August 10, 2020 (Press release, TAE Life Sciences, AUG 6, 2020, View Source [SID1234563175]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Date: Monday, August 10, 2020
Time: 1:40 PM Eastern Time
Location: Virtual Webcast

BiomX to Report Second Quarter 2020 Financial Results on Aug. 13, 2020

On August 6, 2020 BiomX Inc. (NYSE: PHGE), a clinical-stage company developing both natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and live audio webcast on Thursday, Aug. 13, 2020, at 8:00 a.m. EDT, to report second quarter 2020 financial results and provide a corporate update (Press release, BiomX, AUG 6, 2020, View Source [SID1234563174]). The conference call dial-in numbers are 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (international). The live and archived webcast will be available in the Investors section of the company’s website at www.biomx.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Horizon Therapeutics plc Announces Pricing of Public Offering of Ordinary Shares

On August 6, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported the pricing of its underwritten public offering of 11,800,000 of its ordinary shares at a price to the public of $71.00 per share (Press release, Horizon Therapeutics, AUG 6, 2020, View Source [SID1234563164]). The net proceeds to the Company from this offering are expected to be approximately $798.9 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company. The Company has also granted the underwriters a 30-day option to purchase up to an additional 1,770,000 ordinary shares. The offering is expected to close on or about August 11, 2020, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Citigroup, Morgan Stanley, J.P. Morgan, Piper Sandler and Stifel are acting as joint book-running managers for the offering. Cowen is acting as a financial advisor to the Company for the offering.

The Company intends to use the net proceeds from this offering to fund future acquisitions or licenses of, or investments in, businesses, technologies, medicines and medicine candidates that the Company believes are complementary to its own, although the Company has no present commitments or agreements to do so, and for general corporate purposes.

A registration statement relating to the ordinary shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained on the SEC’s website or by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by phone at 800-831-9146; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by phone at 866-803-9204; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at [email protected] or by phone at 800-747-3924; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by email at [email protected] or by phone at 415-364-2720.

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, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction