Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Phase 2 Multi-Indication Trial Using Vidutolimod

On December 20, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that patient dosing was initiated in the anti-PD-1 refractory cutaneous squamous cell carcinoma (CSCC) arm of a Phase 2 multi-indication study evaluating the efficacy and safety of vidutolimod in combination with cemiplimab for the treatment of patients with anti-PD-1 refractory CSCC (Press release, Checkmate Pharmaceuticals, DEC 20, 2021, View Source [SID1234597478]). Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component.

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"Initiation of dosing in this trial marks a significant step forward in our pursuit of a potential new treatment option for patients affected by CSCC, a life-threatening non-melanoma skin cancer," said Alan Fuhrman, interim President and Chief Executive Officer of Checkmate. "This multi-indication trial is an important element of our plan to expand on the indications that can be potentially treated using vidutolimod."

Syndax Announces Closing of Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On December 20, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the closing of its previously announced underwritten public offering of 3,802,144 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 645,000 additional shares, and to certain investors, pre-funded warrants to purchase 1,142,856 shares of its common stock at an exercise price of $0.0001 (Press release, Syndax, DEC 20, 2021, View Source [SID1234597475]). The public offering price of each share of common stock was $17.50 and the public offering price of each pre-funded warrant was $17.4999 per underlying share, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $86.5 million.

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Goldman Sachs & Co. LLC and Cowen acted as joint book-running managers for the offering. BTIG acted as lead manager for the offering. B. Riley Securities acted as co-manager for the offering.

The shares were offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

Race raises full $29.7 million in heavily oversubscribed Share Purchase Plan

On December 20, 2021 Race Oncology Limited ("Race") reported that its Share Purchase Plan (SPP) has closed heavily oversubscribed with $43.9m received in applications from 2,340 shareholders (Press release, Race Oncology, DEC 20, 2021, View Source [SID1234597473]). In line with the terms of the SPP, $29.7m will be accepted, with funds to be applied to Race’s "full case" funding scenario, as set out in Race’s 2021 Annual General Meeting (ASX announcement: 23 November 2021).

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"The Race team has been humbled by the extraordinary show of shareholder support for our Share Purchase Plan and we sincerely thank all those who participated. The number of applications reflects enthusiasm for the significant potential of our lead drug Zantrene, and this enables us to implement our planned clinical and drug development plans across the three-pillar program. We move into 2022 in an exceptional position, with many critical, reportable milestones ahead of us."

Race’s Managing Director and CEO, Mr Phil Lynch
"I would like to personally thank all our shareholders for their generous support of our plans for Zantrene. It is extremely humbling to have so many of our shareholders willing to join and support us on the exciting journey to bring Zantrene back to patients in need."

Race’s Chief Scientific Officer and Executive Director, Dr Daniel Tillett
Use of funds
Funds raised under the SPP will be used as follows: Phase 1b/2 FTO solid tumour clinical trial ($8.0 million); cardio-protection Phase 2b clinical trial in breast cancer patients ($7.5 million); Phase 2 EMD AML/MDS clinical trial in Europe ($9.2 million); improved formulations of Zantrene ($3.2 million); preclinical cardio-protection studies ($1.0 million); and the development of new molecules ($0.8 million).

About the SPP
Race offered a non-underwritten SPP to eligible existing shareholders (in Australia and New Zealand) at the $3.00 issue price. The SPP closed on Friday 17 December 2021 with subscriptions received for $43,953,272.63.

After scale-back, the amount raised under the SPP was $29,700,000, comprising the issue of 9.9 million new ordinary fully paid shares at $3.00 per share, representing approximately 6.6% of the Company’s issued capital as at 21 December 2021.

New shares issued under the SPP will be allocated today and holding statements despatched, with trading expected to begin on the Australian Securities Exchange on the 22 December 2021.

Allocation policy
When determining the amount by which to scale back an Application, Race has taken into account a number of factors, including the size of an applicant’s shareholding, the extent to which Eligible Shareholders have sold or bought additional Shares after the Record Date and the date an application was made. Scale back for Shares held by Custodians was applied at the level of the underlying beneficiary.

Where shareholders were scaled back, they will receive the number of Shares determined by the Company in its absolute discretion, rounded up to the nearest whole Share. If Race rejects or scales-back an application or purported application, the Company will promptly return to the Eligible Shareholder any relevant application monies, without interest.

Eligible Directors, Mr Phillip Lynch, Ms Mary Harney and Dr Daniel Tillett all applied for their full entitlements. Dr John Cullity was ineligible due to being resident in the USA.

Filtricine Preclinical Results Published

On December 20, 2021 Filtricine reported that the preclinical research results of its proprietary medical food technology, Targeted Nutrients Deprivation (TND), have been published in Nutrition and Cancer.
"Broad Anti-Cancer Activity Produced by Targeted Nutrients Deprivation (TND) of Multiple Non-Essential Amino Acids" (Press release, Filtricine, DEC 20, 2021, View Source [SID1234597472])

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Filtricine’s core medical food technology is the deprivation of non-essential amino acids (NEAAs) to manage cancer. Cancer cells, but not normal cells, require those NEAAs due to their heightened and rewired metabolism. Mice fed TND medical food diet with implanted human-derived tumors showed marked reduction in tumor growth. In combination with chemotherapy and immunotherapy, TND diet enhanced the efficacy of tumor suppression. TND diet was entirely safe in mice.

Filtricine is developing a human version of the TND diet, Tality, as a medical food to manage cancer. Filtricine is sponsoring a clinical study at Stanford University School of Medicine for the use of Tality in the management of prostate cancer. Tality is available to prostate cancer patients through this trial. If you are interested in joining the trial, please contact the trial coordinator. Deirdre Crommie at 650-387-7797 or [email protected]

Tality is also available to all cancer patients for free through a volunteer study. Please contact [email protected] if you would like to know more.

Senti Bio and Dynamics Special Purpose Corp. Announce Business Combination Agreement to Create Publicly Listed Company Pioneering Gene Circuit-Engineered Cell and Gene Therapies

On December 20, 2021 Senti Biosciences, Inc. ("Senti Bio"), a leading Gene Circuit company, and Dynamics Special Purpose Corp. (Nasdaq: DYNS) ("Dynamics"), a special purpose acquisition company (SPAC) led by Omid Farokhzad, MD, Executive Chair of the Board of Directors, and Mostafa Ronaghi, PhD, Chief Executive Officer, reported they have entered into a definitive business combination agreement to create a public company focused on Gene Circuit-engineered cell and gene therapies (Press release, Senti Biosciences, DEC 20, 2021, View Source [SID1234597470]). Upon closing of the transaction, the combined company will be named Senti Biosciences, Inc. ("the Company") and will be led by Tim Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. The Company plans to list its common stock on the Nasdaq Capital Market. Dr. Farokhzad, who is currently serving as CEO and Chair of Seer, and David Epstein, Dynamics board member and former CEO of Novartis Pharmaceuticals, will be joining the Senti Bio Board of Directors upon closing of the transaction.

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Senti Bio uses its Gene Circuit platform to program cell and gene therapies with potentially enhanced capabilities. Gene Circuits, which are created via synthetic biology and encoded as novel and proprietary combinations of DNA sequences, enable cells to sense inputs, compute decisions with biological logic, and respond to disease environments.

"Humans have always sought medicines that can treat illnesses with more precision, efficacy, and safety. However, existing drugs are still unable to match the complexity of many diseases, such as cancer and beyond. With recent advances in synthetic biology, computation, and massive biological data generation, I believe that we have a unique opportunity to engineer intelligent cell and gene therapies that directly tackle the heterogeneity and dynamic nature of disease, which have the potential to fundamentally transform our therapeutic arsenal," said Dr. Lu. "We’re tremendously grateful for the strong support from our new and current world-class investors and from the experienced entrepreneurs, executives, and scientists at Dynamics. This fuel will amplify our team’s vision and efforts to drive Gene Circuit-engineered cell and gene therapies to patients."

"Dynamics is looking forward to partnering with Senti to power the next generation of disruptive cell and gene therapies," said Dr. Farokhzad. "The foundational technology of Senti—engineering Gene Circuits with programmable computer-like logic in cells—has game-changing implications for treating a variety of cancers, as well as potential applications beyond oncology. We believe that Senti’s pipeline of product candidates offers the potential to greatly enhance cancer therapy for both solid and liquid tumors, while reducing well-known limitations of current therapies. The Dynamics team, board, and advisors are thrilled to work with the Senti team as they define the future of potentially life-changing therapeutics for patients."

Senti Bio Pipeline and Collaborations
Senti Bio’s internal therapeutic pipeline is focused on allogeneic chimeric antigen receptor natural killer (CAR-NK) cell therapies for cancer. The Company’s lead development candidates include SENTI-202 for acute myeloid leukemia (AML) and SENTI-301 for hepatocellular carcinoma (HCC); Senti Bio anticipates filing Investigational New Drug (IND) applications in 2023 for both candidates.

SENTI-202 is designed to prevent the killing of healthy cells by leveraging a NOT logic gate, while concurrently targeting two tumor-associated antigens for enhanced AML killing by leveraging an OR logic gate, thus overcoming the limitations of other cell therapy approaches to treating AML
SENTI-301 is designed to target an HCC-specific antigen while leveraging multi-armed, controlled cytokine release for enhanced anti-cancer activity, thus overcoming the limitations of other cell therapy approaches to treating HCC
Senti Bio has established collaborations with biopharmaceutical companies that demonstrate the broad potential of Gene Circuits in other therapeutic areas and treatment modalities.

Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Senti Bio are developing next-generation gene therapies with Gene Circuits that have the potential to improve precise targeting of the central nervous system, eye, and/or liver
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, and Senti Bio are developing Gene Circuit-engineered cell therapies for a potentially broad array of therapeutic areas within the field of regenerative medicine
Planned Milestones and Uses of Proceeds
Proceeds from the PIPE and merger transaction are expected to provide Senti Bio with capital to further develop its Gene Circuit technologies and therapeutic pipeline, including:

Filing an IND, anticipated in 2023, for SENTI-202, a logic-gated allogeneic CAR-NK cell therapy being designed to target and eliminate AML cells while sparing the healthy bone marrow;
Filing an IND, anticipated in 2023, for SENTI-301, a multi-armed allogeneic CAR-NK cell therapy being developed for the treatment of HCC;
Continuing to expand the breadth of Senti Bio’s Gene Circuit technologies across multiple diseases and modalities to uniquely enable therapeutics previously not possible, including advancing its gene circuit platform with additional programs, such as SENTI-401, a logic-gated allogeneic CAR-NK cell therapy that is being designed to more precisely target and eliminate colorectal cancer, or CRC, cells while sparing healthy cells elsewhere in the body; and
Building out and operating clinical-scale cGMP manufacturing capabilities for allogeneic CAR-NK cell therapies.
Summary of Transaction
The transaction values the combined company at a pro forma equity value of $601 million, assuming a $10.00 per share price and no shareholder redemptions. As a result of the transaction, the combined company is expected to have more than $296 million in gross proceeds from a combination of approximately $230.0 million in cash held in Dynamics’ trust account (assuming no Dynamics shareholders exercise their redemption rights at closing) and more than $66 million, at $10.00 per share, from a fully committed PIPE.

Existing Dynamics shareholders, including funds managed by ARK Investment Management LLC, funds and accounts managed by Counterpoint Global (Morgan Stanley Investment Management), Invus, funds and accounts advised by T. Rowe Price Associates, Inc., have, in the aggregate, committed not to redeem over $86 million of Dynamics’ publicly traded shares in exchange for receiving approximately 965,000 newly issued shares of common stock, attributable to an equal number of shares currently owned by Dynamics Sponsor LLC, the sponsor of Dynamics, that will be contemporaneously surrendered to the combined company.

The PIPE includes participation from healthcare and technology investors, including 8VC, Amgen Ventures, funds and accounts managed by Counterpoint Global (Morgan Stanley Investment Management), Invus, LifeForce Capital, NEA, Parker Institute for Cancer Immunotherapy, funds and accounts advised by T. Rowe Price Associates, Inc., and others.

All existing Senti Bio equity holders will roll the entirety of their equity holdings into the combined company and are expected to hold approximately 40% of the issued and outstanding equity of the combined company immediately following the closing (assuming no Dynamics shareholders exercise their redemption rights at closing). Certain existing Senti Bio equity holders and Dynamics Sponsor LLC will be subject to a twelve month lock-up, subject to certain customary exceptions. Certain existing Senti Bio equity holders will be subject to an eighteen month lock-up, subject to certain additional exceptions that may reduce it to twelve months.

The transaction, which has been approved by each of Dynamics’ Board of Directors and Senti Bio’s Board of Directors, is expected to be completed in the second quarter of 2022, subject to approval by Dynamics’ and Senti Bio’s shareholders and satisfaction, or the waiver of, customary closing conditions identified in the business combination agreement.

J.P. Morgan is acting as lead capital markets advisor to Dynamics and co-placement agent for the PIPE. Morgan Stanley & Co. LLC is acting as financial advisor to Dynamics and co-placement agent to Dynamics for the PIPE. BofA Securities is acting as exclusive financial advisor to Senti Bio and as co-placement agent for the PIPE.

Davis Polk & Wardwell LLP is serving as legal advisor to Dynamics. Goodwin Procter LLP is serving as legal advisor to Senti Bio, and Latham & Watkins LLP is serving as legal advisor to J.P. Morgan, Morgan Stanley & Co. LLC and BofA Securities in their role as placement agents.

A prerecorded presentation and associated materials will be available on Deal Roadshow after 9:00 AM ET on December 20, 2021